First human experience with the 17-beta-estradiol-eluting stent: the Estrogen And Stents To Eliminate Restenosis (EASTER) trial.
OBJECTIVE
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.
Abizaid
Alexandre
A
Institute Dante Pazzanese of Cardiology, Av. Dr. Dante Pazzanese 500, Ibirapuera, São Paulo, SP, Brazil. aabizaid@uol.com.br
Albertal
Mariano
M
Costa
Marco A
MA
Abizaid
Andrea S
AS
Staico
Rodolfo
R
Feres
Fausto
F
Mattos
Luiz A
LA
Sousa
Amanda G M R
AG
Moses
Jeffrey
J
Kipshidize
Nicholas
N
Roubin
Gary S
GS
Mehran
Roxana
R
New
Gishel
G
Leon
Martin B
MB
Sousa
J Eduardo
JE
D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000473:pathology / Q000628:therapy*; D004958:Estradiol / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D015607:Stents; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
D004958:Estradiol