Обзор американских кардиологических журналов за неделю (ссылки)

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SYNTAX: Angina slightly improved in CABG vs. PCI patients
Cohen D. N Engl J Med. 2011;364:1016-1026.

A new quality-of-life substudy of the SYNTAX trial has shown that among patients with three-vessel or left main coronary artery disease, there was greater angina relief in those treated with CABG compared with percutaneous coronary intervention at 6 and 12 months.

In the Synergy Between PCI With Taxus and Cardiac Surgery (SYNTAX) trial, a group of investigators allocated 1,800 patients (mean age, 65 years) with three-vessel disease or left main CAD to be treated with either PCI with paclitaxel-eluting stents (Taxus, Boston Scientific; n=903) or CABG (n=897). Using the Seattle Angina Questionnaire (SAQ) and the Medical Outcomes Study 36-Item Short-Form Health Survey, they then assessed health-related quality of life at four intervals: baseline, 1 month, 6 months and 12 months.

At 6 and 12 months vs. baseline, both groups had significantly higher scores with both surveys, indicating better health status. A greater improvement on the angina-frequency subscale of the SAQ, however, was reported in the CABG group at 6 (P=.04) and 12 (P=.03) months, yet the differences between groups were small and did not reach 2 points for either periods. Although freedom from angina assessed by SAQ was similar for both procedures at 1 and 6 months, there was a trend toward an improvement in the CABG group at 1 year (P=.05).

In the conclusion of the study, the researchers said the symptomatic benefits of CABG were counterbalanced by the more rapid recovery and improved short-term health status achieved with PCI.

The study was funded by Boston Scientific. Previous coverage of the SYNTAX trial can be accessed here.
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Menopausal symptoms reported at onset of menopause not associated with increased risk for CVD events
Szmuilowicz ED. Menopause. 2011;doi:10.1097/gme.0b013e3182014849.

Vasomotor symptoms that occur early in menopause do not appear to be associated with increased risk for CVD and are instead associated with decreased risks for total CVD events, stroke and all-cause mortality. Symptoms that occur late in menopause, however, are linked to increased coronary heart disease risk and all-cause mortality, researchers reported in a new study.

Emily D. Szmuilowicz, MD, MS, and colleagues conducted a study to investigate associations between menopausal vasomotor symptoms, clinical CVD events and all-cause mortality in a group of more than 60,000 women from the Women's Health Initiative (WHI) Observational Study. Their study focused on incident CVD events and all-cause mortality in four groups of women:

Women with no vasomotor symptoms at menopause onset and no symptoms at WHI enrollment (reference group; n=18,799).
Women with vasomotor symptoms at menopause onset but not at WHI enrollment (early symptoms; n=24,753).
Women with vasomotor symptoms at menopause onset and at WHI enrollment (persistent symptoms; n=15,084).
Women with vasomotor symptoms at WHI enrollment but not at menopause onset (late symptoms; n=1,391).

"Our study is the first to investigate the relationships between menopausal symptoms and CV events, and the first to examine the timing of menopausal symptoms," Szmuilowicz, a clinical instructor of medicine at Northwestern University, said in an interview. "The key finding of the study is that the menopausal symptoms experienced by the majority of women at mid-life do not indicate an increased risk for CVD in the future."

Compared with women who had no vasomotor symptoms, women who exhibited early symptoms had a HR of 0.94 for major coronary heart disease, 0.83 for stroke, 0.89 for total CVD and 0.92 for all-cause mortality. Women who had late vasomotor symptoms had HRs of 1.32 for major CHD, 1.14 for stroke, 1.23 for total CVD and 1.29 for all-cause mortality compared with women who had no symptoms. The researchers found no significant association with clinical CVD events among women who had persistent vasomotor symptoms.

"The predictive value of vasomotor symptoms for clinical CVD events may vary with the onset of vasomotor symptoms at different stages of menopause," the researchers concluded. “Future studies will also be necessary to investigate whether vasomotor symptoms that develop for the first time in later postmenopausal years represent a pathophysiologic process distinct from the classic perimenopausal vasomotor symptoms."

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Troponin I assay improved detection of MI in patients with suspected ACS
Mills N. JAMA. 2011;305:1210-1216.

In a patient population with suspected acute coronary syndrome, a sensitive troponin I assay was able to increase the prognosis of MI and further identified patients at high risk for death and MI.

Researchers from Edinburgh, Scotland, performed this study using a sensitive troponin I assay (Abbott Architect assays, Abbott Laboratories) to detect cardiac injury in patients with suspected ACS who were admitted to the Royal Infirmary of Edinburgh.

The study was split into two phases: validation (n=1,038), or before lowering the threshold of detection of myocardial necrosis from 0.2 to 0.05 ng/mL with the assay; and implementation (n=1,054), or after lowering the threshold. The patients were then stratified into three groups based on myocardial necrosis concentration: less than 0.05 ng/mL (n=1,340); 0.05 to 0.19 ng/mL (n=170); and at least 0.2 ng/mL (n=582).

During the validation phase, event-free survival, which incorporated rates of recurrent MI and death, at 1 year was worse in patients with plasma troponin levels from 0.05 to 0.19 ng/mL, resulting in a death and MI rate of 39% vs. 7% in those with troponin assay concentrations of less than 0.05 ng/mL (P<.001) and 24% in those with concentrations of 0.2 ng/mL or more (P=.007).

However, lowering the diagnostic threshold to 0.05 ng/mL in patients with troponin concentrations of 0.05 to 0.19 ng/mL correlated with a reduced risk of mortality and recurrent MI from 39% to 21% (P=.01).

“In patients presenting with suspected ACS, the use of a sensitive troponin I assay increased the detection of MI by 29% and identified patients who were at the highest risk of recurrent MI and death,” the researchers wrote, later adding that the percentage “may increase further with future improvements in assay performance allowing the 99th percentile to be used as the diagnostic threshold. This greater diagnostic performance will have implications for public health targets, government statistics, health care resources, and on the employment prospects and insurance policies of our patients.” – by Brian Ellis

Clinicians have been reluctant to use the proper cutoff values with sensitive assays because they more often see elevations that are difficult to explain. However, when they do, they realize that they have been missing large numbers of patients who do poorly if not treated, but benefit substantially from appropriate therapy.

However, in this study, the 10% CV value was used. This was still a big jump from the prior standard, but it would be of interest to see if using the 99th percentile value of 0.012 ng/mL would have identified still more patients at risk. It is this value that we [in the joint task force] advocate using in the definition of acute MI, something that is misstated by the authors. The fact that the group with values <0.05 ng/mL had a much lower event rate does not exclude the likelihood that there was a group between the values of 0.012 and 0.05 ng/mL that was at risk and could also have been helped by more aggressive therapy. The authors mention this but do not provide any data about this group.
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Transient ischemic attack doubled risk for MI
Burns J. Stroke. 2011;doi:10.1161/STROKEAHA.110.593723.

Those who experience a transient ischemic attack have twice the annual incidence of MI compared with the general population. This risk proved to be especially high in those who were younger than 60 years of age, new data suggest.

“CAD is the leading cause of death after TIA,” the researchers wrote. “Despite the key role played by CAD … reliable estimates of the risk of MI after TIA and the excess risk of MI in those who have had a TIA compared with the general population are lacking.”

This led the group of researchers from the Mayo Clinic in Rochester, Minn., to cross-reference pre-existing incidence cohorts from the Rochester Epidemiology Project for TIA and MI. The final study population included 388 patients who were at risk for incident MI after TIA. These data were then compared with MI incidences in the general population.

During a median follow-up of 10.2 years, the mean annual occurrence of MI after TIA was 0.95%, with an RR compared with the general population of 2.09 (95% CI, 1.52-2.81). This risk proved to be highest among patients aged younger than 60 years (RR=15.1; 95% CI, 4.11-38.6). For those who had an MI after TIA, the risk for death was more than three times higher than those who did not have an MI after TIA (HR=3.19; 95% CI, 2.19-4.66).

Additionally, researchers reported the following independent risk factors for MI after TIA: use of lipid-lowering therapy at the time of TIA (HR=3.1; 95% CI, 1.2-8); male sex (HR=2.19; 95% CI, 1.18-4.06); and increasing age (per 10 years, HR=1.51; 95% CI, 1.14 -2.01).

“Given that CAD plays an important role in the mortality of patients after TIA, these data support the existing concept that careful attention to the primary prevention of CAD is warranted in all patients who have had TIA and that screening for asymptomatic CAD may be useful in select TIA patients,” the researchers concluded.

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Recent MI possible significant risk factor for postoperative MI, death
Livhits M. Ann Surg. 2011;doi:10.1097/SLA.0b013e3182125196.

Patients who experienced an MI within 30 days of an operation had higher rates of MI 30 days after the procedure, as well as mortality at 1 year, according to a new study in the Annals of Surgery.

Christian de Virgilio, MD, principal investigator at Los Angeles Biomedical Research Institute and the study’s corresponding researcher, told CARDIOLOGY TODAY that this study “provides contemporary data regarding the risk of postoperative MI in patients who have had a recent prior MI, across a broad spectrum of surgical procedures.”

In the study, de Virgilio and colleagues utilized the California Patient Discharge Database to retrospectively analyze patients (n=563,842) who underwent cholecystectomy, colectomy, hip surgery, elective abdominal aortic aneurysm repair and lower extremity amputation from 1999 to 2004. They compared rates of postoperative 30-day MI, 30-day mortality and 1-year mortality between patients with and without a recent MI.

Results showed that postoperative MI rate among patients with a recent MI decreased substantially over time (0-30 days, 32.8%; 31-60 days, 18.7%; 61-90 days, 8.4%; 91-180 days, 5.9%), with rates of 30-day mortality sharing a similar trend (0-30 days, 14.2%; 31-60 days, 11.5%; 61-90 days, 10.5%; 91-180 days, 9.9%). Additionally, MI within 30 days of an operation correlated with a higher risk for postoperative MI (RR range, 9.98-44.29), 30-day mortality (RR range, 1.83-3.84) and 1-year mortality (RR range, 1.56–3.14).

For de Virgilio, these findings should increase awareness of the importance of a recent MI as a major predictor of having another MI and of perioperative death.

“In light of these data, patients with a recent MI who are being considered for elective surgery should carefully weigh the risks and benefits of the procedure and, if at all possible, delay surgery for at least 2 months — if not longer,” he said. “They should [also] be evaluated by a cardiologist to determine whether further intervention is needed prior to surgery.” – by Brian Ellis

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Asthma may be linked to increased incidence of diabetes, heart disease

Asthmatics were more than twice as likely to develop diabetes mellitus as non-asthmatics, according to findings presented at the 2011 Annual Meeting of the American Academy of Allergy, Asthma & Immunology in San Francisco.

The retrospective population-based study aimed to evaluate potential associations between asthma and proinflammatory conditions, including inflammatory bowel disease, rheumatoid arthritis, diabetes mellitus and coronary artery disease, in 2,392 patients with asthma and 4,784 matched controls.

The incidence rates of proinflammatory conditions were calculated per 100,000 population. The incidence of inflammatory bowel disease was 16.7 in the non-asthmatic cohort and 21.2 in the asthmatic cohort. For rheumatoid arthritis, the incidence increased from 55.3 among non-asthmatics to 81.8 among asthmatics. The incidence of diabetes mellitus increased from 104 in the non-asthmatic group to 138.4 in the asthmatic group. Asthma also was associated with an increased incidence of coronary artery disease, 134 vs. 188.6.

The HR for developing diabetes mellitus among asthmatics compared with non-asthmatics was 2.11 (95% CI, 1.43-3.13). The risk for coronary artery disease also was significantly increased (HR=1.43; 95% CI, 1.02-2.01).

The risks for inflammatory bowel disease (HR=1.31) and rheumatoid arthritis (HR=1.42) were not significantly higher in the asthma cohort.

“Given that coronary artery disease and diabetes mellitus are major morbidities in adults, we believe that clinicians need to be aware of our findings,” Young Juhn, MD, associate professor of medicine at the Mayo Clinic in Rochester, Minn., said of the findings in a press briefing. “Symptoms of coronary artery disease and diabetes should be assessed during routine follow-up care.”

Juhn said the patient and control populations were individuals from the Rochester, Minn., area who were diagnosed or contacted between 1964 and 1983. “Asthma diagnosis was based on clinical criteria for asthma, not physician diagnosis,” he said. “Outcome events were also based on clinical criteria or ICD code.”

Asthma increased the risk for the studied proinflammatory conditions by about 50%, Juhn said.

“Rheumatoid arthritis and inflammatory bowel disease did not reach statistical significance,” he said. “This could be explained by limited statistical power, meaning a small sample size. However, it should be noted that rheumatoid arthritis and inflammatory bowel disease have lower incidence than the other diseases.”

Juhn said more focus should be placed on surveillance of asthma status. “It might be prudent to monitor the impact of asthma epidemiology on the epidemiology of these proinflammatory conditions, given that they have increased over the last 2 decades,” he said.

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ACCF/AHA/HFSA 2011 Survey Results: Current Staffing Profile of Heart Failure Programs, Including Programs That Perform Heart Transplant and Mechanical Circulatory Support Device Implantation
[Ссылки доступны только зарегистрированным пользователям ]

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PARTNER A: Mortality comparable between TAVR and AVR procedures

American College of Cardiology 60th Annual Scientific Sessions

NEW ORLEANS – New results from the PARTNER A cohort have indicated that despite a higher rate of stroke among patients treated with transcatheter aortic valve replacement compared with aortic valve replacement, rates of mortality were similar between both procedures at 1 year.

The trial included 699 high-risk older patients (median age, 84.1 years) with severe aortic stenosis who were randomly assigned to receive either transcatheter aortic valve replacement (TAVR; Sapien, Edwards Lifesciences; n=348) or aortic valve replacement (AVR; n=348). The primary endpoint was all-cause mortality at one year, with stroke and major vascular and bleeding events serving as additional endpoints.

Despite a more favorable outcome for TAVR in mortality (3.4% vs. 6.5%) and symptoms at one month, by one year both rates were similar between the two procedures. Important differences, however, were reported in rates of stroke at one year (TAVR, 5.1% vs. AVR, 2.4%), vascular complications at one month (TAVR, 11% vs. AVR, 3.2%), major bleeding (TAVR, 9.3% vs. AVR, 19.5%) and new-onset irregular heart rhythms of atrial fibrillation (TAVR, 8.6% vs. AVR, 16%).

“This opens up a new set of patients who may very well benefit as much by TAVR as by conventional the gold standard surgery,” said Craig R. Smith, MD, chief, division of cardiothoracic surgery, New York-Presbyterian Hospital, Columbia University Medical Center, New York, and the study’s co-principal investigator, in a press conference. “As everyone knows no one wants surgery — no one should want surgery — and an equivalent therapy is always a good thing.”

Upcoming for the PARTNER trial is the recently approved PARTNER II trial which will pair the next generation of TAVR and a different catheter-based delivery system against the valve and delivery method used in the first trial. – by Brian Ellis

For more information:
Smith C. LBCT I, Session 3010. Presented at: ACC 60th Annual Scientific Sessions; April 2-5, 2011; New Orleans.

You are all witnessing history in the making. Those of you who saw Dr. Smith’s presentation really did see history unfolding. I think it probably will be seen as one of the biggest steps in CV medicine as far as intervention is concerned potentially in our lifetime. If we look back to balloon angioplasty, the advent of stents, and then drug-eluting stents, probably on the life-scale of the calendar [percutaneous valve intervention ] will be seen as the next major turning point.

These extraordinary results are accomplished because of an unprecedented team work between a cardiologist, cardiac surgeon and the associate care givers. I just want to emphasize that if we fail to not pay equal attention to what we have done in this trial after this device is approved, I don’t think we will be able to replicate these results. The cardiac surgeon profession and the cardiology profession, particularly interventional cardiologists, had a sometimes not easy relationship over the past 50 years, but now over the past 5 years as evidenced by this trial on how we interact with each other, how we perform as a single team, are really diametrically opposite … So I think it is critical to emphasize that.
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PARTNER B: Data reveal TAVR cost-competitive in elderly, inoperable patients

American College of Cardiology 60th Annual Scientific Sessions

NEW ORLEANS – Transcatheter aortic valve replacement proved to be cost-effective when compared with standard care for patients with severe aortic stenosis who were not candidates for surgery, according to PARTNER cohort B data.

Researchers of the PARTNER trial randomly assigned patients (mean age, 83 years) to receive either transcatheter aortic valve replacement (TAVR; n=179) or standard non-surgical care (n=179) that included medication and balloon aortic valvuloplasty. They derived the one-year cost-effectiveness data on all patients from medical resource utilization data, as well as hospital billing for a sub-set of patients, and then projected long-term survival from this data.

Initially, the cost of TAVR, including care before and after the procedure, was roughly $78,000, with the cost of the system estimated at $30,000. During the first year, those in the standard care group were more than twice as likely to be hospitalized for CV reasons, which resulted in follow-up costs being $23,000 more expensive at one year when compared with the TAVR group, which partially offset initial costs of TAVR.

According to estimates, there was a gain in life expectancy of approximately 1.9 years with the TAVR approach (3.1 years vs. 1.2 years). Each year of life gained corresponded with an incremental cost-effectiveness ratio of roughly $50,200, or approximately $62,000 per each quality-adjusted life year gained.

In a press conference, Matthew R. Reynolds, MD, director, economics and quality of life research at Harvard Clinical Research Institute, Boston, explained that “These life-time projections are necessary to understand the return on the upfront investment because most of the cost is incurred at the beginning … Based on lifetime projections, we estimated an $8,000 difference for incremental cost associated with TAVR which is significant. We also estimated a survival gain which is also quite significant… of almost 2 years in this extremely high risk and elderly population.”

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Target BP levels for patients with diabetes, high-risk hypertension remain debatable

American College of Cardiology 60th Annual Scientific Sessions

NEW ORLEANS — The amount and quality of evidence indicating ideal target BP levels in patients with diabetes or high-risk hypertension was up for discussion at the American College of Cardiology 60th Annual Scientific Sessions.

“The current ACCORD trial was designed to answer the question of optimal BP control,” Stanley S. Franklin, MD, of the University of California, Irvine Heart Disease Prevention Program, said during a presentation here. “But targeting systolic BP to 119 mm Hg vs. 133.5 mm Hg did not reduce composite rate of CV events in ACCORD, so the crux of this debate is: Should office systolic BP be less than 140 mm Hg, less than 135 mm Hg or lower?”

Contradictory evidence

Franklin, who spoke in support of targeting BP below 130/80 mm Hg, cited population studies from the Prospective Study Collaboration Oxford Group that show that systolic BP correlates with cardiovascular risk to as low as 115 mm Hg at all ages. He also noted that the Framingham Heart Risk Equations indicate an additive effect of combining diabetes with hypertension and an even higher risk when combining with other risk factors, suggesting that BP levels are “only one part of global risk of assessment.”

In addition, Franklin said, stages of CV disease may yield different endpoints for therapy. “Indeed, the wide spectrum of disease over time may require different treatment thresholds and different treatment goals.”

Accuracy of BP measurements must also be taken into consideration, according to Franklin. The 11-country International Database on Ambulatory BP monitoring in relation to CV Outcomes (IDACO) study revealed that researchers found sustained hypertension in a little less than 50% of patients, white coat hypertension in more than 50% of patients and approximately 10% of clinic-normotensive patients had masked hypertension. About 73% of middle-aged to older patients, however, were misdiagnosed by clinic measurements, spurring Franklin to question whether a high rate of misclassification by office assessment played a role in recruitment for the ACCORD study.

Furthermore, another study denoted only a 5-mm Hg difference between patients with masked hypertension and normotensive patients. Results also revealed a statistically higher percentage of target organ damage, kidney disease or left ventricular hypertrophy in patients with masked hypertension, according to Franklin.

“Perhaps the question is not whether lower is better but if whether the earlier you diagnose and treat, the better,” he said.

Franklin stressed the importance of measuring standing BP and nocturnal dipping as well, highlighting one study that indicated a correlation between postural hypertension and increased stroke risk in certain patients, such as the elderly, patients with type 2 diabetes or those with peripheral neuropathy. He pointed out that, because of high rates of misclassification by clinic or office BP measurements, the American Heart Association and the American Society of Hypertension recommend beginning therapy with raised office BP, borderline or prehypertension in the presence of organ damage. In the absence of organ damage, home BP measurement can be valuable, Franklin said, noting that treatment may also be initiated if daytime ambulatory BP exceeds 135/85 mm Hg. Nevertheless, he warned against lowering BP too much in frail patients with diabetes.

The need for more data

In response, William C. Cushman, MD, chief of preventive medicine section at Veterans Affairs Medical Center in Memphis, Tenn., explained that no data confirm the benefits of targeting a BP of 130/80 mm Hg in patients with diabetes or high-risk hypertension. The ACCORD trial, he noted, afforded robust data in a high-risk population of more than 4,700 participants. The systolic BP was lower than 140 mm Hg in the majority of participants in the standard BP goal group, which targeted a systolic BP goal of less than 140 mm Hg, he said. In the intensive therapy group, which targeted a systolic BP of less than 140 mm Hg, the average number of drugs required to achieve a systolic BP of 119.3 mm Hg was 3.4, and slightly more than two drugs in the regular therapy group, which averaged systolic BP of 133.5 mm Hg, according to Cushman. The benefits of attaining this target, however, did not reach statistical significance.

“Results of ACCORD and previous studies provide no conclusive evidence that BP should be reduced with antihypertensive drugs below 120 mm Hg or 130 mm Hg,” Cushman said. “These trials also do not conclusively prove that we shouldn’t aim for less than 120 mm Hg, but they provide the best evidence to date, and, therefore, do not offer conclusive evidence that we should do it.”

Moreover, Cushman emphasized that lowering BP targets would potentially mean millions of new diagnoses of hypertension. These “new” patients will require therapy and monitoring, and those patients already diagnosed with hypertension will need more drugs and monitoring, and those patients already diagnosed with hypertension will need more drugs and monitoring to reach desired BP levels. This may also have a negative effect in the form of a J-curve, Cushman said, and if treatment is neither harmful nor beneficial, then that poses other problems. Monitoring would become more frequent and costly while adverse event would also become more common.

“It could waste patients’ and payers’ resources and time, and possibly deflects us away from something we have the resources to do,” he said.

Adherence may also decline, according to Cushman. Patients who are already taking eight to 10 drugs, for example, may decide to stop buying certain medications to alleviate cost or just because they want to take fewer pills. Nevertheless, they may be making the wrong choices, he said.

Both Cushman and Franklin acknowledged that more research is needed in this area and expressed hope that future trials will provide more conclusive data. – by Melissa Foster

Disclosures: Dr. Cushman has served as a consultant for Takeda Pharmaceuticals, Sanofi Aventis, Bristol Meyers-Squibb, Novartis, Daiichi Sankyo and Theravance. Dr. Franklin reports no relevant financial disclosures. Dr. Vongpatanasin reports no relevant financial disclosures.
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Abnormal glucose tolerance linked with endothelial dysfunction in setting of CAD

American College of Cardiology 60th Annual Scientific Sessions

NEW ORLEANS – According to new research, endothelial dysfunction was associated with abnormal glucose tolerance in patients who had coronary artery disease and unknown diabetes mellitus.

Researchers from Kokura Memorial Hospital in Japan enrolled 95 consecutive patients with CAD (37 with ACS and 58 with stable angina), normal fasting glucose levels (<110 mg/dL and HbA1c <6.5%) who underwent successful PCI between March and September 2010. They then assessed glucose metabolism and endothelial function using a 75 g oral glucose tolerance test and flow-mediated dilatation of the brachial artery.

Results from the 75-g oral glucose tolerance test separated the patients into those with normal glucose (n=25), those with impaired glucose tolerance (n=43) and those with diabetes (n=27). Flow-mediated dilatation in the diabetes group was lower (3.8% ± 1.3%) than that reported in both the normal (5.0% ± 2.1%) and the impaired glucose tolerance (5.2% ± 2.5%) groups. The researchers reported that only 2-hour postload glucose level was associated with flow-mediated dilatation (r=.10, P=.007).

“Endothelial dysfunction is associated with abnormal glucose tolerance, especially 2-hour post-load glucose level,” the researchers wrote in their abstract. “It indicates that early diagnosis and intervention for abnormal glucose tolerance may improve the endothelial dysfunction in patients with CAD and unknown diabetes mellitus.”

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Acute MI rates lower in men, women since Red Dress Campaign

American College of Cardiology 60th Annual Scientific Sessions

NEW ORLEANS – Since its inception in 2002, the National Heart, Lung and Blood Institute’s Red Dress Campaign has been associated with a decreased incidence of acute MI among both men and women, according to data presented here.

“Over the last few years there’s been a lot of awareness of women in public health and cardiovascular disease. Some research has been done to demonstrate the increase, and we wanted to see if this increase translated into improved outcomes in treatment patterns in women,” Liana M. Spano-Brennan, DO, cardiology fellow, told Cardiology Today.

Using the New Jersey Myocardial Infarction Data Acquisition System database, Spano-Brennan and colleagues at the University of Medicine and Dentistry of New Jersey’s Robert Wood Johnson Medical School identified 315,246 patients who presented to hospitals in New Jersey for acute MI between 1986 and 2007. Almost half (40.9%) of patients identified were female. The researchers examined the effect the campaign has had on acute MI incidence, management and outcomes.

The overall incidence of acute MI (per 100,000) decreased between 1986 and 2007, with the most notable decline observed in men (women: 321 to 197; P<.0001 and men: 598 to 311; P<.0001). According to the researchers, after 2002, the trend increased.

Over the observed period of 22 years, though the rate of left heart catheterization increased 5-fold for women and 3-fold for men, the likelihood of left heart catheterization was still low among women (OR=0.78; 95% CI, 0.77-0.79). The percent difference between men and women undergoing percutaneous coronary intervention increased from 2.2% in 1986 to 9.4% in 2007 (P<.0001), among those who received left heart catheterization.

Both in-hospital and one-year mortality was higher among women compared with men (OR=1.30; 95% CI, 1.27-1.34 for in-hospital and OR=1.10; 95% CI, 1.08-1.13 for one-year). However, the mortality rate did not decrease significantly after 2002.
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Combination ezetimibe, simvastatin plus niacin may benefit patients with hyperlipidemia

American College of Cardiology 60th Annual Scientific Sessions

NEW ORLEANS — Treatment with combination ezetimibe and simvastatin plus extended-release niacin may aid patients with hyperlipidemia in achieving target LDL cholesterol, non-HDL cholesterol and apolipoprotein B levels, according to data presented here.

To compare the efficacy of combination ezetimibe and simvastatin plus extended-release niacin with either treatment alone, researchers conducted a randomized, double blind study involving patients with type IIA and IIB hyperlipidemia.

“What we looked at in this combination with ezetimibe and the statin along with extended-release niacin how that supports the attainment of recommended LDL, non-HDL and apolipoprotein B goals and showing that the combination allows you in this patient population to get to significantly more patients to get to those goals,” Andrew M. Tershakovec, MD, MPH, researcher for Merck, told Cardiology Today.

Patients were randomly assigned to one of the following regimens:
10 mg/20 mg of combination ezetimibe and simvastatin plus up to 2 g of niacin for 64 weeks.
10 mg/20 mg of combination ezetimibe and simvastatin alone for 64 weeks.
Up to 2 g of niacin for 24 weeks then 10 mg/20 mg of combination ezetimibe and simvastatin plus up to 2 g of niacin for 40 weeks or more.
Up to 2 g of niacin for 24 weeks then 10 mg/20 mg of combination ezetimibe and simvastatin alone for 40 weeks or more.

Tershakovec and colleagues also assessed lipid outcomes in subgroups of patients with high risk for coronary heart disease, diabetes, metabolic syndrome and those without diabetes or metabolic syndrome.

Results revealed that considerably more patients receiving combination ezetimibe and simvastatin plus niacin reached concomitant LDL cholesterol, non-HDL cholesterol and apolipoprotein B levels when compared with those receiving niacin and combination ezetimibe and simvastatin at 24 weeks and combination ezetimibe and simvastatin at 64 weeks. In all subgroups, attainment rates remained higher for patients receiving the combination treatment plus niacin vs. niacin alone at 24 and 64 weeks. In addition, rates were generally greater with combination ezetimibe and simvastatin plus niacin vs. the combination treatment alone. Concomitant attainment of all three target lipid levels was most consistent with the single level attainment of non-HDL cholesterol.

“What this shows is that the combination of ezetimibe/statin and niacin is a very potent,” Tershakovec said. “I think niacin-based therapy has been around a long time, but the outcomes data are relatively limited. However, the data that do exist are positive.”

He noted that two large outcome studies examining the use of extended-release niacin will also provide physicians with more insight into how to implement these treatments into clinical practice.

“Seeing those outcomes data would be very informative on what the utility of therapies like this really are,” Tershakovec said. – by Melissa Foster

Disclosure: Dr. Tershakovec is an employee for Merck as well as a company stockholder.

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STICH: CABG plus medical therapy yields marginal benefit in patients with HF, CAD

American College of Cardiology 60th Annual Scientific Sessions

NEW ORLEANS – The addition of CABG to a regimen of optimal medical therapy in patients with HF and coronary artery disease was not associated with a significant benefit, but surgery was linked with lower risk for death from heart disease, results from the STICH trial suggested.

Researchers for the randomized Surgical Treatment of Ischemic Heart Failure trial enrolled 1,212 patients from 99 centers in 22 countries and randomly assigned them to either optimal medical therapy (n=602) or medical therapy plus CABG (n=610). Average follow-up was 56 months. The trial represented the largest randomized, controlled study comparing CABG plus optimal medical therapy to medical therapy alone in this patient population conducted to date.

According to the study data, the death rate in the CABG group was 36% vs. 41% with medical therapy alone, but the finding did not reach statistical significance (P=.12). However, CABG was linked with lower rates of CV death (28% vs. 33% with medical therapy alone; P=0.05) and lower rates of the combined endpoint of death from any cause plus hospitalization for heart disease (58% vs. 68% with medical therapy alone; P<.001). The researchers noted that 55 patients assigned to the surgery group did not undergo surgery, and 100 patients assigned to medical therapy alone ended up undergoing CABG. When looking specifically at the patients who had received their assigned treatments, however, CABG reduced any-cause death by 25% (P=0.005).

While the survival benefit of CABG was apparent after 2 years, the researchers cautioned that there was a higher up-front risk with CABG than with medical therapy alone.

“CAD should continue to be assessed among all patients presenting with HF, and in HF patients with CAD on medical therapy, CABG should now be considered to reduce CV mortality and morbidity,” Eric J. Velazquez, MD, associate professor of medicine and director of the cardiac diagnostic unit and echocardiography laboratories at Duke University Medical Center in Durham, N.C., said in a presentation. “The durability of CABG benefits will be tested in the STICH Extension Study, which is ongoing.” – by Eric Raible

Disclosure: Dr. Velazquez reports no relevant financial disclosures.
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Study: Myocardial viability imaging, CABG effectiveness not linked

American College of Cardiology 60th Annual Scientific Sessions

NEW ORLEANS – Myocardial viability imaging was not associated with the effectiveness of CABG, results from a viability substudy of the STICH trial indicated.

Researchers for the substudy recruited 601 patients from the STICH study and assigned them to undergo either nuclear perfusion scanning or dobutamine echocardiography. Of those, 487 were determined to have myocardial viability (243 assigned to medical therapy and 244 to CABG) and 144 patients did not have myocardial viability (60 assigned to medical therapy and 54 to CABG).

Although the death rate was 37% among patients with myocardial viability (P=0.003) and 51% among patients without myocardial viability, the association became statistically insignificant when baseline characteristics were adjusted for (P for interaction=0.528).

“Imaging may be important in individual patients, but there are many other factors that contribute to outcomes in patients with CAD and HF with or without surgery,” Robert O. Bonow, MD, professor of medicine and director of the Center for Cardiovascular Innovation at Northwestern University in Chicago, told Cardiology Today. “These include comorbidities like kidney failure, diabetes and overall left ventricular function that are more important factors in a multivariable analysis than just the myocardial viability data alone.” – by Eric Raible
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EVEREST II: Safety, efficacy remain stable at 2 years

American College of Cardiology 60th Annual Scientific Sessions

NEW ORLEANS — Two-year data from the EVEREST II trial indicate that percutaneous repair with MitraClip is as effective as surgery in select patients with mitral regurgitation. Updated study results were presented here by study author Ted Feldman, MD, director of the cardiac catheterization laboratory at NorthShore University HealthSystem in Illinois.

Initial results from EVEREST II demonstrated that the safety of MitraClip (Abbott Vascular) was greater compared with surgery, but also that MitraClip was inferior to surgery in reducing mitral regurgitation. One-year results were presented at the ACC 59th Annual Scientific Sessions in 2010. The current results suggest that at 2 years, 78% of patients who received the MitraClip device (Abbott Vascular) did not need surgery.

“The fundamental finding is that everything was very stable between 1 and 2 years. The Kaplan-Meier curves for mortality and reoperation remain, literally, completely flat through that time period. Gains in left ventricular performance and clinical outcome were very stable,” Feldman said during a press conference.

The study included 279 patients with grade 3+ or 4+ mitral regurgitation who were randomly assigned at 2:1 to receive the MitraClip (n=184) or standard surgery (n=95). Treatment efficacy was measured by freedom from death, absence of new mitral valve surgery and mitral regurgitation lower than grade 3+. Results were similar between the two groups: 62.7% of patients in the MitraClip group met this endpoint vs. 66.3% in the surgery group.

Major adverse events were significantly lower in the MitraClip group compared with surgery: 15% vs. 47.9% (P<.001). This difference is mainly explained, Feldman said, by the percentage of patients requiring a blood transfusion at ≥2 units (13.3% in the MitraClip arm vs. 44.7% in the surgery arm).

At 2 years, the researchers report no device embolization, fracture, erosion or migration. In addition, the occurrence of single leaflet device attachment remained unchanged between 1 and 2 years.

Primary effectiveness results were similar between years 1 and 2: 55.2% at 1 year vs. 51.7% at 2 years in the MitraClip group and 73.0% at 1 year vs. 66.3% at 2 years in the surgery group.

According to Feldman, both treatment strategies reduced mitral regurgitation and showed clinical benefit through 2 years, which includes significantly improved LV volumes and NYHA functional class. Follow-up will continue for 5 years. - Stacey L. Fisher

Disclosures: The EVEREST II study received funding from Evalve Inc. Dr. Feldman is a consultant for Abbott, which acquired Evalve in 2009.

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PRECOMBAT: Sirolimus-eluting stent non-inferior to CABG in patients with unprotected left main CAD

American College of Cardiology 60th Annual Scientific Sessions

NEW ORLEANS — Data from the PRECOMBAT trial have suggested that angioplasty with a sirolimus-eluting stent was noninferior to CABG in a composite endpoint of major adverse cardiac or cerebrovascular events at 1 year among patients with unprotected left main coronary artery disease.

The Premier of Randomized Comparison of Bypass Surgery Versus Angioplasty Using Sirolimus-eluting Stent in Patients with Left Main Coronary Artery Disease (PRECOMBAT) trial included 600 patients who were randomly assigned to either CABG (n=300) or angioplasty with a sirolimus-eluting stent (SES; Cypher, Cordis; n=300). All patients of the prospective, open-label trial had unprotected left main coronary artery (ULMCA) stenosis. The primary outcome was a composite of major adverse cardiac or cerebrovascular events that included all-cause mortality, stroke, MI and ischemia-driven target vessel revascularization (TVR) at 12 months.

According to results, the primary outcome was 8.7% in the CABG arm vs. 6.7% in the SES arm (P=.39), which remained similar at 24 months (SES, 12.2% vs. CABG, 8.1%; P=.12). Rates of death, MI or stroke at 2 years (CABG 4.7% vs. 4.4% SES) did not differ to a statistically significant extent, although ischemia-driven TVR did favor CABG (CABG, 4.2% vs. SES, 9.0%; P=.022).

“We didn’t find any hard endpoint concern in MI, stroke or all-cause death, just a difference in ischemia-driven TVR. The TVR concern is of frequent clinical relevance, however it is not such a strong one,” Seung-Jung Park, MD, PhD, professor of medicine, University of Ulsan College of Medicine, Seoul, Korea and lead study author, told Cardiology Today, later adding that he is anticipating large numbers of upcoming prospective, randomized studies that will give clearer answers on these hard endpoints in percutaneous coronary intervention vs. CABG procedures. – by Brian Ellis

Disclosure: Dr. Park has received consulting fees/honoraria as well as research grants from Cordis.
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RAPS: Better graft closure reported in radial artery vs. saphenous vein grafts

American College of Cardiology 60th Annual Scientific Sessions

NEW ORLEANS — Among patients with three-vessel disease who underwent CABG, those who received radial artery grafts compared with saphenous vein grafts had lower rates of occlusion after more than 7 years following the procedure.

“The study we’ve presented is the first multi-institutional, longitudinal, randomized comparison, so this is fairly unique data,” said Stephen E. Fremes, MD, MSc, study lead author and head of the division of cardiac and vascular surgery, Schulich Heart Centre, Sunnybrook Health Sciences Centre, Toronto, in a press conference. “Hopefully it will be persuasive and won’t detract from the use of radial arteries.”

In the randomized Radial Artery Patency Study (RAPS), investigators enrolled 561 patients who underwent CABG for three-vessel disease at 13 Canadian centers. Patients were treated with both a saphenous vein graft and a radial graft at two different diseased vessel sites. The primary endpoint was functional graft occlusion at least five years after surgery, while the secondary endpoint was complete graft occlusion.

During a mean of 7.6 years following procedure in 269 patients, researchers found substantially fewer radial arteries were occluded vs. saphenous vein grafts (12% vs. 18.8%; P=.05). Similarly, rates of complete occlusion were lower in radial arteries (8.9% vs. 17.8%; P=.004), as were rates of functional graft occlusion (12% vs. 18.8%; P=.05). Furthermore, graft stenosis of greater than 25% or occlusion was also lower in the radial arm (21.9% vs. 33.8%; P=.004). – by Brian Ellis

For more information:
Fremes S. LBCT II, Session 3013. Presented at: ACC 60th Annual Scientific Sessions; April 2-5, 2011; New Orleans.

It has pretty much fallen out of favor using the radial artery and yet since vein grafts are perceived to be so inferior to internal mammary grafts you look for something else and maybe new things will come in the future. But the RAPS trial was counter to the VA trial, which showed at one year 89% patency for veins and 89% for radial artery. Here with a longer follow-up and with a little different way the trial was done, this looks a little better. So I think this is going to reinvigorate surgeons to use radial arteries more. I would expect this will have a clinical impact.
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Meta-analysis: Lipid-lowering therapy may be most beneficial when started early

American College of Cardiology 60th Annual Scientific Sessions

NEW ORLEANS — The mortality benefits afforded by lipid-lowering therapy persist after trial randomization in clinical trials where both arms receive active therapy, according to data from a meta-analysis.

William J. Kostis, PhD, MD, of Massachusetts General Hospital in Boston, and colleagues aimed to determine whether the mortality benefit bestowed by lipid-lowering therapy persists after the end of clinical trials when both treatment and placebo groups are advised to take active therapy.

The researchers used Medline, the Cochrane Library, Web of Science and ClinicalTrials.gov to identify eight randomized trials of lipid-lowering medications (including 5 statin trials); all trials included secondary reports describing the results observed at study completion. They then calculated odds ratios for all-cause and cardiovascular mortality for both the randomized and open-label follow-up phases of each trial trial (when all patients were advised to take active therapy). The results were compared using a random-effects meta-analysis.

Data for 44,255 patients and 8,144 deaths were included. According to Kostis, during the randomized phase, patients randomly assigned to active therapy were about six-and-a-half-times more likely to receive it compared with those assigned to placebo.

“The ratio of the percentage of patients receiving active therapy among the group randomized to receive it to the percentage of those receiving active therapy among those randomized to placebo (AMR) was 6.52 (inter quartile ratio (IQR)= 4.88-10.11),” the researchers wrote.

In the open-label phase, the proportion of patients originally assigned to placebo who were administered active therapy was nearly identical to those initially randomly assigned to active therapy (AMR=1.02; IQR=0.92-1.14).

Mortality rates – both all-cause (OR=0.84; 95% CI, 0.76-0.93) and CV (OR=0.72; 95% CI, 0.63-0.82) – were lower in the group assigned to active therapy during the randomization phase. This decrease in mortality continued when both groups received active therapy in the open-label phase (all-cause mortality: OR=0.90; 95% CI ,0.84-0.97; and CV mortality: OR=0.82; 95% CI, 0.73-0.93).

Kostis told Cardiology Today that the results of this analysis demonstrate that patients should be treated earlier, and that long-term statin therapy may not always be necessary. - Stacey L. Fisher

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ACC 2011
Diastolic Heart Failure: Beyond Recognizing a Preserved Ejection Fraction
By Jeffrey Hertzberg, MD, MS | 4 Апрель 2011 г.

Diastolic heart failure (or HFPEF—heart failure with preserved ejection fraction) is characterized by inadequate myocardial relaxation and diastolic filling ("stiff ventricle"), with heart failure signs and symptoms despite normal ejection fraction. The most common cause is long-standing hypertension. Current thinking regarding the underlying pathophysiology stresses poor diastolic reserve that is inadequate to meet the demands of exercise in HFPEF, in contrast with early studies which focused on the "stiff" ventricle in resting subjects. During exercise in normal subjects, rapidly relaxing ventricles "suck" blood out of the atria; in HFPEF, ventricular filling during exercise is markedly impaired, with cardiac output inadequate to meet demand. Other recent studies have revealed additional layers of complexity:

•Systolic abnormalities are part of HFPEF: despite grossly preserved systolic ejection fraction, systolic reserve is inadequate—systolic contractility doesn’t adequately increase with exercise. This research has shed new light on the functional limitations present in HFPEF patients.
•Poor vasodilator reserve function: normal subjects experience peripheral vasodilation with exercise; this afterload decrease enhances cardiac output to meet demand. Endothelial dysfunction in patients with HFPEF prevents this response.

Therapy: No therapy has demonstrated clear evidence for improved outcomes in diastolic heart failure. Aggressive use of beta blockers has fallen out of favor for most HFPEF patients because it can exacerbate chronotropic incompetence (inability to increase heart rate to meet cardiac output demands seen in HFPEF). The primary approach in the treatment of HFPEF remains aggressive treatment of controllable risk factors, and the use of cardiac rehabilitation to improve exercise tolerance through conditioning of peripheral tissue oxygen extraction. HFPEF and ischemic heart disease can present as comorbid conditions with four primary risk factors that can all be present in the same patient: hypertension, advanced age, renal insufficiency, and diabetes.

Diabetes appears to be a powerful independent risk factor for HFPEF, associated with abnormal left ventricular filling even in the absence of hypertension. Diastolic dysfunction is seen in 30% to 70% of patients with type 2 diabetes; the likely mechanisms include altered endothelial function, defective energy metabolism, and microvascular disease—diabetes is associated with left ventricular hypertrophy as an independent risk factor. Given that worldwide diabetes prevalence will increase from 135 million in 1995 to 300 million in 2025, primary care physicians can expect to treat an enormous number of new HFPEF patients in the coming years.

Regarding ischemic syndromes and HFPEF, it is paradoxically observed that:

•Chest pain can occur in the setting of HFPEF and relatively normal coronary arteries.
•Unstable angina is more prevalent in heart failure patients with preserved EF than with garden variety systolic dysfunction.

Echocardiography and other functional studies can help distinguish ischemic heart disease from symptomatology related to diastolic dysfunction, and is important because patients with HFPEF can present with chest pain unrelated to coronary artery disease. The lack of wall motion abnormalities or other functional changes indicative of ischemia can help avoid unnecessary angiography in this cohort.

Current Concepts in Diastolic Heart Failure: Highlights from "Diastolic Heart Failure, Beyond Recognizing a Preserved Ejection Fraction," a panel presentation at ACC.11, April 3, 2011. New Orleans, La.
Co-chairs: Anita Deswal, MD, Christopher O’Connor, MD
Synthesizing material from presenters: Eric Veslazquez, MD (Duke University), Barry Borlaug, MD (Mayo Clinic), Michael Fowler, MD (Stanford), and Carolyn Lam, MD (Mayo Clinic).

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RIVAL: More favorable outcomes documented for radial vs. femoral access

American College of Cardiology 60th Annual Scientific Sessions

NEW ORLEANS — New data presented here from the largest randomized trial to date comparing radial and femoral access for coronary angiography and intervention have revealed radial access to be superior in vascular complications while still leading to a similar success rate compared with femoral access.

The international, multicenter RIVAL trial was designed to help answer the question as to which access site is the most optimal for coronary angiography and intervention in patients with acute coronary syndromes. The trial included 7,021 patients who were randomized to receive either radial (n=3,507) or femoral (n=3,514) access. Investigators defined the primary outcome as incidence of death, MI, stroke or non-CABG-related major bleeding at 30 days.

At follow-up, both access sites produced comparable results in the primary outcome (radial, 3.7% vs. femoral, 4%; P=.50). Similarly, angiographic success rates were even between arms (radial, 95.4% vs. femoral, 95.2%; P=.83).

Significant differences, however, were reported with major vascular access site complications, which favored the radial cohort (1.4% vs. 3.7%; P<.001). These complications, according to Sanjit S. Jolly, MD, study investigator and assistant professor of medicine, McMaster University, Hamilton, Ontario, Canada, in a press conference, included large hematomas at the access site, pseudoaneurysms, arteriovenous fistulas as well as other vascular site surgical repair.

“The implications for practice [of this study] are that both approaches are safe and effective in the coronary,” he said. “We believe that the more you do the better you get, which is an important phenomenon [showing] that volume is important, particularly in radial access. And, finally, both patients and physicians may end up choosing the radial approach because of its similar efficacy and reduced vascular complications.” – by Brian Ellis
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RESOLUTE US: TLF lowered at 1 year with Resolute vs. Endeavor stent

American College of Cardiology 60th Annual Scientific Sessions

NEW ORLEANS – Compared with a historical cohort treated with the Endeavor zotarolimus-eluting stent, patients who received the Resolute zotarolimus-eluting stent had significantly improved target lesion failure at one year, according to results of the RESOLUTE US trial.

Researchers in this trial enrolled 1,402 patients from 116 sites in the United States and split them into two cohorts: clinical (n=1,242) and angiographic (n=160). Patients received revascularization with the Resolute zotarolimus-eluting stent (Medtronic) either due to stable or unstable angina, while 34.4% of the population presented with diabetes at baseline.

At 1 month, target lesion failure (TLF) of all patients, which was defined as MI, cardiac death or clinically-driven target lesion revascularization, was 1.4% with one death reported due to cardiac causes, whereas at 12 months the rate of TLF was 4.7% with 18 deaths reported (9 due to cardiac causes).

The researchers then compared the main analysis cohort of this trial (n=1,001; evaluable n=982), which utilized 2.5 mm to 3.5 mm stents in single lesions only, to historical control patients (n=1,076) that received the Endeavor zotarolimus-eluting stent (Medtronic). The primary endpoint of TLF at one year was 3.7% in the Resolute group vs. 6.5% in the Endeavor group (P-noninferiority <.001; post-hoc P-superiority=.002).

“I think this study provides interesting additional information, certainly on effectiveness, in particular on some lingering safety issues with a stent thrombosis rate of 0.1% [that included] only two episodes both occurring in patients that received 2.25 stents and in patients that did not receive dual antiplatelet therapy fairly early after treatment,” said Martin B. Leon, MD, professor of medicine, Columbia University/New York Presbyterian Hospital, and trial researcher, in a press conference. “So I think we come away feeling that the composite of the data indicates a very effective and safe device, now finally treated in a US population. Tthis will hopefully lead to an FDA consideration for availability of this stent in the United States.” – by Brian Ellis

For more information:
Leon M. LBCT III, Session 3014. Presented at:ACC 60th Annual Scientific Sessions; April 2-5, 2011; New Orleans.

The Resolute stent is a further refinement of a second generation drug-eluting stent (DES). I think the most interesting part is that the Resolute stent changed the elution characteristics of the same drug used in the Endeavor stent. There is really no other DES that has done this iteration, so we can now understand what changing the elution profile does. What we found was that Resolute stent lowers the TLF rate as compared to the Endeaver stent. Prolonging the drug elution profile can indeed help reduce intimal proliferation resulting in better clinical outcome.

The Resolute stent, hopefully when it gets approved by the FDA, will add another new third generation DES to treat complex patients. We currently only have only two second generation DES, but adding another with a prolonged drug elution profile will help treat patients with complex disease.
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ISAR-CABG: DES superior to BMS in saphenous vein graft lesions

American College of Cardiology 60th Annual Scientific Sessions

NEW ORLEANS — In what researchers called the largest randomized, multicenter trial comparing stents in saphenous vein graft lesions, drug-eluting stents were found to led to a lower composite rate of death, MI and repeat revascularization.
“Usually, all randomized trials comparing drug-eluting stents [DES] and bare-metal stents [BMS] have excluded lesions located in the saphenous vein grafts,” Julinda Mehilli, MD, director, clinical research and data coordinating, Intracoronary Stenting and Antithrombosis Research (ISAR) Center, German Heart Center, Munich, and study investigator, said in a press conference, later adding that the two trials comparing both stents in this indication included only 160 patients and produced incomplete results. “Thus the aim of the ISAR-CABG study was to have a study adequately powered for clinical endpoints to compare DES and BMS.”

The German researchers of the ISAR-CABG trial enrolled 610 patients who had undergone CABG and had ischemic symptoms or evidence of myocardial ischemia in the presence of at least 50% de novo stenosis in saphenous vein grafts. The patients were then randomly assigned to receive either drug-eluting (DES; n=303; mean age, 71.4 years) or bare metal (BMS; n=307; mean age, 71.5 years) stents. DES used in the study included the sirolimus-eluting (Cypher, Cordis), biodegradable polymer sirolimus-eluting and paclitaxel-eluting (Taxus, Boston Scientific) stents.

The study’s primary endpoint was defined as the composite of major adverse cardiac events (MACE) including death, MI and target lesion revascularization (TLR) at 1-year, while the secondary endpoints were individual rates of death, MI, ARC [Academic Research Consortium]-definite thrombosis and the need for TLR over one year.

Early data at 30 days indicated MACE rates of 5.9% in the BMS arm vs. 2.6% in the DES (P=.05). Similarly, researchers found that the primary endpoint occurred more frequently in the BMS group compared with the DES (22.1% vs. 15.4%; P=.03). The only secondary endpoint to differ to a statistically significant extent was TLR, which favored the DES group (7.2% vs. 13.1%; P=.02).

Following the conference, Mehilli spoke with Cardiology Today and explained that prior to these findings people were afraid of DES because the risk of more and longer stent thrombosis compared with BMS, not to mention the high risk of occlusion at long-term with saphenous vein grafts.

“This randomized controlled trial, the first with such a large number of patients powered for clinical endpoints, gives a definite answer: DES are safe. They don’t increase mortality, MI or stent thrombosis rate, and instead reduce the revascularization rate in bypass lesions,” she said. - by Brian Ellis

For more information:
Mehilli J. LBCT III, Session 3014. Presented at: ACC 60th Annual Scientific Sessions; April 2-5, 2011; New Orleans.

The reason trials like this are important is because the interventional community has been criticized for putting in DES off-label. Be that as it may, there are some safety concerns about that practice and those concerns seem to have been supported by the R-RISK trial which showed that patients who had drug-coated stents as opposed to uncoated seemed to have higher mortality. That was a small trial and I think it was largely driven by the fact that the patients who had the non-coated stents placed had a 0% observed mortality which is somewhat implausible. Patients who’ve had bypass surgery before develop new blockages. Those patients tend not to be immortal to say the least. So I think that is an example of a type-1 statistical error.

That’s why we needed to do a larger, more adequately powered trial. To the credit of this ISAR group, this is a very helpful trial showing that these devices seem to be both safe and efficacious in this “off-label” indication.

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REMEDIAL II: Contrast-induced acute kidney injury lowered with RenalGuard System

American College of Cardiology 60th Annual Scientific Sessions

NEW ORLEANS — Compared with conventional hydration treatment, use of the RenalGuard System in patients with chronic kidney disease improved the safety of image-guided cardiology procedures, which led to fewer cases of contrast-induced acute kidney injury, according to findings presented here.

“This trial demonstrates that the RenalGuard System [PLC Medical Systems] is very good device to prevent contrast-induced acute kidney injury in high-risk patients,” said Carlo Briguori, MD, PhD, lead study author and director, Laboratory of Interventional Cardiology, Clinica Mediterranea, Naples, in a press conference.

The Italy-based study was conducted at four interventional cardiology centers and included 292 patients with chronic kidney disease. Patients were scheduled for coronary and/or peripheral angiography and/or angioplasty between January 2009 and December 2010. They were randomized to receive either conventional hydration that included a combination of N-acetylcysteine (NAC) and sodium bicarbonate solution or hydration with normal saline plus NAC and low-dose furosemide controlled by the RenalGuard System. Biomarkers such as serum creatinine (sCr) and cystatin C were assessed the day before and up to 1 week following the procedure.

The researchers reported that the primary endpoint of the development of contrast-induced acute kidney injury CI-AKI (sCr increase ≥0.3 mg/dL at 48 hours) was nearly two times higher in the conventional treatment group (20.5% vs. 11%; P=.025). Non-statistically significant more patients experienced stage 2 or 3 damage in the conventional arm (23% vs. 6%; P=.14) as well.

Additional analysis revealed that a lower rate of in-hospital renal failure requiring dialysis occurred in the RenalGuard System group (0.7% vs. 4.1%; P=0.056), although rates of in-hospital stay and major adverse events were similar between groups.

For Briguori, the rate of dialysis was the most important clinical finding, because it shows the possibility to prevent this very improbable complication. – by Brian Ellis
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Platinum chromium stent performance comparable to cobalt chromium stent at 1 year

American College of Cardiology 60th Annual Scientific Sessions

NEW ORLEANS — Results from the PLATINUM trial indicated that the safety and efficacy of the platinum chromium everolimus-eluting stent were noninferior to those of a cobalt chromium everolimus-eluting stent at 1 year.

Researchers for the trial enrolled 1,530 patients undergoing angioplasty between January and September 2009 and randomly assigned them to receive either a platinum chromium stent (n=768) or a cobalt chromium stent as a control (n=762). The composite primary endpoint consisted of target vessel-related cardiac death, target vessel-related MI or ischemia-driven target lesion revascularization (TLR).

According to the results, the platinum chromium stent was noninferior to the cobalt chromium stent (3.4% vs. 2.9%; P=.001 for noninferiority). There were also no differences between the groups for other safety and efficacy measures, including stent thrombosis (0.4% vs. 0.4%) and TLR (1.9% vs. 1.9%). There were no differences in all-cause mortality between the two groups (3.0% in cobalt chromium group vs. 2.4% in platinum chromium; P=.049).

“A novel platinum chromium everolimus-eluting stent has been developed which has been shown to be noninferior to the predicate cobalt chromium everolimus-eluting stent for target lesion failure, with nonsignificant differences in measures of safety and efficacy demonstrated through 12-month follow-up after PCI,”Gregg W. Stone, MD, professor of medicine and director of CV research at New York Presbyterian Hospital/Columbia University Medical Center, said in a presentation.

Stone pointed out that the study’s limitations included the exclusion of patients with acute MI, chronic total occlusion, bifurcation, left main coronary artery lesions, saphenous vein graft lesions, ostial lesions or lesions with thrombus or excessive tortuosity or calcification. The trial was also not designed to assess differences in deliverability, acute performance or ease of use. – by Eric Raible
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EXCELLENT: Guidelines may have overestimated length of DAPT after DES

American College of Cardiology 60th Annual Scientific Sessions

NEW ORLEANS — Instead of the 12 months currently recommended by guidelines for dual antiplatelet therapy following drug-eluting stent insertion, new data from the EXCELLENT trial have suggested that 6 months of therapy may be all that is necessary to produce equivalent results.

In order to generate these findings, researchers conducted a 19-center trial in which 1,443 patients were randomly assigned to 6 or 12 months of dual-antiplatelet therapy (DAPT) in addition to aspirin following insertion of a drug-eluting stent. Inclusion criteria of the prospective, open-label trial included >50% stenosis by visual estimation, evidence of myocardial ischemia and location of target lesion in a native coronary artery. The patients were then followed for at least 2 additional years.

Among the 1,428 patients in which 12-month data was available for, target vessel failure – cardiac death, MI and target vessel revascularization – occurred in 4.7% of patients in the 6-month group and 4.4% in the 12-month group. This primary endpoint, according to analysis, showed non-inferiority between 6-month and 12-month groups with a pre-specified non-inferiority margin of 40 percent (P=0.0031).

Additionally, the safety endpoint, which was a composite of death, MI, cerebrovascular accident, stent thrombosis and thrombolysis in MI bleeding, was 3.4% in the 6-month group vs. 3.1% in the 12-month group (P=.678).

“At least in low-risk patients, [those] non-diabetic and treated with second generation DES, we may safely discontinue clopidogrel [Plavix, Sanofi-Aventis] at about 6 months, especially in patients that are at high-risk of bleeding,” concluded Hyeon-Cheol Gwon, MD, PhD, with the department of cardiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea, and study researcher, in a press conference. - by Brian Ellis
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MAGELLAN: Rivaroxaban efficacy comparable to enoxaparin in acutely ill

American College of Cardiology 60th Annual Scientific Sessions

NEW ORLEANS — Results of the MAGELLAN trial demonstrate that, when used as thromboprophylaxis in acutely ill hospital patients, rivaroxaban was not inferior to enoxaparin when used short-term and was slightly superior to enoxaparin followed by placebo when used long-term. However, compared with enoxaparin, rivaroxaban was associated with an increased rate of bleeding.

“Not only did we show that rivaroxaban was effective in this setting, but we also showed that at 35 days patients are still at risk for venous thrombosis,” Alexander T. Cohen, MD, of the department of surgery at King's College Hospital, London, said during a press conference. “We had a 5.7% frequency in the control arm, which was higher than the benchmark data of about 4%.”

The phase 3 trial compared oral rivaroxaban with subcutaneous enoxaparin (Lovenox, Sanofi-Aventis) in patients admitted to the hospital for acute HF, acute infectious disease and acute respiratory insufficiency or other acute medical conditions. Patients from 52 countries (n=8,101) were randomly assigned to rivaroxaban for 35 days (n=4,050) or enoxaparin for 10 days (n=4,051); both groups received placebo. The primary endpoint was a composite of asymptomatic proximal deep vein thrombosis, symptomatic deep vein thrombosis, symptomatic non-fatal pulmonary embolism and venous thromboembolism-related death. The primary safety outcome was a composite of treatment-related major bleeding and clinically relevant non-major bleeding.

At 10-days follow-up, the primary endpoint was similar between both groups: 2.7% of patients in both arms experienced the primary endpoint (relative risk ratio=0.968; P=.0025 for non-inferiority, one-sided).

At 35-days follow-up, researchers documented superiority in the rivaroxaban arm compared with enoxaparin followed by placebo: 4.4% of patients in the rivaroxaban group experienced the primary endpoint vs. 5.7% in the enoxaparin group (relative RR=0.771; P=.0211 for superiority, two-sided).

Conversely, enoxaparin was superior to rivaroxaban in reducing the rate of bleeding at both 10 and 35 days: at 10-days 1.2% of patients in the enoxaparin arm experienced clinically relevant bleeding vs. 2.8% of patients in the rivaroxaban group (relative RR=2.3; P<.0001). Similarly at 35 days, 1.7% of patients in the enoxaparin group had clinically relevant bleeding vs. 4.1% of patients in the rivaroxaban group (relative RR=2.5; P<.0001). According to Cohen, rates of liver and CV events were similar in both groups.

“We’ve shown that we have an effective drug; we have an ongoing problem and we have to look carefully at the bleeding and see if we can work out why this occurred and whether there are any groups that can benefit,” Cohen said. – by Stacey L. Fisher

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OSCAR: Olmesartan improves outcomes in patients with diabetes

American College of Cardiology 60th Annual Scientific Sessions

NEW ORLEANS — Combination therapy with olmesartan and a calcium antagonist was associated with similar rates of CV events and mortality when compared with a high-dose angiotensin II receptor antagonist alone in patients with CVD. However, dual therapy appeared inferior to AII receptor antagonist monotherapy in patients with diabetes, according to results of the OSCAR study.

High-dose AII receptor antagonists are more effective than low-dose AII receptor antagonists for the prevention of CVD in patients with diabetic nephropathy or heart failure; however, the question of whether combination therapy with an ARB plus a calcium antagonist is superior to AII receptor antagonist monotherapy remains unanswered.

Hisao Ogawa, MD, PhD, professor in the department of CV medicine at Kumamoto University in Japan, and colleagues aimed to address this question by initiating the Olmesartan and Calcium Antagonists Randomized (OSCAR) study.

“The OSCAR Study is the first single trial in the world to examine the effect of high-dose AII receptor antagonist and AII receptor antagonist plus calcium antagonist in high-risk elderly patients,” Ogawa said during a press conference here.

Between June 2005 and May 2007, Ogawa and colleagues recruited 1,164 high-risk patients aged 65 to 84 years from 134 institutions in Japan. To qualify for inclusion, patients had to have uncontrolled blood pressure despite receiving treatment with the AII receptor antagonist olmesartan (Benicar, Daiichi Sankyo) and CVD or type 2 diabetes. The study’s primary endpoint was a composite of CV events, including cerebrovascular disease, coronary artery disease, HF, other atherosclerotic diseases, diabetic microvascular diseases and renal dysfunction, as well as all-cause mortality.

Patients were randomly assigned to receive daily high-dose olmesartan (40 mg) or a calcium antagonist plus olmesartan (20 mg). At 36 months, adequate blood pressure control was observed in both treatment groups. However, compared with monotherapy, combination therapy induced considerably greater decreases in BP, according to the researchers. Mean systolic BP was a mean 2.4 mm Hg lower and mean diastolic BP 1.7 mm Hg lower.

The researchers noted no significant differences between the two treatment arms in the number of primary endpoints. Fifty-eight events occurred in the monotherapy group vs. 48 in the combination group (HR=1.31; 95% CI, 0.89-1.92).

Results of a subgroup analysis, however, revealed a statistically significant difference between treatment groups in patients with pre-existing CVD. Patients assigned to combination therapy experienced considerably fewer CV events and death compared with those assigned monotherapy (24 vs. 51; HR=1.63; 95% CI, 1.06-2.52).

In addition, a second subgroup analysis indicated a higher rate of the primary outcome between treatment arms in patients with diabetes only, with 14 events occurring in the combination group and seven occurring in the AII receptor antagonist monotherapy group (HR=0.52, 95% CI, 0.21-1.28). The researchers also noted a significant treatment-by-subgroup interaction for the primary endpoints between patients with CVD and patients with diabetes only.

These results suggest that the relative effect of the two therapies is dependent on the presence of CVD or diabetes, according to the researchers. – by Melissa Foster
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NAGOYA HEART: ARB, calcium antagonist equally effective in patients with diabetes, hypertension

American College of Cardiology 60th Annual Scientific Sessions

NEW ORLEANS — Valsartan, an angiotensin II receptor blocker, and amlodipine, a calcium antagonist, comparably reduced adverse CV events in hypertensive patients with diabetes or glucose intolerance, according to data presented here.

“Many hypertension treatment guidelines recommend angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs) as first-line treatment for hypertensive patients with diabetes, especially for prevention of major CV events,” Toyoaki Murohara, MD, PhD, lead researcher of the NAGOYA HEART Study, said during a press conference. “But some clinical trials show that calcium antagonists are almost equally effective in reducing the risk of CV disease as compared to ARBs.”

The NAGOYA HEART Study is the first randomized trial comparing the efficacy of an ARB with a calcium antagonist, according to Murohara. For the trial, Murohara and colleagues recruited 1,150 hypertensive patients with diabetes or glucose intolerance at 46 facilities in Japan. Between October 2004 and July 2010, the researchers randomly assigned patients to receive valsartan (Diovan, Novartis) or amlodipine (Norvasc, Pfizer) as first-line treatment. The study’s primary outcome measure was a composite of CV events, including acute myocardial infarction, stroke, coronary revascularization, hospital admission resulting from congestive heart failure (CHF) and sudden cardiac death. Blood pressure and HbA1c levels were also monitored.

Follow-up lasted a median of 3.2 years, with analysis occurring every month for the first 3 months and then every 1 to 3 months thereafter. Results revealed that 54 patients (9.4%) assigned to valsartan and 56 (9.7%) assigned to amlodipine experienced the primary outcome (HR=0.97; 95% CI, 0.66-1.4), suggesting no significant differences between treatment groups. Analysis of individual components of the primary outcome, however, indicated that the incidence of hospital admission for CHF was higher in the amlodipine group, with the event occurring in three patients (0.5%) in the valsartan arm vs. 15 patients (2.6%) in the amlodipine arm (HR=0.2; 95% CI, 0.06-0.69).

BP and HbA1c levels also appeared similar between the groups, the researchers said. At 54 months, BP decreased to 131/73 mm Hg in the valsartan group and 132/74 mm Hg in the amlodipine group. HbA1c levels were lowered to 6.7% in both groups.

“Our present paper shows that ARB is superior to a calcium antagonist in HF, and clinical trends already show ACE inhibitors slow [the development of] some of the complications of diabetes,” Murohara said. “Our study results support the current guidelines recommending ARB and ACE inhibitors for first-line treatment in diabetic patients with hypertension.”
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Specialized clinic improved outcome in patients with AF

American College of Cardiology 60th Annual Scientific Sessions

NEW ORLEANS – Rates of CV-related mortality and hospitalization were improved in patients with atrial fibrillation treated in a specialized clinic that adheres to AF guidelines when compared with usual care, according to new data.

“In order to improve outcomes in our patients, we developed a AF clinic which was characterized by substation of care by specialized nurses and they also delegated a software program … which stays with you and warns you in case you’ve made the wrong decision and it also suggests the most appropriate therapy,” said Robert G. Tieleman, MD, PhD, study investigator and cardiologist at the Martini Hospital, Groningen, the Netherlands, in a press conference. “We believed that doing this approach would improve outcome in these patients.”

Tieleman and fellow researchers tested this theory by analyzing the outcomes of patients (n=712) who were newly diagnosed with AF referred to the specialized AF clinic (n=356) or usual care (n=356). Baseline data revealed similar rates of CV conditions including hypertension, stroke, coronary artery disease and HF between the AF clinic and usual care arms. The primary endpoint was a composite of CV mortality, life-threatening effects of drugs, and hospitalization due to HF, stroke, acute MI, systemic embolism, bleeding and arrhythmic events.

After a mean 22-month follow-up, the primary endpoint was reported in 14.3% of the AF clinic arm vs. 20.8% of the usual care arm (HR=0.65; 95% CI, 0.45-0.93). Lower rates were also found in the AF clinic arm regarding deaths (1.1% vs. 3.9%; HR=0.28, 95% CI 0.09-0.85) and hospitalizations (13.5% vs. 19.1%; HR=0.66; 95% CI 0.46-0.96).

In his concluding remarks, Tieleman said that this study is at least the first step towards treating more patients with this approach, “but we also have to improve cost-effectiveness,” he said. “But I think these are very promising data.” – by Brian Ellis

[Chevychelov]

Patients may benefit from lower recommended BMI targets

American College of Cardiology 60th Annual Scientific Sessions

NEW ORLEANS — Recommended normal BMI parameters may be higher than necessary, as new data indicate that CV risk factors increase as BMI increases, beginning with a BMI of 20.

Glenn Lee, MBBS, and colleagues from the National University Health System and Khoo Puat Hospital in Singapore studied more than 3,000 adults who were referred for routine employment health screening for traditional CV risk factors. The mean age of the cohort was 38.9 years; mean BMI was 25.2; and 89.9% were men. The researchers excluded patients with diabetes and vascular disease.

According to the results, the overall prevalence of new diabetes cases was 2.4%. The majority of patients (84.5%) were classified as low risk, using the Framingham Risk Score.

The mean BMI of the cohort was 25.2. Analysis indicated a strong association between BMI and blood pressure, HDL and LDL levels; HDL and LDL levels were significantly worse with a BMI greater than 20. Systolic and diastolic BP rose significantly with a BMI greater than 22. The researchers noted a dose-response relationship for all risk factors, with the exception of LDL levels. Instead, these levels plateaued with a BMI greater than 26.

"Significant dose-response increases in traditional risk factors occurred at a BMI that is well within the normal range. Given the step-wise and additive nature of CV risk factors and the consistent correlation with a rising BMI of above 20, this calls into question what can be considered a truly normal BMI," Lee told Cardiology Today. "That's our major concern. Are we really being too lenient with these recommended guidelines for Caucasian populations (25) and Asian populations (23) or should we lower it?"

Lee also noted that several other studies support their findings, with one trial, which was published in Circulation in 2007 by Razak et al, suggesting that Asians may benefit from lowering the recommended BMI to 21. Another study conducted by Odegaard et al and published in PLoS One also suggested that the normal BMI for nonsmokers aged younger than 65 years should range from 18.5 to 21.4. Lee said this area requires further investigation.

"We would like to investigate and follow this cohort to see if this trend between CV risks and BMI persists as they age, and if these trends translate into increased cardiovascular event and mortality rates," Lee said. – by Melissa Foster

For more information:
Lee G. Poster 1079-304. Presented at: ACC 60th Annual Scientific Sessions; April 2-5, 2011; New Orleans.
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Aspirin use in patients with diabetes requires careful consideration
American College of Cardiology 60th Annual Scientific Sessions

NEW ORLEANS — Aspirin has been proven to be effective in reducing the risk for CV events; however, patients with diabetes are a unique population that requires special considerations before treatment. While aspirin therapy is recommended, further exploration into dosing strategies, stronger antiplatelet therapy and the clinical interaction between aspirin and patients with diabetes is essential, a speaker said here.

“A landmark stage published in 1990 really set the stage as to why diabetics are different and why antiplatelet therapy may be effective in this population,” Jeffrey S. Berger, MD, of the NYU Cardiac and Vascular Institute at the NYU Langone Medical Center in New York, said during a presentation. “Compared with nondiabetics, diabetics had greater platelet activity.”

Berger noted that one study currently being conducted at NYU suggests that markers of platelet activity correspond well with an increasing prevalence of diabetes, even in patients without CVD. Data from other trials support this association, and these results raised an important question: Can measuring platelet activity prevent a future event? At present, this question remains unanswered but warrants further investigation, he said.

In addition, physicians must consider dosing when treating with aspirin. Berger explained that aspirin inhibits COX-1 and, thus, reduces amounts of platelet activation and vascular constriction. However, aspirin at higher doses also reportedly inhibits prostacyclin, which causes an effect opposite of thromboxane. Therefore, Berger emphasized that physicians be careful not to prescribe too much aspirin, even among patients with diabetes.

Many physicians believe that patients with diabetes have a different clinical response to aspirin than those without the disease. Berger pointed out that this is a misconception, however, and cited data from a large meta-analysis that indicated no significant differences in aspirin’s effect on decreasing myocardial infarctions, stroke or all-cause mortality in patients with diabetes compared with those without the disease. Most importantly, he said, research showed no significant interaction in how aspirin prevents CV events between patients with the diabetes and those without.

Despite aspirin’s efficacy in decreasing CV benefits, the medication has been linked with serious adverse events, such as major bleeding, with research showing a low number needed to treat and a low number needed to harm.

“Thinking about it this way, for every 1,000 patients treated for 5 years, three ischemic events are avoided, but three major bleeds are caused,” Berger said. “So when you’re thinking about who should get aspirin, you should think about the absolute benefit and the absolute risk.”

Future studies

Because patients with diabetes are a special population, researchers and physicians should consider whether stronger antiplatelet therapies are required. Berger said future studies must take other medications into account. Statins, fish oil and ACE inhibitors, for example, have antiplatelet activity and this effect may attenuate some of aspirin's effect for patients with diabetes. He also noted that dosing strategies may have to be altered, such as administering aspirin twice a day instead of once daily. Additionally, improved tools for monitoring aspirin’s effect on preventing CV events would also be extremely valuable, according to Berger.

“There is no significant clinical interaction between diabetics and nondiabetics regarding the effect of aspirin. If remains uncertain if diabetics may need a different strategy of dosing or a stronger antiplatelet therapy, and I think future clinical trials should address these issues,” Berger said. – by Melissa Foster
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New analyses yield insufficient data on safety of rosiglitazone

American College of Cardiology 60th Annual Scientific Sessions

NEW ORLEANS — Current evidence remains insufficient to incriminate or exonerate rosiglitazone, on the basis of recent analyses, according to Sanjay Kaul, MD, and George A. Diamond, MD.

The safety of rosiglitazone was questioned in 2007 after a meta-analysis by Steven E. Nissen, MD, and Kathy Wolski, MPH, of the Cleveland Clinic, was published in The New England Journal of Medicine. The original meta-analysis, which included 56 trials of more than 35,000 patients, found a 43% increased risk for myocardial infarction and a 64% increased risk for CV death among rosiglitazone users. Nissen and Wolski recently updated their meta-analysis, and found that rosiglitazone was associated with a 28% greater risk for MI and no associated with CV death.

Because the updated analysis excluded 15 trials on MI and 29 trials on CV death, Kaul and Diamond, both from Cedars-Sinai Medical Center, sought to determine whether these exclusions biased the updated results on the CV safety of rosiglitazone (Avandia, GlaxoSmithKline). They compared the index study with meta-analyses of the 56 trials that were originally included and used different pooling methods.

According to the results, ORs ranged from 1.17 to 1.28 for MI and from 0.94 to 1.03 for CV death.

“Corrected models resulted in smaller ORs and narrower confidence intervals than did uncorrected models,” Kaul and Diamond wrote in their study abstract. “Although corrected risks remain elevated, none are statistically significant, except for the ‘treat as one trial’ method employed by the authors that is prone to bias.”

Further, ORs were nonsignificant when Kaul and Diamond excluded results of the DREAM trial or the seven trials in which rosiglitazone is not indicated or is contraindicated.

“Given the fragility of the data … additional data will be required to adjudicate these inconclusive results,” Kaul and Diamond said. - by Katie Kalvaitis

[Chevychelov]

Antiarrhythmics After Ablation of Atrial Fibrillation (5A Study): Six–Month Follow-Up Study
Circulation: Arrhythmia and Electrophysiology
Journal of the American Heart Association
The authors previously demonstrated that treatment with antiarrhythmic drugs (AADs) during the first 6 weeks after atrial fibrillation (AF) ablation reduces the incidence of clinically significant atrial arrhythmias and need for cardioversion or hospitalization for arrhythmia management. Whether early rhythm suppression decreases longer-term arrhythmia recurrence is unknown. The authors now report the 6–month follow-up data from this study.
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Multivessel Awake Off–Pump Coronary Bypass Grafting Using Median Approach: Technical Considerations
Innovations
Official Journal of the International Society for Minimally Invasive Cardiothoracic Surgery
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Permanent Pacemaker Insertion After CoreValve Transcatheter Aortic Valve Implantation: Incidence and Contributing Factors (the UK CoreValve Collaborative)
Circulation
Journal of the American Heart Association
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Acute Coronary Syndrome Pathways: Alignment With a Bundled Care Reimbursement Model
Critical Pathways in Cardiology
Official Journal of the Society of Chest Pain Centers
[Ссылки доступны только зарегистрированным пользователям ]
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Is there a role for surgeons in transcatheter mitral valve procedures?
Current Opinion in Cardiology
[Ссылки доступны только зарегистрированным пользователям ]
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Preventing Heart Disease Today & Tomorrow in Youth
Nutrition Today
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