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用于房颤卒中预防的达比加群与维生素 K 拮抗剂的患者感知和治疗便利性:长期抗凝治疗经验真实世界评估(RE-LATE)研究。

Patient perception and treatment convenience of dabigatran versus vitamin K antagonist when used for stroke prophylaxis in atrial fibrillation: Real-world Evaluation of Long-term Anticoagulant Treatment Experience (RE-LATE) study.

机构信息

Department of Internal Medicine, Daegu Catholic University College of Medicine, Daegu, Republic of Korea.

Department of Internal Medicine, Catholic University of Korea, Seoul, Republic of Korea

出版信息

Open Heart. 2021 Dec;8(2). doi: 10.1136/openhrt-2021-001745.

Abstract

PURPOSE

Dabigatran is a direct thrombin inhibitor approved for stroke prophylaxis in patients with non-valvular atrial fibrillation (NVAF). Real-world data about patient preference, satisfaction and convenience in patients in Asia are not available. The study aimed to explore the perception of patients with newly diagnosed NVAF regarding dabigatran versus vitamin K antagonists (VKAs), when used for stroke prevention.

PATIENTS AND METHODS

This was a multinational, multicentre, non-interventional study involving 49 sites across 5 countries in South East Asia and South Korea where 934 patients newly diagnosed with NVAF were initiated on either dabigatran (N=591) or VKA (N=343). Data were collected at baseline and over two follow-up visits across 6 months. Treatment satisfaction and patient convenience were evaluated using the Perception on Anticoagulant Treatment Questionnaire-2 (PACT-Q2).

RESULTS

The mean age of the patients was 65.9±10.4 years, and 64.2% were male. Mean CHADS-VASc score was 2.4±1.5, and mean HAS-BLED score was 1.2±0.9. At baseline, patients initiated on dabigatran had higher stroke risk, bleeding risk, creatinine clearance and proportion of patients with concomitant illnesses compared with patients initiated on VKAs. Treatment convenience was perceived to be significantly better with dabigatran versus VKAs at visits 2 and 3 (p=0.0423 and 0.0287, respectively). Treatment satisfaction was significantly better with dabigatran compared with VKAs at visit 3 (p=0.0300).

CONCLUSION

In this study, dabigatran is associated with better patient perception in terms of treatment convenience and satisfaction compared with VKAs when used for stroke prevention in newly diagnosed NVAF patients from South East Asia and South Korea.

TRIAL REGISTRATION NUMBER

NCT02849509.

PLAIN LANGUAGE SUMMARY

Patient satisfaction with dabigatran versus VKAs in South East Asia. Patients with atrial fibrillation are at high risk of stroke and require anticoagulants for stroke prevention. Two such anticoagulants are dabigatran and VKAs. We wanted to compare the extent of satisfaction and treatment convenience among newly diagnosed patients with atrial fibrillation from the South East Asian region when they were given either dabigatran or VKAs. Consenting patients filled out a standardised questionnaire called the PACT-Q2 over three visits after they were started on either dabigatran (591 patients) or VKAs (343 patients). We found that satisfaction and convenience were significantly higher when patients received dabigatran than when they received VKAs.

摘要

目的

达比加群酯是一种直接凝血酶抑制剂,已批准用于预防非瓣膜性心房颤动(NVAF)患者的中风。关于亚洲患者对达比加群酯与维生素 K 拮抗剂(VKA)的偏好、满意度和便利性的真实世界数据尚不清楚。本研究旨在探讨新诊断为 NVAF 的患者对达比加群酯与 VKA 预防中风的看法。

患者和方法

这是一项多中心、多国、非干预性研究,涉及东南亚和韩国的 49 个地点,共有 934 名新诊断为 NVAF 的患者分别接受了达比加群酯(N=591)或 VKA(N=343)治疗。在 6 个月的两次随访中,分别在基线和两次随访时收集数据。使用抗凝治疗感知问卷-2(PACT-Q2)评估治疗满意度和患者便利性。

结果

患者的平均年龄为 65.9±10.4 岁,64.2%为男性。平均 CHADS-VASc 评分为 2.4±1.5,HAS-BLED 评分为 1.2±0.9。基线时,与接受 VKA 治疗的患者相比,接受达比加群酯治疗的患者中风风险、出血风险、肌酐清除率和合并疾病患者比例更高。与 VKA 相比,在第 2 次和第 3 次就诊时,达比加群酯治疗的便利性被认为明显更好(p=0.0423 和 0.0287)。与 VKA 相比,达比加群酯在第 3 次就诊时的治疗满意度明显更高(p=0.0300)。

结论

在这项研究中,与 VKA 相比,达比加群酯在预防东南亚和韩国新诊断为 NVAF 患者的中风方面,与更好的患者感知相关,包括治疗便利性和满意度。

临床试验注册号

NCT02849509。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5a24/8640669/8da364ddebcd/openhrt-2021-001745f01.jpg

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