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【NEJM】比伐卢定与普通肝素在经皮冠状动脉介入
Adnan Kastrati, M.D., Franz-Josef Neumann, M.D., Julinda Mehilli, M.D., Robert A. Byrne, M.B., M.R.C.P.I., Raisuke Iijima, M.D., Heinz Joachim Büttner, M.D., Ahmed A. Khattab, M.D., Stefanie Schulz, M.D., James C. Blankenship, M.D., Jürgen Pache, M.D., Jan Minners, M.D., Melchior Seyfarth, M.D., Isolde Graf, Pharm.D., Kimberly A. Skelding, M.D., Josef Dirschinger, M.D., Gert Richardt, M.D., Peter B. Berger, M.D., Albert Schömig, M.D., for the ISAR-REACT 3 Trial Investigators
ABSTRACT
Background Whether bivalirudin is superior to unfractionated heparin in patients with stable or unstable angina who undergo percutaneous coronary intervention (PCI) after pretreatment with clopidogrel is unknown.
Methods We enrolled 4570 patients with stable or unstable angina (with normal levels of troponin T and creatine kinase M who were undergoing PCI after pretreatment with a 600-mg dose of clopidogrel at least 2 hours before the procedure; 2289 patients were randomly assigned in a double-blind manner to receive bivalirudin, and 2281 to receive unfractionated heparin. The primary end point was the composite of death, myocardial infarction, urgent target-vessel revascularization due to myocardial ischemia within 30 days after randomization, or major bleeding during the index hospitalization (with a net clinical benefit defined as a reduction in the incidence of the end point). The secondary end point was the composite of death, myocardial infarction, or urgent target-vessel revascularization.
Results The incidence of the primary end point was 8.3% (190 patients) in the bivalirudin group as compared with 8.7% (199 patients) in the unfractionated-heparin group (relative risk, 0.94; 95% confidence interval [CI], 0.77 to 1.15; P=0.57). The secondary end point occurred in 134 patients (5.9%) in the bivalirudin group and 115 patients (5.0%) in the unfractionated-heparin group (relative risk, 1.16; 95% CI, 0.91 to 1.49; P=0.23). The incidence of major bleeding was 3.1% (70 patients) in the bivalirudin group and 4.6% (104 patients) in the unfractionated-heparin group (relative risk, 0.66; 95% CI, 0.49 to 0.90; P=0.008).
Conclusions In patients with stable and unstable angina who underwent PCI after pretreatment with clopidogrel, bivalirudin did not provide a net clinical benefit (i.e., it did not reduce the incidence of the composite end point of death, myocardial infarction, urgent target-vessel revascularization, or major bleeding) as compared with unfractionated heparin, but it did significantly reduce the incidence of major bleeding. (ClinicalTrials.gov number, NCT00262054 [ClinicalTrials.gov] .)
Bivalirudin versus Unfractionated Heparin during Percutaneous Coronary Intervention
比伐卢定与普通肝素在经皮冠状动脉介入术中应用的比较
ABSTRACT
摘要
Background Whether bivalirudin is superior to unfractionated heparin in patients with stable or unstable angina who undergo percutaneous coronary intervention (PCI) after pretreatment with clopidogrel is unknown.
背景：对于接受经皮冠状动脉介入（PCI）并接受氯吡格雷预处理的稳定性或不稳定性心绞痛患者，比伐卢定优于比普通肝素尚不清楚。
Methods We enrolled 4570 patients with stable or unstable angina (with normal levels of troponin T and creatine kinase M who were undergoing PCI after pretreatment with a 600-mg dose of clopidogrel at least 2 hours before the procedure; 2289 patients were randomly assigned in a double-blind manner to receive bivalirudin, and 2281 to receive unfractionated heparin. The primary end point was the composite of death, myocardial infarction, urgent target-vessel revascularization due to myocardial ischemia within 30 days after randomization, or major bleeding during the index hospitalization (with a net clinical benefit defined as a reduction in the incidence of the end point). The secondary end point was the composite of death, myocardial infarction, or urgent target-vessel revascularization.
方法：我们入选了4570例稳定性或不稳定性心绞痛患者，他们在PCI术前至少2小时接受了600mg氯吡格雷预处理。2289例患者随机双盲接受比伐卢定，2281例患者接受普通肝素。主要终点为包括随机30天内的死亡、心肌梗死、因心肌缺血的急性靶血管重建和住院期间主要出血事件的复合终点（将终点事件的减少作为临床净获益）。次要终点为死亡、心肌梗死和急性靶血管重建的复合终点。
Results The incidence of the primary end point was 8.3% (190 patients) in the bivalirudin group as compared with 8.7% (199 patients) in the unfractionated-heparin group (relative risk, 0.94; 95% confidence interval [CI], 0.77 to 1.15; P=0.57). The secondary end point occurred in 134 patients (5.9%) in the bivalirudin group and 115 patients (5.0%) in the unfractionated-heparin group (relative risk, 1.16; 95% CI, 0.91 to 1.49; P=0.23). The incidence of major bleeding was 3.1% (70 patients) in the bivalirudin group and 4.6% (104 patients) in the unfractionated-heparin group (relative risk, 0.66; 95% CI, 0.49 to 0.90; P=0.008).
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作者:admin@医学,生命科学 2011-04-17 05:14
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