Author + information
- Received September 17, 2018
- Revision received November 18, 2018
- Accepted November 27, 2018
- Published online March 18, 2019.
- Rosli Mohd Ali, MDa,
- Muhamad Ali S.K. Abdul Kader, MDb,
- Wan Azman Wan Ahmad, MDc,
- Tiong Kiam Ong, MDd,
- Houng Bang Liew, MDe,
- Al-Fazir Omar, MDf,
- Ahmad Syadi Mahmood Zuhdi, MDc,
- Amin Ariff Nuruddin, MDf,
- Beatrix Schnorr, PhDg and
- Bruno Scheller, MDh,∗ ()
- aCardiac Vascular Sentral Kuala Lumpur, Kuala Lumpur, Malaysia
- bCardiology Department, Hospital Pulau Pinang, George Town, Malaysia
- cCardiology Department, University Malaya Medical Center, Kuala Lumpur, Malaysia
- dCardiology Department, Sarawak Heart Centre, Kota Samarahan, Malaysia
- eCardiology Department and Clinical Research Center, Queen Elizabeth Hospital II, Kota Kinabalu, Malaysia
- fCardiology Department, National Heart Institute Malaysia, Kuala Lumpur, Malaysia
- gExperimental Radiology, Charité, Berlin, Germany
- hCardiology Department, University Hospital of Saarland, Homburg/Saar, Germany
- ↵∗Address for correspondence:
Prof. Dr. Bruno Scheller, Clinical and Experimental Interventional Cardiology, University of Saarland, 66421 Homburg/Saar, Germany.
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)
Dr. Scheller owns stock in InnoRa GmbH, Berlin, Germany. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received September 17, 2018.
- Revision received November 18, 2018.
- Accepted November 27, 2018.
- 2019 American College of Cardiology Foundation
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