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Published on: February 28, 2012
Diabetes and Obesity and Treatment Effect of Early Rhythm Control vs Usual Care in Patients With Atrial Fibrillation:
Andreas Metzner1,2, Stephan Willems3, Katrin Borof1
1Department of Cardiology, University Heart and Vascular Center, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Insights
Early rhythm control therapy is effective and safe for patients with atrial fibrillation, regardless of body mass index (BMI) or diabetes status. This approach reduces cardiovascular events in diverse patient populations.
Area of Science:
- Cardiology
- Clinical Trials
- Atrial Fibrillation Management
Background:
- The EAST-AFNET 4 trial established early rhythm control therapy's benefit in reducing cardiovascular events for early atrial fibrillation (AF) patients.
- The impact of body mass index (BMI) and diabetes on these outcomes was previously unknown.
Purpose of the Study:
- To assess the effects of BMI and diabetes on the outcomes of early rhythm control therapy in patients with early AF.
- To determine if early rhythm control therapy's effectiveness and safety are modified by obesity or diabetes.
Main Methods:
- A secondary analysis of the EAST-AFNET 4 randomized clinical trial (NCT01288352) was conducted.
- Patients were analyzed based on randomization to early rhythm control or usual care, with subgroups for BMI (obesity vs. non-obesity) and diabetes status.
- The primary composite outcome included cardiovascular death, stroke, heart failure hospitalization, or acute coronary syndrome.
Main Results:
- Obesity (BMI ≥30) did not alter the effectiveness of early rhythm control therapy (P for interaction = 0.22).
- Diabetes did not interact with the treatment effect of early rhythm control therapy (P for interaction = 0.93), with similar safety outcomes observed.
- Patients with obesity were younger and had more nonparoxysmal AF than those without obesity.
Conclusions:
- Early rhythm control therapy is effective and safe in patients with early atrial fibrillation, irrespective of their BMI or diabetes status.
- These findings support the use of early rhythm control therapy in a broad range of AF patients, including those with common comorbidities like obesity and diabetes.
Importance:
The EAST-AFNET 4 randomized clinical trial demonstrated that early rhythm control therapy added to anticoagulation therapy and therapy of concomitant conditions reduces the primary composite outcome of cardiovascular death, stroke, hospitalization because of heart failure, or acute coronary syndrome compared to usual care. However, the impact of body mass index (BMI, calculated as weight in kilograms divided by height in meters squared) and diabetes on outcomes in EAST-AFNET 4 is not known.
Objective:
To assess the effects of BMI and diabetes on outcomes in EAST-AFNET 4.
Design, Setting, And Participants:
EAST-AFNET 4 is an international, investigator-initiated, parallel-group, open, blinded outcome assessment randomized clinical trial conducted in 11 European countries. Patients who had early atrial fibrillation (AF, diagnosed ≤1 year before enrollment) and cardiovascular conditions were eligible for inclusion. The current analysis is a prespecified secondary analysis of the EAST-AFNET 4 trial performed in the final, locked dataset assigning patients to therapy group on the basis of randomization (intention-to-treat population). EAST-AFNET 4 was conducted from June 2010 to May 2020, and this secondary analysis of the final locked data base was performed in 2024.
Intervention:
EAST-AFNET 4 randomly assigned patients to either early rhythm control or usual care.
Main Outcomes And Measure:
The primary outcome of this analysis and the EAST-AFNET 4 trial is a composite of cardiovascular death, stroke, hospitalization because of heart failure, or acute coronary syndrome.
Results:
There were 1086 patients with obesity (BMI ≥30; mean [SD] BMI 34.5 [4.2]) and 1690 patients without obesity (BMI <30; mean [SD] BMI 25.9 [2.6]). Overall mean patient age was 70 years, and 1293 patients (46.6%) were female. Patients with obesity were younger (mean [SD] age, 68 [8.6] vs 72 [7.7] years) and had more frequently nonparoxysmal AF patterns (31% vs 24%) than patients without obesity. There was no difference in mean (SD) CHA2DS2-VASc score (3.4 [1.3] vs 3.3 [1.3]). Obesity did not change the effect of early rhythm control therapy on the first primary outcome (hazard rate point estimates: BMI <30, 0.84; BMI ≥30, 0.69; P for interaction = .22). Patients with diabetes were younger (mean [SD] age, 69 [8.6] vs 71 [8.2] years; P = .001) and had a higher mean CHA2DS2-VASC score (4.06 vs 3.11; P < .001). Diabetes did not interact with the treatment effect of early rhythm control (diabetes: hazard ratio [HR], 0.77; 95% CI, 0.57-1.05 vs no diabetes: HR, 0.78; 95% CI, 0.64-0.96; P for interaction = .93). There was no difference in safety outcomes between patients with and without diabetes (64 of 351 patients [18.2%] vs 167 of 1039 patients [16.1%]; P for interaction = .99).
Conclusions And Relevance:
This secondary analysis of the EAST-AFNET 4 randomized clinical trial shows that early rhythm control therapy retains its effectiveness and safety in patients with and without diabetes and patients with and without obesity.
Trial Registration:
ClinicalTrials.gov Identifier: NCT01288352.
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