Mid-term results of subintimal angioplasty for critical limb ischemia 5-year outcomes

OBJECTIVE: Compare effectiveness of subintimal angioplasty versus bypass surgery for TASC C and D femoropopliteal lesions. METHODS: Of 1076 patients referred with pulmonary vascular disease from 2002 to 2007, 206 SIAs in 190 patients and 128 bypass grafts in 119 patients were studied. All patients had rest pain and/or tissue loss. Primary endpoints were amputation-free survival AFS and sustained clinical improvement. Secondary endpoints were major adverse events MAE, binary restenosis rate, freedom from target lesion revascularization TLR, and a special quality-adjusted life year QALY endpoint QTWiST that incorporated both length and quality of life. RESULTS: At 5 years, clinical improvement was sustained in 82.8% of the SIA group versus 68.2% of the BS patients p ≤ 0.106. Five-year all-cause survival was similar for SIA 78.6% and BS 80.1%; p ≤ 0.734, as was AFS SIA 72.9% versus BS 71.2%; p ≤ 0.976. Hyperfibrinogenemia p ≤ 0.009 and C-reactive protein p ≤ 0.019 had negative effects on AFS. Five-year freedom from binary restenosis was 72.8% for SIA versus 65.3% for BS p ≤ 0.700. While the 5-year freedom from TLR rates SIA 85.9% versus BS 72.1%, p ≤ 0.262 was not statistically significant, the risk of MAE p < 0.002 and length of hospital stay p < 0.0001 were significantly reduced. Q-TWiST significantly improved p < 0.001 and cost-per-QALY was reduced with SIA. The 5-year risk of reintervention p > 0.05 and mean number of procedures p ≤ 0.078 were similar. CONCLUSION: Five-year freedom from MAE was enhanced by 20% in the SIA group, with substantial cost reduction and better Q-TWiST. SIA is a minimally invasive technique that expands amputation-free and symptom-free survival.