Overview
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.
Description
Drug-coated balloon angioplasty is increasingly used across a broad range of coronary anatomies and clinical presentations. However, much of the available evidence comes from selected populations, indication-specific cohorts, or studies that include only patients after successful lesion preparation or successful DCB delivery. Such designs may underestimate device delivery failure, changes in the intended strategy, bailout stenting, and other procedural limitations.
RW-DCB is designed to evaluate the complete intended coronary DCB strategy in an all-comer population. Patients will remain eligible when the selected DCB cannot cross the lesion, cannot be delivered, or cannot be inflated, and when the strategy subsequently changes to another DCB, drug-eluting stent implantation, surgery, or medical therapy. Planned hybrid treatment will be distinguished from unplanned bailout treatment.
The first eligible procedure for each participant will be the patient-level index procedure. All lesions treated or evaluated during that procedure will be recorded and classified according to their relationship with the intended DCB strategy. Subsequent coronary procedures, including treatment of a new culprit lesion with another DCB, will remain linked to the same participant and will not create a new patient-level index procedure.
Data will be collected using a pseudonymized patient identifier with linked information for procedures, lesions, DCB devices, follow-up assessments, and clinical events. The registry will capture clinical presentation, lesion indication and anatomical characteristics, lesion preparation, the immediate post-preparation result, exact DCB platform and dimensions, delivery and inflation outcomes, final PCI strategy, procedural complications, and antiplatelet and anticoagulant treatment. No protocol-mandated angiographic follow-up is required.
The primary endpoint is time to first target lesion failure through 12 months after the index procedure. Target lesion failure comprises cardiovascular death, target vessel myocardial infarction, or clinically indicated target lesion revascularization according to Drug-Coated Balloon Academic Research Consortium definitions. Secondary outcomes will include the individual components of the primary endpoint, all-cause death, any myocardial infarction, stroke, any coronary revascularization, hospitalization for heart failure, lesion thrombosis, bleeding, device and procedural success, delivery failure, bailout stenting, and other procedural complications. Outcomes will be assessed at discharge, 30 days, 6 months, 12 months, and 24 months.
Prespecified analyses will evaluate outcomes according to the intended DCB strategy, treatment ultimately received, lesion indication, clinical and anatomical modifiers, lesion preparation, specific DCB platform, center, operator experience, and calendar period. Additional analyses will examine cardiac allograft vasculopathy and repeated coronary procedures. Comparisons between specific DCB platforms will be performed only when sample size, event count, covariate completeness, and overlap between treatment groups are sufficient.
Eligibility
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.
