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.