Twelve-month outcomes in patients with diabetes implanted with a zotarolimus-eluting stent: results from the E-Five Registry

Abstract

Objective: To retrospectively evaluate the 12-month effectiveness of the Endeavor zotarolimus-eluting stent (ZES) in diabetic versus non-diabetic patients enrolled in the E-Five Registry.

Design and setting: The E-Five Registry is a prospective, multicentre registry of 8314 patients presenting with symptomatic coronary artery disease treated with the Endeavor (ZES). Patients were treated at 188 centres located in 37 countries across Europe, Latin America and Asia Pacific.

Patients: There were 2721 (32.7%) patients with diabetes (DM) and among these patients 682 were insulin-treated (ITDM) and 2039 were non-insulin-treated diabetic patients (NITDM). Interventions All enrolled patients received an Endeavor ZES and were followed for 12 months.

Main outcome measurements: The primary outcome measure was major adverse cardiac event (MACE) at 12 months. Secondary endpoints included target lesion revascularisation (TLR), target vessel revascularisation (TVR), target vessel failure (TVF) and stent thrombosis.

Results: Compared with non-DM patients, DM patients had higher rates of MACE (9.7% vs 6.4%, p<0.001), TLR (5.3% vs 4.0%, p=0.028) and Academic Research Consortium (ARC) definite and probable stent thrombosis (1.5% vs 0.9%, p=0.041). Compared with non-DM patients, ITDM patients had higher rates of MACE (12.6% vs 6.4%, p<0.001). ITDM patients had higher rates of death (6.7% vs 1.7%, p<0.001), cardiac death (4.5% vs 1.2%, p<0.001) and TLR (6.5% vs 4.0%, p=0.011) than non-DM patients.

Conclusions: The Endeavor ZES performed well in DM patients; however, DM patients experienced higher rates of adverse clinical events compared with non-DM patients. TRIAL REG NO:

Clinical trial registration information: http://www.clinicaltrials.gov; Unique identifier: NTC00623441.

Trial registration: ClinicalTrials.gov NCT00623441.

Conflict of interest statement

Competing interests: AKJ, CL, ITM and MTR have served as consultants to Medtronic, Inc. MTR has received research/grant support from Medtronic, Inc and since this paper was written has become VP Medical Affairs, Coronary & Peripheral Division, Medtronic, Inc. JM is a stockholder and employee of Medtronic, Inc. CL has served as a consultant for Angio Score Ltd. ITM has served as an advisory board member for Boston Scientific; MTR has served as a consultant to Abbott Vascular, Cordis Corporation, JenaValve Technology, GmbH, Lombard Medical Technologies plc and Volcano and has received research/grant support from Abbott Vascular, Boston Scientific, CardioBridge GmbH, and Cordis Corporation.

Figures

Figure 1

Kaplan-Meier curves showing cumulative incidence of (A) major adverse cardiac events (MACE) in non-diabetics (non-DM), insulin-treated diabetics (ITDM) and non-insulin-treated diabetic (NITDM) patients; (B) target lesion revascularisation (TLR) in non-diabetics (non-DM), insulin-treated diabetics (ITDM) and non-insulin-treated diabetic (NITDM) patients; (C) definite or probable stent thrombosis in non-diabetics (non-DM), insulin-treated diabetics (ITDM), and non-insulin-treated diabetic (NITDM) patients.