First human experience with the 17-beta-estradiol-eluting stent: the Estrogen And Stents To Eliminate Restenosis (EASTER) trial.

Objectives: The purpose of the study was to examine the safety and efficacy of 17-beta-estradiol-eluting stent implantation on coronary de novo lesions.

Background: Recent animal data indicate that local delivery of 17-beta-estradiol promotes re-endothelialization, inhibits cell migration and proliferation, and prevents restenosis.

Methods: A total of 30 consecutive patients underwent 17-beta-estradiol-eluting BiodVysio (Biocompatibles Ltd., London, United Kingdom) stent implantation for the treatment of coronary de novo lesions. Clinical, angiographic, and intravascular ultrasound (IVUS) analysis was performed at six-month follow-up.

Results: All stents were successfully deployed and patients were discharged home without clinical events. A total of two patients exceeded 50% intra-stent narrowing by angiography, whereas no patients experienced edge restenosis. One patient had focal intra-stent restenosis (60% diameter stenosis) with no symptoms and negative stress test, whereas the other patient had diffuse restenosis, requiring target vessel revascularization. No other patient experienced any major adverse cardiac event. Follow-up IVUS revealed a neointimal hyperplasia volume of 32.3 +/- 16.4 mm(3), whereas the stent volume was 143.7 +/- 43.7 mm(3), resulting in a neointimal volume obstruction of 23.5 +/- 12.5%. None of the patients had > or =50% volume obstruction by IVUS.

Conclusions: Implantation of 17-beta-estradiol-eluted BiodVysio stents appears feasible and safe, showing low rates of binary restenosis and revascularization. These results warrant further confirmation with a large, randomized multicenter trial.