Published Online
on December 22, 2003

A more recent version of this article appeared on January 20, 2004

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Submitted on March 20, 2003
Revised on October 10, 2003
Accepted on October 13, 2003

Chronic Arterial Responses to Polymer-Controlled Paclitaxel-Eluting Stents. Comparison With Bare Metal Stents by Serial Intravascular Ultrasound Analyses: Data From the Randomized TAXUS-II Trial

Kengo Tanabe MD, Patrick W. Serruys MD, PhD^*, Muzaffer Degertekin MD, Giulio Guagliumi MD, Eberhard Grube MD, Charles Chan MD, Thomas Munzel MD, Jorge Belardi MD, Witold Ruzyllo MD, Luc Bilodeau MD, Henning Kelbaek MD, John Ormiston MD, Keith Dawkins MD, Louis Roy MD, Bradley H. Strauss MD, Clemens Disco MSc, Jörg Koglin MD, Mary E. Russell MD, Antonio Colombo MD, and for the TAXUS II Study Group

From Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands (K.T., P.W.S., M.D.); Ospedali Riuniti di Bergamo, Bergamo, Italy (G.G.); Heart Center Siegburg, Siegburg, Germany (E.G.); Singapore General Hospital, Singapore (C.C.); Universitaetsklinikum Eppendorf, Hamburg, Germany (T.M.); Instituto Cardiovascular de Buenos Aires, Buenos Aires, Argentina (J.B.); National Institute of Cardiology, Warsaw, Poland (W.R.); Montreal Heart Institute, Montreal, Canada (L.B.); Rigshospitalet, Heart Center, Copenhagen, Denmark (H.K.); Mercy Hospital, Auckland, New Zealand (J.O.); Southhampton General Hospital, Southampton, Great Britain (K.D.); Hospital Laval, Ste-Foy, Canada (L.R.); St Michael’s Hospital, University of Toronto, Toronto, Ontario, Canada (B.H.S.); Cardialysis BV, Rotterdam, The Netherlands (C.D.); Boston Scientific Corporation, Natick, Mass (J.K., M.E.R.); and Centro Cuore Colombus, Milan, Italy (A.C.).

^* To whom correspondence should be addressed. E-mail: p.w.j.c.serruys{at}erasmusmc.nl.

Background--Polymer-controlled paclitaxel-eluting stents have shown a pronounced reduction in neointimal hyperplasia compared with bare metal stents (BMS). The aim of this substudy was to evaluate local arterial responses through the use of serial quantitative intravascular ultrasound (IVUS) analyses in the TAXUS II trial.

Methods and Results--TAXUS II was a randomized, double-blind study with 536 patients in 2 consecutive cohorts comparing slow-release (SR; 131 patients) and moderate-release (MR; 135 patients) paclitaxel-eluting stents with BMS (270 patients). This IVUS substudy included patients treated with one study stent who underwent serial IVUS examination after the procedure and at 6-month follow-up (BMS, 152 patients; SR, 81; MR, 81). The analyzed stented segment (15 mm) was divided into 5 subsegments in which mean vessel area (VA), stent area (SA), lumen area (LA), intrastent neointimal hyperplasia area (NIHA), and peristent area (VA-SA) were measured. NIHA was significantly reduced in SR (0.7±0.9 mm², P<0.001) and MR (0.6±0.8 mm², P<0.001) compared with BMS (1.9±1.5 mm²), with no differences between the two paclitaxel-eluting release formulations. Longitudinal distribution of neointimal hyperplasia throughout the paclitaxel-eluting stent was uniform. Neointimal growth was independent of peristent area at postprocedure examination in all groups. There were progressive increases in peristent area from BMS to SR to MR (0.5±1.7, 1.0±1.8, and 1.4±2.0 mm², respectively; P<0.001). The increase in peristent area was directly correlated with increases in VA.

Conclusions--Both SR and MR paclitaxel-eluting stents prevent neointimal formation to the same degree compared with BMS. However, the difference in peristent remodeling suggests a release-dependent effect between SR and MR.

Key words: stents • restenosis • drugs • angioplasty

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