1-year clinical outcomes of diabetic patients treated with everolimus-eluting bioresorbable vascular scaffolds: A pooled analysis of the ABSORB and the SPIRIT trials

Takashi Muramatsu, Yoshinobu Onuma, Robert Jan Van Geuns, Bernard Chevalier, Tejas M. Patel, Ashok Seth, Roberto Diletti, Hector M. García-García, Cécile C. Dorange, Susan Veldhof, Wai Fung Cheong, Yukio Ozaki, Robert Whitbourn, Antonio Bartorelli, Gregg W. Stone, Alexandre Abizaid, Patrick W. Serruys

Research output: Contribution to journalArticle

Abstract

Objectives The aim of this study was to evaluate 1-year clinical outcomes of diabetic patients treated with the Absorb bioresorbable vascular scaffold (BVS). Background Clinical outcomes of diabetic patients after BVS implantation have been unreported. Methods This study included 101 patients in the ABSORB Cohort B trial and the first consecutive 450 patients with 1 year of follow-up in the ABSORB EXTEND trial. A total of 136 diabetic patients were compared with 415 nondiabetic patients. In addition, 882 diabetic patients treated with everolimus-eluting metal stents (EES) in pooled data from the SPIRIT trials (SPIRIT FIRST [Clinical Trial of the Abbott Vascular XIENCE V Everolimus Eluting Coronary Stent System], SPIRIT II [A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System], SPIRIT III [Clinical Trial of the XIENCE V Everolimus Eluting Coronary Stent System (EECSS)], SPIRIT IV Clinical Trial [Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System]) were used for the comparison by applying propensity score matching. The primary endpoint was a device-oriented composite endpoint (DoCE), including cardiac death, target vessel myocardial infarction, and target lesion revascularization at 1-year follow-up. Results The cumulative incidence of DoCE did not differ between diabetic and nondiabetic patients treated with the BVS (3.7% vs. 5.1%, p = 0.64). Diabetic patients treated with the BVS had a similar incidence of the DoCE compared with diabetic patients treated with EES in the matched study group (3.9% for the BVS vs. 6.4% for EES, p = 0.38). There were no differences in the incidence of definite or probable scaffold/stent thrombosis (0.7% for both diabetic and nondiabetic patients with the BVS; 1.0% for diabetic patients with the BVS vs. 1.7% for diabetic patients with EES in the matched study group). Conclusions In the present analyses, diabetic patients treated with the BVS showed similar rates of DoCEs compared with nondiabetic patients treated with the BVS and diabetic patients treated with EES at 1-year follow-up.

Original languageEnglish
Pages (from-to)482-493
Number of pages12
JournalJACC: Cardiovascular Interventions
Volume7
Issue number5
DOIs
Publication statusPublished - 2014

Keywords

  • bioresorbable scaffold
  • coronary artery disease
  • diabetes mellitus
  • drug-eluting stent

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Medicine(all)

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    Muramatsu, T., Onuma, Y., Van Geuns, R. J., Chevalier, B., Patel, T. M., Seth, A., Diletti, R., García-García, H. M., Dorange, C. C., Veldhof, S., Cheong, W. F., Ozaki, Y., Whitbourn, R., Bartorelli, A., Stone, G. W., Abizaid, A., & Serruys, P. W. (2014). 1-year clinical outcomes of diabetic patients treated with everolimus-eluting bioresorbable vascular scaffolds: A pooled analysis of the ABSORB and the SPIRIT trials. JACC: Cardiovascular Interventions, 7(5), 482-493. https://doi.org/10.1016/j.jcin.2014.01.155