Paclitaxel-Eluting Stents versus Bare-Metal Stents in Acute Myocardial Infarction.
Paclitaxel-Eluting Stents versus Bare-Metal Stents in Acute Myocardial Infarction.
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DOI：
10.1056/nejmoa0810116
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发表时间：
2009-05-07
影响因子：
158.5
通讯作者：
Mehran, Roxana
中科院分区：
文献类型：
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作者：
Stone, Gregg W.;Lansky, Alexandra J.;Mehran, Roxana
背景资料：在接受直接经皮冠状动脉介入治疗（PCI）的ST段抬高型心肌梗死患者中，药物洗脱支架与裸金属支架相比的安全性和有效性尚无共识。方法：我们以3：1的比例将3006例ST段抬高型心肌梗死患者随机分配接受紫杉醇洗脱支架（2257例患者）或相同的裸金属支架（749例患者）。该研究的两个主要终点是12个月缺血靶病变血运重建率（分析的优效性）和死亡、再梗死、卒中或支架内血栓形成的复合安全性结局指标（非劣效性，3.0%界值）。主要的次要终点是13个月时血管造影显示的再狭窄。结果：与裸金属支架组相比，接受紫杉醇洗脱支架组的患者12个月时缺血驱动的靶病变血运重建率显著降低（4.5% vs. 7.5%;风险比，0.59; 95%置信区间[CI]，0.43 - 0.83; P=0.002）和靶血管血运重建（5.8% vs. 8.7%;风险比，0.65; 95% CI，0.48 - 0.89; P=0.006），复合安全性终点的发生率非劣效（8.1% vs. 8.0%;风险比，1.02; 95% CI，0.76 - 1.36;绝对差异，0.1个百分点; 95% CI，-2.1至2.4;非劣效性P=0.01;优效性P=0.92）。接受紫杉醇洗脱支架和裸金属支架治疗的患者12个月死亡率（分别为3.5%和3.5%; P=0.98）和支架内血栓形成率（分别为3.2%和3.4%; P=0.77）相似。紫杉醇洗脱支架组13个月二元再狭窄率显著低于裸金属支架组（10.0% vs. 22.9%;风险比，0.44; 95%CI，0.33 - 0.57; P
Background: There is no consensus regarding the safety and efficacy of drug-eluting stents, as compared with bare-metal stents, in patients with ST-segment elevation myocardial infarction who are undergoing primary percutaneous coronary intervention (PCI).Methods: We randomly assigned, in a 3:1 ratio, 3006 patients presenting with ST-segment elevation myocardial infarction to receive paclitaxel-eluting stents (2257 patients) or otherwise identical bare-metal stents (749 patients). The two primary end points of the study were the 12-month rates of target-lesion revascularization for ischemia (analysis powered for superiority) and a composite safety outcome measure of death, reinfarction, stroke, or stent thrombosis (powered for noninferiority with a 3.0% margin). The major secondary end point was angiographic evidence of restenosis at 13 months.Results: Patients who received paclitaxel-eluting stents, as compared with those who received bare-metal stents, had significantly lower 12-month rates of ischemia-driven target-lesion revascularization (4.5% vs. 7.5%; hazard ratio, 0.59; 95% confidence interval [CI], 0.43 to 0.83; P=0.002) and target-vessel revascularization (5.8% vs. 8.7%; hazard ratio, 0.65; 95% CI, 0.48 to 0.89; P=0.006), with noninferior rates of the composite safety end point (8.1% vs. 8.0%; hazard ratio, 1.02; 95% CI, 0.76 to 1.36; absolute difference, 0.1 percentage point; 95% CI, -2.1 to 2.4; P=0.01 for noninferiority; P=0.92 for superiority). Patients treated with paclitaxel-eluting stents and those treated with bare-metal stents had similar 12-month rates of death (3.5% and 3.5%, respectively; P=0.98) and stent thrombosis (3.2% and 3.4%, respectively; P=0.77). The 13-month rate of binary restenosis was significantly lower with paclitaxel-eluting stents than with bare-metal stents (10.0% vs. 22.9%; hazard ratio, 0.44; 95% CI, 0.33 to 0.57; P