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(Circulation. 2002;106:1788.)
© 2002 American Heart Association, Inc.

Clinical Investigation and Reports

7-Hexanoyltaxol–Eluting Stent for Prevention of Neointimal Growth

An Intravascular Ultrasound Analysis From the Study to COmpare REstenosis rate between QueST and QuaDS-QP2 (SCORE)

Toru Kataoka, MD; Eberhard Grube, MD; Yasuhiro Honda, MD; Yoshihiro Morino, MD; Seung-Ho Hur, MD; Heidi N. Bonneau, RN, MS; Antonio Colombo, MD; Carlo Di Mario, MD, PhD; Giulio Guagliumi, MD; Karl E. Hauptmann, MD; Mark R. Pitney, MBBS; Alexandra J. Lansky, MD; Simon H. Stertzer, MD; Paul G. Yock, MD; Peter J. Fitzgerald, MD, PhD, for the SCORE Investigators

From the Center for Research in Cardiovascular Interventions, Stanford University, Stanford, Calif (T.K., Y.H., Y.M., S.H., S.H.S., P.G.Y., P.J.F.); Heart Center Siegburg, Siegburg, Germany (E.G.); Highlands Consulting, Inc, San Jose, Calif (H.N.B.); Columbus Clinic, Milan, Italy (A.C., C.D.M.); San Raffaele Hospital, Milan, Italy (A.C., C.D.M.); Divisione di Cardiologia Ospedali, Riuniti di Bergamo, Bergamo, Italy (G.G.); Krankenhaus der Barmherzigen Brüder, Trier, Germany (K.E.H.); Eastern Heart Clinic, Prince of Wales Hospital, Sydney, Australia (M.R.P.); and the Cardiovascular Research Foundation, New York City, NY (A.J.L.).

Correspondence to Dr Peter J. Fitzgerald, Center for Research in Cardiovascular Interventions, Stanford University Medical Center, 300 Pasteur Drive, Room H3554, Stanford, CA 94305. E-mail ivus{at}crci.stanford.edu

Background— Inhibition of neointimal tissue growth has been demonstrated in preliminary human feasibility studies with a stent-based polymer sleeve delivering 7-hexanoyltaxol. The Study to COmpare REstenosis rate between QueST and QuaDS-QP2 (SCORE) trial is a human, randomized, multicenter trial comparing 7-hexanoyltaxol (QP2)-eluting stents (qDES) with bare metal stents (BMS) in the treatment of de novo coronary lesions. The purpose of this substudy was to evaluate the acute expansion property and long-term neointimal responses of qDES compared with BMS as assessed by intravascular ultrasound (IVUS).

Methods and Results— A total of 122 (qDES 66, BMS 56) patients were enrolled into the IVUS substudy. All IVUS images (immediately after the procedure and at 6-month follow-up) were analyzed at an independent core laboratory in a blind manner. At baseline, qDES achieved stent expansion similar to BMS. At follow-up, qDES showed reduced neointimal growth by 70% at the tightest cross section and by 68% over the stented segment (P<0.0001 for both), resulting in a significantly larger lumen in qDES than in BMS. Unlike intracoronary brachytherapy, there was no evidence of negative edge effects, unhealed dissections, or late stent-vessel wall malapposition over the stented and adjacent references segments in either group.

Conclusions— Detailed IVUS analysis revealed that qDES had comparable acute mechanical and superior long-term biological effects to BMS. Although the long-term benefits and limitations of this technology require further investigation, the reduction in neointimal thickenings demonstrated that local delivery of 7-hexanoyltaxol through polymer sleeves augments conventional mechanical treatment of atherosclerotic disease.

Key Words: cardiovascular diseases • drugs • restenosis • stents • ultrasonics

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