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Comparative Study
. 2025 Jan 20;21(2):e105-e118.
doi: 10.4244/EIJ-D-24-00951.

Early outcomes of the novel Myval THV series compared to SAPIEN THV series and Evolut THV series in individuals with severe aortic stenosis

Niels van Royen  1 , Ignacio J Amat-Santos  2   3 , Martin Hudec  4 , Matjaz Bunc  5 , Alexander Ijsselmuiden  6   7 , Peep Laanmets  8 , Daniel Unic  9 , Béla Merkely  10 , Renicus S Hermanides  11 , Vlasis Ninios  12 , Marcin Protasiewicz  13 , Benno J W M Rensing  14 , Pedro L Martin  15 , Fausto Feres  16 , Manuel De Sousa  17 , Eric Van Belle  18 , Axel Linke  19 , Alfonso Ielasi  20 , Matteo Montorfano  21   22 , Mark Webster  23 , Konstantinos Toutouzas  24 , Emmanuel Teiger  25 , Francesco Bedogni  26 , Michiel Voskuil  27 , Manuel Pan  28 , Oskar Angerås  29   30 , Won-Keun Kim  31   32 , Jürgen Rothe  33   34 , Ivica Kristić  35 , Vicente Peral  36 , Ben J L Van den Branden  6 , Dirk Westermann  33 , Barbara Bellini  22 , Mario Garcia-Gomez  2   3 , Akihiro Tobe  37 , Tsung-Ying Tsai  37   38 , Scot Garg  39   40 , Ashokkumar Thakkar  41 , Udita Chandra  41 , Marie-Claude Morice  42   43 , Osama Soliman  37 , Yoshinobu Onuma  37   44 , Patrick W Serruys  37 , Andreas Baumbach  45   46
Affiliations
Comparative Study

Early outcomes of the novel Myval THV series compared to SAPIEN THV series and Evolut THV series in individuals with severe aortic stenosis

Niels van Royen et al. EuroIntervention. .

Abstract

Background: There are limited head-to-head randomised trials comparing the performance of different transcatheter heart valves (THVs).

Aims: We aimed to evaluate the non-inferiority of the balloon-expandable Myval THV series compared to the balloon-expandable SAPIEN THV series or the self-expanding Evolut THV series.

Methods: The LANDMARK trial randomised 768 patients in a 1:1 ratio, (Myval THV series [n=384] vs contemporary series with 50% SAPIEN THV series [n=192] and 50% Evolut THV series [n=192]). The non-inferiority of Myval over the SAPIEN or Evolut THV series in terms of the 30-day primary composite safety and effectiveness endpoint as per the third Valve Academic Research Consortium (VARC-3) was tested in an intention-to-treat population with a predefined statistical power of 80% (1-sided alpha of 5%) for a non-inferiority margin of 10.44%.

Results: The Myval THV series achieved non-inferiority for the primary composite endpoint over the SAPIEN THV series (24.7% vs 24.1%, risk difference [95% confidence interval {CI}]: 0.6% [not applicable {NA} to 8.0]; p=0.0033) and the Evolut THV series (24.7% vs 30.0%, risk difference [95% CI]: -5.3% [NA to 2.5]; p<0.0001). The incidences of pacemaker implantation were comparable (Myval THV series: 15.0%, SAPIEN THV series: 17.3%, Evolut THV series: 16.8%). At 30 days, the mean pressure gradient and effective orifice area were significantly better with the Myval THV series compared to the SAPIEN THV series (p<0.0001) and better with the Evolut THV series than with the Myval THV series (p<0.0001). At 30 days, the proportion of moderate to severe prosthetic valve regurgitation was numerically higher with the Evolut THV series compared to the Myval THV series (7.4% vs 3.4%; p=0.06), while not significantly different between the Myval THV series and the SAPIEN THV series (3.4% vs 1.6%; p=0.32).

Conclusions: The Myval THV series is non-inferior to the SAPIEN THV series and the Evolut THV series in terms of the primary composite endpoint at 30 days.

Clinical trial registration: ClinicalTrials.gov: NCT04275726; EudraCT number 2020-000,137-40.

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Conflict of interest statement

N. van Royen reports grant funding and personal fees from Abbott; grants from Philips, Biotronik, and Medtronic; speaker fees from MicroPort, Bayer, and RainMed Medical outside the submitted work; and travel support to attend meeting from Meril Life Sciences. I.J. Amat-Santos reports being a proctor for Medtronic, Boston Scientific, and Meril Life Sciences. A. Ijsselmuiden reports consulting fees from Meril Life Sciences, Angiocare, PulseCath, and Cardiawave; received an institutional grant from Medtronic and Abbott. D. Unic reports payment for workshops from Medtronic; and is a member of the Medtronic EMEA surgical advisory board. B. Merkely reports institutional grants and speaker fees from Abbott, AstraZeneca, Biotronik, Boehringer Ingelheim, CSL Behring, Daiichi Sankyo, DUKE Clinical Institute, Medtronic, and Novartis; institutional fees from Boston Scientific, Bristol-Myers Squibb, Eli Lilly, Terumo, and VIFOR Pharma. R.S. Hermanides reports speaker fees from Amgen, Novartis, Edwards Lifesciences, Meril Life Sciences, and Abbott outside the submitted work. P. Martin reports a proctorship grant from Meril Life Sciences; and an educational event grant from Medtronic. E. van Belle is president of the French Interventional Working Group (GACI) and a Board member of EAPCI. A. Linke received grants from Edward Lifesciences and Novartis; speaker honoraria from Edwards Lifesciences, Abiomed, Abbott, Boston Scientific, Novartis, Pfizer, BMS, Daiichi Sankyo, AstraZeneca, Boehringer Ingelheim, Meril Life Sciences, and Corvia; travel support from AstraZeneca, Abbott, Meril Life Sciences, Abiomed and Boston Scientific; is a partial patent holder with Boston Scientific; is a stock option holder with Pi-Cardia, Transverse Medical and Filterlex. K. Toutouzas reports proctorship with Abbott, Meril Life Sciences and Medtronic; consulting fees from Gore Medical; is a Board member of the Hellenic Society of Cardiology. M. De Sousa Almeida reports lecture fees from Medtronic and Novartis; travel support from Medtronic, Terumo and Boston Scientific. F. Bedogni reports grants, consulting fees, payment/honoraria/speaker fees and travel support to attend meetings from Medtronic, Abbott, Boston Scientific and Meril Life Sciences; and reports participation in a DSMB for Abbott. M. Pan reports lecture fees from Medtronic and Abbott. O. Angerås reports proctorship and speaker fees with Meril Life Sciences and Abbott; speaker fees from Medtronic; and support for attending meetings from Meril Life Sciences. W.-K. Kim reports honoraria or consultancy fees from Edwards Lifesciences; consulting fees from Boston Scientific, Meril Life Sciences and Abbott; and participation on data and safety monitoring board for HID Imaging and P&F. J. Rothe reports personal fees for consulting/proctoring from Meril Life Sciences, Medtronic, and Qatna; and travel support for attending meetings from Meril Life Sciences, Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific. D Westermann reports personal fees from Abiomed, AstraZeneca, Boehringer Ingelheim, Novartis, Meril Life Sciences and Medtronic. A. Tobe reports a grant from the Fukuda Foundation for Medical Technology. S. Garg reports honoraria or consultancy fees from Biosensors. U. Chandra and A. Thakkar are full employees of Meril Life Sciences. M.-C. Morice reports that she is shareholder and CEO of CERC, a CRO involved in the trial; and minor shareholder of Electroducer. O. Soliman reports research grants from Biosensors, Boston Scientific, Cardiawave and Meril Life Sciences. P.W. Serruys reports consultancy fees from SMT, Novartis, Meril Life Sciences, and Philips. A. Baumbach reports consultation and speaker fees from AstraZeneca, Sinomed, MicroPort, Medtronic, Faraday, Pi-Cardia, Biosensors, JenaValve and Meril Life Sciences. The other authors have no conflicts of interest to declare.

References

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