ORIGINAL ARTICLE   

Minerva Cardiology and Angiology 2023 April;71(2):182-8

DOI: 10.23736/S2724-5683.22.05989-0

Copyright © 2022 EDIZIONI MINERVA MEDICA

language: English

Which predilatation balloons provide the best lesion preparation prior to use of drug coated balloons in de-novo lesions? Results from the PREPARE study

Sandeep BASAVARAJAIAH ¹, Vinoda SHARMA ², Dante AGIP-FUSTAMANTE ³, Santiago J. CAMACHO FREIRE ³, Rami EL-MOKDAD ⁴, Gurbir BHATIA ¹, Bhagya H. LOKU WADUGE ¹, Alfonso IELASI ⁵, José F. DÍAZ FERNÁNDEZ ³, Sampath ATHUKORALA ¹, Bernardo CORTESE ^{4, 6} ✉

¹ Heartlands Hospital, University Hospitals of Birmingham, Birmingham, UK; ² Birmingham City Hospital, Birmingham, UK; ³ Juan Ramón Jiménez University Hospital, Huelva, Spain; ⁴ San Carlo Clinic, Milan, Italy; ⁵ Sant’Ambrogio Institute, Milan, Italy; ⁶ Cardiovascular Research and Innovation Foundation, Milan, Italy

BACKGROUND: There is a lack of data on the clinical outcomes following the use of different strategies for lesion preparation prior to the use of drug-coated balloons (DCB). In this study, we have explored the clinical outcomes between different types of predilatation balloons: semi-compliant (SB), non-compliant (NB) and scoring balloons (ScB) used when preparing de-novo lesions prior to the use of DCB.
METHODS: We retrospectively evaluated all patients who underwent treatment with DCB for de-novo lesions between 2011-2019 at 4 high-volume European centres. The measured study endpoints were cardiac-death, TV-MI, TLR and MACE.
RESULTS: During the study period, 553 patients were treated with DCB for de-novo lesions, 327 with SB only, 172 with NB and 54 with ScB. There were some differences in the procedural characteristics between the 3 groups. Predilatation balloons were significantly larger in the ScB, and NB groups as compared to the SB (2.7 mm and 2.6 mm vs. 2.3 mm; P<0.001). The reference vessel diameter was significantly larger in the NB group as compared to the ScB and SB (2.6 mm vs. 2.2 mm and 2.3 mm; P<0.001). During the median follow-up duration of 547-days, there were no differences in the hard-clinical endpoints, however, TLR was significantly higher in the ScB as compared to SB and NB group (11% vs. 3.4% and 4.7%; P=0.02).
CONCLUSIONS: The PREPARE study results do not suggest routine use of ScB prior to DCB in de-novo lesions.

KEY WORDS: Angioplasty, balloon, coronary; Cardiology; Coronary stenosis