Takashi Muramatsu1, Yoshinobu Onuma2, Robert-Jan van Geuns2, Bernard Chevalier3, Tejas M Patel4, Ashok Seth5, Roberto Diletti2, Hector M García-García2, Cécile C Dorange6, Susan Veldhof6, Wai-Fung Cheong7, Yukio Ozaki8, Robert Whitbourn9, Antonio Bartorelli10, Gregg W Stone11, Alexandre Abizaid12, Patrick W Serruys13. 1. Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands; Department of Cardiology, Fujita Health University Hospital, Toyoake, Japan. 2. Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands. 3. Institut Cardiovasculaire Paris Sud, Massy, France. 4. Krishna Heart Institute, Ahmedabad, India. 5. Fortis Escorts Heart Institute, New Delhi, India. 6. Abbott Vascular, Diegem, Belgium. 7. Abbott Vascular, Santa Clara, California. 8. Department of Cardiology, Fujita Health University Hospital, Toyoake, Japan. 9. Cardiovascular Research Center, St. Vincent's Hospital, Melbourne, Victoria, Australia. 10. Centro Cardiologico Monzino, IRCCS, University of Milan, Milan, Italy. 11. Columbia University Medical Center/New York-Presbyterian Hospital and Cardiovascular Research Foundation, New York, New York. 12. Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil. 13. Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands. Electronic address: p.w.j.c.serruys@erasmusmc.nl.
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. (ABSORB Clinical Investigation, Cohort B; NCT00856856; ABSORB EXTEND Clinical Investigation; NCT01023789; Clinical Trial of the Abbott Vascular XIENCE V Everolimus Eluting Coronary Stent System [SPIRIT FIRST]; NCT00180453; A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System [SPIRIT II]; NCT00180310; Clinical Trial of the XIENCE V Everolimus Eluting Coronary Stent System [EECSS] [SPIRIT III]; NCT00180479; Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System [SPIRIT IV Clinical Trial]; NCT00307047).
OBJECTIVES: The aim of this study was to evaluate 1-year clinical outcomes of diabeticpatients treated with the Absorb bioresorbable vascular scaffold (BVS). BACKGROUND: Clinical outcomes of diabeticpatients 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 diabeticpatients were compared with 415 nondiabeticpatients. In addition, 882 diabeticpatients 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 nondiabeticpatients treated with the BVS (3.7% vs. 5.1%, p = 0.64). Diabeticpatients treated with the BVS had a similar incidence of the DoCE compared with diabeticpatients 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 nondiabeticpatients with the BVS; 1.0% for diabeticpatients with the BVS vs. 1.7% for diabeticpatients with EES in the matched study group). CONCLUSIONS: In the present analyses, diabeticpatients treated with the BVS showed similar rates of DoCEs compared with nondiabeticpatients treated with the BVS and diabeticpatients treated with EES at 1-year follow-up. (ABSORB Clinical Investigation, Cohort B; NCT00856856; ABSORB EXTEND Clinical Investigation; NCT01023789; Clinical Trial of the Abbott Vascular XIENCE V Everolimus Eluting Coronary Stent System [SPIRIT FIRST]; NCT00180453; A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System [SPIRIT II]; NCT00180310; Clinical Trial of the XIENCE V Everolimus Eluting Coronary Stent System [EECSS] [SPIRIT III]; NCT00180479; Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System [SPIRIT IV Clinical Trial]; NCT00307047).
Authors: Jung Min Ahn; Duk Woo Park; Sung Jin Hong; Young Keun Ahn; Joo Yong Hahn; Won Jang Kim; Soon Jun Hong; Chang Wook Nam; Do Yoon Kang; Seung Yul Lee; Woo Jung Chun; Jung Ho Heo; Deok Kyu Cho; Jin Won Kim; Sung Ho Her; Sang Wook Kim; Sang Yong Yoo; Myeong Ki Hong; Seung Jea Tahk; Kee Sik Kim; Moo Hyun Kim; Yangsoo Jang; Seung Jung Park Journal: Korean Circ J Date: 2017-11-06 Impact factor: 3.243