The impact of patient and lesion complexity on clinical and angiographic outcomes after revascularization with zotarolimus- and everolimus-eluting stents: A substudy of the RESOLUTE all comers trial (a randomized comparison of a zotarolimus-eluting stent with an everolimus-eluting stent for percutaneous coronary intervention)

Giulio G. Stefanini, Patrick W. Serruys, Sigmund Silber, Ahmed A. Khattab, Robert J. Van Geuns, Gert Richardt, Pawel E. Buszman, Henning Kelbæk, Adrianus J. Van Boven, Sjoerd H. Hofma, Axel Linke, Volker Klauss, William Wijns, Carlos MacAya, Philippe Garot, Carlo Di Mario, Ganesh Manoharan, Ran Kornowski, Thomas Ischinger, Antonio L. BartorelliPierre Gobbens, Stephan Windecker

Research output: Contribution to journalArticle

Abstract

Objectives: The aim of this study was to investigate the impact of patient and lesion complexity on outcomes with newer-generation zotarolimus-eluting stents (ZES) and everolimus-eluting stents (EES). Background: Clinical and angiographic outcomes of newer-generation stents have not been described among complex patients. Methods: Patients enrolled in the RESOLUTE All Comers trial (A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention) were stratified into "complex" and "simple." Results: Of 2,292 patients, 1,520 (66.3%) were complex and treated with ZES (n = 764) or EES (n = 756). Event rates were higher among complex patients, and results did not differ between ZES and EES, regardless of complexity. At 1 year, target lesion failure was 8.9% in ZES- and 9.7% in EES-treated complex patients (p = 0.66) and 6.8% in ZES- and 5.7% in EES-treated simple patients (p = 0.55). Rates of cardiac death (1.3% vs. 2.2%, p = 0.24), target-vessel myocardial infarction (4.3% vs. 4.4%, p = 0.90), and clinically indicated target lesion revascularization (4.4% vs. 4.0%, p = 0.80) were similar for both stent types among complex patients. Definite or probable stent thrombosis occurred in 20 (1.3%) complex patients with no difference between ZES (1.7%) and EES (0.9%, p = 0.26). Angiographic follow-up showed similar results for ZES and EES in terms of in-stent percentage diameter stenosis (22.2 ± 15.4% vs. 21.4 ± 15.8%, p = 0.67) and in-segment binary restenosis (6.6% vs. 8.0%, p = 0.82) in the complex group. Conclusions: In this all-comers randomized trial, major adverse cardiovascular events were more frequent among complex than simple patients. The newer-generation ZES and EES proved to be safe and effective, regardless of complexity, with similar clinical and angiographic outcomes for both stent types through 1 year. (RESOLUTE-III All Comers Trial: A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention; NCT00617084)

Original languageEnglish
Pages (from-to)2221-2232
Number of pages12
JournalJournal of the American College of Cardiology
Volume57
Issue number22
DOIs
Publication statusPublished - May 31 2011

Keywords

  • complex
  • drug-eluting stent
  • everolimus
  • off-label
  • zotarolimus

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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    Stefanini, G. G., Serruys, P. W., Silber, S., Khattab, A. A., Van Geuns, R. J., Richardt, G., Buszman, P. E., Kelbæk, H., Van Boven, A. J., Hofma, S. H., Linke, A., Klauss, V., Wijns, W., MacAya, C., Garot, P., Di Mario, C., Manoharan, G., Kornowski, R., Ischinger, T., ... Windecker, S. (2011). The impact of patient and lesion complexity on clinical and angiographic outcomes after revascularization with zotarolimus- and everolimus-eluting stents: A substudy of the RESOLUTE all comers trial (a randomized comparison of a zotarolimus-eluting stent with an everolimus-eluting stent for percutaneous coronary intervention). Journal of the American College of Cardiology, 57(22), 2221-2232. https://doi.org/10.1016/j.jacc.2011.01.036