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A late-breaking trial presentation yesterday, by Professor Mandeep R. Mehra (Harvard Medical School and Brigham and Women’s Hospital, Boston, MA, USA), reported a comprehensive analysis of the COMMANDERHF trial, focussing on stroke and transient ischaemic attacks (TIAs) (LBT34).
In the primary analysis of the trial—which included 5,022 patients with chronic heart failure (after an episode of recent worsening) and underlying coronary artery disease but normal sinus rhythm—there was no difference between placebo and low-dose rivaroxaban in the composite endpoint of death, myocardial infarction or stroke.1 However, the data indicated that one of the composite components, stroke, was significantly reduced with rivaroxaban. The current analysis examined the occurrence, timing, severity and effects of rivaroxaban (2.5 mg twice daily) on stroke or TIA.
“We were also interested in investigating potential predictors to help us identify which patients with normal sinus rhythm were at the greatest risk of stroke and so would benefit from rivaroxaban,” explains Prof. Mehra. In fact, tools used to assess stroke risk in patients with atrial fibrillation (AF), such as CHA2DS2-VASc score, were reasonably good predictors of stroke in these patients with normal sinus rhythm, just as in AF.
The primary efficacy outcome for this post-hoc analysis was time to a first event of all-cause stroke or TIA. Over a median follow-up of 20 months, 150 all-cause stroke or TIA events occurred, with ischaemic stroke accounting for 82% of stroke events. Overall, 31% of first-time strokes were fatal and 16.5% were disabling. Prior stroke was the only independent predictor of stroke as a first event after an episode of worsening heart failure with reduced ejection fraction.
Rivaroxaban significantly reduced all-cause stroke or TIA by 32% compared with placebo (1.29 events vs 1.90 events per 100 patient years; hazard ratio 0.68; 95% confidence intervals 0.49–0.94; p=0.02).
The number-needed-to-treat was 164 patients. The principal safety endpoint, fatal bleeding or bleeding into a critical space, occurred at a similar rate between the arms (0.63 events vs 0.78 events per 100 patient-years). The results indicate that for selected patients low-dose rivaroxaban can provide a stroke-risk reduction benefit with a low incidence of harm.
“Stroke is one of the most devastating diagnoses,” says Prof. Mehra, “and even if the risk is small, we owe it to our patients to do our best to prevent it.”
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