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

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

SUBMITTER: Scheller B 

PROVIDER: S-EPMC11522860 | biostudies-literature | 2024 Nov

REPOSITORIES: biostudies-literature