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Concomitant Oral Anticoagulant and Nonsteroidal Anti-Inflammatory Drug Therapy in Patients With Atrial Fibrillation
Bridgeport Hosp, Yale New Haven Hlth, Dept Internal Med, Bridgeport, CT USA.
Heidelberg Univ, Mannheim, Germany;Boehringer Ingelheim GmbH & Co KG, Ingelheim, Germany.
Boehringer Ingelheim GmbH & Co KG, Ingelheim, Germany.
Populat Hlth Res Inst, Hamilton Hlth Sci, Hamilton, ON, Canada;McMaster Univ, Hamilton, ON, Canada.
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2018 (English)In: Journal of the American College of Cardiology, ISSN 0735-1097, E-ISSN 1558-3597, Vol. 72, no 3, p. 255-267Article in journal (Refereed) Published
Abstract [en]

BACKGROUND Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly used medications that can potentially increase the risk of bleeding and thrombosis. OBJECTIVES This study quantified the effect of NSAIDs in the RE-LY (Randomized Evaluation of Long Term Anticoagulant Therapy) trial. METHODS This was a post hoc analysis of NSAIDs in the RE-LY study, which compared dabigatran etexilate (DE) 150 and 110 mg twice daily (b.i.d.) with warfarin in patients with atrial fibrillation. Treatment-independent, multivariate-adjusted Cox regression analysis assessed clinical outcomes by comparing NSAID use with no NSAID use. Interaction analysis was obtained from treatment-dependent Cox regression modeling. Time-varying covariate analysis for NSAID use was applied to the Cox model. RESULTS Among 18,113 patients in the RE-LY study, 2,279 patients used NSAIDs at least once during the trial. Major bleeding was significantly elevated with NSAID use (hazard ratio [HR]: 1.68; 95% confidence interval [CI]: 1.40 to 2.02; p < 0.0001). NSAID use did not significantly alter the risk of major bleeding for DE 150 or 110 mg b.i.d. relative to warfarin (pinteraction = 0.63 and 0.93, respectively). Gastrointestinal major bleeding was significantly elevated with NSAID use (HR: 1.81; 95% CI: 1.35 to 2.43; p < 0.0001). The rate of stroke or systemic embolism (stroke/SE) with NSAID use was significantly elevated (HR: 1.50; 95% CI: 1.12 to 2.01; p = 0.007). The use of NSAIDs did not significantly alter the relative efficacy on stroke/SE for DE 150 or 110 mg b.i.d. relative to warfarin (p(interaction) = 0.59 and 0.54, respectively). Myocardial infarction rates were similar with NSAID use compared with no NSAID use (HR: 1.22; 95% CI: 0.77 to 1.93; p = 0.40). Patients were more frequently hospitalized if they used an NSAID (HR: 1.64; 95% CI: 1.51 to 1.77; p < 0.0001). CONCLUSIONS The use of NSAIDs was associated with increased risk of major bleeding, stroke/SE, and hospitalization. The safety and efficacy of DE 150 and 110 mg b.i.d. relative to warfarin were not altered. (Randomized Evaluation of Long Term Anticoagulant Therapy [RE-LY]; NCT00262600)

Place, publisher, year, edition, pages
ELSEVIER SCIENCE INC , 2018. Vol. 72, no 3, p. 255-267
Keywords [en]
anticoagulation, atrial fibrillation, bleeding, NSAID, stroke prevention
National Category
Cardiac and Cardiovascular Systems
Identifiers
URN: urn:nbn:se:uu:diva-361266DOI: 10.1016/j.jacc.2018.04.063ISI: 000438182700003PubMedID: 30012318OAI: oai:DiVA.org:uu-361266DiVA, id: diva2:1253772
Funder
AstraZenecaAvailable from: 2018-10-05 Created: 2018-10-05 Last updated: 2019-01-24Bibliographically approved

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Oldgren, JonasWallentin, Lars

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