The Success of Opening Single CTO Lesions to Improve Myocardial Viability Study (SOS-comedy)

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effect of percutaneous coronary intervention (PCI) on myocardial viability in coronary artery disease patients with single coronary total occlusion (CTO) lesions.

Detailed Description
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Patients with coronary artery disease might benefit from successful percutaneous coronary intervention (PCI). However, there is currently no consensus on an optimal treatment modality for single lesions resulting in coronary total occlusion (CTO). Since the other coronary arteries are often lesion-free, or with stenosis of less than 50%, patients often present with no symptoms. Although the expert consensus on CTO lesion suggests reducing the incidence of long-term adverse events via successful revascularization, there are few retrospective studies on single CTO lesions. To date, it is unclear whether successful PCI based on optimal medication treatment (OMT) can increase myocardial viability and the extent of myocardial viability related to prognosis of those CTO patients. Therefore, the aim of this multi-center, prospective, open labeled, non-randomized controlled study was to determine if the improvement to myocardial viability in single CTO patients with successful PCI plus OMT was superior to that of patients with only OMT.

Official Title
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The Success of Opening Single CTO Lesions to Improve Myocardial Viability Study (SOS-comedy)

Conditions
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Hibernation, Myocardial, Complete Occlusion of Coronary Artery

Intervention / Treatment
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* Device: stenting or balloon expansion
* Drug: aspirin, clopidogrel, ticagrelor, atorvastatin, rosuvastatin, betaloc


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of stable or unstable angina LVEF > 35% on transthoracic echocardiography measurement Single lesion occluding the coronary artery detected by angiography or MSCTA, with or without stenosis of other coronary arteries (≤ 50% stenotic lesion) Availability for follow-up for up to 12 months No major barriers to provide written consent Exclusion Criteria: Acute Q-wave myocardial infarction during the latest 3 months Revascularization in the non-culprit artery during the latest one month Unsuitable for PCI Unable to tolerate dual antiplatelet treatment (DAPT) Severe abnormal hematopoietic system, such as platelet count of < 100×109/L or > 700×109/L and white blood cell count of < 3×109/L Active bleeding or bleeding tendency Severe coexisting conditions, such as severe renal insufficiency (GFR < 60 ml/min•1.73m2), severe hepatic dysfunction [elevated ALT (glutamic-pyruvic transaminase) or AST (glutamic-oxal acetic transaminase) level by more than three-fold of the normal limitation], acute or chronic heart failure (NYHA III-IV), acute infectious diseases, immune disorders, malignancy, etc. Life expectancy < 12 months Pregnancy or planning pregnancy Drug allergies or contraindications to aspirin, clopidogrel, ticagrelor, statins, contract, anticoagulant, stent, etc. Participation or planning to participate in another clinical trial during the same period Refusal to comply with the study protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PCI using stenting or balloon expansion<br>Opening single CTO lesions using drug-eluting stents (such as Xience V and Prime, Endeavor Resolute, Taxus express and Libete, Excel, Partner, BUMA, YINYI, TIVOLI,Firebird2,FireHawk, and Coroflex) or balloon expansion plus optimal medical therapy. Intravascular ultrasound (IVUS),optimal coherence tomgraphy (OCT) or fractional flow reserve (FFR) is used if they are needed. Optimal medical therapy includes dual antiplatelet therapy and statins. And optimal medical therapy should include adequate ventricular rate-limiting medication (i.e. Beta-blocker or rate-limiting calcium antagonist) where appropriate. Anti-angina therapy should be used if the patients have symptoms. | Device: stenting or balloon expansion<br>* all species of drug-eluting stent ((such as Xience, Endeavor, Taxus, Excel, Firebird) implantation or balloon expansion (POBA)<br>* Other names: percutaneous coronary intervention;Drug: aspirin, clopidogrel, ticagrelor, atorvastatin, rosuvastatin, betaloc<br>* Optimal medical therapy includes dual antiplatelet therapy and statins (aspirin, clopidogrel, ticagrelor, atorvastatin, rosuvastatin, betaloc). And optimal medical therapy should include adequate ventricular rate-limiting medication (i.e. Beta-blocker or rate-limiting calcium antagonist) where appropriate. Anti-anginal therapy should be used if the patients have symptom.<br>|
| No Intervention: Optimal medical therapy<br>Optimal medical therapy. It includes dual antiplatelet therapy and statins. And optimal medical therapy should include adequate ventricular rate-limiting medication (i.e. Beta-blocker or rate-limiting calcium antagonist) where appropriate. Anti-anginal therapy should be used if the patients have symptom. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes to myocardial viability | Changes to myocardial viability from baseline assessed with the use of combined positron emission tomography and computerized tomography (PET-CT) system | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac events | including all-cause mortality, cardiac death, first or recurrent acute myocardial infarction, recurrent angina, target lesion revascularization (TLR), heart failure, and re-hospitalization | 12 months | 
| The rates of target vascular revascularization (TVR), TLR, and stent thrombosis |  | 12 months | 
| Changes to left ventricular ejection fraction (LVEF) | Changes to LVEF in % assessed with the use of cardiac MRI and transthoracic echocardiography (TTE). | 12 months | 
| Changes to myocardial infarct size | Changes to myocardial infarct size in percentage of total myocardial size assessed with the use of cardiac MRI. | 12 months | 
| Changes to left ventricular mass (LVM) | Changes to LVM in g assessed with the use of cardiac MRI. | 12 months | 
| Changes to cardiac output (CO) | Changes to cardiac CO in in L/min/m2 assessed with the use of cardiac MRI. | 12 months | 
| Changes to stroke volume (SV) | Changes to SV in ml assessed with the use of cardiac MRI. | 12 months | 
| Changes to maximum left ventricular ejection rate | Changes to maximum left ventricular ejection rate in % assessed with the use of cardiac MRI. | 12 months | 
| Changes to maximum left ventricular filling rate | Changes to maximum left ventricular filling rate in % assessed with the use of cardiac MRI. | 12 months | 
| Changes to maximum slope | Changes to maximum slope assessed with the use of cardiac MRI. | 12 months | 
| Changes to left ventricular end-diastolic diameter (LVEDd) | Changes to LVEDd in mm assessed with the use of TTE. | 12 months | 
| Changes to left ventricular end-systolic diameter (LVESd) | Changes to LVESd in mm assessed with the use of TTE. | 12 months | 
| Changes to cardiac systolic function | Changes to cardiac systolic function in E/A, E'/A', Ea/Aa, EDT in ms assessed with the use of TTE. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PET-CT, Cardiac magnetic resonance (CMR) imaging, Major adverse cardiac events (MACEs), coronary artery disease