Outcomes from transcatheter aortic valve replacement procedures with both Boston Scientific‘s (NYSE:BSX) Acurate Neo and Edwards Lifesciences‘ (NYSE:EW) Sapien 3 have been found to be similar at 30 days, according to a new study reported by Healio.
Results from the trial were published in the journal JACC: Cardiovascular Interventions, according to the report.
The study explored the use of both Edwards’ balloon-expandable valve and Boston Scientific’s self-expanding valve in a total of 933 patients undergoing TAVR procedures.
The study analyzed 622 patients treated with Edwards Sapien 3 and 311 individuals treated with the Acurate Neo and found comparable rates of in-hospital complications of 2.4% and 1.9%, respectively, according to Healio. Rates of major vascular complications were found to be 8.5% and 10.3% while life threatening bleeding was reported to be 3.7% and 4.2%, respectively.
Device failure rates were also comparable between the two valves, with the Sapien 3 at 9.6% while the Acurate Neo had a reported rate of 10.9%.
Differences between the 2 valves included rates of paravalvular leakage, with the Acurate Neo associated with a 4.8% rate versus a lower 1.8% rate with the Sapien 3, while the Acurate Neo was associated with fewer gradients of at least 20 mm Hg at 3.2% versus 6.9% and permanent pacemaker implants at 9.9% versus 15.5%, according to Healio.
No significant differences were reported in 30-day mortality or in an early safety composite endpoint determined by Valve Academic Research Consortium, according to the report.
“Both technologies have been used in large clinical registries with very good clinical outcomes. The only randomized comparison between both technologies in earlier-generation devices showed superiority for device success with balloon-expandable over self-expanding [transcatheter heart valves]; however, clinical outcome at 1 year was equivalent,” Dr. Oliver Husser of the Klinik für Herz-und Kreislauferkrankungen, Deutshes Herzzentrum München and colleagues wrote in the study, according to Healio.