safety and efficacy of drug-coated balloon angioplasty for the treatment of chronic total occlusions

Conditions: Coronary Artery Disease; Coronary Occlusion; Percutaneous Coronary Intervention; Chronic Total Occlusion of Coronary Artery; Drug-Eluting Stents

Summary: the purpose of this study is to investigate the safety and efficacy of drug-coated balloon angioplasty for the treatment of chronic total occlusions patients with chronic total occlusion (cto) lesion.

recruited cto patients will be divided into two groups: those undergoing pci of drug-coated balloon (dcb group), and those undergoing pci of drug eluting stent implantation (des group). the primary outcome assessed will be the late lumen loss evaluation at a 12-month of follow-up appointment. secondary outcomes include occurrence of major cardiac events (maces), myocardial viability, operate success, quality of life changes which will be compared to a baseline measurement.

Eligibility criteria:
inclusion criteria * patients between 18 and 80 years of age * must comply all the evaluations and follow-up protocols * clinical diagnosis of cto detected using coronary angiography (at least one other major vessel should have exhibited no less than 75% stenosis) * patients should present with left ventricular ejection fraction (lvef) above 35% determined using transthoracic echocardiography * cto located in an epicardial coronary artery with a reference diameter of ≥ 2.5 mm exclusion criteria * patients have suffered from acute myocardial infarction within the previous 3 months * lesion located in the left main artery (stenosis ≥50%) * clinical diagnosis of rheumatic valvular disease * clinical diagnosis of severe arrhythmia * with history of revascularization within the cto artery * lesions unsuitable for pci * severely abnormal hematopoietic systems, such as platelet counts \ 700 x 109/ l and white blood cell counts \< 3 x 109/l * patients with active bleeding or bleeding tendencies (active ulcers, short-term ischemic stroke, history of hemorrhagic stroke, intracranial space occupying lesions, recent craniocerebral trauma, and other bleeding or bleeding tendency) * patients with severe coexisting condition including: severe renal function dysfunction \[glomerular filtration rate (gfr) less than 60 ml/min • 1.73 m2), severe hepatic dysfunction \[glutamic-pyruvic transaminase (alt) or glutamic-oxal acetic transaminase (alt) elevated more than three times that of the upper limit of the normal reference\], severe heart failure (nyha classification iii-iv), acute infectious diseases and immune disorders, tumors, surgery within 3 months, a life expectancy less than 12 months, pregnancy or planning to become pregnant, history of allergy or adverse reactions to aspirin, clopidogrel, ticagrelor, stains, contrast material, anticoagulant, or stents * patients cannot tolerate dual antiplatelet treatment (dapt) * patients are unable to communicate due to cognitive impairment, auditory or visual impairment * patients are participating in another trial for medication or an apparatus and in which the main endpoint has not been reached, or plan to participate in a clinical trial within 12 months of the intervention

Keywords: chronic total occlusion drug-coated balloon balloon angioplasty drug-eluting stent