Laser in infrapopliteal and popliteal stenosis 2 study (LIPS2): Long-term outcomes of laser-assisted balloon angioplasty versus balloon angioplasty for below knee peripheral arterial disease.

BACKGROUND: Laser-assisted balloon angioplasty (LABA) has been shown to be more effective in achieving angiographic success for treatment for below knee peripheral artery disease (PAD) compared with balloon angioplasty alone(BA). However, long-term outcomes of LABA compared with BA for popliteal and infrapopliteal PAD are unknown.

METHODS: We evaluated data on 726 patients undergoing LABA (n = 395) and BA (n = 331) for popliteal and infrapopliteal PAD retrospectively at a single center (2007-2012). Outcomes included long-term ipsilateral major limb amputation, revascularization and mortality (median follow-up = 36 months).

RESULTS: Baseline features were similar in two groups with the exception of more TASC-D lesions (92.4 vs. 66.5%; P < 0.0001) and chronic total occlusions (86.4 vs. 49.5%; P < 0.0001) in LABA group. Angiographic success was higher in LABA compared with BA (97.7 vs. 89.2%; P < 0.0001). Ipsilateral major limb amputation (4.1 vs. 5.1%, P = 0.48) and repeat revascularization (25.1 vs. 23.3%, P = 0.47) were similar in LABA and BA patients despite unfavorable baseline angiographic characteristics in the former. Compared with BA, death was more frequently in LABA group (35.2 and 26.3%, P = 0.01), a reflection of higher comorbid conditions in this group (adjusted HR 1.05, 95% CI 0.79-1.39).

CONCLUSION: Despite worse baseline angiographic characteristics compared with BA, LABA was associated with higher angiographic success and similar ipsilateral major amputation, repeat revascularization, and long-term mortality. Future randomized clinical trial should evaluate the efficacy of LABA compared with BA (particularly drug-eluting) in improving limb salvage and reducing repeat revascularization in these high-risk PAD patients.