The DECISION-CTO Extended 10 Y Follow-up

Prior treatment

• Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.

Other illness

• History of bleeding diathesis or coagulopathy
• Known hypersensitivity or contra-indication to contrast agent and heparin
• ST-elevation acute myocardial infarction requiring primary stenting
• Culprit total occlusion presented with acute coronary syndrome suggesting acute or recent occlusion
• Characteristics of lesion 1) Left main disease 2) In-stent restenosis 3) Graft vessels 4) Distal epicardial coronary artery CTO lesions 5) Two vessel proximal segment CTOs
• Hematological disease (Neutropenia \<3000/mm3, Thrombocytopenia \<100,000/mm3)
• Non-cardiac co-morbid conditions are present with limited life expectancy or that may result in protocol non-compliance (per site investigator's medical judgment).

Lab values

• Hepatic dysfunction, liver enzyme (ALT and AST) elevation ≥ 3 times normal
• Renal dysfunction, creatinine ≥ 2.0mg/dL
• Left ventricular ejection fraction \<30%

Other

• Pregnant state
• Three vessel CTOs
• Contraindication to aspirin, clopidogrel or other commercial antiplatelet agent

• Clinical 1) Patients with angina or silent ischemia and documented ischemia 2) Patients who are eligible for intracoronary stenting 3) Age \>18 years
• Angiographic 1) De novo lesion Chronic Total Occlusion (CTO) 2) Reference vessel size ≥ 2.5 mm by visual estimation 3) At least one CTO lesions located in proximal or mid epicardial coronary artery.
  • (If the patient has two CTO lesions, one CTO lesion should be located in proximal or mid epicardial coronary artery)
• CTO definition: TIMI (Thrombolysis in Myocardial Infarction) flow 0 or 1 with estimated duration over 3 months
  • The duration of the occlusion was determined by the interval from the last episode of acute coronary syndrome, or
  • In patients without a history of acute coronary syndrome, from the first episode of effort angina consistent with the location of the occlusion
  • Angiographically defined total occlusion over 3 months
  • If no definite symptom with total occlusion, two experienced operators decide CTO in consideration of angiographical morphology (degree of calcification, bridging collaterals, non-tapered stump, angiographic filling from collaterals)