Department of Surgery, The Jikei University School of Medicine, Tokyo, Japan.
Department of Radiology, Nara Medical University Hospital, Nara, Japan.
J Vasc Surg. 2021 Dec;74(6):1958-1967.e2. doi: 10.1016/j.jvs.2021.05.056. Epub 2021 Jun 26.
We assessed the long-term safety and efficacy of endovascular stent grafting to treat long, complex lesions in the superficial femoral artery (SFA).
The present prospective, multicenter study at 15 Japanese hospitals assessed heparin-bonded stent grafts used to treat long SFA lesions in patients with symptomatic peripheral arterial disease. The inclusion criteria were Rutherford category 2 to 5 symptoms (grade 5 without active infection), an ankle brachial index of ≤0.9, and SFA lesions ≥10 cm long with ≥50% stenosis. The key efficacy and safety outcomes were primary-assisted patency and adverse events through 24 months, respectively. The secondary outcomes included primary patency, secondary patency, freedom from target lesion revascularization (fTLR), and Vascular Quality of Life questionnaire score.
Of the 103 patients (mean age, 74.2 ± 7.0 years; 82.5% male), 100 (97.1%) had intermittent claudication. The average lesion length was 21.8 ± 5.8 cm; 87 lesions (84.5%) were TASC (Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease) C or D (65.7% chronic total occlusions). Of the 103 patients, 92 and 61 were evaluable through 24 and 60 months, respectively. At 24 months, the Kaplan-Meier-estimated primary-assisted patency, primary patency, and secondary patency rate was 85.7% (95% confidence interval [CI], 76.3%-91.5%), 78.8% (95% CI, 68.8%-85.9%), and 92.0% (95% CI, 82.4%-96.5%), respectively. The mean ankle brachial index was 0.64 ± 0.12 at baseline and 0.94 ± 0.19 at 24 months (P < .0001). At 24 and 60 months, the fTLR was 87.2% (95% CI, 78.9%-92.3%) and 79.1% (95% CI, 67.9%-86.8%), respectively. No device- or procedure-related life- or limb-threatening critical events or acute limb ischemia cases were observed through 5 years. No stent fractures were detected on the annually scheduled follow-up radiographs. The vascular quality of life questionnaire and walking impairment questionnaire scores were significantly increased at 1 through 24 months compared with the baseline scores (P < .0001 for both). One patient had required conversion to open bypass during the 5-year follow-up period.
Stent grafting of long and complex SFA lesions in patients with claudication is safe and effective through long-term follow-up, with 79.1% fTLR and no leg amputation, acute limb ischemia, or stent fractures through 5 years.
评估血管内支架移植物治疗股浅动脉（SFA）长而复杂病变的长期安全性和疗效。
本研究为前瞻性、多中心研究，在日本 15 家医院开展，评估肝素结合支架移植物治疗有症状外周动脉疾病患者的长段 SFA 病变。纳入标准为 Rutherford 分类 2 至 5 级症状（无活动性感染的 5 级）、踝肱指数≤0.9 和 SFA 病变长度≥10cm，狭窄≥50%。主要疗效和安全性终点分别为 24 个月时的一期辅助通畅率和不良事件。次要结局包括一期通畅率、二期通畅率、免于靶病变血运重建（fTLR）率和血管生活质量问卷评分。
103 例患者（平均年龄 74.2±7.0 岁；82.5%为男性）中，100 例（97.1%）有间歇性跛行。平均病变长度为 21.8±5.8cm；87 处病变（84.5%）为 TASC（跨大西洋血管内学会共识文件对周围动脉疾病的管理）C 或 D 型（65.7%为慢性完全闭塞）。103 例患者中，92 例和 61 例分别在 24 个月和 60 个月时可评估。24 个月时，Kaplan-Meier 估计的一期辅助通畅率、一期通畅率和二期通畅率分别为 85.7%（95%CI，76.3%-91.5%）、78.8%（95%CI，68.8%-85.9%）和 92.0%（95%CI，82.4%-96.5%）。基线时平均踝肱指数为 0.64±0.12，24 个月时为 0.94±0.19（P<0.0001）。24 个月和 60 个月时，fTLR 分别为 87.2%（95%CI，78.9%-92.3%）和 79.1%（95%CI，67.9%-86.8%）。5 年内无器械相关或手术相关的危及生命或肢体严重不良事件或急性肢体缺血发生。5 年内每年定期随访的放射影像学检查未发现支架断裂。血管生活质量问卷和行走障碍问卷评分在 1 个月至 24 个月时与基线评分相比显著升高（均 P<0.0001）。1 例患者在 5 年随访期间需要转为开放旁路手术。
通过长期随访，对有跛行症状的患者的长段和复杂 SFA 病变进行支架移植物治疗是安全有效的，5 年内免于 fTLR 率为 79.1%，无截肢、急性肢体缺血或支架断裂。
