接受新一代药物洗脱支架治疗的急性冠脉综合征合并糖尿病患者的短期双联抗血小板治疗。

Short-term dual antiplatelet therapy in diabetic patients admitted for acute coronary syndrome treated with a new-generation drug-eluting stent.

机构信息

Department of Cardiology, Zuyderland Medical Centre, Heerlen, The Netherlands.

Diagram B.V., Zwolle, The Netherlands.

出版信息

Diabetes Metab Res Rev. 2022 Jul;38(5):e3530. doi: 10.1002/dmrr.3530. Epub 2022 Apr 22.

DOI:10.1002/dmrr.3530

PMID:35395144

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9541907/

Abstract

BACKGROUND

The optimal duration of dual antiplatelet therapy (DAPT) in patients with diabetes mellitus (DM) admitted with acute coronary syndrome (ACS) and treated with a drug-eluting stent (DES) remains unclear. This is a prespecified sub-study from the Randomised Evaluation of short-term DUal antiplatelet therapy in patients with acute Coronary syndromE treated with a new generation DES (REDUCE) trial that was designed to determine the efficacy and safety of short-term versus standard 12 months DAPT in diabetic patients with ACS undergoing percutaneous coronary intervention (PCI) using the COMBO stent.

METHODS

In this study we included ACS diabetic patients enroled in the REDUCE trial treated with the COMBO stent and randomly assigned to either 3 or 12 months of DAPT. The primary study endpoint was the composite of all-cause mortality, myocardial infarction (MI), stent thrombosis (ST), stroke, target vessel revascularisation (TVR), and bleeding complications at 12 and 24 months follow-up.

RESULTS

A total of 307 diabetic patients were included, of which 162 (52.8%) in the 3 months DAPT group and 145 (47.2%) in the 12 months DAPT group. Patient characteristics, PCI success, and number of stents used were similar in the 3 and 12 months DAPT groups. Occurrence of the primary study endpoint at 12 and 24 months follow-up was comparable between the two groups (3.1 vs. 3.5%, p = 0.865, and 15.8 vs. 14.9%, p = 0.824, respectively). Moreover, the prevalence of the specific clinical outcome parameters (all-cause mortality), MI, ST, stroke, TVR, and bleeding was similar in both study groups.

CONCLUSIONS

This sub-analysis shows similar clinical outcomes following 3 months DAPT as compared to 12 months DAPT in diabetic patients undergoing PCI for ACS using the COMBO stent. These results suggest that, even in this particular subset of patients, short duration of DAPT might be considered safe. Future larger studies are warranted to provide more precise estimations in terms of safety and efficacy of short term DAPT in these high-risk patients.

摘要

背景

急性冠状动脉综合征（ACS）合并糖尿病（DM）接受药物洗脱支架（DES）治疗的患者，双抗血小板治疗（DAPT）的最佳持续时间仍不明确。这是随机评估接受新一代 DES 治疗的急性冠状动脉综合征患者短期双重抗血小板治疗的疗效和安全性（REDUCE）试验的预先指定子研究，旨在确定使用 COMBO 支架行经皮冠状动脉介入治疗（PCI）的 ACS 合并糖尿病患者中，短期与标准 12 个月 DAPT 的疗效和安全性。

方法

本研究纳入 REDUCE 试验中接受 COMBO 支架治疗并随机分为 3 个月或 12 个月 DAPT 的 ACS 合并糖尿病患者。主要研究终点是 12 和 24 个月随访时全因死亡率、心肌梗死（MI）、支架血栓形成（ST）、卒中和靶血管血运重建（TVR）以及出血并发症的复合终点。

结果

共纳入 307 例糖尿病患者，其中 3 个月 DAPT 组 162 例（52.8%），12 个月 DAPT 组 145 例（47.2%）。3 个月和 12 个月 DAPT 组患者特征、PCI 成功率和支架使用数量相似。两组在 12 和 24 个月随访时主要研究终点的发生率相似（3.1% vs. 3.5%，p=0.865，15.8% vs. 14.9%，p=0.824）。此外，两组特定临床结局参数（全因死亡率）、MI、ST、卒中和 TVR 的发生率相似。

结论

本亚组分析显示，与 12 个月 DAPT 相比，使用 COMBO 支架治疗 ACS 的糖尿病患者行 PCI 后 3 个月 DAPT 具有相似的临床结局。这些结果表明，即使在这一特定患者亚组中，短期 DAPT 也可能是安全的。未来需要更大规模的研究来提供这些高危患者短期 DAPT 安全性和疗效的更精确估计。