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经皮冠状动脉介入治疗支架内再狭窄病变:ADAPT-DES 研究报告。

Percutaneous coronary intervention of lesions with in-stent restenosis: A report from the ADAPT-DES study.

机构信息

Clinical Trials Center, Cardiovascular Research Foundation, New York, NY.

Clinical Trials Center, Cardiovascular Research Foundation, New York, NY; Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ; Hôpital du Sacré-Coeur de Montréal, Université de Montréal, Montréal, Quebec, Canada.

出版信息

Am Heart J. 2018 Mar;197:142-149. doi: 10.1016/j.ahj.2017.11.011. Epub 2017 Dec 5.

Abstract

BACKGROUND

There is a paucity of data from large contemporary cohorts of patients with in-stent restenosis (ISR) treated with drug-eluting stents (DESs), and no studies have examined the impact of high platelet reactivity (HPR) on the occurrence of ischemic events after ISR percutaneous coronary intervention (PCI) with DESs. We sought to report outcomes after PCI of ISR lesions and its association with HPR.

METHODS

Patients in the prospective, multicenter ADAPT-DES study were stratified according to whether they had ISR versus non-ISR PCI. Two-year outcomes were compared between the groups using Cox proportional hazards models. HPR was defined as on-clopidogrel P2Y12 platelet reaction units >208 as measured by the VerifyNow assay; target vessel failure (TVF) was defined as the composite of all-cause death, myocardial infarction, or ischemia-driven target vessel revascularization.

RESULTS

Among the 8,582 patients included in the ADAPT-DES study, 840 (9.8%) patients underwent successful ISR PCI. ISR PCI was independently associated with a higher 2-year risk of TVF (adjusted hazard ratio [HR] 1.95; 95% CI 1.68-2.27; P<.001) and stent thrombosis (adjusted HR 1.95; 95% CI 1.08-3.51; P=.027) but not bleeding (adjusted HR 0.94; 95% CI 0.73-1.21; P=.64). There was no statistical interaction between HPR and ISR versus non-ISR PCI in regard to TVF (adjusted P=.81).

CONCLUSIONS

ISR PCI is associated with a considerably higher risk of 2-year adverse ischemic events, with HPR conferring similar risk in ISR and non-ISR PCI. More effective therapeutic strategies for managing ISR lesions are necessary.

摘要

背景

目前缺乏关于药物洗脱支架(DES)治疗的支架内再狭窄(ISR)大样本当代患者的数据,且尚无研究探讨血小板高反应性(HPR)对 DES 治疗 ISR 经皮冠状动脉介入治疗(PCI)后缺血事件发生的影响。我们旨在报告 ISR 病变 PCI 后的结局及其与 HPR 的相关性。

方法

前瞻性、多中心 ADAPT-DES 研究中的患者根据是否存在 ISR 行 PCI 而分层。采用 Cox 比例风险模型比较两组的 2 年结局。采用 VerifyNow 检测血小板反应单位(P2Y12)测定氯吡格雷抑制率>208 定义为 HPR;靶血管失败(TVF)定义为全因死亡、心肌梗死或缺血驱动的靶血管血运重建的复合终点。

结果

ADAPT-DES 研究共纳入 8582 例患者,其中 840 例(9.8%)患者成功接受 ISR PCI。ISR PCI 与较高的 2 年 TVF 风险独立相关(校正风险比[HR]1.95;95%置信区间[CI]1.68-2.27;P<.001)和支架血栓形成(校正 HR 1.95;95% CI 1.08-3.51;P=.027),但与出血(校正 HR 0.94;95% CI 0.73-1.21;P=.64)无关。HPR 与 ISR 与非 ISR PCI 之间在 TVF 方面无统计学交互作用(校正 P=.81)。

结论

ISR PCI 与 2 年不良缺血事件风险显著增加相关,HPR 对 ISR 和非 ISR PCI 均有相似的风险。需要采取更有效的治疗策略来管理 ISR 病变。

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