First direct comparison of clinical outcomes between European and Asian cohorts in transcatheter aortic valve implantation: The Massy study group vs. the PREVAIL JAPAN trial

Background The efficacy and safety of transcatheter aortic valve implantation (TAVI) in Asian populations were unknown. The purpose of this study was to compare directly the clinical outcomes of the first Japanese trial and a European single-center experience after TAVI. Methods and results Between April 2010 and October 2011, 64 patients were included in the PREVAIL JAPAN multicenter trial which was set up to evaluate the safety and efficacy of the Edwards SAPIEN XT™ (Edwards Lifesciences, Irvine, CA, USA) in high-risk Japanese patients with severe aortic stenosis. Between March 2010 and January 2012, 237 consecutive patients treated with TAVI using the Edwards SAPIEN XT™ prosthesis at Institut Cardiovasculaire Paris Sud were prospectively included in the Massy cohort. We compared the clinical outcomes of these two cohorts. Patients were of similar age (83.4 ± 6.6 years vs. 84.5 ± 6.1 years, p = 0.25), but logistic EuroSCORE was higher in the Massy cohort (20.2 ± 11.7% vs. 15.6 ± 8.0%, p