Cardioverter defibrillator implantation without induction of XXXX : a single-blind, non-inferiority, randomised controlled trial (SIMPLE).

@entity1 @entity1479 @entity712 @entity64 @entity737 @entity2224 @entity204
BACKGROUND: Defibrillation testing by induction and termination of @entity2224 is widely done at the time of implantation of @entity737 ( @entity737 ). We aimed to compare the efficacy and safety of @entity1479 implantation without defibrillation testing versus the standard of @entity1479 implantation with defibrillation testing. METHODS: In this single-blind, randomised, multicentre, non-inferiority trial (Shockless IMPLant Evaluation [SIMPLE]), we recruited @entity1 aged older than 18 years receiving their first @entity1479 for standard indications at 85 hospitals in 18 countries worldwide. Exclusion criteria included pregnancy, awaiting transplantation, particpation in another randomised trial, unavailability for follow-up, or if it was expected that the @entity1479 would have to be implanted on the right-hand side of the chest. @entity1 undergoing initial implantation of a Boston Scientific @entity1479 were randomly assigned (1:1) using a computer-generated sequence to have either defibrillation testing (testing group) or not (no-testing group). We used random block sizes to conceal treatment allocation from the @entity1 , and randomisation was stratified by clinical centre. Our primary efficacy analysis tested the intention-to-treat population for non-inferiority of no-testing versus testing by use of a composite outcome of @entity204 or failed appropriate shock (ie, a shock that did not terminate a spontaneous episode of @entity2224 ). The non-inferiority margin was a hazard ratio (HR) of 1  5 calculated from a proportional hazards model with no-testing versus testing as the only covariate; if the upper bound of the 95% CI was less than 1  5, we concluded that @entity1479 insertion without testing was non-inferior to @entity1479 with testing. We examined safety with two, 30 day, adverse event outcome clusters. The trial is registered with ClinicalTrials.gov, number NCT00800384. FINDINGS: Between Jan 13, 2009, and April 4, 2011, of 2500 eligible @entity1 , 1253 were randomly assigned to defibrillation testing and 1247 to no-testing, and followed up for a mean of 3  1 years (SD 1  0). The primary outcome of @entity204 or failed appropriate shock occurred in fewer @entity1 (90 [7% per year]) in the no-testing group than @entity1 who did receive it (104 [8% per year]; HR 0  86, 95% CI 0  65-1  14; pnon-inferiority <0  0001). The first safety composite outcome occurred in 69 (5  6%) of 1236 @entity1 with no-testing and in 81 (6  5%) of 1242 @entity1 with defibrillation testing, p=0  33. The second, pre-specified safety composite outcome, which included only events most likely to be directly caused by testing, occurred in 3  2% of @entity1 with no-testing and in 4  5% with defibrillation testing, p=0  08. @entity712 needing intravenous treatment with inotropes or diuretics was the most common adverse event (in 20 [2%] of 1236 @entity1 in the no-testing group vs 28 [2%] of 1242 @entity1 in the testing group, p=0  25). INTERPRETATION: Routine defibrillation testing at the time of @entity1479 implantation is generally well tolerated, but does not improve shock efficacy or reduce @entity204 . FUNDING: Boston Scientific and the Heart and @entity64 Foundation (Ontario Provincial office).
