TY - JOUR
T1 - 1-year clinical outcomes of diabetic patients treated with everolimus-eluting bioresorbable vascular scaffolds
T2 - A pooled analysis of the ABSORB and the SPIRIT trials
AU - Muramatsu, Takashi
AU - Onuma, Yoshinobu
AU - Van Geuns, Robert Jan
AU - Chevalier, Bernard
AU - Patel, Tejas M.
AU - Seth, Ashok
AU - Diletti, Roberto
AU - García-García, Hector M.
AU - Dorange, Cécile C.
AU - Veldhof, Susan
AU - Cheong, Wai Fung
AU - Ozaki, Yukio
AU - Whitbourn, Robert
AU - Bartorelli, Antonio
AU - Stone, Gregg W.
AU - Abizaid, Alexandre
AU - Serruys, Patrick W.
N1 - Funding Information:
The ABSORB Cohort B, the ABSORB EXTEND, the SPIRIT FIRST, the SPIRIT II, the SPIRIT III, and the SPIRIT IV trials have been sponsored and funded by Abbott Vascular . Dr. Cheong, Ms. Veldhof, and Ms. Dorange are full-time employees of Abbott Vascular. Dr. Bartorelli has served on the advisory board, as a consultant for, and received minor honoraria from Abbott Vascular. Dr. Stone has served as a consultant for Boston Scientific and Reva Medical. Dr. van Geuns has received speaker fees from Abbott Vascular. Dr. Chevalier has served as a consultant for Abbott Vascular. Dr. Patel is the Chairman of Apex Heart Institute. Dr. Seth is the Chairman of Fortis Heart Institute. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
PY - 2014/5
Y1 - 2014/5
N2 - 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.
AB - 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.
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U2 - 10.1016/j.jcin.2014.01.155
DO - 10.1016/j.jcin.2014.01.155
M3 - Article
C2 - 24746650
AN - SCOPUS:84901269957
SN - 1936-8798
VL - 7
SP - 482
EP - 493
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 5
ER -
