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新型P2Y12抑制剂时代早期支架内血栓形成的发生率及临床特征(PLATIS-2研究)

Incidence and Clinical Features of Early Stent Thrombosis in the Era of New P2y12 Inhibitors (PLATIS-2).

作者信息

Asher Elad, Abu-Much Arsalan, Goldenberg Ilan, Segev Amit, Sabbag Avi, Mazin Israel, Shlezinger Meital, Atar Shaul, Zahger Doron, Polak Arthur, Beigel Roy, Matetzky Shlomi

机构信息

Leviev Heart Center, Sheba Medical Center, Tel Hashomer, affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

Division of Cardiology, Galilee Medical Center, Nahariya, Israel.

出版信息

PLoS One. 2016 Jun 16;11(6):e0157437. doi: 10.1371/journal.pone.0157437. eCollection 2016.

Abstract

Early stent thrombosis (EST) (≤ 30 days after stent implantation) is a relatively rare but deleterious complication of percutaneous coronary intervention (PCI). Administration of newer P2Y12 inhibitors (prasugrel and ticagrelor) combined with aspirin has been shown to reduce the incidence of sub-acute and late stent thrombosis, compared with clopidogrel. We investigated the "real life" incidence of EST in patients from a large acute coronary syndrome (ACS) national registry, where newer P2Y12 inhibitors are widely used. Patients were derived from the ACS Israeli Survey (ACSIS), conducted during 2006, 2008, 2010 and 2013. Major adverse cardiac events (MACE) at 30days were defined as all-cause death, recurrent ACS, EST and stroke.Of the 4717 ACS patients who underwent PCI and stenting, 83% received clopidogrel and 17% newer P2Y12 inhibitors. The rate of EST was similar in both groups (1.7% in the newer P2Y12 inhibitor group vs. 1.4% in the clopidogrel-treated patients, p = 0.42). Results were consistent after multivariate analysis (adjusted HR = 1.06 [p = 0.89]). MACE occurred in 6.4% in the newer P2Y12 inhibitor group compared with 9.2% in the clopidogrel group (P<0.01). However, multivariate logistic regression modeling showed that treatment with newer P2Y12 inhibitors was not significantly associated with the secondary endpoint of MACE when compared with clopidogrel therapy [OR = 1.26 95%CI (0.93-1.73), P = 0.136]. The incidence of "real life" EST at 1month is relatively low, and appears to be similar in patients who receive newer P2Y12 inhibitors as well as in those who receive clopidogrel.

摘要

早期支架内血栓形成(EST)(支架植入后≤30天)是经皮冠状动脉介入治疗(PCI)相对罕见但有害的并发症。与氯吡格雷相比,使用新型P2Y12抑制剂(普拉格雷和替卡格雷)联合阿司匹林已被证明可降低亚急性和晚期支架内血栓形成的发生率。我们调查了一个大型急性冠状动脉综合征(ACS)国家登记处患者中EST的“实际”发生率,该登记处广泛使用新型P2Y12抑制剂。患者来自2006年、2008年、2010年和2013年进行的以色列急性冠状动脉综合征调查(ACSIS)。30天时的主要不良心脏事件(MACE)定义为全因死亡、复发性ACS、EST和中风。在4717例接受PCI和支架植入的ACS患者中,83%接受氯吡格雷,17%接受新型P2Y12抑制剂。两组的EST发生率相似(新型P2Y12抑制剂组为1.7%,氯吡格雷治疗组为1.4%,p = 0.42)。多变量分析后结果一致(调整后的HR = 1.06 [p = 0.89])。新型P2Y12抑制剂组的MACE发生率为6.4%,氯吡格雷组为9.2%(P<0.01)。然而,多变量逻辑回归模型显示,与氯吡格雷治疗相比,新型P2Y12抑制剂治疗与MACE的次要终点无显著相关性[OR = 1.26,95%CI(0.93 - 1.73),P = 0.136]。1个月时“实际”EST的发生率相对较低,接受新型P2Y12抑制剂的患者与接受氯吡格雷的患者似乎相似。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9576/4911066/fa87d095bfdb/pone.0157437.g001.jpg

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