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12.1.3.2 Surgical Revascularization

• When surgery is performed for CLI, bypass to the popliteal or infrapopliteal

arteries (i.e. tibial, pedal) should be constructed with suitable autogenous vein.

(Class I recommendation/Level of evidence A)

• Surgical procedures are recommended to establish in-line blood ow to the foot

in patients with non-healing wounds or gangrene. (Class I recommendation/

Level of evidence C-LD)

• In patients with CLI for whom endovascular revascularization has failed and a

suitable autogenous vein is not available, prosthetic material can be effective for

bypass to the below-knee popliteal and tibial arteries. (Class IIa recommenda-

tion/Level of evidence B-NR)

• A staged approach to surgical procedures is reasonable in patients with isch-

aemic rest pain. (Class IIa recommendation/Level of evidence C-LD)

12.1.3.3 Wound Healing

• An interdisciplinary care team should evaluate and provide comprehensive care

for patients with CLI and tissue loss to achieve complete wound healing and a

functional foot. (Class I recommendation/Level of evidence B-NR)

• In patients with CLI, intermittent pneumatic compression (arterial pump) devices

may be considered to augment wound healing and/or ameliorate severe isch-

aemic rest pain. (Class IIb recommendation/Level of evidence B-NR).

• In patients with CLI, the effectiveness of hyperbaric oxygen therapy for wound

healing is unknown. (Class IIb recommendation/Level of evidence C-LD)

• Prostanoids are not indicated in patients with CLI. (No benet/Level of evi-

dence B-R)

12 Chronic Limb-Threatening Ischemia (Critical Limb Ischemia)

(Note: R Randomized; NR Nonrandomized; LD Limited Data)

12.1.4 Global Vascular Guidelines ontheManagement

ofChronic Limb-Threatening Ischemia—Joint Guidelines oftheSociety forVascular Surgery, European Society forVascular Surgery, andWorld Federation ofVascular Societies [4]

Strong recommendations of these guidelines include:

4.3 Treat all patients with CLTI with an antiplatelet agent. (Strong recommendation;

level of evidence A, high).

4.7 Use moderate or high-intensity statin therapy to reduce all-cause and cardiovas-

cular mortality in patients with CLTI. (Strong recommendation; level of evi-

dence A, high).

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271

4.8 Control hypertension to target levels of <140mm Hg systolic and<90mmHg

diastolic in patients with CLTI. (Strong recommendation; level of evidence B,

moderate)

4.10 Use metformin as the primary hypoglycemic agent in patients with type 2 DM

and CLTI. (Strong recommendation; level of evidence A, high)

6.6 Use an integrated threatened limb classication system (such as WIFI) to stage

all CLTI patients who are candidates for limb salvage. (Strong recommendation;

level of evidence C, low).

6.11 Offer revascularization to all average-risk patients with advanced limb-

threatening conditions (e.g., WIFI stage 4) and signicant perfusion decits

(e.g., WIFI ischaemia grades 2 and 3). (Strong recommendation; level of evi-

dence C, low)

6.17 Perform ultrasound vein mapping when available in all CLTI patients who are

candidates for surgical bypass. (Strong recommendation; level of evidence C, low)

6.22 Correct inow disease alone in CLTI patients with multilevel disease and low-

grade ischemia (e.g., WIFI ischemia grade 1) or limited tissue loss (e.g., WIFI

wound grade 0/1) and in any circumstance in which the risk-benet of additional

outow reconstruction is high or initially unclear. (Strong recommendation;

level of evidence C, low).

6.23 Re-stage the limb and repeat the hemodynamic assessment after performing

inow correction in CLTI patients with inow and outow disease. (Strong rec-

ommendation; level of evidence C, low).

6.25 Use an endovascular-rst approach for treatment of CLTI patients with moder-

ate to severe (e.g., GLASS stage IA) aorto-iliac (AI) disease, depending on the

history of prior intervention. (Strong recommendation; level of evidence B,

moderate)

6.27 Perform open CFA [common femoral artery] endarterectomy with patch angio-

plasty, with or without extension into the PFA [profound femoral artery], in CLTI

patients with hemodynamically signicant (> 50% stenosis) disease of the com-

mon and deep femoral arteries. (Strong recommendation; level of evidence

C, low).

6.32 In average-risk CLTI patients with infrainguinal disease, base decisions of

endovascular intervention vs. open surgical bypass on the severity of limb threat

(e.g., WIFI), the anatomic pattern of disease (e.g., GLASS), and the availability

of autologous vein. (Strong recommendation; level of evidence C, low).

6.40 Use autologous vein as the preferred conduit for infrainguinal bypass surgery

in CLTI. (Strong recommendation; level of evidence B, moderate)

6.42 Perform intraoperative imaging (angiography, duplex ultrasound or both) on

completion of open bypass surgery for CLTI and correct signicant technical

defects if feasible during the index operation. (Strong recommendation; level of

evidence C, low).

7.5. Do not offer vasoactive drugs or debrinating agents (ancrod) in patients in

whom revascularization is not possible. (Strong recommendation; level of evi-

dence C, low)

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7.6 Do not offer HBOT [hyperbaric oxygen therapy] to improve limb salvage in

CLTI patients with severe, uncorrected ischemia (e.g., WIFI ischemia grade 2/3).

(Strong recommendation; level of evidence B, moderate).

9.2 Offer primary amputation to CLTI patients who have pre-existing dysfunctional

or unsalvageable limb, a poor functional status (e.g., bedridden), or a short life

expectancy after shared decision-making with the patient and health care team.

(Strong recommendation; level of evidence C, low)

9.6 Involve a multidisciplinary rehabilitation team from the time a decision to

amputate has been made until successful completion of rehabilitation has been

achieved. (Strong recommendation; level of evidence C, low).

9.7 Continue to observe CLTI patients who have undergone amputation at least

yearly to monitor progression of disease in the contralateral limb and to maintain

optimal medical therapy and risk factor management. (Strong recommendation;

level of evidence C, low)

10.1 Continue best medical therapy for PAD, including the long-term use of anti-

platelet and statin therapies, in all patients who have undergone lower extremity

revascularization. (Strong recommendation; level of evidence A, high).

10.10 Offer intervention for duplex ultrasound-detected vein graft lesions with an

associated peak systolic velocity (PSV) of >300cm/s and a PSV ratio>3.5 or

grafts with low velocity (midgraft PSV<45cm/s) to maintain patency. (Strong

recommendation; level of evidence B, moderate)

10.11 Maintain long-term surveillance after surgical or catheter-based revision of a

vein graft, including DUS graft scanning where available, to detect recurrent

graft- threatening lesions. (Strong recommendation; level of evidence B,

moderate)

10.14 Provide mechanical ofoading as a primary component for care of all CLTI

patients with pedal wounds. (Strong recommendation; level of evidence A, high).

10.14 Provide counseling on continued protection of the healed wound and foot to

include appropriate shoes, insoles and monitoring of inammation. (Strong rec-

ommendation; level of evidence A, high)

12 Chronic Limb-Threatening Ischemia (Critical Limb Ischemia)

12.2 Suggested Objective Performance Goals (OPG)

forEvaluating New Catheter-Based Treatments inCritical Limb Ischemia (CLI)

Conte etal. [5] developed a set of suggested objective performance goals (OPG) for evaluating new catheter-based treatments in critical limb ischemia (CLI), based on evidence from historical controls. A set of outcome variables as the basis for safety and efcacy targets was dened:

• Amputation was dened by major index limb loss at or proximal to the transtib-

ial level.

• Major adverse cardiovascular event (MACE) included myocardial infarction and

stroke in addition to death from any cause.

12.2 Suggested Objective Performance Goals (OPG) forEvaluating New…

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273

• RAO was dened as any reintervention or above ankle amputation of the

index limb.

• RAS was dened as any reintervention, above ankle amputation of the index

limb, or stenosis.

• Major reinterventions included the creation of a new surgical bypass graft, the

use of thrombectomy or thrombolysis (ie, procedures done in the setting of lost

primary-assisted patency), or a major surgical graft revision such as a jump graft

or an interposition graft.

• Major adverse limb event (MALE): Above ankle amputation of the index limb or

major reintervention (new bypass graft, jump/interposition graft revision, or

thrombectomy/thrombolysis)

• Primary efcacy endpoint of perioperative death or any major adverse limb event.

(a) Perioperative targets (30-day events) for overall CLI cohort

• MACE: 6.2% (death: 2.7% / myocardial infarction (MI) 3.1%/cerebrovascular accident (CVA) 1.0%). Safety objective performance goal (OPG): 8%

• MALE: 6.1%. Safety OPG: 8%

• Amputation 1.9%. Safety OPG: 3%

(b) Perioperative targets (30-day events) for clinical high risk (age≥80 and tissue

loss) subgroup

• MACE: 11.8% (death: 6.6%/MI 5.2%/CVA 2.2%). Safety OPG 18%

• MALE: 5.1%. Safety OPG: 10%

• Amputation 2.9%. Safety OPG: 7%

subgroup

• MACE: 7.3% (death: 2.8%/MI 4.2%/CVA 1.2%). Safety OPG 10%

• MALE: 6.1%. Safety OPG: 9%

• Amputation 2.2%. Safety OPG: 4%

(d) Efcacy outcomes (1year) for overall CLI cohort and suggested OPG for each

endpoint. Rates reported as proportion free from adverse event.

• MALE and perioperative death: 76.9%. Efcacy OPG: 71%

• AFS (Amputation-free survival): 76.5%. Efcacy OPG: 71%

• RAS: 46.5%. Efcacy OPG: 39%

• RAO 61.3%. Efcacy OPG: 55%

• Limb salvage: 88.9%. Efcacy OPG: 84%

• Survival: 85.7%. Efcacy OPG: 80%

(e) Efcacy outcomes (1year) for clinical high risk (age≥80 and tissue loss) sub-

group. Rates reported as proportion free from adverse event.

• MALE and perioperative death: 69.1%. Efcacy OPG: 61%

• AFS: 60.5%. Efcacy OPG: 53%

• RAS: 40.4%. Efcacy OPG: 29%

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• RAO 62.8%. Efcacy OPG: 54%

• Limb salvage: 86.5%. Efcacy OPG: 80%

• Survival: 70.3%. Efcacy OPG: 63%

(f) Efcacy outcomes (1year) for anatomic high risk (infra-popliteal) subgroup.

Rates reported as proportion free from adverse event.

• MALE and perioperative death: 74.0%. Efcacy OPG: 67%

• AFS: 74.4%. Efcacy OPG: 68%

• RAS: 44.0%. Efcacy OPG: 36%

• RAO 58.3%. Efcacy OPG: 51%

• Limb salvage: 86.6%. Efcacy OPG: 81%

• Survival: 85.9%. Efcacy OPG: 80%

12 Chronic Limb-Threatening Ischemia (Critical Limb Ischemia)

12.3 Results

12.3.1 Randomized Trials

12.3.1.1 BEST-CLI Clinical Trial-Surgery or Endovascular Therapy forChronic Limb-Threatening Ischemia

Farber etal. [6] performed the Best Endovascular versus Best Surgical Therapy in Patients with CLTI (BEST-CLI) trial to determine whether endovascular revascularization was superior to surgical revascularization in patients with CLTI caused by infrainguinal peripheral artery disease who were judged to be suitable candidates for both approaches. In this international, randomized trial, 1830 patients with CLTI and infrainguinal peripheral artery disease were enrolled in two parallel-cohort trials. Patients who had a single segment of great saphenous vein that could be used for surgery were assigned to cohort 1. Patients who needed an alternative bypass conduit were assigned to cohort 2. The primary outcome was a composite of a major adverse limb event—which was dened as amputation above the ankle or a major limb reintervention (a new bypass graft or graft revision, thrombectomy, or thrombolysis)—or death from any cause. In cohort 1, after a median follow-up of 2.7years, a primary-outcome event occurred in 302 of 709 patients (42.6%) in the surgical group and in 408 of 711 patients (57.4%) in the endovascular group (hazard ratio,

0.68; 95% condence interval [CI], 0.59 to 0.79; P<0.001). In cohort 2, a primary-

outcome event occurred in 83 of 194 patients (42.8%) in the surgical group and in 95 of 199 patients (47.7%) in the endovascular group (hazard ratio, 0.79; 95% CI,

0.58 to 1.06; P=0.12) after a median follow-up of 1.6years. In patients with CLTI

who had an adequate single segment of great saphenous vein for conduit and were considered to be suitable candidates for both endovascular intervention and surgical bypass, initial bypass surgery was associated with a lower incidence of major adverse limb events or death than initial endovascular intervention. In patients

12.3 Results

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without a suitable great saphenous vein, results associated with initial endovascular intervention were not signicantly different from those associated with initial bypass surgery.

12.3.1.2 Bypass Versus Angioplasty forSevere Ischaemia oftheLeg (BASIL)-2

Bypass versus Angioplasty for Severe Ischaemia of the Leg (BASIL)-2 was an open-label, pragmatic, multicentre, phase 3, randomised trial [7]. Eligible patients were those who presented with chronic limb-threatening ischaemia and who required an infra-popliteal, with or without an additional more proximal infrainguinal, revascularisation procedure to restore limb perfusion. Participants were randomly assigned (1:1) to receive either vein bypass (vein bypass group) or best endovascular treatment (best endovascular treatment group) as their rst revascularisation procedure. The primary outcome was amputation-free survival dened as time to major (above the ankle) amputation of the trial leg or death from any cause (whichever occurred rst). 345 participants with CLTI were enrolled in the trial and randomly assigned: 172 (50%) to the vein bypass group and 173 (50%) to the best endovascular treatment group. 108 (63%) of 172 patients in the vein bypass group and 92 (53%) of 173 patients in the best endovascular treatment group had a major amputation or died (adjusted HR 1·35 [95% CI 1.02–1.80]; p=0.037). The median amputation-free survival was 3·3years [IQR 2.1–4.3] in the vein bypass group and

4.4years [IQR 3.4–5.9] in the best endovascular group. The BASIL-2 trial showed

that a vein bypass rst revascularisation strategy led to a 35% increased risk of major amputation or death in patients with CLTI who required an infrapopliteal revascularisation procedure to restore limb perfusion compared with a best endovascular treatment rst revascularisation strategy. This difference was mainly driven by fewer deaths in the best endovascular treatment rst revascularisation group as limb-based outcomes were similar between the two groups.

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12.3.2 Systematic Reviews/Meta-Analyses

12.3.2.1 WIFI Classication System

Van Reijen etal. [8] reviewed the available evidence regarding the value of the WIfI classication in patients presenting with CLTI to predict the 1year major amputation risk and the benet of revascularisation. There were 12 studies comprising 2669 patients, most of whom underwent endovascular or open revascularisation. Data for each WIfI stage from four studies (569 patients, 575 limbs) reporting on major amputation were pooled. The estimated risk of a major amputation after 1year was 0% for WIfI stage I patients, 8% for stage II, 11% for stage III, and 38%

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Table 12.1 Observed 1-year outcomes by Wound, Ischemia, and foot Infection (WIfI) composite score substratication in patients undergoing a rst-time lower extremity revascularization for chronic limb-threatening ischemia (according to [9])

WIfI-Composite-Score Limbs (n) Limb salvage (%) Freedom from RAS (%) Survival (%)

Composite 1-3 336 96 58 85 Composite 4-6 557 89 54 79 Composite 7-9 100 67 43 78

RAS reintervention, amputation or stenosis Limbs graded in all three WIfI components

12 Chronic Limb-Threatening Ischemia (Critical Limb Ischemia)

for stage IV. Five studies comprising 757 patients and 786 limbs reported on AFS.The estimated 1year AFS was 83% for patients classied as WIFI stage I, 76% for stage II, 75% for stage III, and 55% for stage IV. The likelihood of an amputation after 1year in patients with CLTI increases with higher WIfI stages, which is important prognostic information. However, prospective evaluations are needed to determine its role in clinical practice.

Darling etal. [9] performed a retrospective record review of patients undergoing a lower extremity revascularization for CLTI. 1336 limbs were included, of which 992 had sufcient data to classify all three WIfI components (wound, ischemia, and foot infection). A WIfI composite score was calculated by summing the three individual WIfI component scores (e.g., a limb with a wound score of 3, an ischemia score of 2, and an infection score of 1 would have a WIfI composite score of 6), and the WIfI mean score was calculated by summing the three individual components and dividing by the number of individual WIfI components. In addition, for statistical purposes, a further subclassication was created within the WIfI composite scores, where limbs were stratied into low-risk (composite scores 1-3), moderaterisk (4-6), and high-risk groups (7-9). The study supported the ability of the SVS WIfI classication system to predict major amputation; however, the novel WIfI mean and WIfI composite scores predicted amputation, RAS events, and mortality more consistently than any other current WIfI scoring system (Table12.1).

12.3.2.2 Conservative Treatment

A systematic review of the available literature was conducted to obtain best estimates of outcomes of conservative treatment in patients with CLTI [10]. Twentyseven publications were included, consisting of 12 observational studies and 15 placebo arms from randomised clinical trials, totalling 1642 patients. Most studies included patients with nonreconstructable CLTI. The pooled 12 month all cause mortality rate in 14 studies comprising 1003 patients was 18%. The pooled major amputation rate from 14 studies comprising 755 patients was 27% after 1year, and pooled AFS rate after 12months in 11 studies with 970 patients was 60%. This review shows that conservative treatment outcomes in patients with chronic limb threatening ischemia are not dismal. Therefore, the conservative treatment option should be discussed with every patient in the decision making process.

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277

The role of cilostazol therapy in patients with advanced PAD and critical limb ischemia (CLI) remains unclear. Desai etal. [11] reviewed ten studies that evaluated the effect of cilostazol vs standard antiplatelet therapy on limb-related and arterial patency-related outcomes. They found that patients who received cilostazol therapy along with open and/or endovascular intervention have overall improved outcomes. Specically, patients who receive cilostazol have improved amputation-free survival, limb salvage rates, and decreased arterial restenosis rates. Additionally, patients who received cilostazol along with endovascular revascularization procedures also demonstrated higher freedom from TLR.There was no difference in allcause mortality between patients who received and did not receive cilostazol therapy. This study included patients with both IC and CLI to help determine the effects of cilostazol therapy in a broader range of patients affected by symptomatic PAD.This inclusion criterion may have introduced confounding variables associated with disease severity, distribution of disease, and types of adjunct interventions offered.

12.3.2.3 Percutaneous Intervention Vs. Bypass Surgery forCLTI

Wang etal. [12] performed a meta-analysis of all available randomized controlled trials and observational clinical studies comparing percutaneous vascular interventions (PVI) vs bypass surgeries (BSX) in patients with CLI. Primary endpoints included overall survival, amputation-free survival, 30-day mortality, and major adverse cardiovascular and cerebrovascular events. They identied 45 cohorts and one randomized controlled trial in over 20,903 patients. In overall population, PVI reduced the risks of 30-day mortality (odds ratio [OR] 0.69), major adverse cardiovascular and cerebrovascular events (OR 0.42), and surgical site infection (OR

0.31), but increased the risks of long-term all-cause mortality (hazard ratio [HR]

1.16) and primary patency failure (HR 1.31). When compared with autogenous BSX, PVI was also associated with additional increased risks of long-term death or amputation (HR 1.41) and secondary patency failure (HR 1.51). In patients with infrapopliteal lesions, PVI had inferior primary patency (HR 1.39) compared with BSX.For patients in good physical condition with long life-expectancy, BSX may represent a better choice compared with PVI, particularly when autogenous bypass is available. Main outcomes of this review are given in Table12.2.

Furthermore, a Cochrane review [13] assessed the effects of bypass surgery in patients with CLTI.Eleven trials reporting a total of 1486 participants were included. Six trials compared bypass surgery with PTA and one each compared with endarterectomy, thromboendarterectomy, thrombolysis, exercise and spinal cord stimulation. Comparing bypass surgery with PTA revealed a possible increase in early postinterventional non-thrombotic complications (OR 1.29, 95% CI 0.96 to 1.73; six studies; 1015 participants) with bypass surgery, but bypass surgery was associated with higher technical success rates. Analyses by different clinical severity of disease (intermittent claudication (IC) or CLI) revealed that peri-interventional complications occurred more frequently in participants with CLI undergoing bypass

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Table 12.2 Percutaneous vascular interventions (PVI) vs. bypass surgeries in patients with CLI.Only the signicant differences are presented. Hazard (HR) or Odds (OR) ratios >1 indicate an increased risk with PVI, HR and OR<1 a lower risk compared to bypass surgery. (According to meta-analysis by [12])

Names of Outcomes

Long-term outcomes –Overall survival HR 19 1.16 1.05-1.27 –Matched/adjusted HR 11 1.15 1.02-1.31 –Vein graft HR 7 1.41 1.20-1.66 Amputation-free survival –Vein graft HR 6 1.41 1.02-1.94 Primary patency –Overall HR 10 1.31 1.08-1.58 –Matched/adjusted HR 4 1.26 1.01-1.57 –Vein graft HR 3 1.36 1.09-1.71 –Infrapopliteal HR 4 1.39 1.10-1.75 Secondary patency –Vein graft HR 3 1.51 1.17-1.95 30-day outcomes –Mortality overall OR 14 0.56 0.33-0.95 MACCEs –Overall OR 10 0.42 0.29-0.61 –CAD/MI OR 10 0.52 0.31-0.87 Wound complications –Overall OR 11 0.25 0.12-0.53 –Hemorrhage OR 5 0.24 0.07-0.87 –Surgical site

infections Infection OR 5 0.14 0.03-0.63

HR Hazard Ratio, OR Odds Ratio, MACCE major adverse cardiovascular and cerebrovascular events, CAD coronary artery diseases, MI myocardial infarction

12 Chronic Limb-Threatening Ischemia (Critical Limb Ischemia)

Effect Measure

OR 6 0.31 0.19-0.51

Number of Studies (n)

Effect Estimate

Condence Interval

surgery than PTA.No differences in periprocedural mortality were identied. The primary patency rate at 1year was higher after bypass surgery than after PTA, but this difference was not shown at 4years. No differences in clinical improvement, amputation rates or mortality within the follow-up period between surgical and endovascular treatment were identied. This analysis has shown that PTA is associated with decreased peri-interventional complications in participants treated for CLI and shorter hospital stay compared with bypass surgery. Surgical treatment seems to confer improved patency rates up to 1year. Endovascular treatment may be advisable in patients with signicant comorbidity. No solid conclusions could be drawn regarding comparisons of bypass surgery with other treatments because of the paucity of available evidence.

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279

12.3.2.4 Revascularization inOctogenarians

The aim of a systematic review and meta-analysis was to assess the clinical outcomes after revascularization in octogenarians with CLTI [14]. Twelve studies with a total of 17,118 patients were included. A 1year mortality rate of 32% was found in octogenarians, which was signicantly higher than in the non-octogenarians (17%). No signicant difference in 1year amputation rate was found (octogenarians 15%; non-octogenarians 12%). AFS was signicantly lower in the octogenarian group. In a subgroup analysis differentiating between endovascular and surgical revascularization, amputation rates were comparable. For octogenarians, those treated conservatively had a mortality rate signicantly higher than those treated by revascularizations. No signicant difference in mortality rate was found between primary amputation and revascularization in octogenarians. As a consequence, the focus should be more on whether patient quality of life is improved by a therapeutic approach rather than increasing physical health and life expectancies of octogenarians.

12.3.2.5 Gender Differences inOutcome inPatients

withSymptomatic PAD

A meta-analysis examined the effect of gender on all-cause mortality and major adverse cardiovascular events (MACE) in patients with symptomatic PAD [15]. For the primary end point of all cause mortality, 13 studies, incorporating 668,690 patients, were evaluated. Male gender was associated with a greater risk of all-cause mortality (HR, 1.13; P< .001) and MACE (HR, 1.10; 9; P<.001). In a stratied analysis, male gender was associated with a higher mortality risk for patients presenting with either critical limb ischemia or mixed clinical presentations but not for those with intermittent claudication. Elevated mortality risk was evident after revascularization (HR, 1.11), hospitalization (HR, 1.15), and amputation (HR, 1.09), although not in outpatient clinics, in men compared with women.

The long-term outcome of men and women after open surgery for CLTI was examined by Kotov etal. [16] in a propensity score matched cohort analysis comprising 6502 matched patients. Data of a German health insurance fund were used. In the matched cohort, the median follow up was 746days for women and 871days for men. Female sex was signicantly associated with better overall survival (hazard ratio, HR, 0.80, log rank p<.001), AFS (HR 0.81, log rank p< .0001), and cardiovascular event free survival (HR 0.84, log rank p< .001) 5years after the index treatment. These investigators also aimed to determine the sex disparities in long-term outcomes after endovascular revascularization of symptomatic peripheral arterial occlusive disease using health insurance claims data [17]. 50,051 patients (47.2% women) were identied and used to compose a matched cohort of 35,232 patients. Female patients exhibited better overall survival, amputation-free survival, and cardiovascular event-free survival at 5years after treatment.

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