Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Metallic Stents for Diffuse Long Coronary Artery Disease

Study Overview
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Brief Summary
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The purpose of this study is to determine whether ABSORB bioresorbable vascular scaffold is non-inferior to XIENCE everolimus-eluting cobalt-chromium stent with respect to target-lesion failure (TLF) at 1 year.

Official Title
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Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Metallic Stents for Diffuse Long Coronary Artery Disease

Conditions
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Percutaneous Transluminal Coronary Angioplasty

Intervention / Treatment
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* Device: everolimus-eluting bioresorbable vascular (Absorb) scaffold
* Device: everolimus-eluting cobalt-chromium (Xience) stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 and more Diffuse long native coronary artery stenosis (>50% by visual estimate) with lesion length of more than 40 mm requiring at least 2 overlapped stents with a reference-vessel diameter of 2.5 to 3.75 mm on visual assessment Patients with silent ischemia, stable or unstable angina pectoris, and acute myocardial infarction including NSTEMI or STEMI The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site Exclusion Criteria: Subject has known hypersensitivity or contraindication to device material and its ingredients (everolimus, poly(L-lactide), poly(DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic, and fluoro polymers that cannot be adequately premedicated Subject has known allergic reaction, hypersensitivity, or contraindication to aspirin; to clopidogrel and prasugrel and ticagrelor; or to heparin and therefore cannot be adequately treated with study medication An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs within 12 m after the procedure STEMI requiring primary percutaneous coronary intervention Cardiogenic shock Restenotic lesions Left main Extreme angulation (≥90°) or excessive tortuosity (≥two 45° angles) proximal to or within the target lesion Heavy calcification proximal to or within the target lesion Compromised left ventricular dysfunction (LVEF <30%) At the time of screening, the subject has a malignancy that is not in remission Terminal illness with life expectancy <1 year Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period Patient's pregnant or breast-feeding or child-bearing potential

Ages Eligible for Study
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Minimum Age: 18 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABSORB BVS<br> | Device: everolimus-eluting bioresorbable vascular (Absorb) scaffold<br> <br> * Other names: ABSORB BVS;|
| Active Comparator: XIENCE EES<br> | Device: everolimus-eluting cobalt-chromium (Xience) stent<br> <br> * Other names: XIENCE EES;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target lesion failure | event rate for composite of cardiac death, target-vessel myocardial infarction [MI], or ischemia-driven target-lesion revascularization | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac death |  | 5 years | 
| Target-vessel myocardial infarction |  | 5 years | 
| Ischemia-driven target-lesion revascularization |  | 5 years | 
| All-cause mortality |  | 5 years | 
| event rate of any myocardial infarction; Q-wave vs Non-Q wave, periprocedural myocardial infarction vs follow-up myocardial infarction |  | 5 years | 
| Any revascularization | Any revascularization; target lesion vs. nontarget lesion, target vessel vs. nontarget vessel, ischemia-driven vs. not ischemia-driven | 5 years | 
| Target-vessel failure | death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization | 5 years | 
| Stent thrombosis |  | 5 years | 
| event rate of device success or procedural success | Device success defined as angiographic evidence of <30% final residual stenosis of the target lesion. Procedural success is defined as mean lesion diameter stenosis ≤50% and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or death. | 5 years | 
| Patient-reported angina status measured by Seattle angina questionnaire |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bioresorbable vascular scaffold, coronary artery disease