Kastrati Adnan, Neumann Franz-Josef, Mehilli Julinda, Byrne Robert A, Iijima Raisuke, Büttner Heinz Joachim, Khattab Ahmed A, Schulz Stefanie, Blankenship James C, Pache Jürgen, Minners Jan, Seyfarth Melchior, Graf Isolde, Skelding Kimberly A, Dirschinger Josef, Richardt Gert, Berger Peter B, Schömig Albert
Deutsches Herzzentrum, Technische Universität, Munich, Germany.
N Engl J Med. 2008 Aug 14;359(7):688-96. doi: 10.1056/NEJMoa0802944.
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.
We enrolled 4570 patients with stable or unstable angina (with normal levels of troponin T and creatine kinase MB) 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.
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).
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.)
对于接受氯吡格雷预处理后行冠状动脉介入治疗（PCI）的稳定型或不稳定型心绞痛患者，比伐卢定是否优于普通肝素尚不清楚。
我们纳入了4570例稳定型或不稳定型心绞痛患者（肌钙蛋白T和肌酸激酶MB水平正常），这些患者在PCI术前至少2小时接受了600mg氯吡格雷预处理；2289例患者以双盲方式随机分配接受比伐卢定治疗，2281例接受普通肝素治疗。主要终点为随机分组后30天内死亡、心肌梗死、因心肌缺血进行紧急靶血管血运重建或住院期间大出血的复合终点（净临床获益定义为终点事件发生率降低）。次要终点为死亡、心肌梗死或紧急靶血管血运重建的复合终点。
比伐卢定组主要终点发生率为8.3%（190例患者），普通肝素组为8.7%（199例患者）（相对危险度，0.94；95%置信区间[CI]，0.77至1.15；P=0.57）。比伐卢定组次要终点发生在134例患者（5.9%），普通肝素组发生在115例患者（5.0%）（相对危险度，1.16；95%CI，0.91至1.49；P=0.23）。比伐卢定组大出血发生率为3.1%（70例患者），普通肝素组为4.6%（104例患者）（相对危险度，0.66；95%CI，0.49至0.90；P=0.008）。
在接受氯吡格雷预处理后行PCI的稳定型和不稳定型心绞痛患者中，与普通肝素相比，比伐卢定未带来净临床获益（即未降低死亡、心肌梗死、紧急靶血管血运重建或大出血复合终点的发生率），但确实显著降低了大出血的发生率。（ClinicalTrials.gov编号，NCT00262054。）
