Hengstenberg Christian, Van Mieghem Nicolas M, Wang Rosa, Ye Xiaomei, Shi Ling, Guo Shien, Chen Cathy, Jin James, Ye Xin, Dangas George, Unverdorben Martin
Division of Cardiology, Department of Internal Medicine II, Vienna General Hospital, Medical University, Vienna, Austria.
Department of Cardiology, Erasmus University Medical Centre, Thoraxcenter, Rotterdam, The Netherlands.
Am J Cardiol. 2023 Dec 15;209:212-219. doi: 10.1016/j.amjcard.2023.09.091. Epub 2023 Oct 14.
ENVISAGE-TAVI AF (Edoxaban versus Standard of Care and Their Effects on Clinical Outcomes in Patients Having Undergone Transcatheter Aortic Valve Implantation-Atrial Fibrillation; NCT02943785) was a prospective, randomized, open-label trial comparing non-vitamin K oral anticoagulant (NOAC) edoxaban with vitamin K antagonists (VKAs) in patients with atrial fibrillation after successful transcatheter aortic valve replacement (TAVR). The effect of edoxaban- or VKA-based therapy on patient-reported outcomes remains unknown, as most studies focus on efficacy and safety. Pre-TAVR patient-reported expectations and post-TAVR Treatment Satisfaction and Convenience with edoxaban or VKA treatment (at months 3 and 12) were analyzed using the Perception of Anticoagulation Treatment Questionnaire (PACT-Q). This analysis included randomized and dosed patients with an evaluable PACT-Q1 assessment at baseline and ≥1 postbaseline assessment (PACT-Q2). Subanalyses included patients stratified by pre-TAVR anticoagulant (NOAC, VKA, no NOAC/VKA). Edoxaban- (n = 585) and VKA-treated (n = 522) patients had similar baseline characteristics and treatment expectations. Pre-TAVR anticoagulant use did not affect treatment expectations. After TAVR, edoxaban-treated patients had significantly higher Treatment Satisfaction and Convenience scores compared with VKA-treated patients at all time points (p <0.001 for all). Among edoxaban-treated patients, those who received VKAs pre-TAVR were significantly more satisfied with treatment than those who received NOACs (p <0.001) or no NOACs/VKAs (p = 0.003); however, there was no significant difference in the perception of convenience (p = 0.927 and p = 0.092, respectively). Conversely, among VKA-treated patients, the type of anticoagulant used pre-TAVR did not affect Treatment Satisfaction or Convenience scores post-TAVR. In conclusion, patients with atrial fibrillation who received edoxaban post-TAVR reported significantly higher Treatment Satisfaction and Convenience scores compared with those who received VKAs, resulting in a clinically meaningful difference between treatment groups.
ENVISAGE-TAVI AF（依度沙班与标准治疗及其对经导管主动脉瓣植入术后房颤患者临床结局的影响；NCT02943785）是一项前瞻性、随机、开放标签试验，比较非维生素K口服抗凝剂（NOAC）依度沙班与维生素K拮抗剂（VKA）在成功进行经导管主动脉瓣置换术（TAVR）后房颤患者中的疗效。依度沙班或基于VKA的治疗对患者报告结局的影响尚不清楚，因为大多数研究集中在疗效和安全性上。使用抗凝治疗认知问卷（PACT-Q）分析了TAVR前患者报告的期望以及TAVR后依度沙班或VKA治疗（在第3个月和第12个月）的治疗满意度和便利性。该分析纳入了在基线时具有可评估的PACT-Q1评估且在基线后有≥1次评估（PACT-Q2）的随机分组和已给药患者。亚组分析包括按TAVR前抗凝剂（NOAC、VKA、未使用NOAC/VKA）分层的患者。接受依度沙班治疗的患者（n = 585）和接受VKA治疗的患者（n = 522）具有相似的基线特征和治疗期望。TAVR前使用抗凝剂并不影响治疗期望。TAVR后，在所有时间点，接受依度沙班治疗的患者的治疗满意度和便利性得分均显著高于接受VKA治疗的患者（所有p值均<0.001）。在接受依度沙班治疗的患者中，TAVR前接受VKA治疗的患者对治疗的满意度显著高于接受NOAC治疗的患者（p <0.001）或未接受NOAC/VKA治疗的患者（p = 0.003）；然而，在便利性认知方面无显著差异（分别为p = 0.927和p = 0.092）。相反，在接受VKA治疗的患者中，TAVR前使用的抗凝剂类型并不影响TAVR后的治疗满意度或便利性得分。总之，与接受VKA治疗的患者相比，TAVR后接受依度沙班治疗的房颤患者报告的治疗满意度和便利性得分显著更高，导致治疗组之间存在具有临床意义的差异。
