Durazzo Anai E S, Machado Fábio S, Ikeoka Dimas T, De Bernoche Cláudia, Monachini Maristela C, Puech-Leão Pedro, Caramelli Bruno
Heart Institute and Vascular Surgery Department, University of São Paulo Medical School, São Paulo, Brazil.
J Vasc Surg. 2004 May;39(5):967-75; discussion 975-6. doi: 10.1016/j.jvs.2004.01.004.
This 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.
One 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.
Fifty 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).
Short-term treatment with atorvastatin significantly reduces the incidence of major adverse cardiovascular events after vascular surgery.
本前瞻性、随机、安慰剂对照、双盲临床试验旨在分析阿托伐他汀与安慰剂相比,对血管手术后6个月心血管事件复合结局发生情况的影响。心血管并发症是接受血管手术患者围手术期发病和死亡的最重要原因。他汀类药物治疗可能通过稳定冠状动脉斑块来减少围手术期心脏事件。
100例患者被随机分配,无论其血清胆固醇浓度如何,每天接受20mg阿托伐他汀或安慰剂治疗,持续45天。随机分组后平均30天进行血管手术,对患者进行为期6个月的前瞻性随访。所研究的心血管事件包括心源性死亡、非致命性心肌梗死、不稳定型心绞痛和中风。
50例患者接受阿托伐他汀治疗,50例接受安慰剂治疗。在6个月的随访期间,17例患者出现主要终点事件,阿托伐他汀组4例,安慰剂组13例。与阿托伐他汀组(8.0%)相比,安慰剂组心脏事件发生率高出三倍多(26.0%;P = 0.031)。采用Kaplan-Meier方法比较两组之间的事件风险,即血管手术后无事件生存情况。与安慰剂组相比,接受阿托伐他汀治疗的患者在血管手术后6个月内心脏事件发生率显著降低(P = 0.018)。
阿托伐他汀短期治疗可显著降低血管手术后主要不良心血管事件的发生率。