American heart journal
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American heart journal · Oct 2001
Randomized Controlled Trial Comparative Study Clinical TrialRegression of left ventricular remodeling in chronic heart failure: Comparative and combined effects of captopril and carvedilol.
This study evaluated the independent and combined effects of captopril and carvedilol on left ventricular remodeling in chronic heart failure. Although angiotensin-converting enzyme inhibitors and b-blockers are known to attenuate the remodeling process in chronic heart failure, a direct comparison of these agents has not been performed. ⋯ Although angiotensin-converting enzyme inhibitor therapy did not alter left ventricular volume, treatment with carvedilol was associated with reductions in chamber volume; both drugs reduced left ventricular mass and sphericity. These beneficial effects on remodeling may help to explain the relative prognostic benefits of these therapies.
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American heart journal · Sep 2001
Randomized Controlled Trial Multicenter Study Clinical TrialAntiarrhythmic drug use in the implantable defibrillator arm of the Antiarrhythmics Versus Implantable Defibrillators (AVID) Study.
Previous retrospective or observational series suggest that many patients with an implantable cardioverter-defibrillator (ICD) will be treated with antiarrhythmic drugs (AADs) to modify the frequency or manifestation of recurrent ventricular arrhythmias. The relative clinical benefit, however, is uncertain, and deleterious interactions can occur. The objective of this clinical investigation was to study the need for, and effects of, concomitant AAD use with the ICD in a prospectively defined cohort. ⋯ The majority of patients who receive ICDs for sustained ventricular tachycardia or ventricular fibrillation can be treated without AADs. Most commonly, AADs are added to combat frequent ICD shocks, which are successfully reduced by AAD therapy.
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American heart journal · Sep 2001
Randomized Controlled Trial Clinical TrialChallenges of subgroup analyses in multinational clinical trials: experiences from the MERIT-HF trial.
International placebo-controlled survival trials (Metoprolol Controlled-Release Randomised Intervention Trial in Heart Failure [MERIT-HF], Cardiac Insufficiency Bisoprolol Study [CIBIS-II], and Carvedilol Prospective Randomized Cumulative Survival trial [COPERNICUS]) evaluating the effects of b-blockade in patients with heart failure have all demonstrated highly significant positive effects on total mortality as well as total mortality plus all-cause hospitalization. Also, the analysis of the US Carvedilol Program indicated an effect on these end points. Although none of these trials are large enough to provide definitive results in any particular subgroup, it is natural for physicians to examine the consistency of results across various subgroups or risk groups. Our purpose was to examine both predefined and post hoc subgroups in the MERIT-HF trial to provide guidance as to whether any subgroup is at increased risk, despite an overall strongly positive effect, and to discuss the difficulties and limitations in conducting such subgroup analyses. ⋯ Just as we must be extremely cautious in overinterpreting positive effects in subgroups, even those that are predefined, we must also be cautious in focusing on subgroups with an apparent neutral or negative trend. We should examine subgroups to obtain a general sense of consistency, which is clearly the case in MERIT-HF. We should expect some variation of the treatment effect around the overall estimate as we examine a large number of subgroups because of small sample size in subgroups and chance. Thus the best estimate of the treatment effect on total mortality for any subgroup is the estimate of the hazard ratio for the overall trial.
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American heart journal · Aug 2001
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialRandomized comparison of a novel anticoagulant, vasoflux, and heparin as adjunctive therapy to streptokinase for acute myocardial infarction: results of the VITAL study (Vasoflux International Trial for Acute Myocardial Infarction Lysis).
Vasoflux is a low-molecular-weight heparin derivative that inhibits factor IXa activation of factor X and catalyzes fibrin-bound thrombin inactivation by heparin cofactor II. We studied whether vasoflux improves the results of thrombolysis with streptokinase for acute myocardial infarction. ⋯ At doses that increase the risk of bleeding, the addition of vasoflux to streptokinase and aspirin did not lead to improved patency rates compared with UFH. Targeting factor IXa and heparin cofactor II may not be a useful adjunct to thrombolysis.
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American heart journal · Aug 2001
Randomized Controlled Trial Clinical TrialSafety and feasibility of a novel rate-smoothed ventricular pacing algorithm for atrial fibrillation.
This study was conducted to establish the safety and performance of a new rate-smoothing pacing algorithm for patients with atrial fibrillation (AF). ⋯ Long-term rate-smoothed pacing is feasible. Because of concerns about pacing-induced heart failure in some patients with rapid ventricular rates, rate-smoothed pacing should be reserved for those who remain symptomatic despite adequate control of the ventricular rate. The RSA may help to reduce symptoms in patients with medically refractory AF; more study is required to define its efficacy in reducing symptoms and morbidity in this population.