Discussion
There are limited data on patients’ perceptions of long-term anticoagulation therapy in NVAF. In this observational study, which was a representative population of 9472 patients with NVAF in 11 European countries and Israel, treatment satisfaction and convenience in patients who switched from a VKA to dabigatran increased significantly from baseline over time. For those patients newly diagnosed with NVAF, treatment satisfaction and convenience were significantly higher for dabigatran compared with VKA therapy. Few, serious and severe ADRs were reported by similar numbers of patients in cohorts A and B, and in dabigatran-treated and VKA-treated cohort B patients. While numbers were low, patients receiving dabigatran versus a VKA reported more ADRs that led to treatment discontinuation, with GI events driving approximately half the discontinuations. However, no difference was observed in severe bleeding events in patients receiving dabigatran compared with VKA. Overall, the safety profile of dabigatran in the RE-SONANCE study was consistent with previous clinical dabigatran and VKA data in the AF setting.15–17
Few studies have assessed patients’ perspectives of anticoagulant therapy in AF. In contrast to our findings, a substudy of the RE-LY trial observed stable health-related quality of life (measured using EQ-5D) scores over 12 months in all treated patients without outcome events, with comparable scores in the dabigatran and warfarin groups.13 This was unexpected, given the known complexities of warfarin treatment. In the PREFER in AF registry, within the first year of NOACs being available in Western Europe, patient-related factors influencing the switch from a VKA to a NOAC included complaints about bruising/bleeding, treatment dissatisfaction, mobility problems and anxiety/depression.11 Patients switching from a VKA to a NOAC had less hypertension, heart valve dysfunction and CHA2DS2-VASc scores,11 possibly reflecting caution on the part of physicians trying a new treatment option. In a small study using the validated Anti-Clot Treatment Scale, warfarin treatment was less favoured than non-warfarin treatments, including more limitations and greater feelings of burden.18
It is recognised that there is a need for improvement in educational strategies around OACs6 9; in order to anticoagulate patients successfully with AF at high risk for stroke and prevent further ischaemic stroke, physicians and patients need to understand fully the rationale behind OAC treatment. Physicians must be provided with evidence regarding which treatment option best suits their patients’ clinical presentation. For example, NOACs should be the first option physicians consider for preventing stroke in patients with AF (including aortic regurgitation or stenosis), although VKAs are indicated for preventing stroke in those patients with AF and a mechanical valve or moderate-to-severe mitral valve stenosis.3 For patients, providing educational strategies can significantly improve their OAC treatment knowledge compared with usual care.8 By regularly evaluating knowledge gaps (eg, international normalised ratio target ranges, which concomitant medications should be avoided and recognising medical complications such as stroke or bleeding), the most appropriate educational programmes can be provided. Such strategies have been shown to increase patients’ use of OACs significantly5 and the number of patients achieving time within therapeutic range.7 Furthermore, educational strategies can significantly reduce the risk of recurrent stroke compared with usual care.5
Other studies have observed higher treatment satisfaction among NOAC versus warfarin users.19–22 It is reasonable to extrapolate that improving anticoagulation treatment satisfaction may increase patients’ adherence to treatment and improve outcomes. Open discussions with patients can help to identify potential barriers to therapy; if patients are involved in their treatment decisions, they may be more likely to take responsibility for their treatment, thereby improving adherence.23 However, despite improved treatment satisfaction with NOACs versus VKAs, recent observational data noted comparable adherence.21 22 The paucity of data regarding treatment satisfaction and outcomes means that further studies are needed to assess the impact of improved patient perceptions.
A strength of this study is that it used the PACT-Q, which is a validated and specific treatment satisfaction instrument for thromboembolic patients with anticoagulant treatment, and is available in numerous languages.10 14 While there are inherent limitations associated with any observational study, the large patient population recruited in this non-interventional study is representative of patients receiving an OAC for stroke prevention in NVAF. Study limitations include the role of reimbursement, which could affect overall treatment adherence and satisfaction, and is highly dependent on a patient’s financial and socioeconomic status. Patient selection bias may also be the reason why only one-third of patients were over 75 years; elderly patients, who could benefit from switching from VKA to dabigatran, may not have been included due to the perception that they might not be able to understand the questionnaires fully. Treatment bias may also have been introduced, as patients might subconsciously consider a new therapy as better. Additionally, due to the real-world nature of the study, patient follow-up was based on routine care instead of a stringent visit schedule, as used in clinical trials. Therefore, there was considerable variation between patient visits from baseline during the study follow-up. To better accommodate this and ensure that most of the collected data could be included in the analysis, more relaxed time windows were defined for V2 and V3. The balance between time window thresholds and potential misclassification was assessed, and it was decided to apply ‘consecutive’ thresholds between V2 and V3 to capture as much of the data as possible, and since the number of patients with extreme visit times was low. Finally, patients may not always be willing to write their honest opinions on a questionnaire or tell the doctor what they really think about the therapy. Although not aimed at assessing patient outcome, the safety profile of the OACs were comparable.