Обзор американских кардиологических журналов за неделю (ссылки)

[Chevychelov]

Researchers identify risk factors, protective agent for thromboembolism in anticoagulated patients with AF
Lip G. Stroke. 2010;41:2731-2738.

Coronary artery disease, smoking and stroke were among the risk factors for thromboembolism in patients with atrial fibrillation given an anticoagulant, whereas alcohol use protected against the condition, new data indicated.

The study included a cohort of patients (n=7,329) with AF who were using either warfarin or ximelagatran. Researchers tested the predictive value of contemporary risk stratification schemes — including CHADS2, Framingham, NICE 2006, ACC/AHA/ESC 2006 and CHA2DS2-VASc — to identify patients at high risk for stroke despite anticoagulation.

According to multivariate analysis, significant predictors of thromboembolism included stroke/transient ischemic attack (HR=2.24; P<.001), CAD (HR=1.52; P=.0047), smoking (HR=2.10; P=.0005) and age of at least 75 years (HR=1.77; P=.0002); however, alcohol use was found to lower risk for thromboembolism (HR=0.70; P=.02).

Additional analysis revealed CHA2DS2-VASc as detecting the highest rate of patients at risk for the condition (94.2%), whereas most other schemes detected only two-thirds of the population at risk. CHA2DS2-VASc also had the highest HR (3.75) of the tested schemes.

__________________________________________________ ________________________
Vitamin K exposure not linked with dabigatran, warfarin outcomes in RE-LY patients
Ezekowitz M. Circulation. 2010;122:2246-2253.

Vitamin K antagonist exposure did not influence the outcome of two different doses of dabigatran when compared with warfarin among patients with atrial fibrillation, results from an analysis of the RE-LY study indicated.

Researchers of the RE-LY trial tested two doses of dabigatran (Pradaxa, Boehringer Ingelheim) — 110 mg or 150 mg twice daily — against warfarin (Coumadin, Bristol-Myers Squibb) in a population of vitamin K antagonist-naive and vitamin K antagonist-experienced patients with AF (total n=18,113).

Study data indicated that among vitamin K antagonist-naive patients, rates of stroke and systemic embolism were 1.57% per year for dabigatran 110 mg, 1.07% for 150 mg and 1.69% for warfarin. Despite comparable rates between 110-mg dabigatran and warfarin (P=.65), dabigatran at 150 mg was superior to the staple drug (P=.005). Similarly, stroke systemic and embolism rates in vitamin K antagonist-experienced patients did not differ between 110-mg dabigatran and warfarin (P=.32) but did differ in the 150-mg dose (P=.007).

Major bleeding rates also favored both doses of dabigatran but only reached statistical significance among patients given dabigatran at 110 mg in the vitamin K antagonist-experienced arm (P=.003). However, intracranial bleeding rates were significantly lower for both doses of dabigatran when compared with warfarin for vitamin K antagonist-naive and vitamin K antagonist-experienced patients.

“It was believed that patients who were vitamin K antagonist-experienced were likely to do better than patients who are new to anticoagulation because they have demonstrated the ability to comply with an anticoagulation regimen, they have a personalized dose of warfarin that achieves a therapeutic INR, and they have passed the ‘vitamin K antagonist stress test,’ thereby reducing the chance of uncovering major sources of bleeding,” the researchers wrote. “This report found that dabigatran, the novel direct thrombin inhibitor, was better than the comparator warfarin for both vitamin K antagonist-naive and -experienced patients and therefore could be used clinically in both cases.”

The major observation from this sub-study of the RE-LY trial demonstrates that both patients starting dabigatran without prior vitamin K antagonism experience and those switching to dabigatran from a vitamin K antagonism (warfarin) exposure benefit from dabigatran at either dose compared with warfarin. So whether or not patients have previously been anticoagulated with warfarin, they can still benefit from this direct thrombin inhibitor.

The original trial showed that dabigatran at a dose of 110 mg was not inferior and at a dose of 150 mg was superior to warfarin for prevention of stroke and systemic embolism. Importantly, bleeding rates were lower for 110 mg and similar for 150 mg compared with warfarin, whereas intracranial bleeding rates were lower for both dabigatran doses. The remaining question to answer will be whether dabigatran is superior or equivalent to rivaroxaban, a factor Xa inhibitor, shown in the ROCKET AF trial to be noninferior to warfarin on an intention-to-treat analysis and superior in an on treatment analysis in patients with higher CHADS risk scores than in RE-LY.

[Chevychelov]

Stroke dropped to fourth leading cause of death in 2008

Stroke has declined from the third to the fourth leading cause of death for the first time in 50 years, according to a new report published by the CDC.

In the report, titled “Deaths: Preliminary Data for 2008,” the CDC reported that compared with 2007, there were 2,202 fewer deaths from stroke in 2008.

Besides the lower mortality rates, stroke descending to the fourth leading cause of death may also be attributed to the modification made by WHO in the way deaths from chronic lower respiratory disease, which currently occupies the third position, are classified and coded. Now, death certificates that independently mention pneumonia with a chronic lower respiratory problem are classified as “chronic obstructive pulmonary disease with acute lower respiratory infection,” a condition that makes up chronic lower respiratory disease, the report stated.

Nevertheless, the fewer deaths represent an encouraging trend for Ralph L. Sacco, MD, president of the American Heart Association, “which can be attributed in part to improved prevention, and in part to the improved quality of care for stroke patients by hospitals, including the increased use of … thrombolytics and the provision of medications demonstrated effective in preventing recurrent strokes,” Sacco said in a press release.

“However, there are still too many deaths, and more people and their families are living with the aftermath of stroke — physical disabilities, caretaker demands, lost income, and extensive health care and rehabilitation costs,” he said. “There is significantly more work to be done in the prevention and treatment of stroke.”
__________________________________________________ _____________________
Surgeon General’s report: Tobacco smoke causes immediate cellular damage

Any exposure to tobacco smoke – including occasional smoking and secondhand smoke – causes immediate cellular damage and tissue inflammation that can lead to serious illness or death, according to a report released today by US Surgeon General Regina M. Benjamin, MD.

“The chemicals in tobacco smoke reach your lungs quickly every time you inhale causing damage immediately,” Benjamin said in press release. “Inhaling even the smallest amount of tobacco smoke can also damage your DNA, which can lead to cancer.”

The report is Benjamin’s first as U.S. Surgeon General and the 30th tobacco-related Surgeon General’s report since 1964.

"Over the last two years we have stepped up efforts to reduce tobacco use, including implementing legislation to regulate tobacco products, investing in local tobacco control efforts and expanding access to insurance coverage for tobacco cessation" said Health and Human Services secretary Kathleen Sebelius in the release. "This will remain a key priority of this Administration."

The report describes how the chemical mixture in tobacco smoke immediately inflames the lining of the lungs, leading, over time, to chronic obstructive pulmonary disease and emphysema. Repeated exposure to tobacco smoke weakens to body’s ability to heal the damage, the report finds.

The report also explains how cigarettes are designed to be more addictive than ever before. Today’s cigarettes deliver nicotine more quickly and efficiently than cigarettes from previous years, the report claims.

Evidence is presented detailing how smoking causes cardiovascular disease and increases the risk for heart attack, stroke and aortic aneurysm. Even brief exposure to secondhand smoke can cause cardiovascular disease or a heart attack, the report claims, describing how certain chemicals in tobacco smoke damage blood vessels and increase the likelihood of blood clots.

Tobacco smoke also complicates blood sugar control, pregnancy and increases the likelihood of sudden infant death syndrome, according to the report.

“This report makes it clear – quitting at any time gives your body a chance to heal the damage caused by smoking,” Benjamin said in the release. “It’s never too late to quit, but the sooner you do it, the better.”

The full report, entitled How Tobacco Smoke Causes Disease: The Biology and Behavioral Basis for Smoking-Attributable Disease, is available online at: [Ссылки доступны только зарегистрированным пользователям ]

__________________________________________________ _____________________
Increasing CAD detected by cardiac CTA escalated CV event risk
Hulten E. J Am Coll Cardiol. 2011;doi:10.1016/j.jacc.2010.10.011.

Researchers of a study appearing in the Journal of the American College of Cardiology found a direct relationship between increasing coronary artery disease detected via cardiac CTA and an increasing risk for major adverse CV events, including death.

“Although the diagnostic accuracy of cardiac CTA has been reported in [more than] 50 studies and meta-analyses, the prognostic value of cardiac CTA for predicting clinical events is less defined. Our systematic review and meta-analysis is the first comprehensive analysis of multiple recent longitudinal studies describing the prognostic value of cardiac CTA,” the researchers wrote. “We have shown that the absence of CAD on cardiac CTA conveys an excellent prognosis for symptomatic patients being evaluated for suspected CAD.”

In the study, researchers searched databases for longitudinal studies of cardiac CTA that included at least 3 months of follow-up and reported major adverse CV events, including death, MI and revascularization. All patients (n=9,592) had suspected CAD and were compiled from 18 studies.

After a median follow-up of 20 months, the pooled annualized event rate for major adverse CV events for obstructive cardiac CTA — defined as any vessel with more than 50% luminal stenosis — was higher than for normal CTA (8.8% vs. 0.17%; P<.05), as was the event rate for death or MI (3.2% vs. 0.15%; P<.05). The pooled negative likelihood ratio for major adverse CV events after normal cardiac CTA findings was 0.008 (P<.001), 1.70 for the positive likelihood ratio (P<.001), 0.99 for sensitivity (P<.001) and 0.41 for specificity (P<.001).

Additionally, there were incremental increases to adverse events when researchers stratified by no CAD, obstructive CAD and nonobstructive CAD, the latter defined as worst stenosis less than 50%.

[Chevychelov]

Impact of Early Statin Therapy on Development of Atrial Fibrillation at the Acute Stage of Myocardial Infarction: Data From the FAST-MI Register
Danchin N, Fauchier L, Marijon E, et al., on behalf of the French registry of Acute ST-elevation and non-ST-elevation Myocardial Infarction (FAST-MI) Investigators.
Heart 2010;96:1809-1814.
Study Question: What is the correlation between early statin therapy and atrial fibrillation in acute myocardial infarction (AMI)?

Predicting Atrial Fibrillation Recurrence With Circulating Inflammatory Markers in Patients in Sinus Rhythm at High Risk for Atrial Fibrillation: Data From the GISSI Atrial Fibrillation Trial
Masson S, Aleksova A, Favero C, et al.
Heart 2010;96:1909-1914.
Study Question: Are markers of inflammation predictive of recurrent atrial fibrillation (AF)?


Guidelines for the Primary Prevention of Stroke. A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association
Goldstein LB, Bushnell CD, Adams RJ, et al.
Stroke 2010;Dec 2:[Epub ahead of print].
Perspective: The following are 10 points to remember about these guidelines.

Progression of Coronary Artery Calcium Predicts All-Cause Mortality
Budoff MJ, Hokanson JE, Nasir K, et al.
JACC Cardiovasc Imaging 2010;3:1229-1236.
Study Question: Is there a value of serial assessment of coronary artery calcium (CAC) scores as measured by electron beam tomography (EBT) for predicting mortality, and if so, which method of measuring calcium progression is most accurate?

Integrating Tobacco Cessation Into Mental Health Care for Posttraumatic Stress Disorder: A Randomized Controlled Trial
McFall M, Saxon AJ, Malte CA, et al.
JAMA 2010;304:2485-2493.
Study Question: Does integrating a smoking cessation treatment into a mental health program for veterans with posttraumatic stress disorder (PTSD) improve long-term smoking abstinence?
Thigh-Length Versus Below-Knee Stockings for Deep Venous Thrombosis Prophylaxis After Stroke: A Randomized Trial
The CLOTS (Clots in Legs Or sTockings after Stroke) Trial Collaboration.
Ann Intern Med 2010;153:553-562.
Study Question: Are knee-length compression stockings as effective as thigh-high stockings in preventing proximal deep venous thrombosis (DVT) in immobile, hospitalized stroke patients?

Prognostic Value of Cardiac Computed Tomography Angiography: A Systematic Review and Meta-Analysis
Hulten EA, Carbonaro S, Petrillo SP, Mitchell JD, Villines TC.
J Am Coll Cardiol 2010;Dec 8:[Epub ahead of print].
Study Question: This is a detailed meta-analysis of the ability of cardiac computed tomography angiography (CCTA) to predict future cardiovascular events and death.

Angiotensin-Converting Enzyme Inhibitor Associated Cough: Deceptive Information from the Physicians' Desk Reference
Bangalore S, Kumar S, Messerli FH.
Am J Med 2010;123:1016-1030.
Study Question: What is the concordance of the rate of cough reported in the literature with reported rates in the Physicians' Desk Reference (PDR)/drug label?

Effects of Telmisartan Added to Angiotensin-Converting Enzyme Inhibitors on Mortality and Morbidity in Hemodialysis Patients With Chronic Heart Failure: A Double-Blind, Placebo-Controlled Trial
Cice G, Di Benedetto A, D'Isa S, et al.
J Am Coll Cardiol 2010;56:1701-1708.
Study Question: Does the angiotensin-receptor blocker (ARB) telmisartan have a favorable impact on morbidity and mortality in subjects with heart failure and end-stage renal disease (ESRD), who are already on angiotensin-converting enzyme (ACE) inhibitor therapy?

Urban Particulate Matter Air Pollution Is Associated With Subclinical Atherosclerosis: Results From the HNR (Heinz Nixdorf Recall) Study
Bauer M, Moebus S, Möhlenkamp S, et al., on behalf of the HNR Study Investigative Group.
J Am Coll Cardiol 2010;56:1803-1808.
Study Question: Is urban particulate matter (PM) air pollution associated with subclinical atherosclerosis?

An Alternative Isovelocity Surface Model for Quantitation of Effective Regurgitant Orifice Area in Mitral Regurgitation with an Elongated Orifice: Application to Functional Mitral Regurgitation
Rifkin RD, Sharma S.
JACC Cardiovasc Imaging 2010;3:1091-1103.
Study Question: Can a "simple, clinically practical" alternative method for calculating isovelocity surface area (ISVSA) be developed for determination of effective regurgitant orifice area (EROA) in functional mitral regurgitation (MR), where the regurgitant orifice is elongated rather than hemispherical

[Chevychelov]

Title: Troponin-Positive, MB-Negative Patients With Non–ST-Elevation Myocardial Infarction: An Undertreated but High-Risk Patient Group: Results From the National Cardiovascular Data Registry Acute Coronary Treatment and Intervention Outcomes Network–Get With The Guidelines (NCDR ACTION-GWTG) Registry
Date Posted: December 15, 2010
Authors: Kontos MC, de Lemos JA, Ou FS, et al.
Citation: Am Heart J 2010;160:819-825.

Study Question:
What is the effect of troponin (Tn) positive ([+]) status without concomitant elevations in creatine kinase-myocardial band (CK-MB) levels on treatment patterns and in-hospital clinical outcomes among non–ST-elevation myocardial infarction (NSTEMI) patients?
Methods:
Direct arrival patients with NSTEMI enrolled in the American College of Cardiology National Cardiovascular Data Registry Acute Coronary Treatment and Intervention Outcomes Network-Get With The Guidelines (NCDR ACTION-GWTG) Registry were included. Patients missing marker data who were Tn negative ([−]) and had coronary artery disease (CAD) were excluded. Troponin (+) patients were categorized as MB (+) (n = 11,563) or MB (−) (n = 4,501). Treatments and in-hospital outcomes were compared between the two groups using logistic regression.
Results:
Of the 16,064 NSTEMI patients, 28% were MB (−). The MB (−) patients were older (median age 68 vs. 65 years) and had more comorbidities (hypertension 71% vs. 66%, diabetes 31% vs. 27%, heart failure 22% vs. 19%; all p values < 0.01). After adjusting for baseline characteristics, MB (−) patients were significantly less likely to receive clopidogrel, antithrombins, glycoprotein IIb/IIIa antagonists, or angiography (all p values < 0.001). In-hospital mortality was lower in MB (−) patients (3.8% vs. 4.9%, p < 0.01), which remained significant after adjusting for baseline variables (odds ratio 0, 69; 95% confidence interval, 0.6-0.9; p = 0.002).
Conclusions:
The authors concluded that patients without known CAD who have NSTEMI and are MB (−) have a higher risk profile, but are less likely to receive guideline-recommended acute pharmacologic treatment than those who are MB (+).
Perspective:
This study suggests that in a contemporary cohort of patients without prior evidence of coronary disease who present with NSTEMI, approximately 25% of patients may have elevation of Tn without concomitant CK-MB elevation. Furthermore, among Tn (+) patients, those who were CK-MB (−) were significantly less likely than those who were CK-MB (+) to receive clopidogrel, antithrombins, and glycoprotein IIb/IIIa antagonists, or to undergo early cardiac catheterization within 24 hours of admission, despite being older and having more risk factors. Given the relatively high mortality in this group of Tn (+)/CK-MB (−) patients, increased emphasis is warranted on improving the quality of care in these high-risk patients and all patients who meet the current universal definition of MI.
__________________________________________________ _______________________
Title: Association of Prior Coronary Artery Bypass Graft Surgery With Quality of Care of Patients With Non–ST-Segment Elevation Myocardial Infarction: A Report From the National Cardiovascular Data Registry Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With The Guidelines
Date Posted: December 2, 2010
Authors: Kim MS, Wang TY, Ou FS, et al.
Citation: Am Heart J 2010;160:951-957.

Study Question:
What is the association between a history of coronary artery bypass grafting (CABG), current treatment patterns, and in-hospital outcomes using data from the National Cardiovascular Data Registry (NCDR), an initiative from the American College of Cardiology Foundation?
Methods:
The investigators analyzed 47,557 patients with non–ST-segment elevation myocardial infarction (NSTEMI) in the 2007-2008 NCDR Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With The Guidelines. Treatment patterns were compared between patients with and without prior CABG. Multivariable regression with generalized estimating equations was used to evaluate the association between prior CABG and in-hospital outcomes.
Results:
In this study, 8,790 NSTEMI patients (18.5%) had a history of CABG. Prior CABG was associated with a significantly lower adjusted likelihood of early cardiac catheterization (adjusted odds ratio [OR], 0.88; 95% confidence interval [CI], 0.83-0.92), higher rates of short-term clopidogrel use (adjusted OR, 1.08; 95% CI, 1.02-1.14), and comparable use of anticoagulant therapy (adjusted OR, 0.96; 95% CI, 0.88-1.04). Adjusted risks of bleeding and in-hospital mortality did not differ significantly between the two groups (adjusted ORs, 1.00; 95% CI, 0.92-1.11 and 0.99, 95% CI 0.87-1.11, respectively).
Conclusions:
The authors concluded that patients with prior CABG are less likely to undergo guideline-recommended early cardiac catheterization, but equally or more likely to receive guideline-recommended antiplatelet and anticoagulant therapy.
Perspective:
This large national cohort study suggests that patients with prior CABG are less likely to undergo an early invasive treatment strategy, but more likely to receive early clopidogrel and short-term anticoagulant therapy when compared to patients without prior CABG. However, despite lower rates of guideline-recommended early cardiac catheterization, patients with a history of CABG presenting with NSTEMI did not appear to have worse short-term clinical outcomes compared to their non–prior CABG counterparts. Additional studies are indicated to assess the long-term effect of these practice differences as well as the impact of these findings on quality metrics.

[Chevychelov]

Focused update features changes in management of AF
Wann LS. Heart Rhythm. 2011;8:157-176.

The American College of Cardiology, American Heart Association and the European Society of Cardiology have announced changes to the 2006 guidelines for the management of patients with atrial fibrillation, one of which stating that strictly controlling a patient’s heart rate is not beneficial over a more lenient approach.

According to the 2011 Focused Update, based on the findings of several trials, including RACE II and AFFIRM, strict treatment for controlling a patient’s heart rate (<80 beats per minute at rest, <110 during a 6-minute walk) was determined to not be beneficial over a more lenient approach of achieving a resting heart rate of less than 110 beats per minute in patients with persistent AF with stable functioning ventricles.


“The evidence showed rigid control did not seem to benefit patients,” L. Samuel Wann, MD, chair of the focused update writing group and director of cardiology at the Wisconsin Heart Hospital, Milwaukee, said in a press release. “We don’t need to be as compulsive about absolute numbers, particularly doing exercise tests and giving multiple drugs based solely on heart rate.”

Drug-specific updates to the guidelines included: classifying the combination of aspirin and clopidogrel (Plavix, Sanofi-Aventis) as “might be considered” in the prevention of stroke or other types of blood clots in AF patients who are poor candidates for warfarin; and recommending that dronedarone (Multaq, Sanofi-Aventis) not be taken by patients with NYHA Class IV HF or those who have had an episode of decompensated HF in the past 4 weeks, particularly if they have depressed ventricular function.

Also highlighted in the focused update were new or revised recommendations that support catheter ablation as a treatment for maintaining normal heart rhythm. According to the update, catheter ablation “is useful in maintaining sinus rhythm” for patients who have symptomatic paroxysmal AF, who have had no success with drug treatment, who do not have severe lung disease, and who have a normal or mildly dilated left atrium and normal or mildly reduced function of the left ventricle.

Disclosure: Dr. Wann reports no relevant financial disclosures.


In medicine, new data is frequently generated through clinical trials and other opportunities that help us better understand our patients and how they will respond to therapy. Because of these changes, it remains critical for the Heart Rhythm Society and other societies to develop and update guidelines for the practicing clinician. Due to the emergence of new AF clinical trial evidence in recent years, it was time to collaborate with the American Heart Association and the American College of Cardiology to update the 2006 Guidelines for the Management of Patients with Atrial Fibrillation. The information provided in the updated guidelines is timely, relevant and based on the latest evidence from important clinical trials. Sharing this information with physicians will ultimately lead to better safety and effectiveness of treatment for our patients.

[Chevychelov]

FDA declines approval of ticagrelor without additional information

The FDA has issued a complete response letter to AstraZeneca that requests additional analyses of the PLATO data in response to the company’s New Drug Application for its P2Y12 inhibitor, ticagrelor. This comes after the Cardiovascular and Renal Drugs Advisory Committee voted 7-1 in July to recommend approval of the drug for the reduction of thrombotic events in patients with acute coronary syndromes.

According to a press release issued by AstraZeneca, the FDA requested only additional analyses of the data presented in the PLATO trial and did not request that additional studies be conducted as a prerequisite for approval. AstraZeneca will be evaluating the contents of the letter and will respond to the agency’s request for additional analyses of the PLATO data as soon as possible, the release stated.

“Our highest priority is to provide the requested PLATO analyses to the FDA and progress to completion of the Brilinta [ticagrelor] New Drug Approval review,” Martin Mackay, president of research and development at AstraZeneca, said in the release.

Click the links to read Cardiology Today’s coverage of the Cardiovascular and Renal Drugs Advisory Committee vote and of the PLATO trial.

__________________________________________________ ______________________
Cryoballoon catheter approved for treatment of paroxysmal AF

Medtronic’s Arctic Front Cardiac CryoAblation Catheter System has been approved by the FDA for use in the setting of paroxysmal atrial fibrillation, making it the first and only cryoballoon indicated for use in this setting, according to a press release.

The FDA’s approval for the catheter came as a result of the Sustained Treatment of Paroxysmal Atrial Fibrillation (STOP AF) trial, which demonstrated efficacy of the device in the treatment of paroxysmal AF. The cryoballoon has currently been used in more than 10,000 patients in more than 200 centers outside of the United States and will now be available for physicians and patients in this country, the release said.

[Chevychelov]

Biomarkers predicted mortality, hospital readmission in decompensated HF
Xue Y. Eur J Heart Fail. 2010;doi:10.1093/eurjhf/hfq210. S

Small elevations of troponin I and B-type natriuretic peptide in patients with decompensated HF were associated with increased 90-day mortality and hospital readmission, according to researchers at the University of California at San Diego.

Although troponin levels were typically less than detectable levels of contemporary assays and, thus, not used routinely to evaluate patients with HF, new high-sensitive troponin assays make it possible to detect troponin in serum of patients with decompensated HF, according to the report.

The researchers studied 144 patients with acute HF who were followed from the time of their admission to the VA San Diego Medical Center to 90 days after discharge. Blood samples were collected on admission, on discharge and on up to 4 consecutive days during hospitalization. The primary endpoints were all-cause mortality and HF-related readmissions within 90 days after discharge. Troponin levels were able to be quantified in more than 99% of the serum samples.

Of the 144 patients, 38 reached mortality or HF-related readmission. Troponin levels of 23.25 mg/L were associated with an increased risk for mortality and readmission. Mortality and HF-related admission were increased in patients with low troponin and high B-type natriuretic peptide levels; patients with high troponin and low B-type natriuretic peptide levels; and in patients with high troponin and high B-type natriuretic peptide levels. Patients whose levels of troponin increased during treatment also had increased mortality. On multivariate analysis, troponin reached statistical significance but B-type natriuretic peptides did not.

“Troponin trend during hospitalization is an important prognostic factor that needs to be taken into consideration during the treatment course of HF exacerbations,” the researchers wrote.
__________________________________________________ _________________________
High mortality, rehospitalization rates found for Medicare recipients after ischemic stroke
Fonarow G. Stroke. 2010;doi:10.1161/STROKEAHA.110.601831.

Close to two-thirds of Medicare beneficiaries died or were rehospitalized within 1 year of being discharged for ischemic stroke, according to newly published data.

Researchers from the United States and Canada collected and analyzed data from 91,134 Medicare fee-for-service beneficiaries. The patients (mean age, 79.3 years; 58% women) were treated between April 2003 and December 2006 at 625 Get With The Guidelines-Stroke hospitals, a program supported by the American Heart Association and the American Stroke Association.

According to study data, 5,662 patients (6.1%) died during hospitalization for ischemic stroke. The unadjusted mortality rate for 30 days after admission was 14.1%, and at 1 year, it was 31.1%. Overall mortality or readmission rate at 1 year of discharge was 61.9%, with no improvements in either reported during the timeframe of the study.

“This study demonstrates that outcomes early after hospitalization for ischemic stroke for Medicare beneficiaries at the hospital level are often poor,” the researchers wrote, adding that the findings underscore the need for quality improvement interventions and systems of care that will improve early, intermediate and long-term outcomes of patients with acute ischemic stroke

[Chevychelov]

2011 ACCF/AHA/HRS Focused Update on the Management of Patients With Atrial Fibrillation (Updating the 2006 Guideline): A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines
Wann LS, Curtis AB, January CT, et al.
J Am Coll Cardiol 2011;57:223-242.
Perspective: The following are 10 points to remember about these updated guidelines on the management of patients with atrial fibrillation (AF).

Metoprolol Versus Amiodarone in the Prevention of Atrial Fibrillation After Cardiac Surgery: A Randomized Trial
Halonen J, Loponen P, Jarvinen O, et al.
Ann Intern Med 2010;153:703-709.
Study Question: Is metoprolol as effective as amiodarone for preventing post-cardiac surgery atrial fibrillation (AF)?

Chest-Compression-Only Versus Standard Cardiopulmonary Resuscitation: A Meta-Analysis
Hupfl M, Selig HF, Nagele P.
Lancet 2010;376:1552-1557.
Study Question: Does chest-compression-only resuscitation (CCOR) improve outcomes compared to conventional cardiopulmonary resuscitation (CCPR)?

Mortality Resulting From Congenital Heart Disease Among Children and Adults in the United States, 1999 to 2006
Gilboa SM, Salemi JL, Nembhard WN, Fixler DE, Correa A.
Circulation 2010;122:2254-2263.
Study Question: What are the temporal trends of mortality resulting from congenital heart disease from 1999 to 2006?

Prediction of Cardiovascular Events in Statin-Treated Stable Coronary Patients by Lipid and Nonlipid Biomarkers
Arsenault BJ, Barter P, DeMicco DA, et al.
J Am Coll Cardiol 2011;57:63-69.
Study Question: What is the predictive value of lipid and nonlipid coronary heart disease (CHD) risk biomarker levels achieved during statin therapy, and the incidence of major cardiovascular events (MCVEs) in patients with stable CHD?

Multiple Biomarkers at Admission Significantly Improve the Prediction of Mortality in Patients Undergoing Primary Percutaneous Coronary Intervention for Acute ST-Segment Elevation Myocardial Infarction
Damman P, Beijk MA, Kuijt WJ, et al.
J Am Coll Cardiol 2011;57:29-36.
Study Question: What is the predictive ability of multiple biomarkers in ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI)?

Association of Troponin T Detected With a Highly Sensitive Assay and Cardiac Structure and Mortality Risk in the General Population
de Lemos JA, Drazner MH, Omland T, et al.
JAMA 2010;304:2503-2512.
Study Question: What are the prevalence and determinants of detectable cardiac troponin T (cTnT) in the population, and are cTnT levels associated with pathological cardiac phenotypes and subsequent mortality

Troponin-Positive, MB-Negative Patients With Non–ST-Elevation Myocardial Infarction: An Undertreated but High-Risk Patient Group: Results From the National Cardiovascular Data Registry Acute Coronary Treatment and Intervention Outcomes Network–Get With The Guidelines (NCDR ACTION-GWTG) Registry
Kontos MC, de Lemos JA, Ou FS, et al.
Am Heart J 2010;160:819-825.
Study Question: What is the effect of troponin (Tn) positive ([+]) status without concomitant elevations in creatine kinase-myocardial band (CK-MB) levels on treatment patterns and in-hospital clinical outcomes among non–ST-elevation myocardial infarction (NSTEMI) patients?

Telemonitoring in Patients With Heart Failure
Chaudhry SI, Mattera JA, Curtis JP, et al.
N Engl J Med 2010;363:2301-2309.
Study Question: Does telephone-based computerized monitoring improve outcomes in subjects with heart failure (HF)?

Depression as a Potential Modulator of Beta-Adrenergic–Associated Leukocyte Mobilization in Heart Failure Patients
Redwine LS, Wirtz PH, Hong S, et al.
J Am Coll Cardiol 2010;56:1720-1727.
Study Question: Clinical outcomes are worse for patients with heart failure (HF) presenting with symptoms of depression. Is sympathetically modulated immune dysregulation associated with depression one of the mechanisms leading to worse prognosis?

Meta-Analysis: Effect of B-Type Natriuretic Peptide Testing on Clinical Outcomes in Patients With Acute Dyspnea in the Emergency Setting
Lam LL, Cameron PA, Schneider HG, Abramson MJ, Muller C, Krum H.
Ann Intern Med 2010;153:728-735.
Study Question: Does B-type natriuretic peptide (BNP) or N-terminal BNP (NT-BNP) testing in patients presenting to the emergency room (ER) with acute dyspnea impact outcomes?

Fractional Flow Reserve for the Assessment of Nonculprit Coronary Artery Stenoses in Patients With Acute Myocardial Infarction
Ntalianis A, Sels JW, Davidavicius G, et al.
JACC Cardiovasc Intv 2010;3:1274-1281.
Study Question: What is the reliability of fractional flow reserve (FFR) of nonculprit coronary stenoses during percutaneous coronary intervention (PCI) in acute myocardial infarction (AMI)?

[Chevychelov]

Sex bias in cardiovascular testing, intervention due to patient preference
Mumma B. Ann Emerg Med. 2010; doi:10.1016/j.annemergmed.2010.09.026

Despite presenting in ED’s with similar symptoms of acute coronary syndrome, women are less likely than men to receive the appropriate diagnostic tests and interventions because they are less apt to follow their physician’s recommendations, according to a cohort study published in Annals of Emergency Medicine.

Researchers enrolled 1,080 patients, 54% of them women, who presented in the ED with symptoms of acute coronary syndrome; 60% were admitted to the hospital. After receiving an explanation of the potential risks and benefits of each test and intervention, patients were surveyed on their preference for noninvasive procedures versus PCI or coronary artery bypass grafting. Patients were also asked about their predilection for compliance with physician recommendations. After 30 days, 96% of study participants were contacted for follow-up on outcomes.

After their initial hospital admission, women were less likely to receive diagnostic testing of any type (38% vs. 45%; 95% CI for the difference –13% to –1.5%). Cardiac catheterization for women was 7% less than for men (10% vs. 17%; 95% CI –11% to –2%). Revascularization was less frequent in either group (4% vs. 6%; 95% CI –5% to 0.6%).

Women and men both preferred stress tests to catheterization (58% vs. 52%; 95% CI –0.06% to 12%), and the proportion of both groups stating they would accept medical advisement for stress testing was similar (85% for both). However, women were less likely than men to state their acceptance for cardiac catheterization (65% vs. 75%; 95 CI –15% to –4%). Women also were less inclined to choose PCI over medical therapy (67% vs. 73%; 95% CI for difference 12% to 0.5%) and less likely to choose coronary artery bypass grafting over medical therapy (61% vs. 68%; 95% CI for difference –13% to 1%).

The researchers posited the disparity in testing and treatment was due in part to women being more risk-averse than men, and to women’s perception that their disease was not severe. “Future studies should focus on delineating why women appear less likely than men to accept physician-recommended evaluation of potential acute coronary syndromes,” the researchers wrote.
__________________________________________________ ________________________
Whey protein beverages lowered BP in young adults
Fluegel S. Int Dairy J. 2010;doi:10.1016/j.idairyj.2010.06.005.

Beverages supplemented with whey protein were associated with lower BP in young adults who had slightly elevated BP or prehypertension, according to researchers from Washington State University.

“Due to the side effects of pharmacological treatment, many people are interested in using diet to control hypertension,” the researchers wrote. “Dairy products contain compounds and minerals that may lower blood pressure, and consumption of dairy and fermented milk products has been associated with lower blood pressure.”

The researchers created whey beverages using whey protein concentrate 80 (WPC80 TemPro, Leprino Foods). Half of the beverages also contained supplemental whey protein, whereas the other half of the beverages served as the control group. Volunteers were recruited using advertisements. The study population was students aged 18 to 26 years, whose BP measurements were taken at the initial screening.

The students were randomly assigned to consume either 28 g per day of the control whey beverage or 28 g per day of the beverage with supplemental protein (along with consuming a normal diet). Among the 71 students enrolled, 25 had normal systolic and diastolic BP at baseline, 42 had prehypertension and four had stage I hypertension.

After 6 weeks of consuming the whey beverages, there was no difference in systolic BP, diastolic BP or mean arterial pressure between the two groups. In the young adults who began the study with elevated diastolic BP and/or systolic BP, the consumption of the whey beverages decreased the systolic BP by 8 mm Hg, decreased the diastolic BP by 8.6 mm Hg and decreased the mean arterial pressure by 6.4 mm Hg.

“The average BP decreases seen in this study are significant from a public health point of view,” the researchers wrote. “Similar decreases in systolic BP and diastolic BP have been associated with large reductions in the risk of stroke, heart disease and overall mortality.”

[Chevychelov]

Pre-cath abciximab before primary PCI linked to higher infarct-related artery patency rates
Prati F. J Am Coll Cardiol Intv. 2010;3:1284-1291.

Pre-cath lab administration of abciximab, both alone and with half-dose reteplase, when preceding primary percutaneous coronary intervention led to higher rates of infarct-related artery patency at baseline coronary angiography vs. standard primary percutaneous coronary intervention, according to data from the FINESSE-ANGIO trial.

Researchers for the Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events-Angiographic (FINESSE-ANGIO) study tested the effects of three different treatments — pre-cath lab administration of half-dose reteplase (Retavase, EKR Therapeutics) plus abciximab (ReoPro, Centocor), abciximab alone or abciximab administered directly before primary PCI — on patency of infarct-related artery during basal coronary angiography. The trial included 637 patients from the FINESSE study.

According to results, patients taking reteplase plus abciximab experienced higher rates of baseline infarct-related artery patency when compared with abciximab alone (76.1% vs. 43.7%; P<.0001) and abciximab taken immediately before PCI procedure (76.1% vs. 32.7%; P<.0001). No significant differences were reported in the post-PCI thrombolysis in MI or the rates of post-PCI TIMI flow grade 3, myocardial blush grade 2/3.

“Primary PCI preceded by pre-catheterization treatment with abciximab alone, and especially with abciximab plus half-dose reteplase, resulted in higher [infarct-related artery] patency rates at baseline coronary angiography compared with standard primary PCI,” the researchers wrote. “Whether clinical benefit correlated with pharmacologically induced or improved pre-PCI myocardial reperfusion may be restricted to higher risk subsets remains to be determined by future prospective studies.”

In an accompanying editorial, Bernard J. Gersh, MB, ChB, DPhil, of the Mayo Clinic, Rochester, Minn.,and Gregg W. Stone, MD,of Columbia University Medical Center, New York, commented on the importance of early treatment.

“For decades, we have appreciated that acute MI is a time-critical phenomenon and that early therapy is crucial for myocardial recovery, especially in the hyperacute phase, when ‘time is myocardium.’ Educating the public to seek treatment at an early stage after symptom onset is likely to reduce mortality to a greater degree than pharmacological facilitation before PCI, although translation of this goal to reality in a community setting is and will continue to be extremely difficult,” Gersh and Stone said.

Disclosure: This study was coordinated in part with research funding from Centocor. Dr. Stone and Dr. Gersh report no relevant financial disclosures.
__________________________________________________ _______________________
Fetal antiretroviral therapy exposure may impair myocardial growth, improve depressed LV function
Lipshultz S. J Am Coll Cardiol. 2011;57:76–85.

Fetal exposure to antiretroviral therapy led to reductions in left ventricular mass and dimension and septal wall thickness, as well as increased left ventricular fractional shortening and contractility. Researchers concluded that exposure to this therapy may cause impairments to myocardial growth while also causing improvements to depressed left ventricular function.

“Abnormalities of LV structure and function are associated with HIV infections, possibly with antiretroviral therapy (ART), and even mild abnormalities independently predict mortality in HIV-infected children,” Steven E. Lipshultz, MD, study investigator, and colleagues wrote. “Nearly 10,000 ART-exposed and HIV-exposed but negative infants are born annually in the US, but are not routinely followed for suspicion of heart disease.”

The US-based researchers analyzed two cohorts of HIV-negative children born to HIV-positive mothers to study the cardiac effects of perinatal exposure to ART. The final study population included 136 ART-exposed, HIV-negative infants from the CHAART-1 trial and 216 non-ART-exposed, HIV-negative infants from the P2C2 HIV study.

According to researchers, unadjusted LV mass z score for CHAART-1 infants at 2 years of age was 0.53 standard deviation (SD) less than in the P2C2 HIV cohort (P=.006), an association that remained, even after adjusting for factors such as sex and ethnicity. Conversely, at 2 years of age, unadjusted LV fractional shortening z score for the ART-exposed infants was 0.45 SD more than that of the non-exposed infants (P=.01). Researchers also reported that septal wall thickness and LV dimension were smaller than expected in ART-exposed
infants, but LV contractility was roughly 1 SD higher at all ages (P<.001).

Based on this data, “We speculate that in utero exposure to ART may impair myocardial growth while initially improving LV function, although LV function was less than normal. These effects are more pronounced in girls,” the researchers wrote. “These findings clearly indicate a need for long-term monitoring of these infants to better define the mechanism of these effects and to evaluate their long-term clinical importance.”
__________________________________________________ _________________________
Complication rates low among patients assigned anticoagulation, antiplatelet therapies undergoing CEA
Rosenbaum A. Ann Vasc Surg. 2010;doi:10.1016/j.avsg.2010.06.007.

Patients assigned anticoagulation and antiplatelet therapies who underwent carotid endarterectomy had a low rate of complications, including MI and stroke, according to data from a retrospective review.

“The number of cases involving patients undergoing vascular procedures who are prescribed clopidogrel or warfarin as treatment options continues to rise,” the researchers wrote. “Our aim was to examine outcomes related to antiplatelet or anticoagulation therapy in patients undergoing carotid endarterectomy. … Similar to previously published data, we reported a low incidence of perioperative stroke, MI and death in patients who underwent carotid endarterectomy and who were either on aspirin, clopidogrel or warfarin.”

Researchers from the Minneapolis Heart Institute Foundation performed the review, which included 260 consecutive patients (mean age, 69.3 years) who were undergoing carotid endarterectomy (CEA) between June 2006 and April 2009. Overall, 171 patients were assigned aspirin, 50 were assigned clopidogrel with or without aspirin, and 10 were assigned warfarin, with the remaining 29 patients not assigned any therapy.

During a mean follow-up of 406 days, researchers reported a complication rate of 7.3% and rates of 30-day stroke of 0.7% and stroke death of 1.1%. Overall, patients who were assigned aspirin, warfarin or clopidogrel had a low incidence of perioperative stroke, MI and death. Additionally, patients assigned clopidogrel were at the highest risk of complication, which the researchers attributed to the higher rates of neck hematomas among patients assigned the drug (16%) when compared with the other three arms (aspirin, 1.7%; warfarin, 0%; no therapy, 0%).

[Chevychelov]

The most popular news stories that appeared on TCTMD in 2010 provide a snapshot of the year in interventional cardiology with a strong focus on stenting and adjunct pharmacology. Below are the 10 most read stories from the past year in descending order. Interestingly, the most popular story was dissimilar from the rest, describing a novel vascular access technology.

1. From TCT 2010: Vascular Access Device Achieves Low Complication Rates

WASHINGTON, DC—A novel vascular access device produces acceptable compression times and low complication rates, according to a first-in-man study of over 1,000 patients. The product is intended to facilitate access to the common femoral artery and to achieve hemostasis without the use of a closure device. (Read more…)

2. From JACC: Cardiovascular Interventions: FFR Guidance for Questionable Lesions Dramatically Cuts Stenting vs. IVUS

Physiological assessment of intermediate lesions with fractional flow reserve (FFR) reduces percutaneous coronary interventions by two thirds compared with intravascular ultrasound (IVUS) evaluation, according to a retrospective study published in the August 2010 issue of JACC: Cardiovascular Interventions. (Read more…)

3. From AHA 2010: Final Results Provide CLOSURE on Device Therapy for PFOs, Cryptogenic Stroke

CHICAGO, IL—While the announcement that CLOSURE I failed to achieve its primary endpoint came months ago on June 17, 2010, the full results of the randomized study were not formally released until Monday, November 15 at the American Heart Association Scientific Sessions 2010. The findings provide even stronger evidence that percutaneous device closure lacks superiority over medical therapy alone in preventing recurrent stroke and mortality in patients with patent foramen ovale (PFO). (Read more…)

4. From ACC/i2 2010: Studies Compare Multiple Drug-Eluting Stents

ATLANTA, GA—Two late-breaking clinical trials presented Monday, March 15, 2010, at the ACC/i2 Summit show mixed results for Endeavor when tested against a first-generation and a next-generation drug-eluting stent (DES). In SORT OUT III, Endeavor continued to lag behind Cypher at 18 months, with the exception of cardiac death and Academic Research Consortium-defined definite stent thrombosis. The ISAR-TEST-2 trial, meanwhile, showed durable results at 2 years for both Endeavor and a polymer-free sirolimus- and probucol-eluting stent referred to as Dual DES. (Read more…)

5. From JACC: IVUS Offers Insights into Very Late Stent Thrombosis with DES, BMS

IVUS findings suggest that very late stent thrombosis may arise by different mechanisms. Disease progression culminating in neointimal or plaque rupture is associated with the event in both DES and bare metal stents (BMS), while stent malapposition is typically found only in DES thrombosis. The findings appear in a study published in the May 4, 2010, issue of the Journal of the American College of Cardiology. (Read more…)

6. From TCT 2010: SPIRIT III: Everolimus-Eluting Stent Safety, Efficacy Maintained at Four-Year Follow-Up

WASHINGTON, DC—The use of everolimus-eluting stents compared with paclitaxel-eluting stents resulted in significantly reduced rates of the composite safety and efficacy measures of target lesion failure (TLF) and major adverse cardiac events (MACE), according to four-year data from the SPIRIT III trial presented at TCT 2010. In addition, there was no evidence of late catch-up in target lesion revascularization (TLR). (Read more…)

7. From ACC/i2 2010: Extending Clopidogrel Beyond 12 Months Not Supported

ATLANTA, GA—Use of dual antiplatelet therapy after implantation of a DES for longer than 12 months does not reduce rates of myocardial infarction (MI) or cardiac death more than aspirin monotherapy, according to late-breaking trial results presented Monday, March 15, 2010, at the annual American College of Cardiology Scientific Session/i2 Summit. (Read more…)

8. From TCT 2010: SYNTAX at 3 Years: PCI Matches CABG in Left Main Disease

WASHINGTON, DC—New results from the SYNTAX trial showed that patients with three-vessel disease derive less benefit from PCI than from CABG at 3 years. But in left main disease patients, both treatments remain equally safe and effective over the same period, according to 2 clinical trial presentations at TCT 2010. (Read more…)

9. From TCT 2010: HORIZONS-AMI at 3 Years: Taxus, Bivalirudin Hold Their Lead

WASHINGTON, DC—At 3 years, STEMI patients who underwent PCI with bivalirudin and paclitaxel-eluting stents continue to fare best over the long-term compared with those receiving heparin plus a glycoprotein IIb/IIIa inhibitor and a BMS, according to late-breaking results from HORIZONS-AMI. (Read more…)

10. From JACC: Selective In-Lab Clopidogrel a Safe Alternative to Pretreatment

Giving patients a 600-mg loading dose of clopidogrel in the cath lab after diagnostic angiography to establish the need for PCI yields outcomes comparable to routine preloading, according to a study published in the August 10, 2010, issue of the Journal of the American College of Cardiology. The wait-and-see approach to clopidogrel administration avoids unnecessary bleeding risk in patients for whom bypass surgery or medical therapy is deemed more appropriate than PCI. (Read more…)

[Chevychelov]

Type 1 diabetes mortality rates decreasing
Secrest AM. Diabetes Care. 2010;33:2573-2579.

Mortality rates for people with type 1 diabetes are decreasing, however, overall rates remain seven times higher than those for the general population, a new study reported.

While researchers at the University of Pittsburgh found no significant differences in mortality rates between sexes, women with type 1 diabetes were 13 times more likely to die compared with women who did not have diabetes. The researchers also discovered differences between races: a much higher proportion of blacks with type 1 diabetes (50.6%) died compared with whites (24%).


“This study was an attempt to document mortality rates of childhood-onset type 1 diabetes over the years, including how rates have improved and how they vary by race,” Trevor Orchard, MD, of the department of epidemiology, Graduate School of Public Health, University of Pittsburgh, told Cardiology Today. “The remarkable finding is the dramatic decline in mortality seen throughout the study for those in later diagnosed cohorts.”

Declines over time

Orchard and colleagues used the childhood-onset type 1 diabetes registry in Allegheny County, Pennsylvania, to identify 1,075 people diagnosed with type 1 diabetes from 1965 to 1979. The cohort was divided into three groups: those diagnosed from 1965 to 1969; 1970 to 1974; and 1975 to 1979. As of Jan. 1, 2008, the researchers ascertained the vital status for 1,043 of the 1,075 people identified. There were 34,363 total person-years of follow-up.

During a median follow-up of 33 years, 279 patients with type 1 diabetes died.

According to other results, men with type 1 diabetes were five times more likely to die compared with men in the general population. There was no difference in mortality between black people with type 1 diabetes compared with black men in the general population.

Mortality rates were lowest for those diagnosed in the late 1970s and highest for those diagnosed in the late 1960s. The standard mortality ratios were 9.3 in those diagnosed from 1965 to 1969, 7.5 in those diagnosed from 1970 to 1974, and 5.6 in those diagnosed from 1975 to 1979. The mortality rate was lower in participants who were diagnosed when younger than 10 years vs. those diagnosed when aged 10 years or older.

The mean age of the participants was 42.8 years, and the mean duration of diabetes was 32 years.

Advances in past decades

The researchers postulated that the main improvement in patients who were most recently diagnosed with type 1 diabetes may be related to dramatic reductions in mortality in the first 5 years of diagnosis. Additionally, they attributed improved rates to better management and awareness of diabetes control and acute complications during the 1980s and 1990s, particularly blood glucose self-monitoring, HbA1c testing and use of blood pressure medications such as angiotensin-converting enzyme inhibitors.

“Women appeared to do poorly, but that is improving. Black people have a particularly poor prognosis, but we think this is partly related to socioeconomic status,” Orchard said. “Things are improving considerably, and I am sure mortality is even better with the advances in treatment since those diagnosed in the 1960s and 1970s.” – by Emily Shafer

The latest that this group was diagnosed was 1979, which was before we had any of the current methods of treatment. Blood glucose monitoring was initiated in the late 1970s, replacing urine glucose testing. The development of the rapid-acting and basal insulin analogues in the 1980s allowed for the more physiologic basal bolus method of administering insulin. We also weren’t attuned to use of ACE inhibitors and lipid-lowering drugs in children, like we are today, for abnormal cardiovascular risk factors. So while the findings of this study may certainly be true for people diagnosed in this timeframe, it is anticipated that those people diagnosed in the 1990s and later will have even better long-term outcomes. It is important to note that these people were all diagnosed in childhood, making us even more aware that the complications of diabetes, especially the CV complications, begin early, and we need to be careful about monitoring for CV disease in our teens and young adults, especially.
__________________________________________________ ___________________
Rivaroxaban may offer safe, effective treatment of venous thrombosis
Bauersachs R. N Engl J Med. 2010;363:2499-2510.

Researchers have reported that rivaroxaban may provide a single-drug approach to the short-term and continued treatment of venous thrombosis and may improve the benefit-to-risk profile of anticoagulation.

The Acute DVT trial, one of three randomized trials of the EINSTEIN program, was an open-label, event-driven, noninferiority study comparing oral rivaroxaban (Xarelto, Bayer; n=1,731) with enoxaparin plus a vitamin K antagonist (n=1,718) for 3, 6 or 12 months in patients with acute, symptomatic deep vein thrombosis. Researchers also carried out a continued treatment trial, which was a randomized, double blind, event-driven superiority study comparing rivaroxaban alone (n=602) with placebo (n=594) for an additional 6 or 12 months in patients who had completed 6 to 12 months of treatment for venous thromboembolism.

Results from the Acute DVT trial indicated noninferiority efficacy for rivaroxaban regarding the primary efficacy outcome of recurrent venous thromboembolism (2.1% vs. 3%; HR=0.68; 95% CI, 0.44-1.04). The principal safety outcome of major bleeding or clinically relevant nonmajor bleeding occurred in 8.1% of the patients in both groups.

According to data from the continued-treatment trial, rivaroxaban had a superior event rate of recurrent venous thromboembolism compared with placebo (1.3% vs. 7.1%; HR=0.18; 95% CI, 0.09-0.39).

This led researchers to conclude that “oral rivaroxaban, at a dose of 15 mg twice daily for the first 3 weeks, followed by 20 mg once daily thereafter, without the need for laboratory monitoring, may provide an effective, safe, single-drug approach to the initial and continued treatment of venous thrombosis.”

[Chevychelov]

Biomarkers improved prediction of mortality in patients with STEMI undergoing primary PCI
Damman P. J Am Coll Cardiol. 2011;57:29-36.

The addition of a multimarker to a model that included established risk factors benefited the prediction of mortality in patients with STEMI who were undergoing primary percutaneous coronary intervention.

“This is one of the first studies to evaluate a multimarker approach for the prediction of baseline risk of long-term death in patients undergoing primary PCI for STEMI,” the researchers wrote. “Incorporation of … three predictive biomarkers in the multimarker risk score yields important information regarding baseline risk and mortality.”

The study included 1,034 patients with STEMI undergoing primary PCI from an intervention center in the Netherlands between Jan. 1, 2005, and Jan. 1, 2007. Researchers tested whether combining N-terminal pro-brain natriuretic peptide, CRP, glucose, cardiac troponin T and estimated glomerular filtration rate improved mortality prediction.

During a mean follow-up of 901 days, 120 patients died. Statistically significant predictors of mortality included glucose, N-terminal pro-brain natriuretic peptide and estimated glomerular filtration rate.

According to researchers, a risk score that incorporated these three biomarkers identified a high-risk STEMI subgroup with a higher mortality vs. an intermediate- or low-risk subgroup (P<.001). Additionally, the three biomarkers, when added to established prognostic factors, improved mortality prediction, which was indicated by the net reclassification improvement (P<.001) and integrated discrimination improvement (P<.01).

“The study provides important pathophysiological information confirming the common roots of ACS, either ST segment elevation or non-ST elevation, and promising clinical improvements in STEMI treatment,” Luigi M. Biasucci, MD, and Roberta Della Bona, MD,both with the department of cardiology, Catholic University of the Sacred Heart, Rome, wrote in an accompanying editorial. “Although their efforts fell short of the objectives, we hope that they will contribute to a more accurate and individualized prognostication and therapy, with consequent reduction in events and the flourishing of novel pathophysiological information.”

__________________________________________________ _____________________
Paclitaxel-eluting stent benefits comparable between men, women
Mehran R. J Am Coll Cardiol Intv. 2010;3:1260-1261.
Mikhail GW. J Am Coll Cardiol Intv. 2010;3:1250-1259.

Women undergoing percutaneous coronary intervention treated with a paclitaxel-eluting stent had similar benefits to men who underwent the same procedure, study data indicated.

“To our knowledge, the ‘TAXUS Woman’ analysis, which included more than 3,000 women, is the largest evaluation to date that examines the influence of sex on long-term performance of a single drug-eluting stent across low- to high-risk patient/lesion characteristics,” the researchers wrote. “This analysis demonstrated that women had significantly more adverse baseline risk factors, yet had comparable safety and efficacy outcomes to men.”

The study included 3,114 women and 6,649 men from five randomized trials and two “real-world” registries who were undergoing PCI with a paclitaxel-eluting stent (Taxus, Boston Scientific). Researchers used outcomes of women (n=395) from the trials treated with bare metal stents as a comparison.

Data specific to the randomized trials revealed that women treated with a paclitaxel-eluting stent had a lower rate of target lesion revascularization than women treated with a bare metal stent (11.5% vs. 22.6%; P<.001). Between both stent groups, there were no significant sex-based differences in death, target lesion revascularization, stent thrombosis and MI at 5 years.

When data from both the trials and registries were analyzed, researchers found that women had similar outcomes as men despite having more adverse baseline characteristics, including advanced age, hypertension and diabetes. Conversely, in the expanded-use cohort — those considered to have patient and/or lesion characteristics considered outside the simple-use population, such as lesion length >28 mm and reference vessel diameter <2.5 mm — women had significantly higher rates of death and target lesion revascularization, although only target lesion revascularization remained higher after multivariate analysis.

In an accompanying editorial, Roxana Mehran, MD, and Annapoorna S. Kini, MD, of the Mount Sinai School of Medicine, New York, said they questioned whether this study was powered enough to provide a definitive conclusion regarding the effectiveness of paclitaxel-eluting stents in women compared with men.

“Although close to 10,000 patients were studied in these well-controlled trials, women represented only a small minority of the population. Therefore, the true comparative effectiveness study of paclitaxel-eluting stent vs. bare metal stent in women was based on only 1,050 female subjects (655 paclitaxel-eluting stent vs. 395 bare metal stent) and was hardly powered to answer the question of safety and efficacy of paclitaxel-eluting stent in women,” they wrote.
__________________________________________________ ______________________
NanoCross catheters recalled

The company ev3 has initiated a voluntary recall of the NanoCross .014” OTW PTA Dilation Catheter because of the potential of cracking or breaking during use. The FDA has classified this as a class I recall.

A cracked or broken catheter shaft could result in the inability to inflate or deflate the balloon, resulting in material separation and possible embolization. This could cause unplanned intravascular or open surgery, vasospasm, prolonged tissue ischemia, bleeding and/or death.

The NanoCross .014” OTW PTA Dilation Catheter is used to dilate stenosis in the iliac, femoral, iliofemoral, popliteal, infra-popliteal and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The recall affects certain lots of the NanoCross .014” OTW PTA Dilation Catheters manufactured between May 27, 2010 and October 18, 2010. Only the catheters from the lots specified on this site are affected by the recall.

[Chevychelov]

Catheter Ablation for Atrial Fibrillation: Are Results Maintained at 5 Years of Follow-Up? Weerasooriya R, Khairy P, Litalien J, et al.
J Am Coll Cardiol 2011;57:160-166.
Study Question: What is the long-term efficacy of radiofrequency catheter ablation (RFCA) of atrial fibrillation (AF)?

Ticagrelor Versus Clopidogrel in Patients With Acute Coronary Syndromes Undergoing Coronary Artery Bypass Surgery: Results From the PLATO (Platelet Inhibition and Patient Outcomes) Trial
Held C, Åsenblad N, Bassand JP, et al.
J Am Coll Cardiol 2011;Dec 29:[Epub ahead of print].
Study Question: What is the efficacy and safety of ticagrelor and clopidogrel in patients with acute coronary syndrome (ACS) undergoing coronary artery bypass graft surgery (CABG)?

Cardiac Outcomes After Pregnancy in Women With Congenital Heart Disease
Balint OH, Siu S, Mason J, et al.
Heart 2010; 96:1656-1661.
Study Question: What are the frequency and determinants of late cardiac events (LCEs) after pregnancy in women with congenital heart disease?

“Do GRACE (Global Registry of Acute Coronary events) risk scores still maintain their performance for predicting mortality in the era of contemporary management of acute coronary syndromes?”
Abu-Assi E, Ferreira-González I, Ribera A, et al.
Am Heart J 2010;160:826-834.
Study Question: What is the performance of the GRACE risk scores (RS) for risk stratification in acute coronary syndromes (ACS) in the era of contemporary management of ACS?

Influence of Age on Associations Between Childhood Risk Factors and Carotid Intima-Media Thickness in Adulthood: The Cardiovascular Risk in Young Finns Study, the Childhood Determinants of Adult Health Study, the Bogalusa Heart Study, and the Muscatine Study for the International Childhood Cardiovascular Cohort (i3C) Consortium
Juonala M, Magnussen CG, Venn A, et al.
Circulation 2010;122:2514-2520.
Study Question: Does age influence the association between childhood risk factors and carotid intima-media thickness (IMT) in adulthood?

Apixaban Versus Enoxaparin for Thromboprophylaxis After Hip Replacement
Lassen MR, Gallus A, Raskob GE, et al.
N Engl J Med 2010;363:2487-2498.
Study Question: What is the relative efficacy and safety of apixaban compared to enoxaparin for thromboprophylaxis following hip replacement?

Variability in the Measurement of Hospital-Wide Mortality Rates
Shahian DM, Wolf RE, Iezzoniet LI, et al.
N Engl J Med 2010;363:2530-2539.
Study Question: What is the clinical rationale, usefulness for informing consumers and practitioners, and statistical method for calculating hospital-wide mortality rates as performance metrics?

Relation Between Renal Function and Response to Cardiac Resynchronization Therapy in Multicenter Automatic Defibrillator Implantation Trial—Cardiac Resynchronization Therapy (MADIT-CRT)
Goldenberg I, Moss AJ, McNitt S, et al.
Heart Rhythm 2010;7:1777-1782.
Study Question: Are markers of prerenal azotemia associated with the response to cardiac resynchronization therapy (CRT)?

Symmetrical and Asymmetrical Dimethylarginine as Predictors for Mortality in Patients Referred for Coronary Angiography: The Ludwigshafen Risk and Cardiovascular Health Study
Meinitzer A, Kielstein JT, Pilz S, et al.
Clin Chem 2011;57:112-121.
Study Question: Asymmetrical dimethylarginine (ADMA), an endogenous nitric oxide synthase inhibitor, has been linked to cardiovascular risk. What is the clinical role of its structural isomer, symmetrical dimethylarginine (SDMA)?

Secondary Prevention After Coronary Artery Bypass Graft Surgery: Findings of a National Randomized Controlled Trial and Sustained Society-Led Incorporation Into Practice
Williams JB, DeLong ER, Peterson ED, Dokholyan RS, Ou FS, Ferguson TB Jr, on behalf of the Society of Thoracic Surgeons and the National Cardiac Database.
Circulation 2011;123:39-45.
Study Question: What are the effects of low-intensity continuous quality improvement (CQI) interventions on secondary prevention adherence after coronary artery bypass grafting (CABG)?

[Chevychelov]

Promising stroke, bleeding rates after cardioversion reported with dabigatran use
Nagarakanti R. Circulation. 2011;123:131-136.

Stroke and major bleeding rates after cardioversion among patients from the RE-LY trial who were taking two doses of dabigatran were low and comparable with those who were treated with warfarin.

In the sub-analysis, investigators analyzed 1,983 cardioversions that were performed on 1,270 patients with nonvalvular atrial fibrillation from the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial. Overall, 647 procedures were performed on patients assigned 110 mg dabigatran (Pradaxa, Boehringer Ingelheim) twice-daily, 672 procedures on those assigned 150 mg dabigatran twice-daily and 664 procedures in patients assigned warfarin (Coumadin, Bristol-Myers Squibb).

At 30 days, stroke and systemic embolism rates were 0.8% in the 110-mg dabigatran arm, 0.3% in 150-mg dabigatran arm and 0.6% in the warfarin group, with differences between both doses of dabigatran not reaching statistical significance when compared with warfarin. Similarly, major bleeding rates between 110 mg dabigatran (1.7%) and 150 mg dabigatran (0.6%) were comparable with warfarin (0.6%).

“The RE-LY trial confirmed the efficacy and safety of warfarin in cardioversion in a large cohort of warfarin-treated patients. It also allowed comparison with the new oral anticoagulant dabigatran. The results show that the two drugs are comparable in this setting,” the researchers concluded.
__________________________________________________ _______________________
Quality measurement of anticoagulation care delivery may lead to better outcomes
Rose A. Circ Cardiovasc Qual Outcomes.2011;doi:10.1161/circoutcomes.110.957738.

New study results have indicated that use of risk-adjusted percent time in therapeutic range data may help oral anticoagulant care delivery sites, especially in large integrated health systems, prevent adverse events from inadequate or excessive anticoagulation. The findings were published online by researchers from Boston University School of Medicine and Bedford Veterans Affairs Medical Center

The researchers profiled the performance of 100 VA outpatient anticoagulation sites based on their respective risk-adjusted percent time in therapeutic range (TTR). Two years of data were collected on 124,551 patients who had received warfarin (Coumadin, Bristol-Myers Squibb) for at least 30 days and had at least two valid intervals of 56 days or less without hospitalization between two INR values. Patients with valvular CVD or with INR values of no more than 1.2 were excluded.

The expected TTR for each patient and each site was calculated based on a risk-adjusted model that included demographics, comorbidities, medications and hospitalizations. The expected TTR site range was 54% to 62%; the observed TTR site range was 38% to 69%. The mean TTR for the entire sample was 58%. Site risk-adjusted performance was 18% less than to 12% more than expected. One site with a challenging patient population (expected TTR, 53.5%; 4.4% less than average) was ranked 27th before risk adjustment (observed TTR, 60.6%; 2.7% more than average) but seventh after risk adjustment, the researchers said. Conversely, another site was ranked 79th before risk adjustment (observed TTR, 53.8%; 4.1% less than average), but “because of its relatively easy case mix” (expected TTR, 58.9%), the site dropped to 92nd.

“Risk adjustment is important for enhancing the credibility of site profiling; without [it], sites could claim that their poor performance was solely because of their case mix,” the researchers wrote. They said risk-adjusted site rankings were consistent from year to year, suggesting their study measured a “quality of care that is stable over time.”