Drug-coated versus conventional balloons to improve recanalization of a coronary chronic total occlusion after failed attempt

Background Chronic total occlusion (CTO) plaque modification (CTO-PM) is often used for unsuccessful CTO interventions. Methods Multicenter, prospective study including consecutive patients with failed CTO recanalization. At the end of the failed procedure, patients received either conventional (CB) or drug-coated balloon (DCB) or at the operator’s discretion for CTO-PM and underwent new attempt of CTO recanalization ∼3 months later. Results A total of 55 patients were enrolled (DCB: 22; CB 33), with a median age of 66 years. Median J-score was 3 and CCS angina class III-IV was present in 40% of the patients. After the first CTO-PCI attempt no in hospital cardiac deaths were registered, with 3.6% rates of in-hospital myocardial infarction. The success rate of the second CTP PCI attempt was 86.8%, with periprocedural complication rate of 5.7% and without difference between DCB and CB groups. Compared with CB, in the DCB group, the second CTO-PCI required a shorter median fluoroscopy time (33 vs 60min, p<0.001), lower contrast volume (170 vs 321cc, p<0.001) and lower radiation dose (1.7 vs 3.3Gy, p<0.001). At 1-year follow up outcomes were comparable between the 2 strategies, target lesion failure occurred in 5.7% and major adverse cardiovascular events in 11.2%. Conclusions PM after CTO recanalization failure is safe and warrants high success rates when 2nd attempt is performed. A DCB strategy for CTO-PM does not seem to ensure higher success or better clinical outcomes, but its use was associated with simpler staged procedures. ### Competing Interest Statement Drs. Amat-Santos and Rinfret are proctors for Boston Scientific. ### Clinical Trial NCT05158686 ### Funding Statement The study was sponsored by FundaciÃ3n Epic in form of an institutional educational grant (Epic-BTK20). ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Not Applicable The details of the IRB/oversight body that provided approval or exemption for the research described are given below: CEIm from Valladolid Este provided approval and was transferred to the ECs from the other participating institutions. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Not Applicable I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Not Applicable I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Not Applicable Data are available for other investigators under request.