Real-World Outcomes of Drug-Coated Balloon Angioplasty in Coronary Artery Disease

The Real-World Drug-Coated Balloon Registry (RW-DCB) is an investigator-initiated, multicenter, observational cohort study evaluating the use of drug-coated balloons (DCBs) during percutaneous coronary intervention (PCI) in routine clinical practice. The registry will include consecutive adults in whom a coronary DCB strategy is planned or attempted, regardless of the clinical presentation, lesion type, DCB platform, success of lesion preparation, successful delivery of the DCB, or final treatment strategy. The study does not assign any treatment or require additional procedures, tests, or visits. All clinical decisions, including lesion preparation, device selection, use of intracoronary imaging or physiology, antithrombotic therapy, and follow-up, remain at the discretion of the treating team. The retrospective cohort will include eligible procedures performed from January 2022 until prospective data collection begins at each participating center. Prospective enrollment will continue for at least 24 months after activation of the first center. Each participant will be followed for up to 24 months after the index procedure. The primary outcome is target lesion failure at 12 months, defined as cardiovascular death, target vessel myocardial infarction, or clinically indicated target lesion revascularization. The registry will also evaluate procedural outcomes, DCB delivery failure, changes in treatment strategy, bailout stenting, other clinical events, antithrombotic treatment, and outcomes associated with lesion preparation and specific DCB platforms. The operational target is at least 2,000 participants, with no upper enrollment limit.

Inclusion Criteria: * Age 18 years or older at the index procedure. * Percutaneous coronary intervention performed at a participating center during its defined study period, in which at least one coronary drug-coated balloon is selected and introduced into the delivery system with intent to treat an epicardial native coronary lesion or a coronary bypass graft lesion. * Source documentation sufficient to identify the index procedure date, patient, target vessel, and intended drug-coated balloon strategy. * All clinical presentations and coronary lesion types are eligible. Exclusion Criteria: * No coronary drug-coated balloon introduced into the delivery system. * Withdrawal of authorization for prospectively collected data, when applicable. Failure to deliver or inflate the intended drug-coated balloon, crossover to another treatment strategy, and incomplete follow-up are not exclusion criteria.