Implantation of paclitaxel-eluting stents in saphenous vein grafts: clinical and angiographic follow-up results from a multicentre study.

Objective: To define the clinical and angiographic follow-up
results after implantation of paclitaxel-eluting stents (PESs) in
stenotic saphenous vein grafts (SVGs). Design: Prospective
multicentre study. Comparison with a control group. Methods: 60
consecutive patients with 65 lesions located in 65 SVGs (mean (SD)
age of vein grafts 11.3 (5.7) years) treated with PES (V-Flex Plus,
2.7 mg/mm2 paclitaxel, Cook) and 60 patients with 60 SVG lesions
treated with bare metal stent (BMS) were included. Lesions had to
be ,20 mm in length and in grafts of 2.75–3.5 mm diameter. The 6
month angiographic follow-up was obtained on 51 lesions (79%) of
the PES group and on 51 lesions (85%) of the BMS group. Results:
Baseline clinical and angiographic characteristics were comparable
between both groups. At angiographic follow-up, three vein grafts
in the PES group and five vein grafts in the BMS group were
occluded. In-stent late lumen loss was lower in PES than in BMS
(0.61 (0.81) vs 1.06 (0.72) mm, respectively; p = 0.021). In-stent
binary restenosis rates were 12% vs 33%, respectively, (p = 0.012).
Linear regression analysis showed BMS to be the only factor with an
effect on late lumen loss (p = 0.011). Target-vessel failure rates
were 18% in the PES group and 41% in the BMS group (p = 0.019),
whereas major adverse cardiac event (MACE) rates at 180 days were
15% and 37%, respectively (p = 0.014). Conclusions: Implantation of
non-polymer-based PES in SVG lesions is associated with a lower
late lumen loss and restenosis rate than those of BMS. There
remains a substantial target-vessel failure rate and MACE rate even
at 6 months owing to graft occlusion or new lesions in the graft.