Two-Year Clinical Outcomes of the REVELATION Study: Sustained Safety and Feasibility of Paclitaxel-Coated Balloon Angioplasty Versus Drug-Eluting Stent in Acute Myocardial Infarction.

ABSTRACT

OBJECTIVES: The randomized REVELATION (REVascularization With PaclitaxEL-Coated Balloon Angioplasty Versus Drug-Eluting Stenting in Acute Myocardial InfarcTION) trial showed that in the setting of ST-segment elevation myocardial infarction (STEMI), a drug-coated balloon (DCB) strategy was non-inferior to a drug-eluting stent (DES) strategy in terms of fractional flow reserve assessed at 9 months. The aim of the present study is to evaluate the long-term clinical outcome of this treatment strategy. METHODS: Between October 2014 and November 2017, a total of 120 patients with a non-severely calcified culprit lesion in a native coronary artery and a residual stenosis of <50% after predilation were randomized to treatment with DCB or DES. Primary clinical endpoint was the occurrence of major adverse cardiac events, defined as death, recurrent myocardial infarction, or target-lesion revascularization, the occurrence of definite ST, and non-coronary artery bypass grafting (CABG) major bleeding. RESULTS: Complete clinical follow-up at 2 years was available for 109 patients (91%). A major adverse cardiac event occurred in 3 patients (5.4%) in the DCB group and 1 patient (1.9%) in the DES group (hazard ratio, 2.86; 95% confidence interval, 0.30-27.53; P=.34). Between 9 months and 2 years, only 1 additional event occurred (target-lesion revascularization in a patient randomized to DCB). CONCLUSION: In this randomized study of DCB vs DES in selected patients presenting with STEMI, 2-year clinical outcome was excellent and comparable between the DCB and DES groups.