ST Elevation Acute Myocardial Infarction
Conditions
Keywords
myocardial infarction, primary PCI, stent
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.
Interventions
stenting of an acute thrombotic lesion in patient within STEMI
DEVICEEverolimus eluting stent
stenting of an acute thrombotic lesion in patient within STEMI
Sponsors
San Giuseppe Moscati Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural and Clinical success | 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
| Measure | Time frame | Description |
|---|---|---|
| The MACE | six months | cumulative incidence of cardiac death, non fatal myocardial infarction and target lesion revascularization |
Other
| Measure | Time frame | Description |
|---|---|---|
| stent thrombosis | six months | cumulative incidence of definite or probable stent thrombosis defined according to the Academic Research Consortium definition |
Countries
Italy
Outcome results
None listed