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Biscetti, F. Lower Extremity Endovascular Revascularization. Encyclopedia. Available online: https://encyclopedia.pub/entry/7884 (accessed on 15 December 2025).
Biscetti F. Lower Extremity Endovascular Revascularization. Encyclopedia. Available at: https://encyclopedia.pub/entry/7884. Accessed December 15, 2025.
Biscetti, Federico. "Lower Extremity Endovascular Revascularization" Encyclopedia, https://encyclopedia.pub/entry/7884 (accessed December 15, 2025).
Biscetti, F. (2021, March 09). Lower Extremity Endovascular Revascularization. In Encyclopedia. https://encyclopedia.pub/entry/7884
Biscetti, Federico. "Lower Extremity Endovascular Revascularization." Encyclopedia. Web. 09 March, 2021.
Lower Extremity Endovascular Revascularization
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This entry is adapted from the peer-reviewed paper 10.3390/ijms22042002

Peripheral artery disease (PAD) is a manifestation of atherosclerosis, which may affect arteries of the lower extremities. The most dangerous PAD complication is chronic limb-threatening ischemia (CLTI). Without revascularization, CLTI often causes limb loss. However, neither open surgical revascularization nor endovascular treatment (EVT) ensure long-term success and freedom from restenosis and revascularization failure. In recent years, EVT has gained growing acceptance among all vascular specialties, becoming the primary approach of revascularization in patients with CLTI. In clinical practice, different clinical outcomes after EVT in patients with similar comorbidities undergoing the same procedure (in terms of revascularization technique and localization of the disease) cause unsolved issues that need to be addressed. Nowadays, risk management of revascularization failure is one of the major challenges in the vascular field.

peripheral artery disease (PAD) chronic limb-threatening ischemia (CLTI) revascularization

1. Introduction

Peripheral artery disease (PAD) is a manifestation of atherosclerosis disease, which may affect arteries in the lower extremities. It is the third most common manifestation of atherosclerosis after coronary artery disease (CAD) and stroke [1]. Fatigue, atypical leg pain, and cramping during ambulation—known as intermittent claudication (IC)—are typical signs of symptomatic PAD [2]. The most dangerous complication of PAD is critical limb ischemia (CLI), which is nowadays defined as chronic limb-threatening ischemia (CLTI) to include a wider and more heterogeneous group of patients with varying degrees of ischemia. The diagnosis of CLTI requires a documented atherosclerotic PAD associated with ischemic rest pain or tissue loss (ulceration or gangrene) [3].

It is estimated that over 230 million persons have PAD worldwide [4]. PAD may implicate a reduced functional capacity with an inevitable worsening in quality of life. Moreover, it is also associated with an increased risk for cardiovascular morbidity and mortality [5]. Therefore, PAD represents a major public health problem with a significant impact on healthcare causing a notable economic burden [6].

Without revascularization, CLTI often results in limb loss. However, neither open surgical revascularization nor endovascular treatment (EVT) guarantee treatment success and freedom from restenosis and revascularization failure [7][8]. In recent years, EVT has gained growing acceptance among all vascular specialties, becoming the primary approach of revascularization in patients with CLTI [9][10][11]. In clinical practice, different clinical outcomes after EVT in patients with similar comorbidities undergoing the same procedure (in terms of revascularization technique and localization of the disease) cause unsolved issues that need to be addressed [12]. Nowadays, the risk management of revascularization failure is one of the major challenges in the vascular field. The aim of this literature review is to identify potential predictors of lower extremity endovascular revascularization (LER) failure and possible prevention strategies.

2. Definitions of Revascularization Failure

Effective revascularization is defined by criteria for both anatomic and hemodynamic success. Indeed, a procedure may be technically successful and clinically unsuccessful. Some approaches may produce a better anatomic result without improving hemodynamics [13].

The endpoints of revascularization are classified into three categories: primary patency, primary-assisted patency, and secondary patency [14]. Primary patency is defined as continuous patency without directly performing an intervention or procedure. Primary-assisted patency is defined as uninterrupted patency, but it is maintained by prophylactic intervention. Secondary patency is the time from the procedure to restenosis [7]. The definition of restenosis is when the luminal diameter is narrowed by over 50% or the cross-sectional area is reduced by over 75% [15]. The complex pathophysiologic mechanism remains incompletely understood. Angioplasty, stent placement, or atherectomy represent a mechanical injury to the vessel, which locally reacts with an inflammatory response. This process may lead to restenosis because of intimal thickening and an increased extracellular matrix [16][17]. Neointimal hyperplasia acts as a main restenosis trigger after stenting. Instead, restenosis after angioplasty or atherectomy results from a combination of constrictive arterial remodeling along with neointimal hyperplasia [18][19][20][21][22].

Currently, endovascular angioplasty includes different techniques such as plain old balloon angioplasty, cryoplasty, cutting balloon angioplasty, and medicated balloon angioplasty. Self-expanding and balloon-expandable are two general types of stents. They are available with or without polytetrafluoroethylene cover, are bioabsorbable, and drug eluting [15]. These technologies were developed mainly to reduce restenosis rates after EVT. However, the discussion of technical considerations is in intentional scientific articles limited and therefore, also in this article restrictedly addressed [3].

Other important outcomes after LER are major adverse limb events (MALE)—defined as composite of acute limb ischemia, major vascular amputations, limb-threatening ischemia leading to urgent revascularization—and major adverse cardiovascular events (MACE)—defined as a composite of acute myocardial infarction, stroke, transient ischemic attack, and cardiovascular death [23][24].

3. Revascularization: When Is It Appropriate?

The goals of EVT in patients affected by PAD are pain relief, wound healing, and functional limb preservation. Nevertheless, revascularization may cause morbidity, which is correlated to many hospital admissions, continuous outpatient care, and significant treatment and health care costs, as well as mortality. Some patients can be appropriately treated with primary amputation or palliative care after multidisciplinary decision-making [3]. Therefore, patients for whom EVT may be beneficial need to be identified to avoid potential failure. Predicting functional outcomes after revascularization is difficult, particularly in patients who are severely deconditioned. The Global Vascular Guidelines (GVG) suggests a structured approach based on a three-step process: patient risk estimation, limb severity, and anatomic pattern of disease (PLAN) [3].

3.1. Patient Risk Estimation

CLTI affects patients with advanced age and multiple comorbidities. In this setting, estimation of operative risk and life expectancy is pivotal. Preoperative cardiac and anesthetic evaluation before limb revascularization is mandatory [3][25][26]. Several procedural risk factors have been identified for the CLTI population. They include advanced age (over 75 or 80 years), CAD, congestive heart failure, diabetes mellitus (DM), chronic kidney disease (CKD), smoking, cerebrovascular disease, tissue loss, body max index (BMI), dementia, functional status, and frailty. In recent years, multiple risk stratification tools have been retrospectively developed for patients who underwent surgical revascularization [3][27][28][29][30][31][32][33][34], but none has been tested prospectively and endorsed by international guidelines.

3.2. Limb Severity

Patients affected by CLTI present a wide-ranging disease severity. The GVG recommends the Society for Vascular Surgery (SVS) threatened limb classification system integrating wound severity, ischemia, and foot infection (WIfI) to stage CLTI [35][36][37][38]. The classification grades each component from 0 to 3, and a higher number indicates an increasing severity. Sixty-four theoretical patient combinations exist, with four possible clinical stages, ranging from a very low to a high amputation risk and revascularization benefit, respectively. WIfI has shown accuracy in predicting amputation risk and revascularization benefit [39][40]. Mayor et al. demonstrated that WIfI allows identifying which group of patients affected by CLTI may benefit from revascularization [41].

3.3. Anatomic Pattern of Disease

The third step of PLAN is the definition of an anatomic disease pattern. The traditional anatomic classification systems for PAD are lesion or segment focused [42][43]. The GVG propose a new approach named global limb anatomic staging system (GLASS) to integrate patterns of disease, hemodynamic improvement after treatment, anatomic durability, clinical stage, and outcomes [3]. This limb anatomic system introduces two novel concepts, which are the target arterial path (TAP) and the estimated limb-based patency (LBP), which is defined as patency along the TAP. GLASS describes three complexity stages for intervention derived from combined femoropopliteal and infrapopliteal GLASS grades (1–4), which represent increasing severity and disease complexity along the TAP [3]. GLASS stages are related to disease complexity for endovascular treatment (EVT), to immediate technical failure, and to one year LBP of the TAP [44]. Kodama et al. examined the relationship between GLASS and clinical outcomes in the Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL)-1 trial patient cohort and found that GLASS was associated with EVT outcomes but not with bypass surgery [44]. This new limb-integrated system may facilitate both shared decision-making and CLTI patient stratification.

4. The Inflammatory State in CLTI

The progression of atherosclerosis is characterized by an inflammatory reaction orchestrated by several molecules belonging to different families of inflammatory mediators, such as cytokines, chemokines, adhesion molecules, and proteolytic enzymes [45][46][47]. Similarly, diabetes and its complications cause a chronic, low-grade inflammatory status [48][49]. Based on this knowledge, Signorelli et al. investigated the plasma levels of inflammatory markers such as interleukin (IL)-6 and tumor necrosis factor (TNF)-α in patients with PAD and in healthy controls [50]. They found, in agreement with previous findings [51], that patients with PAD show an inflammation marker profile different from that of controls. In literature, data regarding markers of inflammation and EVT outcomes in patients with PAD are presented. Barani et al. found that the inflammatory mediators IL-6, TNF-α, N, and high-sensitivity C-reactive protein (CRP) were associated with 1-year mortality in CLTI patients [52]. For TNF-α and N, this association was independent of other variables such as age, sex, gangrene, active treatment, lipid-lowering therapy, leukocyte count, renal function, and cholesterol levels. Schillinger et al. demonstrated that pre- and post-intervention CRP levels were associated with restenosis after percutaneous transluminal angioplasty (PTA) of the distal popliteal and tibio-peroneal arteries, which indicates that inflammation plays a crucial role in the pathophysiology process [53]. Higher CRP levels were also found in diabetic patients who underwent PTA of the lower limb [54]. Bleda et al. analyzed the possible association between CRP and fibrinogen before EVT and during 1-year follow-up as well as its variation during the study period [55]. They found a significant correlation between basal levels of CRP and fibrinogen and the incidence of re-intervention, cardiovascular events, and death during follow-up. Moreover, Stone et al. found that after lower extremity endovascular interventions, elevated preprocedural CRP levels are associated with MALE and elevated levels of CRP and BNP are associated with late cardiovascular events [56].

Given these previous data, we hypothesized a correlation between osteoprotegerin (OPG), TNF-α, IL-6, and CRP levels at baseline before EVT and outcomes in patients with diabetes, PAD, and CLTI [12]. Indeed, OPG is a recognized marker of atherosclerosis in diabetic patients, has a role in calcium metabolism, and directly interacts with the vascular endothelium [57][58][59][60]. TNF-α has a pivotal role in the pathway of diabetic atherosclerosis [61]. IL-6 has positive effects on endothelial function and aortic stiffness, as demonstrated by data from patients treated with IL-6 inhibitors [62]. CRP improves foam cell formation in atherosclerotic plaque and promotes platelet adhesion [63]. In our study, we found a significant linear trend between increasing levels of each cytokine and risk of MALE and MACE in patients with diabetes, PAD, and CLTI who underwent an endovascular procedure [12].

In addition, high mobility group box-1 (HMGB-1) is a nuclear protein that controls gene expression and starts pro-inflammatory responses in damaged and necrotic endothelial cells, taking part in inflammatory pathways [64][65][66]. Studies described a relationship between HMGB-1 levels, diabetes, and its complications [67]. Oozawa et al. found increased HMGB1 plasma levels in diabetic patients with PAD [68]. We demonstrated in a large population of diabetic patients that HMGB-1 plasma levels are significantly increased in patients affected by PAD with a positive correlation with clinical severity of vascular damage [60].

Assessment of the inflammatory state, quantifying serum cytokines, may support physicians to identify a subset of patients more susceptible to failure after the EVT.

The possibility that anti-inflammatory therapy can improve outcomes of LER should be investigated.

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