This study is designed to verify the safety and efficacy of Lepu® NeoVas™ Bioabsorbable Coronary Artery Rapamycin-eluting Stent System combined with different antiplatelet therapies in the treatment of coronary heart disease.
Age 18 or above, male or non-pregnant female.
Evidence of myocardial ischemia (e.g., stable angina, unstable angina, medium-low risk NSTEMI, STEMI with onset more than 1 week, old myocardial infarction or asymptomatic myocardial ischemia), and suitable for PCI surgery.
The target lesion is in-situ coronary artery lesion, the total length of single lesion is no more than 40mm (the total length of stent is no more than 48mm), and the diameter of the target lesion is between 2.75mm and 3.75mm (visual measurement).
The diameter stenosis of target lesion is ≥70% in visual (or ≥50% with clinical evidence of myocardial ischemia in that range), and the TIMI blood flow is greater than grade 1.
Acute ST-segment elevation myocardial infarction within 1 week.
Left main coronary artery disease, branch vessel diameter≥2.0mm, three-vessel coronary artery disease and bridge vessel disease; visible thrombus in the target vessel.
Severe distortion, severe calcification that cannot be successfully predilated, and other lesions that are not suitable for stent delivery and deployment.
Intra-stent restenosis.
Parallel
Single anti-platelet therapy
DrugAspirin in combination with a P2Y12 receptor antagonist (either clopidogrel or ticagrelor will be selected by investigators according to the degree of ischemia) in the first year after PCI. Aspirin will be discontinued one year after surgery and clopidogrel will be continued until 5 years after surgery.
Dual anti-platelet therapy
DrugAspirin in combination with a P2Y12 receptor antagonist (either clopidogrel or ticagrelor will be selected by investigators according to the degree of ischemia) in the first year after PCI. Patients continue to take dual antiplatelet (DAPT) drugs, including aspirin and clopidogrel, for 2 more years; then aspirin will be used alone from the 4th year to the 5th year.
Net adverse clinical event (NACE)
NACE includes POCE (including all-cause death, all non-fatal myocardial infarction (Universal Definition of Myocardial Infarction, 4th Edition), any revascularization, and stroke), and major bleeding events of grade 2, 3, and 5 as defined by BARC.
Target lesion failure (TLF)
Target lesion failure (TLF) includes cardiac death, target vessel myocardial infarction (TV-MI) and ischemic-driven target lesion revascularization (ID-TLR).
Comparison of net adverse clinical events
Bleeding events of grade 3 and 5 as defined by BARC
Bleeding events of grade 2, 3 and 5 as defined by BARC
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