Author + information
- Received October 21, 2013
- Revision received December 30, 2013
- Accepted January 4, 2014
- Published online May 1, 2014.
- Takashi Muramatsu, MD, PhD∗,†,
- Yoshinobu Onuma, MD∗,
- Robert-Jan van Geuns, MD, PhD∗,
- Bernard Chevalier, MD‡,
- Tejas M. Patel, MD§,
- Ashok Seth, MD||,
- Roberto Diletti, MD∗,
- Hector M. García-García, MD, PhD∗,
- Cécile C. Dorange, MSc¶,
- Susan Veldhof, RN¶,
- Wai-Fung Cheong, PhD#,
- Yukio Ozaki, MD, PhD†,
- Robert Whitbourn, MD∗∗,
- Antonio Bartorelli, MD††,
- Gregg W. Stone, MD‡‡,
- Alexandre Abizaid, MD, PhD§§,
- Patrick W. Serruys, MD, PhD∗∗ (, )
- ABSORB Cohort B, the ABSORB EXTEND, and the SPIRIT FIRST, II, III, and IV Investigators
- ∗Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands
- †Department of Cardiology, Fujita Health University Hospital, Toyoake, Japan
- ‡Institut Cardiovasculaire Paris Sud, Massy, France
- §Krishna Heart Institute, Ahmedabad, India
- ||Fortis Escorts Heart Institute, New Delhi, India
- ¶Abbott Vascular, Diegem, Belgium
- #Abbott Vascular, Santa Clara, California
- ∗∗Cardiovascular Research Center, St. Vincent's Hospital, Melbourne, Victoria, Australia
- ††Centro Cardiologico Monzino, IRCCS, University of Milan, Milan, Italy
- ‡‡Columbia University Medical Center/New York–Presbyterian Hospital and Cardiovascular Research Foundation, New York, New York
- §§Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil
- ↵∗Reprint requests and correspondence:
Dr. Patrick W. Serruys, Department of Interventional Cardiology, Thoraxcenter, Erasmus Medical Center, Ba 583, Dr Molewaterplein 40, 3015 GD, Rotterdam, the Netherlands.
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).
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.
- Received October 21, 2013.
- Revision received December 30, 2013.
- Accepted January 4, 2014.
- American College of Cardiology Foundation