ABSORB STEMI: the TROFI II Study is one of the first randomized clinical trials which compares the durable polymer based everolimus-eluting XIENCE with the bioresorbable everolimus-eluting ABSORB scaffold in STEMI patients.
Seven sites distributed over Denmark, Spain, Switzerland and The Netherlands are actively involved and including patients. To date all patients have been enrolled; the first patients were seen for the 6 months clinical follow-up and 6 month imaging OFDI (primary endpoint) was successfully performed.
The findings of this study will be important to elucidate disease-specific application of bioresorbable coronary scaffolds and may provide the basis for large scale clinical trials.
Design of ABSORB STEMI: the TROFI II Study: a European multicenter randomized study to assess the safety and performance of ABSORB bioresorbable scaffold in the treatment of 190 STEMI patients. The primary objective is to assess the neointimal healing score (by OFDI) at 6 months follow-up by comparing with a metallic DES (XIENCE). The Principal Investigators are Stephan Windecker (Switzerland), Manel Sabate (Spain) and Patrick Serruys (the Netherlands).
Scientific Grants to ECRI: Abbott Vascular and Terumo.
All patients have been enrolled for the ABSORB STEMI: the Trofi II study!