IMPORTANCE: While effective in preventing @entity64 in @entity1 with @entity955 ( @entity955 ), @entity1229 is limited by a narrow therapeutic profile, a need for lifelong coagulation monitoring, and multiple drug and diet interactions. OBJECTIVE: To determine whether a local strategy of mechanical left atrial appendage (LAA) closure was noninferior to @entity1229 . DESIGN, SETTING, AND @entity1 : PROTECT @entity955 was a multicenter, randomized (2:1), unblinded, Bayesian-designed study conducted at 59 hospitals of 707 @entity1 with @entity955 and at least 1 additional @entity64 risk factor (CHADS2 score >= 1). Enrollment occurred between February 2005 and June 2008 and included 4-year follow-up through October 2012. Noninferiority required a posterior probability greater than 97.5% and superiority a probability of 95% or greater; the noninferiority margin was a rate ratio of 2.0 comparing event rates between treatment groups. INTERVENTIONS: Left atrial appendage closure with the device (n   =   463) or @entity1229 (n   =   244; target international normalized ratio, 2-3). MAIN OUTCOMES AND MEASURES: A composite efficacy end point including @entity64 , systemic @entity887 , and @entity65 , analyzed by intention-to-treat. RESULTS: At a mean (SD) follow-up of 3.8 (1.7) years (2621 @entity1 -years), there were 39 events among 463 @entity1 (8.4%) in the device group for a primary event rate of 2.3 events per 100 @entity1 -years, compared with 34 events among 244 @entity1 (13.9%) for a primary event rate of 3.8 events per 100 @entity1 -years with @entity1229 (rate ratio, 0.60; 95% credible interval, 0.41-1.05), meeting prespecified criteria for both noninferiority (posterior probability, >99.9%) and superiority (posterior probability, 96.0%). @entity1 in the device group demonstrated lower rates of both @entity65 (1.0 events per 100 @entity1 -years for the device group [17/463 @entity1 , 3.7%] vs 2.4 events per 100 @entity1 -years with @entity1229 [22/244 @entity1 , 9.0%]; hazard ratio [HR], 0.40; 95% CI, 0.21-0.75; P   =   .005) and all-cause mortality (3.2 events per 100 @entity1 -years for the device group [57/466 @entity1 , 12.3%] vs 4.8 events per 100 @entity1 -years with @entity1229 [44/244 @entity1 , 18.0%]; HR, 0.66; 95% CI, 0.45-0.98; P   =   .04). CONCLUSIONS AND RELEVANCE: After 3.8 years of follow-up among @entity1 with @entity955 at elevated risk for @entity64 , percutaneous LAA closure met criteria for both noninferiority and superiority, compared with @entity1229 , for preventing the combined outcome of @entity64 , systemic @entity887 , and @entity65 , as well as superiority for cardiovascular and all-cause mortality. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00129545.

Percutaneous left atrial appendage closure vs XXXX for @entity955 : a randomized clinical trial.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'patient', 'PARTICIPANTS'] @entity64 :: ('MESH:D020521', 'Disease') :: ['stroke'] @entity887 :: ('MESH:D004617', 'Disease') :: ['embolism'] @entity955 :: ('MESH:D001281', 'Disease') :: ['atrial fibrillation', 'nonvalvular AF', 'AF'] @entity65 :: ('MESH:D002318', 'Disease') :: ['cardiovascular mortality', 'cardiovascular/unexplained death', 'cardiovascular death'] @entity1229 :: ('MESH:D014859', 'Chemical') :: ['warfarin']
@entity1229 :: (MESH:D014859,Chemical) :: ['warfarin']
