Systematic versus selective stent placement after superficial femoral artery balloon angioplasty: A multicenter prospective randomized study☆☆☆★

Article Outline

• Abstract
• Methods
  • Inclusion criteria and patient selection
  • Preoperative evaluation
  • Randomization process
  • Surgical technique
  • Follow-up
  • End points
  • Validation of end points and clinical events
  • Statistical analysis
• Results
  • Demographics
  • Operative procedure
  • Main end point
  • Secondary end points
• Discussion
• Conclusions
• Acknowledgements
• Appendix. Study organization
  • Scientific committee
  • Participating centers and number of cases
  • Imaging recording and arteriogram review
  • Committee for validation of critical events
  • Data recording and treatment
  • Software monitoring
  • Statistical analysis
  • Center monitoring
• References
• Copyright

Abstract 

Purpose: Outcome with selective or systematic stenting with the Palmaz vascular stent was compared in patients with limb-threatening ischemia or persistent disabling claudication despite medical therapy, with less than 7 cm stenosis or occlusion of the superficial femoral artery. Methods: This was a multicenter prospective randomized trial with centralized allocation of treatment and independent review of vascular events. The primary end point was presence of more than 50% stenosis at 1-year angiographic follow-up. Secondary end points were survival; occurrence of vascular events in the treated leg; and number of failed procedures, defined as more than 50% stenosis or death at 1 year. Results: Two hundred twenty-seven patients were enrolled in the study, 112 in the selective stent group, and 115 in the systematic stent group. Seventeen patients (15%) in the selective stent group received a stent after suboptimal results of percutaneous transluminal angioplasty. Angiograms for 140 patients were available at 1-year follow-up and demonstrated no statistical difference between the two groups; more than 50% stenosis of the dilated site was noted in 21 of 65 patients (32,3%) in the selective stent group and 26 of 75 patients (34.7%) in the systematic stent group (P = .85, Fisher exact test). Survival in the percutaneous transluminal angioplasty and stent groups was, respectively, 92% and 96% at 1 year, 89% and 93% at 2 years, and 82% and 80% at 4 years (P = .40, log-rank test). Survival free of new vascular events in the treated limb was 77% and 65% at 1 year, 70% and 53% at 2 years, and 57% and 44% at 4 years (P = .017, log-rank test). Number of failed procedures at 1 year was 29 of 86 (33%) and 30 of 89 (34%) (P = 0.9). Conclusion: Systematic stenting of short stenosis or occlusion of the superficial femoral artery is not justified. Palmaz vascular stent placement should be reserved for use in patients with suboptimal results of balloon angioplasty. (J Vasc Surg 2003;37:487-94.)

Percutaneous transluminal angioplasty (PTA) is commonly the initial treatment option in patients with limb-threatening ischemia or persistent disabling claudication despite medical therapy, with relatively short lesions, of the superficial femoral artery.

The long-term patency rate with PTA alone, however, remains relatively poor, varying from 40% to 71% at 2 years. Meta-analysis of 12 series of patients demonstrated 3-year patency rates of 62% ± 9% for claudication and 43% ± 7% for limb salvage.¹ Factors that may adversely affect outcome include symptom (claudication vs critical ischemia), type of lesion (stenosis vs occlusion), length of lesion, and outflow.², ³, ⁴, ⁵, ⁶

Stents have been designed to improve the technical success rate and overall arterial patency after PTA. By fixing the plaque against the arterial wall, stents prevent immediate recoil and obstructive plaque dissection. However, there is a tendency for development of intrastent hyperplasia, which may compromise long-term results.

Early studies demonstrated effective results with stenting in the superficial femoral artery.⁷, ⁸, ⁹, ¹⁰, ¹¹, ¹² Limits of stenting were also delineated, with the poorest results obtained in patients with long lesions or with critical ischemia.¹³, ¹⁴

Three randomized studies¹⁵, ¹⁶, ¹⁷ comparing PTA alone versus PTA plus stent placement in the superficial artery all failed to demonstrate a benefit to stenting insofar as long-term patency and symptom relief. However these studies included a relatively small number of patients, with short follow-up.

The current prospective randomized study was undertaken before the results of the above-mentioned studies were available. The purpose of the study was to compare results of systematic or selective stenting of the superficial femoral artery after balloon angioplasty in patients with lesions smaller than 7 cm and disabling claudication or lower limb critical ischemia. Special emphasis was placed on patency at 1 year, as demonstrated on a control angiogram, and to occurrence of ischemic events in the ipsilateral leg during 4 years of follow-up.

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Methods 

Between June 1995 and December 1997, 227 patients who had undergone superficial femoral angioplasty were randomly allocated to undergo balloon angioplasty plus systematic stenting, PTA alone, or PTA plus stenting, because of suboptimal results of PTA.

All patients were informed of the purpose of the study and signed an informed consent. The protocol was approved by the ethics committee of Henri Mondor Hospital, Créteil, France, on Jan 16, 1995. The study was carried out in accord with the Hurriet regulation, which defines the rules for scientific protocols in France, and with good clinical practice guidelines.

Inclusion criteria and patient selection 

Patients of either sex with severe claudication or limb-threatening ischemia (stage IIb, III, or IV, Society for Vascular Surgery/International Society for Cardiovascular Surgery classification) and who had stenosis or occlusion of the superficial femoral artery, as demonstrated on a pretreatment angiogram, were eligible. Inclusion criteria included inflow vessels free of significant lesion; single superficial femoral artery lesion located between 1 cm from the origin of the superficial artery and 5 cm proximal to the projection of the knee joint on anteroposterior angiographic views; lesion length between 1 and 7 cm; and sufficient outflow, with at least one patent leg artery. Exclusion criteria included pregnancy, acute ischemia, previous endovascular or open surgery in the treated superficial femoral or popliteal artery, allergy to iodine, hemorrhagic diathesis, hypercoagulation, and enrollment in an ongoing trial. In each patient only one leg was included in the trial.

Preoperative evaluation 

Preoperative evaluation included analysis of symptoms; clinical examination; duplex scanning to assess the entire lower limb arterial system, with ankle/brachial index (ABI) measurement; and angiography including anteroposterior and lateral views.

Pre-operative risks factors also were recorded.

Randomization process 

Patients were selected on the basis of the inclusion and exclusion criteria. Once they agreed to participate in the study, they were recorded on a pre-randomization list. On the day of the procedure, eligible patients were randomized from the operating room after the guide wire successfully crossed the lesion.

The randomization process was centralized at the Department of Pharmacology Clinique, Lyon, France. Pre-randomization was carried out with dedicated software by fax or telephone call at least 24 hours before randomization. During the operation, randomization was made by phone call.

Surgical technique 

Lesions were approached through an ipsilateral femoral puncture. With angiographic guidance, a 0.035 inch Terumo (Louvain, Belgium) guide wire was passed through the lesion. A balloon dilating catheter was placed in the lesion and inflated to 8 to 12 atm. Noncompliant balloon catheters, ultra-thin (Meditech; Boston Scientific, Boston, Mass) were used in 82% of patients, and Olbert balloon catheters (Cordis Johnson & Johnson) were used in 18% of patients. One-half milligram per kilogram of body weight of standard heparin was administered before dilatation. In the group of patients randomized to undergo balloon angioplasty, if results were suboptimal as demonstrated on the control angiogram, ie, residual stenosis greater than 30% or dissection, the balloon was inflated one more time in an attempt to model the lesions. According to the results, the physician had the choice of retracting the balloon catheter without any further intervention or of placing a stent. In the group of patients allocated to undergo primary stenting, the stent was placed either before or after dilation of the lesion. Only balloon expandable Palmaz stents (Cordis or Johnson & Johnson interventional systems) of various sizes were used in the study. Two stents were placed in lesions larger than 5 cm.

At the end of the procedure angiograms including views of the treated site and of the popliteal and legs arteries were obtained. Postoperatively, patients were given low molecular weight heparin for 24 hours, then aspirin (300 mg/d) or ticlopidine indefinitely.

Follow-up 

Follow-up included symptom assessment, clinical examination, duplex scanning of the treated sites and run-off, and ABI measurement. Follow-up examinations were performed before hospital discharge; at 1, 3, 6, 12, 18, and 24 months; and yearly thereafter for 4 years.

Repeat angiography was performed at 1-year follow-up, or sooner if the patient experienced clinical impairment or abnormalities were seen on follow-up duplex scans.

All clinical events were recorded for the duration of the study.

End points 

The primary end point was the presence of more than 50% stenosis at 1-year postoperative angiography.

Secondary end points were survival; occurrence of clinical disorders including cardiac events, transcient ischemic attack (stroke), deep venous thrombosis or pulmonary embolism, pulmonary or renal complications, and miscellaneous life-threatening complications; occurrence, according to time of follow-up, of vascular events in the treated leg including acute ischemia, clinical stage worsening, trash foot, and need for another vascular procedure or major amputation; and number of failed procedures at 1 year, defined as more than 50% restenosis or death.

Validation of end points and clinical events 

Preoperative and postoperative angiograms were reviewed separately by two independent vascular radiologists who did not participate in the study. They were provided with a CD-ROM which contained all preoperative and 1-year angiograms. Degree of stenosis was calculated with automated measurement software. When there was disagreement of more than 30% between the two reviewers, films were reviewed by a third independent reviewer, whose judgment prevailed.

Clinical events, both general and local vascular, were reviewed by an independent committee composed of vascular surgeons, vascular specialists, and cardiologists.

Statistical analysis 

Statistical analysis was performed at EA 643 University of Lyon, France.

Analysis was done on an intent-to-treat basis

Statistical analysis was performed with the χ² test, Fisher exact test, t test, and log-rank test, with SAS 7 software.

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Results 

In 24 of 251 eligible patients, the guide wire could not be placed through the lesion. Thus 227 patients were enrolled in the study, 112 allocated to the angioplasty selective stenting group and 115 allocated to the systematic stenting group.

Compliance with the study protocol and follow-up was relatively good, with only 9.6% of information sheets missing (5642 collected, 6241 expected).

Demographics 

The angioplasty group included 66 (59%) men, and the angioplasty plus stent group included and 76 (66%) men (P = .265), with mean age 66.42 ± 11.7 years and 66.54 ± 11.15 years, respectively (P = .937). In the angioplasty group, 89 patients (79%) had claudication, 7 patients (6.25%) had rest pain, and 16 patients (14.29%) had gangrene or ulcer, compared with 91 patients (79%) with claudication, 7 patients (6.09%) with rest pain, and 17 patients (14.78%) with gangrene or ulcer in the angioplasty plus stent group. ABI at rest was 0.72 ± 0.22 (SD) and 0.74. ± 0.20 (P = .519), and after exercise testing was 0.48 ± 0.18 and 0.52 ± 0.19 (P = .82). Mean lesion length in the two groups, respectively, was 25.11 ± 17.8 mm (range, 20-70 mm) and 25.36 ± 18 mm (range, 30-70 mm) (P = .91).

Patient risk factors are given in Table I, and lesion characteristics are given in Table II.

Table I. Demographic data

Table II. Pretreatment arteriographic data

SFA, Superficial femoral artery.

There were no statistical differences between the two groups.

Operative procedure 

An ipsilateral common femoral approach was used in all cases. The mean length of the balloon was 3.75 ± 1.5 cm and 3.82 ± 1.6 cm (P = .7), with a mean diameter of 5.47 ± 0.76 mm and 5.37 ± 0.74 mm (P = 0.3).

In the stent group, one stent was used in 92 patients (80%) and two stents in 23 patients (20%). Palmaz stents P394 were placed in 56 patients (48%), P294 in 30 (26%), P204 in 42 (34%), and P154 in 3 (3%).

In 59 patients (52%) in the PTA group versus 28 patients (24%) in the stent group, the balloon was reinflated (P = .001) to obtain a better morphologic aspect on the control angiogram.

In the PTA group, 15 patients (13%) required stent placement because of unsatisfactory results after angioplasty alone. One patient (0.8%) with 40% residual stenosis did not receive a stent.

Perioperative complications in the two groups occurred, respectively, in 5 patients (4.9%) and 10 patients (8.6%) (P = 0.2) and included thrombosis (2 patients [1.7%] vs 2 patients [1.7%]), embolism (2 patients [1.7%] vs 5 patients [4%]), arterial rupture (1 patient [0.9%] vs 0 patients), and introducer site problems, defined as difficulty in puncturing the artery or in placing the introducer sheath or guide wire (0 patients vs 3 patients [2.6%]).

Additional procedures performed to treat complications are listed in Table III.

Table III. Complementary procedures

There were no statistically significant differences between the two groups (P = 0.341).

Within the first postoperative month, there were no deaths, but one general complication in each group. Minor complications at the puncture site were noted in 7 patients in each group (6.3% vs 6.1%). One patient in the PTA group and 4 in the stent group required blood transfusion (P = 0.2). One patient in the angioplasty only group required a major amputation, compared with no patients in the stent group. There were 5 minor amputations in the angioplasty group (4%) and 2 in the stent group (1.7%) (P = .73), all in patients with gangrene.

Pre-discharge duplex scanning was performed in 103 patients (94%) and 104 patients (93%), respectively. Mean ABI at rest was 0.96 ± 16 and 96 ± 17 (P = 0.88); after exercise it was 0.83 ± 23 and 0.88 ± 23 after exercise (P = .40). The difference was not statistically significant compared with preoperative assessment (P = 0.2). Respective duplex scanning results improved in 91% and 88% of patients, remained stable in 6.5% and 8.8%, and worsened in 2% and 3%.

Mean duration of hospitalization was 4.99 ± 5.48 and 5.84 ± 7.9 days (P = .41).

Respectively, 92.8% and 88.7% of patients returned directly to home, 4.5% and 7.8% went to a convalescent home, and 2.7% and 3.48% were referred to another hospital (P = .51).

Main end point 

At 1 year, 81 patients (80%) in the angioplasty only group and 83 patients (75.5%) in the angioplasty plus stent group had, respectively, 65 and 75 angiograms available for evaluation. Table IV shows the distribution of lesions as determined by the imaging committee.

Table IV. Distribution and grade of superficial femoral artery lesions at 1-year follow-up angiography

PTA, Percutaneous transluminal angioplasty.

Twenty-one procedures (32%) in the PTA group and 26 (34%) in the stent group fulfilled the criteria for failure (P = .85). Total occlusion of the treated site was noted in 7 patients (10.77%) and 12 patients (16%), respectively (P = 0.3). The differences were not statistically different. In 23 patients without angiograms, a duplex scan was available at 1 year. Two of 13 patients in the PTA group and 1 of 10 patients in the stent group had more than 50% stenosis of the treated artery.

Secondary end points 

The number of failed procedures at 1 year (death or >50% stenosis) was 29 of 86 (33%) and 30 of 89 (34%), respectively (P = .9).

Median follow-up was 2.43 years (SE .08), ranging from 8 days to 4 years.

Cumulative survival rate is shown in Fig 1.

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• Fig. 1. 

  Comparison of balloon angioplasty and stenting in superficial femoral artery. Cumulative survival.

Twenty-nine patients died during follow-up, 16 (114%) in the PTA group and 13 (11%) in the stent group.

The number and distribution of critical clinical events in both groups are shown in Table V.

Table V. Critical clinical events during study^*

TIA, Transient ischemic attack; DVT, deep vein thrombosis; PE, pulmonary embolism.

Cumulative survival rate free of vascular events is shown in Fig 2.

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• Fig. 2. 

  Comparison of balloon angioplasty and stenting in superficial femoral artery. Cumulative survival free of vascular critical events on the ipsilateral leg.

There were more events in the PTA plus stent group (P = .017).

The list and frequency of vascular events during the entire follow-up period are shown in Table VI.

Table VI. Vascular local events in treated limb during study^*

P = .001.

The difference was not statistically significant (P = .001).

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Discussion 

This prospective multicenter study demonstrates that systematic stenting with a Palmaz stent is not justified after balloon angioplasty to treat relatively short superficial femoral artery lesions. One-year control angiograms and clinical findings over 4-year follow-up failed to show any advantage to stenting. Worse, there were significantly more local vascular events in the stent group as assessed either by total number of events or with life table analysis.

These results confirm the conclusions of three similar studies.¹⁵, ¹⁶, ¹⁷ A study from Sweden¹⁷ included 34 patients with femoral occlusion. Only 20 patients were available at 1-year follow-up for angiographic evaluation. There was a trend toward better clinical improvement and rise in ABI at 1 year in the stent group, but without reaching statistical significance. At angiography, recurrent occlusion was seen in 75% of patients in the PTA group and 33% in the stent group (P = .17), whereas the rate of recurrent stenosis was significantly higher in the stent group (50% vs 25%) (P = .033).

A study from The Netherlands¹⁶ included 51 patients with occlusion or stenosis of the superficial femoral artery. Follow-up included only clinical examination and duplex scanning. Results were not statistically different. With life-table analysis the cumulative rate of clinical and hemodynamic success after 1 year was 85% in the angioplasty group and 74% in the stent group (not significant). Primary patency at 1 year, assessed with color-flow duplex ultrasound scanning, was 74% in the angioplasty group and 62% in the stent group (not significant).

A study from Germany¹⁵ reported 141 patients with short stenosis or occlusion of the femoropopliteal segment. Follow-up included clinical assessment, ABI measurement, and color duplex ultrasound scanning or angiography at 6 or 12 months. Follow-up angiograms obtained at 12 to 36 months were available for 46 limbs (29.9%). Again no differences were found. Hemodynamic and clinical success at 1 and 2 years in the PTA group was 72% and 65%, respectively, versus 77% and 65% in the stent group (not significant). Cumulative 1-year and 2-year angiographic primary patency rates were 63% and 53%, respectively, for both groups.

The results of the four studies are quite consistent. The current study had several original features. The methods were in agreement with modern standards for such a study, ie, centralized randomization and treatment of data, independent assessment of end points, and relatively large number of enrolled patients, which enabled valid statistical analysis. We targeted specific lesions, stenosis or occlusion less than 7 cm, with good inflow and acceptable outflow rates. In addition, we tried to eliminate as many technical failures as possible; randomization occurred only if the guide wire crossed the lesion. These strict criteria were used to test the role of stenting and to prevent bias due to other causes of poor outcome, as discussed above. The main end point was angiography at 1 year, with review by three independent vascular radiologists. Clinical follow-up was extended to 4 years. The weaknesses of the study were the great variability in the number of patients enrolled in each center, ranging between 1 and 50 patients. Also, only 140 arteriograms (61%) were available at 1 year. The compliance rate for a new angiogram is in the range noted in the Swedish study but much higher than that in the German study. This underlines the difficulty of obtaining angiograms in patients who have few or no complaints.

While successful in the early stage, systematic stent application failed to improve overall patency. The causes of failure of stenting in the femoropopliteal segment are currently well-known. Acute postoperative stent occlusion occurred relatively infrequently in the current series, observed in 3.13% of our patients, which is in the range noted in previously reported series.¹², ¹⁶, ¹⁸, ¹⁹ Intra-stent hyperplasia was responsible for most late failure. Occurrence peaked within the first 18 months, but over the longer term results remained stable. In addition to patency seen on the angiogram at 1 year, clinically significant events occurred more frequently in the stent group than in the PTA group. This raises concern that stenting may worsen the lesion after endovascular treatment in superficial femoral artery. This observation is only applicable to the Palmaz stents used in this series. Although there are no firm data, results may be different with different stent material (steel vs nitinol) and stent design (autoexpandable vs self-expandable).

It is not clear whether our observations are applicable to different arterial segments.

The Dutch trial¹⁹ comparing systematic and selective iliac stenting failed to demonstrate a difference in patency rate after 2 years in the two groups.

In the renal artery, no randomized study has thus far been performed. Blum²⁰ showed that 60 months after systematic stent placement to treat ostial stenosis, 84% of patients were free of primary occlusion. Recurrent stenosis of more than 50% of the vessel diameter occurred in 8 of 74 arteries (11%). Repeat intervention resulted in a secondary patency rate of 92%.

In the carotid segment, we reported 7% intra-stent hyperplasia after angioplasty and stenting.²¹ Conversely, two randomized studies of the coronary circulation demonstrated better patency with stenting after 6 months. Fischman et al²² reported that at 6 months patients with stented lesions continued to have a larger luminal diameter(1.74 ± 0.60 mm vs 1.56 ± 0.65 mm; P = .007) and a lower rate of recurrent stenosis (31.6% vs 42.1%; P = .046) than did patients who had undergone balloon angioplasty. In a study by Serruys et al,²³ mean (±SD) minimal luminal diameter immediately after the procedure was 2.48 ± 0.39 mm in the stent group versus 2.05 ± 0.33 mm in the angioplasty group; at follow-up, the diameter was 1.82 ± 0.64 mm in the stent group and 1.73 ± 0.55 mm in the angioplasty group (P = .09). The rate of more than 50% recurrent stenosis was 22% and 32% percent, respectively (P = .02). An update of the Benestent-I trial²⁴ demonstrated that the early benefit of stenting was durable. At 5 years, in the PTA group 27.3% of patients had undergone target lesion revascularization, compared with 17.2% of patients in the stent group (P = .008). However, event-free survival rate (59.8% vs 65.6%; P = .20) between the stent and PTA groups no longer achieved statistical significance.

It is still uncertain whether the better results in the coronary circulation as opposed to the femoral and iliac arteries are due to differences in the healing process, artery texture, flow velocity, resistance to flow, size of stent, drug regimen, or the method of follow-up.

Will recent developments in stent technology improve the results of superficial femoral artery stenting? Trials are under way to test the role of adjuvant drugs, gene therapy, and brachytherapy to reduce intra-stent hyperplasia. Beneficial effects of coated stents have been shown in the coronary circulation over the short term, but evidence is lacking insofar as long-term results and non-coronary arteries are concerned. Alternative endovascular treatments such as subintimal angioplasty²⁵, ²⁶ and remote endarterectomy²⁷ also must be evaluated against the more conventional and relatively disappointing approach of femoral stenting.

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Conclusions 

With current stent technology, systematic stenting of short stenosis or occlusion of the superficial femoral artery is not justified. Stent placement should be reserved for patients with suboptimal results after balloon angioplasty.

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Acknowledgements 

Supported by grants from Cordis, Johnson & Johnson, Lafon, Aventis, and Société Française de Chirurgie Vasculaire.

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Appendix. Study organization 

Scientific committee 

Pr J.-P. Becquemin, Pr J.-P. Favre, Dr J. Marzelle, and Dr A. Leizorovicz

Participating centers and number of cases 

Drs Agé, Drevet, and Lepine, Clinique Mutualiste, Lyon, France (n = 16)

Pr Alimi, Hôpital Nord, Marseille, France (n = 1)

Pr Azorin, Hôpital Avicenne, Bobigny, France (n = 6)

Pr Becquemin and Dr Desgranges, Hôpital Henri Mondor, Crétiel, France (n = 50)

Drs Bergeron and Amichot, Hôpital St Joseph, Marseille, France (n = 19)

Dr Cardon, Clinique les Franciscaines, Nimes, France (n = 14)

Dr Chatelard, Clinique du Tonkin, Villeurbanne, France (n = 4)

Pr Favre, Hôpital Nord, St-Etienne, France (n = 17)

Pr Castellani and Dr Martinez, Hopital de Tours, France (n = 9)

Pr Gouny, Hôpital Tenon, Paris, France (n = 4)

Drs Jausseran and Ferdani, Hôpital St Joseph, Marseille, France (n = 1)

Drs Lermusiaux and Artru, Clinique du Pré, Le Mans, France (n = 6)

Pr Magne, Dr Voirin, and CH Michallon, Hôpital La Tronche, Grenoble, France (n = 7)

Dr Marcadé, Clinique du Mail, la Rochelle, France (n = 5)

Drs Marzelle and Cormier, Clinique la Defense, Nanterre, France (n = 8)

Dr Mialhe, Clinique Notre Dame, Draguignan, France (n = 12)

Dr Paneau, Clinique Saint Joseph, Colmar, France (n = 7)

Dr Sarradon, Polyclinique les Fleurs, Ollioules, France (n = 9)

Pr Prat, Dr Vasseur, and Pr Stankowiak, Centre Hospitalier Lille, France (n = 2)

Drs Tobiana and Chaircop, Centre Hospitalier Beziers, France (n = 7)

Pr Watelet, Centre Hospitalier Charles Nicolles, Rouen, France (n = 12)

Dr Vrielynck, Polyclinique St Andre, Reims, France (n = 1)

Dr Billon, Clinique Mutualiste St-Etienne, France (n = 7)

Dr Bosiers, Alegemeen Ziekenhuis, Dendermonde, Belgium (n = 3)

Imaging recording and arteriogram review 

Dr Cardon, Pr Bartoli, Pr Rousseau, and Dr Kobeiter

Committee for validation of critical events 

Pr Gueret, Pr Nussaume, Pr Emmerich, Dr Boissier, Dr Cron, and Dr Helou

Data recording and treatment 

Dr Leizorovisz, Dr Gauthier, Dr Gelas-Dore, Dr Cherief, and Dr C. Cornu

Software monitoring 

N Visèle, F Lorenzilli, N Rodrigo, and M Hervé

Statistical analysis 

C. Nemoz

Center monitoring 

C. Lowe, C. Corsin, and S. Dufourmantelle

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