Cardio Trial Files Throwback Thursday: Medical Therapy +/- Revascularization in T2DM & CAD, Prophylactic Defibrillator in Prior MI, and Ticagrelor vs. Clopidogrel in PAD
A Randomized Trial of Therapies for Type 2 Diabetes and Coronary Artery Disease
BARI 2D Study Group. NEJM (June 2009)
Bottom Line: This randomized 2x2 factorial clinical trial of 2368 patients with type 2 diabetes mellitus and stable ischemic heart disease compared prompt revascularization with intensive medical therapy to intensive medical therapy alone and insulin-sensitization to insulin-provision therapy. The study was stratified according to the choice of percutaneous coronary intervention (PCI) or coronary-artery bypass grafting (CABG) as the more appropriate intervention. After 5 years, there was no significant difference in the primary endpoints of death and major cardiovascular events between the groups. However, in the CABG stratum, the incidence of major cardiovascular events was numerically lower in the revascularization group (22.4%) compared to the medical therapy group (30.5%, P=0.01; P=0.002 for the interaction between stratum and study group). Adverse events and serious adverse events were generally similar among the randomization groups, but severe hypoglycemia was more frequent in the insulin-provision group.
Prophylactic Implantation of a Defibrillator in Patients with Myocardial Infarction and Reduced Ejection Fraction
Moss AJ et al. NEJM (March 2002)
Bottom Line: This randomized, controlled trial enrolled 1232 patients with a prior myocardial infarction and a left ventricular ejection fraction of 0.30 or less. Patients were randomly assigned in a 3:2 ratio to receive an implantable defibrillator or conventional medical therapy. After an average follow-up of 20 months, the mortality rate in the defibrillator group was 14.2%, compared to 19.8% in the conventional-therapy group. The hazard ratio for the risk of death from any cause in the defibrillator group was 0.69 (95% CI, 0.51 to 0.93; P=0.016). The results suggest that prophylactic implantation of a defibrillator improves survival and should be considered as a recommended therapy.
Ticagrelor versus Clopidogrel in Symptomatic Peripheral Artery Disease
Hiatt WR et al. NEJM (January 2017)
Bottom Line: This double-blind, event-driven trial randomized 13,885 patients with symptomatic peripheral artery disease to receive monotherapy with ticagrelor (90 mg twice daily) or clopidogrel (75 mg once daily). The primary efficacy end point was a composite of adjudicated cardiovascular death, myocardial infarction, or ischemic stroke, and the primary safety end point was major bleeding. The primary efficacy end point occurred at similar rates in both groups - 10.8% in the ticagrelor group and 10.6% in the clopidogrel group (hazard ratio, 1.02; 95% CI, 0.92 to 1.13; P=0.65). Acute limb ischemia and major bleeding occurred at similar rates in both groups (1.7% and 1.6%, respectively). The results of this study indicate that ticagrelor is not superior to clopidogrel for the reduction of cardiovascular events in patients with symptomatic peripheral artery disease.
Cardio Trial Files Issue #CRD-2024-21
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