22 Dec 2017
ACURATE neo™ Aortic Valve System shows safety & efficacy results comparable to SAPIEN 3
Sponsored by Boston Scientific
Multi-centre propensity-matched comparison study1 between ACURATE neo Aortic Valve System and Edwards SAPIEN 3 Transcatheter Heart Valve, published in October’s edition of the Journal of the American College of Cardiology (JACC) shows comparable procedural outcomes.
List of outcomes:
- Observational, propensity-matched multicenter comparison of ACURATE neo and SAPIEN 3 from 3 high volume centers in Germany (DHZ Munich, UK Regensburg, Kerckhoff Klinikum Bad Nauheim)
- 1,121 consecutive patients between Jan. 2014 and Jan. 2016 with symptomatic, severe stenosis of the native aortic valve treated with transfemoral TAVI using ACURATE neo (n = 311) or SAPIEN 3 (n = 810)
- To increase statistical power, a 1-to-2 nearest neighbor matching was used to identify 2 control cases treated with SAPIEN 3 (n = 622) for each case treated with ACURATE neo (n = 311)
- Endpoints: device failure and early safety composite endpoint at 30 days according to VARC-2 criteria
Key facts highlighted in the study:
Comparable performance for ACURATE neo and SAPIEN 3 with no significant differences at 30 days in safety outcomes, including the VARC-2 early safety and device failure composite endpoints.*
© Europa Group – Original recording at PCR London Valves 2017
References
* Comparable VARC-2 device failure composite endpoint with ACURATE neo versus SAPIEN 3 (10.9% vs. 9.6%, p=n.s.) and early safety composite endpoint (15.8% vs. 15.6%, p=n.s.).
** According to VARC-2, elevated gradients >20 mmHg are defined as mild stenosis, are assessed as Device Failure and may indicate prosthetic valve dysfunction.
- Husser O, et al. Multicenter comparison of novel self-expanding versus balloon-expandable transcatheter heart valves. JACC Cardiovasc Interv. 2017 Oct 23;10(20):2078-2087.
SH-512201-AA NOV2017
Page published on December 2017
With an unrestricted educational grant from Boston Scientific
