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Study of First-in-Class WATCHMAN® Device Shows 75 Percent Reduction in Stroke Risk in Patients with Atrial Fibrillation Not Eligible for Oral Anticoagulation Therapy
Date:5/11/2012

larly and pump blood efficiently.  Patients in atrial fibrillation are at greater risk for stroke due to the migration of clots formed in the left atrial appendage (LAA).  Anticoagulants such as warfarin have traditionally been the only therapy for reducing stroke risk in these patients.  The Boston Scientific percutaneously delivered WATCHMAN Device is an alternative to long-term anticoagulation in patients eligible for anticoagulant therapy.  It is designed to close the LAA, thereby preventing clots forming within the appendage and being dislodged into the bloodstream where they can potentially cause a stroke. 

"Findings from the ASAP Study are promising in that closure of the LAA with the WATCHMAN Device produced a significant reduction in the expected ischemic stroke rate for this patient population," said Dr. Reddy.  "These results are very impressive and show potential for an effective device-based solution for higher-risk patients with limited pharmacologic options to reduce their risk of stroke."

For patients in the ASAP Study, the average baseline CHADS2 score of 2.8 equated to a predicted ischemic stroke rate of approximately 7.1 percent per year.  The observed rate of ischemic stroke for patients implanted with the WATCHMAN Device was 1.7 percent per year, a 75 percent reduction in stroke risk from the predicted stroke rate based on the CHADS2 score (p<0.01).  The corresponding upper confidence bound yielded a stroke rate of 4.4 percent per year, lower than the predicted stroke rate of 7.1 percent. 

Stroke rates in the ASAP study were similar to those observed in the PROTECT AF study, which assessed similar subjects not contraindicated to warfarin.
In the multi-center, randomized PROTECT AF trial, the WATCHMAN Device proved to be non-inferior to warfarin and demonstrated a 38 percent relative risk reduction for stroke, cardiovascular death and systemic embolism compared to long-term
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SOURCE Boston Scientific Corporation
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