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ORIGINAL RESEARCH article
Front. Cardiovasc. Med.
Sec. Cardiovascular Surgery
Volume 12 - 2025 | doi: 10.3389/fcvm.2025.1587713
Single-Centre, Single-Blind, Randomized, Active-Controlled Phase-3 Non-Inferiority Study to Investigate the Safety and Efficacy of the Cardioplegic Solution CardioplexolÔ Running Head: Pivotal study of CardioplexolÔ solution
Provisionally accepted
Hendrik Tevaearai Stahel1,2*
Gabriel Weiss3,4Peter Landowski3,4Sandra Folkmann3,4Marieluise Harrer3,4Bernard Voet5Martin Grabenwöger4,6,7- 1Cardiovascular Department, Inselspital, Bern University Hospital, University of Bern, Switzerland, Berne, Switzerland
- 2University of Bern, Bern, Bern, Switzerland
- 3Department of Cardiovascular Surgery, Clinic Floridsdorf, Vienna, Austria, Vienna, Austria
- 4Karl Landsteiner Institute for Cardiac and Vascular Surgical Research, Vienna, Austria
- 5Voet Consulting, Berlin, Germany
- 6Department of Cardiovascular Surgery, Clinic Floridsdorf, Vienna, Austria, Berlin, Austria
- 7Faculty of Medicine, Sigmund Freud Private University Vienna, Vienna, Austria
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Objectives: Effective and reliable cardioplegic cardiac arrest is crucial for maximizing myocardial protection and preserving postoperative contractile function. Aim of this study was to demonstrate, in line with an ongoing European registration procedure, the efficacy and safety of the new CardioplexolÔ solution.Methods: Single-centre, single-blind, randomized, active-controlled phase-3 non-inferiority trial comparing CardioplexolÔ and Buckberg solutions during cardiac surgery. Patients planed for elective CABG, valve surgery and/or aortic root surgery, were considered eligible after meeting all inclusion and exclusion criteria. Peak troponin-T (TnT) during the first 24-hours post-reperfusion was defined as primary endpoint. Intraoperative and ICU-related secondary endpoints were also evaluated, as were safety endpoints. Results: Out of 248 operated patients, 226 (100 CardioplexolÔ, 126 Buckberg) were considered for per-protocol analysis. Peak-TnT was similar in both groups (0.77 vs. 0.78 ng/ml) and non-inferiority of CardioplexolÔ was confirmed. Delay before complete cardiac arrest (11 vs. 71 sec, p<0.001) and cross-clamp time (51.2 vs. 60.7 min, p<0.001) were shorter after CardioplexolÔ. The defibrillation rate was also significantly reduced (10% vs. 52%, p<0.001). Although not statistically significant, cumulative dose of catecholamines within 24 hours postreperfusion (6'202 vs. 7'170 µg/kg, p=0.07), and ICU stay (38.1 vs. 44.0 hours, p=0.110) also appeared reduced after Cardioplexol TM . Mortality was lower after Cardioplexol TM (1 pt. vs. 5 pts.). Safety parameters were comparable in both groups.Efficacy and safety of Cardioplexol were demonstrated.
Keywords: cardiac surgery, Cardioplegic solution, cardioplegia, Myocardial protection, Extracorporeal Circulation, randomized controlled trial
Received: 04 Mar 2025; Accepted: 15 Apr 2025.
Copyright: © 2025 Tevaearai Stahel, Weiss, Landowski, Folkmann, Harrer, Voet and Grabenwöger. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Hendrik Tevaearai Stahel, Cardiovascular Department, Inselspital, Bern University Hospital, University of Bern, Switzerland, Berne, Switzerland
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