■最近对一项大型注册表的分析显示,男性与女性相比,Watchman左心耳封堵装置的围手术期结果存在差异。我们研究的目的是调查提交给美国食品和药物管理局审查的Watchman设备上市前临床研究中男性和女性的5年事件发生率。
■我们对来自4项研究的2256名患者进行了患者水平的荟萃分析:PROTECTAF(房颤患者的栓塞保护)和PREVAIL(房颤患者的Watchman左心房闭合装置与长期华法林治疗的前瞻性随机评估)随机对照试验(持续接受CAPPREA-2)评估的结果是缺血性卒中(IS),IS/全身性栓塞,出血性中风(HS),和全因死亡率。使用混合效应Cox回归模型和按性别治疗相互作用的统计检验来比较男性和女性的左心耳封堵术与华法林。使用与CHADS2评分作为协变量的相同模型生成CHADS2评分的危险比调整(aHRs)。使用Kaplan-Meier方法和对数秩检验评估时间至事件终点。
■对于2项随机对照试验中的Watchman与华法林,性别和IS治疗之间没有显著的相互作用,IS/全身性栓塞,HS,和全因死亡率(P>.05);Watchman组的男性和女性的HSaHR均低于华法林组,这对男性具有统计学意义(AHR,0.163;95%CI,0.045-0.593)。此外,当汇集所有研究时,使用Watchman装置治疗的女性和男性之间的结局没有差异.
■这些数据表明,性别不会显着影响非瓣膜性心房颤动患者Watchman装置的长期安全性和有效性;但是,需要进一步的研究。
UNASSIGNED: A recent analysis of a large registry showed differences in periprocedural outcomes of the
Watchman left atrial appendage closure device in males compared with females. The objective of our study was to investigate the 5-year event rate in males and females enrolled in the
Watchman device premarket clinical studies submitted for US Food and Drug Administration review.
UNASSIGNED: We conducted a patient-level meta-analysis of 2256 patients from 4 studies: the PROTECT AF (Embolic Protection in Patients with Atrial Fibrillation) and PREVAIL (Prospective Randomized Evaluation of the
Watchman Left Atrial Appendage Closure Device in Patients with Atrial Fibrillation vs Long-Term Warfarin Therapy) randomized controlled trials and their continued-access registries-CAP1 (Continued Access to PROTECT AF) and CAP2 (Continued Access to PREVAIL). The outcomes evaluated were ischemic stroke (IS), IS/systemic embolism, hemorrhagic stroke (HS), and all-cause mortality. Mixed-effects Cox regression models and statistical testing for treatment-by-sex interaction were used to compare left atrial appendage closure vs warfarin in males and females. Hazard ratios adjusted (aHRs) for CHADS2 scores were generated using the same model with CHADS2 score as a covariate. Time-to-event end points were evaluated using the Kaplan-Meier method and log-rank test.
UNASSIGNED: For Watchman vs warfarin in the 2 randomized controlled trials, there was no significant interaction between sex and treatment for IS, IS/systemic embolism, HS, and all-cause mortality (P > .05); both males and females in the
Watchman group had a lower aHR for HS than that in the warfarin group, which was statistically significant for males (aHR, 0.163; 95% CI, 0.045-0.593). In addition, there were no differences in outcomes between females and males treated with the
Watchman device when pooling all studies.
UNASSIGNED: These data suggest that sex does not significantly affect the long-term safety and effectiveness of the Watchman device in patients with nonvalvular atrial fibrillation; however, further studies are needed.