Clinical trial NCT03870815: Long-term Outcomes and Prognostic Factors in Patient Undergoing CABG or PCI
Official title: Registry for Long-term Clinical Outcomes and Prognostic Factors in Patient With Coronary Artery Disease Undergoing Coronary Artery Bypass Graft Surgery or Percutaneous Coronary Intervention With Second Generation Drug-Eluting Stent
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischemic Heart Disease
Keywords: Ischemic heart disease
Coronary artery bypass grafting
Percutaneous coronary intervention
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2019-03-12
Enrollment: 10000
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: About 10,000 patients with suspected ischemic heart disease and who underwent PCI with DES or CABG.

Brief summary: 1. To evaluate the long-term clinical outcomes and prognostic factors in patients with coronary artery disease undergoing coronary artery bypass graft surgery.
2. To evaluate the long-term clinical outcomes and prognostic factors in patients with coronary artery disease undergoing percutaneous coronary intervention with drug-eluting stent.

Detailed description: Coronary artery disease (CAD) still remains one of the world's leading causes of death, despite markedly improvement of devices and technologies on past several decades. The treatment strategy for CAD included medical treatment, percutaneous coronary intervention (PCI), and coronary-artery bypass grafting (CABG). CABG is a procedure in which autologous arteries or veins are used as grafts to bypass coronary arteries that are partially or completely obstructed by atherosclerotic plaque. During the past decade, there has been nearly a 30% decline in CABG procedures, despite abundant evidence to support the effectiveness and safety of the operation.This decline has been accompanied by a corresponding increase in PCI. To date, there have been numerous studies to compare the clinical outcomes between PCI and CABG for patients with CAD. Among them, SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery) trial demonstrated CABG is associated with lower incidence of major adverse cardiac and cerebrovascualr events in patients with high SYNTAX score, compared with PCI. In this regard, the current guidelines recommend that CABG is preferred method for care of stable ischemic heart disease patients with three-vessel or left main coronary artery disease. However, most randomized controlled studies do not reflect the contemporary practice, because they have been performed in the era of bare metal stents or first-generation drug-eluting stent (DES). In addition, there have been limited data regarding the prognostic factors for long-term clinical outcomes in patients undergoing PCI with DES or CABG. Therefore, the investigators sought to compare the clinical outcomes between PCI with DES or CABG, and to identify prognostic factors for long-term clinical outcomes in patients who underwent PCI with DES or CABG.

Eligibility criteria: Inclusion Criteria:

* Patients who suspected ischemic heart disease and underwent CABG or PCI with DES

Exclusion Criteria:

* Age \< 18 years

Primary outcomes:
measure: Cardiac Death
timeFrame: 5-Year after the index procedure
Secondary outcomes:
measure: All-cause Death
timeFrame: 5-Year after the index procedure
measure: Myocardial infarction
timeFrame: 5-Year after the index procedure
measure: Target-vessel revascularization
timeFrame: 5-Year after the index procedure
measure: Any revascularization
timeFrame: 5-Year after the index procedure
measure: Bleeding
timeFrame: 5-Year after the index procedure
measure: Cerebrovascular accident
timeFrame: 5-Year after the index procedure
measure: MACCE (major adverse cardiac and cerebrovascular accident)
timeFrame: 5-Year after the index procedure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Young Bin Song, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kwon W, Choi KH, Jeong DS, Lee SY, Lee JM, Park TK, Yang JH, Hahn JY, Choi SH, Chung SR, Cho YH, Sung K, Kim WS, Gwon HC, Lee YT, Song YB. Comparison of long-term cardiovascular and renal outcomes between percutaneous coronary intervention and coronary artery bypass grafting in multi-vessel disease with chronic kidney disease. Front Cardiovasc Med. 2022 Sep 12;9:951113. doi: 10.3389/fcvm.2022.951113. eCollection 2022.
citation: Choi KH, Song YB, Jeong DS, Jang YH, Hong D, Lee SY, Youn T, Bak M, Min KM, Lee JM, Park TK, Yang JH, Hahn JY, Choi JH, Choi SH, Chung SR, Cho YH, Sung K, Kim WS, Gwon HC, Lee YT. Differential effects of dual antiplatelet therapy in patients presented with acute coronary syndrome vs. stable ischaemic heart disease after coronary artery bypass grafting. Eur Heart J Cardiovasc Pharmacother. 2021 Nov 3;7(6):517-526. doi: 10.1093/ehjcvp/pvaa080.