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.
Patients Screened: 30
Patients Enrolled: 30
Mean Follow Up: 12 months
Mean Patient Age: Mean 61 years
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
Angiographic restenosis rates at six-month follow-up
Twelve-month clinical events including MACE, and six-month angiographic and IVUS assessment of lesions at follow-up (both in-stent and in-segment)
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.
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)
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.
Keywords: Estradiol, Coronary Restenosis, Immersion, Thrombosis, Ethanol, Estrogens, Coronary Vessels, Phosphorylcholine, Diabetes Mellitus, Stents
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