Temporarily interrupting anticoagulation therapy in patients with atrial fibrillation (AF) is common and may carry considerable risk for bleeding and strokes, regardless of whether they are treated with rivaroxaban or warfarin, a study published online Feb. 19 in Circulation found.
While anticoagulation therapy is often stopped for a variety of reasons, “there are limited data regarding downstream thrombotic and bleeding outcomes in these populations, and even less is known about TI [temporary interruption] of novel oral anticoagulants (NOACs) in periprocedural settings,” explained the authors, led by Matthew W. Sherwood, MD, of the Duke Clinical Research Institute in Durham, N.C.
Using data from the ROCKET AF study (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation), which found rivaroxaban (Xarelto, Janssen) noninferior to warfarin in preventing stroke and thromboembolic events in certain patients with non-valvular AF, the investigators evaluated the risks associated with TI of both drugs.
They defined TI as stopping a study drug for three or more days for any cause with no switch to an open-label anticoagulant and restarting the drug within 30 days.
TI occurred in one-third of the 14,236 patients who received at least one dose of a study drug. Only 6 percent of the TI participants received bridging therapy. The rates of stroke/systemic embolism were similar in both the rivaroxaban and warfarin groups (0.30 percent and 0.41 percent per 30 days). The risk of major bleeding was also similar between the two groups (0.99 percent in the rivaroxaban group and 0.79 percent in the warfarin group).
Although the investigators acknowledged that among the study’s limitations is the use of retrospective data that could potentially introduce bias, they argued that their findings suggest that clinicians should avoid TI due to the risk of adverse outcomes.
“Further investigation is needed to determine the optimal management strategy in AF patients requiring TI of anticoagulation,” they wrote.
The ROCKET AF trial received funding from Johnson & Johnson and Bayer Healthcare.