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Rivaroxaban likely bests aspirin for preventing certain recurrent strokes

Journal
JAMA Neurology
Reuters Health - 01/11/2021 - In patients with recent embolic strokes of undetermined source (ESUS) and left ventricular (LV) dysfunction, anticoagulation with rivaroxaban was superior to aspirin in reducing recurrent stroke, a post-hoc analysis of a phase 3 trial shows.

"LV dysfunction may be a novel risk factor for stroke that may be treatable with anticoagulation," Dr. Alexander Merkler of Weill Cornell Medical College in New York City told Reuters Health by email. "This work builds upon our preliminary data suggesting that LV dysfunction leads to thrombus formation and subsequent cardiac embolism and stroke."

"Anticoagulation may reduce the risk of stroke in patients with LV dysfunction," he said, "but a dedicated randomized clinical trial is necessary." The team currently is seeking funding for such a trial.

As reported in JAMA Neurology, the post-hoc exploratory analysis included data from 502 participants with LV dysfunction (mean age, 67; 26% women) and 6,605 participants without LV dysfunction (mean age, 67; 38% women) enrolled in the NAVIGATE ESUS trial.

Participants were randomized to receive either 15 mg of rivaroxaban or 100 mg of aspirin once daily.

The analysis examined whether rivaroxaban was superior to aspirin at reducing the risk of (1) the trial's primary outcome of recurrent stroke or systemic embolism and (2) the secondary outcome of recurrent stroke, systemic embolism, myocardial infarction, or cardiovascular mortality during a median follow-up of 10.4 months.

Among participants with LV dysfunction, the annualized primary event rates were 2.4% in those receiving rivaroxaban versus 6.5% in those taking aspirin. Among those without LV dysfunction, rates were similar for those taking rivaroxaban (5.3%) versus aspirin (4.5%).

Participants with LV dysfunction taking rivaroxaban had a significantly lower risk of the primary outcome (HR, 0.36), whereas those without LV dysfunction had similar risks on rivaroxaban or aspirin (HR, 1.16). Results were similar for the secondary outcome.

The authors conclude, as Dr. Merkler indicated, "A dedicated secondary stroke prevention trial in patients with LV dysfunction should be considered to evaluate the efficacy and safety of anticoagulation to prevent cardiac embolism and subsequent stroke."

Dr. Jim Liu, a cardiologist at The Ohio State University Wexner Medical Center in Columbus commented in an email to Reuters Health that the findings "make sense," since "certain patients with LV dysfunction can be at higher risk for forming blood clots in the heart, which can in turn lead to strokes. Using anticoagulants in patients with LV dysfunction who have had a stroke should be something to think about because it would help address a potential cause of the stroke."

"The major concern with any anticoagulation medication would be bleeding complications," he noted. "In patients who have an underlying issue that may predispose them to bleeding or at higher risk for bleeding, adding an anticoagulation medication could be detrimental. Even if there are benefits with stroke reduction, it would be necessary to know if those benefits would be offset by potential bleeding risks."

That said, he added that the study "raises the important question that perhaps stroke patients with LV dysfunction should be treated differently than other stroke patients."

"We'll have to wait and see what future studies hold," Dr. Liu concluded.

SOURCE: https://bit.ly/3BH8Oko JAMA Neurology, online October 25, 2021.

By Marilynn Larkin



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