Angiographic follow-up of genous bioengineered stent in acute myocardial infarction (GENAMI)-a pilot study.

ABSTRACT

OBJECTIVE: GENAMI, an angiographic follow-up study was undertaken to evaluate the safety and efficacy of a new generation endothelial progenitor cell (EPC) capture stent, GENOUS during primary angioplasty for ST-elevation myocardial infarction (MI). METHODS: Eleven consecutive patients with acute ST-elevation MI underwent primary percutaneous coronary intervention (PCI) using a bio-engineered GENOUS EPC stent. RESULTS: Procedural success was 100%. Ten patients who survived underwent a follow-up angiography at 8 months. There was no instance of stent thrombosis during the follow-up period up to 12 months. The quantitative angiographic (quantitative coronary analysis [QCA]) follow-up data showed a late loss at 8 months of 0.97 +/- 0.94 mm and the late loss index was 44.35 +/- 40.47% with angiographic restenosis seen in 5 of 10 patients (50%). One of these patients with provocable ischemia underwent repeat PCI. CONCLUSIONS: The QCA data of this study shows a high late loss with frequent angiographic restenosis during follow-up with this stent during primary PCI for acute STEMI. This observation, with important clinical implications, needs to be confirmed in larger studies.