Long-term follow up of diabetic patients treated with sirolimus-eluting stents. An angiographic and three-dimensional intravascular ultrasound study.

Background: Sirolimus-eluting stents (SES) have already demonstrated their long-term effectiveness in suppressing neointimal hyperplasia in non-high risk patients. The long-term follow up of diabetic patients treated with SES has not been yet evaluated.

Methods And Results: Quantitative coronary angiography and intravascular ultrasound analysis were performed in 35 diabetic patients treated with a SES at short- (6.0 +/- 1.0 months) and long-term (18.5 +/- 4.9 months) follow up. There were no significant changes in the in-stent minimum lumen diameter (MLD) between short- and long-term follow up (2.69 +/- 0.46 vs. 2.61 +/- 0.44 mm; p = 0.5), as well as in the in-lesion MLD (2.38 +/- 0.54 vs. 2.30 +/- 0.62 mm; p = 0.6). None of the patients reached binary restenosis (diameter stenosis > 50%) at either follow-up periods. Stent obstruction volume by 3-D IVUS was very small at short-term follow up and has remained virtually the same at long-term follow up (3.4% vs. 3.5%; p = 0.8). There were no aneurysm formations, late stent strut malappositions or late stent thromboses.

Conclusion: The present study demonstrates the 18-month efficacy and safety of SES for the treatment of diabetic patients without the so-called late catch-up phenomenon.