The Success of Opening Single CTO Lesions to Improve Myocardial Viability Study (SOS-comedy)
- Conditions
- Hibernation, MyocardialComplete Occlusion of Coronary Artery
- Interventions
- Device: stenting or balloon expansionDrug: aspirin, clopidogrel, ticagrelor, atorvastatin, rosuvastatin, betaloc
- Registration Number
- NCT02767401
- Lead Sponsor
- The First Affiliated Hospital of Dalian Medical University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PCI using stenting or balloon expansion stenting or balloon expansion 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. PCI using stenting or balloon expansion aspirin, clopidogrel, ticagrelor, atorvastatin, rosuvastatin, betaloc 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.
- Primary Outcome Measures
Name Time Method Changes to myocardial viability 12 months Changes to myocardial viability from baseline assessed with the use of combined positron emission tomography and computerized tomography (PET-CT) system
- Secondary Outcome Measures
Name Time Method Major adverse cardiac events 12 months including all-cause mortality, cardiac death, first or recurrent acute myocardial infarction, recurrent angina, target lesion revascularization (TLR), heart failure, and re-hospitalization
The rates of target vascular revascularization (TVR), TLR, and stent thrombosis 12 months Changes to left ventricular ejection fraction (LVEF) 12 months Changes to LVEF in % assessed with the use of cardiac MRI and transthoracic echocardiography (TTE).
Changes to myocardial infarct size 12 months Changes to myocardial infarct size in percentage of total myocardial size assessed with the use of cardiac MRI.
Changes to left ventricular mass (LVM) 12 months Changes to LVM in g assessed with the use of cardiac MRI.
Changes to cardiac output (CO) 12 months Changes to cardiac CO in in L/min/m2 assessed with the use of cardiac MRI.
Changes to stroke volume (SV) 12 months Changes to SV in ml assessed with the use of cardiac MRI.
Changes to maximum left ventricular ejection rate 12 months Changes to maximum left ventricular ejection rate in % assessed with the use of cardiac MRI.
Changes to maximum left ventricular filling rate 12 months Changes to maximum left ventricular filling rate in % assessed with the use of cardiac MRI.
Changes to maximum slope 12 months Changes to maximum slope assessed with the use of cardiac MRI.
Changes to left ventricular end-diastolic diameter (LVEDd) 12 months Changes to LVEDd in mm assessed with the use of TTE.
Changes to left ventricular end-systolic diameter (LVESd) 12 months Changes to LVESd in mm assessed with the use of TTE.
Changes to cardiac systolic function 12 months Changes to cardiac systolic function in E/A, E'/A', Ea/Aa, EDT in ms assessed with the use of TTE.