Published Online
on February 14, 2005

A more recent version of this article appeared on February 22, 2005

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Submitted on December 10, 2003
Revised on November 3, 2004
Accepted on November 10, 2004

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.).

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

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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