下肢血运重建患者对氯吡格雷的反应。
Response to clopidogrel in patients undergoing lower extremity revascularization.
机构信息
Leon H. Charney Division of Cardiology, Department of Medicine, New York University Grossman School of Medicine, New York, NY, USA.
Division of Vascular Surgery, Department of Surgery, New York University Grossman School of Medicine, New York, NY, USA.
出版信息
Vascular. 2023 Dec;31(6):1110-1116. doi: 10.1177/17085381221103417. Epub 2022 May 19.
OBJECTIVES
Clopidogrel is effective at decreasing cardiovascular events in patients with peripheral artery disease (PAD); however, its effect on limb outcomes are less known. This study investigated the variability in response to clopidogrel and its relationship with clinical limb outcomes.
METHODS
Three hundred subjects were enrolled in the Platelet Activity and Cardiovascular Events (PACE) study prior to lower extremity revascularization, of whom 104 were on clopidogrel. Light transmission platelet aggregation was measured in response to ADP 2 m immediately prior to revascularization. Patients were followed longitudinally for a median follow-up of 18 months. The primary endpoint was major adverse limb events (MALE) defined by major amputation or reoperation of the affected limb. Patients were stratified into groups according to percent ADP-induced aggregation. Poor response to clopidogrel was defined by >50% aggregation.
RESULTS
Overall, the median age was 70 (63, 76) and 35.6% were female. Twenty-nine (27.9%) patients experienced MALE during their follow-up. Median aggregation to ADP 2 m was 22.5% (Q1-Q3: 10%, 50%) and 27 subjects (26%) were clopidogrel poor responders. Baseline aggregation was higher in subjects who went on to develop a MALE than those without MALE (43% vs 20%, = .017). Subjects with aggregation > median (22.5%) were more likely to experience MALE than aggregation < median (38.5% vs 17.3%, = .029). After multivariable adjustment for age, sex, race/ethnicity, BMI, diabetes, coronary artery disease, and aspirin use, aggregation > median was associated with MALE (adjusted HR [aHR] 2.67, 95% CI 1.18-6.01, = .018). When stratified by established cut-offs for responsiveness to clopidogrel (50% aggregation), poor responders were more likely to experience MALE than normal responders (44.4% vs 22.1%, aHR 2.18, 95% CI 1.00-4.78, = .051).
CONCLUSIONS
Among patients undergoing lower extremity revascularization on clopidogrel, higher baseline percent aggregation is associated with increased risk for major adverse limb events.
目的
氯吡格雷可有效降低外周动脉疾病（PAD）患者的心血管事件；然而，其对肢体结局的影响知之甚少。本研究旨在探讨氯吡格雷反应的变异性及其与临床肢体结局的关系。
方法
在下肢血运重建前，300 例患者入组血小板活性和心血管事件（PACE）研究，其中 104 例服用氯吡格雷。在血运重建前即刻，用 ADP 2µmol/L 测量光透射血小板聚集。中位随访 18 个月，对患者进行纵向随访。主要终点为主要不良肢体事件（MALE），定义为受影响肢体的主要截肢或再次手术。根据 ADP 诱导的聚集百分比将患者分为不同组。氯吡格雷反应不良定义为聚集率>50%。
结果
总体而言，中位年龄为 70（63，76）岁，35.6%为女性。29 例（27.9%）患者在随访期间发生 MALE。ADP 2µmol/L 时的中位聚集率为 22.5%（Q1-Q3：10%，50%），27 例（26%）为氯吡格雷反应不良者。发生 MALE 的患者基线聚集率高于无 MALE 的患者（43% vs 20%， =.017）。聚集率>中位数（22.5%）的患者发生 MALE 的可能性大于聚集率<中位数（38.5% vs 17.3%， =.029）。在校正年龄、性别、种族/民族、BMI、糖尿病、冠心病和阿司匹林使用后，聚集率>中位数与 MALE 相关（校正 HR[aHR]2.67，95%CI1.18-6.01， =.018）。当按氯吡格雷反应的既定截断值（50%聚集率）分层时，反应不良者发生 MALE 的可能性大于反应正常者（44.4% vs 22.1%，aHR 2.18，95%CI1.00-4.78， =.051）。
结论
在下肢血运重建的氯吡格雷治疗患者中，较高的基线聚集率与重大不良肢体事件风险增加相关。
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