March 9, 2017
Stryker's DAWN Trial Enrollment Ended After Interim Review Indicates Success
March 9, 2017—Stryker announced an early end to patient enrollment in the DAWN clinical trial comparing mechanical thrombectomy with the company's Trevo Retriever plus medical therapy versus medical therapy alone when initiated within 6 to 24 hours after time last known well. The study was designed to enroll up to a maximum of 500 patients, with a prespecified interim analysis of data to assess efficacy upon enrollment of the first 200 patients.
According to Stryker, the independent Data Safety Monitoring Board recommended stopping study enrollment based on the preplanned interim review of data from the first 200 patients, which concluded that multiple prespecified stopping criteria were met. A final analysis of the data will be conducted upon completion of the remaining patient follow-up.
DAWN is an international, multicenter, blinded endpoint assessment, randomized study. The purpose of the study is to evaluate if mechanical thrombectomy with the Trevo Retriever plus medical management leads to superior clinical outcomes at 90 days as compared with medical management alone in appropriately selected patients treated 6 to 24 hours after last seen well. The Trevo Retriever indication within the DAWN trial is currently approved for investigational use only by the US Food and Drug Administration in the United States under an investigational device exemption study approval, advised Stryker.
In Stryker's announcement, DAWN Coprincipal Investigator Tudor Jovin, MD, commented, “Treating acute stroke patients with large vessel occlusion who present later than 6 hours from last seen well has the potential to help thousands of stroke patients around the world. These patients, many of whom present to the hospital outside of the 6-hour time window, could have a better chance for an independent life with improved clinical outcomes.” Dr. Jovin is from the University of Pittsburgh Medical Center in Pittsburgh, Pennsylvania.
Raul Nogueira, MD, the study's coprincipal investigator, added, “If the final results of the DAWN trial are positive, it will provide physicians who treat stroke with evidence of the benefits of thrombectomy even when administered out as far as 24 hours and should help to make decisions clearer as to which patients to treat.” Dr. Nogueira is from Grady Memorial Hospital/Emory University in Atlanta, Georgia.
Stryker and the DAWN investigators are now focused on gathering and securing all of the remaining patient data for final statistical analysis. If confirmed positive, the outcomes of the DAWN trial may represent a major change in patient selection for endovascular therapy for stroke, noted the company.