51 research outputs found
Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease
BACKGROUND
We evaluated whether rivaroxaban alone or in combination with aspirin would be more
effective than aspirin alone for secondary cardiovascular prevention.
METHODS
In this double-blind trial, we randomly assigned 27,395 participants with stable atherosclerotic vascular disease to receive rivaroxaban (2.5 mg twice daily) plus aspirin (100 mg
once daily), rivaroxaban (5 mg twice daily), or aspirin (100 mg once daily). The primary outcome was a composite of cardiovascular death, stroke, or myocardial infarction. The study was stopped for superiority of the rivaroxaban-plus-aspirin group after
a mean follow-up of 23 months.
RESULTS
The primary outcome occurred in fewer patients in the rivaroxaban-plus-aspirin group
than in the aspirin-alone group (379 patients [4.1%] vs. 496 patients [5.4%]; hazard
ratio, 0.76; 95% confidence interval [CI], 0.66 to 0.86; P<0.001; z=−4.126), but major
bleeding events occurred in more patients in the rivaroxaban-plus-aspirin group (288
patients [3.1%] vs. 170 patients [1.9%]; hazard ratio, 1.70; 95% CI, 1.40 to 2.05;
P<0.001). There was no significant difference in intracranial or fatal bleeding between
these two groups. There were 313 deaths (3.4%) in the rivaroxaban-plus-aspirin group
as compared with 378 (4.1%) in the aspirin-alone group (hazard ratio, 0.82; 95% CI,
0.71 to 0.96; P=0.01; threshold P value for significance, 0.0025). The primary outcome
did not occur in significantly fewer patients in the rivaroxaban-alone group than in the
aspirin-alone group, but major bleeding events occurred in more patients in the rivaroxaban-alone group.
CONCLUSIONS
Among patients with stable atherosclerotic vascular disease, those assigned to rivaroxaban (2.5 mg twice daily) plus aspirin had better cardiovascular outcomes and more
major bleeding events than those assigned to aspirin alone. Rivaroxaban (5 mg twice
daily) alone did not result in better cardiovascular outcomes than aspirin alone and
resulted in more major bleeding events. (Funded by Bayer; COMPASS ClinicalTrials.gov
number, NCT01776424.
Serum trace element levels in children receiving antiepileptic drug therapy: A cross-sectional study
Venous Thrombosis in Cancer Patients: Insight from the Frontline Survey
10.1634/theoncologist.8-4-381Oncologist84381-388OCOL
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