需要口服抗凝治疗的经皮冠状动脉介入治疗患者的抗血栓策略：一项网状荟萃分析。

Antithrombotic strategies in patients needing oral anticoagulation undergoing percutaneous coronary intervention: A network meta-analysis.

机构信息

Division of Cardiology, Department of Medical Science, University of Turin, Turin, Italy.

Coronary Care Unit, University of Pavia and Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.

出版信息

Catheter Cardiovasc Interv. 2021 Mar;97(4):581-588. doi: 10.1002/ccd.29192. Epub 2020 Aug 13.

DOI:10.1002/ccd.29192

PMID:32790145

Abstract

BACKGROUND

The optimal antithrombotic regimen in patients with a concomitant indication for oral anticoagulation (OAT) presenting with acute coronary syndrome (ACS) or undergoing percutaneous coronary intervention (PCI) remains unclear.

OBJECTIVES

To perform a network meta-analysis of all randomized controlled trials (RCTs) evaluating different antithrombotic regimens among patients with ACS or undergoing PCI requiring OAT.

METHODS

Network meta-analysis was performed in a frequentist framework. Antithrombotic regimens were categorized by OAC type (vitamin K antagonist-based [VKA]; non-VKA OAT [NOAC]) and antiplatelet agents (P2Y inhibitor only: dual therapy [DAT]; P2Y plus aspirin: triple therapy [TAT]). Safety outcomes were Thrombolysis in Myocardial Infarction (TIMI) major bleeding and intracranial hemorrhage (ICH). Efficacy outcomes were cardiovascular death, myocardial infarction, stroke and stent-thrombosis (ST).

RESULTS

Five RCTs were included, encompassing 10,797 patients (atrial fibrillation 69-100%, ACS 28-62%, PCI 77-100%). Both VKA and NOAC-based DAT regimens reduced the occurrence of TIMI major bleeding compared to VKA TAT (VKA DAT: RR 0.62, 95% CI 0.39-0.98; NOAC DAT: RR 0.52, 95% CI 0.39-0.70). Nevertheless, only NOAC DAT significantly reduced the occurrence of ICH compared to VKA TAT (RR 0.33, 95% CI 0.17-0.64). Ischemic outcomes were similar among the four treatment regimens. However, numerical, potentially clinically important, higher ST occurrence was observed for NOAC DAT as compared to both VKA TAT (1.50, 95% confidence interval [CI] 0.96-2.33) and NOAC TAT (1.86, 95% CI 0.93-3.73).

CONCLUSION

DAT regimens present the highest safety profile among antithrombotic strategies, with a NOAC-specific impact on ICH reduction. NOAC DAT might entail clinically important higher ST occurrence, warranting a case-by-case comprehensive evaluation that integrates patient- and procedure-related residual ischemic risk with the patient-specific bleeding risk.

摘要

背景

在同时存在口服抗凝治疗（OAT）适应证并伴有急性冠状动脉综合征（ACS）或经皮冠状动脉介入治疗（PCI）的患者中，最佳的抗血栓形成方案仍不明确。

目的

对评估 OAT 患者 ACS 或 PCI 时不同抗血栓形成方案的所有随机对照试验（RCT）进行网络荟萃分析。

方法

在频率论框架内进行网络荟萃分析。抗血栓形成方案按 OAC 类型（维生素 K 拮抗剂[VKA]；非 VKA OAT[NOAC]）和抗血小板药物（仅 P2Y 抑制剂：双重治疗[DAT]；P2Y 加阿司匹林：三重治疗[TAT]）进行分类。安全性结局为心肌梗死溶栓治疗（TIMI）大出血和颅内出血（ICH）。疗效结局为心血管死亡、心肌梗死、卒中和支架血栓形成（ST）。

结果

纳入了 5 项 RCT，共纳入 10797 例患者（房颤 69-100%，ACS 28-62%，PCI 77-100%）。与 VKA TAT 相比，VKA 基础 DAT 方案和 NOAC 基础 DAT 方案均降低了 TIMI 大出血的发生（VKA DAT：RR 0.62，95%CI 0.39-0.98；NOAC DAT：RR 0.52，95%CI 0.39-0.70）。然而，只有 NOAC DAT 与 VKA TAT 相比显著降低了 ICH 的发生（RR 0.33，95%CI 0.17-0.64）。四种治疗方案的缺血结局相似。然而，与 VKA TAT（1.50，95%置信区间[CI]0.96-2.33）和 VKA TAT（1.86，95%CI 0.93-3.73）相比，NOAC DAT 观察到 ST 发生率较高，数值上具有潜在的临床重要性。