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利伐沙班治疗伴肾功能损害的心房颤动患者的不良临床结局及相关预测因素。

Adverse Clinical Outcomes and Associated Predictors in Rivaroxaban-Treated Atrial Fibrillation Patients With Renal Impairment.

机构信息

Faculty of Nursing, University of Murcia, Instituto Murciano de Investigación Biosanitaria (IMIB-Arrixaca), CIBERCV, Murcia, Spain.

Cardiology Department, Hospital Universitario Reina Sofía, Universidad de Córdoba, Instituto Maimónides de Investigación Biomédica (IMIBIC), Córdoba, Spain.

出版信息

Am J Cardiol. 2023 Sep 15;203:122-127. doi: 10.1016/j.amjcard.2023.06.105. Epub 2023 Jul 22.

Abstract

Renal impairment confers worse prognosis in patients with atrial fibrillation (AF) but there is scarce evidence about the influence of direct-acting oral anticoagulants in routine clinical practice. Herein, we compared clinical outcomes between patients with AF with and without renal impairment on rivaroxaban and investigated predictors for clinical outcomes in patients with AF with renal impairment. This was a multicenter study including patients with AF on rivaroxaban for at least 6 months. During 2.5 years follow-up, ischemic strokes (IS)/transient ischemic attacks (TIA)/systemic embolisms (SE)/myocardial infarctions (MI), major bleeding, and major adverse cardiovascular events (MACE) were recorded. Creatinine clearance (CrCl) was estimated using the Cockroft-Gault equation, renal impairment was defined as a CrCl <60 ml/min, and 1,433 patients (34.8% with CrCl <60 ml/min) were included. Patients with CrCl <60 ml/min showed higher event rates for major bleeding (1.87%/year vs 0.62%/year; p = 0.003) and MACE (1.97%/year vs 0.62%/year; p = 0.002) but similar event rates for IS/TIA/SE/MI (0.66%/year vs 0.67%/year; p = 0.955). In patients with renal impairment, CHADS-VASc was associated with higher risk of IS/TIA/SE/MI; HAS-BLED and any dependency level were associated with higher risk of major bleeding; and male gender and heart failure were associated with higher risk of MACE. Antiplatelets were independently associated with increased risk of IS/TIA/SE/MI and MACE. In conclusion, in patients with AF on rivaroxaban, the incidence of IS/TIA/SE/MI did not increase in those with renal impairment, suggesting that rivaroxaban may be an effective option in this subgroup. In patients with AF, male gender, heart failure, dependency, antiplatelets, CHADS-VASc, and HAS-BLED were associated with increased risk of adverse outcomes.

摘要

肾功能损害会使房颤(AF)患者的预后更差,但在常规临床实践中,关于直接作用的口服抗凝剂的影响证据很少。在此,我们比较了利伐沙班治疗的 AF 患者中伴有和不伴有肾功能损害患者的临床结局,并探讨了伴有肾功能损害的 AF 患者临床结局的预测因素。这是一项多中心研究,纳入了至少服用利伐沙班 6 个月的 AF 患者。在 2.5 年的随访期间,记录了缺血性卒(IS)/短暂性脑缺血发作(TIA)/系统性栓塞(SE)/心肌梗死(MI)、大出血和主要不良心血管事件(MACE)。使用 Cockroft-Gault 方程估算肌酐清除率(CrCl),定义肾功能损害为 CrCl <60 ml/min,共纳入 1433 例患者(34.8% CrCl <60 ml/min)。CrCl <60 ml/min 的患者,大出血(1.87%/年 vs 0.62%/年;p=0.003)和 MACE(1.97%/年 vs 0.62%/年;p=0.002)的发生率更高,但 IS/TIA/SE/MI 的发生率相似(0.66%/年 vs 0.67%/年;p=0.955)。在肾功能损害患者中,CHADS-VASc 与 IS/TIA/SE/MI 的风险增加相关;HAS-BLED 和任何依赖程度与大出血的风险增加相关;男性和心力衰竭与 MACE 的风险增加相关。抗血小板药物与 IS/TIA/SE/MI 和 MACE 的风险增加独立相关。结论:在服用利伐沙班的 AF 患者中,肾功能损害患者的 IS/TIA/SE/MI 发生率并未增加,这表明利伐沙班可能是该亚组的有效选择。在 AF 患者中,男性、心力衰竭、依赖、抗血小板药物、CHADS-VASc 和 HAS-BLED 与不良结局风险增加相关。

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