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LIPS2: Balloon angioplasty with or without laser assistance yields similar long-term outcomes for below-knee PAD
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Compared with balloon angioplasty alone, patients with popliteal and infrapopliteal peripheral artery disease who underwent excimer laser-assisted balloon angioplasty had higher angiographic success, but similar rates of ipsilateral major amputation, repeat revascularization and long-term death, according to results of the LIPS2 study.
Researchers studied data on 726 patients who underwent laser-assisted balloon angioplasty (LABA; n = 395) or balloon angioplasty alone (BA; n = 331) for critical limb ischemia due to popliteal/infrapopliteal PAD. All procedures were performed at a single tertiary hospital from 2007 to 2012. Use of LABA or BA was at the discretion of the operator. The most common laser-assisted devices used were the Turbo Elite 0.9 to 2.3 mm and Turbo Tandem 2.0 (Spectranetics). BA was performed with a variety of balloon catheters, according to the study background.
Previous results of the LIPS study demonstrated safety and greater procedural success with LABA compared with BA in this population. LIPS2 was designed to evaluate long-term clinical outcomes beyond the index procedure. The primary endpoint was survival without the need for ipsilateral major limb amputation. Mean follow-up in LIPS2 was 36 months.
Both groups had similar baseline characteristics, but patients in the LABA group had more TASC-D lesions (92.4% vs. 66.5%) chronic total occlusions (86.4% vs. 49.5%).
Angiographic success was significantly higher with LABA (97.7% vs. 89.2%; P < .0001).
The rate of ipsilateral major limb amputation was 4.1% in the LABA group vs. 5.1% in the BA group (P = .48). The rate of repeat revascularization was also similar between the LABA and BA groups (25.1% vs. 23.3%; P = .47). More patients in the LABA group died during follow-up (35.2% vs. 26.3%; P = .01). According to the researchers, the higher rate of death may reflect the higher comorbid conditions in the LABA group.
“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,” the researchers wrote. “Future randomized clinical trials should evaluate the efficacy of LABA compared with BA in improving limb salvage and reducing repeat revascularization in these high-risk PAD patients.” – by Jennifer Byrne
Disclosure: The researchers report no relevant financial disclosures.
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