Department of Cardiology, The People's Hospital of China Medical University, The People's Hospital of Liaoning Province, Shenyang, Liaoning, People's Republic of China.
Department of Science and Education, The People's Hospital of China Medical University, The People's Hospital of Liaoning Province, Shenyang, Liaoning, People's Republic of China.
Catheter Cardiovasc Interv. 2019 Feb 15;93(S1):825-831. doi: 10.1002/ccd.28087. Epub 2019 Feb 5.
To assess the efficacy and safety of bivalirudin during percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) in high-bleeding-risk elderly patients.
Bivalirudin reduces PCI-related bleeding; however, its efficacy and safety in patients with CTO, especially elderly patients with a high bleeding risk, remain unclear.
This single-center prospective randomized controlled trial assigned 123 high-bleeding-risk elderly patients with CTO to either the unfractionated heparin (UFH) group (n = 55) or the bivalirudin group (n = 68). The primary efficacy endpoint was the incidence of major adverse cardiac events (MACEs) during hospitalization and at the 6-month follow-up. The safety endpoint was bleeding or procedure (access)-related complications after PCI.
MACE incidence was 17.6% and 20.0% in the bivalirudin and UFH groups, respectively (P = 0.82). Bleeding Academic Research Consortium (BARC) type 1-2 bleeding events during hospitalization were comparable between the groups (UFH: 10.9% vs. bivalirudin: 8.8%, P = 0.77). No BARC type 3-5 bleeding events or severe procedure (access)-related complications (subcutaneous hematoma >5 cm) occurred in either group. At the 6-month follow-up, MACE incidence was comparable between the groups (UFH: 3.6% vs. bivalirudin: 1.5%, P = 0.59). The Kaplan-Meier analysis revealed that MACE-free survival rates were comparable between the groups (P = 0.43). One case of BARC type 3-5 bleeding (fatal intracranial hemorrhage) was observed in the UFH group at the 6-month follow-up.
Bivalirudin and UFH showed comparable efficacy and safety in elderly patients with a high bleeding risk, undergoing PCI for CTO lesions.
评估比伐卢定在高出血风险老年患者经皮冠状动脉介入治疗（PCI）治疗慢性完全闭塞（CTO）中的疗效和安全性。
比伐卢定可减少 PCI 相关出血；然而，其在 CTO 患者中的疗效和安全性，特别是在高出血风险的老年患者中，仍不清楚。
这项单中心前瞻性随机对照试验将 123 例高出血风险的 CTO 老年患者随机分为普通肝素（UFH）组（n=55）和比伐卢定组（n=68）。主要疗效终点是住院期间和 6 个月随访时的主要不良心脏事件（MACE）发生率。安全性终点是 PCI 后出血或手术（入路）相关并发症。
比伐卢定组和 UFH 组的 MACE 发生率分别为 17.6%和 20.0%（P=0.82）。住院期间 BARC 1-2 型出血事件在两组间无差异（UFH：10.9%比伐卢定：8.8%，P=0.77）。两组均未发生 BARC 3-5 型出血事件或严重手术（入路）相关并发症（皮下血肿＞5 cm）。6 个月随访时，两组的 MACE 发生率无差异（UFH：3.6%比伐卢定：1.5%，P=0.59）。Kaplan-Meier 分析显示两组间 MACE 无事件生存率无差异（P=0.43）。UFH 组在 6 个月随访时发生 1 例 BARC 3-5 型出血（致命性颅内出血）。
在接受 PCI 治疗 CTO 病变的高出血风险老年患者中，比伐卢定与 UFH 的疗效和安全性相当。
