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EXPRESS PUBLICATION

First human experience with the 17-beta-estradiol–eluting stent

The estrogen and stents to eliminate restenosis (EASTER) trial

Alexandre Abizaid, MD, PhD^*,*, Mariano Albertal, MD, PhD^*, Marco A. Costa, MD, PhD, Andrea S. Abizaid, MD, PhD^*, Rodolfo Staico, MD^*, Fausto Feres, MD, PhD^*, Luiz A. Mattos, MD, PhD^*, Amanda G. M. R. Sousa, MD, PhD^*, Jeffrey Moses, MD, Nicholas Kipshidize, MD, Gary S. Roubin, MD, Roxana Mehran, MD, Gishel New, MD^||, Martin B. Leon, MD and J. Eduardo Sousa, MD, PhD^*

^* Institute Dante Pazzanese of Cardiology, São Paulo, Brazil
University of Florida-Shands, Jacksonville, Florida, USA
Lenox Hill Hospital, New York, New York, USA
Cardiovascular Research Foundation, New York, New York, USA
^|| Box Hill Hospital, Melbourne, Australia

Manuscript received August 5, 2003; revised manuscript received December 4, 2003, accepted December 9, 2003.

^* Reprint requests and correspondence: Dr. Alexandre Abizaid, Av. Dr. Dante Pazzanese 500, Ibirapuera, São Paulo, SP, Brazil, CEP: 04012-909.
aabizaid{at}uol.com.br

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 mm³, whereas the stent volume was 143.7 ± 43.7 mm³, resulting in a neointimal volume obstruction of 23.5 ± 12.5%. None of the patients had 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.

Abbreviations and Acronyms   IVUS = intravascular ultrasound   PC = phosphorylcholine   QCA = quantitative coronary angiography

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