Romanian Society of Pharmaceutical Sciences
 

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CORONARY ANGIOPLASTY WITH DRUG-COATED BALLOONS: CLINICAL EFFICACY AND TOXICITY OF SIROLIMUS VERSUS PACLITAXEL – A NARRATIVE REVIEW

VALENTIN CHIONCEL 1,2, CIPRIAN PUȘCAȘU 3*, FLAVIUS GHERASIE 1,2, CORINA ANDREI 3, ANCA ZANFIRESCU 3, CLAUDIU I. STOICESCU 1,4

1 Department of Cardiology, “Carol Davila” University of Medicine and Pharmacy, 37 Dionisie Lupu Street, 020021, Bucharest, Romania
2 Emergency Clinical Hospital Dr. Bagdasar-Arseni, 12 Berceni Road, 041915, Bucharest, Romania
3 Department of Pharmacology and Clinical Pharmacy, Faculty of Pharmacy, “Carol Davila” University of Medicine and Pharmacy, 6 Traian Vuia Street, 020956, Bucharest, Romania
4 University Clinical Hospital Bucharest, 169 Splaiul Independenței Street, 050098, Bucharest, Romania

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In-stent restenosis (ISR) and small-vessel disease remain major challenges in contemporary percutaneous coronary intervention. Drug-coated balloons (DCBs) with paclitaxel and sirolimus are utilised to address these challenges. These antiproliferative agents differ markedly in physicochemistry and carrier requirements. We conducted a narrative review (PubMed, EMBASE, Google Scholar; January 2009 - March 2025) of randomised trials and registries comparing the efficacy and toxicity of paclitaxel- and sirolimus-coated balloons. Over 1,500 patients in 30 studies were included. Paclitaxel-DCBs (3 μg/mm²) achieved late lumen loss (LLL) of 0.09 - 0.54 mm, target lesion revascularisation (TLR) rates under 10%, and major adverse cardiac events (MACE) between 7 - 12%. Sirolimus-DCBs (1 - 12 μg/mm²) demonstrated LLL of 0.09 - 0.32 mm, TLR < 10%, and MACE < 10% in most cohorts. Both platforms exhibited very low thrombosis (< 1%) and minimal major bleeding. Contemporary sirolimus platforms match or slightly exceed paclitaxel efficacy, supporting their interchangeable use and guiding device selection based on drug properties, lesion complexity, and patient risk.