PROTECT AF: Difference between revisions

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In 2013, further follow up data from the original patients were published providing more longitudinal safety information. <ref>{{#pmid:23325525}}</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>{{#pmid:24998121}}</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>{{#pmid:23583249}}</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>
In 2013, further follow up data from the original patients were published providing more longitudinal safety information. <ref>{{#pmid:23325525}}</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>{{#pmid:24998121}}</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>{{#pmid:23583249}}</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>
The 2025 [[OPTION]] trial found a strategy of AF ablation followed by placement of a newer generation WATCHMAN device to be noninferior or superior for AF events when compared to AF ablation followed by anticoagulation among adults with non-valvular AF and an elevated CHA2DS-VASc score.


==Guidelines==
==Guidelines==
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