Incomplete stent apposition after implantation of paclitaxel-eluting stents or bare metal stents: Insights from the randomized TAXUS II trial

Kengo Tanabe, Patrick W. Serruys, Muzaffer Degertekin, Eberhard Grube, Giulio Guagliumi, Wilhelm Urbaszek, Johannes Bonnier, Jean Michel Lablanche, Tomasz Siminiak, Jan Nordrehaug, Hans Figulla, Janusz Drzewiecki, Adrian Banning, Karl Hauptmann, Dariusz Dudek, Nico Bruining, Ronald Hamers, Angela Hoye, Jurgen M R Ligthart, Clemens DiscoJörg Koglin, Mary E. Russell, Antonio Colombo

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
Pages (from-to)900-905
Number of pages6
JournalCirculation
Volume111
Issue number7
DOIs
Publication statusPublished - Feb 22 2005

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Keywords

  • Angioplasty
  • Drugs
  • Stents
  • Ultrasound

ASJC Scopus subject areas

  • Physiology
  • Cardiology and Cardiovascular Medicine

Cite this

Tanabe, K., Serruys, P. W., Degertekin, M., Grube, E., Guagliumi, G., Urbaszek, W., Bonnier, J., Lablanche, J. M., Siminiak, T., Nordrehaug, J., Figulla, H., Drzewiecki, J., Banning, A., Hauptmann, K., Dudek, D., Bruining, N., Hamers, R., Hoye, A., Ligthart, J. M. R., ... Colombo, A. (2005). Incomplete stent apposition after implantation of paclitaxel-eluting stents or bare metal stents: Insights from the randomized TAXUS II trial. Circulation, 111(7), 900-905. https://doi.org/10.1161/01.CIR.0000155607.54922.16