Rotational Atherectomy or Balloon-Based Techniques to Prepare Severely Calcified Coronary Lesions.

BACKGROUND

The comparative efficacy of percutaneous techniques for the preparation of calcified lesions before stenting remains poorly studied.

OBJECTIVES

This study sought to compare the performance of up-front rotational atherectomy (RA) or balloon-based techniques before drug-eluting stent implantation in severely calcified coronary lesions as assessed by angiography and optical coherence tomography (OCT).

METHODS

Patient-level data from the PREPARE-CALC (Comparison of Strategies to Prepare Severely Calcified Coronary Lesions) and ISAR-CALC (Comparison of Strategies to Prepare Severely Calcified Coronary Lesions) randomized trials were pooled. The primary endpoint was stent expansion as assessed by OCT imaging. The secondary endpoints included stent eccentricity, stent asymmetry, angiographic acute lumen gain, strategy success and in-hospital occurrence of cardiac death, target vessel myocardial infarction, and repeat revascularization.

RESULTS

Among 274 patients originally randomized, 200 participants with available OCT data after lesion preparation with RA (n = 63), a modified balloon (MB, n = 103), or a super high-pressure balloon (n = 34) before stenting were analyzed. The use of RA versus MB or a super high-pressure balloon led to comparable stent expansion (73.2% ± 11.6% vs 70.8% ± 13.6% vs 71.8% ± 12.2%, P = 0.49) and stent asymmetry (P = 0.83). Compared with RA or MB, a super high-pressure balloon was associated with less stent eccentricity (P = 0.03) with a numerically higher acute lumen gain, albeit not significantly different (P = 0.08). Strategy success was more frequent with RA versus MB (P = 0.002) and numerically more frequent with RA versus a super high-pressure balloon (P = 0.06). Clinical outcomes did not differ between groups.

CONCLUSIONS

In patients with severely calcified lesions undergoing drug-eluting stent implantation, lesion preparation with RA, MB, or a super high-pressure balloon was associated with comparable stent expansion. A super high-pressure balloon is associated with less stent eccentricity, whereas strategy success is more frequent with RA.

Informations de copyright

Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Funding Support and Author Disclosures The PREPARE-CALC trial was an investigator-initiated trial, which was financed by the Heart Center, Segeberger Kliniken GmbH, Bad Segeberg, Germany. The ISAR-CALC trial was an investigator-initiated trial, which was supported by a research grant from SIS Medical AG and Boston Scientific. Dr Rheude has received speaker fees from SIS Medical AG. Dr Allali has received speaker/proctoring honoraria from Boston Scientific and Biotronik. Dr Cuculi has received speaker and consulting fees from Abbott Vascular and SIS Medical AG. Dr Kufner has received speaker and consulting fees from AstraZeneca, Bristol Myers Squibb, and Translumina not related to the current work. Dr Bossard has received speaker and consulting fees from Abbott Vascular and SIS Medical AG. Dr Joner has received lecture fees and research grants from Edwards Lifesciences and Boston Scientific; and is a consultant for Biotronik and Orbus Neich. Dr Byrne has received research funding to the institution from Abbott Vascular, Biosensors, and Boston Scientific. Dr Cassese has received lectures/proctoring honoraria from SIS Medical AG; and has received research funding to the institution from SIS Medical AG and Boston Scientific for the conduct of the ISAR-CALC trial. Dr Abdel-Wahab reports that his hospital received speaker honoraria and/or consulting fees on his behalf from Medtronic and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.