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

Drug-Eluting Stent Implantation Versus Optimal Medical Treatment in Patients

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.

Study Overview

• Status: Terminated
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: optimal medical therapy; Procedure: Cypher, xience, Endeavor, Taxus

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 840
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Pune, India, I
    • Ruby Hall Clinic
• Indonesia
  • Jakarta, Indonesia
    • Medistra Hospital
• Korea, Republic of
  • Anyang, Korea, Republic of
    • Sam Anyang Hospital
  • Bucheon, Korea, Republic of
    • Soonchunhyang University Hospital, Buchen
  • Cheonan, Korea, Republic of
    • Soonchunhyang University Hospital, Cheonan
  • Cheongju, Korea, Republic of
    • Chungbuk National University Hospital
  • Chuncheon, Korea, Republic of
    • Kangwon National University Hospital
  • Daegu, Korea, Republic of
    • Keimyung University Dongsan Medical Center
  • Daejeon, Korea, Republic of
    • Chungnam National University Hospital
  • Daejeon, Korea, Republic of
    • The Catholic University of Korea, Daejeon St.Mary's Hospital
  • GangNeung, Korea, Republic of
    • GangNeung Asan Hospital
  • Jeonju, Korea, Republic of
    • Chonbuk National University Hospital
  • Kwangju, Korea, Republic of
    • Chonnam National University Hospital
  • Pusan, Korea, Republic of
    • Pusan National University Yangsan Hospital
  • Pusan, Korea, Republic of
    • Dong-A University Medical Center
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of
    • Kangbuk Samsung Hospital
  • Seoul, Korea, Republic of
    • Hallym University Medical Center, Hangang Sacred Heart Hospital
  • Seoul, Korea, Republic of
    • The Catholic University of Korea, Kangnam St.Mary's Hospital
  • Sŏngnam, Korea, Republic of
    • Bundang CHA Hospital
  • Ulsan, Korea, Republic of
    • Ulsan University Hospital
  • Wonju, Korea, Republic of
    • Wonju Christian Hospital
• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital
  • Taipei, Taiwan
    • Shin Kong Hospital
• Thailand
  • Bangkok, Thailand
    • King Chulalongkorn Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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 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 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

1. Angiographically defined total occlusion over 3 months
2. 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:

1. History of bleeding diathesis or coagulopathy
2. Pregnant state
3. Three vessel CTO
4. Known hypersensitivity or contra-indication to contrast agent and heparin
5. ST-elevation acute myocardial infarction requiring primary stenting
6. Characteristics of lesion 1) Left main disease 2) In-stent restenosis 3) Graft vessels 4) Distal epicardial coronary artery CTO lesions
7. Hematological disease
8. Hepatic dysfunction, liver enzyme (ALT and AST) elevation 3 times normal
9. Renal dysfunction, creatinine more than 2.0
10. Contraindication to aspirin, clopidogrel or other commercial antiplatelet agent
11. Left ventricular ejection fraction
12. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
13. 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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: CardioVascular Research Foundation, Korea

Publications and helpful links

General Publications

• Lee SW, Lee PH, Ahn JM, Park DW, Yun SC, Han S, Kang H, Kang SJ, Kim YH, Lee CW, Park SW, Hur SH, Rha SW, Her SH, Choi SW, Lee BK, Lee NH, Lee JY, Cheong SS, Kim MH, Ahn YK, Lim SW, Lee SG, Hiremath S, Santoso T, Udayachalerm W, Cheng JJ, Cohen DJ, Muramatsu T, Tsuchikane E, Asakura Y, Park SJ. Randomized Trial Evaluating Percutaneous Coronary Intervention for the Treatment of Chronic Total Occlusion. Circulation. 2019 Apr 2;139(14):1674-1683. doi: 10.1161/CIRCULATIONAHA.118.031313.
• Azzalini L, Vo M, Dens J, Agostoni P. Myths to Debunk to Improve Management, Referral, and Outcomes in Patients With Chronic Total Occlusion of an Epicardial Coronary Artery. Am J Cardiol. 2015 Dec 1;116(11):1774-80. doi: 10.1016/j.amjcard.2015.08.050. Epub 2015 Sep 11.

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2010
• Primary Completion (Actual): July 22, 2019
• Study Completion (Actual): July 22, 2019

Study Registration Dates

• First Submitted: March 1, 2010
• First Submitted That Met QC Criteria: March 1, 2010
• First Posted (Estimate): March 2, 2010

Study Record Updates

• Last Update Posted (Actual): August 2, 2019
• Last Update Submitted That Met QC Criteria: July 31, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: stent; chronic total occlusion; medical therapy
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 2009-0647

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is not a publicly funded trial.