Drug-Eluting Stent Implantation Versus Optimal Medical Treatment in Patients With Chronic Total Occlusion (DECISION-CTO)

Study Overview
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Brief Summary
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The purpose of this study is to compare the safety and effectiveness of drug-eluting stent implantation compared to optimal medical treatment in patients with chronic total occlusion.

Detailed Description
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Prospective, two arms, randomized multi-center trial in Asian-pacific region. Following angiography, patients with chronic total occlusion (more than 3 months) have documented myocardial ischemia or symptoms of angina, and eligible for stenting without any exclusion criteria will be randomized 1:1 to: a) drug-eluting stent vs. b) optimal medical treatment. All patients will be followed for at least 3 year. The subjects with chronic total occlusion but failed to random for any reason, they will be enrolled in registry group. The random design was closed at the date of 22 July 2019 however already randomized subjects and subjects from registry design continue 10 years follow-up on IRIS-CTO registry.

Official Title
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Drug-Eluting Stent Implantation Versus Optimal Medical Treatment in Patients

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Cypher, xience, Endeavor, Taxus
* Drug: optimal medical therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical Patients with angina or silent ischemia and documented ischemia Patients who are eligible for intracoronary stenting Age > 18 years Angiographic De novo lesion CTO Reference vessel size 2.5 mm by visual estimation 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 flow 0 and 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) Exclusion Criteria: History of bleeding diathesis or coagulopathy Pregnant state Three vessel CTO Known hypersensitivity or contra-indication to contrast agent and heparin ST-elevation acute myocardial infarction requiring primary stenting Characteristics of lesion 1) Left main disease 2) In-stent restenosis 3) Graft vessels 4) Distal epicardial coronary artery CTO lesions Hematological disease Hepatic dysfunction, liver enzyme (ALT and AST) elevation 3 times normal Renal dysfunction, creatinine more than 2.0 Contraindication to aspirin, clopidogrel or other commercial antiplatelet agent Left ventricular ejection fraction Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period. 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Optimal medical therapy<br>optimal medical therapy | Drug: optimal medical therapy<br>* optimal medical therapy<br>* Other names: intensive medical therapy;|
| Active Comparator: drug-eluting stent<br>Cypher, xience, Endeavor, Taxus | Procedure: Cypher, xience, Endeavor, Taxus<br>* all species of drug-eluting stent implantation<br>* Other names: percutaneous coronary intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite outcomes of all cause death, myocardial infarction, stroke, and any revascularization for 3 years after randomization | at the median of 3 years | at 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All Death (Cardiac death) |  | at 3 years & 5 years | 
| Angina class; Quality of life, clinical outcomes at 5 years |  | at 3 years & 5 years | 
| Myocardial infarction, stroke,any revascularization, CTO-vessel related revascularization, hospitalization due to acute coronary syndrome, left ventricular ejection fraction |  | at 3 years & 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic total occlusion, stent, medical therapy