P2Y12 Inhibitor-based SAPT Versus Conventional DAPT After PCI With BioFreedom Ultra Drug-coated Stent for Unprotected Left Main Disease (ULTRA-LM) (ULTRA-LM)
Left Main Coronary Artery Stenosis
About this trial
This is an interventional treatment trial for Left Main Coronary Artery Stenosis focused on measuring P2Y12 inhibitor-based single antiplatelet therapy, Dual antiplatelet therapy, Left main coronary artery disease, Percutaneous coronary intervention, Drug-coated stent, Polymer-free drug-eluting stent
Eligibility Criteria
Inclusion Criteria: Age ≥18 years. Patient with chronic or acute coronary syndrome (unstable angina, or non-ST-elevation acute coronary syndrome). Subject with significant unprotected (ostial, mid-shaft, or distal) LMCA stenosis who underwent successful LMCA PCI with ≥1 BioFreedom Ultra polymer-free drug-coated stent (Biosensors International, Switzerland) according to current ESC guidelines on myocardial revascularization and/or local Heart Team decision. Subject willing to participate and able to understand, read and sign the informed consent document before the planned procedure. Exclusion Criteria: Contraindications to PCI and/or DES implantation. Inability to adhere to DAPT for at least 6 months. Patient already on DAPT. Patients on oral anticoagulation. Previous coronary artery bypass surgery. LMCA in-stent restenosis or stent thrombosis. Recent ST-elevation myocardial infarction <5 days prior to randomization. Cardiogenic shock/hemodynamic instability at the time of intervention and/or need for mechanical/pharmacologic hemodynamic support. Participation or planned participation in another clinical trial, except for observational registries. Life expectancy <1 year. Pregnancy.
Sites / Locations
- Geneva University Hospitals
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
P2Y12 inhibitor-based single antiplatelet therapy strategy arm
Conventional DAPT strategy arm
Successful LMCA PCI with ≥1 BioFreedom Ultra polymer-free drug-coated stent (Biosensors International, Switzerland) Potent P2Y12 inhibitor-based SAPT with ticagrelor 90 mg bd, or prasugrel 5 or 10 mg od at the discretion of the investigator, during 2 years. Aspirin stopped after LMCA PCI or at latest at hospital discharge. De-escalation from ticagrelor 90 mg bd, or prasugrel 5 or 10 mg od, to clopidogrel 75 mg od is possible at 12 months, at the discretion of the investigator.
Successful LMCA PCI with ≥1 BioFreedom Ultra polymer-free drug-coated stent (Biosensors International, Switzerland) DAPT combining aspirin (≥75 mg od) and a P2Y12 receptor inhibitor (clopidogrel 75 mg od, ticagrelor 90 mg bd, prasugrel 5 or 10 mg od at the discretion of the investigator) during 6 or 12 months, followed by aspirin SAPT. In patients with index ACS who have tolerated DAPT for 12 months without a bleeding complication, a prolonged DAPT course with aspirin and ticagrelor 60 mg bd beyond 12 months (up to 3 years) may be considered in those with high thrombotic risk and without an increased risk for major or life-threatening bleeding, and those with moderately elevated thrombotic risk.