OPTIMIZE-APT: Tailored Versus Conventional Antiplatelet Therapy After Intravascular Imaging-guided Drug-eluting Stent Implantation

Prior treatment

• Any surgery requiring general anesthesia or discontinuation of aspirin and/or an ADP antagonist is planned within 12 months after the procedure.

Other illness

• Hypersensitivity or contraindication to device material and its degradants and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated.
• Any history of hemorrhagic stroke or intracranial hemorrhage / TIA or ischemic stroke within the past 6 months
• A known intolerance or hypersensitivity to a study drug (aspirin, clopidogrel or ticagrelor) or heparin
• A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer.
• History of liver cirrhosis (Child-Pugh B or C) or biliary tract obstruction
• Active bleeding or extreme-risk for major bleeding (e.g. active peptic ulcer disease, gastrointestinal pathology with a high risk for bleeding, malignancies with a high risk for bleeding)

Lab values

• Persistent thrombocytopenia (platelet count \<80,000/μl)
• Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.

Age

• Life expectancy \< 1 years for any non-cardiac or cardiac causes

Other

• Angiographic exclusion criteria: any of the followings 1. Bypass graft lesions 2. Lesions in which impaired delivery of imaging catheters is expected:
  • Extreme angulation (≥90°) proximal to or within the target lesion.
  • Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion.
  • Heavy calcification proximal to or within the target lesion.
• In-stent restenosis
• Patients requiring long-term oral anticoagulants or cilostazol
• Cardiogenic shock at the index admission
• Patient's pregnant or breast-feeding
• Unwillingness or inability to comply with the procedures described in this protocol.

• Men or women ≥19 years
• Typical chest pain or objective evidence of myocardial ischemia suitable for PCI
• Significant de novo coronary artery lesions suitable for DES implantation
• Patients who underwent optimized stent implantation either by IVUS or OCT
  • Using IVUS
  • MSA \>5.5 mm2, or MSA \>90% of the MLA at the distal reference segment
  • Plaque burden \<50% with 5 mm of both stent edge
  • No edge dissection; thrombus or plaque protrusion occupying \< 10% of the stent area
  • Using OCT
  • MSA \>4.5 mm2, or MSA \>90% of the MLA at the distal reference segment
  • No significant malapposition
  • No significant edge dissection†; thrombus or plaque protrusion occupying \< 10% of the stent area
  • (\*Significant malapposition is defined as strut separation ≥ 0.3 mm from the vessel wall extending over a length \> 3 mm.
  • †Significant dissection is defined as a dissection penetrating the medial layer and extending over more than one quadrant.)
• 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