BACKGROUND: The Stent Comparative Restenosis (SCORES) Saphenous Vein Graft (SVG) Registry was a multicenter, prospective registry designed to evaluate the safety and efficacy of a self-expanding, nickel-titanium (nitinol) stent for de novo SVG lesions. METHODS: In all, 159 patients with de novo vein graft lesions > or =2.75 and < or =4.25 mm in diameter and <30 mm in length underwent stenting with the Radius self-expanding stent. The primary end point was target vessel failure (TVF) at 9 months, which was defined as a composite of procedural failure, death, myocardial infarction, or target vessel revascularization. RESULTS: Procedural success was achieved in 96.8% of patients, and the 30-day incidence of major adverse cardiac events was 2.5%. The binary rate of restenosis at 6 months was 28.6%. By 9 months, the rate of TVF was 24.5%, and the rate of major adverse cardiac events was 23.1%. The 9-month Kaplan-Meier survival rates for freedom from TVF and target lesion revascularization were 76.0% and 87.9%, respectively. No clinical or angiographic characteristic was predictive of restenosis. CONCLUSIONS: In de novo atherosclerotic SVG disease, the use of a self-expanding, nitinol stent was associated with high initial procedural success and favorable early and intermediate outcomes. Because few studies have examined the influence of stent composition and design in SVG disease, these findings not only show the safety and efficacy of this self-expanding stent in de novo SVG disease, but also merit further comparison with balloon-expandable stents.
BACKGROUND: The Stent Comparative Restenosis (SCORES) Saphenous Vein Graft (SVG) Registry was a multicenter, prospective registry designed to evaluate the safety and efficacy of a self-expanding, nickel-titanium (nitinol) stent for de novo SVG lesions. METHODS: In all, 159 patients with de novo vein graft lesions > or =2.75 and < or =4.25 mm in diameter and <30 mm in length underwent stenting with the Radius self-expanding stent. The primary end point was target vessel failure (TVF) at 9 months, which was defined as a composite of procedural failure, death, myocardial infarction, or target vessel revascularization. RESULTS: Procedural success was achieved in 96.8% of patients, and the 30-day incidence of major adverse cardiac events was 2.5%. The binary rate of restenosis at 6 months was 28.6%. By 9 months, the rate of TVF was 24.5%, and the rate of major adverse cardiac events was 23.1%. The 9-month Kaplan-Meier survival rates for freedom from TVF and target lesion revascularization were 76.0% and 87.9%, respectively. No clinical or angiographic characteristic was predictive of restenosis. CONCLUSIONS: In de novo atherosclerotic SVG disease, the use of a self-expanding, nitinol stent was associated with high initial procedural success and favorable early and intermediate outcomes. Because few studies have examined the influence of stent composition and design in SVG disease, these findings not only show the safety and efficacy of this self-expanding stent in de novo SVG disease, but also merit further comparison with balloon-expandable stents.