Compared with aspirin alone, aspirin plus rivaroxaban reduced ischemic stroke by almost half, according to results presented at the International Stroke Conference.
For the COMPASS trial, Mukul Sharma, MD, from the department of medicine at McMaster University, and colleagues enrolled 27,395 patients with stable CAD or peripheral artery disease. Patients with CAD had MI within 20 years or multivessel disease. Patients with PAD had a prior operation for PAD or intermittent claudication plus asymptomatic carotid stenosis 50% or carotid revascularization.
As Cardiology Today previously reported, in the main results of COMPASS, patients assigned aspirin plus rivaroxaban (Xarelto, Janssen Pharmaceuticals) 2.5 mg twice daily had fewer vascular events and a better net clinical benefit outcome compared with those assigned aspirin alone. The study was stopped for superiority after 23 months.
Sharma presented the stroke-related outcomes at ISC.
Those with incident stroke — 1.2% of the cohort — were older and more likely to be Asian, have hypertension, diabetes, or HF compared with those who did not have stroke, according to the researchers.
Risk for any stroke was lower in those assigned aspirin plus rivaroxaban vs. those assigned aspirin alone (HR = 0.58; 95% CI, 0.44-0.76). Those assigned rivaroxaban alone had a numerically lower risk for stroke vs. aspirin alone (HR = 0.82; 95% CI, 0.65-1.05), but it was not statistically significant, Sharma said.
Compared with aspirin alone, aspirin plus rivaroxaban reduced risk for ischemic or uncertain stroke (HR = 0.51; 95% CI, 0.38-0.69), as did rivaroxaban alone (HR = 0.66; 95% CI, 0.5-0.88), according to the researchers.
Hemorrhagic stroke was not different in aspirin plus rivaroxaban vs. aspirin alone, though risk was higher in rivaroxaban alone vs. aspirin alone (HR = 2.7; 95% CI, 1.31-5.58).
Disabling stroke at 7 days, defined as a modified Rankin Scale score of 3 to 6, occurred less in the aspirin plus rivaroxaban group vs. the aspirin-alone group, both among those with overall stroke (HR = 0.58; 95% CI, 0.37-0.89) and with ischemic or uncertain stroke (HR = 0.43; 95% CI, 0.26-0.71), the researchers found. In those with hemorrhagic stroke, there was no difference between the groups in disabling stroke.
In patients at highest risk for stroke, the combination therapy reduced stroke risk from 1.5% per year to 0.8% per year (HR = 0.54; 95 CI: 0.34-0.78), the researchers reported.
The results represent “a significant advance in stroke prevention for those with CAD and PAD without AF,” Sharma said. – by Dave Quaile
Sharma M, et al. LB7. Presented at: International Stroke Conference; Jan. 23-26, 2018; Los Angeles.
The COMPASS trial was funded by Bayer. Sharma reports he is a consultant for Bayer, Boehringer Ingelheim, Bristol-Myers Squibb and Daiichi Sankyo.