Efficacy and Safety of Shortening Dual Antiplatelet Therapy Duration with IVUS Guidance in PCI Patients

This multicenter, double-blind, randomized controlled trial will evaluate the clinical outcomes of DAPT de-escalation at 1 month compared to 12 months, in patients who have undergone PCI with drug-eluting stent (DES) implantation. The study aims to optimize post-PCI treatment duration while reducing associated risks such as bleeding complications. Intravascular ultrasound (IVUS) will be used to guide stent placement and optimize results, especially in high-risk, complex cases.

Participants will be randomly assigned to two groups:

• One month of DAPT, followed by monotherapy with a P2Y12 inhibitor.
• Standard 12 months of DAPT. Patients will be followed for 12 months after the intervention to track cardiovascular events, bleeding complications, and overall safety.

Inclusion criteria

• Patients aged 18 years or older.
• Patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES).
• Patients with the following clinical indications for PCI:

• 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.
• Chronic Coronary Syndrome: Requiring coronary revascularization.
• Patients who agree to participate and provide informed consent.

Exclusion criteria

• 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.
• Severe Chronic Kidney Disease: Patients with an estimated glomerular filtration rate (eGFR) of less than 20 ml/min/1.73 m² or patients on dialysis.
• Chronic Anticoagulation Therapy: Patients requiring chronic oral anticoagulation (e.g., warfarin, DOACs) beyond DAPT.
• Thrombocytopenia: Platelet count less than 100,000/mm³.
• Contraindications to Antiplatelet Therapy: Allergy or intolerance to aspirin or P2Y12 inhibitors.
• Liver Disease: Patients with cirrhosis or significant liver dysfunction.
• Limited Life Expectancy: Patients with a life expectancy of less than 12 months due to other non-cardiac conditions.
• Other Medical Conditions: Any condition that might interfere with adherence to the study protocol or follow-up schedule.