Multicentre randomised controlled trial of the clinical and cost-effectiveness of a bypass-surgery-first versus a balloon-angioplasty-first revascularisation strategy for severe limb ischaemia due to infrainguinal disease. The Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial

Health Technology Assessment

Volumn 14, Issue 14, 2010, Pages 1-236

  Bradbury, A W ^a   Adam, D J ^a   Bell, J ^a   Forbes, J F ^b   Fowkes, F G R ^b   Gillespie, I ^b   Raab, G ^c   Ruckley, C V ^b  

^a UNIVERSITY OF BIRMINGHAM   (United Kingdom)

^b UNIVERSITY OF EDINBURGH   (United Kingdom)

^c EDINBURGH NAPIER UNIVERSITY   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

AMPUTATION; ARTICLE; ATHEROSCLEROSIS; BYPASS SURGERY; CLINICAL TRIAL; CONSULTATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COST EFFECTIVENESS ANALYSIS; DISEASE FREE SURVIVAL; GRAFT FAILURE; HEALTH CARE PLANNING; HOSPITAL COST; HUMAN; INFRAINGUINAL DISEASE; INTERMETHOD COMPARISON; INTERVENTIONAL RADIOLOGY; LEG REVASCULARIZATION; LIMB ISCHEMIA; MORBIDITY; MULTICENTER STUDY; OPERATION DURATION; OVERALL SURVIVAL; PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY; PERIPHERAL VASCULAR DISEASE; PROSTHESIS; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SURGICAL MORTALITY; SURGICAL RISK; UNITED KINGDOM; VEIN BYPASS;

AGED; AGED, 80 AND OVER; ANGIOPLASTY, TRANSLUMINAL, PERCUTANEOUS CORONARY; CORONARY ARTERY BYPASS; COST-BENEFIT ANALYSIS; FEMALE; GREAT BRITAIN; HUMANS; ISCHEMIA; LIGAMENTS; LOWER EXTREMITY; MALE; MYOCARDIAL REVASCULARIZATION; SEVERITY OF ILLNESS INDEX;

EID: 77950670635     PISSN: 13665278     EISSN: None     Source Type: Journal    
DOI: 10.3310/hta14140     Document Type: Article

References (216)

1. TASC. Management of peripheral arterial disease (PAD). TransAtlantic Inter-Society Consensus (TASC). Section D: chronic critical limb ischaemia. Eur J Vasc Endovasc Surg 2000;19(Suppl. A):S144-243.
2. Cavanagh PR, Lipsky BA, Bradbury AW, Botek G. Treating diabetic foot ulcers. Lancet 2005;366:1725-35.
3. Burns P, Gough S, Bradbury AW. Management of peripheral arterial disease in primary care. BMJ 2003;326:584-8.
4. Alber M, Romiti M, Brochado-Neto FC, Pereira CAB. Meta-analysis of alternate autogenous vein bypass grafts to infrapopliteal arteries. J Vasc Surg 2005;42:449-55.
5. Wolf GL, Wilson SE, Cross AP. Percutaneous transluminal angioplasty versus operation for peripheral arteriosclerosis. J Vasc Surg 1989;9:1-9.
6. van der Zaag ES, Legemate DA, Prins MH, Reekers JA, Jacobs MJ. Angioplasty or bypass for superficial femoral artery disease? A randomised controlled trial. Eur J Vasc Endovasc Surg 2004;28:132-7.
7. Papavassiliou VG, Walker SR, Bolia A, Fishwick G, London N. Techniques for the endovascular management of complications following lower limb percutaneous transluminal angioplasty. Eur J Vasc Endovasc Surg 2003;25:125-30.
8. Lipsitz EC, Ohki T, Veith FJ, Rhee SJ, Kurvers H, Timaran C, et al. Fate of collateral vessels following subintimal angioplasty. J Endovasc Therapy 2004;11:269-73.
9. Lipsitz EC, Veith FJ, Ohki T. The value of subintimal angioplasty in the management of critical lower extremity ischemia: failure is not always associated with a rethreatened limb. J Cardiovasc Surg 2004;45:231-7.
10. Hobbs SD, Yapanis M, Burns PJ, Wilmink AB, Bradbury AW, Adam DJ. Peri-operative myocardial injury in patients undergoing surgery for critical limb ischaemia. Eur J Vasc Endovasc Surg 2005;29:301-4.
11. Giswold ME, Landry GJ, Sexton GJ, Yeager RA, Edwards JM, Taylor LM Jr, et al. Modifiable patient factors are associated with reverse vein graft occlusion in the era of duplex scan surveillance. J Vasc Surg 2003;37:47-53.
12. Nguyen LL, Conte MS, Menard MT, Gravereaux EC, Chew DK, Donaldson MC, et al. Infrainguinal vein bypass graft revision: factors affecting longterm outcome. J Vasc Surg 2004;40:916-23.
13. Ishii Y, Gossage JA, Dourado R, Sabharwal T, Burnand KG. Minimum internal diameter of the greater saphenous vein is an important determinant of successful femorodistal bypass grafting that is independent of the quality of the runoff. Vascular 2004;12:225-32.
14. Bates MC, Aburahma AF. An update on endovascular therapy of the lower extremities. J Endovasc Therapy 2004;11(Suppl. 2):II107-27.
15. Baird RN, Bradley MD, Murphy KP. Tibioperoneal angioplasty and bypass. Acta Chirurg Belgica 2003;103:383-7.
16. Bradbury AW. Angioplasty is the first line treatment for critical limb ischaemia: the case against. In Greenhalgh RM, editor. Vascular and endovascular controversies (25th Charing Cross International Symposium 2003). Philadelphia: WB Saunders; 2003. pp. 295-307.
17. Loftus IM, Hayes PD, Bell PR. Subintimal angioplasty in lower limb ischaemia. J Cardiovasc Surg 2004;45:217-29.
18. Salas CA, Adam DJ, Papavassiliou VG, London NJ. Percutaneous transluminal angioplasty for critical limb ischaemia in octogenarians and nonagenarians. Eur J Vasc Endovasc Surg 2004;28:142-5.
19. Treiman GS. Subintimal angioplasty for infrainguinal occlusive disease. Surg Clin Nth Am 2004;84:1365-80.
20. Holm J, Arfridsson B. Chronic lower limb ischaemia. A prospective randomised controlled trial comparing the 1-year results of vascular surgery and percutaneous transluminal angioplasty (PTA). Eur J Vasc Surg 1991;5:517-22.
21. Nasr MK, McCarthy RJ, Hardman J, Chalmers A, Horrocks M. The increasing role of percutaneous transluminal angioplasty in the primary management of critical limb ischaemia. Eur J Vasc Endovasc Surg 2002;23:398-403.
22. Roddy SP, Darling RC 3rd, Maharaj D, Chang BB, Paty PS, Kreienberg PB, et al. Gender-related differences in outcome: an analysis of 5880 infrainguinal arterial reconstructions. J Vasc Surg 2003;37:399-402.
23. Al-Omran M, Tu JV, Johnston KW, Mamdani MM, Kucey DS. Outcome of revascularization procedures for peripheral arterial occlusive disease in Ontario between 1991 and 1998: a population-based study. J Vasc Surg 2003;38:279-88.
24. Saketkhoo RR, Razavi MK, Padidar A, Kee ST, Sze DY, Dake MD. Percutaneous bypass: subintimal recanalization of peripheral occlusive disease with IVUS guided luminal re-entry. Tech Vasc Intervent Radiol 2004;7:23-7.
25. Desgranges P, Boufi M, Lapeyre M, Tarquini G, van Laere O, Losy F, et al. Sub-intimal angioplasty: feasible and durable. Eur J Vasc Endovasc Surg 2004;28:138-41.
26. Clair DG, Dayal R, Faries PL, Bernheim J, Nowygrod R, Lantis JC 2nd, et al. Tibial angioplasty as an alternative strategy in patients with limbthreatening ischemia. Ann Vasc Surg 2005;19:63-8.
27. Atar E, Siegel Y, Avrahami R, Bartal G, Bachar GN, Belenky A. Balloon angioplasty of popliteal and crural arteries in elderly with critical chronic limb ischemia. Eur J Radiol 2005;53:287-92.
28. Surowiec SM, Davies MG, Eberly SW, Rhodes JM, Illig KA, Shortell CK, et al. Percutaneous angioplasty and stenting of the superficial femoral artery. J Vasc Surg 2005;41:269-78.
29. Trocciola SM, Chaer R, Dayal R, Lin SC, Kumar N, Rhee J, et al. Comparison of results in endovascular interventions for infrainguinal lesions: claudication versus critical limb ischemia. Am Surg 2005;71:474-80.
30. Tefera G, Hoch J, Turnipseed WD. Limb-salvage angioplasty in vascular surgery practice. J Vasc Surg 2005;41:988-93.
31. Tartari S, Zattoni L, Rolma G, Sacco A. Subintimal angioplasty of infrapopliteal artery occlusions in the treatment of critical limb ischaemia. Short-term results. Radiol Med 2004;108:265-74.
32. Leng GC, Davis M, Baker D. Bypass surgery for chronic lower limb ischaemia. Cochrane Database Syst Rev 2000;3:CD002000.
33. Jackson MJ, Wolfe JH. Are infra-inguinal angioplasty and surgery comparable? Acta Chirurg Belg 2001;101:6-10.
34. Bradbury AW, Ruckley CV. Angioplasty for lower limb ischaemia: time for randomised controlled trials. Lancet 1996;347:277-8.
35. Bradbury A, Bell J, Lee AJ, Prescott RJ, Gillespie I, Brittenden J, et al. on behalf of the BASIL Trial Delphi Consensus Group. Bypass or angioplasty for severe limb ischaemia? A Delphi consensus study. Eur J Vasc Endovasc Surg 2002;24:411-16.
36. Schermerhorn ML, Cronenwett JL, Baldwin JC. Open surgical repair versus endovascular therapy for chronic lower-extremity occlusive disease. Annu Rev Med 2003;54:269-83.
37. Bradbury A, Wilmink T, Lee AJ, Bell J, Prescott R, Gillespie I, et al. Bypass versus angioplasty to treat severe limb ischemia: factors that affect treatment preferences of UK surgeons and interventional radiologists. J Vasc Surg 2004;39:1026-32.
38. Tsetis D, Belli AM. The role of infrapopliteal angioplasty. Br J Radiol 2004;77:1007-15.
39. Bell J, Papp L, Bradbury AW. Bypass or angioplasty for severe ischaemia of the leg: the BASIL trial. In Greenhalgh RM, Powell JT, Mitchell AW. editors. Vascular and endovascular opportunities. London: W.B. Saunders; 2000. pp. 485-94.
40. Wolfe JHN, Wyatt MG. Critical and sub-critical limb ischaemia. Eur J Vasc Endovasc Surg 1997;13:578-82.
41. Caruana MF. Bradbury AW. Adam DJ. The validity, reliability, reproducibility and extended utility of ankle to brachial pressure index in current vascular surgical practice. Eur J Vasc Endovasc Surg 2005;29:443-51.
42. EuroQol Group. EuroQol: a new facility for the measurement of health-related quality of life. Health Policy 1990;16:199-208.
43. Ware JE, Sherbourne CD. The MOS 36-item shortform health survey (SF-36): conceptual framework and item selection. Med Care 1992;30:473-83.
44. Dolan P. Modeling valuations for EuroQol health states. Med Care 1997;35:1095-108.
45. Ware JE, Kosinski M, Dewey JE. How to score version two of the SF-36R health survey. Lincoln, RI: Quality Metric; 2000.
46. Abadie A, Drukker D, Herr JL, Imbens GW. Implementing matching estimators for average treatment effects in Stata. Stata J 2004;4:290-311.
47. NHS National Services Scotland. Scottish Health Service costs, year ended 31st March, 2004. Edinburgh: Information Services Division, NHS National Services Scotland; 2004.
48. Michaels J, Brazier J, Palfreyman S, Shackley P, Slack R. Cost and outcome implications of the organisation of vascular services. Health Technol Assess 2000;4(11).
49. Conte MS, Bandyk DF, Clowes AW, Moneta GL, Namini H, Seely L. Risk factors, medical therapies and peri-operative events in limb salvage surgery: observations from the PREVENT III multicentre trial. J Vasc Surg 2005;42:456-65.
50. Adam DJ, Beard JD, Cleveland T, Bell J, Bradbury AW, Forbes JF, et al. BASIL trial participants. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Lancet 2005;366:1925-34.
51. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG. TASC II Working Group. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Eur J Vasc Endovasc Surg 2007;33(Suppl. 1):S1-75.
52. Bollinger A, Breddin K, Hess H, Heystraten FM, Kollath J, Konttila A, et al.. Semi-quantitative assessment of lower limb atherosclerosis from routine angiographic images. Atherosclerosis 1981;38:339-46.
53. Morgan MB, Crayford T, Murrin B, Fraser SC. Developing the Vascular Quality of Life Questionnaire: a new disease-specific quality of life measure for use in lower limb ischemia. J Vasc Surg 2001;33:679-87.
54. NHS National Services Scotland. Scottish Health Service costs, year ended 31st March, 2007. Edinburgh: Information Services Division, NHS National Services Scotland; 2007.
55. Barber JA, Thompson SG. Analysis of cost data in randomized trials: an application of the nonparametric bootstrap. Stat Med 2000;19:3219-36.
56. Karrison T. Restricted mean life with adjustment for covariates. J Am Stat Assoc 1987;82:1169-76.
57. Grambsch P, Therneau T. Proportional hazards tests and diagnostics based on weighted residuals. Biometrika 1994;81:515-26.
58. Copas JB. Regression, prediction and shrinkage. J Royal Stat Soc Ser B 1983;45:311-45.
59. Brazier J, Roberts J, Deverill M. The estimation of a preference-based measure of health from the SF-36. J Health Econ 2002;21:271-92.
60. van Buuren S, Boshuizen HC, Knook, DL. Multiple imputation of missing blood pressure covariates in survival analysis. Stat Med 1999;18:681-94.
61. Royston P. Multiple imputation of missing values: Update of ice. Stata J 2005;5:527-36.
62. Epstein DM, Sculpher MJ, Manca A, Michaels J, Thompson SG, Brown LC, et al. Modelling the longterm cost-effectiveness of endovascular or open repair for abdominal aortic aneurysm. Br J Surg 2008;95:183-90.
63. de Vries M, Ouwendijk R, Kessels AG, de Haan MW, Flobbe K, Hunink MG, et al. Comparison of generic and disease-specific questionnaires for the assessment of quality of life in patients with peripheral arterial disease. J Vasc Surg 2005;41:261-8.
64. Prieto L, Sacristan JA. Problems and solutions in calculating quality-adjusted life years (QALYs) Health Qual Life Outcomes 2003;1:80.
65. Fenwick E, O'Brien B, Briggs A. Cost-effectiveness acceptability curves: facts, fallacies and frequently asked questions. Health Econ 2004;13:405-15.
66. Thompson MM, Sayers RD, Reid A, Underwood MJ, Bell PR. Quality of life following infragenicular bypass and lower limb amputation. Eur J Vasc Endovasc Surg 1995;9:310-13.
67. Fratezi AC, Albers M, De Luccia ND, Pereira CA. Outcome and quality of life of patients with severe chronic limb ischaemia: a cohort study on the influence of diabetes. Eur J Vasc Endovasc Surg 1995;10:459-65.
68. Hernandez-Osma E, Cairols MA, Marti X, Barjau E, Riera S. Impact of treatment on the quality of life in patients with critical limb ischaemia. Eur J Vasc Endovasc Surg 2002;23:491-4.
69. Hallin A, Bergqvist D, Fugl-Meyer K, Holmberg L. Areas of concern, quality of life and life satisfaction in patients with peripheral vascular disease. Eur J Vasc Endovasc Surg 2002;24:255-63.
70. Shechter M, Auslander G, Weinmann EE, Bass A. Quality of life and social support following distal arterial bypass in elderly patients. Israel Med Assoc J 2003;5:322-5.
71. Nehler MR. Coll JR. Hiatt WR. Regensteiner JG. Schnickel GT. Klenke WA, et al. Functional outcome in a contemporary series of major lower extremity amputations. J Vasc Surg 2003;38:7-14.
72. StataCorp. Stata Statistical Software: Release 10. College Station (TX): StataCorp LP; 2007.
73. Nehler MR, McDermott MM, Treat-Jacobson D, Chetter I, Regensteiner JG. Functional outcomes and quality of life in peripheral arterial disease: current status. Vasc Med 2003;8:115-26.
74. Slovacek L, Slovakova B, Chovane V, Vackova P, Kaslikova M, Bohutinska H, et al. The effect of selected health, demographic and psychosocial aspects on quality of life in patients with peripheral arterial occlusive disease - a prospective analysis. Acta Med (Hradec Kralove) 2007;50:125-7.
75. Brothers TE, Cox MH, Robison JG, Elliott BM, Nietert P. Prospective decision analysis modeling indicates that clinical decisions in vascular surgery often fail to maximize patient expected utility. J Surg Res 1987;120:278-87.
76. Brothers TE, Robison JG, Elliott BM. Prospective decision analysis for peripheral vascular disease predicts future quality of life. J Vasc Surg 2007;46:701-8.
77. Sottiurai V, White JV. Extensive revascularization or primary amputation: which patients with critical limb ischemia should not be revascularized? Sem Vasc Surg 2007;20:68-72.
78. Engelhardt M, Bruijnen H, Scharmer C, Jezdinsky N, Wolfle K. Improvement of quality of life six months after infrageniculate bypass surgery: diabetic patients benefit less than non-diabetic patients. Eur J Vasc Endovasc Surg 2006;32:182-7.
79. Albers M, Fratezi AC, De Luccia N. Assessment of quality of life of patients with severe ischemia as a result of infrainguinal arterial occlusive disease. J Vasc Surg 1992;16:54-9.
80. Pell JP, Fowkes FG, Lee AJ. Indications for arterial reconstruction and major amputation in the management of chronic critical lower limb ischaemia. The Scottish and Northern Vascular. Eur J Vasc Endovasc Surg 1997;13:315-21.
81. Pell JP, Donnan PT, Fowkes FG, Ruckley CV. Quality of life following lower limb amputation for peripheral arterial disease. Eur J Vasc Surg 1993;7:448-51.
82. Gibbons GW, Burgess AM, Guadagnoli E, Pomposelli FB Jr, Freeman DV, Campbell DR, et al. Return to well-being and function after infrainguinal revascularization. J Vasc Surg 1995;21:35-44.
83. Deneuville M, Perrouillet A. Survival and quality of life after arterial revascularization or major amputation for critical leg ischemia in Guadeloupe. Ann Vasc Surg 2006;20:753-60.
84. Sabeti S, Czerwenka-Wenkstetten A, Dick P, Schlager O, Amighi J, Mlekusch I, et al. Quality of life after balloon angioplasty versus stent implantation in the superficial femoral artery: findings from a randomized controlled trial. J Endovasc Ther 2007;14:431-7.
85. Landry GJ. Functional outcome of critical limb ischemia. J Vasc Surg 2007;45(Suppl. A):141-8.
86. Tangelder MJ, McDonnel J, Van Busschbach JJ, Buskens E, Algra A, Lawson JA, et al. Quality of life after infra-inguinal bypass grafting surgery. Dutch Bypass Oral Anticoagulants or Aspirin (BOA) Study Group. J Vasc Surg 1999;29:913-19.
87. Moore HL, White JV. Determination and importance of clinical and patient-based measures in outcome assessment of peripheral arterial occlusive disease. Semin Vascular Surg 2001;14:22-8.
88. Davies AH, Hawdon AJ, Sydes MR, Thompson SG, VGST Participants. Is duplex surveillance of value after leg vein bypass grafting? Principal results of the Vein Graft Surveillance Randomised Trial (VGST). Circulation 2005;112:1985-91.
89. Johnson BF, Evans L, Drury R, Datta D, Morris-Jones W, Beard JD. Surgery for limb threatening ischaemia: a reappraisal of the costs and benefits. Eur J Vasc Endovasc Surg 1995;9:181-8.
90. Johnson BF, Singh S, Evans L, Drury R, Datta D, Beard JD. A prospective study of the effect of limbthreatening ischaemia and its surgical treatment on the quality of life. Eur J Vasc Endovasc Surg 1997;13:306-14.
91. Chetter IC, Spark JI, Scott DJ, Kent PJ, Berridge DC, Kester RC. Prospective analysis of quality of life in patients following infrainguinal reconstruction for chronic critical ischaemia. Br J Surg 1998;85:951-5.
92. Holtzman J, Caldwell M, Walvatne C, Kane R. Long-term functional status and quality of life after lower extremity revascularization. J Vasc Surg 1999;29:395-402.
93. Inderbitzi R, Buettiker M, Enzler M. The long-term mobility and mortality of patients with peripheral arterial disease following bilateral amputation. Eur J Vasc Endovasc Surg 2003;26:59-64.
94. Dippel E, Shammas N, Takes V, Coyne L, Lemke J. Twelve-month results of percutaneous endovascular reconstruction for chronically occluded superficial femoral arteries: a quality-of-life assessment. J Inv Cardiol 2006;18:316-21.
95. Wann-Hansson C, Hallberg IR, Risberg B, Lundell A, Klevsgard R. Health-related quality of life after revascularization for peripheral arterial occlusive disease: long-term follow-up. J Adv Nurs 2005;51:227-35.
96. Wixon CL, Mills JL, Westerband A, Hughes JD, Ihnat DM. An economic appraisal of lower extremity bypass graft maintenance. J Vasc Surg 2000;32:1-12
97. Goshima KR, Mills JL Sr, Hughes JD. A new look at outcomes after infra-inguinal bypass surgery: traditional reporting standards systematically underestimate the expenditure of effort required to attain limb salvage. J Vasc Surg 2004;39:330-5.
98. Holler D, Claes C, von der Schulenburg JM. Treatment costs and quality of life of patients with peripheral arterial occlusive disease - the German perspective. Vasa 2004;33:145-53.
99. Callaghan BG, Condie ME. A post-discharge quality of life outcome measure for lower limb amputees: test-retest reliability and construct validity. Clin Rehab 2003;17:858-64.
100. Vascular Surgical Society of Great Britain and Ireland. Critical limb ischaemia: management and outcome. Report of a national survey. Eur J Vasc Endovasc Surg 1995;10:108-13.
101. Porter JM. Endovascular arterial intervention: expression of concern. J Vasc Surg 1995;21:995-7.
102. Bolia A. Percutaneous intentional extraluminal (subintimal) recanalization of crural arteries. Eur J Radiol 1998;28:199-204.
103. Parsons RE, Suggs WD, Lee JJ, Sanchez LA, Lyon RT, Veith FJ. Percutaneous transluminal angioplasty for the treatment of limb threatening ischemia: do the results justify an attempt before bypass grafting? J Vasc Surg 1998;28:1066-71.
104. Varty K, Nydahl S, Nasim A, Bolia A, Bell PR, London NJM. Results of surgery and angioplasty for the treatment of chronic severe lower limb ischaemia. Eur J Vasc Endovasc Surg 1998;16:159-63.
105. Vraux H, Hammer F, Verhelst R, Goffette P, Vandelene B. Sub-intimal angioplasty of tibial vessel occlusions in the treatment of critical limb ischaemia: mid-term results. Eur J Vasc Endovasc Surg 2000;20:441-6.
106. Stewart J, O'Halloran C, Harrigan P, Spencer JA, Barton JR, Singleton SJ. Identifying appropriate tasks for the preregistration year: modified Delphi technique. BMJ 1999;319:224-9.
107. Campbell SM, Cantrill JA, Roberts D. Prescribing indicators for UK general practice: Delphi consultation study. BMJ 2000;321:425-8.
108. Ayanian JZ, Landrum MB, Normand SL, Guadagnoli E, McNeil BJ. Rating the appropriateness of coronary angiography - do practicing physicians agree with an expert panel and with each other? N Engl J Med 1998;338:1896-904.
109. Desai TR, Meyerson SL, Skelly CL, MacKenzie KS, Bassiouny HS, Katz D, et al. Patency and limb salvage after infrainguinal bypass with severely compromised ("blind") outflow. Arch Surg 2001;13:635-42.
110. Al-Omran M, Tu JV, Johnston KW, Mamdani MM, Kucey DS. Outcome of revascularization procedures for peripheral arterial occlusive disease in Ontario between 1991 and 1998: a population-based study. J Vasc Surg 2003;38:279-88.
111. Ferraresi R, Centola M, Ferlini M, Da Ros R, Caravaggi C, Assaloni R, et al. Long-term outcomes after angioplasty of isolated, below-the-knee arteries in diabetic patients with critical limb ischaemia. Eur J Vasc Endovasc Surg 2009;37:336-42.
112. Lipsitz EC, Ohki, Veith FJ, Suggs WD, Wain RA, Cynamon J, et al. Does subintimal angioplasty have a role in the treatment of severe lower extremity ischemia? J Vasc Surg 2003;37:386-91.
113. Tefera G, Turnipseed W, Tanke T. Limb salvage angioplasty in poor surgical candidates. Vasc Endovasc Surg 2003;37:99-104.
114. DeRubertis BG, Faries PL, McKinsey JF, Chaer RA, Pierce M, Karwowski J, et al. Shifting paradigms in the treatment of lower extremity vascular disease: a report of 1000 percutaneous interventions. Ann Surg 2007;246:415-22.
115. DeRubertis BG, Pierce M, Ryer EJ, Trocciola S, Kent KC, Faries PL. Reduced primary patency rate in diabetic patients after percutaneous intervention results from more frequent presentation with limbthreatening ischemia. J Vasc Surg 2008;47:101-8.
116. Abando A, Akopian G, Katz SG. Patient sex and success of peripheral percutaneous transluminal arterial angioplasty. Arch Surg 2005;140:757-61.
117. Ishii H, Kumada Y, Toriyama T, Aoyama T, Takahashi H, Yamada S, et al. Cilostazol improves long-term patency after percutaneous transluminal angioplasty in hemodialysis patients with peripheral artery disease. Clin J Am Soc Nephrol 2008;3:1034-40.
118. Werk M, Langner S, Reinkensmeier B, Boettcher HF, Tepe G, Dietz U, et al. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation 2008;118:1358-65.
119. Perera GB, Lyden SP. Current trends in lower extremity revascularization. Surg Clin North Am 2007;87:1135-47.
120. Zeller T. Current state of endovascular treatment of femoro-popliteal artery disease. Vasc Med 2007;12:223-34.
121. White CJ, Gray WA. Endovascular therapies for peripheral arterial disease: an evidence-based review. Circulation 2007;116:2203-15.
122. Lee LK, Kent KC. Infrainguinal occlusive disease: endovascular intervention is the first line therapy. Adv Surg 2008;42:193-204.
123. Khan S, Flather M, Mister R, Delahunty N, Fowkes G, Bradbury A, et al. Characteristics and treatments of patients with peripheral arterial disease referred to UK vascular clinics: results of a prospective registry. Eur J Vasc Endovasc Surg 2007;33:442-50.
124. Schanzer A, Hevelone N, Owens CD, Beckman JA, Belkin M, Conte MS. Statins are independently associated with reduced mortality in patients undergoing infrainguinal bypass graft surgery for critical limb ischemia J Vasc Surg 2008;47:774-8.
125. Feringa HH, Bax JJ, Hoeks S. van Waning VH, Elhendy A, Karagiannis S, et al. A prognostic risk index for long-term mortality in patients with peripheral arterial disease. Arch Int Med 2007;167:2482-9.
126. Aung PP, Maxwell HG, Jepson RG, Price JF, Leng GC. Lipid-lowering for peripheral arterial disease of the lower limb. Cochrane Database Syst Rev 2007;4:CD000123.
127. Feringa HH, Karagiannis SE, van Waning VH, Boersma E, Schouten O, Bax JJ, et al. The effect of intensified lipid-lowering therapy on long-term prognosis in patients with peripheral arterial disease. J Vasc Surg 2007;45:936-43.
128. Heart Protection Study Collaborative Group. Randomized trial of the effects of cholesterollowering with simvastatin on peripheral vascular and other major vascular outcomes in 20,536 people with peripheral arterial disease and other high-risk conditions. J Vasc Surg 2007;45:645-54.
129. Collins TC, Souchek J, Beyth RJ. Benefits of antithrombotic therapy after infrainguinal bypass grafting: a meta-analysis. Am J Med 2004;117:93-9.
130. Carter A, Murphy MO, Halka AT, Turner NJ, Kirton JP, Murray D, et al. The natural history of stenoses within lower limb arterial bypass grafts using a graft surveillance program. Ann Vasc Surg 2007;21:695-703.
131. Welten GM, Schouten O, Hoeks SE, Chonchol M, Vidakovic R, van Domburg RT, et al. Long-term prognosis of patients with peripheral arterial disease: a comparison in patients with coronary artery disease. J Am Coll Cardiol 2008;51:1588-96.
132. Owens CD, Ho KJ, Conte MS. Lower extremity vein graft failure: a translational approach. Vasc Med 2008;13:63-74.
133. Conte MS, Lorenz TJ, Bandyk DF, Clowes AW, Moneta GL, Seely BL. Design and rationale of the PREVENT III clinical trial: edifoligide for the prevention of infrainguinal vein graft failure. Vasc Endovasc Surg 2005;39:15-23.
134. Feinglass J, Pearce WH, Martin GJ, Gibbs J, Cowper D, Sorensen M, et al. Postoperative and amputationfree survival outcomes after femorodistal bypass grafting surgery: findings from the Department of Veterans Affairs National Surgical Quality Improvement Program. J Vasc Surg 2001;34:283-90.
135. Faries PL, Arora S, Pomposelli FB Jr, Pulling MC, Smakowski P, Rohan DI, et al. The use of arm vein in lower-extremity revascularization: results of 520 procedures performed in eight years. J Vasc Surg 2000;31:50-9.
136. Landry GJ, Moneta GL, Taylor LM Jr., Edwards JM, Yeager RA, Porter JM. Long-term outcome of revised lower-extremity bypass grafts. J Vasc Surg 2002;35:56-62.
137. Landry GJ, Liem TK, Mitchell EL, Edwards JM, Moneta GL. Factors affecting symptomatic vs. asymptomatic vein graft stenoses in lower extremity bypass grafts. Arch Surg 2007;142:848-53.
138. Fowkes F, Leng GC. Bypass surgery for chronic lower limb ischaemia [update of Cochrane Database Syst Rev 2000;3:CD002000; PMID: 10908520]. Cochrane Database Syst Rev 2008;2:CD002000.
139. Kasapis C, Henke PK, Chetcuti SJ, Koenig GC, Rectenwald JE, Krishnamurthy VN, et al. Routine stent implantation vs. percutaneous transluminal angioplasty in femoropopliteal artery disease: a meta-analysis of randomized controlled trials. Eur Heart J 2009;30:44-55.
140. Bosiers M, Cagiannos C, Deloose K, Verbist J, Peeters P. Drug-eluting stents in the management of peripheral arterial disease. Vasc Health Risk Management 2008;4:553-9.
141. Koppensteiner R, Spring S, Amann-Vesti BR, Meier T, Pfammatter T, Rousson V, et al. Low-molecularweight heparin for prevention of restenosis after femoropopliteal percutaneous transluminal angioplasty: a randomized controlled trial. J Vasc Surg 2006;44:1247-53.
142. Schindler C, Mueller A, Bramlage P, Boecking W, Kirch W, Schweizer J. Comparison of selective AT1-receptor blockade versus ACE inhibition for restenosis prophylaxis in patients with peripheral occlusive arterial disease after stent angioplasty: a randomized, controlled, proof-of-concept study. Angiology 2008;58:710-16.
143. Jacobs DL, Motaganahalli RL, Cox DE, Wittgen CM, Peterson GJ. True lumen re-entry devices facilitate subintimal angioplasty and stenting of total chronic occlusions: initial report. J Vasc Surg 2006;43:1291-6.
144. Zeller T, Tiefenbacher C, Steinkamp HJ, Langhoff R, Wittenberg G, Schluter M, et al. Nitinol stent implantation in TASC A and B superficial femoral artery lesions: the Femoral Artery Conformexx Trial (FACT). J Endovasc Ther 2008;15:390-8.
145. Krankenberg H, Schluter M, Steinkamp HJ, Burgelin K, Scheinert D, Schulte KL, et al. Nitinol stent implantation versus percutaneous transluminal angioplasty in superficial femoral artery lesions up to 10 cm in length: the femoral artery stenting trial (FAST). Circulation 2007;116:285-92.
146. Schillinger M, Sabeti S, Loewe C, Dick P, Amighi J, Mlekusch W, et al. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery N Engl J Med 2006;354:1879-88.
147. Schmehl J, Tepe G. Current status of bare and drugeluting stents in infrainguinal peripheral vascular disease. Exp Rev Cardiovasc Ther 2008;6:531-8.
148. Tan JW, Yeo KK, Laird JR. Excimer laser assisted angioplasty for complex infrainguinal peripheral artery disease: a 2008 update. J Cardiovasc Surg 2008;49:329-40.
149. Rocha-Singh KJ, Jaff MR, Crabtree TR, Bloch DA, Ansel G. VIVA Physicians, Inc. Performance goals and endpoint assessments for clinical trials of femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease. Cath Cardiovasc Intervent 2007;69:910-19.
150. Diehm N, Baumgartner I, Jaff M, Do DD, Minar E, Schmidli J, et al. A call for uniform reporting standards in studies assessing endovascular treatment for chronic ischaemia of lower limb arteries. Eur Heart J 2007;28:798-805.
151. Weinberger J, Rundback JH, Ratchford EV. Regulatory approval of peripheral endovascular revascularization devices in the United States: is the horse still in the barn? Am J Therap 2005;12:186-91.
152. Diehm N, Diehm C, Kalka C, Dick F. Peripheral endovascular revascularization trials: high noon for uniform reporting standards. Acta Chir Belg 2008;108:382-5.
153. Diehm N, Pattynama PM, Jaff MR, Cremonesi A, Becker GJ, Hopkins LN, et al. Clinical endpoints in peripheral endovascular revascularization trials: a case for standardized definitions. Eur J Vasc Endovasc Surg 2008;36:409-19.
154. Goshima KR, Mills JL Sr, Hughes JD. A new look at outcomes after infrainguinal bypass surgery: traditional reporting standards systematically underestimate the expenditure of effort required to attain limb salvage. J Vasc Surg 2004;39:330-5.
155. Espinola-Klein C, Rupprecht HJ, Bickel C, Lackner K, Savvidis S, et al. AtheroGene Investigators. Different calculations of ankle-brachial index and their impact on cardiovascular risk prediction. Circulation 2008;118:961-7.
156. White JV, Rutherford RB, Ryjewski C. Chronic subcritical limb ischemia: a poorly recognized stage of critical limb ischemia. Semin Vasc Surg 2007;20:62-7.
157. Brass EP, Anthony R, Dormandy J, Hiatt WR, Jiao J, Nakanishi A, et al. Circulase investigators. Parenteral therapy with lipo-ecraprost, a lipidbased formulation of a PGE1 analog, does not alter six-month outcomes in patients with critical leg ischemia. J Vasc Surg 2006;43:752-9.
158. Tang TY, Prytherch DR, Walsh SR, Athanassoglou V, Seppi V, Sadat U, et al. Association with the Audit and Research Committee of the Vascular Society of Great Britain & Ireland. The development of a VBHOM-based outcome model for lower limb amputation performed for critical ischaemia. Eur J Vasc Endovasc Surg 2009;37:62-6.
159. Alexander J, Gutierrez CM, Katz S. Non-greater saphenous vein grafting for infrageniculate bypass. Am Surg 2002;68:611-14.
160. Alcocer F, Jordan WD Jr, Wirthlin DJ, Whitley D. Early results of lower extremity infrageniculate revascularization with a new polytetrafluoroethylene graft. Vascular 2004;12:318-24.
161. Bosiers M, Deloose K, Verbist J, Schroe H, Lauwers G, Lansink W, et al. Heparin-bonded expanded polytetrafluoroethylene vascular graft for femoropopliteal and femorocrural bypass grafting: 1-year results. J Vasc Surg 2006;43:313-18.
162. Gulkarov I, Malik R, Yakubov R, Gagne P, Muhs BE, Rockman C, et al. Early results for belowknee bypasses using Distaflo. Vasc Endovasc Surg 2008;42:561-6.
163. Hamdan AD, Rayan SS, Hook SC, Campbell DR, Akbari CM, LoGerfo FW, et al. Bypasses to tibial vessels using polytetrafluoroethylene as the solo conduit in a predominantly diabetic population. Vasc Endovasc Surg 2002;36:59-63.
164. Lauterbach SR, Torres GA, Andros G, Oblath RW. Infragenicular polytetrafluoroethylene bypass with distal vein cuffs for limb salvage: a contemporary series. Arch Surg 2005;140:487-93.
165. Faries PL, Arora S, Pomposelli FB Jr, Pulling MC, Smakowski P, Rohan DI, et al. The use of arm vein in lower-extremity revascularization: results of 520 procedures performed in eight years. J Vasc Surg 2000;31; 50-9.
166. Sandford RM, Bown MJ, Sayers RD, London JN, Naylor AR, McCarthy MJ. Is infrainguinal bypass grafting successful following failed angioplasty? Eur J Vasc Endovasc Surg 2007;34:29-34.
167. Loftus IM, Hayes PD, Bell PR. Subintimal angioplasty in lower limb ischaemia. J Cardiovasc Surg 2004;45:217-29.
168. Schanzer A, Mega J, Meadows J, Samson RH, Bandyk DF, Conte MS. Risk stratification in critical limb ischemia: derivation and validation of a model to predict amputation-free survival using multicenter surgical outcomes data. J Vasc Surg 2008;48:1464-71.
169. Nowygrod R, Egorova N, Greco G, Anderson P, Gelijns A, Moskowitz A, et al. Trends, complications, and mortality in peripheral vascular surgery. J Vasc Surg 2006;43:205-16.
170. Feinglass J, Pearce WH, Martin GJ, Gibbs J, Cowper D, Sorensen M, et al. Postoperative and amputationfree survival outcomes after femorodistal bypass grafting surgery: findings from the Department of Veterans Affairs National Surgical Quality Improvement Program. J Vasc Surg 2001;34:283-90.
171. Shrikhande GV, Hamdan AD, Monahan TS, Pomposelli FB Jr, Scovell SD, Logerfo FW, et al. Low ejection fraction predicts shortened survival in patients undergoing infrainguinal arterial reconstruction. World J Surg 2007;31:2422-6.
172. Mehta RH, Honeycutt E, Shaw LK, Sketch MH Jr. Clinical characteristics associated with poor longterm survival among patients with diabetes mellitus undergoing saphenous vein graft interventions. Am Heart J 2008;156:728-35.
173. Schanzer A, Hevelone N, Owens CD, Beckman JA, Belkin M, Conte MS. Statins are independently associated with reduced mortality in patients undergoing infrainguinal bypass graft surgery for critical limb ischemia. J Vasc Surg 2008;47:774-8.
174. Nguyen LL, Hevelone N, Rogers SO, Bandyk DF, Clowes AW, Moneta GL, et al. Disparity in outcomes of surgical revascularization for limb salvage: race and gender are synergistic determinants of vein graft failure and limb loss. Circulation 2009;119:123-30.
175. Lip GY, Barnett AH, Bradbury A, Cappuccio FP, Gill PS, Hughes E, et al. Ethnicity and cardiovascular disease prevention in the United Kingdom: a practical approach to management. J Hum Hypertens 2007;21:183-211.
176. Collins TC, Petersen NJ, Suarez-Almazor M, Ashton CM. The prevalence of peripheral arterial disease in a racially diverse population. Arch Int Med 2003;163:1469-74.
177. Hobbs SD, Wilmink AB, Bradbury AW. Ethnicity and peripheral arterial disease. Eur J Vasc Endovasc Surg 2003;25:505-12.
178. Collins TC, Petersen NJ, Suarez-Almazor M, Ashton CM. Ethnicity and peripheral arterial disease. Mayo Clin Proc 2005;80:48-54.
179. Criqui MH, Vargas V, Denenberg JO, Ho E, Allison M, Langer RD, et al. Ethnicity and peripheral arterial disease: the San Diego Population Study. Circulation 2005;112:2703-7.
180. Rowe VL, Kumar SR, Glass H, Hood DB, Weaver FA. Race independently impacts outcome of infrapopliteal bypass for symptomatic arterial insufficiency. Vasc Endovasc Surg 2007;41:397-401.
181. Dillingham TR, Pezzin LE, Mackenzie EJ. Racial differences in the incidence of limb loss secondary to peripheral vascular disease: a population-based study. Arch Phys Med Rehab 2002;83:1252-7.
182. Jaar BG, Astor BC, Berns JS, Powe NR. Predictors of amputation and survival following lower extremity revascularization in hemodialysis patients. Kidney Int 2004;65:613-20.
183. Feinglass J, Abadin S, Thompson J, Pearce WH. A census-based analysis of racial disparities in lower extremity amputation rates in Northern Illinois, 1987-2004. J Vasc Surg 2008;47:1001-7.
184. Dick P, Barth B, Mlekusch W, Sabeti S, Amighi J, Schlager O, et al. Complications after peripheral vascular interventions in octogenarians. J Endovasc Therapy 2008;15:383-9.
185. Mlekusch W, Exner M, Sabeti S, Amighi J, Schlager O, Wagner O, et al. Serum creatinine predicts mortality in patients with peripheral artery disease: influence of diabetes and hypertension. Atherosclerosis 2004;175:361-7.
186. Pasqualini L, Schillaci G, Pirro M, Vaudo G, Siepi D, Innocente S, et al. Renal dysfunction predicts long-term mortality in patients with lower extremity arterial disease. J Int Med 2007;262:668-77.
187. O'Hare AM, Feinglass J, Sidawy AN, Bacchetti P, Rodriguez RA, Daley J, et al. Impact of renal insufficiency on short-term morbidity and mortality after lower extremity revascularization: data from the Department of Veterans Affairs' National Surgical Quality Improvement Program. J Am Soc Nephrol 2003;14:1287-95.
188. O'Hare AM, Sidawy AN, Feinglass J, Merine KM, Daley J, Khuri S, et al. Influence of renal insufficiency on limb loss and mortality after initial lower extremity surgical revascularization. J Vasc Surg 2004;39:709-16.
189. Guerrero A, Montes R, Munoz-Terol J, Gil-Peralta A, Toro J, Naranjo M, et al. Peripheral arterial disease in patients with stages IV and V chronic renal failure. Nephrol Dialysis Transpl 2006;21:3525-31.
190. Hobbs SD, Wilmink AB, Adam DJ, Bradbury AW. Assessment of smoking status in patients with peripheral arterial disease. J Vasc Surg 2005;41:451-6.
191. Galal W, van Gestel YR, Hoeks SE, Sin DD, Winkel TA, Bax JJ, et al. The obesity paradox in patients with peripheral arterial disease. Chest 2008;134:925-30.
192. Hasanadka R, Brown KR, Rilling WS, Rossi PJ, Hieb RA, Hohenwalter EJ, et al. The extent of lower extremity occlusive disease predicts short- and longterm patency following endovascular infra-inguinal arterial intervention. Am J Surg 2008;196:629-33.
193. Malmstedt J, Leander K, Wahlberg E, Karlstrom L, Alfredsson L, Swedenborg J. Outcome after leg bypass surgery for critical limb ischemia is poor in patients with diabetes: a population-based cohort study. Diabetes Care 2008;31:887-92.
194. Paraskevas KI, Baker DM, Pompella A, Mikhailidis DP. Does diabetes mellitus play a role in restenosis and patency rates following lower extremity peripheral arterial revascularization? A critical overview. Ann Vasc Surg 2008;22:481-91.
195. Nehler MR, Brass EP, Anthony R, Dormandy J, Jiao J, McNamara TO, et al. for the Circulase investigators. Adjunctive parenteral therapy with lipo-ecraprost, a prostaglandin E1 analog, in patients with critical limb ischemia undergoing distal revascularization does not improve 6-month outcomes. J Vasc Surg 2007;45:953-61.
196. Marston WA, Davies SW, Armstrong B, Farber MA, Mendes RC, Fulton JJ, et al. Natural history of limbs with arterial insufficiency and chronic ulceration treated without revascularization. J Vasc Surg 2006;44:108-14.
197. Nehler MR, Peyton BD. Is revascularization and limb salvage always the treatment for critical limb ischemia? J Cardiovasc Surg 2004;45:177-84.
198. Reed AB, Delvecchio C, Giglia JS. Major lower extremity amputation after multiple revascularizations: was it worth it? Ann Vasc Surg 2008;22:335-40.
199. Chung J, Bartelson BB, Hiatt WR, Peyton BD, McLafferty RB, Hopley CW, et al. Wound healing and functional outcomes after infrainguinal bypass with reversed saphenous vein for critical limb ischemia. J Vasc Surg 2006;43:1183-90.
200. Taylor SM. Current status of heroic limb salvage for critical limb ischemia. Am Surg 2008;74:275-84.
201. Novo S, Coppola G, Milio G. Critical limb ischemia: definition and natural history. Curr Drug Targets 2004;4:219-25.
202. McCaslin JE, Hafez HM, Stansby G. Lower-limb revascularization and major amputation rates in England. Br J Surg 2007;94:835-9.
203. Cao P, De Rango P. Endovascular treatment of peripheral arterial disease: yet so far from evidence! Eur J Vasc Endovasc Surg 2009;37:501-3.
204. Kashyap VS, Pavko ML, Bishop PD, Nassoiy SP, Eagleton MJ, Clair DG, et al. Angiography underestimates peripheral atherosclerosis: lumenography revisited. J Endovasc Ther 2007;15:117-25.
205. Rutherford RB, Baker JD, Ernst C, Johnston KW, Porter JM, Ahn S, et al. Recommended standards for reports dealing with lower extremity ischemia: revised version. J Vasc Surg 1997;26:517-38.
206. Ihnat DM, Duong ST, Taylor ZC, Leon LR, Mills JL Sr, Goshima KR, et al. Contemporary outcomes after superficial femoral artery angioplasty and stenting: the influence of TASC classification and runoff score. J Vasc Surg 2008;47:967-74.
207. Graziani L, Silvestro A, Bertone V, Manara E, Andreini R, Sigala A, et al. Vascular involvement in diabetic subjects with ischemic foot ulcer: a new morphologic categorization of disease severity. Eur J Vasc Endovasc Surg 2007;33:453-60.
208. Davies MG, Saad WE, Peden EK, Mohiuddin IT, Naoum JJ, Lumsden AB. Percutaneous superficial femoral artery interventions for claudication - does runoff matter? Ann Vasc Surg 2008;22:790-8.
209. Tangelder MJ, Algra A, Lawson JA, Eikelboom BC. Risk factors for occlusion of infrainguinal bypass grafts. Eur J Vasc Endovasc Surg 2000;20:118-24.
210. Currie IC, Wakeley CJ, Cole SE, Wyatt MG, Scott DJ, Baird RN, et al. Femoropopliteal angioplasty for severe limb ischaemia. Br J Surg 1994;81:191-3.
211. Pedersen G, Laxdal E, Amundsen SR, Dregelid E, Jonung T, Nyheim T, et al. Flow measurement before and after papaverine injection in aboveknee prosthetic femoropopliteal bypass. J Vasc Surg 2006;43:729-34.
212. Davies AH, Magee TR, Parry R, Horrocks M, Baird RN. Evaluation of distal run-off before femorodistal bypass. Cardiovasc Surg 1996;4:161-4.
213. Alback A, Biancari F, Schmidt S, Mikkola P, Kantonen I, Matzke S, et al. Haemodynamic results of femoropopliteal percutaneous transluminal angioplasty. Eur J Vasc Endovasc Surg 1998;16:7-12.
214. Seeger JM, Pretus HA, Carlton LC, Flynn TC, Ozaki CK, Huber TS. Potential predictors of outcome in patients with tissue loss who undergo infrainguinal vein bypass grafting. J Vasc Surg 1999;30:427-35.
215. Stewart AH, Lucas A, Smith FC, Baird RN, Lamont PM. Pre-operative hand-held Doppler run-off score can be used to stratify risk prior to infrainguinal bypass surgery. Eur J Vasc Endovasc Surg 2002;23:500-4.
216. Grambsch P, Therneau T. Proportional hazards tests and diagnostics based on weighted residuals. Biometrika 1994:81:515-26.