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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
all species of drug-eluting stent ((such as Xience, Endeavor, Taxus, Excel, Firebird) implantation or balloon expansion (POBA)
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.
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
Time frame: 12 months
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
Time frame: 12 months
The rates of target vascular revascularization (TVR), TLR, and stent thrombosis
Time frame: 12 months
Changes to left ventricular ejection fraction (LVEF)
Changes to LVEF in % assessed with the use of cardiac MRI and transthoracic echocardiography (TTE).
Time frame: 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.
Time frame: 12 months
Changes to left ventricular mass (LVM)
Changes to LVM in g assessed with the use of cardiac MRI.
Time frame: 12 months
Changes to cardiac output (CO)
Changes to cardiac CO in in L/min/m2 assessed with the use of cardiac MRI.
Time frame: 12 months
Changes to stroke volume (SV)
Changes to SV in ml assessed with the use of cardiac MRI.
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Time frame: 12 months
Changes to maximum left ventricular ejection rate
Changes to maximum left ventricular ejection rate in % assessed with the use of cardiac MRI.
Time frame: 12 months
Changes to maximum left ventricular filling rate
Changes to maximum left ventricular filling rate in % assessed with the use of cardiac MRI.
Time frame: 12 months
Changes to maximum slope
Changes to maximum slope assessed with the use of cardiac MRI.
Time frame: 12 months
Changes to left ventricular end-diastolic diameter (LVEDd)
Changes to LVEDd in mm assessed with the use of TTE.
Time frame: 12 months
Changes to left ventricular end-systolic diameter (LVESd)
Changes to LVESd in mm assessed with the use of TTE.
Time frame: 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.
Time frame: 12 months