Li Jiawen, Li Yulong, Su Shuhong, Wang Zhifang, Liu Haiwei, Yang Weixian, Qiao Shubin, Yang Yuejin, Xu Bo, Gao Runlin, Yuan Jinqing, Zhao Xueyan
Department of Cardiology, National Clinical Research Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, 100037 Beijing, China.
Department of Cardiology, Xinxiang Central Hospital, 453000 Xinxiang, Henan, China.
Rev Cardiovasc Med. 2023 Jul 31;24(8):218. doi: 10.31083/j.rcm2408218. eCollection 2023 Aug.
Bivalirudin reduces ischemic and hemorrhagic events in patients undergoing primary percutaneous coronary intervention (PCI), but the safety and efficacy for such individuals are unclear. Our aim was to evaluate the long-term safety and efficacy of bivalirudin in patients undergoing elective PCI.
We examined 957 patients with bivalirudin anticoagulation and 1713 patients with unfractionated heparin (UFH) anticoagulation with and without glycoprotein IIb/IIIa inhibitors (GPI). The primary endpoint was net adverse clinical events (NACE), a composite of death, myocardial infarction, revascularization, stent thrombosis, stroke, and bleeding. The secondary endpoints were bleeding and major adverse cardiovascular and cerebrovascular events (MACCE).
In one year of follow-up, 307 (11.5%) NACEs, 72 (2.7%) bleedings, and 249 (9.3%) MACCEs occurred. Statistically, patients with bivalirudin anticoagulation had less NACE [hazard ratio (HR): 0.75, 95% confidence interval (CI): 0.58-0.96, = 0.021] and bleeding (HR: 0.58, 95% CI: 0.34-0.99, = 0.045) but not less MACCE, than did those with UFH anticoagulation. Furthermore, the risk of bleeding in the bivalirudin group was lower than in the UFH with GPI group ( = 0.001) but not lower than in the group of UFH without GPI ( = 0.197).
In patients who undergo elective PCI, the use of bivalirudin significantly decreased the risk of NACE and bleeding without increasing the risk of MACCE; the reduction of bleeding risk with bivalirudin was mainly attributed to the presence of GPIs in the UFH group.
比伐卢定可减少接受直接经皮冠状动脉介入治疗（PCI）患者的缺血和出血事件，但此类患者的安全性和有效性尚不清楚。我们的目的是评估比伐卢定在接受择期PCI患者中的长期安全性和有效性。
我们检查了957例接受比伐卢定抗凝治疗的患者以及1713例接受普通肝素（UFH）抗凝治疗且使用或未使用糖蛋白IIb/IIIa抑制剂（GPI）的患者。主要终点是净不良临床事件（NACE），这是一个由死亡、心肌梗死、血运重建、支架血栓形成、中风和出血组成的复合终点。次要终点是出血以及主要不良心血管和脑血管事件（MACCE）。
在一年的随访中，发生了307例（11.5%）NACE、72例（2.7%）出血事件和249例（9.3%）MACCE。在统计学上，与接受UFH抗凝治疗的患者相比，接受比伐卢定抗凝治疗的患者发生NACE的情况较少[风险比（HR）：0.75，95%置信区间（CI）：0.58 - 0.96，P = 0.021]，出血情况也较少（HR：0.58，95% CI：0.34 - 0.99，P = 0.045），但MACCE情况并不更少。此外，比伐卢定组的出血风险低于UFH联合GPI组（P = 0.001），但不低于未使用GPI的UFH组（P = 0.197）。
在接受择期PCI的患者中，使用比伐卢定可显著降低NACE和出血风险，而不会增加MACCE风险；比伐卢定降低出血风险主要归因于UFH组中存在GPI。
