This study is a prospective, multicenter, open-label, observational study to investigate the impact of using drug-coated balloons (DCBs) in the treatment of coronary artery lesions in patients with multivessel coronary artery disease (MVD), as opposed to the default strategy of using only drug-eluting stents (DES). The investigators aim to assess changes in clinical practice towards a hybrid treatment strategy (DES and DCB) and its effects on clinical outcomes.
Study Type
OBSERVATIONAL
Enrollment
500
For the procedure, the drug-coated balloon (Agent®, Boston Scientific, USA) that can be used for both de-novo coronary lesions and in-stent restenosis lesions is used.
When using drug-eluting stents, the latest 2nd generation drug-eluting stent (Synergy®, Boston Scientific, USA) should be used in accordance with the latest guidelines.
Bon-Kwon Koo
Seoul, South Korea
RECRUITINGThe reclassification rate of the treatment strategy
The reclassification rate according to the change in treatment approach from the default strategy of using only drug-eluting stents (DES-only) to the hybrid strategy of using both drug-coated balloons and drug-eluting stents in the treatment of multivessel coronary artery disease.
Time frame: At the time of procedure
Rate of change in treatment pattern from drug-eluting stents to drug-coated balloons in target vessel therapy
Rate of change in treatment pattern from drug-eluting stents to drug-coated balloons in target vessel therapy
Time frame: At the time of procedure
Rate of change in treatment pattern from drug-eluting stents to drug-coated balloons in target lesion therapy
Rate of change in treatment pattern from drug-eluting stents to drug-coated balloons in target lesion therapy
Time frame: At the time of procedure
Cardiovascular death
Cardiovascular death
Time frame: 1 year
All-cause death
All-cause death
Time frame: 1 year
Non-fatal myocardial infarction (MI)
Non-fatal myocardial infarction (MI)
Time frame: 1 year
Target vessel MI excluding periprocedural MI
Target vessel MI excluding periprocedural MI
Time frame: 1 year
Target vessel MI including periprocedural MI
Target vessel MI including periprocedural MI
Time frame: 1 year
Clinically indicated target lesion revascularization
Clinically indicated target lesion revascularization
Time frame: 1 year
Clinically indicated target vessel revascularization
Clinically indicated target vessel revascularization
Time frame: 1 year
Any revascularization
Any revascularization
Time frame: 1 year
Vessel or stent thrombosis, definite or probable by Academic Research Consortium (ARC) definition
Vessel or stent thrombosis, definite or probable by Academic Research Consortium (ARC) definition
Time frame: 1 year
Cardiovascular death or target vessel MI
Cardiovascular death or target vessel MI
Time frame: 1 year
All-cause death or non-fatal MI
All-cause death or non-fatal MI
Time frame: 1 year
Target vessel failure (TVF), including cardiovascular death, target vessel MI, or clinically indicated target vessel revascularization
Target vessel failure (TVF), including cardiovascular death, target vessel MI, or clinically indicated target vessel revascularization
Time frame: 1 year
Target lesion failure (TLF), including cardiovascular death, target lesion MI, or clinically indicated target lesion revascularization
Target lesion failure (TLF), including cardiovascular death, target lesion MI, or clinically indicated target lesion revascularization
Time frame: 1 year
Cardiovascular death, target vessel MI, or vessel or stent thrombosis
Cardiovascular death, target vessel MI, or vessel or stent thrombosis
Time frame: 1 year
All-cause death, non-fatal MI, or clinically indicated target vessel revascularization
All-cause death, non-fatal MI, or clinically indicated target vessel revascularization
Time frame: 1 year
Major bleeding events (BARC type 2, 3, or 5)
Major bleeding events (BARC type 2, 3, or 5)
Time frame: 1 year
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