The second-generation SAPIEN XT balloon-expandable valve was found to have a higher 5-year rate of structural valve deterioration (SVD) compared with surgical aortic valve replacement (SAVR) and the third-generation SAPIEN 3, according to study results published in the Journal of the American College of Cardiology.

Investigators sought to compare the 5-year incidence of SVD in intermediate-risk patients with severe aortic stenosis who had transcatheter aortic valve replacement (TAVR) or SAVR in the PARTNER (Placement of Aortic Transcatheter Valves) 2A trial and registry (ClinicalTrials.gov Identifier: NCT01314313). Patients were randomly assigned to receive TAVR with the SAPIEN XT or SAVR. In the SAPIEN 3 registry, patients were assigned to TAVR with the SAPIEN 3 (ClinicalTrials.gov Identifier: NCT03222128).

The study’s primary end point was the incidence of SVD, a composite of SVD-related hemodynamic valve deterioration during echocardiographic follow-up and/or SVD-related bioprosthetic valve failure (BVF) at 5 years.

Participants were grouped into 3 cohorts: SAPIEN XT TAVR (n=774; mean age, 81.6±6.5; 52.8% men); SAVR (n=664; mean age, 81.4±6.7; 54.2% men); and SAPIEN 3 TAVR (n=891; mean age, 81.8±6.6; 60.9% men).


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Patients receiving SAPIEN-XT TAVR vs SAVR had greater: 5-year exposure-adjusted incidence rate of SVD (1.61±0.24% vs 0.63±0.16% per 100 patient-years, respectively), SVD-related BVF (0.58±0.14% vs 0.12±0.07% per 100 patient-years, respectively), and all-cause (structural or nonstructural) BVF (0.81±0.16% vs 0.27±0.10% per 100 patient-years, respectively’ P ≤.01 for all).

Participants in the SAPIEN 3 TAVR group and in a propensity score–matched SAVR cohort had comparable 5-year rates of: SVD (0.68±0.18% vs 0.60±0.17%, respectively; P =.71), SVD-related BVF (0.29±0.12% vs 0.14±0.08%, respectively; P = 0.25), and all-cause BVF (0.60±0.15% vs 0.32±0.11%; P =.32, respectively). In addition, the 5-year rates of SVD and SVD-related BVF were significantly lower in the SAPIEN 3 group compared with the matched SAPIEN XT TAVR cohort.

Among several Study limitations include the fact that randomization was conducted in the SAPIEN XT vs SAVR comparison but not in SAPIEN 3 vs SAVR comparison. Also, the occurrence of echocardiography-defined stage 2 or 3 SVD could not be assessed in 22% of this population because echocardiograms were not available or incomplete.

“[These results support the] use of the SAPIEN 3 valve as an alternative to SAVR in patients at high, intermediate, or low surgical risk,” concluded the study authors.

Disclosures: Edwards Lifesciences sponsored the PARTNER 2A trial and SAPIEN 3 study, and some of the authors declared affiliations with medical device companies. Please see the original reference for a full list of disclosures.

Reference

Pibarot P, Ternacle J, Jaber WA, et al. Structural deterioration of transcatheter versus surgical aortic valve bioprostheses in the PARTNER-2 trial. J Am Coll Cardiol. 2020;76(16):1830-1843.