Estrogen And Stents To Eliminate Restenosis - EASTER


Estrogen And Stents To Eliminate Restenosis (EASTER) was a single-center study designed to examine the safety and feasibility of 17-beta-estradiol–eluting stents to inhibit restenosis in de novo coronary lesions in humans.


Treatment of de novo lesions with a 17-beta-estradiol-eluting stent would be safe and would result in acceptable rates of restenosis, major adverse cardiac events (MACE), and follow-up angiographic and intravascular ultrasound (IVUS) lesion characteristics.

Study Design

Study Design:

Patients Screened: 30
Patients Enrolled: 30
Mean Follow Up: 12 months
Mean Patient Age: Mean 61 years
Female: 30%

Patient Populations:

Patients undergoing elective PCI for single, short (<18 mm in length) de novo lesions in native coronary arteries with diameter 2.5-3.5 mm

Primary Endpoints:

Angiographic restenosis rates at six-month follow-up

Secondary Endpoints:

Twelve-month clinical events including MACE, and six-month angiographic and IVUS assessment of lesions at follow-up (both in-stent and in-segment)

Drug/Procedures Used:

The BiodivYsio stent delivery system (balloon-expandable stent coated with phosphorylcholine, which can act as a sponge) was used, and stents were coated with a solution of 17-beta-estradiol in ethanol by a process of immersion, drying, pipetting solution onto the stent, and re-drying. Stents were immediately deployed after this process was complete.

Each patient received one 18 mm stent (3.0-3.5 mm in diameter) after predilation. Stents were deployed at high pressure (>14 atm), and the need for postdilation was guided by IVUS.

Concomitant Medications:

Aspirin (325 mg/day, indefinitely) at least 12 hours before the procedure, and clopidogrel (300 mg at least six hours prior to stent implantation and 75 mg daily continued for 60 days)

Principal Findings:

Thirty patients were enrolled. Overall, the study population was low risk, with only three patients (10%) who were diabetic. The mean lesion length was 9.1 mm, and the mean reference diameter was 2.8 mm. Stent implantation was successful in all patients, with no adverse in-hospital events.

One patient (3.3%) underwent target lesion revascularization at six-month follow-up due to symptomatic angiographic restenosis. There were no cases of stent thrombosis or other major cardiovascular events at up to 12 months of follow-up.

At six-month angiographic follow-up, two patients (6.7%) had developed angiographic restenosis, and in-segment late loss (within the stent and including 5 mm margins on either edge) was 0.34 mm. On IVUS analysis, the mean neointimal volume of obstruction was 23.5%, with no patients having >50% volume obstruction. There were no cases of stent malapposition at follow-up.


In this small, single-center initial clinical study of a 17-beta-estradiol-eluting stent to treat de novo coronary artery lesions, usage of the stent appeared safe, with a low restenosis rate and low amount of late loss of luminal diameter. Among the several caveats limiting generalizability of this initial study are the small sample size, the relatively low-complexity lesions treated, and the low-risk profile of the enrolled patient population.


Abizaid A, Albertal M, Costa MA, et al. First human experience with the 17-beta-estradiol-eluting stent: the Estrogen And Stents To Eliminate Restenosis (EASTER) trial. J Am Coll Cardiol 2004;43:1118-21.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Chronic Angina

Keywords: Estradiol, Coronary Restenosis, Immersion, Thrombosis, Ethanol, Estrogens, Coronary Vessels, Phosphorylcholine, Diabetes Mellitus, Stents

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