Bioresorbable Vascular Scaffold in Patient With ST Elevation Myocardial Infarction: a Randomized Comparison With Everolimus Eluting Stent
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- ST Elevation Acute Myocardial Infarction
- Sponsor
- San Giuseppe Moscati Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Procedural and Clinical success
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
Evaluation of the feasibility and safety of Bioresorbable Vascular Scaffold (BVS) in patient treated with primary PCI (pPCI).
Detailed Description
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.
Investigators
Emilio Di Lorenzo MD PhD
Dott. Emilio Di Lorenzo
San Giuseppe Moscati Hospital
Eligibility Criteria
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);
- •Participation in other trials
Outcomes
Primary Outcomes
Procedural and Clinical success
Time Frame: Patients will be followed for the duration of hospital stay (4-8 days)
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)
Secondary Outcomes
- The MACE(six months)