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Randomized Controlled Trial Clinical Trial
Reduction in cardiovascular events after vascular surgery with atorvastatin: a randomized trial.
- Anai E S Durazzo, Fábio S Machado, Dimas T Ikeoka, Cláudia De Bernoche, Maristela C Monachini, Pedro Puech-Leão, and Bruno Caramelli.
- Heart Institute and Vascular Surgery Department, University of São Paulo Medical School, São Paulo, Brazil. anaidurazzo@uol.com.br
- J. Vasc. Surg. 2004 May 1;39(5):967-75; discussion 975-6.
ObjectivesThis prospective, randomized, placebo-controlled, double-blind clinical trial was performed to analyze the effect of atorvastatin compared with placebo on the occurrence of a 6-month composite of cardiovascular events after vascular surgery. Cardiovascular complications are the most important cause of perioperative morbidity and mortality among patients undergoing vascular surgery. Statin therapy may reduce perioperative cardiac events through stabilization of coronary plaques.MethodsOne hundred patients were randomly assigned to receive 20 mg atorvastatin or placebo once a day for 45 days, irrespective of their serum cholesterol concentration. Vascular surgery was performed on average 30 days after randomization, and patients were prospectively followed up over 6 months. The cardiovascular events studied were death from cardiac cause, nonfatal myocardial infarction, unstable angina, and stroke.ResultsFifty patients received atorvastatin, and 50 received placebo. During the 6-month follow-up primary end points occurred in 17 patients, 4 in the atorvastatin group and 13 in the placebo group. The incidence of cardiac events was more than three times higher with placebo (26.0%) compared with atorvastatin (8.0%; P =.031). The risk for an event was compared between the groups with the Kaplan-Meier method, as event-free survival after vascular surgery. Patients given atorvastatin exhibited a significant decrease in the rate of cardiac events, compared with the placebo group, within 6 months after vascular surgery (P =.018).ConclusionShort-term treatment with atorvastatin significantly reduces the incidence of major adverse cardiovascular events after vascular surgery.
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