TY - JOUR
T1 - 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
AU - Somsen, Yvemarie B. O.
AU - de Winter, Ruben W.
AU - Wu, Jiawei
AU - Hoek, Roel
AU - Sprengers, Ralf W.
AU - Verouden, Niels J.
AU - Claessen, Bimmer E. P. M.
AU - Kleijn, Sebastiaan A.
AU - Twisk, Jos W. R.
AU - Henriques, José P.
AU - Spratt, James C.
AU - Rissanen, Tuomas T.
AU - McEntegart, Margaret B.
AU - Maehara, Akiko
AU - Nap, Alexander
AU - Knaapen, Paul
N1 - Publisher Copyright:
© 2025 The Authors
PY - 2025/10/1
Y1 - 2025/10/1
N2 - 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).
AB - 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).
UR - https://www.scopus.com/pages/publications/105004177949
U2 - 10.1016/j.ahj.2025.03.023
DO - 10.1016/j.ahj.2025.03.023
M3 - Article
C2 - 40204209
SN - 0002-8703
VL - 288
SP - 65
EP - 76
JO - American heart journal
JF - American heart journal
ER -