Barria Perez Alberto E, Rao Sunil V, Jolly Sanjit J, Pancholy Samir B, Plourde Guillaume, Rimac Goran, Poirier Yann, Costerousse Olivier, Bertrand Olivier F
Quebec Heart-Lung Institute, Quebec, Quebec, Canada.
Duke Clinical Research Institute, Durham, North Carolina.
Am J Cardiol. 2016 Apr 15;117(8):1256-66. doi: 10.1016/j.amjcard.2016.01.015. Epub 2016 Jan 28.
Bivalirudin is an alternative to unfractionated heparin (UFH) anticoagulation during percutaneous coronary intervention. Previously, we have reported clinical benefit on major bleeding in favor of bivalirudin compared with UFH monotherapy but inconclusive results on mortality. Controversial data have been reported in the last 2 years. We conducted an updated meta-analysis including randomized trials and observational studies, which evaluated ischemic and bleeding outcomes for bivalirudin compared with UFH-only during percutaneous coronary intervention. We included 18 observational studies and 12 randomized trials published from 2003 to 2015. Primary outcomes were major adverse cardiovascular events within 30 days including death, myocardial infarction, and urgent revascularization and stent thrombosis, major bleeding, and transfusion. Overall, we found a significant risk reduction with bivalirudin for major bleeding (odds ratio [OR] 0.59, 95% confidence interval [CI] 0.49 to 0.71, p <0.0001) and for transfusion (OR 0.79, 95% CI 0.66 to 0.95, p = 0.01) and similar risk for major adverse cardiovascular events (OR 0.98, 95% CI 0.86 to 1.12, p = 0.80). However, there was a substantial increased risk of stent thrombosis associated with bivalirudin (OR 1.52, 95% CI 1.11 to 2.08, p = 0.009). No impact on mortality was found. Meta-regression analyses on major bleeding suggested that bivalirudin was more effective than UFH at doses >60 IU/kg and independent of radial access. In conclusion, compared with UFH monotherapy, bivalirudin remains associated with less bleeding risk but higher stent thrombosis risk. Further study remains required to define its role in current antithrombotic armamentarium.
比伐卢定是经皮冠状动脉介入治疗期间普通肝素（UFH）抗凝的替代药物。此前，我们曾报道与UFH单药治疗相比，比伐卢定在大出血方面具有临床益处，但在死亡率方面结果尚无定论。过去两年有相互矛盾的数据报道。我们进行了一项更新的荟萃分析，纳入了随机试验和观察性研究，这些研究评估了经皮冠状动脉介入治疗期间比伐卢定与仅使用UFH相比的缺血和出血结局。我们纳入了2003年至2015年发表的18项观察性研究和12项随机试验。主要结局为30天内的主要不良心血管事件，包括死亡、心肌梗死、紧急血运重建和支架血栓形成、大出血及输血。总体而言，我们发现比伐卢定可显著降低大出血风险（比值比[OR]0.59，95%置信区间[CI]0.49至0.71，p<0.0001）和输血风险（OR 0.79，95%CI 0.66至0.95，p=0.01），且主要不良心血管事件风险相似（OR 0.98，95%CI 0.86至1.12，p=0.80）。然而，与比伐卢定相关的支架血栓形成风险显著增加（OR 1.52，95%CI 1.11至2.08，p=0.009）。未发现对比伐卢定对死亡率有影响。对大出血的Meta回归分析表明，比伐卢定在剂量>60 IU/kg时比UFH更有效，且与桡动脉入路无关。总之，与UFH单药治疗相比，比伐卢定仍与较低的出血风险相关，但支架血栓形成风险较高。仍需进一步研究以确定其在当前抗栓治疗方案中的作用。
