Ten-Year Outcomes of Stents Versus Coronary-Artery Bypass Grafting for Left Main Coronary Artery Disease (MAIN COMPARE)

• ClinicalTrials.gov Identifier: NCT02791412
• Recruitment Status: Completed
• First Posted: June 6, 2016
• Last Update Posted: June 26, 2018
• Sponsor: Seung-Jung Park
• Collaborator: CardioVascular Research Foundation, Korea
• Information provided by (Responsible Party): Seung-Jung Park, Asan Medical Center

Tracking Information

• First Submitted Date: May 30, 2016
• First Posted Date: June 6, 2016
• Last Update Posted Date: June 26, 2018
• Actual Study Start Date: January 13, 2017
• Actual Primary Completion Date: May 30, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 1, 2016)

composite event [ Time Frame: 10 years ]

all-cause death, myocardiac infarction, revascularization

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Ten-Year Outcomes of Stents Versus Coronary-Artery Bypass Grafting for Left Main Coronary Artery Disease
• Official Title: Ten-Year Outcomes of Stents Versus Coronary-Artery Bypass Grafting for Left Main Coronary Artery Disease in Korea : Multicenter, Long-term, Observational Trial
• Brief Summary: The purpose of this study is to evaluate long-term outcome of treatment(percutaneous coronary intervention or coronary-artery bypass graft) in unprotected left main coronary artery stenosis in Korea.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patients undergone percutaneous coronary intervention or coronary-artery bypass graft for treatment of unprotected left main disease
• Condition: Coronary Arteries
• Intervention: Procedure: percutaneous coronary intervention or coronary-artery bypass graft

Study Groups/Cohorts

unprotected left main

undergone percutaneous coronary intervention or coronary artery bypass graft

Intervention: Procedure: percutaneous coronary intervention or coronary-artery bypass graft

Publications *

• Yoon YH, Ahn JM, Lee JB, Kang DY, Park H, Jeong YJ, Lee J, Kim JH, Yang Y, Hyun J, Lee PH, Park DW, Park SJ. Time-Dependent Impact of Sex on the Long-Term Outcomes After Left Main Revascularization. J Am Heart Assoc. 2022 Mar;11(5):e021720. doi: 10.1161/JAHA.121.021720. Epub 2022 Feb 22.
• Kang DY, Ahn JM, Yun SC, Park H, Cho SC, Kim TO, Park S, Lee PH, Lee SW, Park SW, Park DW, Park SJ. Long-Term Clinical Impact of Intravascular Ultrasound Guidance in Stenting for Left Main Coronary Artery Disease. Circ Cardiovasc Interv. 2021 Oct;14(10):e011011. doi: 10.1161/CIRCINTERVENTIONS.121.011011. Epub 2021 Oct 19.
• Lee K, Ahn JM, Yoon YH, Kang DY, Park SY, Ko E, Park H, Cho SC, Park S, Kim TO, Lee PH, Lee SW, Park SW, Park DW, Park SJ. Long-Term (10-Year) Outcomes of Stenting or Bypass Surgery for Left Main Coronary Artery Disease in Patients With and Without Diabetes Mellitus. J Am Heart Assoc. 2020 Apr 21;9(8):e015372. doi: 10.1161/JAHA.119.015372. Epub 2020 Apr 20.
• Kim TO, Ahn JM, Kang DY, Kim SO, Park S, Park H, Lee PH, Lee SW, Park SW, Park DW, Park SJ. Rates and Independent Correlates of 10-Year Major Adverse Events and Mortality in Patients Undergoing Left Main Coronary Arterial Revascularization. Am J Cardiol. 2020 Apr 15;125(8):1148-1153. doi: 10.1016/j.amjcard.2020.01.023. Epub 2020 Jan 29.
• Yoon YH, Ahn JM, Kang DY, Park H, Cho SC, Lee PH, Lee SW, Park SW, Park DW, Park SJ. Impact of SYNTAX Score on 10-Year Outcomes After Revascularization for Left Main Coronary Artery Disease. JACC Cardiovasc Interv. 2020 Feb 10;13(3):361-371. doi: 10.1016/j.jcin.2019.10.020.
• Park DW, Ahn JM, Yun SC, Yoon YH, Kang DY, Lee PH, Lee SW, Park SW, Seung KB, Gwon HC, Jeong MH, Jang Y, Kim HS, Seong IW, Park HS, Ahn T, Chae IH, Tahk SJ, Park SJ. 10-Year Outcomes of Stents Versus Coronary Artery Bypass Grafting for Left Main Coronary Artery Disease. J Am Coll Cardiol. 2018 Dec 11;72(23 Pt A):2813-2822. doi: 10.1016/j.jacc.2018.09.012. Epub 2018 Sep 24.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 25, 2018): 2240
• Original Estimated Enrollment (submitted: June 1, 2016): 2000
• Actual Study Completion Date: May 30, 2018
• Actual Primary Completion Date: May 30, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Unprotected left main disease

Exclusion Criteria :

• No exclusion criteria

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 19 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT02791412
• Other Study ID Numbers: AMCCV2016-08
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: This is not a publicly funded trial.

• Current Responsible Party: Seung-Jung Park, Asan Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Seung-Jung Park
• Original Study Sponsor: Same as current
• Collaborators: CardioVascular Research Foundation, Korea
• Investigators: Not Provided
• PRS Account: Asan Medical Center
• Verification Date: June 2018