经导管主动脉瓣置换术后直接口服抗凝剂与维生素 K 拮抗剂的比较。
Direct oral anticoagulants versus vitamin K antagonist after transcatheter aortic valve implantation.
机构信息
Department III of Internal Medicine, Heart Center, Faculty of Medicine and University Hospital of Cologne, Cologne, Germany
Department III of Internal Medicine, Heart Center, Faculty of Medicine and University Hospital of Cologne, Cologne, Germany.
出版信息
Heart. 2023 Oct 26;109(22):1706-1713. doi: 10.1136/heartjnl-2023-322548.
OBJECTIVE
After transcatheter aortic valve implantation (TAVI), the optimal regimen of anticoagulant therapy in patients with an additional indication for oral anticoagulation remains a matter of debate. This study investigates the efficacy of direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs) in patients after TAVI in a real-world population.
METHODS
The German Aortic Valve RegistrY (GARY) is a prospective, multicentre registry enrolling patients undergoing invasive treatment for aortic valve disease. From January 2011 to December 2019, 1 41 790 patients from 92 hospitals in Germany were enrolled. Anticoagulatory treatment regimens were assessed at hospital discharge for patients after TAVI procedures. All-cause mortality and the combined endpoint 'cardiac and cerebrovascular events' containing myocardial infarction, stroke, transient ischaemic attack, aortic prosthesis reintervention and all-cause mortality in the first year after TAVI were examined by treatment regimen.
RESULTS
Of 45 598 patients (mean age 80.7±5.7 years, 49.3% males) undergoing TAVI, 16 974 patients (37.2%) received an anticoagulant regimen that included VKA or DOAC. Hereof, the majority of patients were prescribed VKA (n=11 333, 66.8%) compared with DOAC (n=5641, 33.2%) with an increase of DOAC use from 9.4% in 2011 to 69.9% in 2019. During the 1-year follow-up, the absolute event rates per 100 person-years for all-cause mortality and the combined endpoint cardiac and cerebrovascular events were 1.9 and 1.3 for VKA-treated and 1.7 and 1.2 for DOAC-treated patients, respectively. After adjustment for baseline confounders, all-cause mortality (HR 0.95, 95% CI 0.88 to 1.01, p=0.114) and cardiac and cerebrovascular event-free survival (HR 0.93, 95% CI 0.86 to 1.01, p=0.071) did not differ significantly between VKA and DOAC groups.
CONCLUSIONS
This study supports evidence of the efficacy of DOAC use after TAVI in patients with an indication for oral anticoagulation.
目的
经导管主动脉瓣置换术（TAVI）后，对于同时存在口服抗凝指征的患者，最佳抗凝治疗方案仍存在争议。本研究旨在真实世界人群中调查直接口服抗凝剂（DOAC）与维生素 K 拮抗剂（VKA）在 TAVI 术后患者中的疗效。
方法
德国主动脉瓣注册研究（GARY）是一项前瞻性、多中心注册研究，纳入了接受主动脉瓣疾病有创治疗的患者。2011 年 1 月至 2019 年 12 月，德国 92 家医院共纳入了 141790 例患者。评估了 TAVI 术后患者出院时的抗凝治疗方案。根据治疗方案，在 TAVI 术后 1 年内，评估全因死亡率和包含心肌梗死、卒中等心脏和脑血管事件的联合终点事件，以及主动脉瓣假体再介入和全因死亡率。
结果
在 45598 例行 TAVI 的患者中（平均年龄 80.7±5.7 岁，49.3%为男性），16974 例（37.2%）接受了包括 VKA 或 DOAC 的抗凝治疗方案。在此类患者中，大多数患者接受 VKA 治疗（n=11333，66.8%），而接受 DOAC 治疗的患者比例为 33.2%（n=5641），2011 年 DOAC 的使用率为 9.4%，2019 年则增加至 69.9%。在 1 年随访期间，全因死亡率和心脏和脑血管事件的联合终点事件的绝对发生率分别为每 100 人年 1.9 和 1.3 例（VKA 治疗）和 1.7 和 1.2 例（DOAC 治疗）。经调整基线混杂因素后，VKA 组和 DOAC 组的全因死亡率（HR 0.95，95%CI 0.88 至 1.01，p=0.114）和心脏和脑血管事件无事件生存率（HR 0.93，95%CI 0.86 至 1.01，p=0.071）差异均无统计学意义。
结论
本研究支持 TAVI 后 DOAC 用于存在口服抗凝指征患者的疗效证据。
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