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

DOI: 10.23736/S2724-5683.22.05989-0


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

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