左心耳闭塞治疗透析心房颤动患者的长期安全性和有效性:一项多中心、前瞻性、开放标签、观察性研究

NDT Plus Pub Date : 2023-09-04 DOI:10.1093/ckj/sfad221
Simonetta Genovesi, Luca Porcu, Paola Rebora, Giorgio Slaviero, Gavino Casu, Silvio Bertoli, Flavio Airoldi, Monique Buskermolen, Maurizio Gallieni, Federico Pieruzzi, Giovanni Rovaris, Alberto Montoli, Emanuela Piccaluga, Giulio Molon, Federico Alberici, Marianna Adamo, Achille Gaspardone, Giuseppe D'Angelo, Pierluigi Merella, Giuseppe Vezzoli, Barbara Trezzi, Patrizio Mazzone
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Methods and Results The purpose of the study was to evaluate the efficacy and safety of LAA occlusion in a cohort of dialysis patients undergoing the procedure (LAA occlusion cohort, n = 106), in comparison with two other ESKD cohorts, one taking warfarin (Warfarin cohort, n = 114) and the other without anticoagulation therapy (No-OAT cohort, n = 148). After a median follow-up of 4 years, a Cox regression model, adjusted for possible confounding factors, showed that the hazard ratios (HRs) of thromboembolic events in the LAA occlusion cohort were 0.19 (95%CI 0.04–0.96; p = 0.045) and 0.16 (95%CI 0.04–0.66; p = 0.011) as compared with Warfarin and No-OAT cohorts, respectively. The HR of bleeding in the LAA occlusion cohort was 0.37 (95%CI 0.16–0.83; p = 0.017) compared to Warfarin cohort, while there were no significant differences between the LAA occlusion and the No-OAT cohort (HR 0.51; 95%CI 0.23–1.12; p = 0.094). 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引用次数: 0

摘要

背景终末期肾病(ESKD)透析患者房颤(AF)患病率高,然而,ESKD合并房颤患者出血的高风险往往阻碍正确抗凝治疗,尽管有较高的血栓栓塞风险。左心耳(LAA)闭塞是一种抗凝治疗(OAT),用于房颤高危人群的血栓栓塞预防。方法与结果本研究的目的是评估LAA闭塞在接受该手术的透析患者队列中的有效性和安全性(LAA闭塞队列,n = 106),并与另外两个ESKD队列进行比较,一个使用华法林(华法林队列,n = 114),另一个不使用抗凝治疗(No-OAT队列,n = 148)。中位随访4年后,Cox回归模型,调整了可能的混杂因素,显示LAA闭塞队列中血栓栓塞事件的危险比(HRs)为0.19 (95%CI 0.04-0.96;p = 0.045)和0.16 (95%CI 0.04-0.66;p = 0.011),分别与华法林组和No-OAT组比较。LAA闭塞组出血的HR为0.37 (95%CI 0.16-0.83;p = 0.017),而LAA闭塞组与no - oat组之间无显著差异(HR 0.51;95%可信区间0.23 - -1.12;P = 0.094)。调整后的Cox回归模型显示,与华法林组相比,接受LAA闭塞的患者死亡率更低(HR 0.60;95%可信区间0.38 - -0.94;p = 0.027)和无oat队列(HR 0.52;95%可信区间0.34 - -0.78;P = 0.002)。根据CHA2DS2VASc评分,LAA闭塞队列中的血栓栓塞事件低于预期(1.7 [95%CI 0.3-3.0] vs 6.7事件/ 100人/年,p <0.001)。结论:在ESKD合并房颤的患者中,LAA闭塞是安全有效的,与OAT或不治疗相比,LAA闭塞可降低死亡率。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Long term safety and efficacy of left atrial appendage occlusion in dialysis patients with atrial fibrillation: a multi-center, prospective, open label, observational study
ABSTRACT Background The prevalence of atrial fibrillation (AF) in end stage kidney disease (ESKD) patients undergoing dialysis is high, however, the high risk of bleeding often hampers with a correct anticoagulation in ESKD patients with AF, despite high thromboembolic risk. Left atrial appendage (LAA) occlusion is a anticoagulation (OAT) for thromboembolism prevention in AF populations with high hemorrhagic risk. Methods and Results The purpose of the study was to evaluate the efficacy and safety of LAA occlusion in a cohort of dialysis patients undergoing the procedure (LAA occlusion cohort, n = 106), in comparison with two other ESKD cohorts, one taking warfarin (Warfarin cohort, n = 114) and the other without anticoagulation therapy (No-OAT cohort, n = 148). After a median follow-up of 4 years, a Cox regression model, adjusted for possible confounding factors, showed that the hazard ratios (HRs) of thromboembolic events in the LAA occlusion cohort were 0.19 (95%CI 0.04–0.96; p = 0.045) and 0.16 (95%CI 0.04–0.66; p = 0.011) as compared with Warfarin and No-OAT cohorts, respectively. The HR of bleeding in the LAA occlusion cohort was 0.37 (95%CI 0.16–0.83; p = 0.017) compared to Warfarin cohort, while there were no significant differences between the LAA occlusion and the No-OAT cohort (HR 0.51; 95%CI 0.23–1.12; p = 0.094). Adjusted Cox regression models showed lower mortality in patients undergoing LAA occlusion as compared with both the Warfarin cohort (HR 0.60; 95%CI 0.38–0.94; p = 0.027) and no-OAT cohort (HR 0.52; 95%CI 0.34–0.78; p = 0.002). Thromboembolic events in the LAA occlusion cohort were lower than expected according to the CHA2DS2VASc score (1.7 [95%CI 0.3–3.0] vs 6.7 events per 100 person/years, p &lt; 0.001). Conclusion In ESKD patients with AF, LAA occlusion is safe and effective and is associated with reduced mortality compared with OAT or no therapy.
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