Antiplatelet Strategy for CCS Patients Undergoing CABG (CABG_DAPT_SAPT)

Clopidogrel Monotherapy in Patients with Chronic Coronary Syndrome Following Coronary Artery Bypass Grafting : a Target Trial Emulation

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 29898

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who were prescribed antiplatete therapy after undergoing CABG

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Dual antiplatelet therapy; Patients who were prescribed dual antiplatelet therapy (aspirin + clopidogrel) at the date of discharge from te index hospitalization for CABG
Aspirin monotherapy; Patients who were prescribed single antiplatelet therapy (aspirin) at the date of discharge from te index hospitalization for CABG
Clopidogrel monotherapy; Patients who were prescribed single antiplatelet therapy (clopidogrel) at the date of discharge from te index hospitalization for CABG

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: March 10, 2025
• First Submitted That Met QC Criteria: March 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Dual antiplatelet therapy; antiplatelet drug; Single antiplatelet therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: Antiplatelet After CABG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No