Treatment of Coronary Drug-Eluting Stent Restenosis by a Sirolimus- or Paclitaxel-Coated Balloon

• Published in: JACC. Cardiovascular interventions Vol. 12; no. 6; pp. 558 - 566
• Main Authors: Ali, Rosli Mohd, Abdul Kader, Muhamad Ali S.K., Wan Ahmad, Wan Azman, Ong, Tiong Kiam, Liew, Houng Bang, Omar, Al-Fazir, Mahmood Zuhdi, Ahmad Syadi, Nuruddin, Amin Ariff, Schnorr, Beatrix, Scheller, Bruno
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 25.03.2019
• Subjects: Aged; Angioplasty, Balloon, Coronary - adverse effects; Angioplasty, Balloon, Coronary - instrumentation; Cardiac Catheters; Cardiovascular Agents - administration & dosage; Cardiovascular Agents - adverse effects; Coated Materials, Biocompatible; Coronary Angiography; coronary in-stent restenosis; Coronary Restenosis - diagnostic imaging; Coronary Restenosis - etiology; Coronary Restenosis - therapy; Female; Humans; Malaysia; Male; Middle Aged; Paclitaxel - administration & dosage; Paclitaxel - adverse effects; paclitaxel-coated balloon; Percutaneous Coronary Intervention - adverse effects; Percutaneous Coronary Intervention - instrumentation; Prospective Studies; Sirolimus - administration & dosage; Sirolimus - adverse effects; sirolimus-coated balloon; Stents; Time Factors; Treatment Outcome; Malaysia; DCB; DES; SCB; paclitaxel-coated balloon; MACE; coronary in-stent restenosis; sirolimus-coated balloon; BMS; ISR; LLL; PCB
• ISSN: 1936-8798; 1876-7605; 1876-7605
• DOI: 10.1016/j.jcin.2018.11.040

The aim of this randomized controlled trial was to investigate a novel sirolimus-coated balloon (SCB) compared with the best investigated paclitaxel-coated balloon (PCB). Treatment of coronary in-stent restenosis (ISR) remains challenging. PCBs are an established treatment option outside the United States with a Class I, Level of Evidence: A recommendation in the European guidelines. However, their efficacy is better in bare-metal stent (BMS) ISR compared with drug-eluting stent (DES) ISR. Fifty patients with DES ISR were enrolled in a randomized, multicenter trial to compare a novel SCB (SeQuent SCB, 4 μg/mm2) with a clinically proven PCB (SeQuent Please Neo, 3 μg/mm2) in coronary DES ISR. The primary endpoint was angiographic late lumen loss at 6 months. Secondary endpoints included procedural success, major adverse cardiovascular events, and individual clinical endpoints such as stent thrombosis, cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, and binary restenosis. Quantitative coronary angiography revealed no differences in baseline parameters. After 6 months, in-segment late lumen loss was 0.21 ± 0.54 mm in the PCB group versus 0.17 ± 0.55 mm in the SCB group (p = NS; per-protocol analysis). Clinical events up to 12 months also did not differ between the groups. This first-in-man comparison of a novel SCB with a crystalline coating shows similar angiographic outcomes in the treatment of coronary DES ISR compared with a clinically proven PCB. (Treatment of Coronary In-Stent Restenosis by a Sirolimus [Rapamycin] Coated Balloon or a Paclitaxel Coated Balloon [FIM LIMUS DCB]; NCT02996318) [Display omitted]