Propensity-Matched Comparison of Evolut-R Transcatheter Aortic Valve Implantation With Surgery in Intermediate-Risk Patients (from the SURTAVI Trial) - 26/08/20
, Nicolas M. Van Mieghem, MD, PhD b, Michael J. Reardon, MD c, Patrick W. Serruys, MD, PhD d, Hemal Gada, MD e, Mubashir Mumtaz, MD e, G. Michael Deeb, MD f, Susheel Kodali, MD g, Isaac George, MD g, Stephan Windecker, MD, PhD h, Neal Kleiman, MD c, Stanley J. Chetcuti, MD f, Carlos Sanchez, MD a, Harold L. Dauerman, MD i, Shuzhen Li, PhD j, Jeffrey J. Popma, MD kHighlights |
• | One hundred and ninety-seven matched pairs of patients receiving TAVR with Evolut R or SAVR were analyzed. |
• | TAVI resulted in significantly better hemodynamics outcomes compared to SAVR. |
• | At 30 days, all-cause mortality or disabling stroke significantly lower with TAVI. |
• | At 1 year, clinical outcomes were comparable between TAVI and SAVR. |
Résumé |
The SURTAVI trial demonstrated the noninferiority of transcatheter aortic valve implantation (TAVI) to surgical aortic valve replacement (SAVR) in patients with severe, symptomatic aortic stenosis at intermediate surgical risk. Most TAVI patients received an early generation device which is no longer commercially available. This analysis compares TAVI outcomes in patients that received the Evolut R valve to those of similar patients randomized to SAVR in the SURTAVI trial. The continued access study of SURTAVI (CAS) enrolled 290 patients. Of them, 252 were implanted with the 23, 26, or 29 mm Evolut R device. Propensity-score matching between this group and SURTAVI SAVR patients with annular diameter of 26 mm or less was based on 22 clinical characteristics, resulting in 197 matched pairs for analysis. The primary end point for comparison was the rate of all-cause mortality or disabling stroke at 1-year. The mean age for TAVI and SAVR patients in the propensity-score matched population was 79.1 years and STS-PROM was 4.0 ± 1.5% for TAVI and 3.9% ± 1.3% for SAVR. The rate of all-cause mortality or disabling stroke at 30-days significantly favored TAVI (0.5% vs 5.1%; p = 0.006). At 1-year TAVI was numerically favored (4.1% vs 8.2%; p = 0.082). In conclusion, compared with SAVR, TAVI using Evolut R had a favorable 30-day safety profile, significantly better hemodynamic performance, and a comparable 1-year rate of all-cause mortality or disabling stroke, suggesting this may be a preferred treatment for patients with severe, symptomatic aortic stenosis at intermediate surgical risk.
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| ClinicalTrials.gov Identifier: NCT01586910 |
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| Funding: Medtronic (Minneapolis, Minnesota) funded the SURTAVI Trial |
Vol 131
P. 82-90 - septembre 2020 Retour au numéro
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