Tevaearai Stahel Hendrik T, Weiss Gabriel, Landowski Peter, Folkmann Sandra, Harrer Marieluise, Voet Bernard, Grabenwöger Martin
Cardiovascular Department, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Department of Cardiovascular Surgery, Clinic Floridsdorf, Vienna, Austria.
Front Cardiovasc Med. 2025 May 15;12:1587713. doi: 10.3389/fcvm.2025.1587713. eCollection 2025.
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 Cardioplexol™ solution.
Single-centre, single-blind, randomized, active-controlled phase-3 non-inferiority trial comparing Cardioplexol™ 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 h post-reperfusion was defined as primary endpoint. Intraoperative and ICU-related secondary endpoints were also evaluated, as were safety endpoints.
Out of 248 operated patients, 226 (100 Cardioplexol™, 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 Cardioplexol™ was confirmed. Delay before complete cardiac arrest (11 vs. 71 s, < 0.001) and cross-clamp time (51.2 vs. 60.7 min, < 0.001) were shorter after Cardioplexol™. The defibrillation rate was also significantly reduced (10% vs. 52%, < 0.001). Although not statistically significant, cumulative dose of catecholamines within 24 h postreperfusion (6,202 vs. 7,170 µg/kg, = 0.07), and ICU stay (38.1 vs. 44.0 h, = 0.110) also appeared reduced after Cardioplexol™. Mortality was lower after Cardioplexol™ (1 pt. vs. 5 pts.). Safety parameters were comparable in both groups.
Efficacy and safety of Cardioplexol™ were demonstrated.
https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-004198-10/results, Eudra CT-No: 2011-004198-10.
有效且可靠的心脏停搏对于最大化心肌保护和维持术后收缩功能至关重要。本研究的目的是根据正在进行的欧洲注册程序，证明新型Cardioplexol™溶液的有效性和安全性。
一项单中心、单盲、随机、活性对照的3期非劣效性试验，比较心脏手术期间Cardioplexol™溶液和巴克伯格溶液。计划进行择期冠状动脉搭桥术、瓣膜手术和/或主动脉根部手术的患者，在符合所有纳入和排除标准后被认为符合条件。再灌注后24小时内的肌钙蛋白-T峰值（TnT）被定义为主要终点。还评估了术中及重症监护病房相关的次要终点以及安全性终点。
在248例接受手术的患者中，226例（100例使用Cardioplexol™，126例使用巴克伯格溶液）被纳入符合方案分析。两组的TnT峰值相似（0.77对0.78 ng/ml），并证实了Cardioplexol™的非劣效性。使用Cardioplexol™后，完全心脏停搏前的延迟时间（11对71秒，<0.001）和主动脉阻断时间（51.2对60.7分钟，<0.001）更短。除颤率也显著降低（10%对52%，<0.001）。尽管无统计学意义，但再灌注后24小时内儿茶酚胺的累积剂量（6202对7170 μg/kg，P = 0.07）以及重症监护病房停留时间（38.1对44.0小时，P = 0.110）在使用Cardioplexol™后也似乎有所减少。使用Cardioplexol™后的死亡率更低（1例对5例）。两组的安全性参数相当。
证明了Cardioplexol™的有效性和安全性。
