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Whether high-dose multivitamins are effective for secondary prevention of atherosclerotic disease is unknown.To assess whether oral multivitamins reduce cardiovascular events and are safe.Double-blind, placebo-controlled, 2 x 2 factorial, multicenter, randomized trial. (ClinicalTrials.gov: NCT00044213) SETTING: 134 U.S. and Canadian academic and clinical sites.1708 patients aged 50 years or older who had myocardial infarction (MI) at least 6 weeks earlier and had serum creatinine levels of 176.8 mol/L (2.0 mg/dL) or less.Patients were randomly assigned to an oral, 28-component, high-dose multivitamin and multimineral mixture or placebo.The primary end point was time to total death, recurrent MI, stroke, coronary revascularization, or hospitalization for angina.The median age was 65 years, and 18% of patients were women. The qualifying MI occurred a median of 4.6 years (interquartile range [IQR], 1.6 to 9.2 years) before enrollment. Median follow-up was 55 months (IQR, 26 to 60 months). Patients received vitamins for a median of 31 months (IQR, 13 to 59 months) in the vitamin group and 35 months (IQR, 13 to 60 months) in the placebo group (P = 0.65). Totals of 645 (76%) and 646 (76%) patients in the vitamin and placebo groups, respectively, completed at least 1 year of oral therapy (P = 0.98), and 400 (47%) and 426 (50%) patients, respectively, completed at least 3 years (P = 0.23). Totals of 394 (46%) and 390 (46%) patients in the vitamin and placebo groups, respectively, discontinued the vitamin regimen (P = 0.67), and 17% of patients withdrew from the study. The primary end point occurred in 230 (27%) patients in the vitamin group and 253 (30%) in the placebo group (hazard ratio, 0.89 [95% CI, 0.75 to 1.07]; P = 0.21). No evidence suggested harm from vitamin therapy in any category of adverse events.There was considerable nonadherence and withdrawal, limiting the ability to draw firm conclusions (particularly about safety).High-dose oral multivitamins and multiminerals did not statistically significantly reduce cardiovascular events in patients after MI who received standard medications. However, this conclusion is tempered by the nonadherence rate.National Institutes of Health.

With the emergence of large multicenter trials over the past 20 years, the numbers of investigators involved and publications resulting from each study have grown exponentially. An efficient, fair, and effective way to establish authorship on study-related manuscripts could diminish conflict among the investigators and help ensure robust and timely dissemination of study results. This article describes a process developed by the investigators in the HF-ACTION (Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training) trial (ClinicalTrials.gov registration number: NCT00047437) to establish authorship of the manuscripts describing the baseline characteristics, study design, and trial outcomes in an equitable and transparent manner based on objective, quantifiable contributions to the study as a whole. The HF-ACTION investigators developed a scoring system that assigned points to investigators by using the criteria established for enrollment, adherence to the exercise program, data completion, committee service, and other trial efforts. The scoring system has been successfully implemented for baseline manuscripts and has allowed many investigators to participate in the HF-ACTION publication process.

Background: Many physicians believe that electrocardiographic characteristics of nonsustained ventricular tachycardia correlate with the risk for sudden death in survivors of myocardial infarction....

The Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) trial, a recent randomized "megatrial" of thrombolytic therapies in acute myocardial infarction, showed a statistically significant decrease of 30-day mortality in patients treated with accelerated-dose tissue plasminogen activator (tPA) compared with streptokinase. The therapeutic and cost implications of the results have been intensely scrutinized, and several commentaries have been written on the interpretation of the study. Questions have been raised about the treatment benefit in certain subgroups, the validity of the results because of the open-label design, the relevance of a 1% absolute benefit in mortality rates, the cost-effectiveness of the drug, and the generalizability of the results. These issues are all important considerations for translating the results of this study into clinical practice worldwide. This article sheds additional light on the interpretation of GUSTO, clarifies misconceptions that may have clouded understanding of the trial results, and discusses the contributions of this trial in advancing our understanding of modern myocardial reperfusion therapy.

To compare return-to-work rates after coronary angioplasty, coronary bypass surgery, and medical therapy in patients with coronary disease.Prospective cohort study.Tertiary care referral center.Between March 1986 and June 1990, we enrolled 1252 patients who were younger than 65 years, who had not had previous coronary revascularization, and who were employed. All patients were followed for 1 year.One-year employment status.After 1 year, 84% of patients who had coronary angioplasty were still working compared with 79% of patients who had bypass surgery and with 76% of patients who received medicine. After adjusting for the more favorable baseline characteristics of patients who had angioplasty (less severe coronary artery disease, better left ventricular function, and less functional impairment), however, no significant differences were noted in 1-year employment rates among the three groups. These adjusted 1-year return-to-work rates were 84% for angioplasty, 80% for surgery, and 79% for medicine (P0.05). In a random subset of 72 patients, 23 patients who had angioplasty returned to work after a median of 18 days (mean, 27 days) compared with 54 days (mean, 67 days) for 24 patients having bypass surgery and with 14 days (mean, 45 days) for 25 patients receiving medicine (P = 0.002).Patients who had coronary angioplasty were able to return to work earlier than those who had bypass surgery, but by 1 year no significant difference was noted in employment rates. Neither revascularization strategy improved employment rates when compared with initial treatment using medical therapy.

To determine whether information from the physician's initial evaluation of patients with suspected coronary artery disease predicts coronary anatomy at catheterization and 3-year survival.Prospective validation of regression model estimates in an outpatient cohort.University medical center.A total of 1030 consecutive outpatients referred for noninvasive testing for suspected coronary artery disease; 168 of these patients subsequently underwent catheterization within 90 days.Information from the initial history, physical examination, electrocardiogram, and chest radiograph was used to predict coronary anatomy (the likelihood of any significant coronary disease, severe disease [left main or three-vessel], and significant left main disease) among 168 catheterized patients and to estimate 3-year survival among all patients. These estimates were compared with those based on treadmill testing. Cardiovascular testing charges were calculated for all patients.Predicted coronary anatomy and survival closely corresponded to actual findings. Compared with the treadmill exercise test, initial evaluation was slightly better able to distinguish patients with or without any coronary disease and was similar in the ability to identify patients at increased risk for dying or with anatomically severe disease. Based on arbitrary definitions, 37% to 66% of patients were at low risk and responsible for 31% to 56% of the charges for cardiovascular testing.The physician's initial evaluation, despite the subjective nature of much of the information gathered, can be used to identify patients likely to benefit from further testing. The development of strategies for cost-conscious quality care must begin with the history, physical examination, and simple laboratory testing.

▪Objective:To determine whether a gender bias exists in referral for coronary bypass graft surgery among patients with catheterization-documented coronary artery disease. ▪Design:Historica...

To determine if patterns of ST depression or elevation during exercise testing provide reliable information about the location of an underlying coronary lesion, we studied 452 consecutive patients with one-vessel disease who underwent treadmill testing. Exercise ST changes were classified as elevation or depression and by lead groups involved. The ST depression occurred most commonly in leads V5 or V6 regardless of which coronary artery was involved. In contrast, anterior ST elevation indicated left anterior descending coronary disease in 93% of cases, and inferior ST elevation indicated a lesion in or proximal to the posterior descending artery in 86% of cases. Furthermore, anterior ST elevation in leads without diagnostic Q waves usually indicated a high-grade, often proximal, left anterior descending stenosis, whereas anterior ST elevation in leads with Q waves usually indicated a totally occluded left anterior descending coronary artery. Thus, ST elevation during exercise testing, although uncommon, is a reliable guide to the underlying coronary lesion, whereas ST depression is not.