1463Differential effectiveness of drug-coated balloon vs. drug-eluting stent for bare-metal or drug-eluting stent restenosis: a primary prespecified subanalysis from the DAEDALUS study

Background/Introduction: Although new-generation drug eluting stent (DES) has substantially reduced the incidence of target lesion revascularisation, in-stent restenosis (ISR) is the leading cause of stent failure. Drug-coated balloon (DCB) angioplasty and repeat stenting with DES are the most effective strategies for the treatment of ISR; however, direct comparison trials have provided mixed results and were not powered for clinical endpoints. Purpose: We pooled individual patient data from all the available randomised clinical trials comparing DCB vs. DES for the treatment of in-stent restenosis and sought to compare the two treatments according to the type of restenosed stent, bare-metal stent (BMS) or DES. Methods: Major electronic databases were searched from November 16th, 2006 (DCB first-in-human) to September 15th, 2017 and a total of nine eligible trials were identified. Principal investigators of all trials agreed to provide data. Variables of interest were extracted, dissimilar data were made uniform across trials, and follow-up was prolonged when possible. The DAEDALUS study was conducted in keeping with the PRISMA, Cochrane Collaboration and GRADE recommendations. The study protocol was registered with PROSPERO.