Cessation of dual antiplatelet treatment and cardiac events after percutaneous coronary intervention (PARIS): 2 year results from a prospective observational study
Cessation of dual antiplatelet treatment and cardiac events after percutaneous coronary intervention (PARIS): 2 year results from a prospective observational study
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DOI：
10.1016/s0140-6736(13)61720-1
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发表时间：
2013-11-23
期刊：
影响因子：
168.9
通讯作者：
Pocock, Stuart
中科院分区：
文献类型：
--
作者：
Mehran, Roxana;Baber, Usman;Pocock, Stuart
背景：双重抗血小板治疗（DAPT）的停止增加了经皮冠状动脉介入治疗（PCI）后不良事件的风险。风险是否随时间变化，取决于DAPT停止的根本原因，或两者都是未知的。我们评估了不同模式的DAPT停止和心血管风险之间的关联后PCI.Methods的巴黎（模式不遵守抗血小板方案的支架植入患者）注册表是一个前瞻性的观察性研究，在美国和欧洲的15个临床站点之间，2009年7月1日，2010年12月2日，接受PCI支架植入术的患者。在一条或多条自体冠状动脉中成功植入支架并出院接受DAPT的成人患者（年龄≥ 18岁）有资格入组。在植入后1、6、12和24个月对患者进行随访。预先指定的DAPT停止类别包括医生建议的停止、短暂中断（用于手术）或中断（不依从或由于出血）。所有不良事件和DAPT停止发作均独立裁定。使用具有时变协变量的考克斯模型，我们检查了DAPT停止对主要不良事件（MACE [心源性死亡、明确或可能的支架内血栓形成、心肌梗死或靶病变血运重建的复合终点]）的影响。DAPT停止和不良事件的发生率计算为至首次事件时间的Kaplan-Meier估计值。本研究注册于ClinicalTrials.gov，编号NCT 00998127。结果我们招募了5031例接受PCI的患者，包括最终研究人群中的5018例。2年内，任何DAPT停止的总体发生率为57.3%。任何停药率为40.8%，中断率为10.5%，中断率为14.4%。相应的总体2年MACE发生率为11.5%，其中大部分（74%）发生在患者接受DAPT时。与接受DAPT的患者相比，因中断治疗导致的MACE的校正风险比（HR）为1.41（95% CI 0.94-2.12; p=0.10），因中断治疗导致的MACE的校正风险比（HR）为1.50（1.14-1.97; p=0.004）。干扰后7天内、8-30天和30天以上，校正HR分别为7.04（3.31-14.95）、2.17（0.97-4.88）和1.3（0.97-1.76）。与继续接受DAPT的患者相比，停药的患者MACE风险较低（0.63 [0.46-0.86]）。排除接受裸金属支架的患者并使用不包括靶病变血运重建的替代MACE定义后，结果相似。解释在现实世界中，对于接受PCI并在DAPT上出院的患者，DAPT停止后的心脏事件取决于临床情况和停止原因，并随时间推移而减弱。虽然PCI后的大多数事件发生在接受DAPT的患者中，但无论支架类型如何，由于破裂导致的事件的早期风险都很大。
Background Dual antiplatelet therapy (DAPT) cessation increases the risk of adverse events after percutaneous coronary intervention (PCI). Whether risk changes over time, depends on the underlying reason for DAPT cessation, or both is unknown. We assessed associations between different modes of DAPT cessation and cardiovascular risk after PCI.Methods The PARIS (patterns of non-adherence to anti-platelet regimens in stented patients) registry is a prospective observational study of patients undergoing PCI with stent implantation in 15 clinical sites in the USA and Europe between July 1, 2009, and Dec 2, 2010. Adult patients (aged 18 years or older) undergoing successful stent implantation in one or more native coronary artery and discharged on DAPT were eligible for enrolment. Patients were followed up at months 1, 6, 12, and 24 after implantation. Prespecified categories for DAPT cessation included physician-recommended discontinuation, brief interruption (for surgery), or disruption (non-compliance or because of bleeding). All adverse events and episodes of DAPT cessation were independently adjudicated. Using Cox models with time-varying covariates, we examined the effect of DAPT cessation on major adverse events (MACE [composite of cardiac death, definite or probable stent thrombosis, myocardial infarction, or target-lesion revascularisation]). Incidence rates for DAPT cessation and adverse events were calculated as Kaplan-Meier estimates of time to the first event. This study is registered with ClinicalTrials.gov, number NCT00998127.Findings We enrolled 5031 patients undergoing PCI, including 5018 in the final study population. Over 2 years, the overall incidence of any DAPT cessation was 57.3%. Rate of any discontinuation was 40.8%, of interruption was 10.5%, and of disruption was 14.4%. The corresponding overall 2 year MACE rate was 11.5%, most of which (74%) occurred while patients were taking DAPT. Compared with those on DAPT, the adjusted hazard ratio (HR) for MACE due to interruption was 1.41 (95% CI 0.94-2.12; p=0.10) and to disruption was 1.50 (1.14-1.97; p=0.004). Within 7 days, 8-30 days, and more than 30 days after disruption, adjusted HRs were 7.04 (3.31-14.95), 2.17 (0.97-4.88), and 1.3 (0.97-1.76), respectively. By contrast with patients who remained on DAPT, those who discontinued had lower MACE risk (0.63 [0.46-0.86]). Results were similar after excluding patients receiving bare metal stents and using an alternative MACE definition that did not include target lesion revascularisation.Interpretation In a real-world setting, for patients undergoing PCI and discharged on DAPT, cardiac events after DAPT cessation depend on the clinical circumstance and reason for cessation and attenuates over time. While most events after PCI occur in patients on DAPT, early risk for events due to disruption is substantial irrespective of stent type.