Late-lumen Changes After Drug-Coated Balloon Angioplasty Versus Drug-Eluting Stents in De Novo Coronary Lesions

Overview

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).

Interventions

• Procedure Drug-eluting stent implantation
  IVUS (OPTICROSS, Boston Scientific, USA) will be recommended to select proper size of predilatation balloon (semi- or non-compliant balloon), DCB, or DES. Optimal lesion preparation is defined as satisfying all of the followings: 1) a fully inflated balloon of the correct size for the vessel (balloon with vessel ratio \>0.90); 2) ≤35% residual stenosis; 3) TIMI (Thrombolysis In Myocardial Infarction) flow grade 3; and 4) the absence of a flow-limiting coronary artery dissection.15 After successf
• Procedure Drug-coated balloon angioplasty
  IVUS (OPTICROSS, Boston Scientific, USA) will be recommended to select proper size of predilatation balloon (semi- or non-compliant balloon), DCB, or DES. Optimal lesion preparation is defined as satisfying all of the followings: 1) a fully inflated balloon of the correct size for the vessel (balloon with vessel ratio \>0.90); 2) ≤35% residual stenosis; 3) TIMI (Thrombolysis In Myocardial Infarction) flow grade 3; and 4) the absence of a flow-limiting coronary artery dissection.15 After successf

Primary outcome measures

• Late-lumen loss [Time frame: 9 months after last patient enrollment]

Secondary outcome measures (12)

• Minimal lumen diameter in QCA [Time frame: 9 months after last patient enrollment]
• % diameter stenosis in QCA [Time frame: 9 months after last patient enrollment]
• Minimal lumen diameter in IVUS [Time frame: 9 months after last patient enrollment]
• Cardiovascular death [Time frame: 1 year after last patient enrollment]
• All-cause death [Time frame: 1 year after last patient enrollment]
• Rate of target vessel-MI [Time frame: 1 year after last patient enrollment]
• Rate of non-fatal MI [Time frame: 1 year after last patient enrollment]
• Rate of target lesion revascularization [Time frame: 1 year after last patient enrollment]
• Rate of target vessel revascularization [Time frame: 1 year after last patient enrollment]
• Rate of any revascularization [Time frame: 1 year after last patient enrollment]
• Rate of vessel or stent thrombosis [Time frame: 1 year after last patient enrollment]
• Cardiovascular death or target vessel-related myocardial infarction [Time frame: 1 year after last patient enrollment]

Eligibility criteria

Inclusion criteria

• Subject must be at least 19 years of age
• Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily
• 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

• Patients unable to provide consent
• Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of drug-eluting stents
• 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
• Patients who have non-cardiac co-morbid conditions with life expectancy <1 year
• Patients who may result in protocol non-compliance (site investigator's medical judgment)
• Patients with cardiogenic shock or cardiac arrest
• Patients with severe left ventricular systolic dysfunction (ejection fraction <30%)
• Patients with severe valvular heart disease requiring open heart surgery
• Pregnant or lactating women

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

South Korea · 8 centers

• Kosin University Gospel Hospital — Busan
• Keimyung University Dongsan Hospital — Daegu
• Chonnam National University — Gwangju
• Jeonbuk National University Hospital — Jeonju
• Samsung Medical Center — Seoul
• Ewha Womans University Mokdong Hospital — Seoul
• Korea University Guro Hospital — Seoul
• Ulsan University Hospital — Ulsan

Identifiers

NCT: NCT06954714 · CNUH-2025-115

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗