Two-Year Clinical Follow-Up in 200 Patients Receiving Sirolimus-Eluting Stents in Lesions at a High Risk of Restenosis

Introduction and objectives. Sirolimus-eluting stents (SESs) have been shown to reduce the rate of restenosis significantly in all types of coronary lesion. However, reports of late cases of thrombosis and restenosis have raised questions about long-term outcome in patients treated with these stents. Our aim was to evaluate long-term outcome in patients undergoing SES placement in lesions at a high risk of restenosis. Patients and method. Since SESs became available, we have used them to treat lesions at risk of restenosis. We studied clinical outcomes in consecutive patients treated with SESs who were followed up for more than 2 years. Results. The study included 200 patients (age 60[11] years, 22% diabetics) who were treated between June 2002 and April 2003 for 309 lesions: 16% were total occlusions, 16.8% in-stent restenoses, 28% diffuse lesions, and 30% small-vessel lesions. The total stent length per patient was 29 (16) mm and the mean diameter was 2.78 (0.27) mm. In a mean clinical follow-up period of 29 (3.2) months (range 24-34 months), there were four deaths, two (1%) of which were cardiac, four (2%) non-fatal infarctions, four (2%) in-stent thromboses (all occurred late, at 3, 7, 26 and 31 months), four (2%) cases requiring target lesion revascularization (at 3, 5, 14 and 15 months), and six (3%) requiring revascularization of a new lesion. Conclusions. Long-term follow-up of patients undergoing SES placement in lesions at a high risk of restenosis revealed a very low restenosis rate. However, the incidence of late thrombosis appeared to be elevated and warrants further evaluation in larger studies.