Coronary interventions

Super high-pressure balloon versus scoring balloon to prepare severely calcified coronary lesions: the ISAR-CALC randomised trial

EuroIntervention 2021;17:481-488. DOI: 10.4244/EIJ-D-20-01000

Tobias Rheude
Tobias Rheude1, MD; Himanshu Rai1, MSc, PhD; Gert Richardt2, MD; Abdelhakim Allali2, MD; Mohamed Abdel-Wahab3, MD; Dmitriy S. Sulimov3, MD; Kambis Mashayekhi4, MD; Mohamed Ayoub4, MD; Florim Cuculi5, MD; Matthias Bossard5, MD; Sebastian Kufner1, MD; Erion Xhepa1, MD, PhD; Adnan Kastrati1,6, MD; Massimiliano Fusaro1, MD; Michael Joner1,6, MD; Robert A. Byrne7,8, MB, BCh, PhD; Salvatore Cassese1, MD, PhD
1. Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Munich, 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, Lucerne, Switzerland; 6. DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany; 7. Cardiology Department, Mater Private Hospital, Dublin, Ireland; 8. Cardiovascular Research, Royal College of Surgeons in Ireland, Dublin, Ireland

Background: The comparative efficacy of balloon-based techniques to prepare severely calcified coronary lesions before stenting remains poorly studied.

Aims: We sought to compare stent expansion following preparation of severely calcified coronary lesions with either a super high-pressure balloon or a scoring balloon.

Methods: In this randomised, open-label trial, patients with severely calcified coronary lesions were enrolled at five centres in Germany and Switzerland. After unsuccessful lesion preparation with a standard non-compliant balloon (<30% reduction of baseline diameter stenosis), participants were randomised to predilation with either a super high-pressure balloon or a 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.

Results: OCT data after DES implantation were available for 70  out of 74 patients (94.6%) enrolled. Lesion preparation with a super high-pressure balloon versus a scoring balloon led to a comparable stent expansion index (0.72±0.12 vs 0.68±0.13; p=0.22). Compared with the scoring balloon, the super high-pressure balloon increased the minimum lumen diameter (2.83±0.34 mm vs 2.65±0.36 mm; p=0.03) and reduced the diameter stenosis (11.6±4.8% vs 14.4±5.6%; p=0.02) without difference in terms of angiographic success (100% vs 97.3%; p>0.99). Strategy success (91.9% vs 83.8%; p=0.48) and procedural success (100% vs 89.2%; p=0.12) were numerically more frequent with the super high-pressure balloon versus the scoring balloon.

Conclusions: In patients with severely calcified coronary artery lesions, preparation with a super high-pressure balloon versus a scoring balloon was associated with comparable stent expansion on intravascular imaging and a trend towards improved angiographic performance.

Visual summary. A ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions: the ISAR-CALC randomised trial.

Visual summary. A ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions: the ISAR-CALC randomised trial.

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calcified stenosiscutting balloondrug-eluting stentoptical coherence tomography
Coronary interventionsOther coronary interventions
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