June 14, 2018
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Rivaroxaban reduces stroke, systemic embolism in frail patients vs. warfarin

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Among patients with nonvalvular atrial fibrillation and frailty, rivaroxaban was associated with reduced risk for stroke and systemic embolism compared with warfarin, according to the results of a cohort study.

In this population, rivaroxaban (Xarelto, Janssen/Bayer) was associated with similar bleeding risk compared with warfarin, whereas dabigatran (Pradaxa, Boehringer Ingelheim) and apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) were associated with similar stroke/systemic embolism risk and similar bleeding risk vs. warfarin.

According to the study background, frailty is a predictor of poor outcomes and decreased adherence to anticoagulation medications in patients with nonvalvular AF.

Brandon K. Martinez, PharmD, from the department of pharmacy practice, University of Connecticut School of Pharmacy, and colleagues performed a retrospective analysis of the U.S. Truven MarketScan database from November 2011 to December 2016. All patients had nonvalvular AF, were prescribed an oral anticoagulant sometime during the study period and were frail, as defined by a score of at least 0.2 on the Johns Hopkins Claims-based Frailty Indicator.

After propensity matching, the researchers compared 1,392 patients assigned apixaban (median age, 86 years; 64% men) with 1,392 patients assigned warfarin (median age, 86 years; 63% men), 1,350 patients assigned dabigatran (median age, 85 years; 65% men) with 1,350 patients assigned warfarin (median age, 86 years; 63% men) and 2,635 assigned taking rivaroxaban (median age, 85 years; 65% men) with 2,635 patients assigned warfarin (median age, 86 years; 64% men).

Outcomes of interest were stroke or systemic embolism and major bleeding. Follow-up was for 2 years or until death or insurance disenrollment.

At 2 years, compared with warfarin, apixaban was associated with similar risk for stroke or systemic embolism (HR = 0.78; 95% CI, 0.46-1.35) and major bleeding (HR = 0.72; 95% CI, 0.49-1.06), and the same was true for dabigatran (HR for stroke/systemic embolism = 0.94; 95% CI, 0.6-1.45; HR for major bleeding = 0.87; 95% CI, 0.63-1.19), according to the researchers.

Martinez and colleagues wrote, however, that compared with warfarin, rivaroxaban was associated with less risk for stroke/systemic embolism at 2 years (HR = 0.68; 95% CI, 0.49-0.95) and similar risk for major bleeding (HR = 1.07; 95% CI, 0.81-1.32).

“There is not widespread consensus on the best way to manage frail patients with [nonvalvular AF] in clinical practice, which is why some patients are not treated at all and remain at high risk of having a stroke,” Craig Coleman, PharmD, professor of pharmacy practice, at the University of Connecticut, said in a press release. “These results show long-term rivaroxaban use reduced stroke and systemic embolism in a vulnerable patient group, without increasing the risk of major bleeding. They also give physicians important insights into a well-tolerated, effective approach to treat their frail patients with [nonvalvular] AF.” – by Erik Swain

Disclosures: The study was funded by Bayer. Coleman reports he receives grant funding and consultancy honoraria from Bayer, Boehringer Ingelheim and Janssen. The other authors report no relevant financial disclosures.