Обзор американских кардиологических журналов за неделю (ссылки)

[Chevychelov]

Title: Risk Score to Predict Serious Bleeding in Stable Outpatients With or at Risk of Atherothrombosis
Topic: Prevention/Vascular
Date Posted: 3/22/2010
Author(s): Ducrocq G, Wallace JS, Baron G, et al., on behalf of the REACH Investigators.
Citation: Eur Heart J 2010;Feb 24:[Epub ahead of print].
Clinical Trial: No
Study Question: What are the predictors of bleeding in outpatients with atherothrombosis?
Methods: The authors developed a risk model to predict major bleeding in 68,236 patients with or at risk of atherothrombosis enrolled in the REACH registry. The primary endpoint was serious bleeding (nonfatal hemorrhagic stroke or bleeding leading to hospitalization and transfusion) over 2 years. Risk factors for bleeding were assessed using modified regression analysis. Multiple potential scoring systems based on the least complex models were constructed and competing scores were compared on their discriminative ability. The final score was validated externally using the CHARISMA population.
Results: Serious bleeding occurred in 804 (1.42%, 95% confidence interval 1.32-1.52) patients between baseline and 2 years. A nine-item bleeding risk score was constructed based on age, peripheral arterial disease, congestive heart failure, diabetes, hypertension, smoking, antiplatelets, oral anticoagulants, and hypercholesterolemia, and the score ranged from 0-23 points. Observed incidence of bleeding at 2 years was 0.46% in patients with a score of ≤6, 0.95% with a score of 7-8, 1.25% with a score of 9-10, and 2.76% with a score of 11 or greater. The score had moderate discrimination in the CHARISMA (c-statistic 0.64) and REACH population (c-statistics 0.68).
Conclusions: This score can help predict future risk of bleeding in patients with atherothrombosis.
Perspective: The issue of bleeding in patients with atherothrombosis is becoming more relevant since a large number of patients are being placed on prolonged (and even lifelong) antithrombotic and/or antiplatelet therapy. This problem is likely to be compounded in the near future as more potent antiplatelet and antithrombotic drugs are approved for clinical use. This risk score provides the first step towards quantifying bleeding risk in patients with atherothrombosis, and further studies are warranted to confirm if the use of this score can help improve patient outcome. Hitinder S. Gurm, M.B.B.S., F.A.C.C

Title: The Risk of Thromboembolism and Need for Oral Anticoagulation After Successful Atrial Fibrillation Ablation
Topic: Arrhythmias
Date Posted: 3/19/2010
Author(s): Thermistoclakis S, Corrado A, Marchlinski FE, et al.
Citation: J Am Coll Cardiol 2010;55:735-743.
Clinical Trial: No
Related Resources
JACC Article: The Risk of Thromboembolism and Need for Oral Anticoagulation After Successful Atrial Fibrillation Ablation

Study Question: Is it safe to discontinue oral anticoagulation therapy (OAT) after catheter ablation of atrial fibrillation (AF)?
Methods: This was a multicenter, retrospective analysis of 3,355 patients who underwent catheter ablation of AF and either were taken off OAT 3-6 months later (Off-OAT group, n = 2,692, mean age 57 years) because of a successful outcome or remained on OAT because of recurrent AF, pulmonary vein stenosis, or severe left atrial mechanical dysfunction (On-OAT group, n = 663, mean age 59 years). The CHADS2 (congestive heart failure, hypertension, age ≥75 years, diabetes, stroke) score was calculated for every patient. The study endpoints were ischemic stroke and major hemorrhage.
Results: In the Off-OAT group, 125 patients had a history of stroke/transient ischemic attack, and 2.9% of patients restarted OAT because of recurrent AF a mean of 10 months after OAT discontinuation. During 28 months of follow-up, ischemic stroke occurred in 0.07% of Off-OAT patients and 0.45% of On-OAT patients. No patient with a CHADS2 score ≥2 had a stroke. The prevalence of major hemorrhage was significantly lower in the Off-OAT group (0.04%) than in the On-OAT group (2%).
Conclusions: OAT can be safely discontinued after successful catheter ablation of AF, even in high-risk patients with a history of stroke. Ongoing OAT after catheter ablation is associated with a >10-fold higher risk of major hemorrhage.
Perspective: Current guidelines recommend indefinite OAT after catheter ablation of AF in high-risk patients, even when AF appears to have been successfully eliminated. This study brings this recommendation into question. Before incorporating the results into clinical practice, it would be prudent to wait for confirmation in a randomized clinical trial. Fred Morady, M.D., F.A.C.C.

[Chevychelov]

Title: The ROSE (Risk Stratification of Syncope in the Emergency Department) Study
Topic: Arrhythmias
Date Posted: 3/19/2010
Author(s): Reed MJ, Newby DE, Coull AJ, Prescott RJ, Jacques KG, Gray AJ.
Citation: J Am Coll Cardiol 2010;55:713-721.
Clinical Trial: No
Related Resources
JACC Article: The ROSE (Risk Stratification of Syncope in the Emergency Department) Study

Study Question: How accurately does a clinical decision rule (CDR) based on clinical and biochemical markers predict outcomes in patients with syncope?
Methods: Data on multiple historical, examination, electrocardiographic, hematological, and biochemical variables including B-type natriuretic peptide (BNP) were gathered prospectively in 529 patients (mean age 64 years) who presented to an emergency department (ED) with syncope. An expert panel developed a Risk Stratification of Syncope in the Emergency Department (ROSE) CDR by reviewing the predictive value of these variables for the 1° endpoint, which was a combination of serious outcomes and mortality at 1 month of follow-up. The CDR then was validated in another cohort of 538 patients (mean age 62 years) with syncope.
Results: The ROSE CDR identified a patient with syncope as being at high risk and appropriate for hospital admission if any one of the following was present: BNP level ≥300 pg/ml, heart rate ≤50 bpm in the ED, fecal occult blood, anemia, chest pain with syncope, abnormal Q wave on the electrocardiogram, or oxygen saturation ≤94% on room air. The sensitivity and specificity of this CDR for a 1° endpoint were 92% and 74%, respectively. In the validation cohort, the sensitivity and specificity of the CDR for a 1° endpoint were 87% and 66%, respectively. The BNP was ≥300 pg/ml in 8/9 (89%) deaths.
Conclusions: The ROSE CDR has a high degree of accuracy for predicting death or a serious outcome in patients with syncope. Among the seven components of the CDR, a BNP ≥300 pg/ml has the highest sensitivity for all-cause mortality.
Perspective: Implementation of this CDR potentially could eliminate a large proportion of unnecessary hospitalizations in low-risk patients with syncope. Fred Morady, M.D., F.A.C.C.

Title: Differences in Patient Survival After Acute Myocardial Infarction by Hospital Capability of Performing Percutaneous Coronary Intervention: Implications for Regionalization
Topic: General Cardiology
Date Posted: 3/19/2010
Author(s): Chen J, Krumholz HM, Wang Y, et al.
Citation: Arch Intern Med 2010;170:433-439.
Clinical Trial: No
Study Question: Do patients with acute myocardial infarction (AMI) have better outcomes if admitted to hospitals with percutaneous coronary intervention (PCI) capability, and do these data support regionalization of MI care?
Methods: The authors evaluated Medicare claims data to assess outcome of patients hospitalized with AMI between January 1, 2004, and December 31, 2006. Hospital level data were evaluated to estimate 30-day risk-standardized mortality rates (RSMRs). The RSMRs for PCI and local non-PCI hospitals were compared within local health care regions defined by hospital referral regions (HRRs).
Results: Of a total 718,028 patients with MI, 72.8% (523,119) were admitted to 1,382 PCI hospitals, and 27.2% (194,909) patients were admitted to 2,491 non-PCI hospitals in 295 HRRs. The 30-day mortality was lower in the PCI hospitals (15.1% vs. 20.7%). The RSMRs were also lower in the PCI hospitals compared with non-PCI hospitals (mean, 16.1% vs. 16.9%; p < 0.001). There was considerable overlap in RSMRs between non-PCI and PCI hospitals within the same HRR. The RSMRs at the best-performing PCI hospital were lower than those at local non-PCI hospitals by 3% or more in 80 HRRs, whereas in 104 HRRs, the RSMRs at the best-performing PCI hospital were lower by 1.5% to 3.0%. Conversely, in 37 HRRs, the RSMRs at the best-performing PCI hospital were either similar to or higher than at local non-PCI hospitals.
Conclusions: Patients with MI have a better outcome when admitted to hospitals with PCI capability, but there is wide variation in outcome at PCI and non-PCI hospitals across different HRRs.
Perspective: This is a very elegantly designed study that evaluates potential regionalization of care for AMI. Although the outcome was in general better at PCI-capable hospitals, this was not universal, and a geographically tailored approach to regionalization would be required to ensure optimal outcome of patients with AMI. Hitinder S. Gurm, M.B.B.S., F.A.C.C.

[Chevychelov]

Title: Statins for the Primary Prevention of Cardiovascular Events in Women With Elevated High-Sensitivity C-Reactive Protein or Dyslipidemia: Results From the Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) and Meta-Analysis of Women From Primary Prevention Trials
Topic: Prevention/Vascular
Date Posted: 3/18/2010
Author(s): Mora S, Glynn RJ, Hsia J, MacFadyen JG, Genest J, Ridker PM.
Citation: Circulation 2010;121:1069-1077.
Clinical Trial: No
Related Resources
Trial: Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER)

Study Question: Is statin therapy effective for primary prevention of cardiovascular disease (CVD) in women?
Methods: Data from the JUPITER study were used for this analysis. A total of 6,801 women ≥60 years, and 11,001 men ≥50 years were included in the study. All participants had a C-reactive protein level ≥2 mg/L and a low-density lipoprotein cholesterol <130 mg/dl. Subjects were randomized to rosuvastatin or placebo and followed for a median of 1.9 years. In addition, a meta-analysis of randomized placebo-controlled trials using statins for primary prevention among women was performed to examine additional trials, including JUPITER. A total of 20,147 women, mean age 60-69 years, were included in the meta-analysis.
Results: Absolute CVD event rates, per 100 person-years in JUPITER, were 0.57 for women randomized to rosuvastatin and 1.04 for women randomized to placebo, and 0.88 for men randomized to rosuvastatin and 1.54 for men randomized to placebo. The relative risk (RR) reduction was 0.54 (95% confidence interval [CI], 0.37-0.80) for women and 0.58 (95% CI, 0.45-0.73) for men. Among women participants from JUPITER, there was a significant reduction in revascularization/unstable angina and nonsignificant reductions in secondary events such as myocardial infarction, stroke, and death. In the meta-analysis of 13,154 women, a significant reduction in primary CVD events was observed with statins (RR, 0.63; 95% CI, 0.49-0.82) and a nonsignificant reduction in total mortality (RR, 0.78; 95% CI, 0.53-1.15).
Conclusions: The authors concluded that data from the JUPITER trial suggest that statins reduce primary CVD events among women, with a relative risk similar to that observed in men. Further data from a meta-analysis supported this conclusion.
Perspective: These data support the use of statins in primary prevention of CVD events among women, particularly those ages ≥60. Identification of long-term risk in women will assist clinicians in identifying women who will receive the greatest primary risk reduction from statin therapy. Elizabeth A. Jackson, M.D., F.A.C.C.

Title: Duration of Dual Antiplatelet Therapy After Implantation of Drug-Eluting Stents
Topic: Interventional Cardiology
Date Posted: 3/17/2010
Author(s): Park SJ, Park DW, Kim YH, et al.
Citation: N Engl J Med 2010;Mar 15:[Epub ahead of print].
Clinical Trial: yes
Related Resources
Trial: Duration of Dual Antiplatelet Therapy After Implantation of Drug-Eluting Stents (DES-LATE)

Study Question: What are the potential benefits and risks of the use of dual antiplatelet therapy beyond a 12-month period in patients receiving drug-eluting stents (DES)?
Methods: In two trials, the investigators randomly assigned a total of 2,701 patients who had received DES and had been free of major adverse cardiac or cerebrovascular events and major bleeding for a period of at least 12 months to receive clopidogrel plus aspirin or aspirin alone. The primary endpoint was a composite of myocardial infarction (MI) or death from cardiac causes. Data from the two trials were merged for analysis.
Results: The median duration of follow-up was 19.2 months. The cumulative risk of the primary outcome at 2 years was 1.8% with dual antiplatelet therapy, as compared with 1.2% with aspirin monotherapy (hazard ratio [HR], 1.65; 95% confidence interval [CI], 0.80-3.36; p = 0.17). The individual risks of MI, stroke, stent thrombosis, need for repeat revascularization, major bleeding, and death from any cause did not differ significantly between the two groups. However, in the dual-therapy group as compared with the aspirin-alone group, there was a nonsignificant increase in the composite risk of MI, stroke, or death from any cause (HR, 1.73; 95% CI, 0.99-3.00; p = 0.051) and in the composite risk of MI, stroke, or death from cardiac causes (HR, 1.84; 95% CI, 0.99-3.45; p = 0.06).
Conclusions: The authors concluded that the use of dual antiplatelet therapy for a period longer than 12 months in patients who had received DES was not significantly more effective than aspirin monotherapy in reducing the rate of MI or death from cardiac causes.
Perspective: In the current study, extended use of dual antiplatelet therapy, for >12 months, was not more effective than aspirin monotherapy in reducing the risk of MI or death from cardiac causes among patients who had received DES. The rates of composite outcomes (MI, stroke, death) were in fact higher with clopidogrel plus aspirin than with aspirin alone, but this difference was not significant. However, it must be noted that the study had inadequate statistical power to allow for a definitive conclusion regarding the safety of clopidogrel discontinuation after 12 months. Additional studies addressing the use of dual antiplatelet therapy after implantation of DES are ongoing, and until such results are available, clinicians should recommend dual antiplatelet therapy for at least 12 months after implantation of DES, as supported by the American Heart Association/American College of Cardiology in a Science Advisory (J Am Coll Cardiol 2007;49:734-9), and the Food and Drug Administration. Debabrata Mukherjee, M.D., F.A.C.C.

[Chevychelov]

Title: Improved Survival Among Patients With Eisenmenger Syndrome Receiving Advanced Therapy for Pulmonary Arterial Hypertension
Topic: Congenital Heart Disease
Date Posted: 3/17/2010
Author(s): Dimopoulos K, Inuzuka R, Goletto S, et al.
Citation: Circulation 2010;121:20-25.
Clinical Trial: No
Study Question: What is the effect of advanced therapy (AT) (pulmonary vasodilators) on survival in patients with Eisenmenger syndrome?
Methods: A retrospective review was performed over a 10-year period at a single center. Survival rates were compared between patients on and off AT with use of a modified version of the Cox model, treating AT as a time-varying covariate.
Results: A total of 229 patients, mean age 34.5 ± 12.6 years, were studied. The majority had complex anatomy (atrioventricular septal defects, univentricular physiology, transposition of the great arteries, aortopulmonary window, common arterial trunk, and operated lesions), with 29.7% of patients having Down syndrome. Mean resting oxygen saturation was 84.3%. Sixty-eight patients (29.7%) were on AT at the beginning of the study period or started on AT at some point during the study period. The majority of patients on AT were on bosentan (73.5%), whereas some were on sildenafil (25%) and epoprostenol (1.5%). During a median follow-up of 4.0 years, 52 patients died, 2 of them while on AT. Patients on AT were at a significantly lower risk of death, both unadjusted and adjusted for baseline clinical differences by propensity score regression adjustment (C-statistic, 0.8; hazard ratio, 0.16; 95% confidence interval, 0.04-0.71; p = 0.015) and propensity score matching (hazard ratio, 0.10; 95% confidence interval, 0.01-0.78; p = 0.028).
Conclusions: Pulmonary vasodilator therapy for pulmonary arterial hypertension in adults with Eisenmenger syndrome was associated with a lower risk of death.
Perspective: This important study is the first large-scale study to demonstrate survival benefit from pulmonary vasodilators in adults with Eisenmenger physiology. Historically, clinicians have favored a minimally interventional approach towards patients with Eisenmenger physiology with a goal of not upsetting the fragile homeostasis often seen in this patient population. The randomized and controlled BREATHE-5 study of bosentan demonstrated improvement in exercise capacity and pulmonary hemodynamics without compromising systemic oxygen saturation (Circulation 2006;114:1807-10). There was no demonstrated mortality benefit over a short study period, and patients generally did not have complex disease. In the current study, a majority of patients had complex disease, and almost one-third had Down syndrome, which is reflective of the population seen at most centers. These results suggest that clinicians should rethink the minimalist strategy often employed in adults with Eisenmenger physiology. Timothy B. Cotts, M.D., F.A.C.C.

[Chevychelov]

Title: Intensive Multifactorial Intervention for Stable Coronary Artery Disease: Optimal Medical Therapy in the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) Trial
Topic: Prevention/Vascular
Date Posted: 3/22/2010 5:00:00 PM
Author(s): Maron DJ, Boden WE, O’Rourke RA, et al.
Citation: J Am Coll Cardiol 2010;55:1348-1358.
Clinical Trial: No
Related Resources
JACC Article: Intensive Multifactorial Intervention for Stable Coronary Artery Disease: Optimal Medical Therapy in the COURAGE Trial
Trial: Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE)

Study Question: What is the effect of the medical therapy used in the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial on coronary risk factors?
Methods: The COURAGE trial tested multiple lifestyle and pharmacologic interventions (optimal medical therapy) with or without percutaneous coronary intervention (PCI) in patients with stable coronary disease. All patients, regardless of treatment assignment, received equivalent lifestyle and pharmacologic interventions for secondary prevention. Most medications were provided at no cost. Therapy was administered by nurse case managers according to protocols designed to achieve predefined lifestyle and risk factor goals. The primary outcome of this analysis is change in coronary risk factors.
Results: A total of 2,287 patients were followed for an average of 4.6 years. There were no differences between groups (PCI or no-PCI at baseline) for the following: mean age was 62 years, 85% male, 86% white, 32% diabetic, 66% hypertensive, 23% current smokers, and 38% had a previous myocardial infarction. Mean baseline values were: low-density lipoprotein cholesterol (LDL-C) 101 mg/dl, high-density lipoprotein cholesterol 39 mg/dl, triglycerides 145 mg/dl, and body mass index 28.8 kg/m2. There were no significant differences between treatment groups in proportion of patients achieving therapeutic goals. The proportion of smokers decreased from 23% to 19% (p = 0.025), those who reported <7% of calories from saturated fat increased from 46% to 80% (p < 0.001), and those who walked ≥150 minutes/week increased from 58% to 66% (p < 0.001). Body mass index increased from 28.8 ± 0.13 kg/m2 to 29.3 ± 0.23 kg/m2 (p < 0.001). Appropriate medication use increased from prerandomization to 5 years as follows: antiplatelets 87% to 96%; beta-blockers 69% to 85%; rennin-angiotensin-aldosterone system inhibitors 46% to 72%; and statins 64% to 93%. Systolic blood pressure decreased from a median of 131 ± 0.49 mm Hg to 123 ± 0.88 mm Hg. LDL-C decreased from a median of 101 ± 0.83 mg/dl to 72 ± 0.88 mg/dl.
Conclusions: Secondary prevention was applied equally and intensively to both treatment groups in the COURAGE trial by nurse case managers with treatment protocols, and resulted in significant improvement in risk factors. Optimal medical therapy in the COURAGE trial provides an effective model for secondary prevention among patients with chronic coronary disease.
Perspective: Congratulations to the COURAGE nurse clinical case managers and investigators. The risk factor reduction in COURAGE far exceeds community practice. One of the messages from this analysis is that nurse case managers trained in changing behavior, nutrition, exercise, smoking cessation, and evidence-based drug therapies provide a standard of care that can exceed that of busy practitioners. Institutions and physicians should consider incorporating nurse case manager care for patients with coronary disease, possibly in consort with cardiac rehabilitation that includes several follow-up visits over the first year. Melvyn Rubenfire, M.D., F.A.C.C.

Title: Alcohol Consumption and Cardiovascular Mortality Among U.S. Adults, 1987 to 2002
Topic: Prevention/Vascular
Date Posted: 3/22/2010 5:00:00 PM
Author(s): Mukamal KJ, Chen CM, Rao SR, Breslow RA.
Citation: J Am Coll Cardiol 2010;55:1328-1335.
Clinical Trial: No
Related Resources
JACC Article: Alcohol Consumption and Cardiovascular Mortality Among U.S. Adults, 1987 to 2002

Study Question: Is alcohol consumption associated with cardiovascular (CV) mortality?
Methods: Data from the National Health Interview Survey, an annual survey of US adults, were used for the analysis. Surveys from 1987 to 2002 were included. Alcohol consumption was examined by usual volume, frequency, and quantity. Information on binge drinking was also included. The outcome of interest was CV mortality, which was obtained through linkage to the National Death Index through 2002.
Results: A total of 245,207 US adults were included in this study, and 10,670 CV disease (CVD) deaths occurred over 1,987,439 person-years of follow-up. Light and moderate alcohol consumption was inversely associated with CV mortality. Compared to lifetime abstainers, a trend towards decreased CVD mortality was observed among lifetime infrequent drinkers (relative risk [RR], 0.95; 95% confidence interval [CI], 0.88-1.02), former drinkers (RR, 1.02; 95% CI, 0.94-1.11), and heavy drinkers (RR, 0.95; 95% CI, 0.82-1.10), whereas a significant decreased risk was observed for light drinkers (RR, 0.69; 95% CI, 0.59-0.82) and moderate drinkers (RR, 0.62; 95% CI, 0.50-0.77). These risks were similar in subgroups of age, sex, and baseline health status. No significant association was observed for CVD mortality and binge drinking. In looking at number of drinks per day, those who consumed three or more drinks per day had an increased risk of CVD mortality compared to those who consumed two drinks per day.
Conclusions: The authors concluded that light and moderate alcohol consumption was associated with reduced CVD mortality among a nationally representative sample of US adults, as compared with lifetime abstainers.
Perspective: These data support current recommendations that light (defined as current use of ≤3 drinks per week) to moderate (defined as >3 to 7 drinks per week for women and >3 to 14 drinks per week for men) alcohol consumption is not associated with increased CVD mortality. However, as the authors point out, this study is observational, and thus, confounding may influence these findings. Clinicians should continue to assess alcohol patterns among their patients, with recommendations tailored to the individual patient’s comorbidities, medication use, and preferences. Elizabeth A. Jackson, M.D., F.A.C.C.

[Chevychelov]

Title: Percutaneous Mitral Valve Repair With the MitraClip System: Acute Results From a Real World Setting
Topic: Interventional Cardiology
Date Posted: 3/23/2010
Author(s): Tamburino C, Ussia GP, Maisano F, et al.
Citation: Eur Heart J 2010;Mar 18:[Epub ahead of print].
Clinical Trial: No
Study Question: What is the short-term safety and efficacy of the percutaneous edge-to-edge repair approach for mitral regurgitation (MR) with the MitraClip system?
Methods: The authors reported their experience with the MitraClip system at two Italian hospitals. The primary efficacy endpoint was acute device success, defined as clip placement with reduction of MR to ≤2 +. The primary acute safety endpoint was 30-day freedom from major adverse events, defined as the composite of death, myocardial infarction, nonelective cardiac surgery for adverse events, renal failure, transfusion of more than 2 units of blood, ventilation for >48 hours, deep wound infection, septicemia, and new onset of atrial fibrillation.
Results: A total of 31 patients were treated between August 2008 and July 2009. The median age of the cohort was 71 years and 25 (81%) were men. The etiology of the MR was functional in 18 patients and degenerative disease in 13. A single clip was successfully implanted in 19 patients and two clips in 12 patients. The median device implantation time was 80 minutes, with procedure duration decreasing with increasing operator experience. At 30 days, there was one intraprocedural cardiac tamponade and one noncardiac death (from a gastrointestinal bleed), resulting in a primary safety endpoint of 93.6%. Acute device success was achieved in 96.8% of patients. There was a reduction in left ventricular diameters, diastolic left ventricular volume, diastolic annular septal–lateral dimension, and mitral valve area from baseline to 30 days.
Conclusions: Percutaneous MR repair using the MitraClip device can be accomplished with favorable short-term safety and efficacy.
Perspective: The results of this study support good short-term safety and efficacy of the MitraClip system. The results of the recently presented EVEREST II trial suggest a lower complication rate with MitraClip compared with open surgical repair and a noninferior clinical success at 1 year. While larger studies are required to assess the long-term safety and efficacy of this device, percutaneous mitral valve repair is likely to emerge as a viable option for many patients in the near future. Hitinder S. Gurm, M.B.B.S., F.A.C.C.

Title: 5-Year Clinical Outcomes in the ICTUS (Invasive versus Conservative Treatment in Unstable coronary Syndromes) Trial: A Randomized Comparison of an Early Invasive Versus Selective Invasive Management in Patients With Non–ST-Segment Elevation Acute Coronary Syndrome
Topic: Interventional Cardiology
Date Posted: 3/24/2010
Author(s): Damman P, Hirsch A, Windhausen F, Tijssen JG, de Winter RJ, on behalf of the ICTUS Investigators.
Citation: J Am Coll Cardiol 2010;55:858-864.
Clinical Trial: yes
Related Resources
JACC Article: 5-Year Clinical Outcomes in the ICTUS Trial: A Randomized Comparison of an Early Invasive Versus Selective Invasive Management in Patients With Non–ST-Segment Elevation Acute Coronary Syndrome
Trial: Invasive Versus Conservative Treatment in Unstable Coronary Syndromes (ICTUS)

Study Question: What is the long-term outcome of patients with non–ST-elevation acute coronary syndromes (ACS) treated with an early invasive versus an ischemia-guided therapy?
Methods: The authors reported the 5-year outcome of patients enrolled in the Invasive versus Conservative Treatment in Unstable coronary Syndromes (ICTUS) trial. This trial randomized 1,200 patients to an early invasive or selective invasive therapy. During the initial hospitalization, 76% of patients in the invasive arm and 40% of patients in the selective invasive therapy arm were revascularized.
Results: The 5-year revascularization rate was 81% in the invasive arm and 60% in the selective invasive arm. The cumulative rate of death or myocardial infarction was higher in the early invasive therapy arm (22.3% vs. 18.1%, hazard ratio, 1.29; 95% confidence interval, 1.00-1.66; p = 0.053). There was no difference in 5-year mortality (11.1% vs. 9.9%; p = 0.49). After risk stratification using the FRISC score, no benefit of an early invasive strategy was observed in reducing death or myocardial infarction in any of the risk groups.
Conclusions: There was no advantage of an early invasive therapy over selectively invasive therapy in patients with ACS.
Perspective: Current guidelines support an early invasive approach to treatment of patients with ACS. Prior studies had suggested better long-term survival with such an approach, but the results of the ICTUS trial suggest that either approach provides a similar outcome. This difference is largely due to the more liberal use of an invasive strategy in patients randomized to the selectively invasive arm such that over 54% of patients in this arm had undergone revascularization (54%) by 1 year. These results suggest that either an early invasive strategy or a selective (albeit liberally) invasive strategy can be used to treat patients with ACS based on patient and physician preference. Hitinder S. Gurm, M.B.B.S., F.A.C.C.

[Chevychelov]

Title: Parental Occurrence of Stroke and Risk of Stroke in Their Children: The Framingham Study
Topic: Prevention/Vascular
Date Posted: 3/23/2010
Author(s): Seshadri S, Beiser A, Pikula A, et al.
Citation: Circulation 2010;121:1304-1312.
Clinical Trial: No
Study Question: How does stroke in parents influence stroke risk in children?
Methods: Data from the Framingham Heart Study and offspring study were used for this analysis. Children with no history of stroke, who had parents with a history of stroke by the age of 65 years and who completed their first, third, fifth, and/or seventh study examination and were followed for up to 8 years after the baseline exam were included in the study population.
Results: A total of 3,443 offspring (53% female, mean age 48 ± 14 years) were included in the cohort. Over 77,534 person-years, a total of 106 parental strokes were documented, of which 74 were ischemic. Among the offspring, 128 strokes occurred, of which 106 were ischemic. In multivariate analysis, parental stroke was associated with an increased incidence of stroke in the offspring (hazard ratio [HR], 2.79; 95% confidence interval [CI], 1.68-4.66 for all stroke, and HR, 3.15; 95% CI, 1.69-5.88 for ischemic stroke) after adjustment for age, sex, and baseline stroke risk factors. This association was observed for both maternal and paternal stroke.
Conclusions: The authors concluded that occurrence of stroke in parents younger than 65 years is associated with increased risk of stroke in their children.
Perspective: These data suggest that parental stroke at an early age is an independent risk factor for stroke. Providers can easily obtain such information, which assists in the identification of patients who may be at increased risk for stroke. Elizabeth A. Jackson, M.D., F.A.C.C.

Title: Relationship Between Plasma Inflammatory Markers and Plaque Fibrous Cap Thickness Determined by Intravascular Optical Coherence Tomography
Topic: Interventional Cardiology
Date Posted: 3/23/2010
Author(s): Li QX, Fu QQ, Shi SW, et al.
Citation: Heart 2010;96:196-201.
Clinical Trial: No
Study Question: What is the relationship between human plaque fibrous cap thickness detected by intravascular optical coherence tomography (OCT) and the plasma levels of inflammatory factors in patients with coronary artery disease (CAD)?
Methods: The authors performed OCT in 46 patients with CAD (12 with acute myocardial infarction, 23 with unstable angina, and 11 patients with stable angina pectoris). Plasma levels of highly sensitive C-reactive protein (hs-CRP), interleukin (IL)-18, and tumor necrosis factor alpha (TNFα) were measured. Lesions with cap thickness less than 65 mcm were classified as thin cap fibroatheromas (TCFAs).
Results: There was an inverse correlation between the plasma levels of inflammatory markers and white blood cell (WBC) count and fibrous cap thickness (r = -0.775 for hs-CRP, r = -0.593 for IL-18, r = -0.60 for TNFα, and r = -0.356 for WBC count). Patients with TCFA had higher plasma levels of inflammatory factors as well as WBC counts than those with thicker fibrous caps. Receiver operator characteristic (ROC) curve analysis determined that an hs-CRP cut-off at 1.66 mg/L would detect TCFA with a sensitivity of 96% and a specificity of 90%, and was the strongest predictor of TCFA.
Conclusions: There is an inverse linear correlation between fibrous cap thickness and plasma levels of inflammatory markers.
Perspective: This is an interesting study that corroborates and extends earlier work (Raffel OC, et al., Arterioscler Thromb Vasc Biol 2007;27:1820-7). This study evaluated patients with different degrees of clinical instability, and it is not clear if the authors could adjust for the expected confounding. Patients with a greater degree of plaque instability are known to have elevation in inflammatory markers, and are also more likely to have TCFA; it would have been preferable to evaluate a more homogenous population. Further studies are warranted to better define peripheral markers of coronary instability. Hitinder S. Gurm, M.B.B.S., F.A.C.C.

[Chevychelov]

Title: Recent Declines in Hospitalizations for Acute Myocardial Infarction for Medicare Fee-for-Service Beneficiaries: Progress and Continuing Challenges
Topic: General Cardiology
Date Posted: 3/25/2010
Author(s): Chen J, Normand SL, Wang Y, Drye EE, Schreiner GC, Krumholz HM.
Citation: Circulation 2010;121:1322-1328.
Clinical Trial: No
Study Question: Have recent efforts to reduce cardiovascular risk had an effect on the rates of acute myocardial infarction (AMI) in the United States in elderly patients?
Methods: Medicare fee-for-service patients hospitalized in the United States with a principal discharge diagnosis of AMI were identified through the use of data from the Centers for Medicare and Medicaid Services from 2002 to 2007, a time period selected to reduce changes arising from the new definition of AMI. The Medicare beneficiary denominator file was used to determine the population at risk. AMI hospitalization rates were calculated annually per 100,000 beneficiary-years with Poisson regression analysis and stratified according to age, sex, and race.
Results: The annual AMI hospitalization rate in the fee-for-service Medicare population fell from 1,131 per 100,000 beneficiary-years in 2002 to 866 in 2007, a relative 23.4% decline. After adjustment for age, sex, and race, the AMI hospitalization rate declined by 5.8%/year. From 2002 to 2007, white men experienced a 24.4% decrease in AMI hospitalizations, whereas black men experienced a smaller decline (18.0%; p < 0.001 for interaction). Black women had a smaller decline in AMI hospitalization rate compared with white women (18.4% vs. 23.3%, respectively; p < 0.001 for interaction).
Conclusions: AMI hospitalization rates fell markedly in the Medicare fee-for-service population between 2002 and 2007. However, black men and women appeared to have had a slower rate of decline compared with their white counterparts.
Perspective: Whatever you are feeling about cost and value, a contemporary national database for major medical diagnosis and treatments should be one of the relatively simple tools of the new health care system. These data should be available upon request for clinical research regarding the effect and cost-effectiveness of diagnostic and treatment paradigms. I see no reason why the data cannot be very rapidly processed to test newer and competing strategies. This type of information will allow us to understand the differences in outcome that are attributable to variables, including gender and ethnicity, as in this study. Melvyn Rubenfire, M.D., F.A.C.C

Title: Cost-Effectiveness of Preparticipation Screening for Prevention of Sudden Cardiac Death in Young Athletes
Topic: Prevention/Vascular
Date Posted: 3/25/2010
Author(s): Wheeler MT, Heidenreich PA, Froelicher VF, Hlatky MA, Ashley EA.
Citation: Ann Intern Med 2010;152:276-286.
Clinical Trial: No
Study Question: What is the cost-effectiveness of electrocardiography (ECG) plus cardiovascular-focused history and physical examination compared with focused history and physical examination alone for preparticipation screening in young athletes?
Methods: A decision model was used to project the costs and survival rates for US male and female athletes participating in high school or college interscholastic sports. Assuming a single screening evaluation in each athlete, models of no screening, only focused history and physical examination, and focused history and physical examination plus ECG were compared. Rates of sudden cardiac death were extrapolated from an Italian study (Corrado D, et al., JAMA 2006;296:1593-1601).
Results: According to the authors’ model, addition of ECG to preparticipation screening saves 2.06 life-years per 1,000 athletes at an incremental total cost of $89 per athlete, and yields a cost-effectiveness ratio of $42,900 per life-year saved (95% confidence interval, $21,200 to $71,300 per life-year saved) compared with cardiovascular-focused history and physical examination alone. Compared with no screening, ECG plus cardiovascular-focused history and physical examination saves 2.6 life-years per 1,000 athletes screened and costs $199 per athlete, yielding a cost-effectiveness ratio of $76,100 per life-year saved ($62,400 to $130,000).
Conclusions: The authors concluded that screening young athletes with 12-lead ECG plus cardiovascular-focused history and physical examination may be cost-effective.
Perspective: No, no, no, no, no. This model—attempting to predict what might be, based on extrapolation of published data—used hotly contested data on sudden cardiac death rates in the Veneto region of Italy. Applied to the US population, the authors found, not surprisingly, that the conclusions drawn by the Italian authors would hold in the US, as well. However, there are very good reasons to believe that the Italian experience does not extrapolate to the US. The very high rate of sudden cardiac death in Italian athletes is due to arrhythmogenic right ventricular dysplasia, occurring at rates far higher than that seen in the US. Perhaps as a result, the rate of sudden cardiac death achieved with screening ECG in Italy now matches the low rates seen in the US without ECG screening. Rather than using the low rates of sudden cardiac death documented without ECG screening in the US, the authors appear to have essentially assured a ‘positive’ study by using data from different populations with different risks and different observed outcomes. David S. Bach, M.D., F.A.C.C.

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Title: Cardiovascular Screening in College Athletes With and Without Electrocardiography: A Cross-Sectional Study
Topic: Prevention/Vascular
Date Posted: 3/25/2010
Author(s): Baggish AL, Hutter AM Jr, Wang F, et al.
Citation: Ann Intern Med 2010;152:269-275.
Clinical Trial: No
Study Question: For purposes of screening college athletes before athletic participation, how do history and physical examination alone compare with a strategy including routine electrocardiography (ECG)?
Methods: Over a 3-year interval, 510 collegiate athletes at Harvard University (Cambridge, MA) who underwent preparticipation screening at the University Health Services were studied. Each participant underwent routine history, physical examination, ECG, and transthoracic echocardiography (TTE) to detect or exclude cardiac findings relevant to sports participation. TTE results were taken as the “gold standard” for disease presence. The performance of screening with history and physical examination only was compared with that of screening integrating history, examination, and ECG.
Results: Cardiac abnormalities relevant to sports participation risk were observed on TTE in 11 of 510 participants (prevalence, 2.2%; including mitral valve prolapse [n = 3], bicuspid aortic valve [n = 2], pulmonic stenosis [n = 1], left ventricular [LV] hypertrophy [n = 2], LV dilation [n = 2], and right ventricular dilation [n = 1]). Screening history and physical examination alone detected abnormalities in 5 of these 11 athletes (sensitivity 45.5%; 95% confidence interval [CI], 16.8-76.2% and specificity 94.4%; CI, 92.0-96.2%). ECG detected five additional participants with cardiac abnormalities (total 10 of 11 participants), with overall sensitivity of 90.9% (CI, 58.7-99.8%). However, including ECG reduced the specificity of screening to 82.7% (CI, 79.1-86.0%) and was associated with a false-positive rate of 16.9% (vs. 5.5% for screening with history and examination only). After further evaluation, athletic participation was restricted in three athletes (one each with TTE findings of pulmonic stenosis, LV hypertrophy, LV dilation).
Conclusions: Adding ECG to medical history and physical examination improves the overall sensitivity of preparticipation cardiovascular screening in athletes. However, this strategy is associated with an increased rate of false-positive results when current ECG interpretation criteria are used.
Perspective: The debate continues as to whether US amateur athletes should undergo a mandatory screening ECG (as is the policy in Italy, and subsequently adopted by the European Union) in addition to only screening history and physical examination (as is the long-standing US policy). On the surface, this study appears to add weight to the argument for routine preparticipation ECG. However, caveats abound, many of which were discussed in an accompanying editorial (Maron BJ, Ann Intern Med 2010;152:324-6). In addition:
The population of student athletes at Harvard might be anticipated to be poorly reflective of all amateur athletes in the US. (In this study, only 10% of screened athletes were black.) Because nonpathologic ECG abnormalities are far more prevalent in black than in white athletes, it could be anticipated that such benign but abnormal ECGs likely were under-represented in this study, and would have served to further reduce the specificity of the ECG.
Low test specificity and the associated high rate of false-positives is a major issue with the routine use of preparticipation ECG. The best-case scenario is that more money is spent to do more tests to prove that everything was OK to begin with. The worse (and probably more realistic) outcome is that amateur athletes are denied the ability to participate—including many with no underlying cardiac disease, and others with disease, but no prohibitive risk. In a country plagued by obesity, diabetes, and their various sequelae, physical activity should be encouraged not just in principle but in practice. Setting a low threshold for exclusion from athletics only will serve to worsen our obesity epidemic.
The authors used as a ‘gold standard’ for disease any abnormality of an echocardiogram. But of the 11 athletes with an ‘abnormal’ TTE, athletic participation was limited in only three (one of whom had an abnormal physical examination). If our societal goal is to detect any cardiac disease in any child or young adult, then intended athletic participation is impertinent, and screening should be instituted universally. If our goal is to detect disease that might pose a risk to the athlete, then the denominator in this study should have been at most three, not 11 students.
David S. Bach, M.D., F.A.C.C.

Title: A Critical Decrease in Dominant Frequency and Clinical Outcome After Catheter Ablation of Persistent Atrial Fibrillation
Topic: Arrhythmias
Date Posted: 3/24/2010
Author(s): Yoshida K, Chugh A, Good E, et al.
Citation: Heart Rhythm 2010;7:295-302.
Clinical Trial: No
Study Question: Is a critical decrease in the dominant frequency (DF) of persistent atrial fibrillation (AF) predictive of a clinical efficacy similar to that observed after termination of AF during radiofrequency ablation (RFA)?
Methods: Antral pulmonary vein isolation (APVI) followed by RFA of complex fractionated atrial electrograms (CFAEs) in the atria and coronary sinus was performed in 100 consecutive patients with persistent AF. The DF of AF in lead V1 and in the coronary sinus was determined by fast Fourier transform analysis at baseline and before termination of AF to identify a critical decrease in DF predictive of sinus rhythm after RFA. Multivariate logistic regression analysis was performed to identify the predictors of freedom from recurrent atrial arrhythmias after catheter ablation.
Results: A ≥11% decrease in DF had the highest accuracy in predicting freedom from atrial arrhythmias, with a sensitivity of 0.71 and a specificity of 0.82 (p < 0.001). At a mean follow-up of 14 ± 3 months after one ablation procedure, sinus rhythm was maintained off antiarrhythmic drugs in 8/35 (23%) and 20/26 (77%) patients with a <11% and ≥11% decrease in DF, respectively (p < 0.001). Sinus rhythm was maintained in 24/39 patients (62%) in whom RFA terminated AF. The duration of RFA and total procedure time were longer in patients with AF termination (95 ± 23 and 358 ± 87 minutes) than in patients with a <11% decrease in the DF (77 ± 16 and 293 ± 70 minutes) or ≥11% decrease in DF (80 ± 17 and 289 ± 73 minutes), respectively (p < 0.01). Among the variables of age, gender, left atrial diameter, duration of AF, left ventricular ejection fraction, duration of RFA, a ≥11% decrease in DF, and termination of AF, a ≥11% decrease in DF (odds ratio [OR], 9.89; 95% confidence interval [CI], 2.84-34.47) and termination during RFA (OR, 4.38; 95% CI, 1.50-12.80) were the only independent predictors of freedom from recurrent atrial arrhythmias.
Conclusions: The authors concluded that a decrease in the DF of AF by 11% in response to APVI and ablation of CFAEs was associated with a probability of maintaining sinus rhythm that was similar to that when RFA terminates AF.
Perspective: In this retrospective analysis of consecutive patients with persistent AF, patients who had a ≥11% decrease in the DF or termination of AF during ablation were more likely to remain in sinus rhythm than patients who remain in AF during RFA and have a lesser decrease in the DF. In fact, a reduction in the dominant frequency by 11% or more without termination of AF by catheter ablation was as predictive of a successful outcome as was termination of AF by RFA. The clinical utility of monitoring DF in real time to guide catheter ablation of AF requires further validation in prospective multicenter studies. Debabrata Mukherjee, M.D., F.A.C.C.

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Title: Prevalence of Diabetes Among Men and Women in China
Topic: Prevention/Vascular
Date Posted: 3/24/2010 5:00:00 PM
Author(s): Yang W, Lu J, Weng J, et al., on behalf of the China National Diabetes and Metabolic Disorders Study Group.
Citation: N Engl J Med 2010;362:1090-1101.
Clinical Trial: No
Study Question: What is the prevalence of diabetes among men and women residing in China?
Methods: A nationally representative sample of 46,239 adults, ages 20 years or older, from 14 provinces and municipalities in China, were included in this study. Subjects underwent glucose testing after an overnight fast, including fasting and 2-hour glucose measures, and oral glucose-tolerance testing. History of diabetes was based on self-report. World Health Organization diagnostic criteria were used to diagnose diabetes.
Results: The China National Diabetes and Metabolic Disorders study is a cross-sectional study conducted from June, 2007 through May, 2008. The age-standardized prevalence of diabetes was 9.7% (10.6% for men and 8.8% for women), and for prediabetes the prevalence was 15.5% (16.1% for men and 14.9% for women). This accounts for an estimated 92.4 million adults with diabetes and 148.2 million adults with prediabetes. The prevalence of diabetes increases with age from 3.2% among adults 20-39 years of age to 20.4% for adults 60 years or older. Prevalence of diabetes also increases with increasing weight, from 4.5% for those with a body mass index (BMI) less than 18.5, to 18.5% for those with a BMI of 30 or greater. Prevalence of diabetes was higher among urban dwellers, as compared to those residing in rural communities (11.4% vs. 8.2%). However, the prevalence of prediabetes was higher among rural residents. The prevalence of isolated impaired glucose tolerance was higher than that of isolated impaired fasting glucose (11.0% vs. 3.2% for men and 10.9% vs. 2.2% for women). In multivariate models, factors associated with diabetes included male sex, older age, family history of diabetes, overweight or obesity, central obesity, increased heart rate, elevated systolic blood pressure, elevated serum triglycerides, and educational level below college.
Conclusions: The authors concluded that the observed prevalence of diabetes and prediabetes suggests a significant public health concern. Strategies for improving the diagnosis of prediabetes and diabetes and the prevention of diabetes are warranted.
Perspective: This cross-sectional study highlights a dramatic increase in diabetes over the past several decades. Given the increased prevalence in other countries, there is a clear need to globalize prevention efforts. Elizabeth A. Jackson, M.D., F.A.C.C.

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Title: Risk of Fatal Arrhythmic Events in Long QT Syndrome Patients After Syncope
Topic: Arrhythmias
Date Posted: 3/17/2010
Author(s): Jons C, Moss AJ, Goldenberg I, et al.
Citation: J Am Coll Cardiol 2010;55:783-788.
Clinical Trial: No
Related Resources
JACC Article: Risk of Fatal Arrhythmic Events in Long QT Syndrome Patients After Syncope

Study Question: What factors are predictive of sudden cardiac death (SCD) after an episode of syncope in patients with the long QT syndrome (LQTS)?
Methods: The subjects of this study were 1,059 patients with LQTS and syncope who were entered into an international LQTS registry. Therapy with beta-blockers was at the discretion of the treating physician. Twenty percent of the patients had an implantable cardioverter defibrillator (ICD). The 1° endpoint was a severe arrhythmic event (SAE), defined as SCD, aborted cardiac arrest, or an appropriate ICD therapy.
Results: An SAE occurred in 210/1,059 patients. The strongest independent predictors of an SAE after an episode of syncope were ≥1 syncopal episodes on beta-blocker therapy (hazard ratio [HR], 3.6 compared to patients with one syncopal episode off beta-blocker therapy), >1 syncopal episode off beta-blocker therapy (HR, 2.0), and female gender with age 14-40 years (HR, 1.9). The strongest independent predictors of subsequent syncope after the start of beta-blocker therapy in patients with a previous syncope episode were male gender with age 0-13 years (HR, 3.2 compared to males with age 14-40 years), and female gender with age 0-13 years (HR, 3.0 compared to males with age 14-40 years).
Conclusions: In patients with LQTS, syncope during beta-blocker therapy is a strong predictor of an SAE and an appropriate indication for an ICD. Young children and women have the highest risk of recurrent syncope despite beta-blocker therapy after a syncopal episode.
Perspective: The factors that account for beta-blocker failure are unclear. The type of beta-blocker or the particular LQTS genotype was not predictive of SAEs in this study. It is possible that noncompliance or undertreatment played a role. Fred Morady, M.D., F.A.C.C.

Title: Thoracic Aortic Aneurysm: Clinically Pertinent Controversies and Uncertainties
Topic: Cardiovascular Surgery
Date Posted: 3/18/2010
Author(s): Elefteriades JA, Farkas EA.
Citation: J Am Coll Cardiol 2010;55:841-857.
Clinical Trial: No
Related Resources
JACC Article: Thoracic Aortic Aneurysm: Clinically Pertinent Controversies and Uncertainties

Perspective: The following are 10 points to remember from this state-of-the-art paper about thoracic aortic aneurysm.

1. This paper addresses clinical controversies and uncertainties regarding thoracic aortic aneurysm and its treatment.

2. The most recent data available from the Centers for Disease Control and Prevention indicate that aneurysm disease is the 18th most common cause of death in all individuals and the 15th most common in individuals older than age 65 years, accounting for 13,843 and 11,147 deaths in these two groups, respectively.

3. Estimating true aortic size is confounded by obliquity, asymmetry, and noncorresponding sites.

4. It is also important to remember that size is not the only important imaging criterion; shape matters as well, especially loss of the normal “waist” of the aorta at the sinotubular junction.

5. Although a virulent disease, thoracic aortic aneurysm is an indolent process. The thoracic aorta grows very slowly—at approximately 0.1 cm per year.

6. Symptomatic aneurysms should be resected regardless of size. It is important to intervene before the aorta reaches 6 cm in the ascending aorta and 7 cm in the descending aorta. Available data suggest that aneurysms in the ascending aorta need corrective surgery when the artery balloons to 5.5 cm.

7. A full spectrum of engineering calculations regarding the mechanical properties of the dilated aorta can be determined via measurement of six independent variables: aortic pressure in systole and diastole, aortic diameter in systole and diastole, and aortic wall thickness in systole and diastole, and may help optimize timing of surgery.

8. Recent evidence shows that many dissections are preceded by a specific severe exertional or emotional event. Findings that acute exertion and emotion often underlie the onset of acute aortic dissection constitute another reasonable rationale for beta-blocker therapy, with the intent of blunting pressure spikes.

9. Thoracic aortic aneurysm is multigenetic; consequently, no easy, comprehensive, full aortic genetic screen is currently generally available.

10. The decision to treat an aneurysm must be made with the same rigor for endovascular therapy as for open surgical therapy. The presence of a small thoracic aneurysm is not a valid indication for endovascular therapy just because stent therapy is available. Debabrata Mukherjee, M.D., F.A.C.C.

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Taper or Stop Clopidogrel?
VA Cooperative Study
MM-WES Study - Effect of Genotyping Warfarin Patients on utcomes
[Ссылки доступны только зарегистрированным пользователям ]

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Title: 5-Year Clinical Outcomes of the ARTS II (Arterial Revascularization Therapies Study II) of the Sirolimus-Eluting Stent in the Treatment of Patients With Multivessel De Novo Coronary Artery Lesions
Topic: Interventional Cardiology
Date Posted: 3/26/2010
Author(s): Serruys PW, Onuma Y, Garg S, et al., on behalf of the ARTS II Investigators.
Citation: J Am Coll Cardiol 2010;55:1093-1101.
Clinical Trial: yes
Related Resources
JACC Article: 5-Year Clinical Outcomes of the ARTS II (Arterial Revascularization Therapies Study II) of the Sirolimus-Eluting Stent in the Treatment of Patients With Multivessel De Novo Coronary Artery Lesions
Trial: Arterial Revascularization Therapies Study II: Sirolimus-Eluting Stent in the Treatment of Patients With Multivessel De Novo Coronary Artery Lesions (ARTS II: 5-Year Results)

Study Question: What are 5-year clinical outcomes, safety, and efficacy of sirolimus-eluting stents (SES) in the ARTS II (Arterial Revascularization Therapies Study II) compared with the outcomes of coronary artery bypass grafting (CABG) and bare-metal stenting (BMS) from the ARTS I trial?
Methods: The ARTS I study was a randomized trial of 1,205 patients with multivessel disease comparing CABG and BMS. The ARTS II study was a nonrandomized trial with the Cypher SES, applying the same inclusion and exclusion criteria, endpoints, and protocol definitions. The ARTS II trial enrolled 607 patients, with an attempt to enroll at least one-third of patients with three-vessel disease. The primary objective of ARTS II was to compare the safety and effectiveness of coronary stent implantation using the SES with the surgical arm of ARTS I.
Results: At 5 years, the death/stroke/myocardial infarction event-free survival rate was 87.1% in ARTS II SES, versus 86.0% (p = 0.1) and 81.9% (p = 0.007) in ARTS I CABG and BMS cohorts, respectively. The 5-year major adverse cardiac and cerebrovascular event (MACCE) rate in ARTS II (27.5%) was significantly higher than ARTS I CABG (21.1%, p = 0.02), and lower than in ARTS I BMS (41.5%, p < 0.001). The cumulative incidence of definite stent thrombosis was 3.8%. Thirty-two percent (56 of 176) of major adverse cardiac events (MACE) at 5 years were related to possible, probable, or definite stent thrombosis.
Conclusions: The authors concluded that at 5 years, SES had a safety record comparable to CABG and superior to BMS, and a MACCE rate that was higher than in patients treated with CABG, and lower than in those treated with BMS.
Perspective: The study reports that the 5-year composite safety endpoint of death, stroke, and myocardial infarction in the SES group was comparable to the CABG group, and lower than the BMS group. The MACCE rate in the SES group on the other hand was higher than the CABG group, which was mainly driven by a higher rate of repeat revascularization in the SES group; however, the MACCE rate of the SES group remained lower than that of the BMS group. Baseline SYNTAX score had a role in the prediction of 5-year MACCE events and suggests that patients with multivessel disease and a low SYNTAX score may be adequately treated with PCI, whereas those patients with high SYNTAX scores benefit from CABG. Debabrata Mukherjee, M.D., F.A.C.C.

Title: Impact of Olmesartan on Progression of Coronary Atherosclerosis: A Serial Volumetric Intravascular Ultrasound Analysis From the OLIVUS (Impact of OLmesartan on progression of coronary atherosclerosis: evaluation by IntraVascular UltraSound) Trial
Topic: Prevention/Vascular
Date Posted: 3/26/2010
Author(s): Hirohata A, Yamamoto K, Miyoshi T, et al.
Citation: J Am Coll Cardiol 2010;55:976-982.
Clinical Trial: yes
Related Resources
JACC Article: Impact of Olmesartan on Progression of Coronary Atherosclerosis: A Serial Volumetric Intravascular Ultrasound Analysis From the OLIVUS Trial

Study Question: What is the effect of the angiotensin II receptor blocker, olmesartan, on the progression of coronary atherosclerosis?
Methods: A prospective, randomized, multicenter trial—Impact of OLmesartan on progression of coronary atherosclerosis: evaluation by IntraVascular UltraSound (OLIVUS)—was performed in 247 stable angina pectoris patients with native coronary artery disease (CAD). IVUS was performed at the time of percutaneous transluminal coronary angioplasty in nonculprit vessels (without angiographically significant lesions). Patients were randomly assigned to receive 10-40 mg of olmesartan or control drug, and were otherwise treated as per physician’s discretion. Serial IVUS examinations (baseline and 14-month follow-up) were performed to assess coronary atheroma volume. Volumetric IVUS analyses included lumen, plaque, vessel volume, percent atheroma volume (PAV), and percent change in total atheroma volume (TAV).
Results: Patient characteristics and blood pressure control were identical between the two groups. However, follow-up IVUS showed significantly decreased TAV and PAV in the olmesartan group (5.4% vs. 0.6 % for TAV and 3.1% vs. -0.7% for percent change in PAV, control vs. olmesartan, p < 0.05 for all).
Conclusions: Omesartan reduced the rate of coronary atheroma progression in patients with stable angina pectoris.
Perspective: Many preclinical studies have shown that blockade of the renin-angiotensin-aldosterone system (RAAS) leads to cardiovascular protection. However, studies looking at the effect of RAAS inhibition on clinical events in patients with CAD and preserved left ventricular function have been inconsistent. The reduction in atheroma progression observed in this study with olmesartan supports possible beneficial vascular effects of angiotensin II receptor inhibition on the background of modern medical therapy. Whether these IVUS changes translate into reduced coronary events will require further study. Daniel T. Eitzman, M.D., F.A.C.C.

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Title: Long-Term Pulmonary Regurgitation Following Balloon Valvuloplasty for Pulmonary Stenosis: Risk Factors and Relationship to Exercise Capacity and Ventricular Volume and Function
Topic: Congenital Heart Disease
Date Posted: 3/26/2010
Author(s): Harrild DM, Powell AJ, Trang TX, et al.
Citation: J Am Coll Cardiol 2010;55:1041-1047.
Clinical Trial: No
Related Resources
JACC Article: Long-Term Pulmonary Regurgitation Following Balloon Valvuloplasty for Pulmonary Stenosis: Risk Factors and Relationship to Exercise Capacity and Ventricular Volume and Function

Study Question: What are the predictors of pulmonary regurgitation (PR) following balloon valvuloplasty for pulmonary stenosis (PS), and what is the impact of PR on ventricular volume and function, and exercise tolerance?
Methods: Patients who had previously undergone balloon valvuloplasty for isolated valvar PS were recruited for this single-institution prospective study. Those with significant residual PS, additional congenital heart disease, or who had undergone cardiac surgery were excluded. Of 183 potentially eligible patients, 41 patients were enrolled and underwent cardiac magnetic resonance imaging (CMR) and exercise testing. Multiple parameters were analyzed for their impact on PR fraction, ventricular volume and function, and exercise function.
Results: Testing occurred a median of 13.1 years after balloon dilation. Median PR fraction was 10%; 34% had PR fraction >15%. Larger balloon-to-annulus ratio (p < 0.001) and younger age at procedure (p = 0.002) were correlated with higher PR fraction. Mean right ventricular (RV) end-diastolic volume z-score was 1.8 ± 1.9. PR fraction correlated closely with indexed RV end-diastolic volume (p < 0.001) and modestly with RV ejection fraction (p < 0.001). Peak VO2 (92% of predicted) and peak heart rate (96% of predicted) were mildly impaired. While no demographic or continuous CMR variable correlated with % of predicted peak VO2 or peak work, when PR fraction was dichotomized, peak VO2 was found to be lower in patients with PR fraction >15% (85% of predicted vs. 96% of predicted; p = 0.03).
Conclusions: Mild PR and RV dilation are common following balloon dilation for PS. Patients with larger PR fraction (>15%) have evidence of modestly impaired exercise capacity.
Perspective: Exercise capacity, as well as RV size and function, have been extensively studied in patients with pulmonary insufficiency in the setting of tetralogy of Fallot. This study assesses pulmonary insufficiency, exercise capacity, and RV status after balloon valvuloplasty for isolated PS. Overall, exercise capacity in this population is quite good, although patients with significant PR may have some exercise impairment. Additionally, a balloon-annulus ratio of >1.4 was associated with development of pulmonary insufficiency. The study is limited by a small sample size and relatively low (approximately 50%) enrollment rate, which may have introduced an enrollment bias. Timothy B. Cotts, M.D., F.A.C.C.

Title: Prognostic Importance of Atrial Fibrillation in Implantable Cardioverter-Defibrillator Patients
Topic: Arrhythmias
Date Posted: 3/26/2010
Author(s): Borleffs CJ, van Rees JB, van Welsenes GH, et al.
Citation: J Am Coll Cardiol 2010;55:879-885.
Clinical Trial: No
Related Resources
JACC Article: Prognostic Importance of Atrial Fibrillation in Implantable Cardioverter-Defibrillator Patients

Study Question: How does atrial fibrillation (AF) affect outcomes in patients with an implantable cardioverter defibrillator (ICD)?
Methods: This was a retrospective analysis of 913 patients (mean age 62 years, mean ejection fraction 32%) who received an ICD and were followed for a mean of approximately 30 months. The impact of AF on mortality and ICD therapies was analyzed.
Results: Seventy-three percent of patients had no AF, 9% had paroxysmal AF, 7% had persistent AF, and 11% had permanent AF. All-cause mortality at 3 years was significantly higher in the patients with permanent AF (32%) than in the patients with no AF (12%), paroxysmal AF (15%), or persistent AF (17%). The proportion of patients with an appropriate ICD therapy by 3 years of follow-up also was significantly higher in the permanent AF group (49%) than in the other three groups (26-29%). The 3-year rate of an inappropriate shock was lowest in the patients without AF (13%) and highest in the patients with permanent AF (32%).
Conclusions: Among ICD recipients, permanent AF is associated with a >2-fold increase in the risk of mortality and appropriate ICD therapies, and all types of AF are associated with a higher risk of inappropriate ICD shocks.
Perspective: The study does not provide any insight into the reasons why permanent AF is associated with higher mortality or a greater probability of ventricular tachycardia/fibrillation that triggers an appropriate ICD therapy. It may be that permanent AF simply is a marker of more severe myocardial disease. Another possible explanation is that the irregular ventricular rate during AF causes heterogeneous depolarization and repolarization, thereby promoting ventricular arrhythmias. Fred Morady, M.D., F.A.C.C.

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Title: Alcohol Consumption, Weight Gain, and Risk of Becoming Overweight in Middle-Aged and Older Women
Topic: Prevention/Vascular
Date Posted: 3/25/2010
Author(s): Wang L, Lee IM, Manson JE, Buring JE, Sesso HD.
Citation: Arch Intern Med 2010;170:453-461.
Clinical Trial: No
Study Question: Does regular alcohol consumption increase weight gain among middle-age and older women?
Methods: Data from the Women’s Health Study (WHS) were used for the present analysis. US women ages 38.9 years or older, with no cardiovascular disease, cancer, or diabetes at baseline, and who were normal weight (defined as a body mass index [BMI] of 18.5 to <25 at baseline) were included in this analysis. Women were asked how often they consumed alcoholic beverages. Body weight was reported at baseline and via eight annual follow-up questionnaires.
Results: A total of 19,200 women were included in the analysis. Over the 12.9 years of follow-up, 7,942 (41%) of these normal weight women became overweight or obese, of which 732 women (3.8%) became obese. An inverse relationship was observed between alcohol consumption at baseline and weight gain. After adjustment for age, baseline BMI, smoking status, nonalcoholic energy intake, physical activity level, and other lifestyle and dietary factors, the risk of becoming overweight or obese was 0.96 for women who consumed 0 to <5 g/day of alcohol, 0.86 for 5 to <15 g/day alcohol intake, 0.70 for 15 to <30 g/day alcohol intake, and 0.73 for 30 g/day or more alcohol intake (p for trend of < 0.001). The corresponding relative risks for becoming obese were 0.75, 0.43, 0.39, and 0.29 for these alcohol consumption categories, as compared to nondrinkers. These associations were similar for subgroups of age, smoking status, physical activity level, and baseline BMI.
Conclusions: The authors concluded that compared to nondrinkers, women who regularly consumed alcohol had a decreased risk of becoming overweight or obese over time.
Perspective: These data suggest that alcohol consumption is not associated with weight gain among middle-age and older women. However, these data do not suggest that alcohol intake can prevent weight gain. Careful evaluation of nutritional status in the context of individual patient’s goals and medical history is key to overall health. Elizabeth A. Jackson, M.D., F.A.C.C.