Long-term outcome of the unrestricted use of everolimus-eluting stents compared to sirolimus-eluting stents and paclitaxel-eluting stents in diabetic patients: the Bern-Rotterdam diabetes cohort study

Abstract

Background: Newer generation everolimus-eluting stents (EES) improve clinical outcome compared to early generation sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES). We investigated whether the advantage in safety and efficacy also holds among the high-risk population of diabetic patients during long-term follow-up.

Methods: Between 2002 and 2009, a total of 1963 consecutive diabetic patients treated with the unrestricted use of EES (n=804), SES (n=612) and PES (n=547) were followed throughout three years for the occurrence of cardiac events at two academic institutions. The primary end point was the occurrence of definite stent thrombosis.

Results: The primary outcome occurred in 1.0% of EES, 3.7% of SES and 3.8% of PES treated patients ([EES vs. SES] adjusted HR=0.58, 95% CI 0.39-0.88; [EES vs. PES] adjusted HR=0.29, 95% CI 0.13-0.67). Similarly, patients treated with EES had a lower risk of target-lesion revascularization (TLR) compared to patients treated with SES and PES ([EES vs. SES], 5.6% vs. 11.5%, adjusted HR=0.68, 95% CI: 0.55-0.83; [EES vs. PES], 5.6% vs. 11.3%, adjusted HR=0.51, 95% CI: 0.33-0.77). There were no differences in other safety end points, such as all-cause mortality, cardiac mortality, myocardial infarction (MI) and MACE.

Conclusion: In diabetic patients, the unrestricted use of EES appears to be associated with improved outcomes, specifically a significant decrease in the need for TLR and ST compared to early generation SES and PES throughout 3-year follow-up.

Keywords: ARC; Academic Research Consortium; Adjusted Hazard Ratio; BMS; Bare-Metal Stents; CI; Confidence Interval; DES; DM; Diabetes Mellitus; Diabetes mellitus; Drug-Eluting Stents; ECG; EES; ElectroCardioGraphy; Everolimus-Eluting Stents; Everolimus-eluting stent; IQR; Inter Quartile Range; MACE; MI; Major Adverse Cardiac Events; Myocardial Infarction; PCI; PES; Paclitaxel-Eluting Stents; Paclitaxel-eluting stent; Percutaneous Coronary Intervention; Percutaneous coronary intervention; RESEARCH; Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital; SD; SES; ST; Sirolimus-Eluting Stents; Sirolimus-eluting stent; Standard Deviation; Stent Thrombosis; T-SEARCH; TLR; TVR; Target-Lesion Revascularization; Target-Vessel Revascularization; Taxus–Stent Evaluated At Rotterdam Cardiology Hospital; X-SEARCH; XIENCE-Stent Evaluated At Rotterdam Cardiology Hospital; aHR.