Endovascular Treatment of External Iliac Artery Stenoses for Claudication with Systematic Stenting
Article Outline
The results of the endovascular treatment of external iliac artery lesions in patients with claudication are not well known. In the literature, very often, the studied populations are not homogenous (people with claudication and with acute ischemia) and the external iliac artery is not differentiated from the primary iliac artery. Moreover, systematic stenting is still debated. Our goal was to study the results of systematic stenting for atheromatous lesions of the external iliac artery in a consecutive and homogenous population of patients with claudication. From June 2000 to December 2006, 90 external iliac arteries were treated with systematic stenting for atheromatous lesions in 81 consecutive patients with claudication (74 men and 7 women, aged 62
±12 years). Lesions were classified according to the Trans-Atlantic Intersociety Consensus (TASC). Endovascular treatment was systematically chosen for TASC A (n=40) and B (n=30) patients and patients at high surgical risk for TASC C (n=18) and D (n=2). One hundred and seven stents were placed; they were 37±21mm long with a 7±0.6mm diameter. Clinical examination and duplex follow-up were carried out at a minimum of 3 months and at the end of the follow-up. There was a 2.2% complication rate, without any deaths (retroperitoneal hematoma). Mean follow-up was 23 months (with a 13-month median). Primary patency rate was 97% (standard error [SE] 2%) at 1 year, 90% (SE 4.6%) at 2 years, and 84% (SE 6.6%) at 3 years. Secondary patency rate was 98% (SE 1.5%) at 1 year, 93% (SE 3.9%) at 2 years, and 93% (SE 4.5%) at 3 years. Ten restenoses were detected and treated by endovascular techniques (n=6), bypass (n=2), or medication (n=2). At the end of the follow-up, the patients were asymptomatic (n=62) or presented with a moderate (n=17) or severe (n=8) claudication. A patient with hemodialysis was amputated at the metatarsal level. No significant predictive restenosis factor was discovered. However, the C or D TASC classification seemed to favor an earlier restenosis (p=0.06). In conclusion, our study demonstrates that, in a larger population than in the literature, systematic stenting on the external iliac artery gives satisfying results in patients with claudication.
Introduction
The endovascular technique is often the first choice to treat mild aortoiliac atheromateous lesions.1 As with every new therapy, its indications and results can change.2, 3 The present consensus is a technique of selective stenting for moderate lesions. This consensus is based on a single prospective randomized study comparing the results of systematic and selective stenting between 1993 and 1997. No significant differences were found between the two techniques.4, 5
Since then, several authors have found results favoring systematic stenting.6, 7, 8 Very often, when lesions are located on the external iliac artery (EIA), reported results concerning patency are not very satisfying,9, 10 especially in women.11 Moreover, in many studies, either the results concerning the common iliac artery (CIA) and the EIA are mixed4 or the populations are not homogenous since they include patients with claudication and patients with acute ischemia.12 Therefore, for patients with claudication who have one or several atheromatous lesions of the EIA, it is difficult to choose a technique and to foresee its long-term results. A recent study by Lee et al.8 compared the results of systematic EIA and CIA stenting in a population of patients with occlusive lesions. In 49 patients treated for EIA lesions, the primary patency rate (PPR) was 93% at 1 year and 90% at 3 years. Since the year 2000, the therapeutic attitude of our endovascular team is to perform percutaneous transluminal angioplasty (PTA) with systematic stenting.
We have assumed that last-generation stents with a thinner meshing would give better results13 and that immediate better cosmetic and hemodynamic results would result in better mid- and long-term PPRs.
This study analyzed systematic EIA stenting results in a homogenous and consecutive population of patients with claudication. Evaluating secondary patency rate (SPR) and searching predictive risk factors of restenosis were the secondary objectives.
Patients and Methods
Population
Ninety EIAs were consecutively treated in 81 patients (74 men, seven women) by systematic stenting in the CHRU in Tours from June 2000 to December 2006. To be eligible for this study, patients had to present with moderate to severe claudication in relation to a significant EIA atheromatous stenosis, isolated or not, and had to be treated by an endovascular technique.
Patients who had undergone a major amputation before the iliac lesion treatment or presented with severe ischemia were not eligible for this study. Demographic data, risk factors, complications, and results were defined according to the criteria proposed by the Ad Hoc Committee on Reporting Standards.14, 15
Arterial hypertension was defined whenever antihypertensive treatment was given or a systolic arterial blood pressure ≥140mm Hg and/or a diastolic arterial blood pressure ≥90mm Hg was discovered. Diabetes was defined when two preprandial glycemia were ≥1.26g/L or when the blood glucose level was ≥2g/L.
Hypercholesterolemia was defined whenever a cholesterol-lowering treatment was applied or when the total cholesterol rate was ≥2g/L. Chronic renal insufficiency was defined when creatinine clearance, according to the Cockroft-Gault formula, was <50mL/min.
A heavy smoker was considered as a weaned smoker after a minimum of 3 months without smoking. Arteriopathic clinical symptomatology in the lower limbs was described according to the classification established by Rutherford et al.14 from the Fontaine stages. Preoperative evaluation included arterial duplex scan of the lower limbs as well as magnetic resonance angiography or arteriography. Lesions on imaging were classified according to the 2000 Trans-Atlantic Intersociety Consensus (TASC).1 Patency of outflow arteries was evaluated according to superficial femoral artery (SFA) patency.16
Conventional surgery or endovascular technique was chosen according to the TASC classification: endovascular treatment was first applied to patients in class A or B. Conventional surgery was performed on patients with class C or D lesions,10, 16, 17 except for those with major surgical risks (severe ischemic coronary disease, acute cardiac insufficiency, severe valvulopathy, major cardiac dysrhythmia) or intermediate risks (renal insufficiency, insulin-requiring diabetes, chronic angina, myocardial infarction history).18 During the study, 125 patients were treated with conventional surgery for diffuse TASC C or D aortoiliac lesions. Since then, a new TASC classification, the TASC II, has been published.2, 3 Isolated EIA occlusions that used to be in class C are now in class B and calcified or long occlusions, which used to be in class D, are now in class C. Stenosis length of class B lesions used to be <5cm but is now <10cm.
Operative Procedure
The therapeutic attitude consisted of systematic stent placement on the treated EIA lesion(s). Stent placement was performed in the operating theater by vascular surgeons, with a homogenous technique. All procedures were carried out under the control of a C-arm (BV29; Philips, Best, the Netherlands), by a humeral or femoral percutaneous punction with a 6- or 7-French introducer. Patients had perioperative intravenous heparin injection (25 or 50mg/kg). When several stents were placed at short intervals, their extremities were superimposed in order to have no <1cm free intervals between two stents. In case of perioperative dissection, an additional stent was placed to treat it. The type of stent was chosen by the surgeon. The global attitude was to use self-expandable nitinol stents (Luminex®; Bard, Tempe, AZ) for long lesions or for lesions requiring coverage of the ostium of the hypogastric artery or crossing of the crural arcade; ballon-expandable stents (Genesis®; Cordis, Miami, FL) were used for tight or calcified short lesions.
When the guidewire could cross the lesion without any difficulty, no predilatation was performed; but in case of occlusive or preocclusive lesion or in case of difficult crossing of the lesion, a predilatation was performed thanks to a balloon whose diameter was smaller than the native artery diameter (4mm).
When a self-expandable stent was placed, stent dilatation was performed with a balloon whose diameter and length were identical to the stent's. The immediate success of this technique was defined by a <30% residual stenosis after angiographic control. This procedure was followed by 15min of manual compression on the access site before applying a compressing bandage, which would remain for 24hr. The length of stay in the hospital was at least 24hr.
Medical Treatment
Immediate postoperative treatment consisted of 5 days with low–molecular weight heparin in association with 75mg/day aspirin and 75mg/day clopidogrel for 1 month, followed by 75mg/day clopidogrel in the long term.
Antivitamin K medication was not prescribed except when an associated cardiological indication was present. At the beginning of our study, only hypercholesterolemic patients were treated with statins, whereas since 2002 all patients have been given this treatment.19
Follow-Up Procedure
After surgery, patients were examined at 3 months and 6 months and then once a year. Follow-up examination included clinical examination and duplex scan of lower limb arteries.
Clinical evaluation was performed according to the Rutherford scale.14 Patients with symptom recurrence, weakening of femoral pulse rate, or a decrease in ankle brachial index (ABI) associated, at the Doppler echography, with an EIA stenosis and hemodynamic repercussions underwent an arteriography or an angio-computed tomography to detect intrastent restenosis or another evolution of the pathology. Stenosis >50% in diameter at the stent level or a located systolic peak >2.5m/sec was considered as intrastent recurrence of the pathology, defining the end of primary patency.14
Endovascular redo surgery was attempted except when an occlusion of the iliac axis or a very diffuse restenosis was detected. PPR was defined by a nonstenosed or <50% stenosed patent artery with no endovascular redo surgery. SPR was defined by a nonstenosed or <50% stenosed patent artery after endovascular redo surgery to treat an intrastent restenosis during the study. A failure of the endovascular technique was defined by recurrence requiring a surgical treatment or a homolateral major amputation, which excluded the patient from the study.
Statistical Analysis
The PPR and SPR as well as the standard error (SE) were calculated according to the method of the survival table described by Rutherford et al.14 Data were presented as mean ± standard deviation or as median and interquartile range when distribution was not normal.
The effect of the different variables on restenosis recurrence was studied by the Cox model. The curves describing the PPR according to time used the Kaplan-Meier method. Statistical analysis was performed using the SAS software, version 9.1 (SAS Institute, Cary, NC) for Windows. Statistical significance was set at p<0.05.
Results
Population
From January 2000 to December 2006, 90 EIAs were treated by selective stenting in 81 patients, 74 men (91%) and seven women (9%), with stage II peripheral arterial occlusive disease (PAOD).
Patients whose stent placement on EIA was due to an etiology other than PAOD (one case of arteritis postirradiation, one lower limb acute ischemia, and one case of traumatic dissection after the use of an embolectomy catheter) were not included.
Mean age was 62±11 years (range 40-86). The most frequently associated risk factors were smoking (97.8%, 50% active smokers and 47.8% weaned smokers), arterial hypertension (69%), hypercholesterolemia (57.8%), and diabetes (15.6%).
Medical history frequently included renal insufficiency (11.1%, 4.4% being dialyzed patients), ischemic cardiopathy (25.6%), cerebral vascular accident (5.6%), and obstructive bronchopneumopathy (37.8%).
Mean length of the lesions was 27±20mm; 82 stenoses and eight occlusions were treated. Stents were placed on 40 iliac lesions classified TASC A (44.4%), 30 iliac lesions classified TASC B (33.3%), 18 iliac lesions classified TASC C (20%), and two iliac lesions classified TASC D (2.3%). Lesion location was proximal (n=59), medial (n=31), or distal (n=29). The SFA was patent in 62.2% of cases. Mean preoperative ABI was 0.67±0.16.
Operative Procedure
Procedures were carried out under local anesthesia by femoral homolateral (n=68), contralateral (n=13), or humeral (n=3) percutaneous access or under general anesthesia in case of associated surgery (n=6).
In total, 107 stents were placed in 90 EIAs. In 81% of cases, a single stent was placed and in 19% of cases two stents were placed. Self-expandable stents were used in 73.3% of cases, balloon-expandable stents in 24.4% of cases, and both types in 2.2% of cases. Stent mean length was 37±21mm (30±15mm for balloon-expandable stents and 54±25mm for self-expandable ones). Stent mean diameter was 7±0.6mm. The procedure was successful in 100% of cases. In seven cases, a bilateral EIA procedure was carried out.
In 25 cases, a homolateral concomitant procedure was performed: CIA stent angioplasty (n=20), SFA stent angioplasty (n=1), open surgery of the femoral tripod (n=6), or above-knee femoropopliteal bypass (n=1).
There were 2.2% peroperative complications: two EIA perforations resulting in a retroperitoneal hematoma, treated with covered stent placement. One of them had an increase in the troponin level, without any electrocardiographic modification. There were no stent infections or distal embolism. Seven perioperative dissections occurred and were treated with placement of an additional stent. In three cases, the hypogastric artery ostium became thrombosed after stent placement.
Patency
The mean follow-up period was 23 months. Median follow-up was 13 months (Q1=7 months, Q3=37 months). The PPR was 97% (SE 2%) at 1 year, 89.7% (SE 4.6%) at 2 years, and 83.7% at 3 years (SE 6.6%) (Table I). The SPR was 98.3% (SE 1.5%) at 1 year, 93.4% (SE 3.9%) at 2 years, and 93.4% (SE 4.5%) at 3 years (Table II). Studied restenosis risk factors are described in Table III. No significant restenosis factors were detected.
Table I. Primary patency of systematic stenting of the EIA in the claudicant
| Time period (months) | Patients (beginning of interval) (n) | Stent restenosis (during interval) (n) | Exits of study (n) | Restenosis rate (during interval) (%) | Cumulative PPR (%, SD) |
|---|---|---|---|---|---|
| 0-6 | 90 | 1 | 19 | 0.012 | 98.7±1.2 |
| 6-12 | 70 | 1 | 19 | 0.017 | 97.0±2.0 |
| 12-18 | 50 | 1 | 10 | 0.022 | 94.9±3.0 |
| 18-24 | 39 | 2 | 5 | 0.055 | 89.7±4.6 |
| 24-30 | 32 | 2 | 4 | 0.067 | 83.7±6.0 |
| 30-36 | 26 | 0 | 2 | 0 | 83.7±6.6 |
| 36-42 | 24 | 1 | 2 | 0.045 | 79.9±7.3 |
| 42-48 | 21 | 0 | 6 | 0 | 79.9±7.8 |
Table II. Secondary patency of systematic stenting of the EIA in the claudicant
| Time period (months) | Patients (beginning of interval) (n) | Stent restenosis (during interval) (n) | Exits of study (n) | Restenosis rate (during interval) (%) | Cumulative SPR (%, SD) |
|---|---|---|---|---|---|
| 0-6 | 90 | 0 | 20 | 0 | 100±0 |
| 6-12 | 70 | 1 | 19 | 1.7 | 98.3±1.5 |
| 12-18 | 50 | 1 | 11 | 2.2 | 96.1±2.7 |
| 18-24 | 38 | 1 | 5 | 2.8 | 93.4±3.9 |
| 24-30 | 32 | 0 | 4 | 0 | 93.4±4.2 |
| 30-36 | 28 | 0 | 4 | 0 | 93.4±4.5 |
| 36-42 | 24 | 0 | 2 | 0 | 93.4±4.9 |
| 42-48 | 22 | 0 | 7 | 0 | 93.4±5.1 |
Table III. Predictive risk factors of restenosis (nonadjusted Cox model)
| Relative risk | 95% Confidence interval | p | |
|---|---|---|---|
| Age | 0.99 | 0.93-1.05 | 0.76 |
| Sex ratio (women vs. men) | 1.35 | 0.26-6.96 | 0.72 |
| Smoking (active vs. previous) | 0.71 | 0.19-2.66 | 0.61 |
| HBP (yes vs. no) | 1.61 | 0.32-7.93 | 0.55 |
| Diabetes (yes vs. no) | 1.19 | 0.15-9.67 | 0.87 |
| Hypercholesterolemia (yes vs. no) | 0.96 | 0.25-3.62 | 0.95 |
| Renal insufficieny (yes vs. no) | 1.92 | 0.40-9.27 | 0.45 |
| Ischemic heart disease (yes vs. no) | 1.62 | 0.40-6.48 | 0.51 |
| COPD (yes vs. no) | 0.75 | 1.18-3.04 | 0.68 |
| Lesion (occlusion vs. stenosis) | 1.58 | 0.19-12.88 | 0.69 |
| Lesion (distal vs. proximal) | 2.84 | 0.67-12.11 | 0.15 |
| Length of lesion (for 1 mm more) | 1.02 | 0.99-1.05 | 0.15 |
| Length of stent (≥45 vs. <45mm) | 1.03 | 1.00-1.05 | 0.11 |
| Stent diameter (for 1 mm more) | 0.61 | 0.19-1.90 | 0.38 |
| Patent vs. occluded SFA | 0.69 | 0.17-2.78 | 0.60 |
| TASC (A or B vs. C or D) | 0.22 | 0.05-0.94 | 0.06 |
| Associated procedure (yes vs. no) | 1.62 | 0.40-6.49 | 0.51 |
| Auto- vs. balloon-expandable stent | 2.49 | 0.59-10.50 | 0.24 |
| Initial ABI (≥0.68 vs. <0.68) | 5.84 | 0.05-745.96 | 0.48 |
In total, 10 EIA intrastent restenoses occurred. Eight patients had a severe claudication, one had a mild claudication, and one presented with trophic disorders of the forefoot, which led to transmetatarsal amputation. Six restenoses received endovascular treatment, six were treated with conventional surgery (one aortobifemoral bypass and one femorofemoral crossover bypass), and two restenoses were not treated (patient's choice).
During the follow-up period, eight patients died, five patients had a homolateral endovascular procedure—SFA stent angioplasty (n=2), CIA stent angioplasty (n=2), EIA stent angioplasty on an outflow stenosis (n=1)—and three patients had an above-knee homolateral femoropopliteal bypass.
Six patients were lost to follow-up. The two patients whose intrastent restenoses were surgically treated were excluded from our study. The last time we heard of the patients, and according to the Rutherford clinical evaluation scale, 62 (70.5%) were asymptomatic (grade +3), 17 (19.3%) had a mild claudication (grade +2), five (5.7%) had a moderate claudication (grade +1), and three (3.4%) had a severe claudication (grade 0). One patient underwent a transmetatarsal amputation (grade −1). There was no major amputation. At the end of the follow-up, mean ABI was 0.79±0.15.
Discussion
In our study, in a population of patients with claudication, PPRs of systematic stenting of atheromatous lesions located on the EIA were 97% at 1 year, 89.7% at 2 years, and 83.7% at 3 years and SPRs were 98.3% at 1 year, 93.4% at 2 years, and 93.4% at 3 years.
Up to now, a single randomized comparative study has analyzed endovascular treatment results of iliac atheromatous lesions.4 Two hundred and sixty-nine patients with claudication were randomized in two groups between 1993 and 1996 in order to compare systematic stenting versus selective stenting of TASC A or B iliac lesions without differentiating EIA and CIA.
At 24 months, no significant differences were found between the two methods: the PPR was 71.3% in the systematic stenting group and 69.9% in the selective stenting group. In the selective stenting group, stent placement was performed in 43% of patients. Stent location on the iliac arteries was not specified. Recently, Klein et al. 5 published results at 6-8 years concerning these same patients: in the systematic stenting group, 33/139 patients had intrastent restenosis versus 38/130 patients in the selective stenting group, which did not establish a significant difference between the two techniques.
These results are lower than ours, which can be explained by the monocentric and retrospective aspect of our study. Moreover, results can be improved by improved materials and adjuvant treatments.
In fact, at the coronary level, the use of stents with thinner meshing and a thinner metallic skeleton has proved to be associated with a significant decrease of restenosis.13 In the Tetteroo et al.4 study, stents that were used belonged to the first generation (hand-crimped Palmaz® stents; Johnson and Johnson, New Brunswick, NJ); they may not give as good results as second-generation stents (Genesis® [Cordis] or Luminex® [Bard]), which were used in our study. Moreover, we chose to treat long lesions with self-expandable nitinol stents (Luminex), which, thanks to their flexibility, can fit the anteroposterior curved anatomy of the EIA. Rigid steel stents have been chosen only for short lesions.
As for adjuvant treatment, in the Tetteroo et al.4 study, patients were only given aspirin, whereas we give our patients aspirin and clopidogrel in association for 1 month and then clopidogrel alone.20
Moreover, statin treatment has proved to be beneficial for arteritis patients even in the absence of hypercholesterolemia.19 In our study, our patients were given a medical treatment which, in association with second-generation stent placements, can explain why our results were better than those of Tetteroo et al.4
A former randomized study by Richter et al.,21 published in 1992, compared the 5-year results of endovascular treatment with iliac stent placement or with angioplasty. The authors concluded that the results had significantly improved after stent placement (PPR 93%) compared with angioplasty alone (PPR 70%).
In our study, we specifically studied the EIA since it is frequently associated with bad results after endovascular treatment. Powell et al.9 studied patency after PTA and selective stenting when at least two iliac segments were damaged. Lesions located on the EIA were significantly predictive of bad results, with 47% and 18% PPRs at 12 and 36 months, respectively. Timaran et al.11 retrospectively studied 67 patients with claudication or critical ischemia who had a stent placed in the EIA. They found global PPRs of 76% and 56% and, in women, only 61% and 47% at 1 and 3 years, respectively. They concluded that EIA treatment gives significantly worse results in women.
In another study, Powell et al.10 defined a score according to the extent of the EIA lesions; thus, they studied in subgroups 75 patients treated with PTA and selective stenting. They found a statistically significant difference in primary patency with EIA lesions >5cm (score >3). These three publications are certainly responsible for the bad reputation of EIAs. However, our study found a satisfactory patency rate. This can be explained by the lack of homogeneity in the populations observed in the three former studies, which took into consideration patients with both claudication and severe ischemia. This can also be explained by the use of selective stenting techniques in these studies. In fact, similar to our study, Lee et al.8 retrospectively compared the primary patency of systematic stenting of the CIA and EIA. They found comparable results between the CIA and EIA, which are in accordance with our results (93% PPR at 1 year, 91% at 2 years, and 90% at 3 years for 49 EIAs); this hints that, in a population of patients with claudication, EIA endovascular treatment gives better results after systematic stenting rather than after selective stenting.
We could not bring forward any statistically significant risk factors of restenosis. However, type C or D iliac lesions are more likely to have a higher restenosis risk (p=0.06). Taking into consideration the changes brought to the first TASC classification, the good results we obtained are related to short lesions belonging to class A in TASC II. A similar result was found by Kudo et al.,16 who studied predictive factors of restenosis in a retrospective study concerning 151 iliac arteries; they discovered that TASC C and D lesions were significantly associated with a high restenosis risk.
Patency of outflow arteries, hemodialyzed chronic renal insufficiency, smoking, and female gender, which are generally considered as restenosis risk factors,16, 17 were not significant in our study (Table III). In our study, neither proximal nor distal location of the lesion on the EIA had any influence on restenosis (p=0.15, Table III).
The systematic stenting technique is faster and easier than the PTA technique since it requires less material. Besides, it reduces PTA complications such as widespread dissections after short lesion treatment or distal embolism; it also enables injection of a smaller dose of contrast, which certainly benefits renally insufficient patients and seems to reduce restenosis risk. Drawbacks are myointimal hyperplasia, cost, and the fact that it does not totally prevent dissections (seven in our study). Bosch et al.22 retrospectively studied the clinical benefit of systematic stenting compared with its cost, concluding that the cost is significantly higher without any significant clinical benefit.
However, we think that primary patency amelioration, such as that described in our study, could, in the long term, reduce expenses by avoiding repeated hospitalizations for iterative PTA procedures.
This study was interesting because of the homogeneity of the population concerned (only patients with claudication) and because of the technique that was used (systematic stenting of the lesion). The main bias of our study lies in its descriptive aspect with lack of a comparative population.
Conclusion
In a population of patients with claudication, the results of endovascular treatment with systematic stenting of EIA lesions belonging to A and B classes in the 2000 TASC are acceptable (16% restenosis at 3 years). To confirm these results, a randomized comparative study between systematic and selective stenting should be carried out. At the same time, it would also be interesting to carry out a comparative study about the resultant costs.
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Presented at the 22nd Annual Meeting of the French Society for Vascular Surgery, Lyon, France, June 2-5, 2007.
PII: S0890-5096(09)00129-0
doi:10.1016/j.avsg.2008.05.019
© 2009 Annals of Vascular Surgery Inc. Published by Elsevier Inc All rights reserved.
