{"id":"b3fe308da456","type":"article","url":"https://hartvaat.nl/2024/03/19/combine-af-noac-s-versus-warfarine-over-bmi-spectrum-bij-af/","title":"COMBINE AF: NOAC's versus warfarine over BMI-spectrum bij AF","title_en":"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.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["apotheker","cardioloog","internist"],"tags":["obesitas"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.123.066279","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.123.066279","authors":["Siddharth M Patel","Eugene Braunwald","Jan Steffel","Giuseppe Boriani","Michael G Palazzolo","Elliott M Antman","Erin A Bohula","Anthony P Carnicelli","Stuart J Connolly","John W Eikelboom","Baris Gencer","Christopher B Granger","David A Morrow","Manesh R Patel","Lars Wallentin","Christian T Ruff","Robert P Giugliano"],"significance":7,"published":"2024-03-19","source_date":"2024-03-19","image":"","kennis":["https://hartvaat.nl/kennis/antistolling/doac-versus-vka-keuze/"],"congress":"","summary_en":"This COMBINE AF patient-level analysis confirmed that NOACs maintain superior efficacy and safety compared with warfarin across the full BMI spectrum in AF, providing reassurance for DOAC use in both normal-weight and obese patients.","created":"2026-07-03T10:30:49Z","updated":"2026-07-03T13:29:52Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"COMBINE AF patiënt-niveau analyse bevestigde dat NOAC's superieur zijn aan warfarine over het hele BMI-spectrum bij AF. Het voordeel was consistent bij normale, overgewichtige en obese patiënten, wat NOAC-gebruik bij alle gewichtsklassen ondersteunt.","abstract_original":"BACKGROUND: The efficacy and safety of non-vitamin-K antagonist oral anticoagulants (NOACs) across the spectrum of body mass index (BMI) and body weight (BW) remain uncertain. METHODS: We analyzed data from COMBINE AF (A Collaboration Between Multiple Institutions to Better Investigate Non-Vitamin K Antagonist Oral Anticoagulant Use in Atrial Fibrillation), which pooled patient-level data from the 4 pivotal randomized trials of NOAC versus warfarin in patients with atrial fibrillation. The primary efficacy and safety outcomes were stroke or systemic embolic events (stroke/SEE) and major bleeding, respectively; secondary outcomes were ischemic stroke/SEE, intracranial hemorrhage, death, and the net clinical outcome (stroke/SEE, major bleeding, or death). Each outcome was examined across BMI and BW. Because few patients had a BMI <18.5 kg/m2 (n=598), the primary analyses were restricted to those with a BMI ≥18.5 kg/m2. RESULTS: Among 58 464 patients, the median BMI was 28.3 (interquartile range, 25.2-32.2) kg/m2, and the median BW was 81.0 (interquartile range, 70.0-94.3) kg. The event probability of stroke/SEE was lower at a higher BMI irrespective of treatment, whereas the probability of major bleeding was lower at a higher BMI with warfarin but relatively unchanged across BMI with NOACs. NOACs reduced stroke/SEE overall (adjusted hazard ratio [HRadj], 0.80 [95% CI, 0.73-0.88]; P<0.001), with a generally consistent effect across BMI (Ptrend across HRs, 0.48). NOACs also reduced major bleeding overall (HRadj, 0.88 [95% CI, 0.82-0.94]; P<0.001), but with attenuation of the benefit at a higher BMI (trend test across BMI [Ptrend], 0.003). The overall treatment effects of NOACs versus warfarin for secondary outcomes were consistent across BMI, with the exception of the net clinical outcome and death. While these outcomes were overall reduced with NOACs (net clinical outcome, HRadj, 0.91 [95% CI, 0.87-0.95]; P<0.001; death, HRadj, 0.91 [95% CI, 0.86-0.97]; P=0.003), these benefits were attenuated at higher BMI (Ptrend, 0.001 and 0.08, respectively). All findings were qualitatively similar when analyzed across BW. CONCLUSIONS: 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. Death and the net clinical outcome are overall reduced with NOACs over warfarin, although there remain uncertainties for these outcomes at a very high BMI and BW."}