Drug-Coated Coronary Balloons in Different Clinical Scenarios

Official title

Procedural Success and Short- and Long-Term Outcomes of Drug-Coated Coronary Balloons Used in Different Clinical Scenarios

Overview

Coronary stents are the best treatment method ever accepted in the treatment of coronary artery stenoses. Due to some limitations and complications of stent use, the operators tried to find new solutions. Drug Coated Balloons (DCBs) have been accepted as a new method in the treatment of in-stent restenosis and small vessel disease. Furthermore, they have been used in the treatment of de novo coronary lesions, chronic total occlusions and bifucation lesions. But data is limited in the short and long term success of DCBs in all these clinical scenarios. In our study we aimed to investigate the procedural success and short and long term outcomes of DCB use in different clinical scenarios.

Detailed description

The DCB-DCS (Drug-Coated Balloon in Different Clinical Scenarios) Registry is a multicenter, observational study designed to evaluate the safety, feasibility, and clinical outcomes of drug-coated balloon (DCB) angioplasty in a broad spectrum of coronary artery disease presentations and lesion subsets in real-world practice across Türkiye. The registry aims to provide comprehensive evidence on contemporary DCB use beyond conventional in-stent restenosis, including de novo small and large vessels, bifurcation lesions, chronic total occlusions, acute coronary syndromes, and complex lesion morphologies.

Consecutive patients undergoing percutaneous coronary intervention (PCI) with a DCB-based strategy, either as a stand-alone therapy or in combination with bailout stenting, will be prospectively and retrospectively enrolled from participating high-volume centers. Detailed demographic, clinical, laboratory, angiographic, procedural, and pharmacological data will be systematically collected. Lesion characteristics will be classified according to standard angiographic and anatomical criteria, and procedural techniques including lesion preparation strategy (plain balloon, cutting/scoring balloon, high-pressure non-compliant balloon, atherectomy), use of intravascular imaging (IVUS, OCT, OFDI), and DCB type, size, and inflation protocol will be recorded.

The registry will assess short-term procedural success and long-term clinical outcomes, including major adverse cardiovascular events (MACE), target lesion failure, target vessel revascularization, myocardial infarction, stent thrombosis (when applicable), and all-cause and cardiovascular mortality. Subgroup analyses will explore the impact of different clinical presentations, lesion subsets, and procedural strategies on outcomes, with particular emphasis on the role of optimal lesion preparation, intravascular imaging guidance, and the need for bailout stenting.

By reflecting routine clinical practice in a large, unselected population, the DCB-DCS Registry seeks to define optimal procedural standards, identify predictors of success and failure, and generate hypothesis-forming data to guide future randomized controlled trials comparing DCB-based strategies with new-generation drug-eluting stents across diverse coronary scenarios.

Primary outcome measures

• Death, target lesion revascularization, target vessel revascularization, myocardial infarction [Time frame: 12 months]

Secondary outcome measures (1)

• Angina, target vessel revascularization, Procedural success and need for bailout stenting, Major bleeding (BARC ≥3) [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

Age ≥18 years. Patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) in whom a drug-coated balloon (DCB) is used as the intended treatment strategy for at least one target lesion.

DCB use in any clinical presentation, including stable coronary artery disease and acute coronary syndromes.

DCB treatment for different lesion subsets, including de novo lesions, in-stent restenosis, bifurcation lesions, small and large vessels, and chronic total occlusions.

Successful lesion preparation allowing DCB angioplasty (residual stenosis ≤30% and absence of flow-limiting dissection before DCB inflation, according to operator judgment).

Availability of baseline clinical, angiographic, and procedural data. Ability to provide informed consent for prospective enrollment or availability of data according to local regulations for retrospective inclusion.

Planned clinical follow-up.

Exclusion criteria

Primary treatment strategy without the use of a drug-coated balloon (e.g., exclusive drug-eluting stent implantation without DCB).

Cardiogenic shock at the time of index procedure. Life expectancy less than 1 year due to non-cardiac comorbidities. Contraindication to antiplatelet therapy. Known severe allergy to contrast media not amenable to premedication. Pregnancy. Inability to comply with clinical follow-up. Participation in another interventional clinical trial that could confound outcome assessment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Turkey (Türkiye) · 5 centers

• Pamukkale University — Denizli
• Bahcelievler Memorial Hospital — Istanbul
• Bezmialem Vakıf Universitesi — Istanbul
• Goztepe Medicalpark Hastanesi — Istanbul
• Kutahya City Hospital — Kütahya

Identifiers

NCT: NCT06915597 · DCB-DCS

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗