Safety and efficacy of everolimus-eluting stents for bare-metal in-stent restenosis.

OBJECTIVE

The aim of this study was to compare the safety and efficacy of the everolimus-eluting stents (EES) with the paclitaxel-eluting stent (PES) and sirolimus-eluting stent (SES) for the treatment of bare-metal in-stent restenosis.

BACKGROUND

The optimal treatment for bare-metal in-stent restenosis remains controversial.

METHODS

The study cohort comprised 322 consecutive patients (543 lesions) who presented with bare-metal in-stent restenosis to our institution and underwent coronary artery stent implantation with EES (114 patients; 181 lesions), PES (65 patients; 116 lesions) and SES (143 patients; 246 lesions). The analyzed clinical parameters were the 1-year rates of death, Q-wave myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), definite stent thrombosis (ST) and major adverse cardiac events (MACE) defined as the composite of death, MI, or TLR at 1-year.

RESULTS

The three groups were well matched for the conventional risk factors except for age and chronic kidney disease. The 1-year analyzed clinical parameters were similar in the three groups: death (EES=3.5%, PES=4.6%, SES=4.2%; p=0.94), MI (EES=3.5%, PES=6.3%, SES=2.1%; p=0.31), TLR (EES=9.8%, PES=9.5%, SES=5.7%; p=0.42), TVR (EES=14.3%, PES=11.1%, SES=11.3%; p=0.74), definite ST (EES=0.9%, PES=3.1%, SES=3.5%; p=0.38) and MACE (EES=14.0%, PES=15.4%, SES=10.5%; p=0.54). Male gender (hazard ratio=0.47; 95% confidence interval=0.25-0.88) and number of treated lesions (hazard ratio=1.47; 95% confidence interval=1.06-2.05) were found to be independent predictors of MACE.

CONCLUSION

The results of the present study indicate that EES may provide similar safety and efficacy as first generation DES for the treatment of patients presenting with bare-metal in-stent restenosis.