Four-year angiographic and intravascular ultrasound follow-up of patients treated with sirolimus-eluting stents

ABSTRACT

Background—Despite the proven superiority of sirolimus-eluting stents (SES) compared with bare stents in the first year after implantation, long-term outcomes of patients treated with these novel devices remain unknown. Our goal was to evaluate the clinical, angiographic, and intravascular ultrasound (IVUS) outcomes of patients treated with SESs 4 years after implantation.Methods and Results—The study included 30 patients treated with sirolimus-eluting Bx Velocity stenting (slow release [SR; n 15] and fast release [FR; n 15]). Twenty-six patients underwent 4-year angiographic and IVUS follow-up and had matched assessments at all time points (index and 4-, 12-, 24-, and 48-month follow-up). One death occurred during the study period in a patient with a patent SES. There were no target-vessel revascularizations or thromboses between 2- and 4-year follow-up examinations. There was no stent thrombosis, target-lesion revascularization, death, or myocardial infarction in the SR group up to 4 years. Cumulative event-free survival rate was 87% for the totalpopulation (80% in the FR group and 93% in the SR group). In-stent late loss was slightly greater in the FR group(0.41 0.49 mm) than the SR group (0.09 0.23) after 4 years. One patient in the FR group had a 52% in-stent restenosis lesion. Percent neointimal hyperplasia volume, as detected by IVUS, remained minimal after 4 years (FR 9.1% and SR 5.7%).Conclusions—This study confirms the longevity of the optimal outcomes observed in patients treated with sirolimuseluting Bx Velocity stents 4 years after implantation. In-stent lumen dimensions remained essentially unchanged at 4-year follow-up, particularly in the population treated with the currently available SES (SR formulation).