Stent thrombosis in randomized clinical trials of drug-eluting stents
Stent thrombosis in randomized clinical trials of drug-eluting stents
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DOI：
10.1056/nejmoa067731
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发表时间：
2007-03-08
影响因子：
158.5
通讯作者：
Cutlip, Donald E.
中科院分区：
文献类型：
--
作者：
Mauri, Laura;Hsieh, Wen-hua;Cutlip, Donald E.
背景：在药物洗脱支架的临床试验中使用的支架内血栓形成的定义是限制性的，并且没有统一的使用方式。方法：我们采用学术研究联盟（ARC）制定的支架血栓分层分类，随机试验包括878例使用西罗莫司洗脱支架的患者，1400例使用紫杉醇洗脱支架的患者，2267例使用裸金属支架的患者。然后我们汇总了4年的随访数据。所有事件均由独立的临床事件委员会裁决。结果：根据最初的方案定义，西罗莫司支架组的累计支架血栓发生率为1.2%，裸金属支架组为0.6% (P=0.20； 95%可信区间[CI]， -0.4至1.5)；紫杉醇支架组的累计支架血栓发生率为1.3%，裸金属支架组为0.8% （P=0.24; 95% CI, -0.3至1.4）。ARC定义的明确或可能的支架血栓发生率，西罗莫司支架组为1.5%，裸金属支架组为1.7% (P=0.70; 95% CI, -1.5至1.0)；紫杉醇支架组为1.8%，裸金属支架组为1.4% （P=0.52; 95% CI, -0.7至1.4）。植入后1 - 4年确定或可能发生事件的发生率，西罗莫司支架组为0.9%，裸金属支架组为0.4%；紫杉醇支架组为0.9%，裸金属支架组为0.6%。结论：在随机临床试验中，药物洗脱支架患者与裸金属支架患者的支架血栓发生率无显著差异，尽管检测出发生率微小差异的能力有限。
BACKGROUND:Definitions of stent thrombosis that have been used in clinical trials of drug-eluting stents have been restrictive and have not been used in a uniform manner.METHODS:We applied a hierarchical classification of stent thrombosis set by the Academic Research Consortium (ARC) across randomized trials involving 878 patients treated with sirolimus-eluting stents, 1400 treated with paclitaxel-eluting stents, and 2267 treated with bare-metal stents. We then pooled 4 years of follow-up data. All events were adjudicated by an independent clinical-events committee.RESULTS:The cumulative incidence of stent thrombosis according to the original protocol definitions was 1.2% in the sirolimus-stent group versus 0.6% in the bare-metal-stent group (P=0.20; 95% confidence interval [CI], -0.4 to 1.5) and 1.3% in the paclitaxel-stent group versus 0.8% in the bare-metal-stent group (P=0.24; 95% CI, -0.3 to 1.4). The incidence of definite or probable stent thrombosis as defined by the ARC was 1.5% in the sirolimus-stent group versus 1.7% in the bare-metal-stent group (P=0.70; 95% CI, -1.5 to 1.0) and 1.8% in the paclitaxel-stent group versus 1.4% in the bare-metal-stent group (P=0.52; 95% CI, -0.7 to 1.4). The incidence of definite or probable events occurring 1 to 4 years after implantation was 0.9% in the sirolimus-stent group versus 0.4% in the bare-metal-stent group and 0.9% in the paclitaxel-stent group versus 0.6% in the bare-metal-stent group.CONCLUSIONS:The incidence of stent thrombosis did not differ significantly between patients with drug-eluting stents and those with bare-metal stents in randomized clinical trials, although the power to detect small differences in rates was limited.