This study is designed to assess the efficacy and safety of de-escalating dual antiplatelet therapy (DAPT) at 1 month compared to the standard 12 months of therapy in patients undergoing percutaneous coronary intervention (PCI) guided by intravascular ultrasound (IVUS). The main outcomes measured will include major adverse cardiovascular and cerebrovascular events (NACCE), bleeding events, and target vessel failure (TVF). The goal is to evaluate whether a shorter duration of DAPT is non-inferior to the standard 12-month regimen in preventing ischemic events while reducing the incidence of bleeding.
Patients aged 18 years or older.
Patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES).
Unstable Angina: Prolonged chest pain at rest, new-onset angina within the past 2 months, or increasing frequency/severity of angina attacks.
Acute Myocardial Infarction (MI): With or without ST-elevation.
Inability to Provide Informed Consent: Patients who are unable or unwilling to provide consent.
Neurological Complications: Stroke or any permanent neurological deficits within the last 3 months.
Coronary Artery Bypass Graft Surgery: History of CABG surgery.
Planned Surgery: Patients who have surgeries planned within the next 12 months.
Parallel
DAPT de-escalation
DrugPatients in this group will receive DAPT (aspirin and a P2Y12 inhibitor) for 1 month, followed by monotherapy with a P2Y12 inhibitor for the remaining 11 months.
Net Adverse Cardiovascular and Cerebrovascular Events (NACCE) within 12 Months Post-PCI
NACCE is a composite of major adverse cardiovascular events (MACEs) and cerebrovascular events, and any significant bleeding event (classified according to BARC 2-5). Cumulative risk of NACCE will be compared between the 1-month DAPT and 12-month DAPT groups.
12-month Target Vessel Failure (TVF) Rate
TVF is defined as a composite of target vessel myocardial infarction (TVMI), target vessel revascularization (TVR), or cardiovascular death related to the target vessel. Cumulative incidence of TVF will be compared between each treatment group.
12-month Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
MACCE includes cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and clinically-driven revascularization or definite stent thrombosis. Cumulative risk of MACCE will be compared between the 1-month DAPT and 12-month DAPT groups.
Major Bleeding Events Classified by BARC (Bleeding Academic Research Consortium) Scale
To compare the rate of significant bleeding, classified according to the Bleeding Academic Research Consortium (BARC) types 2 to 5, between the two groups.
Clinical Characteristics of PCI Patients at Baseline (Descriptive Analysis of Demographics and Clinical Data)
This outcome measure will include a detailed analysis of the clinical characteristics of patients undergoing PCI. The data will include demographics (age, gender), cardiovascular risk factors (diabetes, hypertension, smoking status), previous cardiovascular events, and other relevant clinical history such as comorbidities. Data will be summarized as means (for continuous variables like age) or percentages (for categorical variables like gender and risk factors). This measure aims to provide a baseline comparison between the two study groups (1-month DAPT vs. 12-month DAPT)
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University Medical Center Ho Chi Minh City (UMC)
Lead sponsor
University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor institution
University of Medicine and Pharmacy at Ho Chi Minh City
Collaborator
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