Original Research

DOI: 10.4244/EIJ-D-23-00868

A randomised trial of sirolimus- versus paclitaxel-coated balloons for de novo coronary lesions

Bruno Scheller1,2, MD; Norman Mangner3, MD; Raban V. Jeger4,5, MD; Samuel Afan6, MD; Felix Mahfoud2,4, MD; Felix J. Woitek3, MD; Gregor Fahrni4,5, MD; Carsten Schwenke7, PhD; Beatrix Schnorr8, PhD; Franz Kleber6, MD

Abstract

Background: Paclitaxel-coated balloons (PCB) are a viable alternative to drug-eluting stents in the treatment of de novo coronary lesions. Whether sirolimus represents an alternative to paclitaxel for drug-coated balloons remains elusive.

Aims: This randomised, controlled, multicentre, non-inferiority trial investigated a novel sirolimus-coated balloon (SCB) with a crystalline coating versus a PCB in de novo coronary lesions.

Methods: To compare a novel SCB with a clinically proven PCB, 70 patients with de novo coronary lesions were enrolled at 4 centres in Germany and Switzerland. The primary endpoint was non-inferiority regarding angiographic late lumen loss (LLL) at 6 months, with a predefined margin of δ=0.35 mm. Secondary endpoints included procedural success, major adverse cardiac events, and individual clinical endpoints.

Results: Quantitative coronary angiography revealed no differences in baseline parameters. At 6 months, in-segment LLL was 0.04±0.39 mm in the PCB group versus 0.11±0.37 mm in the SCB group (non-significant), respectively. The mean difference between SCB and PCB was 0.07 mm (95% confidence interval: –0.12 to 0.26). Non-inferiority at the predefined margin of 0.35 was shown. Clinical event rates up to 12 months were not different between the groups (3 target lesion revascularisations in the PCB group versus 2 in the SCB group, no myocardial infarctions, no deaths).

Conclusions: The novel SCB showed similar angiographic outcomes in the treatment of de novo coronary disease as compared with a clinically proven PCB (ClinicalTrials.gov: NCT03908450).

Sign in to read
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

Volume 20 Number 21
Nov 4, 2024
Volume 20 Number 21
View full issue


Key metrics

Suggested by Cory

Editorial

10.4244/EIJ-E-23-00052 Mar 18, 2024
Comparative preclinical assessment of drug-coated balloons: a blessing and a curse for clinical translation
Joner M and Wild L
free

Editorial

10.4244/EIJ-E-24-00053 Nov 4, 2024
The future of sirolimus-coated balloon use in percutaneous coronary intervention
Yeh R and Lalani C
free

Original Research

10.4244/EIJ-D-23-00425 Mar 18, 2024
Biological differences of three paclitaxel- and sirolimus-coated balloons on coronary lesions in a rabbit model
Aihara K et al
free
Trending articles
95.95

State-of-the-Art

10.4244/EIJ-D-24-00066 Apr 21, 2025
Management of complications after valvular interventions
Bansal A et al
free
76.55

State-of-the-Art

10.4244/EIJ-D-23-00840 Sep 2, 2024
Aortic regurgitation: from mechanisms to management
Baumbach A et al
free
63

Image – Interventional flashlight

10.4244/EIJ-D-22-00074 Jun 3, 2022
Transcatheter aortic valve repair for aortic regurgitation with the Cusper device
Feld Y et al
free
58.2

Clinical research

10.4244/EIJ-D-23-00344 Sep 18, 2023
Clinical outcomes of TAVI with the Myval balloon-expandable valve for non-calcified aortic regurgitation
Sanchez-Luna JP et al
free
49.1

Original Research

10.4244/EIJ-D-25-00331 May 21, 2025
One-month dual antiplatelet therapy followed by prasugrel monotherapy at a reduced dose: the 4D-ACS randomised trial
Jang Y et al
open access
49.1

Original Research

10.4244/EIJ-D-25-00331 Jul 21, 2025
One-month dual antiplatelet therapy followed by prasugrel monotherapy at a reduced dose: the 4D-ACS randomised trial
Jang Y et al
open access
31.1

Expert Review

10.4244/EIJ-D-24-00535 May 5, 2025
Catheter-based techniques for pulmonary embolism treatment
Costa F et al
30.4

Clinical Research

10.4244/EIJ-D-21-00363 Jan 28, 2022
Membranous septum morphology and risk of conduction abnormalities after transcatheter aortic valve implantation
Jørgensen T et al
free
X

PCR
Impact factor: 9.5
2024 Journal Citation Reports®
Science Edition (Clarivate Analytics, 2025)
Online ISSN 1969-6213 - Print ISSN 1774-024X
© 2005-2025 Europa Group - All rights reserved