Clinical trial NCT03871127: Ten-Year Outcomes of PRE-COMBAT Trial
Official title: Ten-Year Outcomes of PREmier of Randomized Comparison of Sirolimus-Eluting Stent Implantation Versus Coronary Artery Bypass Surgery for Unprotected Left Main Coronary Artery Stenosis: PRE-COMBAT Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: PCI
CABG
Left main
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2019-03-12
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subject group enrolled in PRECOMBAT trial

Brief summary: This study evaluates Ten-Year Outcomes of PREmier of Randomized Comparison of Sirolimus-Eluting Stent Implantation Versus Coronary Artery Bypass Surgery for Unprotected Left Main Coronary Artery Stenosis(PRECOMBAT trial).

Detailed description: This study is an extended one of PRECOMBAT trial.

Eligibility criteria: Inclusion Criteria:

* Subject group enrolled in PRECOMBAT trial

Primary outcomes:
measure: Composite outcome
timeFrame: 10 year
Secondary outcomes:
measure: All-cause mortality
timeFrame: 10 year
measure: Cardiac death
timeFrame: 10 year
measure: Myocardial infarction
timeFrame: 10 year
measure: Cerebrovascular accident
timeFrame: 10 year
measure: Target vessel revascularization
timeFrame: 10 year
measure: Target lesion revascularization
timeFrame: 10 year
measure: Stent thrombosis
timeFrame: 10 year
measure: Binary restenosis in both in-stent and in-segment
timeFrame: 10 year
measure: Graft reocclusion rate
timeFrame: 10 year
measure: Graft patency rate
timeFrame: 10 year
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
References:
citation: Yang Y, Jeong YJ, Hyun J, Lee J, Kim JH, Kim S, Kang DY, Lee PH, Ahn JM, Park DW, Park SJ; PRECOMBAT Investigators. Prognostic Value of Sex After Revascularization for Left Main Coronary Disease: Extended PRECOMBAT Study. JACC Asia. 2021 Nov 9;2(1):19-29. doi: 10.1016/j.jacasi.2021.08.009. eCollection 2022 Feb.
citation: Jeong YJ, Ahn JM, Hyun J, Lee J, Kim JH, Yang Y, Choe K, Park H, Kang DY, Lee PH, Kang SJ, Lee SW, Kim YH, Lee CW, Park SW, Park SJ, Park DW. Ten-year Outcomes After Drug-Eluting Stents or Bypass Surgery for Left Main Coronary Disease in Patients With and Without Diabetes Mellitus: The PRECOMBAT Extended Follow-Up Study. J Am Heart Assoc. 2021 Jul 20;10(14):e019834. doi: 10.1161/JAHA.120.019834. Epub 2021 Jul 9.
citation: Lee J, Ahn JM, Kim JH, Jeong YJ, Hyun J, Yang Y, Lee JS, Park H, Kang DY, Lee PH, Park DW, Park SJ; on the behalf of the PRECOMBAT Investigators. Prognostic Effect of the SYNTAX Score on 10-Year Outcomes After Left Main Coronary Artery Revascularization in a Randomized Population: Insights From the Extended PRECOMBAT Trial. J Am Heart Assoc. 2021 Jul 20;10(14):e020359. doi: 10.1161/JAHA.120.020359. Epub 2021 Jul 6.
citation: Park DW, Ahn JM, Park H, Yun SC, Kang DY, Lee PH, Kim YH, Lim DS, Rha SW, Park GM, Gwon HC, Kim HS, Chae IH, Jang Y, Jeong MH, Tahk SJ, Seung KB, Park SJ; PRECOMBAT Investigators. Ten-Year Outcomes After Drug-Eluting Stents Versus Coronary Artery Bypass Grafting for Left Main Coronary Disease: Extended Follow-Up of the PRECOMBAT Trial. Circulation. 2020 May 5;141(18):1437-1446. doi: 10.1161/CIRCULATIONAHA.120.046039. Epub 2020 Mar 30.