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(Circulation. 2004;109:627-633.)
© 2004 American Heart Association, Inc.

Clinical Investigation and Reports

Vascular Responses at Proximal and Distal Edges of Paclitaxel-Eluting Stents

Serial Intravascular Ultrasound Analysis From the TAXUS II Trial

Patrick W. Serruys, MD; Muzaffer Degertekin, MD; Kengo Tanabe, MD; Mary E. Russell, MD; Giulio Guagliumi, MD; John Webb, MD; Jaap Hamburger, MD; Wolfgang Rutsch, MD; Christoph Kaiser, MD; Robert Whitbourn, MD; Edoardo Camenzind, MD; Ian Meredith, MD; François Reeves, MD; Christoph Nienaber, MD; Edouard Benit, MD; Clemens Disco, MSc; Jörg Koglin, MD; Antonio Colombo, MD, for the TAXUS II Study Group

From Thoraxcenter (P.W.S., M.D., K.T.), Erasmus MC, Rotterdam, the Netherlands; Boston Scientific Corporation (M.E.R., J.K.), Natick, Mass; Ospedali Riuniti di Bergamo (G.G.), Bergamo, Italy; St Paul’s Hospital (J.W.), Vancouver, Canada; Vancouver General Hospital (J.H.), Vancouver, Canada; Universitätsklinikum Charite (W.R.), Medizinische Klinik, Berlin, Germany; University Hospital Basel (C.K.), Basel, Switzerland; St Vincent’s Hospital (R.W.), Melbourne, Australia; Hôpital Cantonal Universitaire (E.C.), Geneva, Switzerland; Monash Medical Centre (I.M.), Victoria, Australia; CHUM Notre-Dame Hospital (F.R.), Montreal, Canada; Universitätsklinikum Rostock (C.N.), Rostock, Germany; Virga Jesse Ziekenhuis (E.B.), Hasselt, Belgium; Cardialysis BV (C.D.), Rotterdam, the Netherlands; and Centro Cuore Columbus (A.C.), Milan, Italy.

Correspondence to Prof P.W. Serruys MD, PhD, Thoraxcenter, Bldg 408, Erasmus MC, Dr Molewaterplein 40, 3015 GD Rotterdam, The Netherlands. E-mail p.w.j.c.serruys{at}erasmusmc.nl

Received May 28, 2003; de novo received August 15, 2003; revision received October 10, 2003; accepted October 13, 2003.

Background— On the basis of brachytherapy experience, edge stenosis has been raised as a potential limitation for drug-eluting stents. We used serial intravascular ultrasound (IVUS) to prospectively analyze vessel responses in adjacent reference segments after implantation of polymer-controlled paclitaxel-eluting stents.

Methods and Results— TAXUS II was a randomized, double-blind trial with 2 consecutive patient cohorts that compared slow-release (SR) and moderate-release (MR) paclitaxel-eluting stents with control bare metal stents (BMS). By protocol, all patients had postprocedure and 6-month follow-up IVUS. Quantitative IVUS analysis was performed by an independent core laboratory, blinded to treatment allocation, in 5-mm vessel segments immediately proximal and distal to the stent. Serial IVUS was available for 106 SR, 107 MR, and 214 BMS patients. For all 3 groups, a significant decrease in proximal-edge lumen area was observed at 6 months. The decrease was comparable (by ANOVA, P=0.194) for patients in the SR (-0.54±2.1 mm²) and MR (-0.88±1.9 mm²) groups compared with the BMS (-1.02±1.9 mm²) group. For the distal edge, a significant decrease in lumen area was only observed with BMS (-0.91±2.0 mm², P<0.0001); this decrease was significantly attenuated with SR (0.08±2.0 mm²) and MR (-0.19±1.7 mm²) stents (P<0.0001 by ANOVA). Negative vessel remodeling was observed at the proximal (-0.48±2.2 mm², P=0.011) but not the distal edges of BMS and at neither edge of SR or MR stents.

Conclusions— The marked reduction in in-stent restenosis with SR or MR stents is not associated with increased edge stenosis at 6-month follow-up IVUS. In fact, compared with BMS, there is instead a significant reduction in late lumen loss at the distal edge with TAXUS stents.

Key Words: angioplasty • drugs • stents • ultrasonics

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