Rosli Mohd Ali1, Muhamad Ali S K Abdul Kader2, Wan Azman Wan Ahmad3, Tiong Kiam Ong4, Houng Bang Liew5, Al-Fazir Omar6, Ahmad Syadi Mahmood Zuhdi3, Amin Ariff Nuruddin6, Beatrix Schnorr7, Bruno Scheller8. 1. Cardiac Vascular Sentral Kuala Lumpur, Kuala Lumpur, Malaysia. 2. Cardiology Department, Hospital Pulau Pinang, George Town, Malaysia. 3. Cardiology Department, University Malaya Medical Center, Kuala Lumpur, Malaysia. 4. Cardiology Department, Sarawak Heart Centre, Kota Samarahan, Malaysia. 5. Cardiology Department and Clinical Research Center, Queen Elizabeth Hospital II, Kota Kinabalu, Malaysia. 6. Cardiology Department, National Heart Institute Malaysia, Kuala Lumpur, Malaysia. 7. Experimental Radiology, Charité, Berlin, Germany. 8. Cardiology Department, University Hospital of Saarland, Homburg/Saar, Germany. Electronic address: bruno.scheller@uks.eu.
Abstract
OBJECTIVES: 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). BACKGROUND: 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. METHODS: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. RESULTS: 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. CONCLUSIONS: 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).
RCT Entities:
OBJECTIVES: 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). BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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).
Authors: Vassilios S Vassiliou; Simon C Eccleshall; Ioannis Merinopoulos; Tharusha Gunawardena; Upul Wickramarachchi; Paul Richardson; Clint Maart; Sulfi Sreekumar; Chris Sawh; Trevor Wistow; Toomas Sarev; Alisdair Ryding; Tim Gilbert; Aris Perperoglou Journal: Clin Res Cardiol Date: 2020-09-02 Impact factor: 5.460