As compared with a standard coronary stent, a sirolimus-eluting stent shows considerable promise for the prevention of neointimal proliferation, restenosis, and associated clinical events.

As measured one year after the procedure, coronary stenting for multivessel disease is less expensive than bypass surgery and offers the same degree of protection against death, stroke, and myocardial infarction. However, stenting is associated with a greater need for repeated revascularization.

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], nϭ15, and fast release [FR], nϭ15) 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 (0.28Ϯ0.4 mm) than in the SR group (Ϫ0. 09Ϯ0.23 mm, Pϭ0.007). 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 Յ35% diameter stenosis. Angiographic lumen loss at the stent edges was also minimal (in-lesion late loss was 0.33Ϯ0.42 mm [FR] and 0.13Ϯ0.29 mm [SR]). In-stent neointimal hyperplasia volume, as detected by IVUS, remained minimal after 2 years (FRϭ 9.90Ϯ9 mm 3 and SRϭ10.35Ϯ9.3 mm 3 ). 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 Ⅲ angiography Ⅲ ultrasonics Ⅲ restenosis A new generation of drug-eluting coronary stents designed to limit restenosis has been developed recently. The clinical success of these novel technologies will depend on a complex interaction between stent, coating matrix, drug, and the vessel wall. Stents coated with sirolimus, a natural macrocyclic lactone with immunosuppressive and antiinflammatory action, represented the first successful attempt to abolish restenosis in human coronary arteries. 1-3 A virtual absence of neointimal proliferation was observed 1 year after implantation of sirolimus-eluting Bx Velocity stents in a pilot study. 2 Subsequently, the RAVEL (a RAndomized comparison of a sirolimus-eluting Bx VELocity stent with a standard stent for coronary revascularization) investigators reported an absence of both angiographic restenosis at 6 months and target-lesion revascularization 1 year after the implantation of sirolimus-eluting stents in a multicenter randomized trial. 3 Although encouraging, potential late side effects of these drug-eluting coronary stents may pose limitations. Lessons from intracoronary brachytherapy include the development of late thrombosis and neointimal proliferation that may occur beyond the first year after treatment. 4 -6 In the present study, we evaluated the clinical...

More information is needed to clarify whether stenting is superior to balloon angioplasty (BA) for unoperated coarctation of the aorta (CoA). From September 1997, 21 consecutive adolescents and adults (24 +/- 11 years) with discrete CoA underwent stenting (G1). The results were compared to those achieved by BA performed in historical group of 15 patients (18 +/- 10 years; P = 0.103; G2). After the procedure, systolic gradient reduction was higher (99% +/- 2% vs. 87% +/- 17%; P = 0.015), residual gradients lower (0.4 +/- 1.4 vs. 5.9 +/- 7.9 mm Hg; P = 0.019), gain at the CoA site higher (333% +/- 172% vs. 190% +/- 104%; P = 0.007), and CoA diameter larger (16.9 +/- 2.9 vs. 12.9 +/- 3.2 mm; P < 0.001) in G1. Aortic wall abnormalities were found in eight patients in G2 (53%) and in one in G1 (7%; P < 0.001). There was no major complication. Repeat catheterization (n = 33) and/or MRI (n = 2) was performed at a median follow-up of 1.0 year for G1 and 1.5 for G2 (P = 0.005). Gradient reduction persisted in both groups, although higher late gradients were seen in G2 (median of 0 mm Hg for G1 vs. 3 for G2; P = 0.014). CoA diameter showed no late loss in G1 and a late gain in G2 with a trend to being larger in G1 (16.7 +/- 2.9 vs. 14.6 +/- 3.9 mm; P = 0.075). Two patients required late stenting due to aneurysm formation or stent fracture in G1. Aortic wall abnormalities did not progress and one patient required redilation in G2. Blood pressure was similar in both groups at follow-up (126 +/- 12/81 +/- 11 for G1 vs. 120 +/- 15/80 +/- 10 mm Hg for G2; P = 0.149 and 0.975, respectively). Although satisfactory and similar clinical outcomes were observed with both techniques, stenting was a better means to relieve the stenosis and minimize the risk of developing immediate aortic wall abnormalities.

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