PP33. Contemporary Management of Critical Lower Limb Ischaemia (CLI) with TASC C and D femoro-popliteal lesions. 5-year Comparative Trial of Subintimal Angioplasty (SIA) or Bypass surgery (BS)

CLI patients face a dismal prognosis with one year mortality up to 30% Infra-popliteal BS is a demanding procedure with poor long-term survival. A minimally invasive therapy with equivalent results would be more appropriate. SIA is easy to execute; requires short hospital admission and lower costs. Primary endpoints are sustained clinical improvement (SCI) and amputation free survival (AFS). Secondary endpoints are BinaryRrestenosis (BR) rate, Freedom from target lesion revascularisation (TLR), risk of Major Adverse Clinical Events (MACE), Quality Time Without Symptoms of disease or Toxicity of Treatment (Q-TWiST) and cost-effectiveness. From 2002-2007, 1076 patients were referred with PVD. 334 primary procedures (SIA=206, BS=128) in 309 patients (NSIA=190, NBS=119) with TASC C and D lesions were prospectively compared Mean age (SIA 73+/−13yrs vs. BS 70+/−14yrs, p=0.127), and co-morbidity severity scores (P>0.05) were similar between groups. 5-year SCI was 82.8% for SIA and 68.2% for BS (p=0.106 h=0.65, 95%CI=[0.38-1.11]). 5-year all-cause survival was similar for SIA (78.6%) and BS (80.1%), p=0.7343. 5-year AFS was comparable (SIA 72.9% vs. BS 71.2%, p=0.9765). Hyper-fibrinogenaemia and elevated CRP had negative effect on AFS (p=0.009, RR2.4, 95%CI=1.2-4.6 and p=0.019, RR1.02, 95%CI=1.01-1.04, respectively). 5-year freedom from BR were (SIA72.8% vs.BS65.3%, p=0.7001). Hyper-homocysteine had significant adverse effect on risk of BR for SIA (p=0.008) and BS (p=0.019) Results were not effected by stent use (35%, p=0.780) or mean number of stents (RR1.3, p=0.330). 5-year freedom from TLR was (SIA 85.9% vs. BS 72.1%, p=0.262). Risk of MAE (P<0.002) and length of hospital stay (LOSSIA14+/−16days vs. LOSBS24+/−23days, P<0.0001) were significantly reduced with SIA. Q-TWiST significantly improved (P<0.001) and cost per QALY (SIA: €5,663 vs BS: €9,172, P<0.05) reduced with SIA. 5-year risk of re-intervention (p>0.05) and mean number of procedures (SIA 1.19 vs. BS 1.10, p=0.078) were similar. BS is an independent risk factor for MACE. 5-year Freedom from MACE in SIA is enhanced by 20%. SIA enhances patient-specific Q-TWiST with substantial cost reduction, is minimally invasive and allows for a high patient turnover without compromising limb salvage. SIA has caused a Paradigm Shift in CLI Management.