基于实践与临床试验的 Watchman 左心耳封堵患者水平分析。
Patient-Level Analysis of Watchman Left Atrial Appendage Occlusion in Practice Versus Clinical Trials.
机构信息
Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, USA; Division of Cardiology, Duke University School of Medicine, Durham, North Carolina, USA.
Center for Outcomes Research and Evaluation, Yale New Haven Health, New Haven, Connecticut, USA.
出版信息
JACC Cardiovasc Interv. 2022 May 9;15(9):950-961. doi: 10.1016/j.jcin.2022.02.029.
OBJECTIVES
The aim of this study was to compare outcomes among patients from the PROTECT-AF (WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation) and PREVAIL (Evaluation of the WATCHMAN Left Atrial Appendage [LAA] Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) left atrial appendage occlusion (LAAO) trials with matched patients from the National Cardiovascular Data Registry LAAO Registry using patient-level data.
BACKGROUND
Patients undergoing LAAO in clinical practice generally have more comorbidities than trial participants.
METHODS
Propensity-matched analyses, with up to 3 registry patients matched to each trial patient, were performed using Cox proportional hazards and Fine-Gray models.
RESULTS
A total of 1,904 registry patients were matched to 667 trial LAAO patients; 1,010 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 in registry patients (2.70% vs 1.21%; HR: 1.951; P = 0.03); warfarin patients had comparable rates of ischemic stroke compared with 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 in registry patients (2.92% vs 6.23%; HR: 0.477; P = 0.004), a difference attributable to noncardiovascular deaths. Mortality was similar (P = 0.44) among trial warfarin (4.48%) and registry (5.86%) patients.
CONCLUSION
In clinical practice, patients who meet trial criteria and undergo LAAO experience a lower risk of ischemic stroke, a similar risk of hemorrhagic stroke, and a higher risk of death after implant versus LAAO trial patients. (WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation [PROTECT-AF], NCT00129545; Evaluation of the WATCHMAN Left Atrial Appendage [LAA] Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy [PREVAIL], NCT01182441).
目的
本研究旨在通过患者水平数据，比较 PROTECT-AF（WATCHMAN 左心耳封堵系统预防房颤患者栓塞）和 PREVAIL（WATCHMAN 左心耳封堵装置对比长期华法林治疗在房颤患者中的应用）左心耳封堵术（LAAO）试验中的患者与全国心血管数据注册处 LAAO 登记处中匹配患者的结局。
背景
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。
方法
采用倾向性匹配分析，每个试验患者最多匹配 3 名登记处患者，采用 Cox 比例风险和 Fine-Gray 模型进行分析。
结果
共 1904 名登记处患者匹配了 667 名试验 LAAO 患者；1010 名登记处患者匹配了 348 名华法林患者。与登记处患者相比，试验 LAAO 患者更易发生需要干预的心包积液（3.8%比 0.6%，P<0.001）、围术期缺血性卒中（0.9%比 0.2%，P=0.005）和装置植入失败（7.5%比 3.6%，P<0.001）。试验 LAAO 患者在 425 天的缺血性卒中风险高于登记处患者（2.70%比 1.21%；HR：1.951；P=0.03）；华法林患者的缺血性卒中发生率与登记处患者相似（1.15%比 1.29%；HR：0.728；P=0.57）。试验 LAAO 和登记处患者的出血性卒中风险无差异（P=0.88）。华法林患者的出血性卒中风险高于登记处患者（1.44%比 0.20%；HR：5.871，P=0.03）。试验 LAAO 患者的死亡率低于登记处患者（2.92%比 6.23%；HR：0.477；P=0.004），这归因于非心血管死亡。试验华法林（4.48%）和登记处（5.86%）患者的死亡率相似（P=0.44）。
结论
在临床实践中，符合试验标准并接受 LAAO 的患者发生缺血性卒中的风险较低，发生出血性卒中的风险相似，但与 LAAO 试验患者相比，植入后死亡风险较高。（WATCHMAN 左心耳封堵系统预防房颤患者栓塞[PROTECT-AF]，NCT00129545；评估房颤患者中使用 WATCHMAN 左心耳[LAA]封堵装置与长期华法林治疗的效果[PREVAIL]，NCT01182441）。
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