Coronary Artery Disease
Conditions
Keywords
Drug-eluting stents, Coronary bifurcation lesions, Double-kissing crush technique, Optical coherence tomography
Brief summary
This study aims to compare vessel response and clinical outcomes of a biodegradable-polymer, ultra-thin strut, drug-eluting stent (Orsiro, Biotronik) and a durable-polymer, thin-strut, drug-eluting stent (Xience, Abbott) for the treatment of coronary bifurcation lesions with two-stent double-kissing crush technique. How the differences in stent platforms affect vessel healing process will be examined by optical coherence tomography.
Detailed description
Patients with true coronary bifurcation lesions (Medina \[1, 1, 1\] or \[0, 1, 1\]) will be enrolled and randomized to undergo two-stent double kissing crush technique with Orsiro or Xience. Pre-intervention and post-stenting optical coherence tomography will be performed during the index procedure. Another parallel prospective registry will enroll patients with bifurcation lesions treated with provisional one-stent strategy. All subjects will receive coronary angiography and optical coherence tomography follow-up at 3 and 12 months.
Interventions
DEVICEOrsiro stent
Orsiro stent
DEVICEXience stent
Xience stent
DEVICEAny drug-eluting stent
Any drug-eluting stent
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients with true coronary bifurcation lesions will be randomized to undergo two-stent DK-crush technique with Orsiro or Xience. Another parallel prospective registry will enroll patients with bifurcation lesions treated with provisional one-stent strategy.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients who are at least 20 years old and present with acute or chronic coronary syndrome. 2. Patients who are suitable for PCI with DES implantation and provide written informed consent. 3. Patients with coronary bifurcation lesion amenable to be treated with 2-stent double-kissing (DK) crush technique. 4. Target vessels suitable for OCT examination. 5. Women of childbearing potential must have a negative pregnancy (serum and/or urine) test within 7 days prior to index procedure in accordance with the institutional standard of care. Female subjects who are surgically sterile or post-menopausal are exempt from having a pregnancy test.
Exclusion criteria
1. Patient who are not suitable candidates for use of dual antiplatelet therapy (DAPT) 2. Estimated glomerular filtration rate \< 45 ml/min/1.73 m2 3. Liver cirrhosis 4. Life expectancy \< 1 year 5. Planned surgery within 3 months 6. Pregnancy, breast-feeding, or plan to be pregnant in the coming 12 months 7. Target bifurcation lesion involved in chronic total occlusion or the culprit vessel of ST-elevation myocardial infarction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of stent strut coverage at bifurcation segments | 3 months post-procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amount of in-stent intimal hyperplasia (mm3) at bifurcation segments | 3 months post-procedure | — |
| Amount of in-segment intimal hyperplasia (mm3) at bifurcation segments | 3 months post-procedure | — |
| Percentage of acquired malapposed struts at bifurcation segments | 3 months post-procedure | — |
| Percentage of stent strut coverage at bifurcation segments | 12 months post-procedure | — |
| In-stent late-lumen loss by quantitative coronary analysis | 3 months post-procedure | — |
| In-segment late lumen loss by quantitative coronary analysis | 3 months post-procedure | — |
| Neointimal thickness (μm) at bifurcation segments | 3 months post-procedure | — |
| Target Vessel Revascularization (TVR) | 3 months post-procedure | — |
| Target Lesion Failure (TLF) | 3 months post-procedure | Cardiac death, target vessel related myocardial infarction (MI), and clinically indicated TLR |
| Major Cardiac Adverse Events (MACE) | 3 months post-procedure | Cardiac death, myocardial infarction (Q wave and non-Q wave), emergent coronary artery bypass surgery, or target vessel revascularization (TVR) |
| Instent late-lumen loss by quantitative coronary analysis | 12 months post-procedure | — |
| Stent thrombosis | 1 months post-procedure | Stent thrombosis (all, definite, definite/probable, probable, possible) according to Academic Research Consortium (ARC) criteria for acute, subacute, late, very late and cumulative stent thrombosis |
| Target Lesion Revascularization (TLR) | 3 months post-procedure | — |
Countries
Taiwan
Contacts
Primary ContactYing-Chang Tung, MD
Backup ContactChi-Jen Chang, MD
Outcome results
None listed