COMPARE STEMI ONE- Comparison Of Reduced DAPT Followed by P2Y12 Inhibitor Monotherapy With Prasugrel vs stAndard Regimen in STEMI Patients Treated With OCT-guided vs aNgio-guided completE Revascularization
The study is a multi-centre, Open-label, Randomized Controlled, 1:1 trial comparing Prasugrel-based short DAPT (30-45 days) followed by Prasugrel monotherapy versus standard DAPT regimen in STEMI patients in terms of safety and efficacy endpoints. In the subgroup of STEMI patients with MVD, a sub-randomization will allow a comparison between a complete revascularization OCT-guided versus complete revascularization angiography-guided stent in terms of efficacy and safety endpoints.
⁃ Eligibility at index procedure
⁃ All STEMI patients who are planned to be treated with PCI:
⁃ ST segment elevation myocardial infarction
⁃ Chest discomfort suggestive of cardiac ischemia ≥20 min at rest with 1 of the following ECG features:
• ST segment elevation ≥2 contiguous ECG leads
• new or presumably new left bundle branch block
⁃ In patients with multivessel disease, treatment only of the culprit lesion / target vessel during primary PCI is recommended.
⁃ Eligibility at 30-45 days
• All patients who have provided informed consent
• Compliance to DAPT with no regimen modifications (Non-adherence Academic Research Consortium 0)
• No occurrence of significant event (such as MI, unplanned revascularisation, stent thrombosis, stroke, major vascular complication/bleeding BARC Types 3 or greater).
• Successful revascularization: - Successful delivery and deployment of the Study device(s), with final residual stenosis of \<30% (visually) for all target lesions.
• Complete revascularization performed when more than 1 significant lesion, during the index procedure or in staged procedure(s) occurring within 15 days from the index procedure. Physiologic assessment highly recommended for lesions with stenosis between 50% and 90%.