Noh Yoojin, Lee Jimin, Shin Sooyoung, Lim Hong-Seok, Bae Soo Kyung, Oh Euichul, Kim Grace Juyun, Kim Ju Han, Lee Sukhyang
College of Pharmacy, Ajou University, Suwon, South Korea.
Department of Cardiology, School of Medicine, Ajou University, Suwon, South Korea.
PLoS One. 2016 Mar 3;11(3):e0150475. doi: 10.1371/journal.pone.0150475. eCollection 2016.
BACKGROUND/OBJECTIVES: Addition of cilostazol or sarpogrelate to the standard dual antiplatelet therapy of aspirin and clopidogrel has been implemented in patients that underwent percutaneous coronary intervention (PCI) with stents in Korea. This study aimed to evaluate the efficacy and safety of triple antiplatelet therapies.
This retrospective cohort study was performed using the Korean National Insurance Claim Data of the Health Insurance Review and Assessment Service from January 1, 2009 to December 31, 2014. The study cohort population consisted of patients with ischemic heart diseases and a history of PCI. They were treated with antiplatelet therapy of aspirin, clopidogrel (AC); aspirin, clopidogrel, cilostazol (ACCi); or aspirin, clopidogrel, sarpogrelate (ACSa) during the index period from January 1, 2010 to December 31, 2011. During the follow-up period up to December 31, 2014, the major adverse cardiac or cerebral events (MACCE) including death, myocardial infarction, target lesion revascularization, and ischemic stroke were assessed. Bleeding complications were also evaluated as adverse drug events.
Out of 93,876 patients with PCI during the index period, 69,491 patients started dual (AC) or triple therapy (ACSa or ACCi). The clinical outcomes of comparing ACSa and ACCi therapy showed beneficial effects in the ACSa group in the prevention of subsequent cardiac or cerebral events. After Propensity score-matching between ACSa and ACCi groups, there were significant differences in MI and revascularization, with corresponding HR of 0.38 (95% CI, 0.20-0.73) and 0.66 (95% CI, 0.53-0.82) in ACSa vs. ACCi at 12 months, respectively. At the 24-month follow-up, the triple therapy groups (ACS or ACC) had a higher incidence of MACCE compared to the dual therapy (AC) group; ACSa vs. AC HR of 1.69 (95% CI, 1.62-1.77); ACC vs. AC HR of 1.22 (95% CI, 1.06-1.41). There was no significant difference in severe or life-threatening bleeding risk among three groups; ACSa vs. AC, HR of 0.68 (95% CI, 0.37-1.24), ACCi vs. AC, HR of 0.91 (95% CI, 0.77-1.09).
Sarpogrelate-containing triple antiplatelet therapy demonstrated comparable rates of MACCE prevention to the conventional dual antiplatelet therapy after PCI without significantly increasing bleeding risk during the two-year follow-up period.
背景/目的:在韩国,接受支架植入的经皮冠状动脉介入治疗(PCI)患者在阿司匹林和氯吡格雷的标准双联抗血小板治疗基础上加用西洛他唑或沙格雷酯。本研究旨在评估三联抗血小板治疗的疗效和安全性。
本回顾性队列研究使用了韩国健康保险审查与评估服务机构2009年1月1日至2014年12月31日的国民保险理赔数据。研究队列人群包括缺血性心脏病患者和PCI病史患者。在2010年1月1日至2011年12月31日的索引期内,他们接受了阿司匹林、氯吡格雷(AC);阿司匹林、氯吡格雷、西洛他唑(ACCi);或阿司匹林、氯吡格雷、沙格雷酯(ACSa)的抗血小板治疗。在截至2014年12月31日的随访期内,评估了包括死亡、心肌梗死、靶病变血管重建和缺血性卒中在内的主要不良心脏或脑血管事件(MACCE)。出血并发症也被评估为药物不良事件。
在索引期内的93,876例PCI患者中,69,491例患者开始接受双联(AC)或三联治疗(ACSa或ACCi)。比较ACSa和ACCi治疗的临床结果显示,ACSa组在预防后续心脏或脑血管事件方面具有有益效果。在ACSa组和ACCi组进行倾向得分匹配后,MI和血管重建存在显著差异,ACSa组与ACCi组在12个月时的相应HR分别为0.38(95%CI,0.20 - 0.73)和0.66(95%CI,0.53 - 0.82)。在24个月随访时,三联治疗组(ACS或ACC)的MACCE发生率高于双联治疗(AC)组;ACSa组与AC组的HR为1.69(95%CI,1.62 - 1.77);ACC组与AC组的HR为1.22(95%CI,1.06 - 1.41)。三组之间严重或危及生命出血风险无显著差异;ACSa组与AC组,HR为0.68(95%CI,0.37 - 1.24),ACCi组与AC组,HR为0.91(95%CI,0.77 - 1.09)。
含沙格雷酯的三联抗血小板治疗在PCI后预防MACCE的发生率与传统双联抗血小板治疗相当,在两年随访期内未显著增加出血风险。