Recommendations for Endovascular Revascularization for Claudication
COR	LOE	Recommendations
I	A	Endovascular procedures are effective as a revascularization option for patients with lifestyle-limiting claudication and hemodynamically significant aortoiliac occlusive disease.12,37,38,232,240,242,246
See Online Data Supplements 35 and 36.		Two separate systematic analyses that included RCTs that enrolled patients with aortoiliac disease reported that endovascular treatment of claudication improved walking parameters and QoL.11,12,233 The CLEVER trial enrolled only patients with aortoiliac disease and compared endovascular therapy to supervised exercise therapy and to medications alone.37,38 At 6-month follow-up, both the endovascular therapy and supervised exercise groups had improved peak walking time compared with medication alone, with a greater improvement in the supervised exercise group.37 By 18 months, there was no significant difference between the endovascular therapy and supervised exercise groups, with a sustained benefit versus medication alone.38 Other RCTs that included patients with aortoiliac disease have shown QoL, as assessed by questionnaires and time to onset of claudication, may be superior with endovascular treatment in combination with a medical and an exercise treatment plan, compared versus medical treatment alone.232,233,246 The ERASE trial randomized patients with claudication and aortoiliac (as well as femoropopliteal) disease to endovascular revascularization plus supervised exercise or supervised exercise alone. After 1 year, patients in both groups had significant improvements in walking distances and health-related QoL, with greater improvements in the combined-therapy group.218 The long-term comparative efficacy of endovascular revascularization versus supervised exercise therapy and medical therapy compared to supervised exercise therapy and medical therapy without revascularization for aortoiliac disease is unknown.
IIa	B-R	Endovascular procedures are reasonable as a revascularization option for patients with lifestyle-limiting claudication and hemodynamically significant femoropopliteal disease.217,232,243–245,250,251
See Online Data Supplement 35.		Multiple RCTs have demonstrated short-term efficacy with endovascular treatment of femoropopliteal disease for claudication versus supervised exercise training or medical therapy, with benefit that diminishes by 1 year.217,232,240–246,250,251 Two separate systematic reviews that included RCTs that enrolled patients with femoropopliteal disease, reported that endovascular treatment of claudication improved walking parameters and QoL.11,12,233 The durability of endovascular treatment for claudication is directly related to vessel patency. Long-term patency is greater in the iliac artery than in the femoropopliteal segment. Furthermore, durability is diminished with greater lesion length, occlusion rather than stenosis, the presence of multiple and diffuse lesions, poor-quality runoff, diabetes mellitus, chronic kidney disease, renal failure, and smoking.252–255 The choice of endovascular therapy as a revascularization approach for claudication due to femoropopliteal disease therefore should include a discussion of outcomes, addressing the risk of restenosis and repeat intervention, particularly for lesions with poor likelihood of long-term durability.
IIb	C-LD	The usefulness of endovascular procedures as a revascularization option for patients with claudication due to isolated infrapopliteal artery disease is unknown.256–258
See Online Data Supplement 35.		Isolated infrapopliteal disease is unlikely to cause claudication. Incidence of in-stent restenosis is high and long-term benefit lacking with bare-metal stenting of the infrapopliteal arteries.256 Studies that have enrolled patients with claudication as well as CLI have demonstrated a benefit of DES versus bare-metal stents or versus drug-coated balloons for revascularization of infrapopliteal lesions.257,258 However, these differences were mainly for patency and restenosis endpoints, and neither of these studies included patient-oriented outcomes, such as walking function or QoL parameters. Additional efficacy data on the use of infrapopliteal drug-coated balloon or DES for the treatment of claudication are likely to be published in the near future.
III: Harm	B-NR	Endovascular procedures should not be performed in patients with PAD solely to prevent progression to CLI.234–237,259–261
See Online Data Supplements 36 and 38.		There are no data to support a practice paradigm of performing endovascular procedures on patients with PAD for the purpose of preventing progression of claudication symptoms to CLI. Reported rates of amputation or progression to CLI from prospective cohort studies of patients with claudication are <10% to 15% over 5 years or more, and increased mortality rate associated with claudication is usually the result of cardiovascular events rather than limb-related events.234–237,262 Similarly, there are no data to support revascularization in patients with asymptomatic PAD. Procedural risks include bleeding, renal failure from contrast-induced nephropathy, and the possibility of adverse limb outcomes.259–261 Therefore, the known risks of endovascular procedures outweigh any hypothetical benefit of preventing progression from asymptomatic PAD or claudication to CLI.