Moreno Raúl, Souza José, Smolnik Rüdiger, Nombela-Franco Luis, Van Mieghem Nicolas M, Hengstenberg Christian, Valgimigli Marco, Jin James, Ohlmann Patrick, Dangas George, Unverdorben Martin, Möllmann Helge
Interventional Cardiology, University Hospital La Paz, Paseo La Castellana, 261, 28046, Madrid, Spain.
Daiichi Sankyo, Inc., Munich, Germany.
Clin Res Cardiol. 2025 Mar;114(3):313-322. doi: 10.1007/s00392-024-02379-5. Epub 2024 Jan 31.
Patients with atrial fibrillation (AF) and a recent (≤ 90 days) percutaneous coronary intervention (PCI) undergoing transcatheter aortic valve implantation (TAVI) are at high bleeding risk due to the addition of oral antiplatelet (OAP) agents on top of oral anticoagulants. Data on outcomes of these patients are needed to optimize antithrombotic treatment.
This analysis compared annualized clinical event rates in patients with and without a recent PCI enrolled in ENVISAGE-TAVI AF, a prospective, randomized, open-label, adjudicator-masked trial comparing edoxaban and vitamin K antagonists in AF patients after TAVI. The primary efficacy and safety outcomes were net adverse clinical events (NACE) and major bleeding.
Overall, 132 (94.3%) patients with a recent PCI (n = 140) received OAP after TAVI, compared with 692 (55.9%) patients without a recent PCI (n = 1237). Among patients with a recent PCI on OAP agents, use of dual antiplatelet therapy decreased to 5.5%, and use of single antiplatelet therapy (SAPT) increased to 78.0% over 3 months post-randomization. Conversely, use of SAPT predominated at all time points in patients without a recent PCI history. There were no significant differences in the incidence of NACE or other outcomes assessed, except for major bleeding events, which were more frequent in patients with vs without a recent PCI history (hazard ratio [95% confidence interval]: 2.17 [1.27, 3.73]; P = 0.005).
Patients with AF undergoing TAVI with a recent PCI have a similar risk of ischemic events and mortality, but an increased risk of major bleeding compared with patients without a recent PCI.
心房颤动（AF）患者且近期（≤90天）接受过经皮冠状动脉介入治疗（PCI），在口服抗凝剂基础上再加用口服抗血小板（OAP）药物后，接受经导管主动脉瓣植入术（TAVI）时出血风险很高。需要这些患者的预后数据来优化抗栓治疗。
本分析比较了纳入ENVISAGE-TAVI AF研究的近期有PCI和无PCI患者的年化临床事件发生率。ENVISAGE-TAVI AF是一项前瞻性、随机、开放标签、裁决者设盲的试验，比较了阿哌沙班和维生素K拮抗剂在TAVI术后AF患者中的应用。主要疗效和安全性结局为净不良临床事件（NACE）和大出血。
总体而言，近期有PCI的132例（94.3%）患者（n = 140）在TAVI术后接受了OAP，而近期无PCI的692例（55.9%）患者（n = 1237）接受了OAP。在接受OAP药物治疗的近期有PCI的患者中，双联抗血小板治疗的使用率在随机分组后3个月降至5.5%，而单联抗血小板治疗（SAPT）的使用率增至78.0%。相反，在近期无PCI病史的患者中，SAPT在所有时间点的使用率均占主导。NACE或其他评估结局的发生率无显著差异，但大出血事件除外，近期有PCI病史的患者大出血事件更频繁（风险比[95%置信区间]：2.17[1.27，3.73]；P = 0.005）。
近期有PCI的AF患者接受TAVI时，缺血事件和死亡风险与无近期PCI的患者相似，但大出血风险增加。
