It was reported to reverse the effects of rivaroxaban and was approved under the FDA s accelerated-approval pathway on the basis of effects in healthy volunteers. Continued approval may be contingent on postmarketing studies to demonstrate an improvement in hemo- stasis in patients. 4.4. Nonpharmacological Stroke Prevention 4.4.1. Percutaneous Approaches to Occlude the LAA Recommendation for Percutaneous Approaches to Occlude the LAA Referenced studies that support the new recommendation are summarized in Online Data Supplement 4. COR LOE Recommendation IIb B-NR Percutaneous LAA occlusion may be considered in patients with AF at increased risk of stroke who have contraindications to long-term NEW: Clinical trial data and FDA approval of the Watchman device necessitated this recommendation. Recommendation-Specific Supportive Text (New) 1. Percutaneous LAA occlusion with the Watchman device has been compared with warfarin in patients with AF (in the absence of moderate to severe mitral stenosis or a mechanical heart valve) at increased risk of stroke in 2 RCTs: the PROTECT AF (WATCHMAN Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation)S4.4.1-1 and the PREVAIL (Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy)S4.4.1-2 trials. A meta-analysis combining data from these 2 trials and their regis- tries demonstrated that patients receiving the device had significantly fewer hemorrhagic strokes than did those receiving warfarin, but there was an increase in ischemic strokes in the device group.S4.4.1-3 However, when periprocedural events were excluded, the dif- ference in ischemic strokes was not significant. Oral anticoagulation remains the preferred ther- apy for stroke prevention for most patients with AF and elevated stroke risk. However, for patients who are poor candidates for long-term oral anticoagu- lation (because of the propensity for bleeding or poor drug tolerance or adherence), the Watchman device provides an alternative. 