The Portico transcatheter aortic valve system was found to be associated with similar rates of death or disabling stroke at 2 years compared with other commercially available valves, but higher rates of death at 30 days, according to a study published in the Lancet.
In this randomized, controlled, noninferiority Portico Re-sheathable Transcatheter Aortic Valve System US Investigational Device Exemption trial (ClinicalTrials.gov Identifier: NCT02000115), investigators recruited high- and extreme-risk patients with severe symptomatic aortic stenosis from 52 medical centers in the United States and Australia. Patients (mean age, 83±7 years; 52.7% women) were randomly assigned (1:1) to receive transcatheter aortic valve replacement with the Portico valve (n=381; Abbott Structural Heart, St Paul, Minnesota) or another commercially available valve (n=369; an intra-annular balloon-expandable Edwards-SAPIEN, SAPIEN XT; aSAPIEN 3 valve [Edwards LifeSciences, Irvine, California]; or a supra-annular self-expanding CoreValve, Evolut-R, or Evolut-PRO valve [Medtronic, Minneapolis, Minnesota]).
The study’s primary safety end point was a composite of all-cause mortality, disabling stroke, life-threatening bleeding requiring transfusion, acute kidney injury requiring dialysis, or major vascular complication at 30 days. The primary efficacy end point was all-cause mortality or disabling stroke at 1 year. Clinical outcomes and valve performance were assessed up to 2 years after the procedure.
The primary safety end point rate was higher in the Portico valve group compared with the other commercially available valve group at 30 days (13.8% vs 9.6%, respectively; absolute difference, 4.2; 95% CI, –0.4 to 8.8), and the rates of the primary efficacy end point were similar between the 2 groups at 1 year (14.8% vs 13.4%, respectively; difference, 1.5%; 95% CI, –3.6 to 6.5). At 2 years, the rates of death (Portico, 22.3%; other valves, 20.2%; P =.40) and disabling stroke (Portico, 3.1%; other valves, 5.0%; P =.23) were similar between the groups.
“We found the Portico valve to meet prespecified non-inferiority criteria for the primary safety and efficacy end points,” concluded the researchers. “However, the composite primary safety end point and the 30-day mortality rates were higher with the Portico valve in the as-treated analysis. The rates of death or disabling stroke, cardiac symptom reduction, and functional status were not significantly different at 1 and 2 years between the Portico valve and commercial valves.”
Study limitations include the fact that both supra-annular self-expanding and balloon-expandable valves were used in the control group.
“The first-generation Portico valve and delivery system used in this study does not offer advantage over other commercially available valves,” the investigators concluded.
Disclosures: Some of the authors declared affiliations with the pharmaceutical industry. Please see the original reference for a complete list of disclosures.
Makkar RR, Cheng W, Waksman R, et al. Self-expanding intra-annular versus commercially available transcatheter heart valves in high and extreme risk patients with severe aortic stenosis (PORTICO IDE): A randomised, controlled, non-inferiority trial. Lancet. 2020;396(10252):669-683.