Evaluation of the effect of oral verapamil on clinical outcome and angiographic -: Restenosis after percutaneous coronary intervention -: The randomized, double-blind, placebo-controlled, multicenter verapamil slow-release for prevention of cardiovascular events after angioplasty (VESPA) trial
Evaluation of the effect of oral verapamil on clinical outcome and angiographic -: Restenosis after percutaneous coronary intervention -: The randomized, double-blind, placebo-controlled, multicenter verapamil slow-release for prevention of cardiovascular events after angioplasty (VESPA) trial
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DOI：
10.1016/j.jacc.2004.02.047
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发表时间：
2004-06-16
影响因子：
24
通讯作者：
Roskamm, H
中科院分区：
文献类型：
--
作者：
Bestehorn, HP;Neumann, FJ;Roskamm, H
我们研究了口服维拉帕米对经皮冠状动脉介入治疗（PCI）后临床结局和血管造影再狭窄的影响。背景迄今为止，还没有建立预防PCI后再狭窄的系统药理学方法。五个小的研究报告令人鼓舞的结果为钙通道阻滞剂。方法我们的随机双盲试验包括700例连续成功的PCI自体冠状动脉。患者接受钙通道阻滞剂维拉帕米，240毫克，每日两次，为期六个月，或安慰剂。主要临床终点是死亡，心肌梗死和靶血管血运重建（TVR）的复合率在一年的随访;血管造影终点是在6个月的随访angiography. ResultsWe获得了完整的临床随访95%的患者，并在94%的计划血管造影进行。接受支架治疗的患者比例为83%。维拉帕米组67例（19.3%）患者和安慰剂组103例（29.3%）患者达到主要临床终点（相对风险[RR] 0.66 [95%置信区间（CI）0.48 - 0.89]; p = 0.002）。组间差异由TVR驱动（维拉帕米组为17.5%，安慰剂组为26.2%; RR 0.67 [95% CI 0.49 - 0.93]; p = 0.006）。维拉帕米组晚期管腔丢失为0.74 ± 0.70 mm，安慰剂组为0.81 ± 0.75转（p = 0.11）。与安慰剂相比，维拉帕米降低了≥ 75%的再狭窄率（7.8%vs.13.7%; RR 0.57 [95%CI 0.35 - 0.92]; p = 0.014）。结论：与安慰剂相比，维拉帕米通过减少TVR的需要，改善了自体冠状动脉PCI术后的长期临床结局。这是由于高度再狭窄率降低所致。U（C）2004由美国心脏病学会基金会。
OBJECTIVES We investigated the effect of oral verapamil on clinical outcome and angiographic restenosis after percutaneous coronary intervention (PCI).BACKGROUND Thus far, there is no established systemic pharmacologic approach for the prevention of restenosis after PCIs. Five small studies reported encouraging results for calcium channel blockers.METHODS Our randomized double-blind trial included 700 consecutive patients with successful PCI of a native coronary artery. Patients received the calcium channel blocker verapamil, 240 mg twice daily for six months, or placebo. Primary clinical end point was the composite rate of death, myocardial infarction, and target vessel revascularization (TVR) during one-year follow-up; the angiographic end point was late lumen loss at the six-month follow-up angiography.RESULTS We obtained complete clinical follow-up in 95% of the patients, and scheduled angiography was performed in 94%. The proportion of patients treated with stents was 83%. The primary clinical end point was reached in 67 (19.3%) patients on verapamil and in 103 (29.3%) patients on placebo (relative risk [RR] 0.66 [95% confidence interval (CI) 0.48 to 0.89]; p = 0.002). This difference between the groups was driven by TVR (17.5% with verapamil vs. 26.2% with placebo; RR 0.67 [95% CI 0.49 to 0.93]; p = 0.006). Late lumen loss was 0.74 +/- 0.70 mm with verapamil and 0.81 +/- 0.75 turn with placebo (p = 0.11). Compared with placebo, verapamil reduced the rate of restenosis greater than or equal to75% (7.8% vs. 13.7%; RR 0.57 [95% CI 0.35 to 0.92]; p = 0.014).CONCLUSIONS Verapamil compared with placebo improves long-term clinical outcome after PCI of native coronary arteries by reducing the need for TVR. This was caused by a reduction in the rate of high-grade restenosis. U (C) 2004 by the American College of Cardiology Foundation.