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稳定型冠心病合并心房颤动患者的最佳长期抗栓治疗:“OLTAT 注册研究”。

Optimal long-term antithrombotic treatment of patients with stable coronary artery disease and atrial fibrillation: "OLTAT registry".

机构信息

Institut de Cardiologie, Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix, Paris, France.

Service de Cardiologie, Centre Hospitalier de Versailles, Hôpital André-Mignot, Le Chesnay, France.

出版信息

Int J Cardiol. 2018 Aug 1;264:64-69. doi: 10.1016/j.ijcard.2018.03.018.

DOI:10.1016/j.ijcard.2018.03.018
PMID:29776575
Abstract

BACKGROUND

The optimal long-term antithrombotic treatment of patients with stable coronary artery disease (CAD) and atrial fibrillation (AF) is a challenge in daily practice. We sought to determine the prevalence of hemorrhagic complications and ischaemic events depending on antithrombotic strategy in patients with stable CAD and AF.

METHODS

The primary outcome was major adverse cardiac and cerebrovascular events (MACCE) defined as a composite of cardiovascular mortality, myocardial infarction and ischaemic stroke. The subsequent risks of MACCE and clinically significant bleedings requiring hospitalisation (major safety outcome) were analyzed in a propensity score-matched analysis by adjusted Cox regression models.

RESULTS

Six hundred and six patients with high thrombotic and bleeding risks (mean age 73.4 ± 9.8 years, 25.2% female, CHA2DS2-VASc score:4.7 ± 1.5, and HAS-BLED score:3.1 ± 1.0) were included, and 127 propensity-matched pairs were analyzed. At inclusion, 172 patients (28.4%) were on oral anticoagulation (OAC) alone (75.6% on VKA and 24.4% on DOAC) and 434 patients (71.6%) on OAC + single antiplatelet therapy (SAPT) (71.9% on VKA and 28.1% on DOAC). At 5-year follow-up, MACCE rate did not significantly differ in both groups (30.9% in OAC + SAPT vs. 26.8% in OAC alone; adjusted HR 1.1 [0.8-1.5], p = 0.58), but clinically significant bleedings (28.3% vs. 18.5%; adjusted HR 1.8 [1.2-2.8], p = 0.005) and total deaths (29.5% vs. 20.8%; adjusted HR 1.4 [95% CI 1.0-2.2], p = 0.049) were higher in patients with OAC + SAPT than in patients with OAC alone.

CONCLUSIONS

In patients with stable CAD and AF, the addition of antiplatelet therapy to VKA or DOAC therapy was independently associated with a higher risk of bleeding and overall mortality, without significant reduction in cardiac and cerebral ischaemic events.

摘要

背景

患有稳定型冠状动脉疾病(CAD)和心房颤动(AF)的患者的最佳长期抗血栓治疗在日常实践中是一个挑战。我们旨在根据抗血栓治疗策略确定稳定型 CAD 和 AF 患者的出血并发症和缺血性事件的发生率。

方法

主要终点是主要不良心脑血管事件(MACCE),定义为心血管死亡率、心肌梗死和缺血性卒中的复合终点。通过调整后的 Cox 回归模型,在倾向评分匹配分析中分析随后的 MACCE 和需要住院治疗的临床显著出血(主要安全性结果)的风险。

结果

纳入了 606 名高血栓形成和出血风险的患者(平均年龄 73.4±9.8 岁,25.2%为女性,CHA2DS2-VASc 评分:4.7±1.5,HAS-BLED 评分:3.1±1.0),并分析了 127 对倾向评分匹配的患者。入组时,172 名患者(28.4%)单独接受口服抗凝治疗(OAC)(75.6%接受 VKA,24.4%接受 DOAC),434 名患者(71.6%)接受 OAC+单药抗血小板治疗(SAPT)(71.9%接受 VKA,28.1%接受 DOAC)。在 5 年随访期间,两组的 MACCE 发生率没有显著差异(OAC+SAPT 组为 30.9%,OAC 组为 26.8%;调整后的 HR 为 1.1[0.8-1.5],p=0.58),但 OAC+SAPT 组的临床显著出血(28.3%比 18.5%;调整后的 HR 为 1.8[1.2-2.8],p=0.005)和总死亡率(29.5%比 20.8%;调整后的 HR 为 1.4[95%CI 1.0-2.2],p=0.049)高于 OAC 组。

结论

在患有稳定型 CAD 和 AF 的患者中,与 VKA 或 DOAC 治疗相比,加用抗血小板治疗与出血和总体死亡率升高独立相关,而心脏和大脑缺血性事件无显著减少。

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