Optical coherence tomography (OCT) offers a high-resolution intravascular imaging modality to accurately assess vessel and lumen geometry and identify the hallmark of a culprit lesion including plaque disruption and thrombus. In addition, the incorporation of the MLD MAX algorithm into daily practice guides an efficient and easily-memorable workflow for optimized OCT-guided percutaneous coronary intervention (PCI) with drug-eluting stents (DES). Regarding the antithrombotic therapy after revascularization, the 2023 ESC guidelines recommend the P2Y12 receptor inhibitor de-escalation (i.e. switching from ticagrelor to clopidogrel) in ACS patients may be considered as an alternative strategy to the default treatment regimen in order to reduce the risk of bleeding events.
Based on the above conclusions, we designed a single-center, prospective, randomized controlled, exploratory study trial to evaluate whether the utility of OCT for guiding PCI with DES followed by antiplatelet de-escalation therapy could further reduce the stent-induced intimal hyperplasia of STEMI patients after stent implantation.
18 ~ 85 years old adult patients;
Patients diagnosed with STEMI and undergoing PCI.
Patients able and willing to give written informed consent and to comply with the requirements of this study protocol.
Prior history of intracranial hemorrhage or ischemic stroke during the past 6 months；
Allergy to aspirin or clopidogrel or ticagrelor;
Occurrence of major adverse cardiovascular event (MACE) within 30 days after undergoing PCI;
Platelet count < 50 × 109/L;
Parallel
OCT-guided PCI
Procedure/SurgeryOCT-guided PCI based on MLD MAX algorithm
Conventional angiography-based PCI
Procedure/SurgeryConventional angiography-based PCI
DAPT de-escalation
DrugAspirin and clopidogrel 30 days after DES implantation
default DAPT regimen
DrugAspirin and ticagrelor 30 days after DES implantation
Neointimal thickness after DES implantation
Stent and luminal cross-sectional areas (CSAs) were measured. Neointimal CSA was calculated as stent CSA minus lumen CSA. Neointimal thickness was measured as the distance between endoluminal surface of neointima and strut, which was obtained at 12-month follow-up.
Major adverse cardiovascular and cerebrovascular events (MACCE)
Defined as a composite endpoints of all-cause death, myofarction, stroke and clinically indicated revascularization
BARC types 2-5 bleeding
Defined as all BARC type 2-5 bleeding events
In-stent thrombosis
In-stent thrombosis was defined as new ST elevation with anginal symptoms or an equivalent due to thrombotic occlusion of the stent placed at the culprit lesion confirmed by coronary angiography during the index hospitalization.
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