absorb stemi: the trofi ii study

Conditions: Acute ST Segment Elevation Myocardial Infarction

Summary: this is a prospective, randomized (1:1), active control, single-blind, non-inferiority, european multicenter clinical trial. the primary objective of this study is to assess the neointimal healing score (as evaluated by intra-coronary ofdi) in patients with st-elevation myocardial infarction (stemi) and treated with abbott vascular absorb everolimus eluting bioresorbable vascular scaffold (bvs) at 6 months follow-up by comparing with a metallic drug eluting stent (xience). furthermore, the safety and feasibility of implanting absorb bvs in patients with stemi is assessed. it is hypothesized that acutely and at 6 months follow-up implantation of the absorb fully bioresorbable everolimus-eluting scaffold is at least as safe as implantation of metallic drug-eluting stent, and that at late follow-up the absorb scaffold could improve the arterial healing process and potentially reduce late stent thrombosis in patients presenting with stemi. this is a preparatory trial in anticipation of a major outcome study.

a total of 190 patients will be included in this trial, at 8-10 european sites. the primary endpoint is arterial healing at 6 month follow up. to assess the arterial healing, at 6 months follow-up all patients will undergo angiographic follow-up with ofdi investigation. to score the arterial healing, a healing score is used.

Eligibility criteria:
inclusion criteria: 1. subject must be at least 18 years of age; 2. primary pci within 24 hours of symptom onset; 3. st-segment elevation of \> 1mm in \> 2 contiguous leads, or (presumably new) left bundle branch block, or true posterior mi with st depression of \>1mm in \>2 contiguous anterior leads; 4. presence of at least one acute infarct artery target vessel with one or more coronary artery stenoses in a native coronary artery within planned device deployment segment (dmax) by visual estimation of ≥ 2.5 mm and ≤ 3.8 mm; 5. subject agrees to not participate in any other investigational or invasive clinical study for a period of 6 months following the index procedure. exclusion criteria: 1. inability to provide informed consent; 2. known pregnancy at time of randomization. female who is breastfeeding at time of randomization; 3. known intolerance to aspirin, heparin, plla (poly(l-lactic acid), everolimus, contrast material; 4. cardiogenic shock; 5. unprotected left main coronary artery stenosis; 6. distal occlusion of target vessel; 7. acute myocardial infarction secondary to stent thrombosis; 8. mechanical complications of acute myocardial infarction; 9. severe tortuous, calcified or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in sub-optimal imaging or excessive risk of complication from placement of an ofdi catheter; 10. fibrinolysis prior to pci; 11. active bleeding or coagulopathy or patients at chronic anticoagulation therapy; 12. subject is currently participating in another clinical trial that has not yet completed its primary endpoint.

Keywords: st-elevation myocardial infarction (stemi) primary percutaneous coronary intervention within 24 hrs healing score ofdi