Temporary interruption or permanent discontinuation of rivaroxaban or warfarin results in similar 30-day stroke and systemic embolism risk in patients with atrial fibrillation (AFib), according to a new post hoc analysis of the ROCKET-AF trial. The analysis, published on Feb. 4 in the Journal of the American College of Cardiology, found a similar number of strokes and thromboembolic events among patients treated with either rivaroxaban or warfarin who discontinued treatment temporarily or permanently. However, among patients transitioning to open-label therapy, there were more events with rivaroxaban (22 vs. six, p<0.0044). The difference was possibly attributable to suboptimal anticoagulation during the transition period, and investigators emphasized that maintaining adequate anticoagulant coverage is essential when transitioning patients from one drug to another.

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ROCKET-AF was a randomized, double-blind comparison of rivaroxaban and warfarin in 14,624 patients with AFib and a high risk of stroke. The study found that rivaroxaban was non-inferior to warfarin in stroke prevention. To determine the risk of stroke after study drug discontinuation, Manesh R. Patel, MD, FACC, Duke Clinical Research Institute, Durham, NC, and colleagues looked at three sets of patients from the trial: those who temporarily discontinued therapy for more than three days, usually because of complications or surgery; patients who discontinued the study drugs early and were evaluated for clinical events; and patients who completed the study and underwent blinded transition to open-label therapy.

After temporary interruption, there were a similar number of strokes and non-central nervous system thromboembolic events with rivaroxaban and warfarin (nine vs. eight, p=0.62).  Following early discontinuation, the number of events was also similar (42 vs. 36, p=0.66). However, among patients transitioning to open-label therapy, there were more events with rivaroxaban (22 vs. six, p<0.0044). The difference was possibly attributable to suboptimal anticoagulation during the transition period, and investigators emphasized that maintaining adequate anticoagulant coverage is essential when transitioning patients from one drug to another.

In an accompanying editorial, Matthew R. Reynolds, MD, MSc, FACC, Harvard Clinical Research Institute, Boston, notes that the "implication from these data is that the most likely explanation for the observed risk in the post-study transition period is not that rivaroxaban has some property resulting in a rebound effect, but rather that the high-risk patients enrolled in the ROCKET AF trial … had a substantial difference in anticoagulation coverage during this period, and the event rates merely reflect the unmasking of their underlying risk. What is clearest from this important subanalysis of the ROCKET-AF trial is that bad things will happen to high-risk AFib patients if they are left untreated with effective anticoagulant therapy for sustained periods."

Meanwhile, Richard Kovacs, MD, FACC, chair of the ACC's Best Practices and Quality Improvement Committee, notes that the study results highlight the importance of continuing to educate providers about guideline-recommended care for the management of AFib. The College has expanded the PINNACLE Registry^® to include a new platform focused on AFib and as of March 2013 is launching the Anticoagulation Initiative, a comprehensive quality effort  to help facilitate a greater understanding of the new treatments and practice patterns, particularly given an increasing number of new anticoagulant treatment options entering the marketplace, he said. “Our care teams need to have the latest information, but also know where there are gaps in our knowledge about these new therapies,” noted Kovacs.

The new initiative will serve as an umbrella for the growing number of ACC tools targeted for use by cardiovascular professionals and their patients, including the AFib Toolkit, developed by experts to help CV professionals treat AFib patients based on the most recent evidence and best practices; A New Era 2.0, a performance improvement activity to help providers improve AFib care; and coming in late March 2013 a new point-of-care mobile app designed to assess stroke and bleeding risk in AFib patients and help with anticoagulation therapy recommendations. In addition, launching in April, an anticoagulation management online clinical community will feature relevant news articles, case challenges, hot topics, videos, and interactive discussions.

Keywords: Quality Improvement, Registries, Stroke, Morpholines, Thiophenes, Boston, Warfarin, Embolism, United States

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