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Hart RG, Sharma M, Mundl H, et al. Rivaroxaban for Stroke Prevention after Embolic Stroke of Undetermined Source. N Engl J Med. 2018 Jun 7;378(23):2191-2201. doi: 10.1056/NEJMoa1802686. Epub 2018 May 16.
Area Score
Internal Medicine

Background Embolic strokes of undetermined source represent 20% of ischemic strokes and are associated with a high rate of recurrence. Anticoagulant treatment with rivaroxaban, an oral factor Xa inhibitor, may result in a lower risk of recurrent stroke than aspirin. Methods We compared the efficacy and safety of rivaroxaban (at a daily dose of 15 mg) with aspirin (at a daily dose of 100 mg) for the prevention of recurrent stroke in patients with recent ischemic stroke that was presumed to be from cerebral embolism but without arterial stenosis, lacune, or an identified cardioembolic source. The primary efficacy outcome was the first recurrence of ischemic or hemorrhagic stroke or systemic embolism in a time-to-event analysis; the primary safety outcome was the rate of major bleeding. Results A total of 7213 participants were enrolled at 459 sites; 3609 patients were randomly assigned to receive rivaroxaban and 3604 to receive aspirin. Patients had been followed for a median of 11 months when the trial was terminated early because of a lack of benefit with regard to stroke risk and because of bleeding associated with rivaroxaban. The primary efficacy outcome occurred in 172 patients in the rivaroxaban group (annualized rate, 5.1%) and in 160 in the aspirin group (annualized rate, 4.8%) (hazard ratio, 1.07; 95% confidence interval [CI], 0.87 to 1.33; P=0.52). Recurrent ischemic stroke occurred in 158 patients in the rivaroxaban group (annualized rate, 4.7%) and in 156 in the aspirin group (annualized rate, 4.7%). Major bleeding occurred in 62 patients in the rivaroxaban group (annualized rate, 1.8%) and in 23 in the aspirin group (annualized rate, 0.7%) (hazard ratio, 2.72; 95% CI, 1.68 to 4.39; P<0.001). Conclusions Rivaroxaban was not superior to aspirin with regard to the prevention of recurrent stroke after an initial embolic stroke of undetermined source and was associated with a higher risk of bleeding. (Funded by Bayer and Janssen Research and Development; NAVIGATE ESUS number, NCT02313909 .).

Comments from MORE raters

Internal Medicine rater

Flawed but important, I think. One could argue that rivaroxaban was under-dosed (the subgroups of creatinine clearance suggest this might have been a problem), and one could argue that the comparator should have been clopidogrel or DAPT as either is probably superior to aspirin in this setting. The higher bleeding risk is a useful reminder that these drugs don't come free.

Internal Medicine rater

Preventing a second thromboembolic stroke is a common clinical problem. Current treatment is ASA, 81 mg. A reasonable hypothesis is that a novel anticoagulant, rivaroxiban, would be more effective than ASA, BUT it wasn’t. ASA is actually better (with fewer bleeding episodes).

Internal Medicine rater

As an internist, it was useful to see that rivaroxaban was NOT helpful in CVA prevention when no cause had been identified, and that aspirin was safer and just as effective.

Neurology rater

This is a good reminder that full-strength anticoagulant drugs should not be used without a specifically known and identified indication. This is essentially the same result obtained a number of years ago with warfarin vs ASA and heparin vs ASA. We are often asked "should I start this patient on an anticoagulant since she/he had a stroke on ASA?" This study provides another reminder to avoid the urge to "do something" when a patient has a problem, unless that "something" is specifically indicated.

Neurology rater

These results may come as a surprise and will immediately and directly impact medical decision-making for patients with stroke.