University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital, Bucharest, Splaiul Independentei 169, 050078, Bucharest, Romania.
I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russian Federation.
J Thromb Thrombolysis. 2021 Nov;52(4):1195-1206. doi: 10.1007/s11239-021-02450-2. Epub 2021 Apr 30.
The oral anticoagulant dabigatran offers an effective alternative to vitamin K antagonists (VKAs) for stroke prevention in atrial fibrillation (AF), yet patient preference data are limited. The prospective observational RE-SONANCE study demonstrated that patients with AF, newly initiated on dabigatran, or switching to dabigatran from long-term VKA therapy, reported improved treatment convenience and satisfaction compared with VKA therapy. This pre-specified sub-study aimed to assess the impact of country and age on patients' perceptions of dabigatran or VKA therapy in AF.
RE-SONANCE was an observational, prospective, multi-national study (NCT02684981) that assessed treatment satisfaction and convenience in patients switching from VKAs to dabigatran (Cohort A), or newly diagnosed with AF receiving dabigatran or VKAs (Cohort B), using the PACT-Q questionnaire. Pre-specified exploratory outcomes: variation in PACT-Q2 scores by country and age (< 65, 65 to < 75, ≥ 75 years) (both cohorts); variation in PACT-Q1 responses at baseline by country and age (Cohort B).
Patients from 12 countries (Europe/Israel) were enrolled in Cohort A (n = 4103) or B (n = 5369). In Cohort A, mean (standard deviation) PACT-Q2 score increase was highest in Romania (convenience: 29.6 [23.6]) and Hungary (satisfaction: 26.0 [21.4]) (p < 0.001). In Cohort B, mean (standard error) increase in PACT-Q2 scores between dabigatran and VKAs was highest in Romania (visit 3: 29.0 [1.3]; 24.5 [0.9], p < 0.001). Mean PACT-Q2 score increase by age (all p < 0.001) was similar across ages. PACT-Q1 responses revealed lowest expectations of treatment success in Romania and greatest concerns about payment in Estonia, Latvia, and Romania, but were similar across ages.
Treatment satisfaction and convenience tended to favor dabigatran over VKAs. Regional differences in treatment expectations exist across Europe.
Trial registration number: ClinicalTrials.gov NCT02684981. Trial registration date: February 18, 2016.
口服抗凝剂达比加群酯为预防心房颤动（AF）中风提供了一种替代维生素 K 拮抗剂（VKA）的有效方法，但患者偏好数据有限。前瞻性观察性 RESONANCE 研究表明，与 VKA 治疗相比，新开始接受达比加群酯或从长期 VKA 治疗转换为达比加群酯的 AF 患者报告治疗便利性和满意度提高。这项预先指定的子研究旨在评估国家和年龄对患者对 AF 中达比加群酯或 VKA 治疗看法的影响。
RESONANCE 是一项观察性、前瞻性、多国研究（NCT02684981），使用 PACT-Q 问卷评估从 VKA 转换到达比加群酯（队列 A）或新诊断为 AF 接受达比加群酯或 VKA（队列 B）的患者的治疗满意度和便利性。预先指定的探索性结果：队列 A（n=4103）和队列 B（n=5369）中，按国家和年龄（<65 岁、65-<75 岁、≥75 岁）的 PACT-Q2 评分变化；队列 B 中，按国家和年龄的基线时 PACT-Q1 反应变化。
来自 12 个国家（欧洲/以色列）的患者被纳入队列 A（n=4103）或 B（n=5369）。在队列 A 中，罗马尼亚（便利性：29.6 [23.6]）和匈牙利（满意度：26.0 [21.4]）的 PACT-Q2 评分升高幅度最大（均 P<0.001）。在队列 B 中，达比加群酯和 VKA 之间 PACT-Q2 评分升高幅度最大的是罗马尼亚（第 3 次就诊：29.0 [1.3]；24.5 [0.9]，P<0.001）。按年龄（均 P<0.001）平均 PACT-Q2 评分升高相似。PACT-Q1 反应表明罗马尼亚的治疗成功率期望最低，爱沙尼亚、拉脱维亚和罗马尼亚对支付的担忧最大，但各年龄组相似。
治疗满意度和便利性倾向于达比加群酯优于 VKA。欧洲各地存在治疗期望的区域差异。
试验注册号：ClinicalTrials.gov NCT02684981。试验注册日期：2016 年 2 月 18 日。
