medwireNews: Myval transcatheter heart valves (THVs) are noninferior to the best-in-practice SAPIEN 3 THVs for the composite endpoint of death, stroke, aortic regurgitation, or valve deterioration at 1 year in patients undergoing transfemoral transcatheter aortic valve implantation (TAVI), suggests the COMPARE-TAVI 1 study.
However, the trial, which was published in The Lancet, did show an increased risk for pacemaker implantation with Myval THVs.
The Danish head-to-head randomized comparison trial of balloon-expandable THVs in adults undergoing transfemoral TAVI for severe aortic stenosis showed that 14% of 514 patients receiving Myval or Myval Octacor (Meril Life Sciences, Vapi, India) and 13% of 517 patients receiving SAPIEN 3 or SAPIEN 3 Ultra (Edwards Life Sciences, Irvine, California, USA) experienced the composite outcome of all-cause death, stroke, moderate or severe aortic regurgitation, or moderate or severe hemodynamic THV deterioration at 1 year.
This gave a 0.9 percentage point difference that was within the 5.3 percentage point margin for noninferiority of Myval versus SAPIEN 3, making Myval “the first THV showing non-inferiority with SAPIEN 3 THVs at 1 year,” according to researchers Christian Juhl Terkelsen (Aarhus University Hospital, Denmark) and colleagues.
They point out that the “non-inferiority margin used in this trial is the smallest to date in any head-to-head comparison of THVs.”
The investigators also note that mortality at 1 year did not differ between the Myval and SAPIEN groups (5 vs 6%), and the two techniques were “similar in terms of TAVI complications and technical success.”
However, they report that Myval THVs were “associated with a greater risk of need for first-time pacemaker implantation at 1 year,” with 21% of 455 patients treated with Myval THVs receiving a pacemaker versus 12% of 468 treated with SAPIEN 3 THVs, a significant 9.0 percentage point difference. This increased risk with Myval “requires further evaluation,” they say.
Patients receiving Myval Octacor required more first-time pacemaker implantations than those receiving Myval, a finding that the researchers write “explains some of the increased pacemaker rates in COMPARE-TAVI 1 compared with the [previous] LANDMARK trial that mainly used first-generation Myval THVs.”
In addition, the degree of oversizing (nominal area of the THV divided by the annulus area) was significantly greater with the use of Myval than SAPIEN 3 THVs (7.5 vs 6.3%). However, the investigators say that this “modest difference” seems unlikely to explain the increased pacemaker need with Myval THVs and suggest other factors may include delivery systems leading to deeper implants, implantation balloons, or variations in skirt designs.
Indeed, they found that, “despite the opportunity for more precise sizing and a higher average degree of oversizing with Myval THVs,” the skirt used for SAPIEN 3 THV appeared to provide better sealing against moderate or severe paravalvular leaks as the primary cause of moderate-to-severe aortic regurgitation, which occurred in 4% versus 1% of patients in the Myval and SAPIEN 3 THV groups, respectively.
In all, 1031 patients were randomly scheduled for transfemoral TAVI with Myval or Myval Octacor THVs (20–32 mm diameter) or SAPIEN 3 (29 mm diameter) or SAPIEN 3 Ultra (20 mm, 23 mm, or 26 mm diameter) THVs, and followed up at 30 days, and 1, 3, 5, and 10 years. The median age of the patients was 81.6 years (77.5–85.0 years), and 60% were men.
All eligible patients were included regardless of valve anatomy, including 98 patients who had bicuspid anatomy, 40 who required a valve-in-valve procedure, and 103 who received an acute or sub-acute TAVI. The researchers say that this “all-comers” inclusion approach contrasts with previous head-to-head comparison trials that “have imposed numerous exclusion criteria.”
Mariama Akodad, from Institut Cardiovasculaire Paris Sud in France, notes in a comment on the study that the inclusion of patients with complex anatomies added “a real-life dimension,” and congratulates the researchers on the trial’s “unprecedented rates of inclusion,” at 77% of 1335 patients treated at the participating hospitals.
However, she also highlights several limitations of the trial, including that the latest SAPIEN 3 THV Ultra Resilia was not used, pre-TAVI predilatation rates were significantly higher in patients treated with Myval compared with SAPIEN 3 (45 vs 21%), and that the findings may not be generalizable to people younger than 75 years of age.
“[L]ong-term advantages of the more recent Myval THVs over the well established SAPIEN 3 platform requires more data, especially in a younger population for whom lifetime management of aortic stenosis is crucial,” the commentator concludes.
medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2025 Springer Healthcare Ltd, part of the Springer Nature Group
