Intracoronary Stenting and Angiographic Restenosis: Promote Endothelial Cells With Estradiol - ISAR-PEACE – Presented at ACC 2007
The goal of the trial was to evaluate percutaneous coronary intervention (PCI) use of a polymer-free, estradiol plus rapamycin-eluting stent (ERES) compared with a polymer-free, rapamycin-eluting stent (RES) among patients with de novo native coronary artery disease.
Patients Enrolled: 502
Mean Follow Up: 1 year
Mean Patient Age: Mean age, 67 years
Age ≥18 years, stable or unstable angina or a positive stress test, and PCIs for de novo lesions in a native coronary artery
Pregnant women; patients with an acute ST-segment elevation MI; malignancies or other comorbid conditions with a life expectancy <12 months; target lesion located in the left main; and a contraindication or known allergy to aspirin, heparin, thienopyridines, rapamycin, estradiol, or stainless steel
In-stent late lumen loss at 6- to 8-month angiographic follow-up
Binary angiographic restenosis, need for target lesion revascularization due to restenosis in the presence of symptoms or signs of ischemia, composite of death or MI, and the incidence of stent thrombosis
Patients were randomized to PCI with either a polymer-free, ERES (n = 252) or a polymer-free, RES (n = 250). Repeat angiography was performed at 6-8 months and clinical follow-up was continued through 1 year.
At study entry, 22% of patients had non-ST elevation myocardial infarction (MI) and 30% had unstable angina. Target vessel was the left anterior descending in 40% of patients. Abciximab was used in 8% of patients, predominantly those with non-ST elevation MI. Follow-up angiography was performed in 81% of patients.
There was no difference between the treatment groups in the primary endpoint of in-stent late lumen loss (0.52 mm for ERES group vs. 0.51 mm for RES group, p = 0.83). There was also no difference in diameter stenosis (28.18% for ERES vs. 27.05% for RES, p = 0.43) or binary restenosis (17.6% vs. 16.9%, p = 0.85).
Stent thrombosis occurred in two patients in the ERES group and three patients in the RES group within 1 year (1% event rate overall). Most of the stent thromboses were early (days 1, 11, 13, 22, and 249) and all occurred while the patients were on clopidogrel therapy. There was no difference in 1-year clinical events between groups, with death in 2.0% of the ERES group and 2.4% of the RES group (p = 0.75); death or MI in 7.9% and 8.0% (p = 0.98), respectively; and target lesion revascularization in 14.3% and 13.2% (p = 0.72).
Among patients with de novo native coronary artery disease undergoing PCI, use of a polymer-free, ERES was not associated with a difference in late lumen loss compared with use of a RES without estradiol at angiographic follow-up.
Estradiol was added to the stent in an attempt to promote rapid re-endothelialization of the stent and to reduce restenosis. It was hypothesized that the re-endothelialization by estradiol might reduce the risk of stent thrombosis, and at the same time limit restenosis. However, no difference was observed at angiographic follow-up in late loss or stenosis. Additionally, stent thrombosis, while a relatively infrequent event, showed no signs of reduction with the addition of estradiol. Further follow-up of these patients is warranted, given the increase in stent thrombosis risk associated with drug-eluting stents after the first year post-PCI to see if any long-term benefit is observed.
Adriaenssens T, Mehilli J, Wessely R, et al. Does addition of estradiol improve the efficacy of a rapamycin-eluting stent? Results of the ISAR-PEACE randomized trial. J Am Coll Cardiol 2007;49:1265-71.
Presented by Dr. Julinda Mehilli at the i2 Summit/American College of Cardiology Annual Scientific Session, New Orleans, LA, March 2007.
Keywords: Myocardial Infarction, Follow-Up Studies, Estradiol, Coronary Restenosis, Drug-Eluting Stents, Sirolimus, Constriction, Pathologic, Angioplasty, Balloon, Coronary, Thrombosis, Polymers, Exercise Test
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