The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)
Super High-Pressure Balloon versus Scoring Balloon to Prepare Severely Calcified Coronary Lesions: The ISAR-CALC Randomized Trial
Tobias Rheude1; Himanshu Rai1; Gert Richardt2; Abdelhakim Allali2; Mohamed Abdel-Wahab3; Dmitriy S. Sulimov3; Kambis Mashayekhi4; Mohamed Ayoub4; Florim Cuculi5; Matthias Bossard5; Sebastian Kufner1; Erion Xhepa1; Adnan Kastrati1,8; Massimiliano Fusaro1; Michael Joner1,8; Robert A. Byrne6,7; Salvatore Cassese1;
1. Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Munich, Germany, GERMANY 2. Heart Center, Segeberger Kliniken, Bad Segeberg, Germany 3. Department of Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany 4. Division of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany 5. Department of Cardiology, Kantonspital Luzern, Switzerland 6. Cardiology Department, Mater Private Hospital, Ireland; 7.Cardiovascular Research, Royal College of Surgeons in Ireland, Dublin, Ireland 8. DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany
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Aims: The comparative efficacy of balloon-based techniques to prepare severely calcified coronary lesions before stenting remains poorly studied. We sought to compare stent expansion following preparation of severely calcified coronary lesions with either super high-pressure balloon or scoring balloon.
Methods and results: In this randomized, open-label trial 74 patients with severely calcified coronary lesions were enrolled at 5 centers in Germany and Switzerland. After unsuccessful lesion preparation with standard non-compliant balloon (<30% reduction of baseline diameter stenosis), participants were randomized to pre-dilation with either super high-pressure balloon or scoring balloon before drug-eluting stent (DES) implantation. The primary endpoint of the study was stent expansion index as assessed by optical coherence tomography (OCT). The key secondary endpoints included angiographic, strategy and procedural success. OCT data after DES implantation was available for 70 patients (94.6%). Lesion preparation with super high-pressure balloon versus scoring balloon led to comparable stent expansion index (0.72±0.12 versus 0.68±0.13; p=0.22). Compared with scoring balloon, super high-pressure balloon increased minimum lumen diameter (2.83±0.34 mm versus 2.65±0.36 mm; p=0.03) and reduced diameter stenosis (11.6±4.8% versus 14.4±5.6%; p=0.02) without difference in terms of angiographic success (100% versus 97.3%; p>0.99). Strategy success (91.9% versus 83.8%; p=0.48) and procedural success (100% versus 89.2%; p=0.12) were numerically more frequent with super high-pressure balloon versus scoring balloon.
Conclusions: In patients with severely calcified coronary artery lesions, preparation with super high-pressure balloon versus scoring balloon was associated with comparable stent expansion on intravascular imaging and a signal toward improved angiographic performance.