The trial, which involved nearly 300 patients, was aimed at evaluating the safety and efficacy of locally administered 17beta-estradiol, the most potent estrogen. The study monitored its ability to prevent restenosis, the re-constriction of the artery, and promote healing in patients following percutaneous transluminal coronary angioplasty (PTCA) and stent implantation.
The safety data show no adverse effects attributable to the locally administered 17beta-estradiol treatment as the across-the-board incidence of major adverse cardiac events (MACE) were identical in all groups; placebo, low-dose 17beta-estradiol and high-dose 17beta-estradiol.
Since the trial included multiply stented patients in which only one stent (per protocol) underwent treatment or placebo, analysis of the single stent subgroup trended towards an improved safety profile with the 17beta-estradiol treatment – particularly in the high-dose subgroup. While not reaching statistical significance, a 32% decrease in MACE and a 68% reduction in urgent percutaneous coronary intervention (PCI) was observed in the high-dose, single-stent 17beta-estradiol group relative to placebo. Also of note was a trend towards lower calcium-channel blocker and nitrate usage in the treated groups.
In conclusion the researchers believe the trial has successfully demonstrated that 17beta-estradiol treatment is safe relative to placebo and able to provide an improved safety profile.
Duravest is sufficiently confident of the safety and efficacy profile to commence enrolling patients in the 1st half of 2006 for a definitive phase III human clinical trial in Europe using the proprietary Estracure 17beta-estradiol eluting coronary stent.