About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- IVUS-guided BioFreedomTM Drug-Coated Stent Implantation + 1-Month DAPT Followed by 11-Month P2Y12 Inhibitor Monotherapy
- Angiography-guided Conventional Drug-Eluting Stent Implantation + 12-Month Dual Antiplatelet Therapy (Aspirin + P2Y12 Inhibitor)
Treatment groups
Sponsors and collaborators
Shenyang Northern Hospital
Lead sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Collaborator