Department of Cardiology, Jiaozuo People's Hospital, Jiaozuo, China.
Department of Cardiology, Chenzhou First People's Hospital, Chenzhou, China.
BMC Cardiovasc Disord. 2022 Jun 25;22(1):290. doi: 10.1186/s12872-022-02716-4.
This prospective, multi-center, intensive monitoring study aimed to systematically assess the occurrence of adverse events (AEs) and adverse drug reactions (ADRs), especially thrombocytopenia and bleeding, as well as their risk factors in Chinese ST-segment elevation myocardial infraction (STEMI) patients receiving bivalirudin as anticoagulant for percutaneous coronary intervention (PCI).
In total, 1244 STEMI patients undergoing PCI and receiving bivalirudin as anticoagulant were enrolled in the present study. Safety data were collected from hospital admission to 72 h after bivalirudin administration; in addition, patients were further followed up at the 30th day with safety data collected at that time.
AEs, severe AEs, ADRs and severe ADRs were reported in 224 (18.0%), 15 (1.2%), 49 (3.9%) and 5 (0.4%) patients, respectively. Importantly, 4 (0.3%) patients were submitted to hospitalization and 6 (0.5%) patients died due to AEs, while 1 (0.1%) patient was submitted to hospitalization but no (0.0%) patient died due to ADRs. Meanwhile, thrombocytopenia and bleeding occurred in 24 (1.9%) and 21 (1.7%) patients, respectively. Further multivariate logistic analysis identified several important independent factors related to AEs, ADRs, thrombocytopenia or bleeding, which included history of cardiac surgery and renal function impairment, high CRUSADE risk stratification, elective operation and combination with glycoprotein IIb/IIIa inhibitors. Moreover, 4 multivariate models were constructed based on the above-mentioned factors, which all showed acceptable predictive value for AEs, ADRs, thrombocytopenia and bleeding, respectively.
Bivalirudin is a well-tolerant anticoagulant in Chinese STEMI patients undergoing PCI procedure.
本前瞻性、多中心、强化监测研究旨在系统评估中国 ST 段抬高型心肌梗死（STEMI）患者经皮冠状动脉介入治疗（PCI）中接受比伐卢定抗凝治疗后不良事件（AE）和药物不良反应（ADR）的发生情况，尤其是血小板减少和出血，以及这些事件的相关危险因素。
本研究共纳入 1244 例行 PCI 且接受比伐卢定抗凝治疗的 STEMI 患者。安全性数据从入院至比伐卢定给药后 72 h 采集；此外，患者还在第 30 天进行了进一步随访，安全性数据在此时采集。
分别有 224 例（18.0%）、15 例（1.2%）、49 例（3.9%）和 5 例（0.4%）患者报告了 AE、严重 AE、ADR 和严重 ADR。重要的是，有 4 例（0.3%）患者因 AE 住院，6 例（0.5%）患者因 AE 死亡，而有 1 例（0.1%）患者因 ADR 住院，但无（0.0%）患者因 ADR 死亡。同时，血小板减少和出血分别发生在 24 例（1.9%）和 21 例（1.7%）患者中。进一步的多变量逻辑分析确定了与 AE、ADR、血小板减少或出血相关的几个重要独立因素，包括心脏手术史和肾功能损害、CRUSADE 风险分层高、择期手术和联合使用糖蛋白 IIb/IIIa 抑制剂。此外，基于上述因素构建了 4 个多变量模型，它们对 AE、ADR、血小板减少和出血的预测价值均具有可接受性。
比伐卢定在接受 PCI 治疗的中国 STEMI 患者中是一种耐受性良好的抗凝剂。
