Clinical trial NCT06954714: Late-lumen Changes After Drug-Coated Balloon Angioplasty Versus Drug-Eluting Stents in De Novo Coronary Lesions
Official title: Late-lumen Changes After Drug-Coated Balloon Angioplasty Versus Drug-Eluting Stents in De Novo Coronary Lesions
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Keywords: drug-coated balloon
intravascular ultrasound
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2025-05-02
Enrollment: 256
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, multi-center, off-label, randomized controlled, non-inferiority trial.
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria

1. Subject must be at least 19 years of age
2. Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily
3. Patients with at least one lesion with greater than 50% diameter stenosis or fractional flow reserve ≤0.80 requiring revascularization in de-novo coronary artery of reference vessel size ≥3.0 mm

Exclusion Criteria

1. Patients unable to provide consent
2. Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of drug-eluting stents
3. Patients with angiographic findings of 1) Left main coronary artery disease 2) In-stent restenosis is the cause of target lesion 3) Target lesion in bypass graft 4) True bifurcation lesion that requires upfront 2-stenting
4. Patients who have non-cardiac co-morbid conditions with life expectancy \<1 year
5. Patients who may result in protocol non-compliance (site investigator's medical judgment)
6. Patients with cardiogenic shock or cardiac arrest
7. Patients with severe left ventricular systolic dysfunction (ejection fraction \<30%)
8. Patients with severe valvular heart disease requiring open heart surgery
9. Pregnant or lactating women

Primary outcomes:
measure: Late-lumen loss
timeFrame: 9 months after last patient enrollment
Secondary outcomes:
measure: Minimal lumen diameter in QCA
timeFrame: 9 months after last patient enrollment
measure: % diameter stenosis in QCA
timeFrame: 9 months after last patient enrollment
measure: Minimal lumen diameter in IVUS
timeFrame: 9 months after last patient enrollment
measure: Cardiovascular death
timeFrame: 1 year after last patient enrollment
measure: All-cause death
timeFrame: 1 year after last patient enrollment
measure: Rate of target vessel-MI
timeFrame: 1 year after last patient enrollment
measure: Rate of non-fatal MI
timeFrame: 1 year after last patient enrollment
measure: Rate of target lesion revascularization
timeFrame: 1 year after last patient enrollment
measure: Rate of target vessel revascularization
timeFrame: 1 year after last patient enrollment
measure: Rate of any revascularization
timeFrame: 1 year after last patient enrollment
measure: Rate of vessel or stent thrombosis
timeFrame: 1 year after last patient enrollment
measure: Cardiovascular death or target vessel-related myocardial infarction
timeFrame: 1 year after last patient enrollment
measure: All-cause death or non-fatal MI
timeFrame: 1 year after last patient enrollment
measure: Target vessel failure
timeFrame: 1 year after last patient enrollment
measure: Target lesion failure
timeFrame: 1 year after last patient enrollment
measure: Cardiovascular death, target-vessel MI, or vessel or stent thrombosis
timeFrame: 1 year after last patient enrollment
measure: All-cause death, non-fatal myocardial infarction, or target vessel revascularization
timeFrame: 1 year after last patient enrollment
measure: BARC type 2, 3, or 5 bleeding
timeFrame: 1 year after last patient enrollment
measure: Cerebrovascular accident
timeFrame: 1 year after last patient enrollment
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University
Study officials:
affiliation: Chonnam National University
name: Young Joon Hong, MD, PhD
role: STUDY_CHAIR
References: