The Portico IDE study found that 30-day safety and one-year effectiveness outcomes of a novel self-expanding transcatheter aortic valve replacement (TAVR) system for patients with severe aortic stenosis (AS) at high or extreme-risk for surgery was noninferior to contemporary FDA-approved TAVR systems available in the United States.
Findings were reported today at the 31st annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine.
PORTICO was a prospective, multi-center, controlled, open-label, non-inferiority intention-to-treat evaluation of the safety and effectiveness of the Portico TAVR system compared with FDA-approved and commercially available TAVR systems.
Between May 2014 and June 2019, 750 patients from 69 sites were randomized 1:1 to each group. For the randomized cohort, baseline characteristics were balanced for both groups; mean age was 83.3 years (±7.3 years), 52.7% were female, and the mean STS score was 6.5%.
Procedural success was comparable between groups (96.5% for Portico versus 98.3% for commercially available TAVR).
The study met both the pre-specified primary safety composite endpoint (all-cause mortality, disabling stroke, life threatening bleeding requiring blood transfusion, acute kidney injury requiring dialysis, or major vascular complications at 30 days, 13.8% vs 9.6%; pnon-inferiority=0.03) and the primary effectiveness composite endpoint (all-cause mortality or disabling stroke at one-year, 14.9% vs 13.4%, pnon-inferiority =0.006).
The study also included a separate 100 patient cohort who underwent Portico valve implantation using the FlexNav Delivery System. The primary safety endpoint for the FlexNav cohort was major vascular complication rate at 30 days.
This cohort demonstrated no deaths or strokes, low rates of major vascular complications (7.0%) and new permanent pacemaker implants (14.6%) as well as a safety profile comparable with the commercially available valve group in the randomized study (8.0% vs 9.6%).
Transcatheter aortic valve replacement has fundamentally changed how we approach patient care. Findings from the Portico IDE study have added important new data to the body of TAVR clinical evidence. By demonstrating results in line with contemporary TAVR systems and an improved delivery system, the Portico valve with FlexNav delivery system has demonstrated IDE clinical results on par with commercially available valves."
Greg Fontana, MD, Director and Chairman, Cardiothoracic Surgery, CardioVascular Institute of Los Robles Regional Medical Center
Dr. Fontana is also the principal investigator.