Published Online
on May 3, 2004

A more recent version of this article appeared on May 11, 2004

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Submitted on September 2, 2003
Revised on March 18, 2004
Accepted on March 23, 2004

Six- and Twelve-Month Results From First Human Experience Using Everolimus-Eluting Stents With Bioabsorbable Polymer

Eberhard Grube MD, Shinjo Sonoda MD, Fumiaki Ikeno MD, Yasuhiro Honda MD, Saibal Kar MD, Charles Chan MBChB, Ulrich Gerckens MD, Alexandra J. Lansky MD, and Peter J. Fitzgerald MD, PhD^*

From the Heart Center Siegburg (E.G., U.G.), Siegburg, Germany; Stanford University Medical Center (S.S., F.I., Y.H., P.J.F.), Stanford, Calif; Cedars Sinai Medical Center (S.K.), Los Angeles, Calif; National Heart Center (C.C), Singapore; and the Cardiovascular Research Foundation (A.J.L.), New York, NY.

^* To whom correspondence should be addressed. E-mail: ivus{at}crci.stanford.edu.

Background--Everolimus, an active immunosuppressive and antiproliferative agent of the same family as sirolimus (rapamycin), has demonstrated significant reduction of neointimal proliferation in animal studies. The First Use To Underscore restenosis Reduction with Everolimus (FUTURE) I trial was the first in-human experience to evaluate the safety and efficacy of everolimus-eluting stents (EES), coated with a bioabsorbable polymer, compared with bare metal stents (BMS).

Methods and Results--FUTURE I was a prospective, single-blind, randomized trial that enrolled 42 patients with de novo coronary lesions (EES 27, BMS 15). Patient and lesion characteristics were comparable between the groups. Major adverse cardiac event rates were low at 30 days and 6 months, without any early or late stent thrombosis for either group (P=NS). Between 6 and 12 months, there were no additional reports of major adverse cardiac events. The 6-month angiographic in-stent restenosis rate was 0% versus 9.1% (1 patient) (P=NS), with an associated late loss of 0.11 mm versus 0.85 mm (P<0.001), and the in-segment restenosis rate was 4% (1 patient) and 9.1% (1 patient) (P=NS) for EES and BMS, respectively. Intravascular ultrasound analysis revealed a significant reduction of percent neointimal volume in EES compared with BMS (2.9±1.9 mm³/mm versus 22.4±9.4 mm³/mm, P<0.001). There was no late stent malapposition in either group. The safety and efficacy of the EES appeared to be sustained at 12 months.

Conclusions--In this initial clinical experience, EES with bioabsorbable polymer demonstrated a safe and efficacious method to reduce in-stent neointimal hyperplasia and restenosis.

Key words: stents • restenosis • drugs • angioplasty • ultrasonics

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