Three-year outcomes from a large prospective, observational multicenter study found that stratified endovascular interventions were highly successful in preventing major amputations among a wide range of patients with varying degrees of peripheral arterial disease (PAD).
Assessing a total of 1,189 patients from 51 sites, researchers from the LIBERTY 360 study compared the use of endovascular treatment among patients in Rutherford categories 2-3 (marked by moderate or severe claudication), those in Rutherford categories 4-5 (marked by rest pain or ischemic ulceration of the toes), and patients with Rutherford category 6 (defined by severe ischemic ulcers or frank gangrene).1,2 Three years after endovascular treatment, no major amputation was reported in 98.5 percent of patients in Rutherford categories 2 or 3, 94 percent of those in Rutherford categories 4 and 5, and 79.9 percent of patients in Rutherford category 6.1
“The low rates of major amputation across patient groups emphasize the advancements that we have made in preventing major amputation, and the impact of focused vascular care in conjunction with wound care,” explains Ehrin J. Armstrong, MD, MSc, a co-author of the study. “Typically, patients with Rutherford category 6 critical limb ischemia are thought to be at extremely high risk for major amputation, and historically many of these patients have been treated with amputation without even attempting revascularization. To me, these results emphasize that, with an established medical team, almost every patient has an opportunity to avoid a below-knee major amputation.”
The study authors also found that follow-up target vessel revascularization (TVR) or target lesion revascularization (TLR) were unnecessary in 71.1 percent of patients in Rutherford categories 2-3, 64.2 percent of those in Rutherford categories 4 and 5, and 61.9 percent of patients in Rutherford category 6.1 Noting that this was an observational study. Dr. Armstrong says the point estimates of freedom from TLR and TVR were on par with other modalities and other established performance goals.
“These results suggest that endovascular intervention, at least in the setting of this clinical study, was associated with excellent clinical outcomes and relatively low rates of re-intervention,” maintains Dr. Armstrong, the Medical Director of the Adventist Heart and Vascular Institute, and an interventional cardiologist at Adventist Health St. Helena Hospital in St. Helena, Calif.
Dr. Armstrong points out that all the patients in the study had disease in the distal leg, either the popliteal or infrapopliteal arteries. While he notes that treatment options for this anatomic segment have been limited to balloon angioplasty, Dr. Armstrong says there is opportunity to improve this technique, or potentially combine it with other therapies to “improve both acute and long-term outcomes.”
In the study, the authors noted that therapies such as drug-eluting stents (DES) and drug-coated balloons (DCB) were “not available or were not commonly used” at the time of patient enrollment.1 Dr. Armstrong says emerging developments with these therapies and others may have considerable promise.
“This is an exciting time in endovascular therapy for chronic limb-threatening ischemia (CLTI),” maintains Dr. Armstrong. “A number of new devices are under investigation for improving outcomes in CLTI, including new DES, new approaches to DCB, and techniques for modifying calcium. I am optimistic that these new therapies will further improve outcomes in the endovascular treatment of CLTI, and eventually translate into lower rates of major amputation.”
- Giannopoulos S, Mustapha J, Gray WA, et al. Three-year outcomes from the LIBERTY 360 study of endovascular interventions for peripheral artery disease stratified by Rutherford category. J Endovasc Ther. 2021;28(2):262-274.
- Agency for Healthcare Research and Quality. Treatment strategies for patients with peripheral artery disease. Available at https://effectivehealthcare.ahrq.gov/products/peripheral-artery-disease-treatment/research-protocol . Published January 31, 2012. Updated January 31, 2013. Accessed May 23, 2021.