3-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis
Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved..
BACKGROUND: Randomized data comparing outcomes of transcatheter aortic valve replacement (TAVR) with surgery in low-surgical risk patients at time points beyond 2 years is limited. This presents an unknown for physicians striving to educate patients as part of a shared decision-making process.
OBJECTIVES: The authors evaluated 3-year clinical and echocardiographic outcomes from the Evolut Low Risk trial.
METHODS: Low-risk patients were randomized to TAVR with a self-expanding, supra-annular valve or surgery. The primary endpoint of all-cause mortality or disabling stroke and several secondary endpoints were assessed at 3 years.
RESULTS: There were 1,414 attempted implantations (730 TAVR; 684 surgery). Patients had a mean age of 74 years and 35% were women. At 3 years, the primary endpoint occurred in 7.4% of TAVR patients and 10.4% of surgery patients (HR: 0.70; 95% CI: 0.49-1.00; P = 0.051). The difference between treatment arms for all-cause mortality or disabling stroke remained broadly consistent over time: -1.8% at year 1; -2.0% at year 2; and -2.9% at year 3. The incidence of mild paravalvular regurgitation (20.3% TAVR vs 2.5% surgery) and pacemaker placement (23.2% TAVR vs 9.1% surgery; P < 0.001) were lower in the surgery group. Rates of moderate or greater paravalvular regurgitation for both groups were <1% and not significantly different. Patients who underwent TAVR had significantly improved valve hemodynamics (mean gradient 9.1 mm Hg TAVR vs 12.1 mm Hg surgery; P < 0.001) at 3 years.
CONCLUSIONS: Within the Evolut Low Risk study, TAVR at 3 years showed durable benefits compared with surgery with respect to all-cause mortality or disabling stroke. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283).
| Errataetall: |
CommentIn: Nat Rev Cardiol. 2023 May;20(5):284. - PMID 36944791 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:81 |
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| Enthalten in: |
Journal of the American College of Cardiology - 81(2023), 17 vom: 02. Mai, Seite 1663-1674 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Forrest, John K [VerfasserIn] |
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| Links: |
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| Themen: |
Aortic stenosis |
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| Anmerkungen: |
Date Completed 28.04.2023 Date Revised 08.02.2024 published: Print-Electronic ClinicalTrials.gov: NCT02701283 CommentIn: Nat Rev Cardiol. 2023 May;20(5):284. - PMID 36944791 Citation Status MEDLINE |
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| doi: |
10.1016/j.jacc.2023.02.017 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 245 | 1 | 0 | |a 3-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis |
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| 500 | |a Date Completed 28.04.2023 | ||
| 500 | |a Date Revised 08.02.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT02701283 | ||
| 500 | |a CommentIn: Nat Rev Cardiol. 2023 May;20(5):284. - PMID 36944791 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved. | ||
| 520 | |a BACKGROUND: Randomized data comparing outcomes of transcatheter aortic valve replacement (TAVR) with surgery in low-surgical risk patients at time points beyond 2 years is limited. This presents an unknown for physicians striving to educate patients as part of a shared decision-making process | ||
| 520 | |a OBJECTIVES: The authors evaluated 3-year clinical and echocardiographic outcomes from the Evolut Low Risk trial | ||
| 520 | |a METHODS: Low-risk patients were randomized to TAVR with a self-expanding, supra-annular valve or surgery. The primary endpoint of all-cause mortality or disabling stroke and several secondary endpoints were assessed at 3 years | ||
| 520 | |a RESULTS: There were 1,414 attempted implantations (730 TAVR; 684 surgery). Patients had a mean age of 74 years and 35% were women. At 3 years, the primary endpoint occurred in 7.4% of TAVR patients and 10.4% of surgery patients (HR: 0.70; 95% CI: 0.49-1.00; P = 0.051). The difference between treatment arms for all-cause mortality or disabling stroke remained broadly consistent over time: -1.8% at year 1; -2.0% at year 2; and -2.9% at year 3. The incidence of mild paravalvular regurgitation (20.3% TAVR vs 2.5% surgery) and pacemaker placement (23.2% TAVR vs 9.1% surgery; P < 0.001) were lower in the surgery group. Rates of moderate or greater paravalvular regurgitation for both groups were <1% and not significantly different. Patients who underwent TAVR had significantly improved valve hemodynamics (mean gradient 9.1 mm Hg TAVR vs 12.1 mm Hg surgery; P < 0.001) at 3 years | ||
| 520 | |a CONCLUSIONS: Within the Evolut Low Risk study, TAVR at 3 years showed durable benefits compared with surgery with respect to all-cause mortality or disabling stroke. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283) | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a aortic stenosis | |
| 650 | 4 | |a low risk | |
| 650 | 4 | |a self-expanding | |
| 650 | 4 | |a surgical aortic valve replacement | |
| 650 | 4 | |a transcatheter aortic valve replacement | |
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