Patient-Level Analysis of Watchman Left Atrial Appendage Occlusion in Practice Versus Clinical Trials.
Patient-Level Analysis of Watchman Left Atrial Appendage Occlusion in Practice Versus Clinical Trials.
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DOI：
10.1016/j.jcin.2022.02.029
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发表时间：
2022-05-09
影响因子：
11.3
通讯作者：
Freeman, James V.
中科院分区：
文献类型：
--
作者：
Friedman, Daniel J.;Du, Chengan;Wang, Yongfei;Agarwal, Vratika;Varosy, Paul D.;Masoudi, Frederick A.;Holmes, David R.;Reddy, Vivek Y.;Price, Matthew J.;Curtis, Jeptha P.;Freeman, James V.
使用患者水平数据，将 PROTECT-AF 和 PREVAIL 左心耳封堵 (LAAO) 试验的患者与国家心血管数据登记处 (NCDR) LAAO 登记处的匹配患者的结果进行比较。在临床实践中接受 LAAO 的患者通常比试验参与者有更多的合并症。使用 Cox 比例风险和 Fine-Gray 模型进行倾向匹配分析，每个试验患者最多匹配 3 名注册患者。共有 1904 名注册患者与 667 名试验 LAAO 患者相匹配； 1010 名登记患者与 348 名华法林患者相匹配。与注册患者相比，试验 LAAO 患者出现更多需要干预的心包积液（3.8% vs. 0.6%，p<0.001）、围手术期缺血性卒中（0.9% vs. 0.2%，p=0.005）和装置植入失败（7.5% vs. 3.6%，p<0.001）。试验 LAAO 患者 425 天缺血性卒中风险高于注册患者（2.70% vs. 1.21%；HR 1.951，p=0.03）；与登记患者相比，华法林患者的缺血性卒中发生率相当（1.15% vs. 1.29%；HR 0.728，p=0.57）。 LAAO 试验患者和注册患者的出血性中风风险相似（p=0.88）。与登记患者相比，华法林患者的出血性中风风险更高（1.44% vs. 0.20%；HR 5.871，p=0.03）。试验 LAAO 患者的死亡率低于注册患者（2.92% vs. 6.23%；HR 0.477，p=0.004），差异归因于非心血管死亡。试验华法林患者 (4.48%) 和登记患者 (5.86%) 的死亡率相似 (p=0.44)。在临床实践中，与 LAAO 试验患者相比，符合试验标准并接受 LAAO 的患者缺血性中风的风险较低，出血性中风的风险相似，植入后死亡的风险较高。我们对来自 PROTECT-AF 和 PREVAIL 左心耳封堵 (LAAO) 试验的患者以及来自国家心血管数据登记处 (NCDR) LAAO 登记处的匹配患者进行了患者水平分析。与注册患者相比，试验 LAAO 患者出现更多需要干预的心包积液、围手术期缺血性卒中和装置植入失败的情况。与试验华法林患者相比，匹配的 LAAO 患者发生缺血性中风的风险相似。与 LAAO 试验患者相比，匹配的 LAAO 在植入后 425 天内缺血性中风的风险较低，出血性中风的风险相似，死亡风险较高。
To compare outcomes among patients from the PROTECT-AF and PREVAIL left atrial appendage occlusion(LAAO) trials with matched patients from the National Cardiovascular Data Registry(NCDR) LAAO Registry using patient-level data. Patients undergoing LAAO in clinical practice generally have more comorbidities than trial participants. Propensity matched analyses, with up to 3 registry patients matched to each trial patient, were performed using Cox proportional hazards and Fine-Gray models. A total of 1904 registry patients were matched to 667 trial LAAO patients; 1010 registry patients were matched to 348 warfarin patients. Compared with registry patients, trial LAAO patients experienced more pericardial effusion requiring intervention(3.8% vs. 0.6% p<0.001), periprocedural ischemic stroke(0.9% vs. 0.2%, p=0.005), and failed device implantation(7.5% vs. 3.6%, p<0.001). The 425-day risk of ischemic stroke in trial LAAO patients was higher than registry patients(2.70% vs. 1.21%; HR 1.951, p=0.03); warfarin patients had comparable rates of ischemic stroke compared to registry patients(1.15% vs. 1.29%; HR 0.728, p=0.57). Hemorrhagic stroke risk was similar among trial LAAO and registry patients(p=0.88). Hemorrhagic stroke risk was greater among warfarin patients versus registry patients(1.44% vs. 0.20%; HR 5.871, p=0.03). Mortality was lower in trial LAAO patients than registry patients(2.92% vs. 6.23%; HR 0.477, p=0.004), a difference attributable to non- cardiovascular deaths. Mortality was similar(p=0.44) among trial warfarin(4.48%) and registry(5.86%) patients. In clinical practice, patients who meet trial criteria and undergo LAAO experience lower risk of ischemic stroke, similar risk of hemorrhagic stroke, and higher risk of death after implant versus LAAO trial patients. We performed a patient-level analysis of patients from the PROTECT-AF and PREVAIL left atrial appendage occlusion(LAAO) trials with matched patients from the National Cardiovascular Data Registry(NCDR) LAAO Registry. Compared with registry patients, trial LAAO patients experienced more pericardial effusion requiring intervention, periprocedural ischemic stroke, and failed device implantation. Matched LAAO patients had a similar risk of ischemic stroke compared to trial warfarin patients. Matched LAAO experienced a lower risk of ischemic stroke, similar risk of hemorrhagic stroke, and higher risk of death in the 425 days after implant compared with LAAO trial patients.
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