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(Circulation. 2005;111:900-905.)
© 2005 American Heart Association, Inc.

Interventional Cardiology

Incomplete Stent Apposition After Implantation of Paclitaxel-Eluting Stents or Bare Metal Stents

Insights From the Randomized TAXUS II Trial

Kengo Tanabe, MD; Patrick W. Serruys, MD, PhD; Muzaffer Degertekin, MD; Eberhard Grube, MD; Giulio Guagliumi, MD; Wilhelm Urbaszek, MD; Johannes Bonnier, MD; Jean-Michel Lablanche, MD; Tomasz Siminiak, MD; Jan Nordrehaug, MD; Hans Figulla, MD; Janusz Drzewiecki, MD; Adrian Banning, MD; Karl Hauptmann, MD; Dariusz Dudek, MD; Nico Bruining, PhD; Ronald Hamers, PhD; Angela Hoye, MBChB; Jurgen M.R. Ligthart, BSc; Clemens Disco, MSc; Jörg Koglin, MD; Mary E. Russell, MD; Antonio Colombo, MD, for the TAXUS II Study Group

From the Thoraxcenter, Erasmus MC, Rotterdam, the Netherlands (K.T., P.W.S., M.D., N.B., R.H., A.H., J.M.R.L.); Heart Center Siegburg, Siegburg, Germany (E.G.); Ospedali Riuniti di Bergamo, Bergamo, Italy (G.G.); Medizinische Klinik Weisser Hirsch, Dresden, Germany (W.U.); Catharina Ziekenhuis Eindhoven, Eindhoven, the Netherlands (J.B.); Hôpital Cardiologique–CHU, Lille, France (M.L.); J. Strus Hospital, Poznan, Poland (T.S.); Haukeland Hospital, Bergen, Norway (J.N.); Friedrich-Schiller-University, Jena, Germany (H.F.); PSK No 7, Zaklad Kardiologii Inwazyjnej, Katowice, Poland (J.D.); John Radcliffe Hospital, Oxford, UK (A.B.); Krankenhaus der Barmherzigen Brüder, Trier, Germany (K.H.); Jagiellonian University, Krakow, Poland (D.D.); Cardialysis BV, Rotterdam, the Netherlands (C.D.); Boston Scientific Corp, Natick, Mass (J.K., M.E.R.); and Centro Cuore Colombus, Milan, Italy (A.C.).

Correspondence to Prof P.W. Serruys, MD, PhD, Thoraxcentre, Bd 406, Erasmus MC, Dr Molewaterplein 40, 3015 GD Rotterdam, The Netherlands. E-mail p.w.j.c.serruys{at}erasmusmc.nl

Received December 10, 2003; revision received November 3, 2004; accepted November 10, 2004.

Background— The clinical impact of late incomplete stent apposition (ISA) for drug-eluting stents is unknown. We sought to prospectively investigate the incidence and extent of ISA after the procedure and at 6-month follow-up of paclitaxel-eluting stents in comparison with bare metal stents (BMS) and survey the clinical significance of ISA over a period of 12 months.

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 intravascular ultrasound (IVUS) substudy included patients who underwent serial IVUS examination after the procedure and at 6 months (BMS, 240 patients; SR, 113; MR, 116). The qualitative and quantitative analyses of ISA were performed by an independent, blinded core laboratory. More than half of the instances of ISA observed after the procedure resolved at 6 months in all groups. No difference in the incidence of late-acquired ISA was observed among the 3 groups (BMS, 5.4%; SR, 8.0%; MR, 9.5%; P=0.306), with a similar ISA volume (BMS, 11.4 mm³; SR, 21.7 mm³; MR, 8.5 mm³; P=0.18). Late-acquired ISA was the result of an increase of vessel area without change in plaque behind the stent. Predictive factors of late-acquired ISA were lesion length, unstable angina, and absence of diabetes. No stent thrombosis occurred in the patients diagnosed with ISA over a period of 12 months.

Conclusions— The incidence and extent of late-acquired ISA are comparable in paclitaxel-eluting stents and BMS. ISA is a pure IVUS finding without clinical repercussions.

Key Words: stents • drugs • angioplasty • ultrasound

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