Coronary Artery Stenosis
Conditions
Keywords
Multivessel Coronary Artery Disease, state of the art, State-of-the-Art Percutaneous Coronary Intervention, Coronary-Artery Bypass Grafting, Diabetes Mellitus
Brief summary
The objective of this randomized study was to compare outcomes of imaging-and physiology-guided state-of-the-art percutaneous coronary intervention (PCI) to coronary artery bypass grafting (CABG) in patients with diabetes and three-vessel CAD (not involving left main).
Interventions
PROCEDUREState-of-the-Art Percutaneous Coronary Intervention
supported by intracoronary imaging (e.g., intravascular ultrasound \[IVUS\] or optical coherence tomography \[OCT\]), intracoronary physiology (e.g., fractional flow reserve \[FFR\] or instantaneous wave-free ratio \[iFR\]), contemporary metallic DES (durable polymer everolimus-eluting stents; XIENCE family stent system, Abbott Vascular), guideline-directed optimal medical therapy \[GDMT\] with advanced cardiovascular (e.g., high-dose statin and advanced strategy of antiplatelet regimens) and anti-diabetic medications \[e.g., a sodium-glucose cotransporter \[SGLT\]-2 inhibitors or Glucagon-like peptide-1 \[GLP-1\] agonists) in patients with type 2 diabetes and three-vessel coronary artery disease (CAD) (not involving left main)
PROCEDUREstandard CABG
Coronary-Artery Bypass Grafting
Sponsors
Duk-Woo Park, MD
CardioVascular Research Foundation, Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The subject must be ≥20 years of age with angina and/or evidence of myocardial ischemia. 2. Patients with type 2 diabetes based on the need for treatment with insulin or oral hypoglycemic drugs or a confirmed elevated blood glucose level (fasting plasma glucose elevation on \>1 occasion of ≥126 mg/dL \[7.0 mmol/L\] or 2-h postprandial of ≥200 mg/dL \[11.1 mmol/L\] during oral glucose tolerance test or random plasma glucose of ≥200 mg/dL \[11.1 mmol/L\] with classic symptoms of hyperglycemia or hyperglycemic crisis or HbA1C ≥6.5% \[48 mmol/mol\]). 3. Significant three-vessel CAD (defined as ≥ 50% diameter stenosis \[DS\] by visual estimation in each of the three major epicardial vessels or major side branches but not involving the left main coronary artery) and equivalently amenable to revascularization by means of either PCI or CABG as determined by the Heart Team at the trial site. 4. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Exclusion criteria
1. Unprotected left main coronary artery disease. 2. The presence of complex coronary disease anatomy or lesion characteristics or other cardiac condition(s) which leads the participating interventional cardiologist to believe that PCI is not suitable (i.e. the subject should be managed with CABG or medical therapy alone). 3. Recent ST-elevation myocardial infarction(\<5 days prior to randomization). 4. Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support. 5. Severe left ventricular dysfunction (ejection fraction \<30%). 6. Requirement for other cardiac or non-cardiac surgical procedure (e.g., valve replacement, aorta surgery, or carotid revascularization). However, a maze procedure or pulmonary vein isolation is allowed. 7. Contraindication or inability to take aspirin or P2Y12 inhibitors (clopidogrel, ticagrelor, or prasugrel) for at least 6 months. 8. Prior CABG. 9. Extremely calcified or tortuous vessels precluding FFR measurement or intracoronary imaging evaluation. 10. More than one major epicardial vessel which is chronically occluded; enrollment of 1 Chronic total occlusion lesion is allowed. 11. Subjects requiring or who may require additional surgery (cardiac or noncardiac) within 1 year. 12. End-stage renal disease requiring renal replacement therapy. 13. Liver cirrhosis. 14. Pregnant and/or lactating women. 15. Concurrent medical condition with a limited life expectancy of less than 2 years. 16. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period. However, where at least one or more conditions are satisfied, it could be an exception according to an investigator's discretion; 1\) Participated in the observational study expected no effect on the safety and/or effectiveness evaluation of this trial. 2\) Screening failed before any interventional factor is involved. 3\) Participated in academic trials like strategic comparison studies conducted under standard therapy provided that there is no additional risk or a specific procedure to a subject and no interference between this trial and other studies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The event rate of major adverse cardiac or cerebrovascular events | 2 years | Major adverse cardiac or cerebrovascular events (MACCE) were defined as a composite of hard clinical endpoints of death from any causes, myocardial infarction, or stroke. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The event rate of death from any cause | 5 years | — |
| The event rate of myocardial infarction | 5 years | — |
| The event rate of repeat revascularization | 5 years | — |
| The event rate of stroke | 5 years | — |
| The event rate of composite of death from any causes, cardiovascular causes, or noncardiovascular causes | 5 years | — |
| The event rate of composite of death or myocardial infarction | 5 years | — |
| The event rate of composite of death, myocardial infarction, stroke or repeat revascularization | 5 years | — |
| The event rate of stent thrombosis | 5 years | by an Academic Research Consortium (ARC) definition |
| The event rate of symptomatic graft occlusion or stenosis | 5 years | — |
| The event rate of bleeding complications | 5 years | BARC (Bleeding Academic Research Consortium) criteria |
| The event rate of periprocedural major adverse events | 5 years | Periprocedural major adverse events means major arrhythmia, any unplanned surgery or therapeutic radiologic procedure, development of acute renal failure, sternal wound dehiscence, infection requiring antibiotics, prolonged intubation (\>48 hours), post-pericardiotomy syndrome, etc. |
| Length of hospital stay | 7 days | — |
| The event rate of rehospitalization | 7 days | any, cardiac, or noncardiac causes |
| The change of functional class | 1, 6, 12, 18, 24, 36, 60 months | Assessed by The Canadian Cardiovascular Society (CCS) Angina Score Classification. The minimum and maximum values are 1 and 4 respectively. A higher score of CCS angina score classification means severe exertional angina. |
| The change of angina-related quality of life index by the Seattle Angina Questionnaire [SAQ] | 1, 12, 24, 36, 60 months | The SAQ is a disease-specific patient-reported outcome (PRO) with 5 domains. The minimum and maximum values are 0 and 100 respectively. A lower score represents poor health status and a high score represents good health status. |
| The change of angina-related quality of life index by the EQ-5D | 1, 12, 24, 36, 60 months | EQ-5D is a standardised measure of health-related quality of life developed by the EuroQol Group. The minimum and maximum values are 5 and 15 respectively. A higher score of EQ-5D means a low quality of life. |
| The number of anti-anginal medications used | 1, 6, 12, 18, 24, 36, 60 months | — |
| Total healthcare costs and cost-effectiveness assessed using total medical expenditures and incremental cost-effectiveness ratio (ICER) | 1, 6, 12, 18, 24, 36, 60 months | Total medical cost will be calculated using predefined cost components related to the index revascularization procedure (PCI or CABG) and subsequent healthcare utilization. The list of cost items includes (but is not limited to): diagnostic catheters, guide catheters, guidewires, balloons, stents, adjunctive devices (e.g., rotablation system, intravascular lithotripsy), professional procedure fees, CABG-related graft categories, hospitalization cost per day (Intensive care unit and ward), and non-invasive cardiac tests. Total costs will be aggregated for each participant and compared between study groups at each scheduled time point. Cost-effectiveness will be assessed using the incremental cost-effectiveness ratio (ICER), calculated as the difference in total costs divided by the difference in clinical effectiveness between the study groups. |
Countries
Australia, China, Hong Kong, India, Japan, Latvia, Lithuania, Malaysia, Serbia, Singapore, South Korea, Taiwan, Thailand, United States
Contacts
CONTACTJung-hee Ham, Project manager
STUDY_CHAIRSeung-jung Park, MD
Asan Medical Center
Outcome results
None listed