Clinical trial NCT00670540: Epidemiology of Thromboembolism Disease: A Cohort Study
Official title: A Prospective Epidemiological Multicenter Cohort Study on Patients Clinically Suspected of Deep Vein Thrombosis or Pulmonary Embolism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vascular Diseases
Embolism and Thrombosis
Phlebitis
Venous Insufficiency
Pulmonary Embolism
Keywords: pulmonary embolism
duplex ultrasound examination
recurrence
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Sanofi
name: Ministry of Health, France
name: SFMV (Société Française de Médecine Vasculaire)
First posted: 2008-05-02
Enrollment: 8256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All male or female inpatients and outpatients hospital and office-based. 18 years old with clinical suspicion of deep vein thrombosis (DVT) or pulmonary embolism (PE).

Patients with cognitive disorders or language impairment preventing collection of risk factor data by history-taking were excluded.

Brief summary: The purpose of this study is to determine different risk factors of thromboembolic disease. Different points will be studied

1. do different types of thromboembolic disease (distal Deep Vein Thrombosis (DVT), proximal DVT, Pulmonary Embolism (PE) and DVT, PE without DVT) have the same clinical significance (risk factors and prognosis) ?
2. Is it necessary to obtain a detailed history of thromboembolic disease ?
3. Do older patients have particular risk factors ?
4. Do preventive treatments modify the level of risk factors and the clinical signs of thromboembolic disease ?
5. Do predictive clinical scores have the same performance for both in and outpatients ?
6. Can patients with a potential high level of thromboembolic risk (surgery, pregnancy) but no clinical thromboembolic symptoms, develop a low risk ?
7. The evolution of the disease in patients with negative or positive Venous ThromboEmbolism (VTE) exploratory tests.

Detailed description: The OPTIMEV study is a prospective epidemiological multicenter cohort study, including in-and outpatients clinically suspected of thromboembolic disease. Deep vein thrombosis is diagnosed using a duplex ultrasound examination, whereas pulmonary embolism is investigated by lung scan scintigraphy or computed helical tomodensitometry and/or duplex ultrasound examination. Initial data on medical history, clinical symptoms, presence of transient and chronic risk factors, diagnosis at the end of the medical examination, diagnostic tests results, treatment (type and duration) are collected by the physician into an electronic medical record. Other general medical considerations are collected (particularly on cardiovascular diseases). A phone follow up at 3 months, 1, 2 and 3 years is realised by the Centre for Clinical Research of Grenoble. All Venous ThromboEmbolism (VTE) positive patients (including superficial vein thrombosis) are contacted. For each VTE positive a negative one is selected (same site, same season). Data on mortality, development or recurrence of VTE, treatments prescribed (type + duration), major bleeding, cancer onset, cardiovascular events and venous insufficiency (leg ulcer) are collected. All these serious adverse events are documented and reviewed by an independent critical events committee.

Eligibility criteria: Inclusion Criteria:

* patient aged more than 18
* male or female
* patients with clinical thromboembolic signs (deep vein thrombosis or pulmonary embolism)

Exclusion Criteria:

* patient less than 18 years old
* patient unable to understand
* patient who refused to participate

Primary outcomes:
measure: Percentage of Participants Who Developed a New or Recurrence of Venous Thromboembolism (VTE)
timeFrame: at 3 years
Secondary outcomes:
measure: Percentage of Participants Who Developed Major Bleeding Events
timeFrame: at 3 years
measure: Percentage of Participants With Treatment Anticoagulant Prescribed
timeFrame: after inclusion
measure: Percentage of Participants Who Developed Cardiovascular Events
timeFrame: at 3 years
measure: Percentage of Participants Who Died From Any Cause
timeFrame: at 3 years
measure: Percentage of Participants Who Developed Cancer Onset
timeFrame: at 3 years
measure: Percentage of Participants Who Developed Venous Insufficiency (Leg Ulcer)
timeFrame: at 3 years
Other outcomes:
Locations:
city: Chenee
country: Belgium
facility: University Hospital ND des Bruyeres Liege
city: Abbeville
country: France
facility: General Hospital
city: Albertville
country: France
facility: Office-based Specialist in vascular medecine
city: Albi
country: France
facility: Office-based Specialist in vascular medecine
city: Alencon
country: France
facility: Office-based Specialist in vascular medecine
city: Ales
country: France
facility: Office-based Specialist in vascular medecine
city: Ambares
country: France
facility: Office-based Specialist in vascular medecine
city: Amberieu En Buget
country: France
facility: Office-based Specialist in vascular medecine
city: Amiens
country: France
facility: Office-based Specialist in vascular medecine
city: Amiens
country: France
facility: University Hospital
city: Ancenis
country: France
facility: Office-based Specialist in vascular medecine
city: Angers
country: France
facility: Office-based Specialist in vascular medecine
city: Angers
country: France
facility: University Hospital
city: Annecy
country: France
facility: Office-based Specialist in vascular medecine
city: Annecy
country: France
facility: Hospital
city: Armentieres
country: France
facility: Hospital
city: Arnouville-les-Gonesse
country: France
facility: Office-based Specialist in vascular medecine
city: Arpajon
country: France
facility: Office-based Specialist in vascular medecine
city: Arras
country: France
facility: Office-based Specialist in vascular medecine
city: Aubenas
country: France
facility: Office-based Specialist in vascular medecine
city: Auch
country: France
facility: Hospital
city: Auxerre
country: France
facility: Office-based Specialist in vascular medecine
city: Bagnoles-de-l'orme
country: France
facility: Office-based Specialist in vascular medecine
city: Beauvais
country: France
facility: Office-based Specialist in vascular medecine
city: Belfort
country: France
facility: University Hospital
city: Bergerac
country: France
facility: Office-based Specialist in vascular medecine
city: Besancon
country: France
facility: Office-based Specialist in vascular medecine
city: Beziers
country: France
facility: Office-based Specialist in vascular medecine
city: Blagnac
country: France
facility: Office-based Specialist in vascular medecine
city: Bordeaux
country: France
facility: Office-based Specialist in vascular medecine
city: Bordeaux
country: France
facility: Hospital St ANDRE
city: Boulogne Sur Mer
country: France
facility: Office-based Specialist in vascular medecine
city: Bourg En Bresse
country: France
facility: Office-based Specialist in vascular medecine
city: Bourgoin Jallieu
country: France
facility: Office-based Specialist in vascular medecine
city: Brest
country: France
facility: Office-based Specialist in vascular medecine
city: Brest
country: France
facility: University Hospital La Cavale Blanche
city: Bretenoux
country: France
facility: Office-based Specialist in vascular medecine
city: Bretigny Sur Orge
country: France
facility: Office-based Specialist in vascular medecine
city: Bron
country: France
facility: Office-based Specialist in vascular medecine
city: Cabestany
country: France
facility: Office-based Specialist in vascular medecine
city: Caen
country: France
facility: University Hospital
city: Caluire Et Cuire
country: France
facility: Office-based Specialist in vascular medecine
city: Cambrai
country: France
facility: Office-based Specialist in vascular medecine
city: Cannes
country: France
facility: Office-based Specialist in vascular medecine
city: Carcassonne
country: France
facility: Office-based Specialist in vascular medecine
city: Carcassonne
country: France
facility: Hospital Antoine Gayraud
city: Castanet Tolosan
country: France
facility: Office-based Specialist in vascular medecine
city: Castres
country: France
facility: Office-based Specialist in vascular medecine
city: Cenon
country: France
facility: Office-based Specialist in vascular medecine
city: Chalon En Champagne
country: France
facility: Office-based Specialist in vascular medecine
city: Chalon Sur Saone
country: France
facility: Office-based Specialist in vascular medecine
city: Chambery
country: France
facility: Office-based Specialist in vascular medecine
city: Chambery
country: France
facility: Hospital
city: Champagnole
country: France
facility: Office-based Specialist in vascular medecine
city: Chantilly
country: France
facility: Office-based Specialist in vascular medecine
city: Charleville Mezieres
country: France
facility: Office-based Specialist in vascular medecine
city: Chartres
country: France
facility: Office-based Specialist in vascular medecine
city: Chateaubriant
country: France
facility: Office-based Specialist in vascular medecine
city: Cholet
country: France
facility: Office-based Specialist in vascular medecine
city: Clamart
country: France
facility: Office-based Specialist in vascular medecine
city: Clapiers
country: France
facility: Office-based Specialist in vascular medecine
city: Clermont Ferrand
country: France
facility: Office-based Specialist in vascular medecine
city: Clermont Ferrand
country: France
facility: Hospital Hotel Dieu
city: Clermont L'Herault
country: France
facility: Office-based Specialist in vascular medecine
city: Clisson
country: France
facility: Office-based Specialist in vascular medecine
city: Cluses
country: France
facility: Office-based Specialist in vascular medecine
city: Colomiers
country: France
facility: Office-based Specialist in vascular medecine
city: Compiegne
country: France
facility: General Hospital
city: Coulommiers
country: France
facility: Office-based Specialist in vascular medecine
city: Crolles
country: France
facility: Office-based Specialist in vascular medecine
city: Denain
country: France
facility: Office-based Specialist in vascular medecine
city: Dieppe
country: France
facility: Office-based Specialist in vascular medecine
city: Dijon
country: France
facility: Office-based Specialist in vascular medecine
city: Dijon
country: France
facility: Hospital Bocage
city: Dijon
country: France
facility: University Hospital
city: Draguignan
country: France
facility: Office-based Specialist in vascular medecine
city: Echirolles
country: France
facility: Office-based Specialist in vascular medecine
city: Ermont
country: France
facility: Office-based Specialist in vascular medecine
city: Evreux
country: France
facility: Office-based Specialist in vascular medecine
city: Fecamp
country: France
facility: Office-based Specialist in vascular medecine
city: Feytiat
country: France
facility: Office-based Specialist in vascular medecine
city: Figeac
country: France
facility: Office-based Specialist in vascular medecine
city: Flers
country: France
facility: Hospital
city: Foix
country: France
facility: Office-based Specialist in vascular medecine
city: Foix
country: France
facility: Hospital Val d'Ariege
city: Fontenay Le Comte
country: France
facility: Office-based Specialist in vascular medecine
city: Glanes
country: France
facility: Office-based Specialist in vascular medecine
city: Grenoble
country: France
facility: Office-based Specialist in vascular medecine
city: Grenoble
country: France
facility: University Hospital Grenoble
city: Gruchet Le Valasse
country: France
facility: Office-based Specialist in vascular medecine
city: Hoenheim
country: France
facility: Office-based Specialist in vascular medecine
city: Issy Les Moulineaux
country: France
facility: Office-based Specialist in vascular medecine
city: Istres
country: France
facility: Office-based Specialist in vascular medecine
city: L'ile Rousse
country: France
facility: Office-based Specialist in vascular medecine
city: La Roche Sur Yon
country: France
facility: Office-based Specialist in vascular medecine
city: La Roche Sur Yon
country: France
facility: Departemental Hospital
city: La Rochelle
country: France
facility: Office-based Specialist in vascular medecine
city: Lannion
country: France
facility: Office-based Specialist in vascular medecine
city: Lattes
country: France
facility: Office-based Specialist in vascular medecine
city: Laval
country: France
facility: Office-based Specialist in vascular medecine
city: Laxou
country: France
facility: Office-based Specialist in vascular medecine
city: Le Chesnay
country: France
facility: Hospital Versailles
city: Le Mans
country: France
facility: Office-based Specialist in vascular medecine
city: Le Quesnoy
country: France
facility: Office-based Specialist in vascular medecine
city: Levallois
country: France
facility: Office-based Specialist in vascular medecine
city: Limoges
country: France
facility: Office-based Specialist in vascular medecine
city: Lisieux
country: France
facility: Office-based Specialist in vascular medecine
city: Lomme
country: France
facility: Hospital Saint Philibert
city: Longjumeau
country: France
facility: Office-based Specialist in vascular medecine
city: Longwy
country: France
facility: Office-based Specialist in vascular medecine
city: Lons Le Saunier
country: France
facility: Office-based Specialist in vascular medecine
city: Lorient
country: France
facility: Office-based Specialist in vascular medecine
city: Louviers
country: France
facility: Office-based Specialist in vascular medecine
city: Lyon
country: France
facility: Hospital Edouard Herriot
city: Lyon
country: France
facility: University Hospital
city: Malemort Sur Correze
country: France
facility: Office-based Specialist in vascular medecine
city: Manosque
country: France
facility: Office-based Specialist in vascular medecine
city: Mantes La Jolie
country: France
facility: Office-based Specialist in vascular medecine
city: Marcq En Baroeul
country: France
facility: Office-based Specialist in vascular medecine
city: Marseille
country: France
facility: Office-based Specialist in vascular medecine
city: Martinique
country: France
facility: Office-based Specialist in vascular medecine
city: Maurepas
country: France
facility: Office-based Specialist in vascular medecine
city: Meaux
country: France
facility: Office-based Specialist in vascular medecine
city: Metz
country: France
facility: Office-based Specialist in vascular medecine
city: Meudon
country: France
facility: Office-based Specialist in vascular medecine
city: Moissac
country: France
facility: Office-based Specialist in vascular medecine
city: Montaigu
country: France
facility: Office-based Specialist in vascular medecine
city: Montbeliard
country: France
facility: Office-based Specialist in vascular medecine
city: Montbeliard
country: France
facility: General Hospital
city: Montivilliers
country: France
facility: Hospital Jacques Monod
city: Montlucon
country: France
facility: Office-based Specialist in vascular medecine
city: Montlucon
country: France
facility: Hospital
city: Montmorillon
country: France
facility: Hospital
city: Montpellier
country: France
facility: Office-based Specialist in vascular medecine
city: Montpellier
country: France
facility: Hospital St Eloi
city: Mulhouse
country: France
facility: Office-based Specialist in vascular medecine
city: Nancy
country: France
facility: Office-based Specialist in vascular medecine
city: Nantes
country: France
facility: Office-based Specialist in vascular medecine
city: Narbonne
country: France
facility: Office-based Specialist in vascular medecine
city: Nice
country: France
facility: Office-based Specialist in vascular medecine
city: Nimes
country: France
facility: Office-based Specialist in vascular medecine
city: Niort
country: France
facility: Office-based Specialist in vascular medecine
city: NOUMEA (Nouvelle Calédonie)
country: France
facility: Office-based Specialist in vascular medecine
city: Noyal Pontivy
country: France
facility: Office-based Specialist in vascular medecine
city: Noyon
country: France
facility: Office-based Specialist in vascular medecine
city: Orange
country: France
facility: Office-based Specialist in vascular medecine
city: Orleans La Source
country: France
facility: Regional Hospital
city: Orleans
country: France
facility: Office-based Specialist in vascular medecine
city: Paris
country: France
facility: Office-based Specialist in vascular medecine
city: Paris
country: France
facility: Hospital Croix Saint Simon
city: Perigueux
country: France
facility: Hospital
city: Peronne
country: France
facility: Office-based Specialist in vascular medecine
city: Pessac
country: France
facility: Office-based Specialist in vascular medecine
city: Poissy
country: France
facility: Office-based Specialist in vascular medecine
city: Poitiers
country: France
facility: Office-based Specialist in vascular medecine
city: Pontarlier
country: France
facility: Office-based Specialist in vascular medecine
city: Pornic
country: France
facility: Office-based Specialist in vascular medecine
city: Puilboreau
country: France
facility: Office-based Specialist in vascular medecine
city: Quimper
country: France
facility: Office-based Specialist in vascular medecine
city: Rambouillet
country: France
facility: Office-based Specialist in vascular medecine
city: Redon
country: France
facility: Office-based Specialist in vascular medecine
city: Reims
country: France
facility: Office-based Specialist in vascular medecine
city: Reims
country: France
facility: University Hospital
city: Riom
country: France
facility: Office-based Specialist in vascular medecine
city: Rivesaltes
country: France
facility: Office-based Specialist in vascular medecine
city: Rochefort
country: France
facility: Office-based Specialist in vascular medecine
city: Rodez
country: France
facility: Office-based Specialist in vascular medecine
city: Rodez
country: France
facility: Hospital
city: Romans Sur Isere
country: France
facility: Office-based Specialist in vascular medecine
city: Rouen
country: France
facility: Office-based Specialist in vascular medecine
city: Sable Sur Sarthe
country: France
facility: Office-based Specialist in vascular medecine
city: Saint Aubin de Medoc
country: France
facility: Office-based Specialist in vascular medecine
city: Saint Benoit
country: France
facility: Office-based Specialist in vascular medecine
city: Saint Brieuc
country: France
facility: Office-based Specialist in vascular medecine
city: Saint Chamond
country: France
facility: Office-based Specialist in vascular medecine
city: Saint Cloud
country: France
facility: Office-based Specialist in vascular medecine
city: Saint Cyr L'ecole
country: France
facility: Office-based Specialist in vascular medecine
city: Saint Egreve
country: France
facility: Office-based Specialist in vascular medecine
city: Saint Etienne
country: France
facility: Office-based Specialist in vascular medecine
city: Saint Etienne
country: France
facility: University Hospital
city: Saint Gaudens
country: France
facility: Office-based Specialist in vascular medecine
city: Saint Genevieve Des Bois
country: France
facility: Office-based Specialist in vascular medecine
city: Saint Germain En Laye
country: France
facility: Office-based Specialist in vascular medecine
city: Saint Hilaire Du Touvert
country: France
facility: Cmc Les Petites Roches
city: Saint Lo
country: France
facility: Office-based Specialist in vascular medecine
city: Saint Lo
country: France
facility: Memorial Hospital
city: Saint Martin Boulogne
country: France
facility: Office-based Specialist in vascular medecine
city: Saint Pierre (ile de La Reunion)
country: France
facility: Office-based Specialist in vascular medecine
city: Saint Priest
country: France
facility: Office-based Specialist in vascular medecine
city: Saint Quentin
country: France
facility: Hospital
city: Sallanches
country: France
facility: Office-based Specialist in vascular medecine
city: Salon de Provence
country: France
facility: Office-based Specialist in vascular medecine
city: Sarcelles
country: France
facility: Office-based Specialist in vascular medecine
city: Sarrebourg
country: France
facility: Office-based Specialist in vascular medecine
city: Sarreguemines
country: France
facility: Office-based Specialist in vascular medecine
city: Saverne
country: France
facility: Office-based Specialist in vascular medecine
city: Savigny Sur Orge
country: France
facility: Office-based Specialist in vascular medecine
city: Sceaux
country: France
facility: Office-based Specialist in vascular medecine
city: Selestat
country: France
facility: Office-based Specialist in vascular medecine
city: Sevres
country: France
facility: Office-based Specialist in vascular medecine
city: Strasbourg
country: France
facility: Office-based Specialist in vascular medecine
city: Strasbourg
country: France
facility: Regional University Hospital
city: Talant
country: France
facility: Office-based Specialist in vascular medecine
city: Tarare
country: France
facility: Office-based Specialist in vascular medecine
city: Toulouse
country: France
facility: Office-based Specialist in vascular medecine
city: Toulouse
country: France
facility: University Hospital Rangueil Larrey
city: Toulouse
country: France
facility: University Hospital Rangueil
city: Toulouse
country: France
facility: University Hospital
city: Tours
country: France
facility: Office-based Specialist in vascular medecine
city: Trois Rivieres (guadeloupe)
country: France
facility: Office-based Specialist in vascular medecine
city: Troyes
country: France
facility: Office-based Specialist in vascular medecine
city: Valence
country: France
facility: Office-based Specialist in vascular medecine
city: Vannes
country: France
facility: Office-based Specialist in vascular medecine
city: Vendome
country: France
facility: Office-based Specialist in vascular medecine
city: Venissieux
country: France
facility: Office-based Specialist in vascular medecine
city: Verrieres Le Buisson
country: France
facility: Office-based Specialist in vascular medecine
city: Versailles
country: France
facility: Office-based Specialist in vascular medecine
city: Vesoul
country: France
facility: Office-based Specialist in vascular medecine
city: Vichy
country: France
facility: Office-based Specialist in vascular medecine
city: Vienne
country: France
facility: Office-based Specialist in vascular medecine
city: Villebon Sur Yvette
country: France
facility: Office-based Specialist in vascular medecine
city: Villefranche Sur Saone
country: France
facility: Office-based Specialist in vascular medecine
city: Villemoisson Sur Orge
country: France
facility: Office-based Specialist in vascular medecine
city: Villeurbanne
country: France
facility: Office-based Specialist in vascular medecine
city: Vincennes
country: France
facility: Office-based Specialist in vascular medecine
city: Viroflay
country: France
facility: Office-based Specialist in vascular medecine
city: Vizille
country: France
facility: Office-based Specialist in vascular medecine
city: Voiron
country: France
facility: Office-based Specialist in vascular medecine
city: Wissembourg
country: France
facility: Office-based Specialist in vascular medecine
city: Wizernes
country: France
facility: Office-based Specialist in vascular medecine
city: Basse Terre
country: Guadeloupe
facility: Office-based Specialist in vascular medecine
Study officials:
affiliation: University Hospital, Grenoble
name: Jean Luc JB BOSSON, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Amiens University Hospital
name: Marie Antoinette SEVESTRE, MD
role: STUDY_CHAIR
References:
citation: Bosson JL, Labarere J, Sevestre MA, Belmin J, Beyssier L, Elias A, Franco A, Le Roux P. Deep vein thrombosis in elderly patients hospitalized in subacute care facilities: a multicenter cross-sectional study of risk factors, prophylaxis, and prevalence. Arch Intern Med. 2003 Nov 24;163(21):2613-8. doi: 10.1001/archinte.163.21.2613.
citation: Samama MM. An epidemiologic study of risk factors for deep vein thrombosis in medical outpatients: the Sirius study. Arch Intern Med. 2000 Dec 11-25;160(22):3415-20. doi: 10.1001/archinte.160.22.3415.
citation: Goldhaber SZ, Visani L, De Rosa M. Acute pulmonary embolism: clinical outcomes in the International Cooperative Pulmonary Embolism Registry (ICOPER). Lancet. 1999 Apr 24;353(9162):1386-9. doi: 10.1016/s0140-6736(98)07534-5.
citation: Stein PD, Hull RD, Ghali WA, Patel KC, Olson RE, Meyers FA, Kalra NK. Tracking the uptake of evidence: two decades of hospital practice trends for diagnosing deep vein thrombosis and pulmonary embolism. Arch Intern Med. 2003 May 26;163(10):1213-9. doi: 10.1001/archinte.163.10.1213.
citation: Sevestre MA, Labarere J, Brin S, Carpentier P, Constans J, Degeilh M, Deslandes B, Elgrishi I, Lanoye P, Laroche JP, Le Roux P, Pichot O, Quere I, Bosson JL; OPTIMEV study. [Optimizing history taking for evaluating the risk of venous thromboembolism: the OPTIMEV study]. J Mal Vasc. 2005 Sep;30(4 Pt 1):217-27. doi: 10.1016/s0398-0499(05)88206-x. French.
citation: Galanaud JP, Arnoult AC, Sevestre MA, Genty C, Bonaldi M, Guyard A, Giordana P, Pichot O, Colonna M, Quere I, Bosson JL; OPTIMEV-SFMV Investigators. Impact of anatomical location of lower limb venous thrombus on the risk of subsequent cancer. Thromb Haemost. 2014 Dec;112(6):1129-36. doi: 10.1160/TH14-04-0351. Epub 2014 Aug 7.
citation: Le Moigne E, Genty C, Meunier J, Arnoult AC, Righini M, Bressollette L, Bosson JL, Le Gal G; OPTIMEV Investigators. Validation of the LEFt score, a newly proposed diagnostic tool for deep vein thrombosis in pregnant women. Thromb Res. 2014 Sep;134(3):664-7. doi: 10.1016/j.thromres.2014.07.009. Epub 2014 Jul 17.
citation: Galanaud JP, Bosson JL, Genty C, Presles E, Cucherat M, Sevestre MA, Quere I, Decousus H, Leizorovicz A. Superficial vein thrombosis and recurrent venous thromboembolism: a pooled analysis of two observational studies. J Thromb Haemost. 2012 Jun;10(6):1004-11. doi: 10.1111/j.1538-7836.2012.04704.x.
citation: Galanaud JP, Sevestre MA, Genty C, Laroche JP, Zizka V, Quere I, Bosson JL; OPTIMEV SFMV investigators. Comparison of the clinical history of symptomatic isolated muscular calf vein thrombosis versus deep calf vein thrombosis. J Vasc Surg. 2010 Oct;52(4):932-8, 938.e1-2. doi: 10.1016/j.jvs.2010.05.019. Epub 2010 Jul 13.