Patients with acute coronary syndrome (ACS) who have both high ischemic risk and high bleeding risk represent a challenging population following percutaneous coronary intervention (PCI), as prolonged dual antiplatelet therapy (DAPT) may reduce ischemic events but increases bleeding complications.This prospective, multicenter, randomized controlled study evaluates the safety and effectiveness of an optimized PCI and antiplatelet therapy strategy in ACS patients with moderate-to-high ischemic risk and high bleeding risk. Eligible patients will be randomized in a 1:1 ratio to either an experimental strategy consisting of intravascular ultrasound-guided implantation of a polymer-free drug-coated stent followed by one month of DAPT and subsequent single antiplatelet therapy, or a control strategy consisting of angiography-guided implantation of contemporary drug-eluting stents followed by standard 12-month DAPT.The primary hypothesis is that the experimental strategy will reduce the incidence of net adverse clinical events, defined as a composite of ischemic and bleeding outcomes, compared with conventional PCI and prolonged DAPT. Participants will be followed for 12 months after the index procedure.
Aged ≥ 18 years old
ACS patients with high bleeding risk (meeting the ARC-HBR criteria)
Moderate-to-high ischemic risk (OPT-CAD score ≥ 90)
Predicted by the investigator to be able to tolerate 12 months of DAPT
Patients with known allergy or contraindication to P2Y12 inhibitors, aspirin, or contrast agents
Patients planning to undergo surgical intervention within 12 months
Left Ventricular Ejection Fraction (LVEF) < 35%
Patients with contraindications to PCI
Parallel
IVUS-guided BioFreedomTM Drug-Coated Stent Implantation + 1-Month DAPT Followed by 11-Month P2Y12 Inhibitor Monotherapy
DeviceIntravascular ultrasound (IVUS)-guided implantation of BioFreedom™ polymer-free drug-coated stent, followed by 1-month dual antiplatelet therapy (DAPT: aspirin + P2Y12 inhibitor) and 11-month P2Y12 inhibitor monotherapy for ACS patients with high bleeding and intermediate-to-high ischemic risk.
Angiography-guided Conventional Drug-Eluting Stent Implantation + 12-Month Dual Antiplatelet Therapy (Aspirin + P2Y12 Inhibitor)
DeviceCoronary angiography-guided implantation of conventional drug-eluting stent (DES), with 12-month standard DAPT (aspirin + P2Y12 inhibitor) for the same patient population.
The 12-month incidence of Net Adverse Clinical Events (NACE)
NACE is defined as a composite endpoint of bleeding and ischemic events, including cardiac death, myocardial infarction, ischemic stroke, definite stent thrombosis, clinically driven target vessel revascularization, or any bleeding (BARC defined type 1, 2, 3, 5 bleeding according to the Bleeding Academic Research Consortium \[BARC\]) (for superiority assessment).
The 12-month incidence of clinically relevant bleeding events (for superiority assessment)
Clinically relevant bleeding events refer to BARC defined type 2, 3, 5 bleeding
The incidence of NACE and clinically relevant bleeding events (including BARC type 2, 3, 5 bleeding) at 30 days and 6 months
Incidence of clinically driven target lesion revascularization (CD-TLR)at 30 days, 6 months, and 12 months
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Shenyang Northern Hospital
Lead sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Collaborator
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