Key result
Zotarolimus-eluting stents fail to significantly reduce 5-year TVF versus other DES in diabetics.
Why the study?
Recent data suggest that the Endeavor Zotarolimus-eluting stent may be inferior to other drug-eluting stents in patients with diabetes mellitus and coronary artery disease.
Does zotarolimus-eluting stent reduce target vessel failure compared to other drug-eluting stents in patients with diabetes mellitus and coronary artery disease?
Does zotarolimus-eluting stent reduce target vessel failure compared to other drug-eluting stents in patients with diabetes mellitus and coronary artery disease?
Absolute Event Rate: 20.2% vs 26.9%
p-value: p=0.065
Zotarolimus-eluting stents demonstrated favorable long-term safety and efficacy outcomes, including significantly lower rates of death and MI at 5 years, compared to first-generation DES in patients with diabetes.
Nonsignificant trend in 5-year target vessel failure does not support preferential use in diabetes; extends long-term meta-analytic data without confirming superiority.
OBJECTIVE: To assess long-term outcomes of Endeavor Zotarolimus-eluting stent (E-ZES) implantation in patients with diabetes mellitus (DM). BACKGROUND: Patients with DM and coronary artery disease have lower restenosis with drug-eluting stent (DES) compared with bare-metal stents. Recent data suggest that the E-ZES is inferior to other DES in this population. METHODS: Patient-level data for 601 patients with DM from the ENDEAVOR III and ENDEAVOR IV trials were pooled, of which 337 were treated with E-ZES and 264 were treated with other DES. The primary outcome was target vessel failure (TVF) in the course of 5 years. Outcomes are reported as rates using Kaplan-Meier (KM) survival method and differences between E-ZES and other stent types (sirolimus-eluting stent or paclitaxel-eluting stent) were compared using the log-rank statistic. The independent effect of stent type on TVF was assessed using Cox proportional hazards regression. RESULTS: Baseline characteristics were similar between the groups. Five-year TVF KM rate estimate was numerically lower for E-ZES, but the difference did not reach statistical significance (20.2 vs. 26.9%, P = 0.065). The 5-year KM rate estimates of major adverse cardiac events (17.7 vs. 26.6%, P = 0.012), death (7.6 vs. 15.0%, P = 0.004), and myocardial infarction (1.3 vs. 5.1%, P = 0.011) were also lower for E-ZES versus other DES. CONCLUSIONS: Patients with DM implanted with E-ZES have favorable long-term outcomes compared to first-generation DES. Long-term performance of DES should be assessed routinely and may differ from initial performance.
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Vardi et al. (2013) studied Diabetes mellitus and coronary artery disease (n=601). Endeavor Zotarolimus-eluting stent (E-ZES) vs. Other drug-eluting stents (sirolimus-eluting or paclitaxel-eluting) was evaluated on Target vessel failure (TVF) at 5 years (p=0.065). Endeavor zotarolimus-eluting stents resulted in a 5-year target vessel failure rate of 20.2% compared to 26.9% for other drug-eluting stents in patients with diabetes mellitus (P=0.065).