Final 3-Year Outcomes of a Randomized Trial Comparing a Self-Expanding to a Balloon-Expandable Transcatheter Aortic Valve
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Final 3-Year Outcomes of a Randomized Trial Comparing a Self-Expanding to a Balloon-Expandable Transcatheter Aortic Valve. / Lanz, Jonas; Möllmann, Helge; Kim, Won-Keun; Burgdorf, Christof; Linke, Axel; Redwood, Simon; Hilker, Michael; Joner, Michael; Thiele, Holger; Conzelmann, Lars; Conradi, Lenard; Kerber, Sebastian; Thilo, Christian; Toggweiler, Stefan; Prendergast, Bernard; Husser, Oliver; Stortecky, Stefan; Deckarm, Sarah; Künzi, Arnaud; Heg, Dik; Walther, Thomas; Windecker, Stephan; Pilgrim, Thomas; SCOPE I Investigators.
In: CIRC-CARDIOVASC INTE, Vol. 16, No. 7, 07.2023, p. e012873.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Final 3-Year Outcomes of a Randomized Trial Comparing a Self-Expanding to a Balloon-Expandable Transcatheter Aortic Valve
AU - Lanz, Jonas
AU - Möllmann, Helge
AU - Kim, Won-Keun
AU - Burgdorf, Christof
AU - Linke, Axel
AU - Redwood, Simon
AU - Hilker, Michael
AU - Joner, Michael
AU - Thiele, Holger
AU - Conzelmann, Lars
AU - Conradi, Lenard
AU - Kerber, Sebastian
AU - Thilo, Christian
AU - Toggweiler, Stefan
AU - Prendergast, Bernard
AU - Husser, Oliver
AU - Stortecky, Stefan
AU - Deckarm, Sarah
AU - Künzi, Arnaud
AU - Heg, Dik
AU - Walther, Thomas
AU - Windecker, Stephan
AU - Pilgrim, Thomas
AU - SCOPE I Investigators
PY - 2023/7
Y1 - 2023/7
N2 - BACKGROUND: In the SCOPE I trial (Safety and Efficacy of the Symetis ACURATE Neo/TF Compared to the Edwards SAPIEN 3 Bioprosthesis), transcatheter aortic valve implantation with the self-expanding ACURATE neo (NEO) did not meet noninferiority compared with the balloon-expandable SAPIEN 3 (S3) device regarding a composite end point at 30 days due to higher rates of prosthetic valve regurgitation and acute kidney injury. Data on long-term durability of NEO are scarce. Here, we report whether early differences between NEO and S3 translate into differences in clinical outcomes or bioprosthetic valve failure 3 years after transcatheter aortic valve implantation.METHODS: Patients with severe aortic stenosis were randomized to transfemoral transcatheter aortic valve implantation with NEO or S3 at 20 European centers. Clinical outcomes at 3 years are compared using Cox proportional or Fine-Gray subdistribution hazard models by intention-to-treat. Bioprosthetic valve failure is reported for the valve-implant cohort.RESULTS: Among 739 patients, 84 of 372 patients (24.3%) had died in the NEO and 85 of 367 (25%) in the S3 group at 3 years. Comparing NEO with S3, the 3-year rates of all-cause death (hazard ratio, 0.98 [95% CI, 0.73-1.33]), stroke (subhazard ratio, 1.04 [95% CI, 0.56-1.92]), and hospitalization for congestive heart failure (subhazard ratio, 0.74 [95% CI, 0.51-1.07]) were similar between the groups. Aortic valve reinterventions were required in 4 NEO and 3 S3 patients (subhazard ratio, 1.32 [95% CI, 0.30-5.85]). New York Heart Association functional class ≤II was observed in 84% (NEO) and 85% (S3), respectively. Mean gradients remained lower after NEO at 3 years (8 versus 12 mm Hg; P<0.001).CONCLUSIONS: Early differences between NEO and S3 did not translate into significant differences in clinical outcomes or bioprosthetic valve failure throughout 3 years.REGISTRATION: URL: https://clinicaltrials.gov, Unique identifier: NCT03011346.
AB - BACKGROUND: In the SCOPE I trial (Safety and Efficacy of the Symetis ACURATE Neo/TF Compared to the Edwards SAPIEN 3 Bioprosthesis), transcatheter aortic valve implantation with the self-expanding ACURATE neo (NEO) did not meet noninferiority compared with the balloon-expandable SAPIEN 3 (S3) device regarding a composite end point at 30 days due to higher rates of prosthetic valve regurgitation and acute kidney injury. Data on long-term durability of NEO are scarce. Here, we report whether early differences between NEO and S3 translate into differences in clinical outcomes or bioprosthetic valve failure 3 years after transcatheter aortic valve implantation.METHODS: Patients with severe aortic stenosis were randomized to transfemoral transcatheter aortic valve implantation with NEO or S3 at 20 European centers. Clinical outcomes at 3 years are compared using Cox proportional or Fine-Gray subdistribution hazard models by intention-to-treat. Bioprosthetic valve failure is reported for the valve-implant cohort.RESULTS: Among 739 patients, 84 of 372 patients (24.3%) had died in the NEO and 85 of 367 (25%) in the S3 group at 3 years. Comparing NEO with S3, the 3-year rates of all-cause death (hazard ratio, 0.98 [95% CI, 0.73-1.33]), stroke (subhazard ratio, 1.04 [95% CI, 0.56-1.92]), and hospitalization for congestive heart failure (subhazard ratio, 0.74 [95% CI, 0.51-1.07]) were similar between the groups. Aortic valve reinterventions were required in 4 NEO and 3 S3 patients (subhazard ratio, 1.32 [95% CI, 0.30-5.85]). New York Heart Association functional class ≤II was observed in 84% (NEO) and 85% (S3), respectively. Mean gradients remained lower after NEO at 3 years (8 versus 12 mm Hg; P<0.001).CONCLUSIONS: Early differences between NEO and S3 did not translate into significant differences in clinical outcomes or bioprosthetic valve failure throughout 3 years.REGISTRATION: URL: https://clinicaltrials.gov, Unique identifier: NCT03011346.
KW - Humans
KW - Aortic Valve/diagnostic imaging
KW - Aortic Valve Stenosis/diagnostic imaging
KW - Prosthesis Design
KW - Heart Valve Prosthesis
KW - Treatment Outcome
KW - Transcatheter Aortic Valve Replacement/adverse effects
U2 - 10.1161/CIRCINTERVENTIONS.123.012873
DO - 10.1161/CIRCINTERVENTIONS.123.012873
M3 - SCORING: Journal article
C2 - 37417229
VL - 16
SP - e012873
JO - CIRC-CARDIOVASC INTE
JF - CIRC-CARDIOVASC INTE
SN - 1941-7640
IS - 7
ER -
