Circulation. 2003;107:381-383
Published online before print January 13, 2003, doi: 10.1161/01.CIR.0000051720.59095.6D
Published online before print January 13, 2003, doi: 10.1161/01.CIR.0000051720.59095.6D
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(Circulation. 2003;107:381.)
© 2003 American Heart Association, Inc.
Brief Rapid Communications |
Two-Year Angiographic and Intravascular Ultrasound Follow-Up After Implantation of Sirolimus-Eluting Stents in Human Coronary Arteries
From the Institute Dante Pazzanese of Cardiology (J.E.S., A.G.M.R.S., A.C.A., A.C.S., A.S.A., F.F., L.A.M.), São Paulo, Brazil; University of Florida-Shands (M.A.C.), Jacksonville, Fla; Thoraxcenter (P.W.S.), Dijkzigt University Hospital, Rotterdam, the Netherlands; Cordis (R.F., J.J.), a Johnson & Johnson Company, Warren, NJ; and Brigham and Women’s Hospital (J.J.P.), Boston, Mass.
Correspondence to Prof J. Eduardo Sousa, MD, PhD, Director of the Institute Dante Pazzanese of Cardiology, Av. Dr Dante Pazzanese, 500, Ibirapuera, 04012180, São Paulo, Brazil.
Background— The safety and efficacy of sirolimus-eluting stenting have been demonstrated, but the outcome of patients treated with this novel technology beyond the first year remains unknown. We sought to evaluate the angiographic, intravascular ultrasound (IVUS), and clinical outcomes of patients treated with sirolimus-eluting stents 2 years after implantation.
Methods and Results— This study included 30 patients treated with sirolimus-eluting Bx Velocity stenting (slow release [SR], n=15, and fast release [FR], n=15) in São Paulo, Brazil. Twenty-eight patients underwent 2-year angiographic and IVUS follow-up. No deaths occurred during the study period. In-stent late loss was slightly greater in the FR group (0.28±0.4 mm) than in the SR group (-0.09±0.23 mm, P=0.007). No patient had in-stent restenosis. At 2-year follow-up, only 1 patient (FR group) had a 52% diameter stenosis within the lesion segment, which required repeat revascularization. The target-vessel revascularization rate for the entire cohort was 10% (3/30) at 2 years. All other patients had 
35% diameter stenosis. Angiographic lumen loss at the stent edges was also minimal (in-lesion late loss was 0.33±0.42 mm [FR] and 0.13±0.29 mm [SR]). In-stent neointimal hyperplasia volume, as detected by IVUS, remained minimal after 2 years (FR= 9.90±9 mm3 and SR=10.35±9.3 mm3).
Conclusions— This study demonstrates the safety and efficacy of sirolimus-eluting Bx Velocity stents 2 years after implantation in humans. In-stent lumen dimensions remained essentially unchanged at 2-year follow-up in the 2 groups, although angiographic lumen loss was slightly higher in the FR group. Restenosis "catch-up" was not found in our patient population.
Key Words: stents • angiography • ultrasonics • restenosis
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