Vascular Response of Orsiro vs. Xience Drug-Eluting Stents for Treating Coronary Bifurcation Lesions

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Parallel, Active Controlled Study to Evaluate the Vascular Response of Orsiro vs. Xience Drug Eluting Stent System in Subjects With Coronary Bifurcation Lesions

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Orsiro stent
* Device: Xience stent
* Device: Any drug-eluting stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are at least 20 years old and present with acute or chronic coronary syndrome. Patients who are suitable for PCI with DES implantation and provide written informed consent. Patients with coronary bifurcation lesion amenable to be treated with 2-stent double-kissing (DK) crush technique. Target vessels suitable for OCT examination. 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: Patient who are not suitable candidates for use of dual antiplatelet therapy (DAPT) Estimated glomerular filtration rate < 45 ml/min/1.73 m2 Liver cirrhosis Life expectancy < 1 year Planned surgery within 3 months Pregnancy, breast-feeding, or plan to be pregnant in the coming 12 months Target bifurcation lesion involved in chronic total occlusion or the culprit vessel of ST-elevation myocardial infarction

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Orsiro<br>Two-stent DK-crush technique with Orsiro | Device: Orsiro stent<br>* Orsiro stent<br>|
| Active Comparator: Xience<br>Two-stent DK-crush technique with Xience | Device: Xience stent<br>* Xience stent<br>|
| Other: Single stent<br>Provisional one-stent strategy with any drug-eluting stent | Device: Any drug-eluting stent<br>* Any drug-eluting stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of stent strut coverage at bifurcation segments |  | 3 months post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neointimal thickness (μm) at bifurcation segments |  | 3 months post-procedure | 
| 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 | 
| Neointimal thickness (μm) at bifurcation segments |  | 12 months post-procedure | 
| Amount of in-stent intimal hyperplasia (mm3) at bifurcation segments |  | 12 months post-procedure | 
| Amount of in-segment intimal hyperplasia (mm3) at bifurcation segments |  | 12 months post-procedure | 
| Percentage of acquired malapposed struts 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 | 
| Target Lesion Revascularization (TLR) |  | 3 months post-procedure | 
| Target Vessel Revascularization (TVR) |  | 3 months post-procedure | 
| Target Lesion Failure (TLF) | Cardiac death, target vessel related myocardial infarction (MI), and clinically indicated TLR | 3 months post-procedure | 
| Major Cardiac Adverse Events (MACE) | Cardiac death, myocardial infarction (Q wave and non-Q wave), emergent coronary artery bypass surgery, or target vessel revascularization (TVR) | 3 months post-procedure | 
| Instent late-lumen loss by quantitative coronary analysis |  | 12 months post-procedure | 
| In-segment late lumen loss by quantitative coronary analysis |  | 12 months post-procedure | 
| Target Lesion Revascularization (TLR) |  | 12 months post-procedure | 
| Target Vessel Revascularization (TVR) |  | 12 months post-procedure | 
| Target Lesion Failure (TLF) | Cardiac death, target vessel related myocardial infarction (MI), and clinically indicated TLR | 12 months post-procedure | 
| Major Cardiac Adverse Events (MACE) | Cardiac death, myocardial infarction (Q wave and non-Q wave), emergent coronary artery bypass surgery, or target vessel revascularization (TVR) | 12 months post-procedure | 
| Stent thrombosis | 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 | 1 months post-procedure | 
| Stent thrombosis | 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 | 3 months post-procedure | 
| Stent thrombosis | 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 | 12 months post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug-eluting stents, Coronary bifurcation lesions, Double-kissing crush technique, Optical coherence tomography