Antiplatelet Strategy for CCS Patients Undergoing CABG

Completed

• Conditions: Chronic Coronary Syndrome; Coronary Artery Bypass Graft CABG

• Registration Number: NCT06881901
• Lead Sponsor: Samsung Medical Center

Brief Summary

To evaluate the long-term outcomes of different antiplatelet strategies, including DAPT, aspirin monotherapy, and clopidogrel monotherapy, in CCS patients undergoing CABG. A retrospective, population-based cohort study was conducted using data from the Korean National Health Insurance Service (K-NHIS) database.

Detailed Description

The use of antiplatelet agents is crucial in preventing atherothrombotic complications and maintaining graft patency after coronary artery bypass grafting (CABG). While dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor is recommended for one year in patients undergoing CABG for acute coronary syndrome (ACS), the optimal antiplatelet strategy for chronic coronary syndrome (CCS) remains unclear. In fact, current guidelines show discrepancies, with the American Heart Association/American College of Cardiology (AHA/ACC) recommending DAPT for one year to reduce the risk of saphenous vein graft (SVG) occlusion (Class IIb), while the European Society of Cardiology (ESC) recommends switching to aspirin monotherapy to reduce bleeding risk and considers DAPT only for high-risk patients (Class IIb). However, aspirin monotherapy may also not be the optimal alternative due to its limited efficacy in preventing thrombotic events and its inability to significantly reduce major bleeding compared to DAPT. Recently, clopidogrel monotherapy has emerged as a promising alternative, potentially offering both ischemic protection and a lower bleeding risk compared to DAPT even compared to aspirin monotherapy. An observational study comparing clopidogrel monotherapy with clopidogrel plus aspirin after CABG found that clopidogrel monotherapy demonstrated comparable to the combination therapy group. While this suggests that clopidogrel monotherapy could be a viable alternative, previous study was limited by its short follow-up duration and lack of bleeding outcome assessment. Thus, the investigators performed target trial emulation to evaluate long-term ischemic and bleeding outcomes associated with DAPT, aspirin monotherapy, and clopidogrel monotherapy in CCS patients following CABG.

Study Timeline

• Study Start: 2010-01-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2025-03
• Study First Submitted: 2025-03-10
• Study First Submitted QC: 2025-03-11
• Last Update Submitted: 2025-03-11
• Study First Posted: 2025-03-18
• Last Update Posted: 2025-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29898

Inclusion Criteria

• Patients with underwent Coronary artery bypass surgery (CABG) between January 2010 and December 2020

Exclusion Criteria

• In-hospital death
• Not prescribed SAPT or DAPT
• Received CABG due to myocardial infarction or had myocardial infarction
• Received CABG due to unstable angina or had unstable angina
• History of PCI
• Pre-existing Intracranial hemorrhage or gastrointestinal bleeding
• Oral anticoagulant prescription at discharge

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major adverse cardiac and cerebrovascular events (MACCE)	10 year after CABG	Composite of all cause death, spontaneous MI, and stroke
Major GI bleeding	10 year after CABG	Major GI bleeding requiring transfusion

Secondary Outcome Measures

Name	Time	Method
All cause death	10 year after CABG	death from any cause
Spontaneous myocardial infarction	10 year after CABG	Myocardial infarction with hospitalozation
Stroke	10 year after CABG	Stroke after CABG
Repeat revascularization	10 year after CABG	Additional PCI or CABG after discharge
Bleeding evet	10 year after CABG	Any bleeding requiring transfusion