Outcome of covered stents for severe aorto-iliac occlusive disease (AIOD) in patients with chronic limb-threatening ischaemia

Objective: To determine early and medium-term outcomes in patients with chronic limb-threatening ischaemia (CLTI) due to Transatlantic Inter-Society Consensus (TASC) C/D aorto-iliac occlusive disease (AIOD) treated with covered stents (CS). Design: A retrospective single-centre case series. Methods: Analysis of consecutive patients treated with CS for TASC C/D AIOD and CLTI between 2006 and 2017. The primary outcome was amputation-free survival (AFS). Secondary outcomes were survival, major limb amputation (MLA), patency, complications and freedom from re-intervention. Results: Eighty-eight patients (61 men; 7 TASC C; 81 TASC D) were treated for CLTI (54 rest pain; 34 tissue loss). One hundred and twenty limbs were revascularised with 99.8% technical success. The 30-day mortality was 4.5%. Postoperative complications occurred in 30 (34%) patients. Seven (8%) patients underwent MLA. AFS was 76.0% (95% CI 65.6 to 83.6) and 66.6% (95% CI 55.2 to 75.7), primary patency 83.9% (95% CI 71.0 to 91.4) and 70.5% (95% CI 52.8 to 82.6), and freedom from re-intervention 92.4% (95% CI 83.8 to 96.5) and 83.2% (95% CI 71.2 to 90.5) at 1 and 3 years, respectively. MLA was not associated with target lesion revascularisation (OR 4.35, 95% CI 0.89 to 21.18, p=0.073) or CS patency (OR 0.33, 95% CI 0.03 to 3.43, p=0.360). Age (HR 1.10, 95% CI 1.05 to 1.14, p<0.001), creatinine (HR 1.01, 95% CI 1.00 to 1.02, p<0.001), urgency (emergency: HR 3.10, 95% CI 0.97 to 9.98, p=0.057; urgent: HR 3.71, 95% CI 1.25 to 10.97, p=0.018), tissue loss (HR 5.34, 95% CI 2.36 to 12.07, p<0.001), postoperative respiratory complications (HR 5.37, 95% CI 1.44 to 20.01, p=0.012), congestive cardiac failure (HR 0.23, 95% CI 0.05 to 0.99, p=0.049) and implantation of bilateral CS (HR 0.38, 95% CI 0.15 to 0.94, p=0.036) were independently associated with AFS. Conclusions: Covered stents in patients with TASC C/D AIOD presenting with CLTI are associated with acceptable early and medium-term outcomes in these multi-morbid patients with reduced life expectancy. CS patency was not associated with MLA or AFS and may therefore represent a poor surrogate endpoint for assessing the efficacy of endovascular intervention for AIOD.