Recommendations for Endovascular Revascularization for CLI
COR	LOE	Recommendations
I	B-R	Endovascular procedures are recommended to establish in-line blood flow to the foot in patients with nonhealing wounds or gangrene.292,293
See Online Data Supplement 39.		The technique chosen for endovascular treatment of CLI is related to anatomic location of lesions, lesion characteristics, and operator experience. Revascularization is performed on hemodynamically significant stenoses that are likely to be limiting blood flow to the limb. For stenoses of 50% to 75%, where the hemodynamic significance is unclear, intravascular pressure measurements may be used to determine hemodynamic significance.294 The BASIL (Bypass versus Angioplasty in Severe Ischemia of the Leg) RCT demonstrated that endovascular revascularization is an effective option for patients with CLI as compared with open surgery.292,293 The primary endpoint of amputation-free survival was the same in the endovascular and surgical arms. Of note, the endovascular arm used only PTA.292,293 Multiple RCTs comparing contemporary surgical and endovascular treatment for patients with CLI are ongoing.15–17 Table 10 addresses factors that may prompt an endovascular versus surgical approach to the patient with CLI.
IIa	C-LD	A staged approach to endovascular procedures is reasonable in patients with ischemic rest pain.295,296
N/A		For patients with multilevel disease who suffer from ischemic rest pain, in-flow lesions are generally addressed first.295,296 Depending on procedural characteristics, including contrast volume used, radiation exposure, and procedure time, out-flow lesions can be addressed in the same setting or at a later time if symptoms persist. This strategy for ischemic rest pain is distinct from the strategy recommended for CLI in the patient with a nonhealing wound or gangrene. In that scenario, restoration of direct in-line flow to the foot is essential for wound healing.
IIa	B-R	Evaluation of lesion characteristics can be useful in selecting the endovascular approach for CLI.297,298
See Online Data Supplement 39.		The lesion characteristics to consider include length, anatomic location, and extent of occlusive disease. For example, if an adequate angioplasty result can be achieved with PTA alone for short (<10 cm) stenoses in the femoropopliteal segment, then stent placement is not necessary.297,298 Presence of thrombosis or calcification at the lesion site will also affect the endovascular approach. In general, the advantages of DES and drug-coated balloons over PTA alone or bare-metal stents are more consistent in the femoropopliteal segment than for infrapopliteal interventions.257,258,299–309 However, these differences are mainly for patency, restenosis, and repeat-revascularization endpoints. Most studies were underpowered or did not examine other patient-oriented outcomes, such as amputation or wound healing in CLI. Endovascular techniques continue to evolve rapidly, and there has been limited literature comparing techniques with regard to clinically significant outcomes, such as amputation or wound healing.
IIb	B-NR	Use of angiosome-directed endovascular therapy may be reasonable for patients with CLI and nonhealing wounds or gangrene.310–319
See Online Data Supplements 39 and 40.		During the past decade, the goal of care with regard to endovascular therapy for the treatment of nonhealing wounds due to CLI has been establishment of direct in-line blood flow to the affected limb. The angiosome concept has also been described in the literature in relation to the treatment of nonhealing wounds. Angiosome-directed treatment entails establishing direct blood flow to the infrapopliteal artery directly responsible for perfusing the region of the leg or foot with the nonhealing wound. Multiple retrospective studies and 1 small nonrandomized prospective study assessing the efficacy of this concept have been published.119,310–321 Meta-analyses of these studies found improved wound healing and limb salvage with angiosome-guided therapy but cautioned that the quality of the evidence was low.322,323 Although the angiosome concept is theoretically satisfying, randomized data comparing the establishment of in-line flow versus angiosome-guided therapy have yet to be published. Furthermore, there is no evidence yet to demonstrate the potential benefit of treating additional infrapopliteal arteries once in-line flow has been established in one artery, regardless of angiosome. Important considerations with regard to angiosome-guided therapy include the potential for longer procedural times, more contrast exposure, and more technically complex procedures. The impact of all these factors needs to be weighed against the likelihood of a technically successful procedure providing hypothetical added benefit over the establishment of in-line blood flow.