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| ID | Type | Description | Link |
|---|---|---|---|
| KOR-2023-02 | Other Grant/Funding Number | Abott |
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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short DAPT | Experimental | Patients with optimized stent results confirmed by OCT will receive 1 month of dual antiplatelet therapy followed by clopidogrel monotherapy. |
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| Standard DAPT | Active Comparator | 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. |
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| Extended DAPT | Active Comparator | Patients with suboptimal stent results and high ischemic risk, as judged by the operator, will remain on dual antiplatelet therapy for 12 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Short DAPT | Drug | Patients receive aspirin and clopidogrel for 1 month after PCI. After 1 month, aspirin is discontinued and clopidogrel monotherapy is continued. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months after the index PCI |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12 months after PCI |
| All bleeding events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Soohyung Park, MD, PhD | Contact | +82-10-3105-3710 | shp503@naver.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular Center, Department of Internal Medicine, Korea University Guro Hospital | Recruiting | Seoul | Gurodong-ro, Guro-gu | 148 | South Korea |
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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| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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This is a prospective, single-center, open-label study with a parallel assignment design. All patients undergo OCT-guided PCI. Based on OCT findings, patients are categorized into two groups: those with optimized stent results receive short-duration DAPT (1 month), while those with suboptimal stent results continue standard DAPT (6-12 months) according to guidelines. Outcomes will be compared between groups.
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| Standard DAPT | Drug | 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. |
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| Extended DAPT | Drug | Patients (with stet unoptimazation results in OCT imaging) receive aspirin and clopidogrel for 12 months after PCI. |
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| OCT-guided PCI | Device | All patients undergo percutaneous coronary intervention with mandatory intravascular imaging using optical coherence tomography to assess stent optimization (expansion, apposition, dissection). |
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Any bleeding by BARC criteria (types 1-5). |
| 12 months after the index PCI |
| All-cause death | Death from any cause. | 12 months after the index PCI |
| Cardiac death | Death due to cardiac causes (e.g., MI, sudden cardiac death, heart failure), per protocol definition. | 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. | 12 months after the index PCI |
| Stent thrombosis | Definite or probable stent thrombosis per ARC definitions. | 12 months |
| Repeat revascularization | Any coronary revascularization (PCI or CABG), including TLR/TVR as defined in the protocol. | 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. | 12 months |
| D014652 |
| Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |