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
Seoul National University Hospital
Lead sponsor
Chong Kun Dang Pharmaceutical
Collaborator
Diomedical
Collaborator