Comparison of Plaque Sealing With Paclitaxel-Eluting Stents Versus Medical Therapy for the Treatment of Moderate Nonsignificant Saphenous Vein Graft Lesions

Abstract

Background-The presence of moderate saphenous vein graft (SVG) lesions is a major predictor of cardiac events late after coronary artery bypass grafting. We determined the effects of sealing moderate nonsignificant SVG lesions with paclitaxel-eluting stents (PES) on the prevention of SVG atherosclerosis progression. Methods and Results-Patients with at least 1 moderate SVG lesion (30% to 60% diameter stenosis) were randomized either to stenting the moderate SVG lesion with a PES (nϭ30, PES group) or to medical treatment alone (nϭ27, medical treatment group). Patients had an angiographic and intravascular ultrasound evaluation of the SVG at baseline and at 12-month follow-up. The primary end points were (1) the ultrasound SVG minimal lumen area at follow-up and (2) the changes in ultrasound atheroma volume in an angiographically nondiseased SVG segment. Mean time from coronary artery bypass grafting was 12Ϯ6 years, and mean low-density lipoprotein cholesterol level was 73Ϯ31 mg/dL. A total of 70 moderate SVG lesions (39Ϯ7% diameter stenosis) were evaluated. Significant disease progression occurred in the medical treatment group at the level of the moderate SVG lesion (decrease in minimal lumen area from 6.3Ϯ3.0 to 5.6Ϯ3.1 mm 2 ; PϽ0.001), leading to a severe flow-limiting lesion or SVG occlusion in 22% of the patients compared with none in the PES group (Pϭ0.014). In the PES group, mean minimal lumen area increased (PϽ0.001) from 6.1Ϯ2.2 to 8.6Ϯ2.9 mm 2 at follow-up (Pϭ0.001 compared with the medical treatment group at 12 months). There were no cases of restenosis or stent thrombosis. No significant atherosclerosis progression occurred at the nonstented SVG segments. At 12-month follow-up, the cumulative incidence of major adverse cardiac events related to the target SVG was 19% in the medical treatment group versus 3% in the PES group (Pϭ0.091). Conclusions-Stenting moderate nonsignificant lesions in old SVGs with PES was associated with a lower rate of SVG disease progression and a trend toward a lower incidence of major adverse cardiac events at 1-year follow-up compared with medical treatment alone, despite very low low-density lipoprotein cholesterol values. This pilot study supports further investigation into the role of plaque sealing in SVGs. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT002289835.

Long‐Term Follow‐Up of Coronary Venous Bypass Graft Lesions Treated with a New Generation Drug‐Eluting Stent with Bioabsorbable Polymer

“…Therefore, the higher cardiac death and MI rate in the SVG group was neither driven by ST nor accelerated by restenosis rate, thus implying an appropriate safety and efficacy profile for the Nobori stent even in this complex lesion and patient subset. Consequently, this stent may also be appropriate for plaque sealing of SVG lesions, a procedure which is suggested to prevent future adverse events in patients with moderate, hemodynamically nonsignificant bypass lesions compared to medical therapy alone …”

Drug-Eluting versus Bare-Metal Stent for Treatment of Saphenous Vein Grafts: A Meta-Analysis

“…SVG interventions currently account for about 5–10% of total percutaneous coronary interventions (PCI) annually in the United States [1], [2]. This number is likely to increase in the near future since there is emerging evidence that even lower degree stenoses (30–60%) may profit from stent implantations;[3] very much in contrast to stenoses in native vessels where increasing data suggest that only hemodynamically significant higher degree stenoses should be treated [4]. The natural and post-interventional biological behaviour of saphenous vein grafts clearly differs from native vessels, they are at higher risk for restenosis [5].…”

Saphenous vein graft disease: causes, prevention, and contemporary treatment strategies

“…The moderate VEin graft LEsion stenting with the Taxus stent and Intravascular ultrasound (VELE-TI) çalışmasında [33] yalnızca tıpsal tedavi edilenlerle karşılaştırıldığında İSS ile tedavi edilen orta derecede darlığı olan SVG lezyonlarında daha iyi lümen alanı sağlanmış ve 1 ve 3 yıllık MACE sıklığı daha düşük bulunmuştur.…”