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Published on: February 28, 2012
Effect of aspirin and warfarin therapy in stroke patients with valvular strands
Shunichi Homma1, Marco R Di Tullio, Robert R Sciacca
1Department of Medicine, Columbia University, College of Physicians and Surgeons, 630 West 168th Street, New York, NY 10032, USA. sh23@columbia.edu
Insights
Valvular strands in ischemic stroke patients do not increase adverse event rates on medical therapy. Warfarin and aspirin showed no significant difference in preventing recurrent events in this population.
Area of Science:
- Cardiology
- Neurology
- Vascular Medicine
Background:
- Valvular strands are linked to ischemic stroke.
- Recurrent event rates and antithrombotic therapy efficacy in stroke patients with valvular strands lack definition and randomized studies.
Purpose of the Study:
- To define the recurrent rate of adverse events in stroke patients with valvular strands.
- To evaluate the efficacy of antithrombotic therapies (warfarin vs. aspirin) in these patients through a randomized trial.
Main Methods:
- The study analyzed 630 stroke patients from the Patent Foramen Ovale in Cryptogenic Stroke Study (PICSS).
- Patients were randomized to warfarin (312) or aspirin (318).
- Endpoints included recurrent ischemic stroke or death; all analyses were blinded and centrally adjudicated.
Main Results:
- Valvular strands were present in 39.4% of analyzed patients (244/619).
- No significant difference in primary endpoints was observed between patients with and without strands (P=0.82).
- Among patients with strands, warfarin and aspirin showed no significant difference in preventing primary endpoints (P=0.21).
Conclusions:
- Valvular strands do not significantly increase recurrent adverse event rates in ischemic stroke patients on medical therapy.
- The study found no evidence supporting an advantage of warfarin or aspirin over the other for this patient group.
Background:
Valvular strands are associated with ischemic stroke. The recurrent rate of adverse events in stroke patients with valvular strands has not been defined and, importantly, there are no randomized studies to evaluate efficacy of antithrombotic therapies in these patients.
Methods:
Patent Foramen Ovale in Cryptogenic Stroke Study (PICSS) enrolled 630 stroke patients, of whom 312 (49.5%) were randomized to warfarin and 318 (50.5%) were randomized to aspirin; 265 patients experienced cryptogenic stroke and 365 experienced stroke with known subtypes. Endpoints were recurrent ischemic stroke or death from any cause. All transesophageal echocardiography studies were blindly, centrally analyzed and all endpoints were blindly adjudicated.
Results:
Overall, of 619 studies analyzed, valvular strands were present in 39.4% of the patients (244/619), 5.8% (36/619) on the aortic valve and 27.8% (172/619) on the mitral valve, and 5.8% (36/619) on both valves. In an intention-to-treat analysis, there was no significant difference in the time to primary endpoints between patients with and without strands in the overall population (P=0.82; hazard ratio: 1.05; 95% CI: 0.70 to 1.57; 2-year event rates: 16.4% versus 15.5%). Among the patients with strands, there was no significant difference in the time to primary endpoints between those treated with warfarin or aspirin (P=0.21; hazard ratio: 0.67; 95% CI: 0.36 to 1.26; 2-year event rates: 13.5% versus 19.6%).
Conclusions:
While on medical therapy, valvular strands do not significantly increase recurrent adverse event rates in patients with ischemic stroke. Furthermore, the study does not provide evidence to support an advantage of warfarin or aspirin for this purpose.
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