| 1. Aboyans V, Ricco JB, Bartelink MEL, et al. 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS): Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteriesEndorsed by: the European Stroke Organization (ESO)The Task Force for the Diagnosis and Treatment of Peripheral Arterial Diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS). Eur Heart J 2018;39:763-816. |
Review/Other-Tx |
N/A |
To to provide guidance on the diagnosis and treatment of peripheral arterial diseases which encompasses all arterial diseases other than coronary arteries and the aorta. |
No results. |
4 |
| 2. Hirsch AT, Haskal ZJ, Hertzer NR, et al. ACC/AHA Guidelines for the Management of Patients with Peripheral Arterial Disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Associations for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (writing committee to develop guidelines for the management of patients with peripheral arterial disease)--summary of recommendations. J Vasc Interv Radiol. 2006;17(9):1383-1397; quiz 1398. |
Review/Other-Tx |
N/A |
Guidelines for the Management of Patients with Peripheral Arterial Disease. |
No results stated in abstract. |
4 |
| 3. Klein AJ, Feldman DN, Aronow HD, et al. SCAI expert consensus statement for aorto-iliac arterial intervention appropriate use. Catheter Cardiovasc Interv. 84(4):520-8, 2014 Oct 01. |
Review/Other-Tx |
N/A |
To guide physicians in the clinical decision-making related to the contemporary application of endovascular intervention among patients with aorto-iliac arterial disease. |
No results in abstract. |
4 |
| 4. Rossi M, Iezzi R. Cardiovascular and Interventional Radiological Society of Europe guidelines on endovascular treatment in aortoiliac arterial disease. Cardiovascular & Interventional Radiology. 37(1):13-25, 2014 Feb. |
Review/Other-Tx |
N/A |
Guideline intended for use in assessing the standard for technical success and safety in aorto-iliac percutaneous endovascular interventions. |
The success of endovascular procedures is strictly related to an accurate planning based mainly on CT- or MR-angiography. TASC II A through C lesions have an endovascular-first option Pre-procedure ASA antiplatelet therapy is advisable in all cases. The application of stents improves the immediate hemodynamic and most likely long-term clinical results. Cumulative mean complication rate is 7.51 % according to the most relevant literature. Most of the complications can be managed by means of percutaneous techniques. |
4 |
| 5. Gerhard-Herman MD, Gornik HL, Barrett C, et al. 2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation 2017;135:e686-e725. |
Review/Other-Dx |
N/A |
To provide a contemporary guideline for diagnosis and management of patients with lower extremity Peripheral Artery Disease (PAD). |
No results available |
4 |
| 6. Cao P, Eckstein HH, De Rango P, et al. Chapter II: Diagnostic methods. [Review]. Eur J Vasc Endovasc Surg. 42 Suppl 2:S13-32, 2011 Dec. |
Review/Other-Dx |
N/A |
To review diagnostic methods for critical limb ischaemia. |
Non-invasive vascular studies can provide crucial information on the presence, location, and severity of critical limb ischaemia (CLI), as well as the initial assessment or treatment planning. Ankle-brachial index with Doppler ultrasound, despite limitations in diabetic and end-stage renal failure patients, is the first-line evaluation of CLI. In this group of patients, toe-brachial index measurement may better establish the diagnosis. Other non-invasive measurements, such as segmental limb pressure, continuous-wave Doppler analysis and pulse volume recording, are of limited accuracy. Transcutaneous oxygen pressure (TcPO(2)) measurement may be of value when rest pain and ulcerations of the foot are present. Duplex ultrasound is the most important non-invasive tool in CLI patients combining haemodynamic evaluation with imaging modality. Computed tomography angiography (CTA) and magnetic resonance angiography (MRA) are the next imaging studies in the algorithm for CLI. Both CTA and MRA have been proven effective in aiding the decision-making of clinicians and accurate planning of intervention. The data acquired with CTA and MRA can be manipulated in a multiplanar and 3D fashion and can offer exquisite detail. CTA results are generally equivalent to MRA, and both compare favourably with contrast angiography. The individual use of different imaging modalities depends on local availability, experience, and costs. Contrast angiography represents the gold standard, provides detailed information about arterial anatomy, and is recommended when revascularisation is needed. |
4 |
| 7. Jansen SCP, van Nistelrooij LPJ, Scheltinga MRM, Rouwet EV, Teijink JAW, Vahl AC. Successful Implementation of the Exercise First Approach for Intermittent Claudication in the Netherlands is Associated with Few Lower Limb Revascularisations. European Journal of Vascular & Endovascular Surgery. 60(6):881-887, 2020 Dec. |
Observational-Tx |
54,504 patients with IC |
To determine the primary treatment (SET, endovascular revascularisation [ER], or open surgery) in relation to secondary lower limb revascularisation and survival in patients with intermittent claudication (IC). |
The five year cohort included 54 504 patients with IC (primary SET n = 39 476, primary ER n = 11 769, and primary open surgery n = 3 259). SET as primary treatment increased from 63% in 2013 to 87% in 2017. Patients who underwent ER or open surgery as a primary treatment had a higher risk of secondary revascularisations (hazard ratio [HR] 1.44; 95% confidence interval [CI] 1.37-1.51; p < .001 and HR 1.45; 95% CI 1.34-1.57; p < .001, respectively) and a higher mortality risk compared with SET as a primary treatment (HR 1.38; 95% CI 1.29-1.48; p < .001 and HR 1.49; 95% CI 1.34-1.65; p < .001, respectively). |
2 |
| 8. Murphy TP, Cutlip DE, Regensteiner JG, et al. Supervised exercise versus primary stenting for claudication resulting from aortoiliac peripheral artery disease: six-month outcomes from the claudication: exercise versus endoluminal revascularization (CLEVER) study. Circulation 2012;125:130-9. |
Experimental-Tx |
111 patients |
To compare the benefits of optimal medical care (OMC), supervised exercise (SE), and stent revascularization (ST) on both walking outcomes and measures of QOL in patients with claudication due to aortoiliac PAD. |
At the 6-month follow-up, change in peak walking time (the primary end point) was greatest for SE, intermediate for ST, and least with OMC (mean change versus baseline, 5.8+/-4.6, 3.7+/-4.9, and 1.2+/-2.6 minutes, respectively; P<0.001 for the comparison of SE versus OMC, P=0.02 for ST versus OMC, and P=0.04 for SE versus ST). Although disease-specific quality of life as assessed by the Walking Impairment Questionnaire and Peripheral Artery Questionnaire also improved with both SE and ST compared with OMC, for most scales, the extent of improvement was greater with ST than SE. Free-living step activity increased more with ST than with either SE or OMC alone (114+/-274 versus 73+/-139 versus -6+/-109 steps per hour), but these differences were not statistically significant. |
1 |
| 9. Djerf H, Millinger J, Falkenberg M, Jivegard L, Svensson M, Nordanstig J. Absence of Long-Term Benefit of Revascularization in Patients With Intermittent Claudication: Five-Year Results From the IRONIC Randomized Controlled Trial. Circ., Cardiovasc. interv.. 13(1):e008450, 2020 01. |
Observational-Tx |
158 patients: Revascularization Group (n=79) and Nonrevascularization Group (n=79) |
To investigate the long-term effectiveness and cost-effectiveness compared with a noninvasive approach. |
Altogether, 158 patients were randomized in a 1:1 ratio. Regarding the primary end point, no intergroup differences were observed for the short form 36 sum or domain scores from baseline to 5 years, except for the short form 36 role emotional domain score, with greater improvement in the nonrevascularization group (n=116, P=0.007). No intergroup differences were observed in the vascular quality of life questionnaire total and domain scores (n=116, NS) or in treadmill walking distances (n=91, NS). A revascularization strategy resulted in almost twice the cost per patient compared with a noninvasive treatment approach ($13 098 versus $6965, P=0.02). |
1 |
| 10. Menke J, Larsen J. Meta-analysis: Accuracy of contrast-enhanced magnetic resonance angiography for assessing steno-occlusions in peripheral arterial disease. Ann Intern Med. 2010; 153(5):325-334. |
Meta-analysis |
32 studies; 1,022 patients |
To summarize evidence of prospective studies about how well MRA identifies or excludes arterial steno-occlusions (50% to 100% lumen reduction) in adults with PAD symptoms. |
Overall, the pooled sensitivity of MRA was 94.7% (95% CI, 92.1% to 96.4%) and the specificity was 95.6% (CI, 94.0% to 96.8%) for diagnosing segmental steno-occlusions. The pooled positive and negative likelihood ratios were 21.56 (CI, 15.70 to 29.69) and 0.056 (CI, 0.037 to 0.083), respectively. MRA correctly classified 95.3%, overstaged 3.1%, and understaged 1.6% of arterial segments. Similar to most studies of CTA in PAD, the primary studies reported the diagnostic accuracy of MRA on a per-segment basis, not a per-patient basis. This meta-analysis of 32 prospective studies further increases the evidence that CE-MRA has high accuracy for identifying or excluding clinically relevant arterial steno-occlusions in adults with PAD symptoms. |
M |
| 11. Fakhry F, Spronk S, van der Laan L, et al. Endovascular Revascularization and Supervised Exercise for Peripheral Artery Disease and Intermittent Claudication: A Randomized Clinical Trial. JAMA. 314(18):1936-44, 2015 Nov 10. |
Observational-Tx |
212 patients total: endovascular revascularization (selective stenting) plus supervised exercise (n = 106) or supervised exercise only (n = 106) |
To assess the effectiveness of endovascular revascularization plus supervised exercise for intermittent claudication compared with supervised exercise only. |
Endovascular revascularization plus supervised exercise (combination therapy) was associated with significantly greater improvement in maximum walking distance (from 264 m to 1501 m for an improvement of 1237 m) compared with the supervised exercise only group (from 285 m to 1240 m for improvement of 955 m) (mean difference between groups, 282 m; 99% CI, 60-505 m) and in pain-free walking distance (from 117 m to 1237 m for an improvement of 1120 m vs from 135 m to 847 m for improvement of 712 m, respectively) (mean difference, 408 m; 99% CI, 195-622 m). Similarly, the combination therapy group demonstrated significantly greater improvement in the disease-specific VascuQol score (1.34 [99% CI, 1.04-1.64] in the combination therapy group vs 0.73 [99% CI, 0.43-1.03] in the exercise group; mean difference, 0.62 [99% CI, 0.20-1.03]) and in the score for the SF-36 physical functioning (22.4 [99% CI, 16.3-28.5] vs 12.6 [99% CI, 6.3-18.9], respectively; mean difference, 9.8 [99% CI, 1.4-18.2]). No significant differences were found for the SF-36 domains of physical role functioning, bodily pain, and general health perceptions. |
1 |
| 12. Norgren L, Hiatt WR, Dormandy JA, et al. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Eur J Vasc Endovasc Surg. 2007;33 Suppl 1:S1-75. |
Review/Other-Dx |
N/A |
To provide an abbreviated document (compared with the publication in 2000), to focus on key aspects of diagnosis and management, and to update the information based on new publications and the newer guidelines. |
Good practice is based on a combination of the scientific evidence, patients’ preferences, and local availability of facilities and trained professionals. Good practice also includes appropriate specialist referral. |
4 |
| 13. Muela Mendez M, Morata Barrado PC, Blanco Canibano E, Garcia Fresnillo B, Guerra Requena M. Preoperative mapping of the aortoiliac territory with duplex ultrasound in patients with peripheral arterial occlusive disease. J Vasc Surg. 68(2):503-509, 2018 08. |
Observational-Dx |
173 patients with a surgical indication for aortoiliac occlusive disease |
To analyze the degree of agreement between DUS mapping of the aortoiliac area and angiography or contrast-enhanced computed tomography angiography (CTA). |
Of 173 DUS mapping tests, 155 were evaluated (89.6%); the remaining 18 were not able to be evaluated because of the patient's obesity or bowel gas. Overall accuracy of DUS for predicting significant artery lesions was as follows: 92% sensitivity (95% confidence interval [CI], 88%-95%), 96% specificity (95% CI, 95%-97%), 89% positive predictive value (95% CI, 86%-93%), and 97% negative predictive value (95% CI, 96%-98%). Agreement with angiography/CTA had a ? index of 0.81 (95% CI, 0.77-0.84), which reflects a good degree of agreement. Surgical indications based on DUS mapping were correct in 89% of cases (138/155). |
2 |
| 14. Garcia-Rivera E, Cenizo-Revuelta N, Ibanez-Marana MA, et al. Doppler Ultrasound as a Unique Diagnosis Test in Peripheral Arterial Disease. Ann Vasc Surg. 73:205-210, 2021 May. |
Observational-Dx |
51 patients with lower limb arterial disease who underwent a revascularizing procedure |
To analyze duplex ultrasound (DUS) and intraoperative angiography concordance for diagnosis of lower limb peripheral artery disease and its value for surgical planning. |
Fifty-one patients were included, with mean age of 71.8 ± 11.96 years (46-94); 23 had chronic kidney disease (45%). In 17 patients (34%), preoperative CT angiography was also performed. DUS showed a sensitivity of 100% (95% confidence interval (CI) [83.3-100%]), 80% (95% CI [50.21-100%,]), and 100% (95% CI [96.43-100%]) at the iliac, femoral, and popliteal sector, respectively, and a specificity of 93.55% (95% CI [83.29-100%]), 95.45% (95% CI [84.48-100%]), and 90.48% (95% CI [75.54-100%]) at the iliac, femoral, and popliteal sector, respectively. The positive predictive value for DUS was 60% (95% CI [7.06-100%]), 88.9% (95% CI [62.8-100%]), and 87.5% (95% CI [68.17-100%]) for the iliac, femoral, and popliteal sectors, respectively, whereas the negative predictive value was 100% (95% CI [98.28-100%]), 91.3% (95% CI [77.61-100%]), and 100% (95% CI, [97.37-100%]). The concordance between DUS and intraoperative angiography showed a k index of 0.587 (P = 0.000) in the iliac sector, 0.799 in the femoral sector (P = 0.000), and 0.699 in the popliteal sector (P = 0.000). The concordance between CT angiography/intraoperative angiography had a k index of 0.71 in the iliac sector (P = 0.0093), 0.566 in the femoral sector (P = 0.006), and 0.5 in the popliteal sector (P = 0.028). DUS-based surgical plan was accurate in 86% of cases (n = 44). |
1 |
| 15. Darwood R, Berridge DC, Kessel DO, Robertson I, Forster R. Surgery versus thrombolysis for initial management of acute limb ischaemia. Cochrane Database Syst Rev 2018;8:CD002784. |
Meta-analysis |
5 studies with 1292 participants |
To determine whether thrombolysis or surgery is the more effective technique in the initial management of acute limb ischaemia due to thromboembolism. |
We identified no new studies for this update. We included five trials with a total of 1292 participants; agents used for thrombolysis were recombinant tissue plasminogen activator and urokinase. Trials were generally of moderate methodological quality. The quality of evidence according to GRADE was generally low owing to risk of bias (lack of blinding), imprecision in estimates, and heterogeneity.Trial results showed no clear differences in limb salvage, amputation, or death at 30 days (odds ratio (OR) 1.02, 95% confidence interval (CI) 0.41 to 2.55, 4 studies, 636 participants; OR 0.97, 95% CI 0.51 to 1.85, 3 studies, 616 participants; OR 0.59, 95% CI 0.31 to 1.14, 4 studies, 636 participants, respectively), and we rated the evidence as low, low, and moderate quality, respectively. Trial results show no clear differences for any of the three outcomes at six months or one year between initial surgery and initial thrombolysis. A single study evaluated vessel patency, so no overall association could be determined (OR 0.46, 95% CI 0.08 to 2.76, 20 participants; very low-quality evidence). Evidence of increased risk of major haemorrhage (OR 3.22, 95% CI 1.79 to 5.78, 4 studies, 1070 participants; low-quality evidence) and distal embolisation (OR 31.68, 95% CI 6.23 to 161.07, 3 studies, 678 participants; very low-quality evidence) was associated with thrombolysis treatment at 30 days, and there was no clear difference in stroke (OR 5.33, 95% CI 0.95 to 30.11, 5 studies, 1180 participants; low-quality evidence). Participants treated by initial thrombolysis had a greater reduction in the level of intervention required, compared with a pre-intervention prediction, at 30 days (OR 9.06, 95% CI 4.95 to 16.56, 2 studies, 502 participants). None of the included studies evaluated time to thrombolysis as an outcome. |
Good |
| 16. Taha AG, Byrne RM, Avgerinos ED, Marone LK, Makaroun MS, Chaer RA. Comparative effectiveness of endovascular versus surgical revascularization for acute lower extremity ischemia. J Vasc Surg 2015;61:147-54. |
Observational-Tx |
154 limbs in 147 patients in the ER Group and 326 limbs in 296 patients in the OR Group |
To evaluate contemporary endovascular and surgical revascularization for acute limb ischemia (ALI). |
A total of 154 limbs were treated in 147 patients in the ER group, compared with 326 limbs in 296 patients in the OR group. The mean follow-up was 14 ± 18.5 months. The majority of patients presented with Rutherford II ischemia (83% for OR, 90% for ER). In Rutherford II patients, technical success was achieved in 90.7% of the OR group vs 79.9% of the ER group (P = .002), with amputation rates of 10.0% vs 7.2% (P = .35) at 30 days and 16.3% vs 13.0% (P = .37) at 1 year, respectively. In Rutherford II patients with failed bypass graft, technical success rate was 95.0% (OR) vs 75.0% (ER) (P = .001), whereas the amputation rate was 6.3% vs 15.38% (P = .13) at 30 days and 24.1% vs 23.1% (P = .90) at 1 year, respectively. The overall 30-day mortality rate was 13.2% (OR) and 5.4% (ER) (P = .012). Overall amputation rates were 13.5% (OR) vs 6.5% (ER) at 30 days (P = .023) and 19.6% (OR) vs 13.0% (ER) at 1 year (P = .074). The primary patency rate was 57% (OR) and 51% (ER) at 1 year (P = .74). Predictors of limb loss by life-table analysis included coronary artery disease (hazard ratio [HR], 2.0; P = .007) and Rutherford category III (HR, 19.0; P < .001). Predictors of death by life-table analysis included age (HR, 1.03; P < .001), end-stage renal disease (HR, 7.28; P < .001), cancer (HR, 1.65; P = .005), and chronic obstructive pulmonary disease (HR, 1.61; P = .005). |
2 |
| 17. Enezate TH, Omran J, Mahmud E, et al. Endovascular versus surgical treatment for acute limb ischemia: a systematic review and meta-analysis of clinical trials. Cardiovasc Diagn Ther 2017;7:264-71. |
Meta-analysis |
6 studies and 1,773 patients |
To compare mortality, limb amputation and recurrent ischemia across both revascularization strategies. |
A total of 1,773 patients were included from six studies (five randomized prospective and one observational retrospective) comparing ENDO and SURG in the setting of ALI. The mean age was 67 years and 65% of patients were male. There were no differences in mortality between the two groups at 1 month [risk ratio (RR) for ENDO vs. SURG is 0.70; 95% confidence interval (CI), 0.33 to 1.50], 6 months (RR 1.12; CI, 0.78 to 1.61) or 12 months (RR 0.74; CI, 0.29 to 1.85). Similarly, there was no significant difference in amputation rates between ENDO and SURG at 1 month (RR 0.75; CI, 0.40 to 1.42), 6 months (RR 0.87; CI, 0.52 to 1.48) or 12 months (RR 0.81; CI, 0.55 to 1.18). When looking into secondary outcomes, recurrent ischemia was not different between the two groups (RR 1.12; CI, 0.75 to 1.67). |
Inadequate |
| 18. Eikelboom JW, Connolly SJ, Bosch J, et al. Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease. N Engl J Med 2017;377:1319-30. |
Observational-Tx |
Rivaroxaban plus Aspirin (N=9152), Rivaroxaban Alone (N=9117), Aspirin Alone (N=9126) |
To evaluate whether rivaroxaban alone or in combination with aspirin would be more effective than aspirin alone for secondary cardiovascular prevention. |
The primary outcome occurred in fewer patients in the rivaroxaban-plus-aspirin group than in the aspirin-alone group (379 patients [4.1%] vs. 496 patients [5.4%]; hazard ratio, 0.76; 95% confidence interval [CI], 0.66 to 0.86; P<0.001; z=-4.126), but major bleeding events occurred in more patients in the rivaroxaban-plus-aspirin group (288 patients [3.1%] vs. 170 patients [1.9%]; hazard ratio, 1.70; 95% CI, 1.40 to 2.05; P<0.001). There was no significant difference in intracranial or fatal bleeding between these two groups. There were 313 deaths (3.4%) in the rivaroxaban-plus-aspirin group as compared with 378 (4.1%) in the aspirin-alone group (hazard ratio, 0.82; 95% CI, 0.71 to 0.96; P=0.01; threshold P value for significance, 0.0025). The primary outcome did not occur in significantly fewer patients in the rivaroxaban-alone group than in the aspirin-alone group, but major bleeding events occurred in more patients in the rivaroxaban-alone group. |
1 |
| 19. Schmit K, Dolor RJ, Jones WS, et al. Comparative effectiveness review of antiplatelet agents in peripheral artery disease. J Am Heart Assoc 2014;3:e001330. |
Review/Other-Tx |
N/A |
To evaluate various treatment modalities for PAD |
No abstract available |
4 |
| 20. A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). The Lancet 1996;348:1329-39. |
Observational-Tx |
19,185 patients |
To assess the potential benefit of clopidogrel, compared with aspirin, in reducing the risk of ischaemic stroke, myocardial infarction, or vascular death in patients with recent ischaemic stroke, recent myocardial infarction, or peripheral arterial disease. |
19,185 patients, with more than 6300 in each of the clinical subgroups, were recruited over 3 years, with a mean follow-up of 1.91 years. There were 1960 first events included in the outcome cluster on which an intention-to-treat analysis showed that patients treated with clopidogrel had an annual 5.32% risk of ischaemic stroke, myocardial infarction, or vascular death compared with 5.83% with aspirin. These rates reflect a statistically significant (p = 0.043) relative-risk reduction of 8.7% in favour of clopidogrel (95% Cl 0.3-16.5). Corresponding on-treatment analysis yielded a relative-risk reduction of 9.4%. There were no major differences in terms of safety. Reported adverse experiences in the clopidogrel and aspirin groups judged to be severe included rash (0.26% vs 0.10%), diarrhoea (0.23% vs 0.11%), upper gastrointestinal discomfort (0.97% vs 1.22%), intracranial haemorrhage (0.33% vs 0.47%), and gastrointestinal haemorrhage (0.52% vs 0.72%), respectively. There were ten (0.10%) patients in the clopidogrel group with significant reductions in neutrophils (< 1.2 x 10(9)/L) and 16 (0.17%) in the aspirin group. |
1 |
| 21. Foley TR, Singh GD, Kokkinidis DG, et al. High-Intensity Statin Therapy Is Associated With Improved Survival in Patients With Peripheral Artery Disease. J Am Heart Assoc. 6(7), 2017 07 15. |
Observational-Tx |
909 patients with claudication or critical limb ischemia (CLI) |
To compare the effectiveness of low- or moderate-intensity (LMI) versus high-intensity (HI) statin dose on clinical outcomes in patients with peripheral artery disease. |
Among 909 patients, 629 (69%) were prescribed statins, and 124 (13.6%) were treated with HI statin therapy. Mean low-density lipoprotein level was similar in patients on LMI versus HI (80±30 versus 87±44 mg/dL, P=0.14). Demographics including age (68±12 versus 67±10 years, P=0.25), smoking history (76% versus 80%, P=0.42), diabetes mellitus (54% versus 48%, P=0.17), and hypertension (88% versus 89%, P=0.78) were similar between groups (LMI versus HI). There was a higher prevalence of coronary artery disease (56% versus 75%, P=0.0001) among patients on HI statin (versus LMI). After propensity weighting, HI statin therapy was associated with improved survival (hazard ratio for mortality: 0.52; 95% confidence interval, 0.33-0.81; P=0.004) and decreased major adverse cardiovascular events (hazard ratio: 0.58; 95% confidence interval 0.37-0.92, P=0.02). |
2 |
| 22. Liu J, Wu Y, Li Z, Li W, Wang S. Endovascular treatment for intermittent claudication in patients with peripheral arterial disease: a systematic review. [Review]. Ann Vasc Surg. 28(4):977-82, 2014 May. |
Meta-analysis |
10 different randomized controlled trials |
To perform a systematic review and meta-analysis to examine whether patients with intermittent claudication can benefit from endovascular treatment (EVT). |
The independent effect of EVT could directly improve the ankle-brachial index (ABI) and walking performance over the short term, but not over the long term. Moreover, compared to SET, EVT had the superiority in improving the ABI, while SET could improve walking performance more efficiently. |
Good |
| 23. Klaphake S, Buettner S, Ultee KH, van Rijn MJ, Hoeks SE, Verhagen HJ. Combination of endovascular revascularization and supervised exercise therapy for intermittent claudication: a systematic review and meta-analysis. [Review]. J Cardiovasc Surg (Torino). 59(2):150-157, 2018 Apr. |
Meta-analysis |
5 studies |
To assess the outcomes after combination treatment of EVR and SET, compared with EVR or SET alone. |
Our search yielded 812 articles, of which 7 were finally included in the systematic review. Three studies reported the outcomes of combination treatment versus SET and three more reported the outcomes of combination versus EVR. Follow-up ranged between 6 and 24 months. Combination treatment was associated with a greater MWD at 6 months compared to EVR only or SET only, with a standardized mean difference (SMD) of 0.86 (95% CI: 0.15, 1.57) and 0.41 (95% CI: 0.17, 0.66), respectively. At twelve months no significant difference in maximum walking distance was observed between combination treatment compared to EVR (SMD 0.96 [95% CI: -0.44, 2.37]) or SET (SMD 0.52 [95% CI: -0.17, 1.20]). Compared to EVR only, the combination treatment was associated with a greater PFWD walking distance at 12 months (SMD 0.73 [95% CI 0.01, 1.45]). Most studies reported only minor differences in quality of life in favor of the combination treatment, or no difference at all. |
Inadequate |
| 24. Pandey A, Banerjee S, Ngo C, et al. Comparative Efficacy of Endovascular Revascularization Versus Supervised Exercise Training in Patients With Intermittent Claudication: Meta-Analysis of Randomized Controlled Trials. [Review]. JACC Cardiovasc Interv. 10(7):712-724, 2017 04 10. |
Meta-analysis |
987 patients from 7 trials |
To compare the efficacy of initial endovascular treatment with or without supervised exercise training (SET) versus SET alone in patients with intermittent claudication. |
A total of 987 patients from 7 trials were included. In pooled analysis, compared with SET only (reference group), patients that underwent combined endovascular therapy and SET had significantly higher maximum walk distance (standardized mean difference 0.79 [95% confidence interval (CI): 0.18 to 1.39]; weighted mean difference 98.9 [95% CI: 31.4 to 166.4 feet], and lower risk of revascularization or amputation (odds ratio 0.19 [95% CI: (0.09 to 0.40]; p < 0.0001, number needed to treat = 8) over a median follow-up of 12.4 months. By contrast, revascularization was not associated with significant improvement in exercise capacity or risk of future revascularization or amputation, compared with SET alone. Follow-up ABI was significantly higher among patients that underwent endovascular therapy with or without SET as compared with SET alone. |
Good |
| 25. Schlieder I, Richard M, Nacar A, et al. Active Tobacco Use in Patients with Claudication Does Not Affect Outcomes after Endovascular Interventions. Ann Vasc Surg. 60:279-285, 2019 Oct. |
Observational-Tx |
138 patients (47 smokers and 91 nonsmokers) |
To determine if it is justified to deny this group of patients endovascular, potentially lifestyle-improving, procedures based on their outcomes. |
One hundred thirty-eight patients met inclusion criteria with 89 being male (64.5%). Forty-seven (34%) were active smokers versus 91 (66%) who were nonsmokers. Mean age at initial intervention for all 138 subjects was 66.34 years (standard deviation 10.7) and was not statistically different between the AS and NS groups. Mean follow-up was 3.6 years and was not significantly different between the two groups. Between the two groups (AS vs NS), there was no statistically significant difference between the rate of reintervention, surgical bypass, and limb loss. We also did not observe any significant difference in the rate of MI, stroke, or death during our follow-up period. |
2 |
| 26. Bath J, Lawrence PF, Neal D, et al. Endovascular interventions for claudication do not meet minimum standards for the Society for Vascular Surgery efficacy guidelines. J Vasc Surg. 73(5):1693-1700.e3, 2021 05. |
Observational-Tx |
16,152 patients who had undergone endovascular interventions for the indication of IC |
To examine the outcomes of endovascular management of intermittent claudication (IC) reported in the Vascular Quality Initiative and compare them with the Society for Vascular Surgery guidelines for IC treatment to determine whether real-world results are within the guidelines. |
A total of 16,152 patients met the inclusion criteria, with a mean age of 66 years. Of the 16,152 patients, 61% were men, 45% were current smokers, and 28% had been discharged without antiplatelet or statin medication. Adjusted analyses revealed that treatment of more than two arteries was associated with a shorter time to IC recurrence (hazard ratio [HR], 1.19; 95% confidence interval [CI], 1.09-1.31) and a shorter time to repeat procedures (HR, 1.25; 95% CI, 1.09-1.45). The use of atherectomy was also associated with a shorter time to IC recurrence (HR, 1.29; 95% CI, 1.08-1.33) and a shorter time to repeat procedures (HR, 1.31; 95% CI, 1.13-1.52). Discharge with antiplatelet and statin medications was associated with a longer time to IC recurrence (HR, 0.84; 95% CI, 0.78-0.91) and a longer time to repeat procedures (HR, 0.77; 95% CI, 0.69-0.87). Life-table analysis at 2 years revealed that only 32% of patients were free from IC recurrence, although 76% had not undergone repeat procedures. Stratified by anatomic treatment level, 37% of isolated aortoiliac interventions, 22% of aortoiliac and femoropopliteal interventions, 30% of isolated femoropopliteal interventions, and 20% of femoropopliteal and tibial interventions had remained free from IC recurrence at 2 years. |
2 |
| 27. Bekken J, Jongsma H, Ayez N, Hoogewerf CJ, Van Weel V, Fioole B. Angioplasty versus stenting for iliac artery lesions. [Review]. Cochrane Database Syst Rev. (5)CD007561, 2015 May 29. |
Review/Other-Tx |
2 RCTs with 397 participants |
To assess the effects of percutaneous transluminal angioplasty versus primary stenting for stenotic and occlusive lesions of the iliac artery. |
We identified two RCTs with a combined total of 397 participants as meeting the selection criteria. One study included mostly stenotic lesions (95%), whereas the second study included only iliac artery occlusions. Both studies were of moderate methodological quality with some risk of bias relating to selective reporting and non-blinding of participants and personnel. The overall quality of evidence was low due to the small number of included studies, the differences in study populations and definitions of the outcome variables. Due to the heterogeneity among these two studies it was not possible to pool the data. Percutaneous transluminal angioplasty (PTA) with selective stenting and primary stenting (PS) resulted in similar improvement in the stage of peripheral arterial occlusive disease according to Rutherford's criteria, resolution of symptoms and signs, improvement of quality of life, technical success of the procedure and patency of the treated vessel. Improvement in walking distance as reported by the patient, measured claudication distance, ulcer healing, major amputation-free survival and delayed complications (> 72 hours) were not reported in either of the studies. In one trial, PTA of iliac artery occlusions resulted in a significantly higher rate of major complications, especially distal embolisation. The other trial showed a significantly higher mean ankle brachial index (ABI) at two years in the PTA group (1.0) compared to the mean ABI in the PS group (0.91); mean difference (MD) 0.09 (95% confidence interval (CI) 0.04 to 0.14; P value = 0.001, analysis performed by review authors). However, at other time points there was no difference. We consider it unlikely that this difference is attributable to the study procedure, and also believe this difference may not be clinically relevant. |
4 |
| 28. Jongsma H, Bekken J, Ayez N, Hoogewerf CJ, Van Weel V, Fioole B. Angioplasty versus stenting for iliac artery lesions. Cochrane Database Syst Rev. 12:CD007561, 2020 12 01. |
Review/Other-Tx |
No new studies |
To assess the effects of percutaneous transluminal angioplasty versus primary stenting for stenotic and occlusive lesions of the iliac artery. |
We identified no new studies for this update. Previously, we identified two RCTs, with a combined total of 397 participants, as meeting the selection criteria. One study included mostly stenotic lesions (95%), whereas the second study included only iliac artery occlusions. Heterogeneity between these two studies meant it was not possible to pool the data. Both studies were of moderate methodological quality with some risk of bias relating to selective reporting and non-blinding of participants and personnel. Both studies occurred in the 1990s and techniques have since evolved. We assessed the overall certainty of the evidence to be low. We downgraded by two levels: one for risk of bias concerns and one for imprecision and indirectness. There was no evidence of a difference following percutaneous transluminal angioplasty (PTA) with selective stenting compared to primary stenting (PS) in technical success rates in either the study involving stenotic lesions (odds ratio (OR) 1.51, 95% confidence interval (CI) 0.77 to 2.99; 279 participants; low certainty evidence); or the study involving iliac artery occlusions (OR 2.95, 95% CI 0.12 to 73.90; 112 participants; low certainty evidence). In one trial, PTA of iliac artery occlusions resulted in a higher rate of major complications, especially distal embolisation (OR 4.50 95% CI 1.18 to 17.14; 1 study, 112 participants; low certainty evidence). Immediate complications were similar in the second study (OR 1.81, 95% CI 0.64 to 5.13; 1 study, 279 participants; low certainty evidence). Neither study reported on delayed complications. No evidence of a difference was seen in symptomatic improvement (OR 1.03, 95% CI 0.47 to 2.27; 1 study, 157 participants; low certainty evidence). The second study did not provide data but reported no differences. For the outcome of patency, no evidence of a difference was seen in the study involving iliac occlusion at two years (OR 1.60, 95% CI 0.34 to 7.44; 1 study, 57 participants; low certainty evidence); or the study involving stenotic lesions at two years (71.3% in the PS group versus 69.9% in the PTA group). Only one study reported on reintervention (six to eight years, OR 1.22, 95% CI 0.67 to 2.23; 1 study, 279 participants; low certainty evidence); and resolution of symptoms and signs (12 months, OR 1.14, 95% CI 0.65 to 2.00; 1 study, 219 participants; low certainty evidence), with no evidence of a difference detected in either outcome. Neither study reported on improvement in walking distance as reported by the patient. |
4 |
| 29. Ye W, Liu CW, Ricco JB, Mani K, Zeng R, Jiang J. Early and late outcomes of percutaneous treatment of TransAtlantic Inter-Society Consensus class C and D aorto-iliac lesions. J Vasc Surg. 2011;53(6):1728-1737. |
Meta-analysis |
16 articles including 958 patients |
To analyze the technical success and long-term patency of the endovascular treatment of TransAtlantic Inter-Society Consensus (TASC) C and D aorto-iliac arterial lesions. |
Sixteen articles consisting of 958 patients were enrolled in this meta-analysis. The pooled estimate for technical success was 92.8% (95% confidence interval [CI], 89.8%-95.0%, 749 cases). Primary patency at 12 months was 88.7% (95% CI, 85.9%-91.0%, 787 cases). Subgroup analyses demonstrated a technical success rate of 93.7% (95% CI, 88.9%-96.5%) and a 12-month primary patency rate of 89.6% (95% CI, 84.8%-93.0%) for TASC C lesions. For TASC D lesions, these rates were 90.1% (95% CI, 76.6%-96.2%) and 87.3% (95% CI, 82.5%-90.9%), respectively. The technical success and 12-month primary patency rates for primary stenting were 94.2% (95% CI, 91.8%-95.9%) and 92.1% (95% CI, 89.0%-94.3%), respectively; for selective stenting, these rates were 88.0% (95% CI, 67.9%-96.2%) and 82.9% (95% CI, 72.2%-90.0%), respectively. The long-term, primary patency rates for patients receiving primary stenting were significantly better than those receiving selective stenting. Publication bias was not significant for these analyses. |
M |
| 30. Goode SD, Cleveland TJ, Gaines PA, collaborators St. Randomized clinical trial of stents versus angioplasty for the treatment of iliac artery occlusions (STAG trial). Br J Surg 2013;100:1148-53. |
Observational-Tx |
112 patients (PTA Group = 55 patients and Stent Group = 57 patients) |
To assess whether stents confer any safety or efficacy advantage over balloon angioplasty for complete iliac artery occlusion. |
There were 118 patients recruited to the study; six were excluded from the analysis owing to major protocol violations, leaving a total of 112 patients for analysis. Some 55 patients had PTA and 57 had a primary iliac stent. Technical success was achieved in 46 patients (84 per cent) in the PTA group and 56 (98 per cent) in the stent group (P = 0.007). There were 11 (20 per cent) major procedural complications after PTA compared with three (5 per cent) after primary stenting (P = 0.010). There were no significant differences in primary or secondary patency between the groups after 1 and 2 years. |
1 |
| 31. Deloose K, Bosiers M, Callaert J, et al. Primary stenting is nowadays the gold standard treatment for TASC II A & B iliac lesions: the definitive MISAGO 1-year results. J Cardiovasc Surg (Torino). 58(3):416-421, 2017 Jun. |
Observational-Tx |
120 patients with TASC II Class A or TASC II Class B aortoiliac lesions |
To evaluate, in a controlled setting, the long-term (up to 24 months) outcome of the self-expanding nitinol rapid exchange Misago® (Terumo Corporation, Tokyo, Japan) stent in TASC II class A and B aortoiliac lesions. |
The primary patency rate for the total patient population was 97.4%. The primary patency rates at 12 months for the TASC II class A and TASC II class B(C) lesions were respectively 98.3% and 96.6%. No statistical significant difference was shown when comparing these 2 groups (P=0.6407). |
2 |
| 32. Sonetto A, Faggioli G, Pini R, et al. Kissing Stent Technique for TASC C-D Lesions of Common Iliac Arteries: Clinical and Anatomical Predictors of Outcome. Ann Vasc Surg. 71:288-297, 2021 Feb. |
Observational-Tx |
51 patients |
To evaluate the technical and clinical success of kissing stenting in this context and to analyze predictors of outcome. |
In a 6-year period, 51 patients fulfilled the inclusion criteria. TS was achieved in 49 (96.1%) cases. Thirty-one patients (60.8%) received a dual antiplatelet therapy (DAPT) for at least 1 month after the procedure. 30-day CS was 94.1%. Median follow-up was 45.7 months (IQR: 24.5, 8-86 range). The CS was 92.6% at 3 years, with a PP of 86.8% and a secondary patency of 93.2% at 3 years. Six (13.2%) iliac axis occluded during the first follow-up year. NSIC was statistically and independently associated with a lower PP (73% vs. 96%, P = 0.03); DAPT was statistically and independently associated with higher PP than single antiplatelet therapy (96% vs. 75%, P = 0.03); these results were confirmed by Cox regression analysis (HR: 0.14, 95%, IC: 0.01-0.89, P = 0.05 for DAPT analysis; HR: 6.8, 95%, IC: 1.21-59, P = 0.05 for NSIC analysis). |
2 |
| 33. Suzuki K, Mizutani Y, Soga Y, et al. Efficacy and Safety of Endovascular Therapy for Aortoiliac TASC D Lesions. Angiology. 68(1):67-73, 2017 Jan. |
Observational-Tx |
2096 patients (2601 limbs with AI occlusive disease) |
To validate the efficacy and safety of endovascular therapy (EVT) for TASC D lesions |
The success rate of the procedure was significantly lower in the TASC D group (91.6% vs 99.3%, P < .01), and more procedure complications occurred in the TASC D group (11.1% vs 5.2%, P < .01). The results of a 5-year follow-up revealed no significant difference in primary patency (77.9% vs 77.1%, P = .17) and major adverse cardiovascular and limb events (MACLE; 30.5% vs 33.4%, P = .42) between the 2 groups. A multivariate analysis revealed complications and critical limb ischemia are independent predictors of MACLE in the TASC D group. |
2 |
| 34. de Donato G, Bosiers M, Setacci F, et al. 24-Month Data from the BRAVISSIMO: A Large-Scale Prospective Registry on Iliac Stenting for TASC A & B and TASC C & D Lesions. Ann Vasc Surg. 2015;29(4):738-750. |
Observational-Tx |
325 patients |
To evaluate the 24-month outcome of stenting in Trans-Atlantic Inter-Society Consensus (TASC) A & B and TASC C & D iliac lesions in a controlled setting. |
Between July 2009 and September 2010, 190 patients with TASC A or B and 135 patients with TASC C or D aortoiliac lesions were included. The demographic data were comparable for TASC A & B cohort and TASC C & D cohort. Technical success was 100%. Significantly more balloon-expandable stents were deployed in TASC A & B lesions, and considerably more self-expanding stents were placed in TASC C & D (P = 0.01). The 24-month primary patency rate after 24 months for the total population was 87.9% (88.0% for TASC A, 88.5% for TASC B, 91.9% for TASC C, and 84.8% for TASC D). No statistically significant difference was shown when comparing these groups. The 24-month primary patency rates were 92.1% for patients treated with the self-expanding stent, 85.2% for patients treated with the balloon-expandable stent, and 75.3% for patients treated with a combination of both stents (P = 0.06). Univariate and multivariable regression analyses using Cox proportional hazards model identified only kissing stent configuration (P = 0.0012) and obesity (P = 0.0109) as independent predictors of restenosis (primary patency failure). Interestingly, as all TASC groups enjoyed high levels of patency, neither TASC category nor lesion length was predictive of restenosis. |
2 |
| 35. Ichihashi S, Higashiura W, Itoh H, Sakaguchi S, Nishimine K, Kichikawa K. Long-term outcomes for systematic primary stent placement in complex iliac artery occlusive disease classified according to Trans-Atlantic Inter-Society Consensus (TASC)-II. J Vasc Surg. 2011;53(4):992-999. |
Observational-Tx |
413 patients |
To compare long-term outcomes of systematic primary stent placement between Trans-Atlantic Inter-Society Consensus (TASC)-II C/D disease and TASC-II A/B disease |
Technical success rates in TASC-II C/D and A/B were both 99%. Procedure times for TASC-II type A, B, C, and D lesions were 98 +/- 40, 124 +/- 50, 152 +/- 55, and 183 +/- 68 minutes, respectively. Procedure time was significantly longer in TASC-II C/D (167 +/- 63 minutes) than in TASC-II A/B (112 +/- 47 minutes; P < .001). The complication rate was significantly higher in TASC-II C/D (9%) than in TASC-II A/B (3%; P = .014). Cumulative primary patency rates at 1, 3, 5, and 10 years were 90%, 88%, 83%, and 71% in TASC-II C/D and 95%, 91%, 88%, and 83% in TASC-II A/B, respectively. No significant differences were apparent between groups (P = .17; Kaplan-Meier method, log-rank test). In multivariate analysis, lesion length was an independent risk factor for in-stent restenosis (hazard ratio, 1.12, P = .03; 95% confidence interval, 1.01-1.24). |
2 |
| 36. Mwipatayi BP, Ouriel K, Anwari T, et al. A systematic review of covered balloon-expandable stents for treating aortoiliac occlusive disease. J Vasc Surg. 72(4):1473-1486.e2, 2020 10. |
Review/Other-Tx |
14 studies |
To evaluate and compare studies reporting the outcomes of the use of covered balloon-expandable (CBE) stents for the treatment of aortoiliac occlusive disease. |
A total of 15 published articles about 14 studies were included in the review. Of these, eight studies were prospective clinical trials and six studies were retrospective real-world studies. The articles included data regarding five different CBE stents, namely, the iCast/Advanta V12, Viabahn VBX, BeGraft, LifeStream, and JOSTENT. Lesion severity was higher in real-world studies, with more TransAtlantic Inter-Society Consensus Classification class D lesions and a higher percentage of occlusions. All studies showed high rates of technical success and patency over the course of 12 months. Long-term data were only available for the iCast/Advanta V12 device, which had a primary patency rate of 74.7% at 5 years. |
4 |
| 37. Mwipatayi BP, Sharma S, Daneshmand A, et al. Durability of the balloon-expandable covered versus bare-metal stents in the Covered versus Balloon Expandable Stent Trial (COBEST) for the treatment of aortoiliac occlusive disease. J Vasc Surg. 64(1):83-94.e1, 2016 Jul. |
Observational-Tx |
25 patients with 168 iliac arteries |
To determine if the initial patency advantage of covered stents (CSs) over bare-metal stents (BMSs) was sustained at the 5-year follow-up. |
The 5-year results of the COBEST showed that the CS had a significantly higher patency rate than the BMS at 18, 24, 48, and 60 months (95.1%, 82.1%, 79.9%, 74.7% for CS vs 73.9%, 70.9%, 63% and 62.5% for BMS; log-rank test, P = .01). On multivariate analysis, the type of stent used (hazard ratio [HR], 2.797; 95% confidence interval [CI], 1.471-5.318; P = .002) and the Rutherford classification (HR, 2.019; 95% CI, 1.278-3.191; P = .026) significantly affected the adjusted primary patency. On subgroup analysis, the CS showed significantly higher patency and a survival benefit compared with the BMS in TASC C and D lesions (HR, 8.639; 95% CI, 54.253-75.753; P = .003). Moreover, fewer patients received target limb revascularization in the CS group than in the BMS group (odds ratio, 2.32; 95% CI, 1.47-3.36; P = .02); however, there was no statistically significant difference in the rate of amputations between the groups. |
1 |
| 38. DeCarlo C, Latz CA, Boitano LT, et al. An Endovascular-First Approach for Aortoiliac Occlusive Disease is Safe: Prior Endovascular Intervention is Not Associated with Inferior Outcomes after Aortofemoral Bypass. Ann Vasc Surg. 70:62-69, 2021 Jan. |
Observational-Tx |
3,056 patients who underwent AFB |
To determine if prior aortoiliac endovascular intervention (AIEI) was predictive of adverse events after aortofemoral bypass (AFB). |
There were 3,056 patients who underwent AFB; 618 had a prior AIEI. Mean age was 60.3 ± 8.7 years, and 58.7% of patients were men. There was no difference in major complications between the 2 groups (AIEI: 23.8%, no AIEI: 24.5%; P-value = 0.70). Factors associated with major complications were chronic obstructive pulmonary disease (odds ratio [OR]: 1.28, 95% confidence interval [CI]: 1.07-1.54; P = 0.008), simultaneous lower extremity intervention (endarterectomy, bypass, or transluminal intervention, OR 1.41, 95% CI: 1.18-1.69; P < 0.001), congestive heart failure (CHF) (OR 1.58, 95% CI: 1.15-2.16; P = 0.004), increased age (OR 1.03 per year, 95% CI: 1.02-1.04; P < 0.001), increasing operative blood loss (OR 1.35 per liter, 95% CI: 1.21-1.50; P < 0.001), increasing operative time (OR 1.07 per hour, 95% CI: 1.02-1.13; P = 0.008), and end-to-side proximal anastomosis (OR 1.23, 95% CI: 1.03-1.46; P = 0.022). One-year MALE-Free survival was 88.2% (95% CI: 85.2-90.7%) for the prior AIEI group and 89.7% (95% CI: 88.3-90.7%) for the group without prior AIEI (logrank P-value = 0.201). Predictors of MALEs/death were history of a bypass (hazard ratio [HR] 1.51, 95% CI: 1.16-1.96; P = 0.002), increasing degree of ischemia on presentation (HR 1.28 per increasing level of ischemia, 95% CI: 1.16-1.41; P < 0.001), diabetes (HR 1.29, 95% CI: 1.05-1.59; P = 0.014), simultaneous peripheral vascular intervention (HR 2.06, 95% CI: 1.02-4.15; P = 0.044), CHF (HR 1.60, 95% CI: 1.18-2.18; P = 0.002), end-stage renal disease on hemodialysis (HR 5.07, 95% CI: 2.45-10.48; P < 0.001), and presenting hemoglobin<9 g/dl (HR 1.76, 95% CI: 1.02-3.02; P = 0.041). One-year survival for the prior AIEI group was 94.5% (95% CI: 92.2-96.1%) and 94.0% (95% CI: 92.9-94.9%) for the group with no prior AIEI (logrank P = 0.486). Prior AIEI did not predict any of the primary outcomes in multivariable analysis. |
2 |
| 39. Antonello M, Squizzato F, Bassini S, Porcellato L, Grego F, Piazza M. Open repair versus endovascular treatment of complex aortoiliac lesions in low risk patients. J Vasc Surg. 70(4):1155-1165.e1, 2019 10. |
Observational-Tx |
114 patients: OSR Group (n = 56) and ER Group (n = 58) |
To compare open surgical repair (OSR) versus endovascular repair (ER) using self-expanding covered stents for complex TransAtlantic Inter-Society Consensus II (TASC) class C or D aortoiliac lesions in low-risk patients, with a specific subanalysis for younger patients. |
Overall, 114 patients (OSR, n = 56; ER, n = 58) were treated, of whom, 70 patients (63%) had bilateral iliac disease involvement, for a total of 182 limbs revascularized (OSR, n = 96; ER, n = 86). Iliac lesions were classified by limb as TASC C (n = 71; 39%) or D (n = 111; 61%). Their mean age was 61.4 ± 8.4 years, and the mean Society for Vascular Surgery comorbidity score was 0.51 ± 0.39, without statistically significant differences between the OSR and ER groups (0.48 ± 0.29 vs 0.56 ± 0.47; P = .357). At 30 days, the ER group had had a shorter length of hospitalization (8.5 ± 6.2 vs 2.6 ± 0.8 days; P < .001) and intensive care unit stay (0.1 ± 0.6 vs 0.9 ± 0.5 day; P < .001) than the OSR group. The cumulative medical (OSR, 7%; ER, 5%; P = .714) and surgical (OSR, 10%; ER, 8%; P = .759) complication rates were similar. At 5 years, the primary patency rate was similar between the two groups (OSR, 87.3%; ER, 81.4%; P = .317). This result was confirmed in the subgroup of "young" patients (OSR, 84.7; ER, 75.0; P = .272). The limb salvage (OSR, 98.9%; ER, 98.4%; P = .920) and freedom from related reintervention (OSR, 74.4%; ER, 73.0%; P = .703) rates were similar. This trend was also confirmed in the "young" patients for both limb salvage (OSR, 98.5%; ER, 97.6%; P = .896) and freedom from related reintervention (OSR, 76.9%; ER, 63.6%; P = .223). Multivariate analysis indicated that the only independent negative predictor of patency was female gender in the ER group (hazard ratio, 2.89; 95% confidence interval, 1.45-26.60; P = .024). |
2 |
| 40. Dorigo W, Piffaretti G, Benedetto F, et al. A comparison between aortobifemoral bypass and aortoiliac kissing stents in patients with complex aortoiliac obstructive disease. J Vasc Surg. 65(1):99-107, 2017 Jan. |
Observational-Tx |
Group 1 (aortobifemoral bypass) = 82 patients and Group 2 (endovascular recanalization with the kissing stent) =128 patients |
To retrospectively compare early and late results of aortobifemoral bypass and endovascular recanalization with the kissing stent technique in the management of TransAtlantic Inter-Society Consensus II (TASC II) C and D lesions in the aortoiliac district in a multicenter study. |
Patients in group 2 were more frequently female and more frequently had diabetes and arterial hypertension than patients in group 1. The indication for surgical intervention was the presence of critical limb ischemia in 29 cases in group 1 (35%) and in 31 cases in group 2 (24%; P = .07). Technical success in group 2 was 98.5%; two patients required immediate conversion to open surgery for iliac rupture. There was one perioperative death in group 1 (mortality rate, 1%; P = .2 in comparison with group 2). Four perioperative thromboses occurred, two in group 1 and two in group 2 (in one case requiring conversion to open surgical intervention), and no amputations at 30 days were recorded. Cumulative postoperative local and systemic complications occurred in 17 patients in group 1 (20.5%) and in 9 patients in group 2 (7%; P < .001). Mean duration of follow-up was 38 months (range, 1-96 months). Survival rates at 6 years were 65.5% (standard error [SE], 0.08) in group 1 and 83.5% (SE, 0.08) in group 2 (P = .08; log-rank, 2.2). At the same time interval, primary, assisted primary, and secondary patency rates were similar; reintervention rates were 6% in group 1 (SE, 0.05) and 11% in group 2 (SE, 0.04; P = .3; log-rank, 0.8). Univariate and multivariate analysis showed that only the presence of critical limb ischemia was independently associated with poorer primary patency during follow-up (hazard ratio, 2.4; 95% confidence interval, 0.9-6.4; P = .05). |
2 |
| 41. Gabel JA, Kiang SC, Abou-Zamzam AM Jr, Oyoyo UE, Teruya TH, Tomihama RT. Trans-Atlantic Inter-Society Consensus Class D Aortoiliac Lesions: A Comparison of Endovascular and Open Surgical Outcomes. AJR Am J Roentgenol. 213(3):696-701, 2019 09. |
Observational-Tx |
32 consecutive patients with symptomatic TASC II D AOID who underwent surgical bypass or endovascular reconstruction |
To compare the clinical and safety outcomes between two groups of patients with Trans-Atlantic Inter-Society Consensus class D (TASC II D) aortoiliac occlusive disease (AIOD): those with higher-risk comorbidity who underwent endovascular reconstruction and those with lower-risk comorbidity who underwent surgical bypass. |
Nineteen patients with higher comorbidity underwent endovascular reconstruction, whereas 13 patients with lower comorbidity underwent surgical bypass. Patients undergoing endovascular reconstruction had an older median age (67.0 vs 62.0 years; p = 0.007), higher rates of hypertension (94.7% vs 61.5%; p = 0.018) and coronary artery disease (26.3% vs 0%; p = 0.044), and advanced renal impairment (mean [± SD] chronic kidney disease stage, 1.4 ± 1.5 vs 0.7 ± 1.3; p = 0.005). There were no significant differences in Rutherford classification between the groups. During long-term follow-up of 2.76 years, endovascular reconstruction and surgical bypass showed equivalent rates of survival (89.5% vs 84.6%; p = 0.683), limb salvage (100.0% vs 92.3%; p = 0.219), and primary or primary-assisted patency (85% vs 85%; p = 0.98). Groups showed similar clinical improvements in walking distance, rest pain, and tissue loss at 30 days (95% vs 85%; p = 0.158) and at long-term follow-up (74% vs 62%; p = 0.599). |
2 |
| 42. Lun Y, Zhang J, Wu X, et al. Comparison of midterm outcomes between surgical treatment and endovascular reconstruction for chronic infrarenal aortoiliac occlusion. J Vasc Interv Radiol. 26(2):196-204, 2015 Feb. |
Observational-Tx |
33 patients (Open Surgery) and 23 Patients (Endovascular) |
To compare the midterm results of aortoiliac stent (AIS) placement with those of surgical treatment in patients with chronic infrarenal aortoiliac occlusion. |
The technical success rate was significantly lower in the AIS group than in the surgery group (83.3% vs 100%; P = .016). Of 68 technically successfully treated patients, 33 underwent surgical revascularization and 35 received AIS placement. There were no significant differences in patient demographics, Rutherford classification, cardiovascular risk factors, and 30-day mortality rates. Surgically treated patients had a longer average postoperative hospital stay (P = .001) and higher rates of postoperative complications, including respiratory failure (P = .010), transient renal dysfunction (P = .002), and multiple organ dysfunction (P = .023). Mean ankle-brachial index increased significantly in both groups (P < .001), but to the same extent. The primary 1-, 3-, and 5-year patency rates were 93.6%, 90.2%, and 90.2%, respectively, in the surgery group, and 91.4%, 81.8%, and 64.2%, respectively, in the AIS group (P = .054). No differences were observed in survival rate (P = .945), limb salvage (P = .860), or secondary patency (P = .916). |
2 |
| 43. Mayor J, Branco BC, Chung J, et al. Outcome Comparison between Open and Endovascular Management of TASC II D Aortoiliac Occlusive Disease. Ann Vasc Surg. 61:65-71.e3, 2019 Nov. |
Observational-Tx |
75 consecutive patients (open: 30; endovascular: 45) |
To evaluate short and midterm outcomes of open and endovascular therapy in TASC II D aortoiliac occlusive disease (AIOD) patients. |
A total of 75 consecutive patients (open: 30; endovascular: 45) were included in this analysis. In the endovascular group, 25 (55.6%) patients were managed using a hybrid approach with 100% technical success. Critical limb ischemia was the indication for intervention in 16.0% of this cohort (open, 13.3% vs. endovascular, 17.8%, P = 0.397). Overall, there were no significant differences in gender (male: open, 50.0% vs. endovascular, 55.6%, P = 0.637) or age (54.5 ± 5.9 years vs. 57.0 ± 8.7 years, P = 0.171). No in hospital deaths occurred in this cohort. The overall complication rate was significantly higher in the open group (43.3% vs. 17.8%, OR 3.5, 95% CI [1.2-10.1], P = 0.016) with peri-operative systemic complications being more likely in the open cohort (40.0% vs. 6.7%, OR 9.3, 95% CI [2.3-37.3], P < 0.001) while technical complications did not differ between the 2 groups (6.7% vs. 11.1%, OR 0.6, 95% CI [0.1-3.1], P = 0.517). Follow up data was available for 68 patients (90.7%), for a mean of 21.3 ± 17.1 months (range: 1-72 months). Re-intervention rates were significantly higher in the endovascular group (3.3% vs. 20.0%, OR 7.2, 95% CI [1.1-14.3], P = 0.038). The overall primary patency at 2 years was significantly higher in the open group (96.7% vs. 80.0%, OR 7.2, 95% CI [1.2-60.5], P = 0.038). Cox regression analysis revealed separation of the primary outcome for open therapy relative to endovascular repair (log rank, P = 0.320). |
2 |
| 44. Rocha-Neves J, Ferreira A, Sousa J, et al. Endovascular Approach Versus Aortobifemoral Bypass Grafting: Outcomes in Extensive Aortoiliac Occlusive Disease. Vasc Endovascular Surg. 54(2):102-110, 2020 Feb. |
Observational-Tx |
27 patients underwent aortobifemoral bypass and 32 patients were submitted to endovascular repair |
To examine the outcomes of the first approach of iliac stenting in TASC type D aortoiliac disease and compare its technical and short-term success to those with primary aortobifemoral (ABF) grafting. |
Twenty-seven patients underwent aortobifemoral bypass and 32 patients were submitted to endovascular repair. The patients undergoing endovascular procedure were more likely to present with chronic heart failure (P = .001) and chronic kidney disease (P = .022) and less likely to have a history of smoking (P = .05). The mean follow-up period was 67.84 (95% confidence interval = 61.85-73.83) months. The open surgery approach resulted in a higher technical success (P = .001); however, limb salvage and patency rates were not different between groups. Endovascular approach was associated with a shorter length-of-stay, both inpatient (6 vs 9 days; P = .041) and patients admitted in the intensive care unit (0 vs 3.81 days; P = .001) as well as lower hospital expenses (US$9281 vs US$23 038; P = .001) with a similar procedure cost (US$2316 vs US$1173; P = .6). No differences were found in the postsurgical quality of life. |
2 |
| 45. Tsai TT, Rehring TF, Rogers RK, et al. The Contemporary Safety and Effectiveness of Lower Extremity Bypass Surgery and Peripheral Endovascular Interventions in the Treatment of Symptomatic Peripheral Arterial Disease. Circulation. 132(21):1999-2011, 2015 Nov 24. |
Observational-Tx |
883 patients undergoing PVI and 975 patients undergoing LEB |
To assess the safety and effectiveness of lower extremity bypass surgery (LEB) and peripheral endovascular interventions (PVIs) in patients with symptomatic claudication and critical limb ischemia. |
In a community-based clinical registry at 2 large integrated healthcare delivery systems, we compared 883 patients undergoing PVI and 975 patients undergoing LEB between January 1, 2005 and December 31, 2011. Rates of target lesion revascularization were greater for PVI than for LEB in patients presenting with claudication (12.3±2.7% and 19.0±3.5% at 1 and 3 years versus 5.2±2.4% and 8.3±3.1%, log-rank P<0.001) and critical limb ischemia (19.1±4.8% and 31.6±6.3% at 1 and 3 years versus 10.8±2.5% and 16.0±3.2%, log-rank P<0.001). However, in comparison with PVI, LEB was associated with increased rates of complications up to 30 days following the procedure (37.1% versus 11.9%, P<0.001). There were no differences in amputation rates between the 2 groups. Findings remained consistent in sensitivity analyses by using propensity methods to account for treatment selection. |
2 |
| 46. Salem M, Hosny MS, Francia F, et al. Management of Extensive Aorto-Iliac Disease: A Systematic Review and Meta-Analysis of 9319 Patients. Cardiovasc Intervent Radiol. 44(10):1518-1535, 2021 Oct. |
Meta-analysis |
9319 patients (66 studies) |
To investigate outcomes in patients with TASC II C/D lesions treated with open bypass procedures (OS), standard endovascular treatments (SEV) or CERAB. |
A total of 9319 patients undergoing intervention for extensive AIOD were identified from 66 studies. Median patient age was 64 years (n = 3204) for SEV, 58 years (n = 240) for CERAB and 59 years for OS (n = 5875). Pooled meta-analysis for 30-day morbidity in patients undergoing SEV, CERAB and OS was 9, 10 and 15%, respectively. Thirty-day mortality rate was 0.79, 0 and 3% in the SEV, CERAB and OS groups, respectively. In these groups, one-year primary and secondary patency was 90, 88, 96 and 96, 97, and 97% whilst three-year primary and secondary patency was 78, 82, 93 and 93, 97, 97% respectively. Five-year primary and secondary patency was 71 and 89% for SEV and 88 and 95% for OS, respectively. CERAB data were only available to 3 years. |
Inadequate |
| 47. Grandjean A, Iglesias K, Dubuis C, Deglise S, Corpataux JM, Saucy F. Surgical and endovascular hybrid approach in peripheral arterial disease of the lower limbs. Vasa. 45(5):417-22, 2016 Sep. |
Observational-Tx |
64 patients treated with a hybrid revascularization approach for an occlusive arterial disease |
To evaluate the efficacy of one-stage hybrid revascularization in patients with multilevel arterial peripheral disease. |
64 patients were included in the study, with a mean follow-up time of 428 days (range: 4 - 1140). The technical success rate was 100 %. The primary, primary assisted and secondary patency rates at 1 year were 39 %, 66 % and 81 %, respectively. The limb-salvage rate was 94 %. The early mortality rate was 3.1 %. Early and midterm complication rates were 15.4 % and 6.4 %, respectively. The early mortality rate was 3.1 %. |
2 |
| 48. Ilano AG, Garvin RP, Ryer EJ, Dove JT, Elmore JR. Patency and limb salvage after femoral endarterectomy and iliac stenting are not affected by severity of iliac disease. J Vasc Surg. 65(5):1336-1343, 2017 05. |
Observational-Tx |
99 patients underwent 111 total FEIS procedures (34 limbs in Group 1 and 77 limbs in Group 2) |
To report our single-institution experience of femoral endarterectomy and iliac artery stenting (FEIS) in patients who are stratified according to the severity of the iliac disease component. |
Between January 1, 2004, and December 31, 2013, 99 patients underwent 111 total FEIS procedures. The mean age of the cohort was 67.4 years. Men composed 61% of patients. Indications for surgery were claudication (41%), ischemic rest pain (36%), and tissue loss (23%). At 5 years of follow-up, there was no difference in primary patency (73% in group 1 vs 68% in group 2 [P = .67]) and limb salvage (90% in group 1 vs 92% in group 2 [P = .51]). There was a trend toward higher overall mortality in group 2 patients vs group 1 patients (53% vs 81%; P = .08), but this did not reach statistical significance. Univariate analysis did not identify any device-related or anatomic factors predictive of patency. |
2 |
| 49. Jorshery SD, Luo J, Zhang Y, Sarac T, Ochoa Chaar CI. Hybrid surgery for bilateral lower extremity inflow revascularization. J Vasc Surg. 70(3):768-775.e2, 2019 Sep. |
Observational-Tx |
1,426 patients |
To compare the perioperative outcomes of HYB surgery with traditional surgery for bilateral inflow revascularization. |
There were 1426 patients (ABF bypass, 976; AXBF bypass, 257; HYB surgery, 193). There were significant differences in the three populations of patients, with ABF bypass patients significantly more likely to have age <70 years (ABF bypass, 84.2%; AXBF bypass, 49.8%; HYB surgery, 58%; P < .001) and more likely to be independent (ABF bypass, 98%; AXBF bypass, 89.1%; HYB surgery, 93.2%; P < .001). Patients undergoing AXBF bypass were significantly more likely to be treated for critical limb ischemia (ABF bypass, 46.5%; AXBF bypass, 72.4%; HYB surgery, 51.8%; P < .001) under emergent conditions (ABF bypass, 0.9%; AXBF bypass, 5.1%; HYB surgery, 3.6%; P < .001). There was no difference in mortality between the three groups (P = .178). After propensity matching, a total of 571 patients with ABF bypass were compared with HYB surgery patients. HYB surgery patients had significantly less pneumonia (ABF bypass, 8.7%; HYB surgery, 1.6%; P < .001), unplanned intubation (ABF bypass, 7.7%; HYB surgery, 3.1%; P = .032), cardiac arrest (ABF bypass, 3.7%; HYB surgery, 0.5%; P = .025), transfusion (ABF bypass, 44.4%; HYB surgery, 18.1%; P < .001), and composite morbidity (ABF bypass, 55%; HYB surgery, 32.6%; P < .001). Patients undergoing ABF bypass had significantly higher mortality (ABF bypass, 4.2%; HYB surgery, 1%; P = .043) and 30-day reoperation (ABF bypass, 17.5%; HYB surgery, 9.3%; P = .009) and longer total hospital length of stay (ABF bypass, 9.79 ± 10.69 days; HYB surgery, 5.79 ± 9.72 days; P < .001). There was no difference in major amputation (P = .607) and readmission (P = .495) between the two groups. |
3 |
| 50. Maitrias P, Deltombe G, Molin V, Reix T. Iliofemoral endarterectomy associated with systematic iliac stent grafting for the treatment of severe iliofemoral occlusive disease. J Vasc Surg. 65(2):406-413, 2017 02. |
Observational-Tx |
108 patients (127 iliofemoral endarterectomies combined with EIA stent grafting) |
To report the midterm outcomes of this approach. |
The procedure was technically successful in 100% of patients. Median diameter of covered stents was 8 mm (range, 6-10 mm). No intraoperative arterial rupture or dissection was observed. Early reoperations (3%) were performed for bleeding, infection, or thrombosis. Median length of stay was 5 days. No 30-day mortality was observed. Median follow-up was 30 months (range, 0-6 years), and overall mortality was 13% (due to cancer in half of the cases). Repeated angioplasty was performed in three (2%) cases, and a subsequent open procedure on the iliofemoral segment was performed in seven (5%) cases. At 2 years, primary patency rate of the treated segment was 91%. The 2-year primary assisted patency and secondary patency rates were 94% and 98%, respectively. Five-year primary, primary assisted, and secondary patency rates were 87%, 92%, and 98%, respectively. |
2 |
| 51. Zavatta M, Mell MW. A national Vascular Quality Initiative database comparison of hybrid and open repair for aortoiliac-femoral occlusive disease. J Vasc Surg. 67(1):199-205.e1, 2018 01. |
Observational-Tx |
879 patients in the OR-CFE group and 1472 in the ER-CFE group |
To sought to analyze the outcomes of revascularization for aortoiliac-femoral occlusive disease by comparing hybrid repair by endovascular revascularization and open common femoral endarterectomy (ER-CFE) with open aortoiliac reconstruction and CFE (OR-CFE). |
After exclusions, the cohort comprised 879 patients in the OR-CFE group and 1472 in the ER-CFE group with follow-up of at least 9 months. Patients with ER-CFE were older (68 ± 9 years vs 63 ± 9 years; P < .001) and were more likely to have diabetes (37% vs 29%; P < .001) or heart failure (13% vs 9%; P < .01). Those receiving OR-CFE were more likely to have received a previous inflow procedure (27% vs 21%; P < .001). A greater number of arterial segments were treated or bypassed for patients undergoing OR-CFE (5.2 ± 1.6 vs 2.9 ± 1.0; P < .01). ER-CFE was associated with lower 30-day mortality (1.8% vs 3.4%; P = .01), shorter length of stay (median 3 vs 7 days; P < .001), and higher 1-year mortality (8.6% vs 6.3%; P = .04). The two cohorts had equivalent major amputation rate (2.8% vs 2.9%; P = .84). Patients with OR-CFE had greater ABI improvement at long-term follow-up (0.39 ± 0.37 vs 0.26 ± 0.23; P < .001) and were more likely to achieve improved ambulatory status (82% vs 65%; P < .001). |
2 |
| 52. Bredahl K, Jensen LP, Schroeder TV, Sillesen H, Nielsen H, Eiberg JP. Mortality and complications after aortic bifurcated bypass procedures for chronic aortoiliac occlusive disease. J Vasc Surg. 62(1):75-82, 2015 Jul. |
Observational-Tx |
3623 aortobifemoral and 144 aortobiiliac bypass procedures |
To assess the early outcome after aortic bifurcated bypass procedures during two decades of growing endovascular activity and identified preoperative risk factors. |
We identified 3623 aortobifemoral and 144 aortobiiliac bypass procedures. The annual caseload fell from 323 to 106 during the study period, but the 30-day mortality at 3.6% (95% confidence interval [CI], 3.0-4.1) and the 30-day major complication rate remained constant at 20% (95% CI, 18-21). Gangrene (odds ratio [OR], 3.3; 95% CI, 1.7-6.5; P = .005) was the most significant risk factor for 30-day mortality, followed by renal insufficiency (OR, 2.5; 95% CI, 1.1-5.8; P = .035) and cardiac disease (OR, 2.1; 95% CI, 1.4-3.1; P < .001). Multiorgan failure, mesenteric ischemia, need for dialysis, and cardiac complications were the most lethal complications, with mortality rates of 94%, 44%, 38%, and 34%, respectively. |
2 |
| 53. National Academies of Sciences, Engineering, and Medicine; Division of Behavioral and Social Sciences and Education; Committee on National Statistics; Committee on Measuring Sex, Gender Identity, and Sexual Orientation. Measuring Sex, Gender Identity, and Sexual Orientation. In: Becker T, Chin M, Bates N, eds. Measuring Sex, Gender Identity, and Sexual Orientation. Washington (DC): National Academies Press (US) Copyright 2022 by the National Academy of Sciences. All rights reserved.; 2022. |
Review/Other-Dx |
N/A |
Sex and gender are often conflated under the assumptions that they are mutually determined and do not differ from each other; however, the growing visibility of transgender and intersex populations, as well as efforts to improve the measurement of sex and gender across many scientific fields, has demonstrated the need to reconsider how sex, gender, and the relationship between them are conceptualized. |
No abstract available. |
4 |
