Share on Facebook
Share on Twitter
Share on LinkedIn
Share by Email
Print
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.
Reference
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.
