Department of Cardiology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.
Department of Cardiac Surgery, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.
Clin Ther. 2021 May;43(5):844-851. doi: 10.1016/j.clinthera.2021.03.004. Epub 2021 Mar 31.
Bivalirudin as a thrombin inhibitor is proven to have a low risk of bleeding during percutaneous coronary intervention (PCI). Some evidence indicates comparable effectiveness and safety between bivalirudin and unfractionated heparin (UFH). Although bivalirudin during PCI offers more clinical and safety benefits to patients with chronic total occlusion (CTO), mostly via radial access, this has not been confirmed. The objective of this study was to examine the efficacy and safety of bivalirudin during percutaneous coronary intervention (PCI) in patients with CTO.
This trial used a retrospective cohort study design. Medical information from 736 patients with CTO who underwent PCI with bivalirudin or UFH at the First Affiliated Hospital of Zhengzhou University from July 2019 to September 2020 was extracted and analyzed. The primary end point was the 30-day incidence of net adverse clinical events (NACEs), and the secondary end point was the major adverse cardiovascular events (MACEs), which were related to safety and efficacy, respectively. Other end points incorporated each component of the primary outcome, target vessel revascularization, and stent thrombosis. Clinical and procedural characteristics at baseline were adjusted by using a logistic regression model.
Overall, 71.5% of patients with CTO used the radial approach. Both groups exhibited nonsignificant differences in the majority of baseline characteristics. The bivalirudin group was associated with a significant reduction in NACEs (12.9% vs 21.5%; P = 0.002) and major bleeding (2.5% vs 8.0%; P = 0.001) versus the UFH group at the end of the 30-day follow-up. The incidence of MACEs, myocardial infarction, death, stroke, stent thrombosis, and target vessel revascularization did not differ significantly between the 2 groups. Moreover, the bivalirudin group also reported a lower incidence of NACEs in the prespecified subgroups.
Bivalirudin exhibited comparative efficacy but superior safety compared with UFH among patients with CTO undergoing PCI. Chinese Clinical Trial Registry: ChiCTR2000034771.
作为一种凝血酶抑制剂，比伐卢定在经皮冠状动脉介入治疗（PCI）中已被证实出血风险较低。有证据表明，比伐卢定与普通肝素（UFH）的疗效和安全性相当。虽然比伐卢定在经桡动脉入路治疗慢性完全闭塞（CTO）患者的 PCI 中为患者带来了更多的临床获益和安全性，但这一点尚未得到证实。本研究的目的是检验比伐卢定在 CTO 患者 PCI 中的疗效和安全性。
本试验采用回顾性队列研究设计。从 2019 年 7 月至 2020 年 9 月，郑州大学第一附属医院使用比伐卢定或 UFH 行 PCI 的 736 例 CTO 患者的医疗信息被提取并分析。主要终点是 30 天净不良临床事件（NACEs）发生率，次要终点是主要不良心血管事件（MACEs），分别与安全性和疗效相关。其他终点包括主要结局的每个组成部分、靶血管血运重建和支架血栓形成。通过使用逻辑回归模型调整基线时的临床和程序特征。
总体而言，71.5%的 CTO 患者采用桡动脉入路。两组在大多数基线特征方面均无显著差异。在 30 天随访结束时，比伐卢定组的 NACEs（12.9% vs. 21.5%；P=0.002）和大出血（2.5% vs. 8.0%；P=0.001）发生率显著低于 UFH 组。两组的 MACEs、心肌梗死、死亡、卒中和支架血栓形成发生率以及靶血管血运重建率无显著差异。此外，比伐卢定组在预先指定的亚组中也报告了较低的 NACEs 发生率。
在接受 PCI 的 CTO 患者中，比伐卢定与 UFH 相比具有相当的疗效，但安全性更高。中国临床试验注册中心：ChiCTR2000034771。
