on January 13, 2003
Circulation. 2003
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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Submitted on September 25, 2002
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.
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 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.
Revised on November 21, 2002
Accepted on November 25, 2002
Two-Year Angiographic and Intravascular Ultrasound Follow-Up After Implantation of Sirolimus-Eluting Stents in Human Coronary Arteries
J. Eduardo Sousa MD, PhD*,
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).
Key words: stents • angiography • ultrasonics • restenosis
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