An interventional study of Short DAPT and Standard DAPT in Stable Angina and Coronary Artery Disease, sponsored by Korea University Guro Hospital. Recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-12-17.
Sponsored by Korea University Guro Hospital · Not applicable, Interventional, and Treatment
This study aims to evaluate whether the use of optical coherence tomography (OCT), an advanced intravascular imaging tool, can improve stent implantation results and make it possible to shorten the duration of dual antiplatelet therapy (DAPT) in patients with stable angina who undergo percutaneous coronary intervention (PCI).
PCI with drug-eluting stents is a standard treatment for patients with stable angina, and these patients are usually prescribed DAPT for 6 to 12 months to prevent stent thrombosis and other complications. However, extended use of DAPT increases the risk of bleeding, which can lead to significant medical problems, especially in patients with high bleeding risk.
OCT provides detailed, high-resolution images of the coronary arteries and the implanted stents, allowing physicians to optimize stent expansion and positioning. By ensuring that the stent is well-placed and fully expanded, OCT guidance may lower the risk of complications, potentially reducing the need for prolonged DAPT.
In this prospective study, patients with stable angina who require stent implantation will be enrolled and treated with OCT-guided PCI followed by a short course of DAPT. Their outcomes will be compared with those managed using conventional strategies.
The primary goal of this trial is to determine whether OCT-guided stent optimization can safely support a short-duration DAPT strategy, thereby reducing bleeding risk without compromising protection against ischemic events such as restenosis, myocardial infarction, or stent thrombosis.
Ischemic heart disease (IHD) remains one of the leading causes of death worldwide, and more than 80% of deaths from coronary artery disease (CAD) occur in individuals aged 65 years or older. Elderly patients often have multiple comorbidities, such as diabetes mellitus, hypertension, and chronic kidney disease, which increase both ischemic and bleeding risks. For these patients, the management of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) is particularly challenging, as physicians must balance ischemic protection against the risk of bleeding complications.
Optical coherence tomography (OCT) provides high-resolution intravascular imaging that allows precise assessment of stent apposition, expansion, and the presence of dissections. Previous studies, including Kubo et al. (2022), have proposed OCT-based criteria for stent optimization, demonstrating that inadequate stent expansion or a minimum lumen area (MLA) \< 4.5 mm² is associated with worse outcomes. However, to date, few clinical studies have directly evaluated whether OCT-guided stent optimization can support individualized adjustment of DAPT duration.
The COMFORT-SHORT study is a prospective, single-center, open-label pilot registry designed to investigate the safety and feasibility of OCT-guided stent optimization in applying short-term DAPT strategies. Patients with stable angina undergoing PCI with drug-eluting stent implantation will be enrolled. All participants will undergo OCT during PCI to evaluate stent deployment. Stent size and length will be determined based on OCT analysis, and final imaging will be reviewed to confirm whether the procedure meets predefined optimization criteria.
Patients whose stents are confirmed as optimized will be transitioned to 1 month of DAPT followed by clopidogrel monotherapy. Patients with suboptimal results (e.g., malapposition, medial dissection, under-expansion) will continue standard DAPT for 6-12 months, based on guideline recommendations and individual bleeding. Importantly, patients with non-optimized stents will not be excluded; they will be followed prospectively, and outcomes will be compared with those of optimized patients.
The primary endpoint is the incidence of net adverse clinical events (NACE) at 12 months, comparing short-term versus standard DAPT strategies according to stent optimization status. All enrolled patients will undergo scheduled follow-up at 1, 6, and 12 months after PCI.
Exclusion Criteria:
Patients with optimized stent results confirmed by OCT will receive 1 month of dual antiplatelet therapy followed by clopidogrel monotherapy.
Drug: Short DAPT · Device: OCT-guided PCI
Patients with suboptimal stent results (malapposition, dissection, under-expansion) with high bleeding risk will continue dual antiplatelet therapy for 6 months, according to guideline recommendations.
Drug: Standard DAPT · Device: OCT-guided PCI
Patients with suboptimal stent results and high ischemic risk, as judged by the operator, will remain on dual antiplatelet therapy for 12 months.
Drug: Extended DAPT · Device: OCT-guided PCI
Patients receive aspirin and clopidogrel for 1 month after PCI. After 1 month, aspirin is discontinued and clopidogrel monotherapy is continued.
Patients with high bleeding risk will receive aspirin and clopidogrel for 6 months after PCI (unoptimization confirmed in OCT), followed by single antiplatelet therapy thereafter.
Patients (with stet unoptimazation results in OCT imaging) receive aspirin and clopidogrel for 12 months after PCI.
All patients undergo percutaneous coronary intervention with mandatory intravascular imaging using optical coherence tomography to assess stent optimization (expansion, apposition, dissection).
Net Adverse Cardiovascular Events (NACE)
Composite of cardiac death, non-fatal myocardial infarction, definite/probable stent thrombosis (ARC definition), stroke, repeat coronary revascularization, or clinically significant bleeding defined as BARC types 2, 3, or 5. Analyses will use time-to-first-event; each component will also be summarized separately as secondary outcomes per protocol.
Time frame: 12 months after the index PCI
Major Adverse Cardiovascular Events (MACE)
Composite of cardiac death, non-fatal myocardial infarction, definite/probable stent thrombosis (ARC), repeat coronary revascularization, or stroke (time-to-first-event).
Time frame: 12 months after PCI
All bleeding events
Any bleeding by BARC criteria (types 1-5).
Time frame: 12 months after the index PCI
All-cause death
Death from any cause.
Time frame: 12 months after the index PCI
Cardiac death
Death due to cardiac causes (e.g., MI, sudden cardiac death, heart failure), per protocol definition.
Time frame: 12 months after the index PCI
Myocardial infarction
MI defined per protocol-specified criteria (e.g., Fourth Universal Definition of MI); adjudicated events will be counted.
Time frame: 12 months after the index PCI
Stent thrombosis
Definite or probable stent thrombosis per ARC definitions.
Time frame: 12 months
Repeat revascularization
Any coronary revascularization (PCI or CABG), including TLR/TVR as defined in the protocol.
Time frame: 12 months
Stroke
Ischemic or hemorrhagic stroke confirmed by clinical assessment and/or neuroimaging, with a new focal neurologic deficit lasting \>24 hours or resulting in death.
Time frame: 12 months
Plan to share: Undecided — Data sharing may be considered after study completion and publication of the main results, depending on institutional policies and participant privacy considerations.
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Korea University Guro Hospital