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

卷:57

Article

Serruys, Patrick W.²  Silber, Sigmund³  van Geuns, Robert J.²  Richardt, Gert⁴  Buszman, Pawel E.⁵  Kelbaek, Henning⁶  van Boven, Adrianus J.⁷  Hofma, Sjoerd H.⁷  Linke, Axel⁸  Klauss, Volker⁹  Wijns, William¹⁰  Macaya, Carlos¹¹  Garot, Philippe¹²  Di Mario, Carlo¹³  Manoharan, Ganesh¹⁴  Kornowski, Ran¹⁵  Ischinger, Thomas¹⁶  Bartorelli, Antonio L.¹⁷  Gobbens, Pierre¹⁸  Windecker, Stephan¹ 

[1] Univ Hosp Bern, Dept Cardiol, Swiss Cardiovasc Ctr Bern, CH-3010 Bern, Switzerland

[2] Erasmus MC, Rotterdam, Netherlands

[3] Kardiol Praxis & Praxisklin, Munich, Germany

[4] Segeberger Kliniken, Herzzentrum, Bad Segeberg, Germany

[5] Med Univ Silesia, Katowice, Poland

[6] Rigshosp, DK-2100 Copenhagen, Denmark

[7] Med Ctr Leeuwarden, Leeuwarden, Netherlands

[8] Herzzentrum Leipzig, Leipzig, Germany

[9] Univ Hosp Munich Innenstadt, Dept Cardiol, Munich, Germany

[10] Onze Lieve Vrouw Hosp, Cardiovasc Ctr Aalst, Aalst, Belgium

[11] Univ Hosp, Serv Cardiol, Madrid, Spain

[12] Inst Cardiovasc Paris Sud, Quincy, France

[13] Royal Brompton Hosp, Dept Cardiol, London SW3 6LY, England

[14] Royal Victoria Hosp, Belfast BT12 6BA, Antrim, North Ireland

[15] Tel Aviv Univ, Dept Cardiol, Rabin Med Ctr, IL-69978 Tel Aviv, Israel

[16] Hosp Bogenhausen, Dept Cardiol, Munich, Germany

[17] Univ Milan, IRCCS, Ctr Cardiol Monzino, Milan, Italy

[18] Cardialysis, Rotterdam, Netherlands

关键词: complex;    drug-eluting stent;    everolimus;    off-label;    zotarolimus;   

DOI  :  10.1016/j.jacc.2011.01.036

来源: Elsevier

【 摘 要 】

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) (J Am Coll Cardiol 2011; 57: 2221-32) (C) 2011 by the American College of Cardiology Foundation

【 授权许可】

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