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(Circulation. 2005;111:2326-2329.)
© 2005 American Heart Association, Inc.
Interventional Cardiology |
From Institute Dante Pazzanese of Cardiology (J.E.S., A.A., F.F., A.C.S., L.F.T., L.A.M., A.G.M.R.S.), São Paulo, Brazil; University of Florida, Shands-Jacksonville (M.A.C.), Jacksonville, Fla; Cordis, a Johnson & Johnson Company (R.F., J.J.), Warren, NJ; Brigham and Womens Hospital (J.J.P.), Boston, Mass; and Thoraxcenter, Dijkzigt University Hospital (P.W.S.), Rotterdam, the Netherlands.
Correspondence to Professor J. Eduardo Sousa, MD, PhD, Institute Dante Pazzanese of Cardiology, Avenida Dr Dante Pazzanese, 500Ibirapuera, 04012180, São Paulo, Brazil.
Received June 15, 2004; de novo received January 17, 2005; accepted January 21, 2005.
Background Despite the proven superiority of sirolimus-eluting stents (SESs) 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 total population (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 sirolimus-eluting 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).
Key Words: angiography restenosis stents
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