Coronary Artery Disease
Conditions
Keywords
drug-coated balloon, intravascular ultrasound
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).
Interventions
PROCEDUREDrug-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 successful lesion preparation, patients will receive either DCB or DES according to randomly allocated groups. In DES group, latest second-generation DES will be used in accordance with standard practice guideline.
PROCEDUREDrug-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 successful lesion preparation, patients will receive either DCB or DES according to randomly allocated groups. In DCB group, commercially available DCB (Agent, Boston Scientific, USA) will be used. DCB angioplasty will be recommended as follows to fully optimized procedural results. First, DCB size should be 1:1 ratio with reference vessel size. Second, delivery time of DCB should be within 30 seconds. Third, total inflation time of DCB will be recommended from 30 to 60 seconds.
Sponsors
Chonnam National University Hospital
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
prospective, multi-center, off-label, randomized controlled, non-inferiority trial.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Late-lumen loss | 9 months after last patient enrollment | Mean difference of late-lumen loss between DCB and DES in IVUS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Contacts
CONTACTSeung Hun Lee, MD, PhD
CONTACTJoon Ho Ahn, MD, PhD
STUDY_CHAIRYoung Joon Hong, MD, PhD
Chonnam National University
Outcome results
None listed