TY - JOUR

T1 - Two-year clinical outcomes after successful transcatheter aortic valve implantation with balloon-expandable versus self-expanding valves

T2 - A subanalysis of the GALILEO trial

AU - Okuno, Taishi

AU - Dangas, George D.

AU - Hengstenberg, Christian

AU - Sartori, Samantha

AU - Herrmann, Howard C.

AU - de Winter, Robert

AU - Gilard, Martine

AU - Tchétché, Didier

AU - Möllmann, Helge

AU - Makkar, Raj R.

AU - Baldus, Stephan

AU - De Backer, Ole

AU - Bendz, Bjørn

AU - Kini, Annapoorna

AU - von Lewinski, Dirk

AU - Mack, Michael

AU - Moreno, Raúl

AU - Schäfer, Ulrich

AU - Wöhrle, Jochen

AU - Seeger, Julia

AU - Snyder, Clayton

AU - Nicolas, Johny

AU - Tijssen, Jan G.P.

AU - Welsh, Robert C.

AU - Vranckx, Pascal

AU - Valgimigli, Marco

AU - Mehran, Roxana

AU - Kapadia, Samir

AU - Sondergaard, Lars

AU - Windecker, Stephan

N1 - Funding Information: The GALILEO trial was supported by the sponsors, Bayer, and Janssen Pharmaceuticals and data from this trial provided to the authors of this publication. Funding Information: Stephan Windecker reports research and educational grants to the institution from Abbott, Amgen, Astra Zeneca, BMS, Bayer, Biotronik, Boston Scientific, Cardinal Health, CardioValve, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Guerbet, InfraRedx, Johnson & Johnson, Medicure, Medtronic, Novartis, Polares, OrPha Suisse, Pfizer, Regeneron, Sanofi‐Aventis, Sinomed, Terumo, and V‐Wave. Stephan Windecker serves as unpaid advisory board member and/or unpaid member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, Astra Zeneca, Bayer. BMS, Boston Scientific, Biotronik, Cardiovalve, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Sinomed, Terumo, V‐Wave and Xeltis, but has not received personal payments by pharmaceutical companies or device manufacturers. He is also member of the steering/executive committee group of several investigator‐initiated trials that receive funding by industry without impact on his personal remuneration. Taishi Okuno reports speaker fees from Abbott. Lars Sondergaard has received consultant fees and/or institutional research grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and Sahajanand Medical Technologies Limited. Helge Möllmann reports speaker fees from Astra Zeneca, Abbott, Bayer, BMS, Boehringer Ingelheim, Boston Scientific, Daiichi Sankyo, Edwards Lifesciences, Pfizer, and SMT. Stephan Baldus reports lectures/consultant fees from Edwards Lifesciences, and Abbott Vascular. Robert Welsh reports research grants from Astra Zeneca, Bayer, and Pfizer. Raul Moreno reports lectures/consultant fees from Edwards Lifesciences, Medtrnoic, Abbott Vascular, Boston Scientific, and Biosensors. Raul Moreno is a proctor for Boston Scientific, Biosensors, and Abbott Vascular. Dr. Herrmann reports institutional research funding from Abbott, Bayer, Boston Scientific, Edwards Lifesciences and Medtronic; consultant fees and speaking honoraria from Edwards Lifesciences and Medtronic. Ulrich Schäfer reports lectures/consultant fees from Edwards Lifesciences, Medtrnoic, Abbott Vascular, and Boston Scientific and grant support from Bayer. Pascal Vranckx reports research and educational grants to the institution from Abbott, Boston Scientific, Daiichi Sankyo, Medtronic, and Terumo. Pascal Vranckx serves as unpaid advisory board member for Abbott. Pascal Vranckx received personal fees from Bayer AG. Pascal Vranckx received personal fees from Daiichi Sankyo, CLS Behring outside the context of this trial. He is also member of the steering/executive committee group of investigator‐initiated trials that receive funding by industry without impact on his personal remuneration. The remaining authors declare no conflict of interest.

PY - 2022

Y1 - 2022

N2 - Background: Midterm data comparing clinical outcomes after successful implantation of self-expanding and balloon-expandable transcatheter heart valves (THV) are limited. We aimed to compare 2-year outcomes after successful transcatheter aortic valve implantation (TAVI) with the Edwards balloon-expandable or the Medtronic self-expanding THV. Methods: Two-year outcomes were analyzed according to the implanted THV in the GALILEO trial. Major adverse cardiac and cerebrovascular events (MACCE) was a composite of all-cause death or thromboembolic events including stroke, myocardial infarction, symptomatic valve thrombosis, systemic embolism, deep-vein thrombosis, or pulmonary embolism. Results: Among 1644 patients recruited in 136 centers across 16 countries between 2015 and 2018, 499 received a self-expanding and 757 patients received a balloon-expandable THV. Patients treated with a self-expanding THV were more likely to be female, and had higher surgical risk, lower hemoglobin levels, and more frequent valve-in-valve procedures than those with a balloon-expandable THV. After multivariable adjustment, there were no significant differences in major clinical outcomes between self-expanding versus balloon-expandable THV: MACCE (17.0% vs. 13.4%, adjusted-hazard ratios [HR] 1.18, 95% confidence intervals [CI]: 0.82−1.69); all-cause death (11.4% vs. 9.3%, adjusted-HR 1.26; 95% CI: 0.78−2.05); cardiovascular death (8.5% vs. 4.0%, adjusted-HR 1.53; 95% CI: 0.82−2.86), any stroke (5.1% vs. 3.7%, adjusted-HR 0.86; 95% CI: 0.43−1.73); major or life-threatening bleeding (5.9% vs. 6.8%, adjusted-HR 0.93; 95% CI: 0.53−1.63). Clinical Trial Registration: https://www.clinicaltrials.gov. NCT02556203. Conclusions: Two-year follow-up data from the GALILEO trial indicate that successful TAVI either with self-expanding or balloon-expandable THVs according to physician discretion did not show difference in rates of MACCE.

AB - Background: Midterm data comparing clinical outcomes after successful implantation of self-expanding and balloon-expandable transcatheter heart valves (THV) are limited. We aimed to compare 2-year outcomes after successful transcatheter aortic valve implantation (TAVI) with the Edwards balloon-expandable or the Medtronic self-expanding THV. Methods: Two-year outcomes were analyzed according to the implanted THV in the GALILEO trial. Major adverse cardiac and cerebrovascular events (MACCE) was a composite of all-cause death or thromboembolic events including stroke, myocardial infarction, symptomatic valve thrombosis, systemic embolism, deep-vein thrombosis, or pulmonary embolism. Results: Among 1644 patients recruited in 136 centers across 16 countries between 2015 and 2018, 499 received a self-expanding and 757 patients received a balloon-expandable THV. Patients treated with a self-expanding THV were more likely to be female, and had higher surgical risk, lower hemoglobin levels, and more frequent valve-in-valve procedures than those with a balloon-expandable THV. After multivariable adjustment, there were no significant differences in major clinical outcomes between self-expanding versus balloon-expandable THV: MACCE (17.0% vs. 13.4%, adjusted-hazard ratios [HR] 1.18, 95% confidence intervals [CI]: 0.82−1.69); all-cause death (11.4% vs. 9.3%, adjusted-HR 1.26; 95% CI: 0.78−2.05); cardiovascular death (8.5% vs. 4.0%, adjusted-HR 1.53; 95% CI: 0.82−2.86), any stroke (5.1% vs. 3.7%, adjusted-HR 0.86; 95% CI: 0.43−1.73); major or life-threatening bleeding (5.9% vs. 6.8%, adjusted-HR 0.93; 95% CI: 0.53−1.63). Clinical Trial Registration: https://www.clinicaltrials.gov. NCT02556203. Conclusions: Two-year follow-up data from the GALILEO trial indicate that successful TAVI either with self-expanding or balloon-expandable THVs according to physician discretion did not show difference in rates of MACCE.

KW - aortic valve setenosis

KW - balloon-expandable valve

KW - GALILEO

KW - major adverse cardiac and cerebrovascular events

KW - self-expanding valve

KW - successful implantation

KW - transcatheter aortic valve implantation

KW - transcatheter heart valve

U2 - 10.1002/ccd.30370

DO - 10.1002/ccd.30370

M3 - Journal article

C2 - 36040717

AN - SCOPUS:85137335601

VL - 100

SP - 636

EP - 645

JO - Catheterization and Cardiovascular Interventions

JF - Catheterization and Cardiovascular Interventions

SN - 1522-1946

IS - 4

ER -