Bioresorbable Vascular Scaffold in Patients With Myocardial Infarction

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

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

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.

Inclusion Criteria:

1. chest pain for more than 30 minutes;
2. 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:

1. Active internal bleeding or a history of bleeding diathesis within the previous 30 days;
2. Contraindication to dual antiplatelet therapy for 12 months;
3. Known allergy to everolimus;
4. A history of stroke within 30 days or any history of hemorrhagic stroke;
5. History, symptoms, or findings suggestive of aortic dissection;
6. High-likelihood of death within BVS resorbtion time;
7. Cardiogenic shock;
8. Infarct artery reference diameter, <2.0 mm or >3.7 mm (i.e. not suitable for currently available BVS sizes);
9. Pregnancy;
10. Participation in other trials