Late-lumen Changes After Drug-Coated Balloon Angioplasty Versus Drug-Eluting Stents in De Novo Coronary Lesions
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT06954714
- Lead Sponsor
- Chonnam National University Hospital
- Brief Summary
This study aims to compare late-lumen loss (LLL) between DCB and DES to treat de novo coronary artery stenosis by intravascular ultrasound (IVUS).
- Detailed Description
Drug-eluting stent (DES) is the standard of care for patients with coronary artery disease who are eligible for percutaneous coronary intervention (PCI).1 During long-term follow-up, remained metallic stent strut continuously related with stent-related cardiovascular events.2 As an alternative option to DES, drug-coated balloon (DCB) which has benefit of having shorter DAPT maintenance duration due to the absence of metallic scaffolds and polymers, has been introduced. Based on meta-analysis based on many randomized clinical trials (RCT),3,4 its use has been established in in-stent restenosis of bare-metal stents and DES.5 Furthermore, recent RCTs demonstrated efficacy and safety of DCB in de novo coronary lesions in small vessels with reference vessel size \<3.0mm.6,7 For the patients with de novo, non-complex coronary artery lesions, REC-CAGEFREE I tested the non-inferiority of DCB angioplasty with DES implantation, irrespective of vessel diameter.8 Overall, 2272 patients were randomly assigned to the DCB or the DES group. At 2 years, adverse events occurred in 6.4% of DCB group and 3.4% of DES group and failed to prove the non-inferiority of DCB angioplasty (P for non-inferiority=0.65). Regarding the heterogenous results, it is questionable that DCB angioplasty for large de novo lesions is safe and effective compared with DES implantation.
On this background, the current study aims to compare late-lumen loss (LLL) between DCB and DES to treat de novo coronary artery stenosis by intravascular ultrasound (IVUS).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 256
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Late-lumen loss 9 months after last patient enrollment Mean difference of late-lumen loss between DCB and DES in IVUS
- Secondary Outcome Measures
Name Time Method Minimal lumen diameter in QCA 9 months after last patient enrollment Mean difference of minimal lumen diameter in QCA
% diameter stenosis in QCA 9 months after last patient enrollment Mean difference of % diameter stenosis in QCA
Minimal lumen diameter in IVUS 9 months after last patient enrollment Mean difference of minimal lumen diameter in IVUS
Cardiovascular death 1 year after last patient enrollment Cardiovascular death
All-cause death 1 year after last patient enrollment All-cause death
Rate of target vessel-MI 1 year after last patient enrollment Target vessel-MI
Rate of non-fatal MI 1 year after last patient enrollment Non-fatal MI
Rate of target lesion revascularization 1 year after last patient enrollment Clinically indicated target lesion revascularization
Rate of target vessel revascularization 1 year after last patient enrollment Clinically indicated target vessel revascularization
Rate of any revascularization 1 year after last patient enrollment Any revascularization
Rate of vessel or stent thrombosis 1 year after last patient enrollment Definite or probable thrombosis
Cardiovascular death or target vessel-related myocardial infarction 1 year after last patient enrollment A composite of cardiovascular death or target vessel-related myocardial infarction
All-cause death or non-fatal MI 1 year after last patient enrollment A composite of all-cause death or non-fatal myocardial infarction
Target vessel failure 1 year after last patient enrollment A composite of cardiovascular death, target-vessel myocardial infarction, and clinically indicated target vessel revascularization
Target lesion failure 1 year after last patient enrollment A composite of cardiovascular death, target-vessel myocardial infarction, and clinically indicated target lesion revascularization
Cardiovascular death, target-vessel MI, or vessel or stent thrombosis 1 year after last patient enrollment A composite of cardiovascular death, target-vessel MI, or vessel or stent thrombosis
All-cause death, non-fatal myocardial infarction, or target vessel revascularization 1 year after last patient enrollment A composite of all-cause death, non-fatal myocardial infarction, or target vessel revascularization
BARC type 2, 3, or 5 bleeding 1 year after last patient enrollment BARC type 2, 3, or 5 bleeding
Cerebrovascular accident 1 year after last patient enrollment Ischemic stroke, hemorrhagic stroke, or transient ischemic attack
Trial Locations
- Locations (1)
Chonnam National University
🇰🇷Gwangju, Korea, Republic of