Cardio Trial Files Throwback Thursday: Stenting vs. Medical Therapy in RAS, Chlorthalidone in HTN, and Rivaroxaban in PAD
Stenting and Medical Therapy for Atherosclerotic Renal-Artery Stenosis
Cooper CJ et al. NEJM (January 2014)
Bottom Line: This randomized controlled trial of 947 participants with atherosclerotic renal-artery stenosis and either systolic hypertension or chronic kidney disease found that renal-artery stenting plus medical therapy did not significantly reduce the rate of the primary composite end point of death from cardiovascular or renal causes, myocardial infarction, stroke, hospitalization for congestive heart failure, progressive renal insufficiency, or the need for renal-replacement therapy compared to medical therapy alone over a median follow-up period of 43 months (35.1% and 35.8%, respectively; hazard ratio with stenting, 0.94; 95% confidence interval [CI], 0.76 to 1.17; P=0.58). There were also no significant differences between the treatment groups in the rates of the individual components of the primary end point or in all-cause mortality. However, there was a consistent modest difference in systolic blood pressure favoring the stent group.
Major Outcomes in High-Risk Hypertensive Patients Randomized to Angiotensin-Converting Enzyme Inhibitor or Calcium Channel Blocker vs Diuretic (ALLHAT)
The ALLHAT Collaborative Research Group. JAMA (December 2002)
Bottom Line: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) was a randomized, double-blind, active-controlled clinical trial conducted from February 1994 through March 2002. A total of 33 357 participants aged 55 years or older with hypertension and at least 1 other CHD risk factor from 623 North American centers were randomly assigned to receive chlorthalidone, amlodipine, or lisinopril. The primary outcome was combined fatal CHD or nonfatal myocardial infarction. Results showed no difference between treatments, and all-cause mortality did not differ between groups. Thiazide-type diuretics were found to be superior in preventing 1 or more major forms of CVD and are less expensive, and should be preferred for first-step antihypertensive therapy.
Rivaroxaban in Peripheral Artery Disease after Revascularization
Bonaca MP et al. NEJM (March 2020)
Bottom Line: This double-blind, randomized trial included 6564 patients with peripheral artery disease who had undergone revascularization and were assigned to receive either rivaroxaban (2.5 mg twice daily) plus aspirin or placebo plus aspirin. The primary outcome was a composite of acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or death from cardiovascular causes. The primary safety outcome was major bleeding, defined according to the Thrombolysis in Myocardial Infarction (TIMI) classification. The incidence of the primary outcome at 3 years was 17.3% in the rivaroxaban group and 19.9% in the placebo group (hazard ratio, 0.85, 95% confidence interval [CI], 0.76 to 0.96; P=0.009). TIMI major bleeding occurred in 62 patients in the rivaroxaban group and in 44 patients in the placebo group (2.65% and 1.87%; hazard ratio, 1.43; 95% CI, 0.97 to 2.10; P=0.07). Rivaroxaban plus aspirin was associated with a significantly lower incidence of the primary outcome than aspirin alone.
Cardio Trial Files Issue #CRD-2025-05
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