Talerico Rosa, Brando Elisa, Luzi Lorenzo, Vedovati Maria Cristina, Giustozzi Michela, Verso Melina, Di Gennaro Leonardo, Basso Maria, Ferretti Antonietta, Porfidia Angelo, De Candia Erica, Pola Roberto, Agnelli Giancarlo, Becattini Cecilia
Department of Geriatric, Orthopedic, and Rheumatologic Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Largo Francesco Vito, 1-00168, Rome, Italy.
IRCCS San Raffaele, Rome, Italy.
Intern Emerg Med. 2024 Sep;19(6):1645-1652. doi: 10.1007/s11739-024-03658-9. Epub 2024 Jun 28.
It is still uncertain whether direct oral anticoagulants (DOACs) perform better than vitamin K antagonists (VKAs) in subjects with non-valvular atrial fibrillation (NVAF) and advanced chronic kidney disease (CKD). The aim of the study was to compare safety and effectiveness of DOACs and VKAs in patients with NVAF and stage 4 CKD (creatinine clearance 15-29 mL/min). We searched the hospital databases of two academic centers to retrospectively identify patients with stage 4 CKD who were on treatment with DOACs or VKAs for NVAF. Safety was the primary outcome of the study and was assessed in terms of incidence of major bleeding (MB). Secondary outcomes were clinically relevant non-major bleeding (CRNMB) and death for any cause. A total of 176 patients (102 on DOACs and 74 on VKAs) were found and included in the analysis. The incidence rate of MB was not statistically different between groups (8.6 per 100 patients-year in the DOAC group and 5.6 per 100 patients-year in the VKA group). Rates of IS/SSE and CRNMB were statistically similar in the two treatment groups, as well. There were less deaths for any cause in the DOAC group than in the VKA group (8.6 and 15.8 per 100 patients-year, respectively), but the difference was not statistically significant. This study found no difference in terms of safety and effectiveness between patients with NVAF and stage 4 CKD treated with DOACs and VKAs. Larger prospective or randomized studies are needed to confirm these findings.
对于非瓣膜性心房颤动(NVAF)和晚期慢性肾脏病(CKD)患者,直接口服抗凝剂(DOACs)是否比维生素K拮抗剂(VKAs)效果更好仍不确定。本研究的目的是比较DOACs和VKAs在NVAF和4期CKD(肌酐清除率15 - 29 mL/min)患者中的安全性和有效性。我们检索了两个学术中心的医院数据库,以回顾性识别接受DOACs或VKAs治疗NVAF的4期CKD患者。安全性是本研究的主要结局,通过严重出血(MB)发生率进行评估。次要结局是临床相关非严重出血(CRNMB)和任何原因导致的死亡。共发现176例患者(102例使用DOACs,74例使用VKAs)并纳入分析。两组之间MB的发生率无统计学差异(DOAC组为每100患者年8.6例,VKA组为每100患者年5.6例)。两个治疗组的缺血性卒中/系统性栓塞(IS/SSE)和CRNMB发生率在统计学上也相似。DOAC组任何原因导致的死亡人数少于VKA组(分别为每100患者年8.6例和15.8例),但差异无统计学意义。本研究发现,在NVAF和4期CKD患者中,使用DOACs和VKAs治疗在安全性和有效性方面没有差异。需要更大规模的前瞻性或随机研究来证实这些发现。