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Pairing oral anticoagulant, NSAID requires ‘careful’ assessment of risks, benefits

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LONDON — In the RE-LY trial, the use of nonsteroidal anti-inflammatory drugs was linked to increased bleeding risk and a higher rate of hospitalizations, according to research presented at the European Society of Cardiology Congress.

Patients with atrial fibrillation who used NSAIDs reaped similar relative benefits as nonusers with dabigatran (Pradaxa, Boehringer Ingelheim) vs. warfarin, but researchers caution that combining NSAIDs with any oral anticoagulant necessitates careful consideration of risks and benefits.

Michael D. Ezekowitz, MBChB, DPhil, of Thomas Jefferson University in Philadelphia, and colleagues compared clinical outcomes in patients from the RE-LY trial (n = 18,113) who used NSAIDs at least once (n = 2,279; 12.6%) and those who never used NSAIDs, assessing the effects of dabigatran (150 mg and 110 mg) and warfarin. The investigators used Cox regression models to determine interaction for treatment-by-subgroup effect.

More women than men used NSAIDs (39% vs. 36.1%; P = .0074). Further, NSAID users were more likely to have valvular heart disease (24.3% vs. 21.4%; P = .0024) but slightly less likely to have congestive HF (30.1% vs. 32.3%; P = .037). Age, CHADS₂ scores, CAD frequency, diabetes and hypertension were all comparable between patient groups.

Although mortality (P = .2109), intracranial hemorrhage (P = .3631) and MI (P = .6674) rates were similar between groups, NSAID users demonstrated greater risk for major bleeding (P < .0001), particularly major gastrointestinal bleeding (P = .0004), as well as life-threatening bleeding (P = .0103) and any bleeding (P < .0001). Additionally, NSAID users were hospitalized more frequently (P < .0001).

The relative benefits of dabigatran vs. warfarin were similar regardless of NSAID use for clinical outcomes of stroke and systemic embolism at 150 mg (HR = 0.56; 95% CI, 0.31-1.01 with NSAID vs. HR = 0.67; 95% CI, 0.53-0.84 without) and 110 mg (HR = 1.03; 95% CI, 0.63-1.69 with NSAID vs. HR = 0.87; 95% CI, 0.7-1.08 without).

Similar results were seen for major bleed with dabigatran 150 mg (HR = 0.88; 95% CI, 0.63-1.22 with NSAID vs. HR = 0.96; 95% CI, 0.83-1.11 without) and 110 mg (HR = 0.82; 95% CI, 0.59-1.14 with NSAID vs. HR = 0.8; 95% CI, 0.68-0.94 without).

The interaction for treatment-by-subgroup effect was not significant for ischemic stroke, life-threatening or intracranial bleeds. Further, the lowest absolute numbers for any bleeds were observed with DE 110 mg.

Reference:

Ezekowitz MD, et al. Abstract 4980. Presented at: European Society of Cardiology Congress; Aug. 29-Sept. 2, 2015; London.

Disclosure: Cardiology Today could not confirm any relevant financial disclosures at the time of publication.