Long-term results of the Japanese multicenter Viabahn trial of heparin bonded endovascular stent grafts for long and complex lesions in the superficial femoral artery.
To assess the long-term safety and efficacy of endovascular stent grafting to treat long, complex lesions in the superficial femoral artery (SFA).This prospective, multicenter study at 15 Japanese hospitals assessed heparin bonded stent grafts for treating long SFA lesions in patients with symptomatic peripheral arterial disease. Inclusion criteria were Rutherford category 2-5 symptoms (grade 5 without active infection), ankle-brachial index (ABI) ≤ 0.9, and SFA lesions ≥ 10 cm with ≥ 50% stenosis. The key efficacy and safety outcomes were primary-assisted patency (PAP) and adverse events through 24 months, respectively. Secondary outcomes included primary patency (PP), secondary patency, freedom from target lesion revascularization (fTLR), and VascuQOL scoring.Of 103 subjects (mean age 74.2 ± 7.0 years; 82.5% male), 100 (97.1%) had intermittent claudication. Average lesion length was 21.8 ± 5.8 cm; 87 lesions (84.5%) were TASC C/D classification (65.7% chronic total occlusions). Ninety-two subjects and 61 subjects were evaluable through 24 months and 60 months, respectively. At 24 months, the Kaplan-Meier-estimated PAP rate was 85.7% (95% CI: 76.3‒91.5%), PP rate was 78.8% (95% CI: 68.8‒85.9%), and secondary patency rate was 92.0% (95% CI: 82.4-96.5%). Mean ABI was 0.64 ± 0.12 at baseline and 0.94 ± 0.19 at 24 months (P
Authors: Takao Ohki, Kimihiko Kichikawa, Hiroyoshi Yokoi, Osamu Iida, Terutoshi Yamaoka, Koji Maeda, Yuji Kanaoka