Giustino Gennaro, Mehran Roxana, Bansilal Sameer, Feit Frederick, Lincoff Michael, Deliargyris Efthymios N, Kirtane Ajay J, Généreux Philippe, Redfors Bjorn, Prats Jayne, Bernstein Debra, Brener Sorin J, Skerjanec Simona, Lansky Alexandra J, Francese Dominic P, Dangas George D, Stone Gregg W
Interventional Cardiovascular Research and Clinical Trials, The Icahn School of Medicine at Mount Sinai, New York, New York.
Interventional Cardiovascular Research and Clinical Trials, The Icahn School of Medicine at Mount Sinai, New York, New York; Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.
Am J Cardiol. 2016 Jul 1;118(1):6-16. doi: 10.1016/j.amjcard.2016.04.005. Epub 2016 Apr 20.
Optimal antithrombotic pharmacotherapy in patients affected by diabetes mellitus (DM) undergoing percutaneous coronary intervention is unclear. We sought to evaluate the safety and efficacy of bivalirudin compared with heparin plus a glycoprotein IIb/IIIa inhibitor (GPI) in patients with DM undergoing percutaneous coronary intervention. We pooled patient-level data from the Randomized Evaluation of PCI Linking Angiomax to Reduced Clinical Events-2, Acute Catheterization and Urgent Intervention Triage strategy, and Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction trials. The primary efficacy end point was the incidence of major adverse cardiac events, defined as the composite of death, myocardial infarction, or unplanned revascularization at 30 days. The primary safety end point was the incidence of 30-day non-coronary artery bypass graft-related major bleeding. All-cause mortality was reported at 30 days and 1 year. Of the 14,737 patients included in the pooled database, 3,641 (24.7%) had DM. Patients with DM had higher rates of 30-day major bleeding and 30-day and 1-year all-cause mortality. There were no differences in 30-day major adverse cardiac events between bivalirudin versus heparin plus GPI in patients with DM (6.9% vs 7.8%; relative risk [RR] 0.89, 95% CI 0.71 to 1.12) or without DM (7.5% vs 6.7%; RR 1.11, 95% CI 0.97 to 1.27; pinteraction = 0.10). Bivalirudin treatment was associated with reduced risk of major bleeding in similar magnitude in patients with DM (4.3% vs 6.6% RR 0.68, 95% CI 0.51 to 0.89) or without DM (3.2% vs 6.1%; RR 0.51, 95% CI 0.43 to 0.61; pinteraction = 0.15). The hemorrhagic benefit of bivalirudin was noted for both access site- and non-access site-related bleeding. Overall, bivalirudin treatment was associated with a significant 1-year mortality benefit (2.7% vs 3.3%; RR 0.82, 95% CI 0.68 to 0.98; p = 0.03), which was consistent between patients with or without DM (pinteraction = 0.30). In conclusion, compared with heparin plus GPI, bivalirudin was associated with similar 30-day antithrombotic efficacy and better 30-day freedom from bleeding and 1-year mortality, irrespective of diabetic status.
对于接受经皮冠状动脉介入治疗的糖尿病（DM）患者，最佳的抗栓药物治疗尚不清楚。我们试图评估比伐卢定与肝素加糖蛋白IIb/IIIa抑制剂（GPI）相比，在接受经皮冠状动脉介入治疗的DM患者中的安全性和有效性。我们汇总了来自“将Angiomax与降低临床事件相联系的PCI随机评估-2”、“急性导管插入术和紧急干预分类策略”以及“急性心肌梗死血管重建和支架置入术结果协调”试验的患者水平数据。主要疗效终点是主要不良心脏事件的发生率，定义为30天时死亡、心肌梗死或非计划血管重建的复合事件。主要安全终点是30天非冠状动脉搭桥术相关的大出血发生率。报告了30天和1年时全因死亡率。在汇总数据库中的14737例患者中,3641例（24.7%）患有DM。DM患者30天大出血发生率以及30天和1年全因死亡率更高。在DM患者（6.9%对7.8%；相对风险[RR]0.89，95%CI0.71至1.12）或非DM患者（7.5%对6.7%；RR1.11，95%CI0.97至1.27；p交互作用=0.10）中，比伐卢定与肝素加GPI相比，30天主要不良心脏事件无差异。比伐卢定治疗使DM患者（4.3%对6.6%，RR0.68，95%CI0.51至0.89）或非DM患者（3.2%对6.1%；RR0.51，95%CI0.43至0.61；p交互作用=0.15）大出血风险降低幅度相似。比伐卢定在穿刺部位相关出血和非穿刺部位相关出血方面均有出血获益。总体而言，比伐卢定治疗使1年死亡率显著降低（2.7%对3.3%；RR0.82，95%CI0.68至0.98；p=0.03），在DM患者和非DM患者中一致（p交互作用=0.30）。总之，与肝素加GPI相比，无论糖尿病状态如何，比伐卢定30天抗栓疗效相似，30天无出血且1年死亡率更低。
