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Published on: June 6, 2025
Stroke Outcomes in the COMPASS Trial.
Mukul Sharma1, Robert G Hart1, Stuart J Connolly1
1McMaster University/Population Health Research Institute, Hamilton, Canada (M.S., R.G.H., S.J.C., J.B., O.S., K.K.H.N., L.C., S.Y., J.W.E.).
The combination of rivaroxaban and aspirin significantly reduced strokes in patients with atherosclerosis compared to aspirin alone. This combination therapy offers a new antithrombotic strategy for stroke prevention.
Area of Science:
- Cardiovascular Medicine
- Pharmacology
- Neurology
Background:
- The COMPASS trial investigated antithrombotic strategies for patients with stable coronary artery or peripheral artery disease.
- Stroke reduction was a key outcome measure in the trial.
- Previous analyses showed a significant benefit of rivaroxaban plus aspirin over aspirin alone.
Purpose of the Study:
- To present detailed analyses of stroke by type, predictors, and antithrombotic effects in key subgroups from the COMPASS trial.
- To evaluate the efficacy of rivaroxaban plus aspirin versus aspirin alone in preventing different types of strokes.
- To identify independent predictors of stroke in patients with established atherosclerotic disease.
Main Methods:
- A randomized trial involving patients with stable coronary artery or peripheral artery disease.
- Three treatment arms: aspirin 100 mg once daily, rivaroxaban 5 mg twice daily, and rivaroxaban 2.5 mg twice daily plus aspirin.
- Exclusion criteria included need for anticoagulation, recent stroke, lacunar stroke history, or intracerebral hemorrhage.
Main Results:
- The combination of rivaroxaban plus aspirin significantly reduced overall stroke occurrence compared to aspirin alone (HR, 0.58; P<0.0001).
- Ischemic/uncertain strokes were reduced by nearly half with the combination therapy (HR, 0.51; P<0.0001).
- Fatal and disabling strokes were also decreased by the combination (HR, 0.58; P=0.01).
- Prior stroke was the strongest independent predictor of incident stroke (HR, 3.63; P<0.0001).
- The benefit of the combination was consistent across high-stroke-risk subgroups, including those with prior stroke.
Conclusions:
- Low-dose rivaroxaban plus aspirin represents a significant advancement in antithrombotic therapy.
- This combination is an effective option for both primary and secondary stroke prevention in patients with clinical atherosclerosis.
- The findings support the use of rivaroxaban plus aspirin in specific patient populations at high risk for stroke.
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