The study aims to find a DCB treatment for STEMI patients can achieve early and mid-term functional outcomes that are not inferior to DES, and realize the strategy of intervention without implantation.
The main objective of this study is to compare a Drug-coated Ballon with Drug-eluting stent in the treatment of coronary arty lesions in STEMI patients in de novo coronary lesions.The study aims to find a DCB treatment for STEMI patients can achieve early and mid-term functional outcomes that are not inferior to DES, and realize the strategy of intervention without implantation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
4,000
Treatment of in suit coronary lesions with drug-coated balloon
Treatment of in suit coronary lesions with drug-eluting balloon
Late luminal loss (LLL)
LLL was the difference between the in-segment minimal lumen diameter after the procedure and at angiographic follow-up, as evaluated by quantitative coronary angiography
Time frame: 9 months
Restenosis rate (RR)
in-stent restenosis
Time frame: 12-24 months
Target lesion failure (TLF)
The occurrence of cardiac death, target vessel myocardial infraction and target vessel revascularization
Time frame: 12-24 months
Target lesion thrombosis
Thrombus was classified as definite, probable, or possible, according to the definitions provided by the Academic Research Consortium (ARC). Regarding timing, ST was defined as early (\<30 days), late (30 days to 1 year), or too late (\>1 year)
Time frame: 12-24 months
MACE
Non-fatal acute myocardial infarction, severe arrhythmia, heart failure, cardiovascular death
Time frame: 12-24 months
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