JACC Cardiovasc Interv. 2014 May;7(5):482-93. doi: 10.1016/j.jcin.2014.01.155. Epub 2014 Apr 16.

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

Muramatsu T¹, Onuma Y², van Geuns RJ², Chevalier B³, Patel TM⁴, Seth A⁵, Diletti R², García-García HM², Dorange CC⁶, Veldhof S⁶, Cheong WF⁷, Ozaki Y⁸, Whitbourn R⁹, Bartorelli A¹⁰, Stone GW¹¹, Abizaid A¹², Serruys PW¹³; ABSORB Cohort B Investigators; ABSORB EXTEND Investigators; SPIRIT FIRST Investigators; SPIRIT II Investigators; SPIRIT III Investigators; SPIRIT IV Investigators.

Author information

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).