多廿烷醇治疗老年急性冠状动脉综合征患者药物洗脱支架置入术后血小板高反应性的疗效与安全性研究:SPIRIT研究预设亚组分析Safety and efficacy of policosanol in elder patients with high on-treatment platelet reactivity after drug-eluting stent implantation: a subgroup analysis of the SPIRIT study
余晓凡,王贺阳,李毅,徐凯,藏红云,郭亮,李璐,赵巍,王效增,韩雅玲
摘要(Abstract):
目的观察多廿烷醇治疗老年急性冠状动脉综合征(acute coronary syndrome,ACS)患者药物洗脱支架(drug eluting stent,DES)置入术后血小板高反应性(high on-treatment platelet reactivity,HPR)的疗效与安全性。方法选取多廿烷醇改善经皮冠状动脉支架置入术后血小板高反应性研究(SPIRIT)中年龄≥60岁、ACS合并HPR患者169例,其中标准双抗组30例(氯吡格雷75 mg、每日1次,维持12个月),双倍氯吡格雷组75例(氯吡格雷150 mg、每日1次,服用30 d,后以75 mg、每日1次,维持至12个月),多廿烷醇组64例(DES置入术后多廿烷醇40 mg、每日1次至术后6个月,氯吡格雷75 mg、每日1次,维持至12个月)。所有患者均接受阿司匹林治疗。主要观察指标为术后30 d时HPR逆转率(定义为血小板聚集率<65%的比例),次要观察指标为24个月时主要不良心血管事件(major adverse cardiovascular event,MACE,包括心源性死亡、非致死性心肌梗死和靶血管血运重建),安全性观察指标为术后24个月按照出血学术研究联合会(bleeding academic research consortium,BARC)等级划分的出血事件。结果术后30 d时,多廿烷醇组HPR逆转率有优于标准双抗组的趋势,但差异无统计学意义(42.9%比23.3%,P=0.068);与双倍氯吡格雷组比较,差异无统计学意义(42.9%比49.3%,P=0.447);术后6个月时,多廿烷醇组HPR逆转率比术后30 d时进一步改善(57.4%比42.9%,P=0.019),且显著优于标准双抗组(57.4%比34.5%,P=0.042),与双倍氯吡格雷组的差异无统计学意义(57.4%比54.1%,P=0.699)。标准双抗组术后24个月MACE事件发生率有高于双倍氯吡格雷组、多廿烷醇组的趋势,但三组间差异并无统计学意义(13.3%比6.7%比4.7%,P=0.352)。双倍氯吡格雷组术后24个月BARC总出血发生率显著高于标准双抗组和多廿烷醇组(17.3%比3.3%比1.6%,P=0.001)。多廿烷醇组、双倍氯吡格雷组和标准双抗组患者术后24个月无MACE事件的累积生存率分别为95.3%、93.3%和86.7%,差异无统计学意义(P=0.146)。结论对于DES置入术后老年ACS合并HPR患者,在标准双抗基础上联用多廿烷醇可以取得与双倍维持剂量氯吡格雷相近的改善HPR的疗效,同时出血风险明显减少,是更为安全、有效的抗血小板治疗策略。
关键词(KeyWords): 多廿烷醇;血小板高反应性;药物洗脱支架
基金项目(Foundation):
作者(Author): 余晓凡,王贺阳,李毅,徐凯,藏红云,郭亮,李璐,赵巍,王效增,韩雅玲
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