Author + information
- Takao Ohki1,
- Kimihiko Kichikawa2,
- Hiroyoshi Yokoi3,
- Masaaki Uematsu4,
- Terutoshi Yamaoka5,
- Takeshi Baba6 and
- Reo Takizawa7
To assess outcomes of stent-grafting of long lesions (≥10 cm) in the superficial femoral artery (SFA) and impact of stent-graft sizing on patency.
This study assessed the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (WL Gore and Associates, Flagstaff, AZ) for treatment of long SFA lesions in Japanese subjects at 15 sites. Inclusion criteria were Rutherford category 2−5, ankle-brachial index (ABI) ≤ 0.9, and lesions length ≥ 10cm. Reference vessel diameters between 4.0 to 7.5 mm were allowed and were accurately measured as opposed to estimated. Sizing was based on the IFU (5 to 20% oversizing). The device was landed at least 1cm into healthy tissue. Dual antiplatelet therapy was required for 6 months. Patients were followed rigorously with 1, 3, 6 and 12 months duplex ultrasound.
103 patients were enrolled (age 74.2±7.0 years; 17.5% female). Average lesion length was 21.8±5.8 cm and 65.7% were totally occluded. Appropriateness of sizing was evaluated by the core lab and of those that could be reviewed, 74% were within IFU oversize range, while only 26% were outside this range. The Kaplan-Meier (KM) estimated primary patency (PP; defined as flow through the device with no TLR) rate was 92.1% (95% CI: 84.8−96.0%), primary assisted patency (PAP) rate was 94.1% (95% CI: 87.3−97.3%), and fTLR was 93.1% (95% CI: 86.1−96.7%) at 12 months. In a subgroup of patients with lesions ≤ 20cm, the primary patency was 100% (n=43). There was no acute limb ischemia (ALI) observed during follow-up, and no fractures were detected.The previously published VIPER trial with this device in US patients reported a sub-analysis grouped by sizing. For limbs with devices oversized ≤ 20% at the proximal edge, better results were shown than those oversized >20% (PP: 88% vs 70%, p<0.05). When the same definition of PP used in the VIPER trial is used in the current study (PSVR ≤ 2.5 with no TLR), the PP results are also 88%. Because of the rigorous sizing methods used, this study supports the earlier results.
Endovascular stent-grafting of long, complicated SFA lesions leads to a high 92.1% PP rate and 94.1% PAP rate without incidence of ALI. For medium length lesions ≤ 20cm, PP was retained for all patients through 12 months. This study supports earlier study sub-analysis results and importance for proper sizing.
ENDOVASCULAR: Peripheral Vascular Disease and Intervention