Comparison of the incidence of major cardiovascular events between the combination of percutaneous intervention and optimal drug therapy and the optimal drug therapy alone in patients with chronic coronary syndrome.
* Main RCT (Randomized Clinical Trial): Patients with chronic coronary syndrome enrolled in the study will be randomized in a 1:1 ratio to either 1) PCI(Percutaneous Coronary Intervention) plus optimal medical therapy or 2) optimal medical therapy alone, with clinical outcomes assessed during follow-up. (2,301 participants) * Nested RCT: An embedded randomized supplementary study was conducted on a subset (220 participants) of the total subjects.
In patients who have decided to use beta-blockers for the control of angina, additional 1:1 randomization evaluates the efficacy of carvedilol sustained-release (SR) and immediate-release (IR) formulations. Both formulations are targeted for use up to the maximal tolerated dose, taking into account patient symptoms.
Patients aged 40 years or older
Patients suspected of having chronic coronary syndrome who have undergone coronary angiography and confirmed stenotic lesions
Patients with stenosis of 70% or more confirmed via Quantitative coronary angiography (50% or more for the left main coronary artery)
Minimum lumen area (MLA) ≤ 4 mm² or plaque burden >70% on intravascular ultrasound (IVUS)
Patients with Left Ventricular Ejection Fraction (LVEF) less than 35%
Patients with cardiogenic shock
Patients with pulmonary edema or heart failure unresponsive to standard treatment
Patients with unstable angina whose symptoms persist despite maximal drug therapy
Parallel
percutaneous coronary intervention
Procedure/SurgeryPCI will be performed in addition to optimal medical therapy.
Guideline-directed Optimal Medical treatment
DrugGuideline-directed optimal medical therapy alone without PCI
Carvedilol Sustained-Release (SR) (Nested RCT subset)
DrugCarvedilol SR (Dilatrend SR; 8/16/32/64 mg) once daily, starting at 32 mg and up-titrated to maximal tolerated dose (up to 128 mg). Applied to Nested RCT participants only (n=220 total across both arms), in whom eligible participants are independently randomized 1:1 to either carvedilol SR or IR - only one formulation is assigned per participant.
Carvedilol Immediate-Release (IR) (Nested RCT subset)
DrugCarvedilol IR (Dilatrend; 3.125/6.25/12.5/25 mg) twice daily, starting at 12.5 mg BID and up-titrated to maximal tolerated dose (up to 50 mg BID). Applied to Nested RCT participants only (n=220 total across both arms), in whom eligible participants are independently randomized 1:1 to either carvedilol SR or IR - only one formulation is assigned per participant.
Number of Participants with Patient-oriented composite outcome (POCO), defined as the composite of cardiovascular death, non-fatal myocardial infarction (MI), or clinically driven revascularization
This outcome applies to the main RCT (n=2,301). POCO is a composite of three components: (1) cardiovascular death; (2) non-fatal myocardial infarction, excluding periprocedural MI; and (3) clinically driven revascularization. The first occurrence of any component is counted as the primary event per participant. Clinically driven revascularization is defined as revascularization of a coronary segment with diameter stenosis ≥50% by quantitative coronary angiography, accompanied by at least one of the following: ischemic ECG(Electrocardiogram) changes at rest; typical ischemic symptoms refractory to medical therapy; unstable angina; positive invasive physiologic test (FFR(Fractional Flow Reserve) ≤0.80 or iFR (Instantaneous Wave-Free Ratio) ≤0.89); or angiographic progression with diameter stenosis ≥70% by quantitative coronary angiography regardless of other criteria.
Change in Seattle Angina Questionnaire-7 (SAQ-7) Summary Score from Baseline to 12 Months (for Nested RCT)
This outcome applies to the Nested RCT substudy only (n=220), in which participants eligible for beta-blocker therapy are independently randomized 1:1 to carvedilol SR or IR, regardless of their main trial allocation. The SAQ-7 is a 7-item validated questionnaire assessing angina-related health status across three domains: physical limitation, angina frequency, and quality of life. Scores range from 0 to 100, with higher scores indicating fewer symptoms and better quality of life. The SAQ-7 Summary score is calculated as the mean of the three domain scores.
Number of Participants with All-cause death
Number of Participants with Cardiovascular death
Number of Participants with Cardiovascular Death or Non-Fatal Myocardial Infarction
Number of Participants with Myocardial Infarction
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Seoul National University Hospital
Lead sponsor
Chong Kun Dang Pharmaceutical
Collaborator
Diomedical
Collaborator
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