Randomized trial (n = 1161 patients in 16 centers) comparing a coated stent with biodegradable biolimus polymer (Biomatrix) versus uncoated stent (Gazelle) in patients with AMI with ST segment elevation.
While there is no doubt about the effectiveness of first generation SF to reduce the rate of reoperations compared with non-drug eluting stents, there is controversy about its safety in AMI context, especially due to occurrence of events such as very late thrombosis and AMI, (Kalesan B, EHJ 2012; De Luca et al, Arch Int Med 2012)
The LEADERS study analysis that compared Biomatrix stent with the Cypher stent, demonstrated superiority of Biomatrix at 4 years of follow-up. A subgroup analysis showed Biomatrix particular benefit in patients with AMI. These findings generated the hypothesis that in the AMI context, the use of Biomatrix is