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PROTECT AF: Difference between revisions
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PROTECT AF was a randomized controlled trial conducted in the US and Europe which randomized 707 patients with non-valvular AF and CHADS2 score of ≥1 to either LAA closure with the WATCHMAN device or to warfarin control in a 2:1 fashion. Those randomized to LAA closure discontinued their warfarin therapy 6 weeks after device placement. The study's objective was to determine noninferiority of LAA closure compared to warfarin. Patients were followed for the primary composite outcome of stroke, cardiovascular or unexplained death, or systemic embolism. With a median follow-up of 18 months, the primary outcome rate was 3.0 per 100 person-years in the LAA closure group compared to 4.9 per 100 person-years in the warfarin control (RR 0.62) and non-inferiority criteria were met. Adverse events were more common in the device group compared to warfarin controls (RR 1.69); in the device group these occurred early, whereas in the warfarin group these occurred late. Notably ischemic strokes were more common in the device group than in the warfarin controls, and most of the events in the device group were attributed to periprocedural air embolism. The authors conclude that LAA closure may be a reasonable option for patients in whom long-term anticoagulation is not desirable. The 2014 AHA/ASA guidelines contend that LAA closure with the WATCHMAN device may be most appropriate for patients with AF at high risk of stroke who are poor candidates for anticoagulation. | PROTECT AF was a randomized controlled trial conducted in the US and Europe which randomized 707 patients with non-valvular AF and CHADS2 score of ≥1 to either LAA closure with the WATCHMAN device or to warfarin control in a 2:1 fashion. Those randomized to LAA closure discontinued their warfarin therapy 6 weeks after device placement. The study's objective was to determine noninferiority of LAA closure compared to warfarin. Patients were followed for the primary composite outcome of stroke, cardiovascular or unexplained death, or systemic embolism. With a median follow-up of 18 months, the primary outcome rate was 3.0 per 100 person-years in the LAA closure group compared to 4.9 per 100 person-years in the warfarin control (RR 0.62) and non-inferiority criteria were met. Adverse events were more common in the device group compared to warfarin controls (RR 1.69); in the device group these occurred early, whereas in the warfarin group these occurred late. Notably ischemic strokes were more common in the device group than in the warfarin controls, and most of the events in the device group were attributed to periprocedural air embolism. The authors conclude that LAA closure may be a reasonable option for patients in whom long-term anticoagulation is not desirable. The 2014 AHA/ASA guidelines contend that LAA closure with the WATCHMAN device may be most appropriate for patients with AF at high risk of stroke who are poor candidates for anticoagulation. | ||
In 2013, further follow up data from the original patients were published providing more longitudinal safety information. <ref> Reddy V, Doshi S, Sievert H, et al. Percutaneous Left Atrial Appendage Closure for Stroke Prophylaxis in Patients With Atrial Fibrillation 2.3-Year Follow-up of the PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) Trial. CIRCULATION. 2013;127:720-729.</ref> The [[PREVAIL]] trial, a subsequent 2014 study involving the WATCHMAN device following the original PROTECT AF protocol, failed to demonstrate non-inferiority of LAA closure to warfarin using the same primary composite endpoint but had significantly lower adverse events when performed by more experienced operators.<ref>Holmes J, David R, Kar S, Price MJ, et al. Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. Journal of the American College of Cardiology. 2014;64:1.</ref> The subsequent follow up [[ASAP]] study (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology) showed the safety of using dual antiplatelets only without the warfarin bridging period allowing the device to be used in patients with absolute contraindications to any length of warfarin use.<ref>Reddy VY, Möbius-Winkler S, Miller MA, et al. Left Atrial Appendage Closure With the Watchman Device in Patients With a Contraindication for Oral Anticoagulation: The ASAP Study (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology). J Am Coll Cardiol. 2013;61(25):2551-2556. doi:10.1016/j.jacc.2013.03.035.</ref> | In 2013, further follow up data from the original patients were published providing more longitudinal safety information. <ref> Reddy V, Doshi S, Sievert H, et al. Percutaneous Left Atrial Appendage Closure for Stroke Prophylaxis in Patients With Atrial Fibrillation 2.3-Year Follow-up of the PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) Trial. CIRCULATION. 2013;127:720-729.</ref> The [[PREVAIL]] trial, a subsequent 2014 study involving the WATCHMAN device following the original PROTECT AF protocol, failed to demonstrate non-inferiority of LAA closure to warfarin using the same primary composite endpoint but had significantly lower adverse events when performed by more experienced operators.<ref>Holmes J, David R, Kar S, Price MJ, et al. Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. Journal of the American College of Cardiology. 2014;64:1.</ref> The subsequent follow up [[ASAP]] study (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology) showed the safety of using dual antiplatelets only without the warfarin bridging period allowing the device to be used in patients with absolute contraindications to any length of warfarin use.<ref>Reddy VY, Möbius-Winkler S, Miller MA, et al. Left Atrial Appendage Closure With the Watchman Device in Patients With a Contraindication for Oral Anticoagulation: The ASAP Study (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology). J Am Coll Cardiol. 2013;61(25):2551-2556. doi:10.1016/j.jacc.2013.03.035.</ref> A 2015 meta-analysis of PROTECT AF and PREVAIL demonstrated that LAA closure reduced the rates of hemorrhagic stroke, cardiovascular or unexplained death, and nonprocedural bleeding compared to warfarin.<ref>{{#pmid:26088300}}</ref> | ||
==Guidelines== | ==Guidelines== | ||