ISAR-PEACE: The Addition of Estradiol to a Rapamycin-Eluting Stent

Luis Gruberg, MD, FACC

Disclosures

April 30, 2007

The results from ISAR-PEACE are similar to those seen previously with estradiol-alone eluting stents.

Delayed reendothelization is associated with an increased risk for late stent thrombosis and restenosis and is a significant limitation of current drug-eluting stents (DES). Estradiol promotes endothelial cell recovery and was used in prior studies as an antiproliferative drug without success. However, estradiol may be a helpful adjunct to the antiproliferative agents used in currently available DES.

The Rapamycin Plus Estradiol-Eluting Stents Versus Rapamycin-Eluting Stents For The Reduction of Coronary Restenosis (ISAR-PEACE)[1] trial was designed to assess the efficacy of rapamycin plus 17-beta-estradiol-eluting stent vs a rapamycin-eluting stent.

ISAR-PEACE was a prospective, multicenter study that enrolled patients with stable or unstable angina or a positive stress test and were scheduled to undergo percutaneous coronary intervention with stent placement for de novo lesions in a native coronary artery. The stent platform that was used was a microporous stainless steel stent that underwent a polymer-free coating.

Primary endpoint: In-stent late lumen loss at follow-up angiogram.

Secondary endpoints:

  • Binary restenosis;

  • Need for target lesion revascularization due to restenosis;

  • Combined incidence of death and myocardial infarction; and

  • Incidence of stent thrombosis at 1 year.

A total of 502 patients were randomized to either the estradiol plus rapamycin-eluting stent (n = 252) or to the DES coated with rapamycin alone (n = 250). Baseline clinical and angiographic characteristics are shown in Table 1 .

At angiographic follow-up, there was no difference between the 2 groups with regard to the rates of in-stent and in-segment late lumen loss or in angiographic binary restenosis ( Table 2 ). In addition, there was no difference in the rates of stent thrombosis or mortality at 1-year follow-up ( Table 2 ).

There was no apparent beneficial effect by adding estradiol to a polymer-free rapamycin-eluting stent during the first year after the procedure.

The results from ISAR-PEACE are similar to those seen previously with estradiol-alone eluting stents. There seems to be no apparent immediate benefit in reducing restenosis rates. Whether it may have some delayed beneficial (or detrimental) effect on the long-term follow-up has yet to be determined. It would have been interesting to assess endothelial function to see whether there were any apparent differences between the 2 groups.

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