IDE Study of Portico TAVR System Demonstrates Safety and Efficacy for High-Risk Patients With Severe Aortic Stenosis

September 27, 2019—The Cardiovascular Research Foundation (CRF) announced that results from the PORTICO investigational device exemption (IDE) study were presented by principal investigator Greg Fontana, MD, at TCT 2019, the 31st annual Transcatheter Cardiovascular Therapeutics scientific symposium, which is sponsored by CRF and held September 25–29 in San Francisco, California.

The PORTICO IDE study found that 30-day safety and 1-year effectiveness outcomes of the Abbott’s Portico 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.

According to CRF, PORTICO was a prospective, multicenter, controlled, open-label, noninferiority 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 the Portico treatment group or the commercially available TAVR devices 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 Society of Thoracic Surgeons score was 6.5%. Procedural success was comparable between groups (96.5% for Portico vs 98.3% for commercially available TAVR).

As reported in the CRF announcement, the study met both the prespecified 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) and the primary effectiveness composite endpoint (all-cause mortality or disabling stroke at 1 year) for Portico compared with commercially available TAVR devices:

• Safety, 13.8% vs 9.6%; P_{noninferiority} = .03
• Effectiveness, 14.9% vs 13.4%; P_{noninferiority} = .006

The study also included a separate 100-patient cohort who underwent Portico valve implantation using the FlexNav delivery system (Abbott). The primary safety endpoint for the FlexNav cohort was the major vascular complication rate at 30 days. This cohort demonstrated no deaths or strokes, low rates of major vascular complications (7%) 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% vs 9.6%).

Dr. Fontana commented in the CRF announcement, “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.”