DACAB Trial: Follow-up Extension (DACAB-FE)

Compare the Efficacy of Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Graft Surgery: Follow-up Extension

This study will include the subjects who enrolled in DACAB trial (NCT02201771) to observe clinical outcomes 5 years after coronary artery bypass grafting（CABG）.

The primary objective is to compare the occurrence of MACE-4 ( a composite of all-cause death, myocardial infarction, stroke, and coronary revascularization) among 3 randomized regimens (T+A, T alone, A alone) in previous DACAB trial within 5 years after CABG.

The secondary objectives are to compare the occurrence of MACE-5( a composite of all-cause death, myocardial infarction, stroke, coronary revascularization and hospitalization for unstable angina); MACE-3 ( a composite of cardiovascular death, myocardial infarction, and stroke); all-cause death; cardiovascular death; myocardial infarction; stroke; coronary revascularization; hospitalization for unstable angina and grafts patency rate among 3 randomized regimens in previous DACAB trial within 5 years after CABG.

The exploratory objectives are to compare the occurrence of MACE-4; MACE-5; MACE-3; all-cause death; cardiovascular death; myocardial infarction; stroke; coronary revascularization and hospitalization for unstable angina between 2 cohorts with or without grafts/vein grafts failure at 1 year angiographic follow-up.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Bypass Grafting; Antiplatelet Therapy
• Intervention / Treatment: Other: non-interventional

Detailed Description

This is a non-interventional, observational study designed to compare clinical outcomes 5 years after CABG in subjects enrolled in DACAB trial.

After completing 12-month randomized treatment from DACAB trial, investigators would not make any interventions or impact on subjects'therapeutic strategy. Aspirin monotherapy would be given to most subjects according to the current guidelines. However, other antiplatelet regimens might be given for subjects by their attending physician based on the subject's individual condition. Subjects would spontaneously undergo regular laboratory test , electrocardiogram (ECG), ultrasound cardiography (UCG), coronary computed tomographic angiography (CCTA) or coronary angiography (CAG) and clinical follow-up according to clinical need and their individual condition. At 5-year (± 3 month) after CABG, a face-to-face visit is scheduled to be performed to collect the occurrence of clinical events, including types and time of events.

Some prospective exploratory analysis are planned. According to the 1-year angiographic outcome of all grafts from the DACAB trial, all subjects will be allocated to 2 non-randomized cohorts: Cohort A with at least one graft failure (Fitzgibbon Grade B or O) at 1 year, and Cohort B without any graft failure at 1 year. Then prospective exploratory analysis will be performed to compare the occurrence of MACE-4; MACE-5; MACE-3; and other outcomes between 2 non-randomized cohorts from 1-year angiographic follow-up to 5 years after CABG. Similar analysis will be performed according to the 1-year angiographic outcome of vein grafts only.

Other preplanned subgroup analysis included: baseline gender, baseline age stratification(70 years), baseline status of acute coronary syndrome, history of hypertension, baseline history of diabetes, baseline history of high-density lipoprotein cholesterol, baseline history of high-density lipoprotein (a) cholesterol, baseline history of prior myocardial infarction, baseline history of stroke, baseline history of peripheral vascular disease, Baseline history of COPD , baseline history of CKD-3 or above , baseline history of smoking, baseline left main coronary artery disease, baseline SYNTAX score stratification, baseline EuroSCORE stratification, baseline CABG with or without cardiopulmonary bypass, baseline CABG with or without internal thoracic artery grafts, baseline CABG with or without complete revascularization.

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Fuwai Central China Cardiovascular Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Nan Jing First Hospital
    • Nanjing, Jiangsu, China, 21002
      • Jiangsu Province Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Changhai Hospital of Shanghai
    • Shanghai, Shanghai, China, 200025
      • Ruijin Hospital, Shanghai JiaoTong University School of Medicine
    • Shanghai, Shanghai, China, 200092
      • Xinhua Hospital, Shanghai Jiaotong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study will include the subjects who enrolled in DACAB trial

Description

Inclusion Criteria:

• This study will include the subjects who enrolled in DACAB trial

Exclusion Criteria:

• This study will include the subjects who enrolled in DACAB trial

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time to the first MACE-4 event	The time to the first occurrence of any MACE-4 event, defined as a composite of all-cause death, myocardial infarction, stroke and coronary revascularization.	within 5 year after CABG

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time to the first MACE-5 event	The time to first occurrence of any MACE-5 event, defined as a composite of all-cause death, myocardial infarction, stroke, coronary revascularization and hospitalization for unstable angina.	within 5 year after CABG
The time to the first MACE-3 event	The time to first occurrence of any MACE-3 event, defined as a composite of cardiovascular death, myocardial infarction, and stroke.	within 5 year after CABG
The time to the first occurrence of all-cause death.	The time to occurrence of any death	within 5 year after CABG
The time to the first cardiovascular death	The time to occurrence of any cardiovascular death	within 5 year after CABG
The time to the first myocardial infarction	The time to occurrence of any myocardial infarction, including STEMI, NSTEMI, or silent MI.	within 5 year after CABG
The time to the first stroke	The time to occurrence of any stroke, including ischemic, hemorrhagic, or unknown type.	within 5 year after CABG
The time to the first coronary revascularization	The time to occurrence of any repeated coronary revascularization, including PCI or CABG, no matter ischemic driven or not.	within 5 year after CABG
The time to the first hospitalization for unstable angina.	The time to occurrence of any hospitalization for unstable angina. By definition, UA is cardiac biomarker negative with no evidence of AMI.	within 5 year after CABG
The rate of grafts failure (Fitzgibbon Grade B+O).	assessed by CCTA or CAG, including artery and vein grafts.	at 5 years after CABG ( if not available, at anytime within 5 year after CABG)

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Investigators: Study Director: Yunpeng Zhu, MD, Ruijin Hospital; Principal Investigator: Mario FL Gaudino, MD, Weill Cornell Medicine NewYork Presbyterian Hospital; Principal Investigator: Qiang Zhao, MD, Ruijin Hospital

Publications and helpful links

General Publications

• Zhu Y, Zhang W, Dimagli A, Han L, Cheng Z, Mei J, Chen X, Wang X, Zhou Y, Xue Q, Hu J, Tang M, Wang R, Song Y, Kang L, Redfors B, Gaudino M, Zhao Q. Antiplatelet therapy after coronary artery bypass surgery: five year follow-up of randomised DACAB trial. BMJ. 2024 Jun 11;385:e075707. doi: 10.1136/bmj-2023-075707.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): June 15, 2021

Study Registration Dates

• First Submitted: June 13, 2019
• First Submitted That Met QC Criteria: June 13, 2019
• First Posted (Actual): June 17, 2019

Study Record Updates

• Last Update Posted (Actual): November 27, 2024
• Last Update Submitted That Met QC Criteria: November 24, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: CABG; Antiplatelet; MACE; grafts patency
• Other Study ID Numbers: ESR-18-13658

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No