Objective 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.
Methods 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.
Results 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).
Conclusions 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.
- atrial fibrillation
- quality of care and outcomes
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Contributors AS is accountable for work in data collection. MT-G led the coordination of the study at her institution. All authors contributed to the drafting, interpretation and reviewing of the manuscript content and provided final approval of the manuscript.
Funding This study was funded by Boehringer Ingelheim International GmbH.
Competing interests DV reports grants and personal fees from Boehringer Ingelheim, during the conduct of the study; grants and personal fees from Bayer, Bristol-Myers Squibb, Daiichi Sankyo, Pfizer and J&J outside the submitted work. DN reports research and speaker fees for Boehringer Ingelheim and speaker fees for Bayer, Pfizer and Takeda. JB-K, NG, DS, AS, TV and MV report no conflicts of interest. BB has received speaker/consultancy fees from Bayer, Boehringer Ingelheim, Berlin-Chemie/Menarini, KRKA, Novartis, Pfizer, Sandoz and Sanofi. MC, AM and WT are employees of Boehringer Ingelheim. PP has received educational grants from Boehringer Ingelheim. MT-G reports personal fees from Boehringer Ingelheim during the conduct of this study; personal fees and non-financial support from Boehringer Ingelheim outside the submitted work and personal fees from Bayer. JV reports personal fees and non-financial support from Bayer, Boehringer Ingelheim, MSD, Pfizer and PRO.MED.CZ outside the submitted work.
Patient consent for publication Not required.
Ethics approval This study was carried out in accordance with the Declaration of Helsinki, International Conference of Harmonisation Tripartite Guideline, Good Clinical Practice, Guidelines for Good Epidemiological Practice and Good Pharmacoepidemiology Practice. The study was initiated in centres once approved by the respective Institutional Review Board/Independent Ethics Committee and competent authority, according to national and international regulations.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon reasonable request. To ensure independent interpretation of clinical study results, Boehringer Ingelheim grants all external authors access to all relevant material, including participant-level clinical study data, and relevant material as needed by them to fulfil their role and obligations as authors under the ICMJE criteria. Furthermore, clinical study documents (eg, study report, study protocol, statistical analysis plan) and participant clinical study data are available to be shared after publication of the primary manuscript in a peer-reviewed journal and if regulatory activities are complete and other criteria met per the Boehringer Ingelheim Policy on Transparency and Publication of Clinical Study Data: https://trials.boehringer-ingelheim.com/transparency_policy.html. Prior to providing access, documents will be examined and, if necessary, redacted and the data will be de-identified to protect the personal data of study participants and personnel and to respect the boundaries of the informed consent of the study participants. Clinical Study Reports and Related Clinical Documents can be requested via this link: https://trials.boehringer-ingelheim.com/trial_results/clinical_submission_documents.html. All such requests will be governed by a Document Sharing Agreement. Bona fide, qualified scientific and medical researchers may request access to de-identified, analysable participant clinical study data with corresponding documentation describing the structure and content of the data sets. On approval, and governed by a Data Sharing Agreement, data are shared in a secured data-access system for a limited period of 1 year, which may be extended upon request. Researchers should use https://clinicalstudydatarequest.com to request access to study data.
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