Abstract
Objectives: The purpose of this study was to evaluate clinical and echocardiographic outcome data of the CHOICE (Randomized Comparison of Transcatheter Heart Valves in High Risk Patients with Severe Aortic Stenosis: Medtronic CoreValve Versus Edwards SAPIEN XT) trial at 5 years. Background: The CHOICE trial was designed to compare device performance of a balloon-expandable (BE) transcatheter heart valve (THV) versus a self-expanding (SE) THV. Methods: The CHOICE trial is an investigator-initiated trial that randomized 241 high-risk patients with severe symptomatic aortic stenosis and an anatomy suitable for treatment with both BE and SE THVs to transfemoral transcatheter aortic valve replacement with either device. The primary endpoint was device success. Patients were followed up to 5 years, with assessment of clinical outcomes, and echocardiographic evaluation of valve function and THV durability. Results: After 5 years, there were no statistically significant differences between BE and SE valves in the cumulative incidence of death from any cause (53.4% vs. 47.6%; p = 0.38), death from cardiovascular causes (31.6% vs. 21.5%; p = 0.12), all strokes (17.5% vs. 16.5%; p = 0.73), and repeat hospitalization for heart failure (28.9% vs. 22.5%; p = 0.75). SE patients had larger prosthetic valve area (1.6 ± 0.5 cm2 vs. 1.9 ± 0.5 cm2; p = 0.02) with a lower mean transprosthetic gradient (12.2 ± 8.7 mm Hg vs. 6.9 ± 2.7 mm Hg; p = 0.001) at 5 years. No differences were observed in the rates of paravalvular regurgitation. Clinical valve thrombosis occurred in 7 BE patients (7.3%) and 1 SE patient (0.8%; p = 0.06), and moderate or severe structural valve deterioration in 6 BE patients (6.6%) and no SE patient (0%; p = 0.018). The rate of bioprosthetic valve failure was low and not significantly different between both groups (4.1% vs. 3.4%; p = 0.63). Conclusions: Five-year follow-up of patients in the CHOICE trial revealed clinical outcomes after transfemoral transcatheter aortic valve replacement with early-generation BE and SE valves that were not statistically significantly different, with limited statistical power. Forward flow hemodynamics were significantly better with the SE valve. Moderate or severe structural valve deterioration was uncommon but occurred more frequently with the BE valve. (A Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: The CHOICE Trial [CHOICE]; NCT01645202)
| Original language | English |
|---|---|
| Journal | JACC: Cardiovascular Interventions |
| Volume | 13 |
| Issue number | 9 |
| Pages (from-to) | 1071-1082 |
| Number of pages | 12 |
| ISSN | 1936-8798 |
| DOIs | |
| Publication status | Published - 11.05.2020 |
Funding
Funded by the Heart Center, Segeberger Kliniken GmbH, Bad Segeberg, Germany. Dr. Abdel-Wahab has been a proctor and consultant for Boston Scientific and Medtronic. Dr. Neumann has received institutional research grants, consultancy fees, and speaker honoraria from Edwards Lifesciences, Daiichi-Sankyo, AstraZeneca, Sanofi, Bayer, The Medicines Company, Bristol-Myers Squibb, Novartis, Roche, Boston Scientific, Biotronik, Ferrer, and Medtronic. Dr. Frerker has received speaker honoraria from Edwards Lifesciences. Dr. Richardt has received an institutional research grant from Biotronik, St. Jude Medical, and Medtronic; and is an advisory board member for Abbott Vascular and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
