Clinical trial NCT06881901: Antiplatelet Strategy for CCS Patients Undergoing CABG
Official title: Clopidogrel Monotherapy in Patients with Chronic Coronary Syndrome Following Coronary Artery Bypass Grafting : a Target Trial Emulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Coronary Syndrome
Coronary Artery Bypass Graft CABG
Keywords: antiplatelet drug
Dual antiplatelet therapy
Single antiplatelet therapy
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 29898
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were prescribed antiplatete therapy after undergoing CABG

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.

Eligibility criteria: 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

Primary outcomes:
measure: Major adverse cardiac and cerebrovascular events (MACCE)
timeFrame: 10 year after CABG
measure: Major GI bleeding
timeFrame: 10 year after CABG
Secondary outcomes:
measure: All cause death
timeFrame: 10 year after CABG
measure: Spontaneous myocardial infarction
timeFrame: 10 year after CABG
measure: Stroke
timeFrame: 10 year after CABG
measure: Repeat revascularization
timeFrame: 10 year after CABG
measure: Bleeding evet
timeFrame: 10 year after CABG
Other outcomes:
Locations:
Study officials:
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