A Randomised Trial of Sirolimus- Versus Paclitaxel-coated Balloons for De Novo Coronary Lesions

Overview

Journal EuroIntervention

Specialties Cardiology & Vascular Diseases
Pharmacology

Date 2024 Nov 4

PMID 39492703

Authors

Bruno Scheller

Norman Mangner

Raban V Jeger

Samuel Afan

Felix Mahfoud

Felix J Woitek

Gregor Fahrni

Carsten Schwenke

Beatrix Schnorr

Franz Kleber

Affiliations

Soon will be listed here.

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).

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