Stone Gregg W, Witzenbichler Bernhard, Guagliumi Giulio, Peruga Jan Z, Brodie Bruce R, Dudek Dariusz, Kornowski Ran, Hartmann Franz, Gersh Bernard J, Pocock Stuart J, Dangas George, Wong S Chiu, Kirtane Ajay J, Parise Helen, Mehran Roxana
Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY 10022, USA.
N Engl J Med. 2008 May 22;358(21):2218-30. doi: 10.1056/NEJMoa0708191.
Treatment with the direct thrombin inhibitor bivalirudin, as compared with heparin plus glycoprotein IIb/IIIa inhibitors, results in similar suppression of ischemia while reducing hemorrhagic complications in patients with stable angina and non-ST-segment elevation acute coronary syndromes who are undergoing percutaneous coronary intervention (PCI). The safety and efficacy of bivalirudin in high-risk patients are unknown.
We randomly assigned 3602 patients with ST-segment elevation myocardial infarction who presented within 12 hours after the onset of symptoms and who were undergoing primary PCI to treatment with heparin plus a glycoprotein IIb/IIIa inhibitor or to treatment with bivalirudin alone. The two primary end points of the study were major bleeding and combined adverse clinical events, defined as the combination of major bleeding or major adverse cardiovascular events, including death, reinfarction, target-vessel revascularization for ischemia, and stroke (hereinafter referred to as net adverse clinical events) within 30 days.
Anticoagulation with bivalirudin alone, as compared with heparin plus glycoprotein IIb/IIIa inhibitors, resulted in a reduced 30-day rate of net adverse clinical events (9.2% vs. 12.1%; relative risk, 0.76; 95% confidence interval [CI] 0.63 to 0.92; P=0.005), owing to a lower rate of major bleeding (4.9% vs. 8.3%; relative risk, 0.60; 95% CI, 0.46 to 0.77; P<0.001). There was an increased risk of acute stent thrombosis within 24 hours in the bivalirudin group, but no significant increase was present by 30 days. Treatment with bivalirudin alone, as compared with heparin plus glycoprotein IIb/IIIa inhibitors, resulted in significantly lower 30-day rates of death from cardiac causes (1.8% vs. 2.9%; relative risk, 0.62; 95% CI, 0.40 to 0.95; P=0.03) and death from all causes (2.1% vs. 3.1%; relative risk, 0.66; 95% CI, 0.44 to 1.00; P=0.047).
In patients with ST-segment elevation myocardial infarction who are undergoing primary PCI, anticoagulation with bivalirudin alone, as compared with heparin plus glycoprotein IIb/IIIa inhibitors, results in significantly reduced 30-day rates of major bleeding and net adverse clinical events. (ClinicalTrials.gov number, NCT00433966 [ClinicalTrials.gov].).
与肝素加糖蛋白IIb/IIIa抑制剂相比，直接凝血酶抑制剂比伐卢定治疗可在抑制缺血方面取得相似效果，同时减少接受经皮冠状动脉介入治疗（PCI）的稳定型心绞痛和非ST段抬高急性冠脉综合征患者的出血并发症。比伐卢定在高危患者中的安全性和有效性尚不清楚。
我们将3602例症状发作后12小时内就诊且正在接受直接PCI的ST段抬高型心肌梗死患者随机分为两组，分别接受肝素加糖蛋白IIb/IIIa抑制剂治疗或单独接受比伐卢定治疗。该研究的两个主要终点是严重出血和综合不良临床事件，综合不良临床事件定义为严重出血或主要不良心血管事件（包括死亡、再梗死、因缺血进行靶血管血运重建和卒中）在30天内的合并情况（以下简称净不良临床事件）。
与肝素加糖蛋白IIb/IIIa抑制剂相比，单独使用比伐卢定抗凝可降低30天净不良临床事件发生率（9.2%对12.1%；相对危险度，0.76；95%置信区间[CI]为0.63至0.92；P = 0.005），原因是严重出血发生率较低（4.9%对8.3%；相对危险度，0.60；95%CI为0.46至0.77；P<0.001）。比伐卢定组在24小时内急性支架血栓形成风险增加，但到30天时无显著增加。与肝素加糖蛋白IIb/IIIa抑制剂相比，单独使用比伐卢定治疗可使30天内心脏原因导致的死亡发生率显著降低（1.8%对2.9%；相对危险度，0.62；95%CI为0.40至0.95；P = 0.03），全因死亡发生率也显著降低（2.1%对3.1%；相对危险度，0.66；95%CI为0.44至1.00；P = 0.047）。
在接受直接PCI的ST段抬高型心肌梗死患者中，与肝素加糖蛋白IIb/IIIa抑制剂相比，单独使用比伐卢定抗凝可显著降低30天严重出血和净不良临床事件发生率。（临床试验注册号，NCT00433966 [ClinicalTrials.gov]）
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