Clin Res Cardiol (2022). https://doi.org/10.1007/s00392-022-02002-5

Ablative- versus balloon-based techniques to prepare severely calcified coronary lesions: A pooled analysis of the PREPARE-CALC and ISAR-CALC randomized trials
T. Rheude1, S. Fitzgerald2, A. Allali3, K. A. Mashayekhi4, T. Gori5, F. Cuculi6, S. Kufner1, R. Hemetsberger7, D. Sulimov2, H. Rai1, M. Ayoub4, M. Bossard6, E. Xhepa1, M. Fusaro8, R. Tölg3, M. Joner9, R. Byrne10, G. Richardt11, A. Kastrati1, S. Cassese9, M. Abdel-Wahab2
1Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, München; 2Klinik für Innere Medizin/Kardiologie, Herzzentrum Leipzig - Universität Leipzig, Leipzig; 3Herzzentrum, Segeberger Kliniken GmbH, Bad Segeberg; 4Klinik für Kardiologie und Angiologie II, Universitäts-Herzzentrum Freiburg / Bad Krozingen, Bad Krozingen; 5Zentrum für Kardiologie, Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz; 6Kantonspital Luzern, Luzern, CH; 7Medizinische Klinik II, Kardiologie und Angiologie, Berufsgenossenschaftlliches Universitätsklinikum Bergmannsheil, Bochum; 8Interventionelle Kardiologie, Klinik Vincentinum, Augsburg; 9Deutsches Herzzentrum München, München; 10Mater Private Dublin, Dublin 7, IE; 11Herz- Gefäßzentrum, Segeberger Kliniken GmbH, Bad Segeberg;

Aims: We sought to investigate the comparative efficacy of ablative- versus balloon-based techniques before drug-eluting stent (DES) implantation in severely calcified coronary lesions.

Methods: This is a patient-level pooled analysis from the PREPARE-CALC and ISAR-CALC randomized trials that investigated the performance of ablative- versus balloon-based techniques before DES implantation in severely calcified coronary lesions. Patients with available optical coherence tomography (OCT) imaging data  after stent implantation were included in this analysis. The primary endpoint was stent expansion on intravascular imaging. Secondary endpoints included stent asymmetry, stent eccentricity and strategy success.


Results:
Among 274 patients originally randomized in the two trials, OCT imaging data after DES implantation was available for 200 participants (73%). Per protocol, lesion preparation was performed using rotational atherectomy (RA, n=63 patients), modified balloons (MB, cutting or scoring balloon, n=103 patients) or super high-pressure balloon (n=34). Baseline clinical and angiographic characteristics were comparable between groups. Lesion preparation with RA versus either MB or super high-pressure balloon was associated with comparable stent expansion (73.2±11.6% versus 70.8±13.6% and 71.8±12.2%; p=0.49). In terms of stent eccentricity, super high-pressure balloon was superior to either RA or MB (max. stent eccentricity: 0.74±0.09 versus 0.70±0.06 and 0.70±0.08; p=0.03). Moreover, acute lumen gain was higher after lesion preparation with super high-pressure balloon compared with MB or RA (1.87±0.43 versus 1.79±0.41 and 1.69±0.38; p=0.08). Strategy success was more frequent with RA compared with either MB or super high-pressure balloon (100% versus 86.4% and 91.2%; p=0.002).

Conclusions: In patients with severely calcified coronary artery lesions, lesion preparation with ablative- and balloon-based techniques leads to comparable DES expansion. Super high-pressure balloon was superior in terms of stent eccentricity, whilst strategy success was more frequent with RA. The clinical impact of these findings warrants further investigation.



https://dgk.org/kongress_programme/jt2022/aV139.html