CLEAR-PATH的出血安全更新:在外周血管造形术后进行30天和12个月的抗血小板治疗
Emilien C J Wegerif1, Manon I Generaal1,2, Linde J Vijn1
1University Medical Center Utrecht, Division of Vascular Surgery, Utrecht, the Netherlands.
EJVES vascular forum
|January 26, 2026
概括
对外围动脉疾病 (PAD) 进行内血管再血管化 (EVR) 后的抗血小板治疗 (APT) 在12个月内显示出较低的重大出血 (MB) 风险. 大多数出血事件发生在EVR后30天内,通常与血管手术有关.
科学领域:
- 心血管医学 心血管医学
- 血管外科 血管外科
- 临床试验 临床试验
背景情况:
- 在周围动脉疾病 (PAD) 患者的内血管再血管化 (EVR) 后,关于抗血小板治疗 (APT) 出血风险的数据有限.
- CLEAR-PATH试验是一项荷兰的多中心,双盲,安慰剂对照的随机试验,研究了PAD管理的这一关键方面.
研究的目的:
- 在症状PAD患者中,在EVR后30天和12个月内确定APT的出血安全性.
- 根据已建立的分类 (TIMI,ISTH,BARC) 来评估主要出血 (MB) 的发生率.
主要方法:
- 经过成功EVR的症状PAD患者被随机分配给接受克洛皮多格雷尔加安慰剂或乙撒利酸12个月.
- 主要终点是12个月内的MB (TIMI分类);次要终点包括30天和12个月内的MB (ISTH,BARC) 和任何出血.
- 由于CLEAR-PATH试验的持续性质,分析是盲目的.
主要成果:
- 在2022年8月至2024年1月期间,470名患者被随机选择.
- 在12个月内,MB发生率为1.9% (TIMI),1.0% (ISTH) 和2.9% (BARC).
- 30天内MB发生率为0.9% (TIMI),0.7% (BARC) 和1.4% (ISTH);七起事件中有六起发生在30天内,其中三起与血管手术有关.
结论:
- 在EVR后的APT下,MB的发病率虽然因分类而异,但一般来说很低.
- 大多数出血事件发生在早期 (30天内) 并且与血管手术有关.
- 在本研究中使用的APT疗法没有引起严重的出血安全问题,支持CLEAR-PATH试验协议的延续.
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