Optimization and Validation of Quality Control Indicators for Coronary Revascularization Based on Antiplatelet Therapy

Condition(s) studied

Study summary

Study Purpose Coronary heart disease (CAD) is a leading global cause of death, with Acute Coronary Syndrome (ACS) as its acute and life-threatening subtype. Percutaneous Coronary Intervention (PCI) plus stent implantation is the first-line treatment for ACS, and post-PCI Dual Antiplatelet Therapy (DAPT, aspirin + P2Y₁₂ inhibitor) is core for thrombosis prevention but increases bleeding risk. Approximately 40% of ACS patients are classified as High Bleeding Risk (HBR). China lacks a unified DAPT quality control system, and the predictive value of the OPT-CAD ischemic risk score for this population remains unvalidated. This study aims to: 1) Evaluate the feasibility and influencing factors of the DAPT quality control system in HBR ACS patients post-PCI; 2) Verify the accuracy of the OPT-CAD score in predicting ischemic risk, providing evidence for personalized treatment.

Eligibility Criteria Inclusion Criteria Aged ≥18 years; Diagnosed with ACS and implanted with at least one drug-eluting stent (DES) during PCI; Meets ARC-HBR (Academic Research Consortium for High Bleeding Risk) HBR definition (1 major criterion or 2 minor criteria); Able to complete OPT-CAD scoring; Tolerates 12-month DAPT (physician assessment); Signs informed consent. Exclusion Criteria Allergy to aspirin, clopidogrel, ticagrelor, or other study-related antiplatelet drugs; Severe ischemia or major bleeding during current hospitalization; Terminal illness with life expectancy \<1 year; Pregnant or planning pregnancy within 1 year; Enrolled in other ongoing clinical studies. Study Process

This is a multi-center prospective cohort study (we will follow eligible patients over 12 months to collect real-world data without changing their standard care) recruiting 3,500 participants nationwide. Post-enrollment:

Receive 6-12 months of standard DAPT (regimen determined by your physician); Follow-ups at 1 month (±7 days), 3 months (±14 days), 6 months (±30 days), and 12 months (±30 days) post-PCI (via phone or outpatient visit) to collect medication adherence, bleeding/ischemic events, and clinical outcomes; Confidential data collection via a secure Electronic Data Capture (EDC) system. Study Endpoints Primary Endpoints Feasibility of the DAPT quality control system, inter-hospital differences in DAPT use, 6-12 month DAPT completion rate, and impact of DAPT interruption on patient outcomes; Accuracy of the OPT-CAD score in predicting ischemic risk for HBR patients. Secondary Endpoints 12-month bleeding event rates (BARC 1-5 types, including minor bleeding like puncture site bleeding and major bleeding like intracranial hemorrhage); 12-month ischemic event rates (including target lesion failure-cardiac death, target vessel-related myocardial infarction, or target lesion revascularization-all-cause death, ischemic stroke, definite stent thrombosis, etc.); DAPT interruption rate, P2Y₁₂ inhibitor discontinuation rate (≥1 week), and aspirin discontinuation rate (≥1 week).

Key Information for Participants Voluntary participation: You may withdraw anytime without penalty or loss of medical benefits; Confidential data protection: Personal information will be anonymized with a unique study ID; Free study-related assessments and follow-ups; Prompt medical care will be provided for any adverse events. For inquiries, contact the study team at the participating hospital.

Eligibility

Primary outcome measure(s)

• The overall composite of 11 performance measures for DAPT-based Quality Control Standard System for Coronary Artery Disease Revascularization. — 12 months
  The proportion of ACS patients scheduled for stent implantation during PCI who undergo risk stratification; The proportion of ACS patients undergoing PCI who initiate DAPT during the procedure; The proportion of ACS patients who maintain DAPT for at least 12 months after PCI; In patients at "high bleeding risk", the proportion of patients whose DAPT regimens are adjusted according to risk; The proportion of patients with implanted BRS who maintain DAPT for more than 12 months; The proportion of patients receiving alternative DAPT regimens due to drug intolerance or allergy; The proportion of implementation of optimized regimens combining anticoagulation with DAPT; The proportion of DAPT adjustment following bleeding events; Incidence of ischemic events: cardiac death, ischemic stroke, definite stent thrombosis, TVR, and TLF; Incidence of bleeding events: BARC Types 3/5 bleeding; The proportion of patients adherent to standardized DAPT.
• Accuracy of the OPT-CAD score in predicting ischemia risk in high-bleeding-risk patients. — 12 months
  The OPT-CAD score (Optimal antiPlatelet Therapy for Chinese patients with Coronary Artery Disease) is an ischemic risk scoring system developed based on the Chinese OPT-CAD registry study (107 centers, 14,032 patients). It is specifically used to predict long-term ischemic events and all-cause mortality in Chinese patients with coronary artery disease, especially those with acute coronary syndrome (ACS). OPT-CAD score ranges from 0 to 257 points in total. Patients are divided into three risk levels based on their total scores, corresponding to different incidences of ischemic events:Low risk 0-90 points ;Medium risk 91-150 points High risk ≥151 points.

Trial sites (1)

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