Arrhythmias & electrophysiologyMeta-analysis
Efficacy and Safety of Non–Vitamin-K Antagonist Oral Anticoagulants Versus Warfarin Across the Spectrum of Body Mass Index and Body Weight: An Individual Patient Data Meta-Analysis of 4 Randomized Clinical Trials of Patients With Atrial Fibrillation
- Individual patient data meta-analysis of randomised trials
- COMBINE AF
Authors' conclusion
The treatment effect of NOACs versus warfarin in atrial fibrillation is generally consistent for stroke/SEE across the spectrum of BMI and BW, whereas the reduction in major bleeding is attenuated in those with higher BMI or BW.
Study context
- Population
- Patients with AF in the 4 pivotal NOAC vs warfarin RCTs; primary analyses restricted to body mass index (BMI) ≥18.5 kg/m²
- Participants
- 58,464 patients · 4 RCTs
- Comparison
- NOAC vs warfarin across BMI and body weight
Pooled result
As reported in the abstract
Stroke/SEE and major bleeding across BMI
NOAC vs WarfarinAdjusted hazard ratio (95% CI)P value
stroke/SEE; Ptrend across HRs 0.48
0.80(0.73–0.88)
P < 0.001major bleeding; Ptrend across BMI 0.003
0.88(0.82–0.94)
P < 0.001- Stroke/SEE effect generally consistent across BMI
- Ptrend 0.48
- Major bleeding benefit attenuated at higher BMI
- Ptrend 0.003
Further pooled results
| Outcome | HRadj (95% CI) | P value | |
|---|---|---|---|
| Net clinical outcome (stroke/SEE, major bleeding or death) · attenuated at higher BMI, Ptrend 0.001 | 0.91 (0.87–0.95) | P < 0.001 | |
| Death · attenuated at higher BMI, Ptrend 0.08 | 0.91 (0.86–0.97) | P = 0.003 | |
| 0.512Adjusted hazard ratio (log scale) |
Ischemic stroke/SEE, intracranial hemorrhage
- Treatment effects consistent across BMI
All outcomes across body weight (BW)
- Findings qualitatively similar across BW
Safety
| Outcome | HRadj (95% CI) | P value | |
|---|---|---|---|
| Major bleeding · benefit attenuated at higher BMI, Ptrend 0.003 | 0.88 (0.82–0.94) | P < 0.001 | |
| 0.512Adjusted hazard ratio (log scale) |
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Efficacy and Safety of Non–Vitamin-K Antagonist Oral Anticoagulants Versus Warfarin Across the Spectrum of Body Mass Index and Body Weight: An Individual Patient Data Meta-Analysis of 4 Randomized Clinical Trials of Patients With Atrial Fibrillation. Circulation. Published 24 January 2024. doi:10.1161/circulationaha.123.066279
Summarised from the published abstract; every number is checked against it