OPtimization of Antiplatelet Therapy After the intervenTION of de Novo Coronary Artery Lesions With Drug-Coated Balloons (OPTION-DCB)
Coronary atherosclerotic disease remains one of the leading causes of mortality and morbidity worldwide. Although percutaneous coronary intervention (PCI) and drug-eluting stents (DES) implantation has significantly improved clinical outcomes, long-term studies have demonstrated that stent-related complications-including late restenosis, very late thrombosis, impaired vascular compliance due to permanent metal residue, and bleeding risk associated with prolonged dual antiplatelet therapy (DAPT)-have yet to be fundamentally resolved. Drug-coated balloon (DCB) has emerged as a "metal-free" alternative strategy, delivering antiproliferative drugs to the vessel wall during balloon expansion, with the aim of reducing metal residue, promoting vascular healing, and lowering the incidence of long-term adverse events.
Multiple high-quality studies have validated the safety and efficacy of DCB in the setting of in-stent restenosis (ISR) and small-vessel de novo lesions. The international DCB consensus has explicitly incorporated ISR and small-vessel disease into the category of established indications. Recent studies have demonstrated that, in small-vessel lesions, DCB is comparable to second-generation DES with respect to target lesion revascularization (TLR) and major adverse cardiovascular events (MACE), while conferring a lower risk of long-term stent-related complications. These advances have prompted relevant expert panels to publish operational standards and indication guidelines for DCB. Meanwhile, the research focus of DCB is gradually expanding toward "large-vessel de novo lesions." This lesion subset is typically characterized by a reference vessel diameter ≥2.75-3.0 mm, high lesion burden, and impaired vascular compliance. Several international studies have found that, under conditions of adequate lesion preparation-defined as residual stenosis <30%, absence of severe dissection, and sufficient lesion expansion-DCB treatment of large-vessel de novo lesions can yield satisfactory outcomes. China has rapidly followed suit, with experts revising the national expert consensus in 2024 to refine the application of drug-coated balloons in coronary stenotic lesions.
Owing to the absence of permanent metallic stent residue and the short duration of local drug action, DCB theoretically permits the use of a less intensive antiplatelet regimen. However, clinical trial evidence regarding the optimal antiplatelet strategy following DCB treatment remains lacking. This study aims to investigate whether, among patients with chronic coronary syndrome (CCS) undergoing DCB treatment, 1 month of dual antiplatelet therapy post-procedure is non-inferior to 6 months of dual antiplatelet therapy with respect to target vessel failure (TVF) at 1 year.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Zhangwei Chen, PhD
- Phone Number: 86 021 64041990
- Email: chen.zhangwei@zs-hospital.sh.cn
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosed with chronic coronary syndrome (CCS);
- Underwent DCB treatment, with no ischemic or bleeding events within 1 month after the procedure;
- Received dual antiplatelet therapy consisting of aspirin plus a P2Y₁₂ receptor inhibitor;
- Agreed to participate in the study.
Exclusion Criteria:
- Left-main lesion; or lesion location/characteristics (e.g., heavy tortuosity, severe focal calcification, complex bifurcation lesions, slow-flow phenomenon) precluding a DCB-only strategy;
- Severe calcified lesions with residual calcium-plate support >50% after lesion pre-treatment;
- Stroke occurring within the recent 3 months, or patients requiring routine anticoagulation therapy;
- Severe hepatic or renal insufficiency (eGFR < 30 mL/min), bleeding diathesis, or recent major bleeding;
- Infertile or pregnant female patients; any factors that may interfere with follow-up or participation in other studies;
- Patients unable to comply with study requirements, with estimated survival < 1 year, or those with psychological or other factors hindering complete follow-up;
- Patients deemed ineligible for participation in this study by the investigators.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1-month DAPT
1-month DAPT post DCB
|
1-month DAPT post DCB
|
|
Active Comparator: 6-month DAPT
6-month DAPT post DCB
|
6-month DAPT post DCB
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Target Vessel Failure
Time Frame: 1 year
|
a composite of cardiac death, target vessel myocardial infarction, and ischemia-driven target vessel revascularization
|
1 year
|
|
BARC bleeding (type 2, 3, or 5)
Time Frame: 1 year
|
BARC bleeding (type 2, 3, or 5)
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B2026-167
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.