Relation between bioresorbable scaffold sizing using QCA-Dmax and clinical outcomes at 1 year in 1,232 patients from 3 study cohorts (ABSORB Cohort B, ABSORB EXTEND, and ABSORB II)

BACKGROUND:Assessment of pre-procedural Dmax of proximal and distal sites has been used for Absorb scaffold size selection in the ABSORB studies.METHODS:A total of 1,248 patients received Absorb scaffolds in the ABSORB Cohort B (ABSORB Clinical Investigation, Cohort B) study (N = 101), ABSORB EXTEND (ABSORB EXTEND Clinical Investigation) study (N = 812), and ABSORB II (ABSORB II Randomized Controlled Trial) trial (N = 335). The incidence of major adverse cardiac events (MACE) (a composite of cardiac death, any myocardial infarction [MI], and ischemia-driven target lesion revascularization) was analyzed according to the Dmax subclassification of scaffold oversize group versus scaffold nonoversize group...

1-Year clinical outcomes of diabeticpatients treated with everolimus-elutingbioresorbable vascular scaffolds: a pooled analysis of the ABSORB and the SPIRIT trials

Objectives The aim of this study was to evaluate 1-year clinical outcomes of diabetic patients treatedwith 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 450patients with 1 year of follow-up in the ABSORB EXTEND trial. A total of 136 diabetic patients werecompared with 415 nondiabetic patients. In addition, 882 diabetic patients treated with everolimuselutingmetal stents (EES) in pooled data from the SPIRIT trials (SPIRIT FIRST [Clinical Trial of the AbbottVascular XIENCE V Everolimus Eluting Coronary Stent System], SPIRIT II [A Clinical Evaluation of the XIENCEV Everolimus Eluting Coronary Stent System], SPIRIT III [Clinical Trial of the XIENCE V Everolimus ElutingCoronary Stent System (EECSS)], SPIRIT IV Clinical Trial [Clinical Evaluation of the XIENCE V EverolimusEluting 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, targetvessel myocardial infarction, and target lesion revascularization at 1-year follow-up.Results The cumulative incidence of DoCE did not differ between diabetic and nondiabetic patientstreated with the BVS (3.7% vs. 5.1%, p » 0.64). Diabetic patients treated with the BVS had a similarincidence 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 orprobable 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...