Makkar RR, Cheng W, Waksman R, et al. - Researchers undertook this prospective, multicentre, non-inferiority, randomised controlled trial (the Portico Re-sheathable Transcatheter Aortic Valve System US Investigational Device Exemption trial [PORTICO IDE]) to evaluate the safety as well as the efficacy of the self-expanding intra-annular Portico transcatheter aortic valve system vs any commercially available valves. From 52 medical centres in the USA and Australia, high and extreme risk patients with severe symptomatic aortic stenosis were recruited. The composite of all-cause death, disabling stroke, life-threatening bleeding needing transfusion, acute kidney injury needing dialysis, or major vascular complication at 30 days, was the primary safety endpoint. Eligible patients were randomized to transcatheter aortic valve replacement with the first generation Portico valve and delivery system or a commercially available valve (either an intra-annular balloon-expandable Edwards-SAPIEN, SAPIEN XT, or SAPIEN 3 valve; or a supra-annular self-expanding CoreValve, Evolut-R, or Evolut-PRO valve). At 2 years, the observed rates of death or disabling stroke in relation to the Portico valve were found to be similar to that of commercial valves. The results also showed higher rates of the primary composite safety endpoint, including mortality at 30 days, in relation to the Portico valve. Findings revealed no benefits of the first-generation Portico valve and delivery system over other commercially available valves.