Bioresorbable Vascular Scaffold in Patients With Myocardial Infarction

Study Overview
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Brief Summary
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Evaluation of the feasibility and safety of Bioresorbable Vascular Scaffold (BVS) in patient treated with primary PCI (pPCI).

Detailed Description
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Background. Drug-eluting stent (DES) implantation may offer benefits in terms of repeat revascularization in patients with ST elevation myocardial infarction (STEMI). The everolimus eluting bioresorbable vascular scaffold (BVS) has shown efficacy and safety in stable patient but not in acute coronary syndromes. The study tested the feasibility and safety of BVS in patient treated with primary PCI (pPCI) Methods. Consecutive STEMI patients admitted within 12 hours of symptom onset and undergoing primary angioplasty and stent implantation at a tertiary center with 24-hour primary PCI capability will be randomly assigned to everolimus eluting stent (EES) or BVS. Primary endpoints are procedural and clinical success. The MACE (cardiac death, non fatal myocardial infarction, target lesion revascularization (TLR)) and definite or probable ST will be evaluated at six months.

Official Title
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Bioresorbable Vascular Scaffold in Patient With ST Elevation Myocardial Infarction: a Randomized Comparison With Everolimus Eluting Stent

Conditions
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ST Elevation Acute Myocardial Infarction

Intervention / Treatment
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* Device: Bioresorbable vascular scaffold
* Device: Everolimus eluting stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: chest pain for more than 30 minutes; ST-segment elevation of 1 mm or more in 2 or more contiguous electrocardiograph leads or with presumably new left bundle-branch block Exclusion Criteria: Active internal bleeding or a history of bleeding diathesis within the previous 30 days; Contraindication to dual antiplatelet therapy for 12 months; Known allergy to everolimus; A history of stroke within 30 days or any history of hemorrhagic stroke; History, symptoms, or findings suggestive of aortic dissection; High-likelihood of death within BVS resorbtion time; Cardiogenic shock; Infarct artery reference diameter, <2.0 mm or >3.7 mm (i.e. not suitable for currently available BVS sizes); Pregnancy; Participation in other trials

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Bioresorbable Vascular Scaffold<br>Implantation of of an everolimus eluting bioresorbable scaffold in patients with STEMI treated with primary PCI | Device: Bioresorbable vascular scaffold<br>* stenting of an acute thrombotic lesion in patient within STEMI<br>* Other names: BVS, ABSORB (Abbot Vascular);|
| Active Comparator: Everolimus Eluting stent<br>Implantation of of an everolimus eluting stent in patients with STEMI treated with primary PCI | Device: Everolimus eluting stent<br>* stenting of an acute thrombotic lesion in patient within STEMI<br>* Other names: Xience Prime (Abbott Vascular);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural and Clinical success | Procedural success: The deployment of BVS at the intended target lesion with a final residual stenosis ≤20% and a TIMI 2-3 coronary flow by visual estimation without major periprocedural complication (death, emergent CABG, coronary perforation, flow limiting coronary dissection). Clinical success: any major in-hospital events (deaths, reinfarction, urgent revascularization, stroke, major bleedings) | Patients will be followed for the duration of hospital stay (4-8 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The MACE | cumulative incidence of cardiac death, non fatal myocardial infarction and target lesion revascularization | six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myocardial infarction, primary PCI, stent