PREVENTATIVE ESTRADIOL FOR INHIBITION OF ANGIOPLASTY RESTENOSIS LESIONS IN (PEARL)
Principal Investigator: Kathryn Hirst, Ph.D.
The Biostatistics Center served as coordinating center for PEARL, funded by the National Institute on Aging (NIA). The primary goal was to investigate the potential of estrogen replacement therapy to inhibit or prevent restenosis in post-menopausal women who have undergone balloon angioplasty with intra-coronary stent insertion. This study was designed to provide pilot data to assess the feasibility and guide the design of a larger multi- center clinical trial. A sample of 100 women at seven clinical centers were randomized to a twelve-week regimen of estradiol administered as a topical patch vs a control patch. The primary outcome is minimum luminal diameter measured by quantitative coronary angiography twelve weeks after the initial revascularization procedure.
NIH/NIA Grant: R01 AG16332-01A1, 1999- 2000.)