Iijima Raisuke, Ndrepepa Gjin, Mehilli Julinda, Byrne Robert A, Schulz Stefanie, Neumann Franz-Josef, Richardt Gert, Berger Peter B, Schömig Albert, Kastrati Adnan
Deutsches Herzzentrum, Technische Universität, Lazarettstr. 36, 80636 Munich, Germany.
Eur Heart J. 2009 Feb;30(3):290-6. doi: 10.1093/eurheartj/ehn586. Epub 2009 Jan 15.
The aim of this study was to identify a subset of patients at high risk of bleeding or myocardial infarction from a percutaneous coronary intervention and to investigate whether such high-risk subsets derive preferential benefit from heparin or bivalirudin.
This study included 4570 patients with coronary artery disease enrolled in the Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment trial and randomized to receive bivalirudin or heparin. Primary outcomes were in-hospital incidence of major bleeding and 30-day incidence of myocardial infarction. Major bleeding, myocardial infarction, and bleeding plus myocardial infarction occurred in 140, 204, and 34 patients, respectively. Older age, female sex, lower body weight, low cholesterol, multi-lesion intervention, complex lesions, and heparin therapy were independent correlates of increased risk of bleeding. Multi-lesion intervention, unstable angina, and lower body weight correlated independently with increased risks of myocardial infarction. Compared with heparin, bivalirudin was associated with a reduction in major bleeding (3.1 vs. 4.6%, P = 0.008), but mostly in low-risk patients. A reduction in the bleeding risk inversely correlated with an increase in the risk of myocardial infarction with bivalirudin (R = -0.61).
Bivalirudin and unfractionated heparin have a differential effect on risk of bleeding and myocardial infarction across various subsets of patients.
本研究旨在识别经皮冠状动脉介入治疗后出血或心肌梗死高风险患者亚组，并调查此类高风险亚组患者从肝素或比伐卢定中是否能获得更大益处。
本研究纳入了4570例冠心病患者，这些患者参与了冠状动脉内支架置入和抗栓治疗方案：冠状动脉治疗快速早期行动试验，并被随机分配接受比伐卢定或肝素治疗。主要结局为住院期间大出血发生率和30天内心肌梗死发生率。大出血、心肌梗死以及大出血加心肌梗死分别发生在140例、204例和34例患者中。年龄较大、女性、体重较低、低胆固醇、多病变干预、复杂病变以及肝素治疗是出血风险增加的独立相关因素。多病变干预、不稳定型心绞痛和体重较低与心肌梗死风险增加独立相关。与肝素相比，比伐卢定与大出血减少相关（3.1%对4.6%，P = 0.008），但主要是在低风险患者中。使用比伐卢定出血风险降低与心肌梗死风险增加呈负相关（R = -0.61）。
比伐卢定和普通肝素对不同患者亚组出血和心肌梗死风险的影响存在差异。
