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双联抗血小板治疗停药与糖尿病或非糖尿病患者药物洗脱支架置入术后不良事件风险的相关性、发生率及模式:PARIS 注册研究结果。

Incidence, Patterns, and Associations Between Dual-Antiplatelet Therapy Cessation and Risk for Adverse Events Among Patients With and Without Diabetes Mellitus Receiving Drug-Eluting Stents: Results From the PARIS Registry.

机构信息

Mount Sinai Heart, Mount Sinai Medical Center, New York, New York; Cardiothoracic Department, Division of Cardiology, University Hospital of Pisa, Pisa, Italy.

Mount Sinai Heart, Mount Sinai Medical Center, New York, New York.

出版信息

JACC Cardiovasc Interv. 2017 Apr 10;10(7):645-654. doi: 10.1016/j.jcin.2016.12.003. Epub 2017 Mar 15.

Abstract

OBJECTIVES

The aim of this study was to examine the frequency and clinical impact of different cessation patterns of dual-antiplatelet therapy (DAPT) after percutaneous coronary intervention with drug-eluting stents among patients with and those without diabetes mellitus (DM).

BACKGROUND

Early DAPT suspension after percutaneous coronary intervention increases the risk for major adverse cardiac events. However, temporal variability in risk and relation to DAPT cessation patterns among patients with DM remain unclear.

METHODS

Using data from the PARIS (Patterns of Non-Adherence to Anti-Platelet Regimens in Stented Patients) registry, 1,430 patients with DM (34%) and 2,777 without DM (66%) treated with drug-eluting stents were identified. DAPT cessation modes were classified as temporary interruption (<14 days), disruption because of bleeding or poor compliance, and physician-recommended discontinuation.

RESULTS

During 2-year follow-up, DM was associated with an increased risk for thrombotic events but a similar risk for bleeding. The cumulative incidence of DAPT cessation was significantly lower in patients with versus those without DM (50.1% vs. 55.4%; p < 0.01), driven largely by less frequent physician-guided discontinuation beyond 1 year. In contrast, 2-year rates of interruption and disruption were similar between groups. When DAPT was interrupted or discontinued under physician guidance, the risk for major adverse cardiac events was unchanged compared with patients with DM on uninterrupted DAPT. Conversely, when DAPT was disrupted, the risk for major adverse cardiac events increased compared with uninterrupted DAPT, regardless of diabetic status, with no evidence of statistical interaction.

CONCLUSIONS

DAPT cessation patterns vary according to diabetic status, with less frequent physician-guided discontinuation among patients with DM. The presence of DM does not emerge as a modifier of cardiovascular risk after DAPT cessation.

摘要

目的

本研究旨在探讨经皮冠状动脉介入治疗(PCI)置入药物洗脱支架后,糖尿病(DM)和非糖尿病患者双重抗血小板治疗(DAPT)停药模式的频率及其对临床结局的影响。

背景

PCI 后早期 DAPT 停药会增加主要不良心脏事件的风险。然而,DM 患者的风险时间变化性以及与 DAPT 停药模式的关系仍不清楚。

方法

利用 PARIS(支架置入患者抗血小板方案不依从模式)注册研究的数据,纳入 1430 例 DM 患者(34%)和 2777 例非 DM 患者(66%),均接受药物洗脱支架治疗。DAPT 停药模式分为临时中断(<14 天)、因出血或药物依从性差而中断,以及医生建议停药。

结果

在 2 年随访期间,DM 与血栓形成事件风险增加相关,但与出血风险相似。与非 DM 患者相比,DM 患者 DAPT 停药的累计发生率显著较低(50.1% vs. 55.4%;p<0.01),这主要是由于 1 年以上医生指导下停药的频率较低所致。相比之下,两组中断和停药的 2 年发生率相似。当 DAPT 在医生指导下中断或停药时,与 DM 患者持续 DAPT 相比,主要不良心脏事件的风险没有变化。相反,无论 DM 状态如何,与持续 DAPT 相比,DAPT 中断时主要不良心脏事件的风险增加,且无统计学交互作用的证据。

结论

DAPT 停药模式因糖尿病状态而异,DM 患者中医生指导下停药的频率较低。DAPT 停药后,DM 的存在并未成为心血管风险的修饰因素。

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