| Title: |
Design and rationale of the drug-coated balloon coronary angioplasty versus stenting for treatment of disease adjacent to a chronic total occlusion (Co-CTO) trial |
| Authors: |
Somsen, YBO; de Winter, RW; Wu, J; Hoek, R; Sprengers, RW; Verouden, NJ; Claessen, BEPM; Kleijn, SA; Twisk, JWR; Henriques, JP; Spratt, JC; Rissanen, TT; McEntegart, MB; Maehara, A; Nap, A; Knaapen, P |
| Publisher Information: |
Elsevier BV |
| Publication Year: |
2025 |
| Collection: |
St George's University of London: Repository |
| Description: |
Background Percutaneous coronary intervention (PCI) of chronic total coronary occlusions (CTOs) typically involves extensive drug-eluting stent (DES) implantation. As a result, patients undergoing CTO PCI are exposed to a relatively high risk of in-stent restenosis and target lesion revascularization. While the application of drug-coated balloons (DCBs) may improve patient outcome by reducing stent burden, randomized controlled trials investigating the use of DCB in CTO PCI are lacking. Methods The Co-CTO trial (NCT04881812) is a single-blind, noninferiority randomized controlled trial enrolling 144 patients undergoing CTO PCI. A hybrid strategy (stenting of the CTO body and DCB treatment of adjacent disease) will be compared to a complete stenting strategy. The primary study endpoint is in-segment percentage diameter stenosis at 1 year follow-up determined by intravascular ultrasound. Secondary endpoints include major adverse cardiovascular events (a composite of cardiac death, nonfatal myocardial infarction, and ischemia-driven target lesion revascularization) at 1 year, angiographic outcomes, and cardiac symptoms (Canadian Cardiovascular Society Grading Scale, New York Heart Association Classification of Dyspnea). Conclusion The Co-CTO trial is the first randomized controlled trial exploring a hybrid strategy (DES + DCB) in patients undergoing CTO PCI. Trial registration Registered at ClinicalTrials.Gov under registration number: NCT04881812 (https://clinicaltrials.gov/study/NCT04881812?cond=cto&intr=drug-coated%20balloon&rank=1). |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/pdf; application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Language: |
English |
| ISSN: |
0002-8703 |
| Relation: |
https://openaccess.sgul.ac.uk/id/eprint/117677/2/1-s2.0-S000287032500105X-main.pdf; https://openaccess.sgul.ac.uk/id/eprint/117677/1/1-s2.0-S000287032500105X-mmc1.docx; Somsen, YBO; de Winter, RW; Wu, J; Hoek, R; Sprengers, RW; Verouden, NJ; Claessen, BEPM; Kleijn, SA; Twisk, JWR; Henriques, JP; et al. Somsen, YBO; de Winter, RW; Wu, J; Hoek, R; Sprengers, RW; Verouden, NJ; Claessen, BEPM; Kleijn, SA; Twisk, JWR; Henriques, JP; Spratt, JC; Rissanen, TT; McEntegart, MB; Maehara, A; Nap, A; Knaapen, P (2025) Design and rationale of the drug-coated balloon coronary angioplasty versus stenting for treatment of disease adjacent to a chronic total occlusion (Co-CTO) trial. American Heart Journal, 288. pp. 65-76. ISSN 0002-8703 https://doi.org/10.1016/j.ahj.2025.03.023 SGUL Authors: Spratt, James |
| DOI: |
10.1016/j.ahj.2025.03.023 |
| Availability: |
https://openaccess.sgul.ac.uk/id/eprint/117677/; https://doi.org/10.1016/j.ahj.2025.03.023 |
| Rights: |
cc_by_4 |
| Accession Number: |
edsbas.955B6E0C |
| Database: |
BASE |