Vinereanu Dragos, Napalkov Dmitry, Bergler-Klein Jutta, Benczur Bela, Ciernik Martin, Gotcheva Nina, Medvedchikov Alexey, Põder Pentti, Simic Dragan, Skride Andris, Tang Wenbo, Trusz-Gluza Maria, Vesely Jiri, Vishnepolsky Tatiana, Vrabec Mirej
Cardiology, University and Emergency Hospital of Bucharest, Bucharest, Other, Romania.
Department of Internal Medicine, I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russian Federation.
Open Heart. 2020 Mar 24;7(1):e001202. doi: 10.1136/openhrt-2019-001202. eCollection 2020.
We evaluated atrial fibrillation (AF) patients' perceptions of anticoagulation treatment with dabigatran or a vitamin K antagonist (VKA) for stroke prevention, according to accepted indications.
The RE-SONANCE observational, prospective, multicentre, international study used the validated Perception on Anticoagulant Treatment Questionnaire (PACT-Q) to assess patients with AF already taking a VKA who were switched to dabigatran (cohort A), and newly diagnosed patients initiated on either dabigatran or a VKA (cohort B). Visit 1 (V1) was at baseline, and visit 2 (V2) and visit 3 (V3) were at 30-45 and 150-210 days after baseline, respectively. Primary outcomes were treatment satisfaction and convenience in cohort A at V2 and V3 versus baseline, and in cohort B for dabigatran and a VKA at V2 and V3.
The main analysis set comprised 4100 patients in cohort A and 5365 in cohort B (dabigatran: 3179; VKA: 2186). In cohort A, PACT-Q2 improved significantly (p<0.001 for all) for treatment convenience (mean change V1 vs V2=20.72; SD=21.50; V1 vs V3=24.54; SD=22.85) and treatment satisfaction (mean change V1 vs V2=17.60; SD=18.76; V1 vs V3=21.04; SD=20.24). In cohort B, mean PACT-Q2 scores at V2 and V3 were significantly higher (p<0.001 for all) for dabigatran versus a VKA for treatment convenience (V2=18.38; SE =0.51; V3=23.34; SE=0.51) and satisfaction (V2=15.88; SE=0.39; V3=19.01; SE=0.41).
Switching to dabigatran from long-term VKA therapy or newly initiated dabigatran is associated with improved patient treatment convenience and satisfaction compared with VKA therapy.
我们根据公认的适应症，评估了房颤（AF）患者对达比加群或维生素K拮抗剂（VKA）预防中风抗凝治疗的认知情况。
RE-SONANCE观察性、前瞻性、多中心国际研究使用经过验证的抗凝治疗认知调查问卷（PACT-Q），对已服用VKA且换用达比加群的房颤患者（A组），以及新诊断并开始使用达比加群或VKA的患者（B组）进行评估。访视1（V1）在基线期，访视2（V2）和访视3（V3）分别在基线期后30 - 45天和150 - 210天。主要结局指标为A组在V2和V3时相对于基线期的治疗满意度和便利性，以及B组在V2和V3时达比加群与VKA的治疗满意度和便利性。
主要分析集包括A组的4100例患者和B组的5365例患者（达比加群：3179例；VKA：2186例）。在A组中，PACT-Q2在治疗便利性（V1与V2的平均变化=20.72；标准差=21.50；V1与V3的平均变化=24.54；标准差=22.85）和治疗满意度（V1与V2的平均变化=17.60；标准差=18.76；V1与V3的平均变化=21.04；标准差=20.24）方面均显著改善（所有p<0.001）。在B组中，V2和V3时达比加群的PACT-Q2平均得分在治疗便利性（V2=18.38；标准误=0.51；V3=23.34；标准误=0.51）和满意度（V
