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

DOI: 10.4244/EIJ-D-20-01000

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
Disclaimer:

As a public service to our readership, this article - peer reviewed by the Editors of EuroIntervention and external reviewers - has been published immediately upon acceptance as it was received in the last round of revision. The content of this article is the responsibility of the authors.

Please note that supplementary movies are not available online at this stage. Once a paper is published in its edited and formatted form, it will be accompanied online by any supplementary movies.

To read the full content of this article, please log in to download the PDF.

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.


Sign in to read and download the full article

Forgot your password?
No account yet? Sign up for free!
Create my pcr account

Join us for free and access thousands of articles from EuroIntervention, as well as presentations, videos, cases from PCRonline.com

Read next article
EAPCI consensus document on myocardial revascularisation failure; antegrade versus retrograde approach from the PROGRESS-CTO Registry; a mini focus on BRS with lessons from the AIDA, ABSORB II and MAGSTEMI trials; LAA closure occluders, new embolic protection devices and more…