Thirty-day safety and one-year effectiveness outcomes of the Portico 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 U.S. The findings from the PORTICO IDE study were presented Sept. 27 during TCT 2019.

The prospective, controlled, open-label, non-inferiority intention-to-treat study randomized 750 patients from 69 sites between May 2014 and June 2019 to either Portico valve implementation or any commercially available TAVR. Baseline characteristics were balanced for both groups, with 52.7 percent being female and the mean age being 83.3 years and a mean STS score of 6.5 percent.

Overall results found procedural success to be comparable between groups (96.5 percent for Portico vs. 98.3 percent for commercially available TAVR). The study also met both the pre-specified primary safety composite endpoint of 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 percent vs 9.6 percent), and the primary effectiveness composite endpoint of all-cause mortality or disabling stroke at one-year (14.9 percent vs. 13.4 percent, respectively).

Greg P. Fontana, MD, FACC, and colleagues noted the study also included a separate cohort consisting of 100 patients who underwent Portico valve implantation using the FlexNav Delivery System. The primary safety endpoint for this cohort was major vascular complication rate at 30 days. This cohort demonstrated no deaths or strokes, low rates of major vascular complications (7.0 percent) and new permanent pacemaker implants (14.6 percent) as well as a safety profile comparable with the commercially available valve group in the randomized study (8.0 percent vs. 9.6 percent), they said.

"TAVR 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," said Fontana. "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."

Keywords: TCT19, Transcatheter Cardiovascular Therapeutics, Angiography, Aortic Valve, Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement, Percutaneous Coronary Intervention

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