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Halting anticoagulation raised risk for stroke in AF patients
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Patients with moderate- to high-risk atrial fibrillation are likely at a higher risk for stroke or systemic embolism when temporarily or permanently discontinuing anticoagulation, according to a sub-analysis of the ROCKET AF trial.
Researchers evaluated patients who were enrolled in the ROCKET AF trial for stroke, non-central nervous system embolism and other thrombotic events, including MI and death up to 30 days after discontinuation of the study drug. All of the patients evaluated had temporary discontinuation, early permanent study drug discontinuation or completed the trial transition to open-label therapy.
The researchers found similar rates of stroke and non-central nervous system embolism between the rivaroxaban (Xarelto, Janssen Pharmaceuticals) and warfarin groups after temporary discontinuation (6.2 vs. 5.05 per 100 patient-years; HR=1.28; 95% CI, 0.49-3.31) and after early permanent discontinuation (25.6 vs. 23.28 per 100 patient-years; HR=1.10; 95% CI, 0.71-1.72).
Study results showed, after the masked end of study transition of open-label warfarin, the rate of stroke was significantly higher in rivaroxaban vs. warfarin-treated patients (6.42 vs. 1.73 per 100 patient-years; HR=3.72; 95% CI, 1.51-9.16). This resulted in an increased risk for all patients discontinuing therapy or transitioning to open-label warfarin (HR=1.5; 95% CI, 1.05-2.15) and showed the importance of anticoagulation coverage during the transition to a therapeutic INR. However, after all discontinuations and end of study transition, stroke, embolism, MI and death were similar (HR=1.08; 95% CI, 0.89-1.32).
“The risk of thrombotic events is significant when anticoagulation is stopped in patients with moderate to high-risk AF,” Jonathan Piccini, MD, of the Duke University Medical Center, said in his presentation on the American Heart Association’s Emerging Science Series webinar. “Accordingly, careful consideration should be given to anticoagulation coverage in these patients.”
For more information:
- Patel M. Abstract #141. Presented at: the American Heart Association Emerging Science Series webinar; April 25, 2012.
Disclosure: Dr. Piccini received a research grant from Johnson & Johnson and Boston Scientific and is a consultant/advisory board member for Forest Laboratories, Johnson & Johnson, Medtronic and Sanofi-Aventis.
Perspective
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Neal Kleiman, MD, FACC, FSCAI
Patel and colleagues conducted a nice study. If patients are treated with a shorter-acting drug, such as rivaroxaban, and treatment is stopped, then they have a few days before the warfarin activity becomes therapeutic. It may just be that the several day time period is enough to permit clots to form in the atria. Patel and colleagues hit the nail right on the head. If a patient is going through a transition, the physician needs to make sure the patient spends as brief a period of time as possible in the subtherapeutic range.
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