Medium-term results from the clinical and angiographic follow-up of patients after angioplasty and implantation of sirolimus-eluting stents.

INTRODUCTION The aim of this study was to evaluate the medium-term clinical and angiographic results, as well as the occurrence and treatment of restenosis, following the implantation of sirolimus-eluting stents (SES) in patients undergoing coronary angioplasty. METHODS All patients who have an SES implanted in our department are entered into a database, with a view to evaluating the use of such stents in everyday clinical practice. This study included patients who consented to repeat angiography 8+/-2.4 months after stent implantation. The study population consisted of 91 patients (63 men, mean age 58+/-8.1 years) with 116 stenoses in all. This represented 17.4% of all patients who had an SES implanted during the study period. All the angiographic examinations were analysed independently using quantitative coronary analysis in order to determine the relationship between clinical and angiographic data and restenosis and late lumen loss. RESULTS The mean vessel diameter was 2.5+/-0.48 mm and the mean lesion length was 12.61+/-1.54 mm. The late lumen loss was 0.04+/-0.49 mm. Restenosis was seen in 10 patients (12 vessels), of whom 4 were diabetics. The restenosis was in-stent in 7 vessels, in-segment in 5, and was localised (length of restenosis <10 mm) in all patients. After repeat angioplasty and SES implantation all the patients with restenosis remained free of symptoms 8+/-1.5 months later. Diabetes mellitus was the only factor to be correlated with restenosis. CONCLUSIONS Restenosis following implantation of SES is mainly localised and occurs with about the same frequency within and outside the stent. The incidence of major cardiac events and restenosis following SES implantation is low. However, their long term efficacy in everyday clinical practice must be proved in large randomised studies in order to confirm the results presented here.