Cardio Trial Files Throwback Thursday: Rosuvastatin in ESRD, Ticagrelor vs. Clopidogrel in ACS, and Continuous-Flow LVAD in HF
Rosuvastatin and Cardiovascular Events in Patients Undergoing Hemodialysis
Fellström BG et al. NEJM (April 2009)
Bottom Line: This international, multicenter, randomized, double-blind, prospective trial evaluated the effects of rosuvastatin (10 mg daily) in 2776 patients aged 50-80 years undergoing maintenance hemodialysis, compared with placebo. After a median follow-up of 3.8 years, rosuvastatin had no significant effect on the primary outcome of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke (hazard ratio 0.96, 95% CI 0.84-1.11, P=0.59). There was also no significant effect on all-cause mortality (hazard ratio 0.96, 95% CI 0.86-1.07, P=0.51).
Ticagrelor versus Clopidogrel in Patients with Acute Coronary Syndromes
Wallentin L et al. NEJM (September 2009)
Bottom Line: This randomized, double-blind, multicenter trial included 18,624 patients admitted to the hospital with an acute coronary syndrome with or without ST-segment elevation. Patients were randomized to receive either ticagrelor (180-mg loading dose, 90 mg twice daily thereafter) or clopidogrel (300-to-600-mg loading dose, 75 mg daily thereafter). The primary outcome, a composite of death from vascular causes, myocardial infarction, or stroke, occurred in 9.8% of patients receiving ticagrelor and 11.7% of those receiving clopidogrel (hazard ratio, 0.84; 95% confidence interval [CI], 0.77 to 0.92; P<0.001). There was no significant difference in the rates of major bleeding between the two groups (11.6% and 11.2%, respectively; P=0.43). However, treatment with ticagrelor was associated with a higher rate of major bleeding not related to coronary-artery bypass grafting (4.5% vs. 3.8%, P=0.03), including more instances of fatal intracranial bleeding and fewer of fatal bleeding of other types. The results of this study suggest that ticagrelor is more effective than clopidogrel in reducing cardiovascular events in patients with acute coronary syndrome. While ticagrelor did not increase the overall rate of major bleeding, it was associated with a higher rate of non–procedure-related bleeding.
Advanced Heart Failure Treated with Continuous-Flow Left Ventricular Assist Device
Slaughter MS et al. NEJM (December 2009)
Bottom Line: This randomized trial enrolled 200 patients with advanced heart failure ineligible for transplantation in a 2:1 ratio to receive either a continuous-flow device or a pulsatile-flow device. At 2 years, the primary composite end point of survival free from disabling stroke and reoperation to repair or replace the device was achieved in 46% of patients with continuous-flow devices vs. 11% of patients with pulsatile-flow devices (hazard ratio, 0.38; 95% confidence interval, 0.27 to 0.54; P<0.001). Furthermore, 58% of patients with continuous-flow devices had superior actuarial survival rates vs. 24% with pulsatile-flow devices (P=0.008). Adverse events and device replacements were also less frequent in patients with continuous-flow devices. Both devices significantly improved the quality of life and functional capacity.
Cardio Trial Files Issue #CRD-2025-01
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