Five-year Irish trial of CLI patients with TASC II type C/D lesions undergoing subintimal angioplasty or bypass surgery based on plaque echolucency.

Purpose: To report a 5-year observational parallel group study comparing the effectiveness of subintimal angioplasty (SIA) to bypass grafting (BG) for treatment of TASC II type C/D lesions in the lower limb arteries of patients with critical limb ischemia (CLI).

Methods: Of 1076 patients referred with PVD from 2002 to 2007, 206 SIAs in 190 patients (104 women; mean age 73+/-13 years) and 128 bypass grafts in 119 patients (77 men; mean age 70+/-14 years) were enrolled in the study. All patients had Rutherford classification 4-6 ischemia manifested as rest pain and/or tissue loss. Primary endpoints were (1) survival free from amputation and (2) sustained clinical improvement [+2 Rutherford category and/or ABI increase >0.15 without target lesion revascularization (TLR)]. Secondary endpoints were major adverse events (MAE), the binary restenosis rate, freedom from TLR, and a special quality-adjusted life year (QALY) endpoint (Q-TWiST) that incorporated both length and quality of life to evaluate treatments. A cost analysis was also performed.

Results: At 5 years, clinical improvement was sustained in 82.8% of the SIA group versus 68.2% of the BG patients (p = 0.106). Five-year all-cause survival was similar for SIA (78.6%) and BG (80.1%; p = 0.734), as was amputation-free survival (SIA 72.9% versus BG 71.2%; p = 0.976). Hyperfibrinogenemia (p = 0.009) and C-reactive protein (p = 0.019) had negative effects on survival without amputation. Five-year freedom from binary restenosis rates were 72.8% for SIA versus 65.3% for BG (p = 0.700). While the 5-year freedom from TLR rates (SIA 85.9% versus BS 72.1%, p = 0.262) were not statistically significant, the risk of MAE (p<0.002) and length of hospital stay (p<0.0001) were significantly reduced in the SIA group. Q-TWiST significantly improved (p<0.001) and cost-per-QALY (SIA euro5663 versus BG euro9172, p<0.002) was reduced with SIA. The 5-year risk of re-intervention (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. SIA is poised to bring about a paradigm shift in the management of CLI.