Patient perceptions of anticoagulant treatment with dabigatran or a vitamin K antagonist for stroke prevention in atrial fibrillation according to region and age: an exploratory analysis from the RE-SONANCE study

Q: What is the clinical evidence from this study?

Study design: Observational. Population: Atrial fibrillation (n=9472). Intervention: Dabigatran vs. Vitamin K antagonist. Primary outcome: PACT-Q2 treatment convenience score at visit 3 (Cohort B) (MD 23.34, p=<0.001).

Dragoş Vinereanu; Д. А. Напалков; Jutta Bergler‐Klein; Béla Benczúr; Martin Ciernik; Nina Gotcheva; Alexey Medvedchikov; Pentti Põder; Dragan Šimić; Andris Skride; Wenbo Tang; Maria Trusz‐Gluza; Jiří Veselý

doi:10.1007/s11239-021-02450-2

April 30, 2021Journal of Thrombosis and ThrombolysisOpen Access

Patient perceptions of anticoagulant treatment with dabigatran or a vitamin K antagonist for stroke prevention in atrial fibrillation according to region and age: an exploratory analysis from the RE-SONANCE study

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Key result

Dabigatran was associated with significantly higher treatment convenience (mean difference 23.34) and satisfaction compared to vitamin K antagonists in newly initiated patients with atrial fibrillation.

Why the study?

Although dabigatran is an effective alternative to VKAs for stroke prevention in AF, patient preference data are limited, prompting this assessment of the impact of country and age on patients' perceptions.

Does dabigatran improve patient-reported treatment convenience and satisfaction compared to vitamin K antagonists in patients with atrial fibrillation?

Key Points

To evaluate the influence of country and age on treatment satisfaction and convenience in patients with atrial fibrillation receiving dabigatran or vitamin K antagonists.
Interventional trial (NCT02684981) assessing patients across 12 countries in Europe and Israel switching from vitamin K antagonists to dabigatran (Cohort A, n = 4,103) or newly diagnosed and prescribed dabigatran or vitamin K antagonists (Cohort B, n = 5,369).
Evaluated patient-reported convenience and satisfaction across age groups (<65, 65 to <75, ≥75 years) and countries using the PACT-Q questionnaire.
In Cohort A, mean (SD) PACT-Q2 score increases were highest in Romania for convenience (29.6 [23.6]) and Hungary for satisfaction (26.0 [21.4]) (p < 0.001).
In Cohort B, dabigatran produced higher mean (SE) PACT-Q2 score increases over vitamin K antagonists, peaking in Romania at visit 3 (29.0 [1.3] vs 24.5 [0.9], p < 0.001).
Mean PACT-Q2 score gains were similar across all age brackets (p < 0.001), while baseline treatment expectations and medication cost concerns varied significantly by country.

Study Design

Type

Observational (n=9,472)

Multicenter

Yes

Structured PICO

Does dabigatran improve patient-reported treatment convenience and satisfaction compared to vitamin K antagonists in patients with atrial fibrillation?

P

Population

9,472 patients with non-valvular atrial fibrillation from 12 countries, either switching from a VKA to dabigatran or newly initiated on dabigatran or a VKA, observed over approximately 6 months.

E

Exposure

Dabigatran (110 mg or 150 mg twice daily)

C

Comparator

Vitamin K antagonists (VKAs)

O

Outcome

Variation in PACT-Q2 scores (treatment convenience and satisfaction) by country and age, and variation in PACT-Q1 responses at baseline by country and agepatient reported

Main Result

Mean Difference: 23.34

p-value: p=<0.001

Dabigatran is associated with higher patient-reported treatment convenience and satisfaction compared to vitamin K antagonists in patients with atrial fibrillation, though regional differences in treatment expectations exist.

Limitations

Observational study design
Low sample sizes in some countries
Residual confounding due to limited comorbidities in propensity score matching
Potential channeling bias
Patients may have been unwilling to express true opinions or had difficulty understanding questions
Subconscious preference for new therapy in switchers
Low sample sizes in some countries making results statistically inconclusive
Propensity score matching considered a limited number of comorbidities, potentially causing residual confounding
Potential bias from reimbursement status
Subjective nature of PACT-Q and potential subconscious preference for new therapy in switchers

Implication

Dabigatran was associated with greater AF patient satisfaction; hypothesis-generating for adherence, requiring randomized confirmation before practice change.

Abstract

BACKGROUND: 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. METHODS: 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). RESULTS: 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. CONCLUSIONS: Treatment satisfaction and convenience tended to favor dabigatran over VKAs. Regional differences in treatment expectations exist across Europe. TRIAL AND CLINICAL REGISTRY: Trial registration number: ClinicalTrials.gov NCT02684981. Trial registration date: February 18, 2016.

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Published by Journal of Thrombosis and Thrombolysis · CC BY

Cite This Study

Vinereanu et al. (2021) conducted an observational in Atrial fibrillation (n=9,472). Dabigatran vs. Vitamin K antagonist was evaluated on PACT-Q2 treatment convenience score at visit 3 (Cohort B) (MD 23.34, p=<0.001). Dabigatran was associated with significantly higher treatment convenience (mean difference 23.34) and satisfaction compared to vitamin K antagonists in newly initiated patients with atrial fibrillation.

synapsesocial.com/papers/6a774cd998f24dbf64bd7b6e https://doi.org/10.1007/s11239-021-02450-2

Topics

Atrial fibrillation

Anticoagulation in AF

Persistent AF management

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Patient perceptions of anticoagulant treatment with dabigatran or a vitamin K antagonist for stroke prevention in atrial fibrillation according to region and age: an exploratory analysis from the RE-SONANCE study

Key Points

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Figures from the paper

Cite This Study

Topics

Patient perceptions of anticoagulant treatment with dabigatran or a vitamin K antagonist for stroke prevention in atrial fibrillation according to region and age: an exploratory analysis from the RE-SONANCE study

Key Points

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Figures from the paper

Cite This Study

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