Enhancements to angioplasty for peripheral arterial occlusive disease: Systematic review, cost-effectiveness assessment and expected value of information analysis

Health Technology Assessment

Volumn 18, Issue 10, 2014, Pages

  Simpson, Emma L ^a   Kearns, Benjamin ^a   Stevenson, Matthew D ^a   Cantrell, Anna J ^a   Littlewood, Chris ^a   Michaels, Jonathan A ^a  

^a UNIVERSITY OF SHEFFIELD   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ANGIOPLASTY, BALLOON; ARTERIAL OCCLUSIVE DISEASES; COST-BENEFIT ANALYSIS; HUMANS; MODELS, ECONOMIC; TREATMENT OUTCOME;

EID: 84894080362     PISSN: 13665278     EISSN: 20464924     Source Type: Journal    
DOI: 10.3310/hta18100     Document Type: Article

References (161)

1. Office for National Statistics. Population estimates for UK, England and Wales, Scotland and Northern Ireland, Mid-2010. Office for National Statistics, 2012. URL: www.ons.gov.uk/ons/publications/re-reference-tables.html?edition=tcm%3A77-231847(accessed July 2012).
2. Tendera M, Aboyans V, Bartelink ML, Baumgartner I, Clement D, Collet JP, et al. ESC guidelines on the diagnosis and treatment of peripheral artery diseases. Eur Heart J 2011;32:2851-906.
3. The Vascular Society of Great Britain and Ireland(VSGBI). The Provision of Services for Patients with Vascular Disease. Edinburgh: VSGBI; 2012.
4. Fowkes FGR, Housley E, Cawood EHH, MacIntyre CCA, Ruckley CV, Prescott RJ. Edinburgh Artery Study: prevalence of asymptomatic and symptomatic peripheral arterial disease in the general population. Int J Epidemiol 1991;20:384-92. http://dx.doi.org/10.1093/ije/20.2.384.
5. Trans-Atlantic Inter-society Consensus. Trans-Atlantic Inter-society Consensus document II on peripheral arterial disease - TASC II. Acta Chir Belg 2007;107:S1-72.
6. Bradbury AW, Bell J, Lee AJ, Prescott RJ, Gillespie I, Stansby G, et al. Bypass or angioplasty for severe limb ischaemia? A Delphi Consensus Study. Eur J Vasc Endovasc Surg 2002;24:411-16. http://dx.doi.org/10.1053/ejvs.2002.1709.
7. Peeters P, Keirse K, Verbist J, Deloose K, Bosiers M. Are bio-absorbable stents the future of SFA treatment? J Cardiovasc Surg 2010;51:121-4.
8. Moher D, Liberati A, Tetzlaff J, Altman DG, the PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Ann Intern Med 2009;151:65-94.
9. Centre for Reviews and Dissemination. Systematic Reviews: CRD's Guidance for Undertaking Reviews in Health Care. 3rd edn. York: University of York; 2009.
10. Cochrane Collaboration. Cochrane handbook for systematic reviews of interventions. URL: www.cochrane-handbook.org/(accessed April 2012).
11. Bosiers M, Peeters P, D'Archambeau O, Hendriks J, Pilger E, Duber C, et al. AMS INSIGHT - absorbable metal stent implantation for treatment of below-the-knee critical limb ischemia: 6-month analysis. Cardiovasc Intervent Radiol 2009;32:424-35.
12. Dick P, Wallner H, Sabeti S, Loewe C, Mlekusch W, Lammer J, et al. Balloon angioplasty versus stenting with nitinol stents in intermediate length superficial femoral artery lesions. Catheter Cardiovasc Interv 2009;74:1090-5. http://dx.doi.org/10.1002/ccd.22128.
13. Greenberg D, Rosenfield K, Garcia LA, Berezin RH, Lavelle T, Fogleman S, et al. In-hospital costs of self-expanding nitinol stent implantation versus balloon angioplasty in the femoropopliteal artery(the VascuCoil Trial). J Vasc Interv Radiol 2004;15:1065-9. http://dx.doi.org/10.1097/01. RVI.0000136293.18041.88.
14. 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. http://dx.doi.org/10.1161/CIRCULATIONAHA.107.689141.
15. Laird JR, Katzen BT, Scheinert D, Lammer J, Carpenter J, Buchbinder M, et al. Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: twelve-month results from the RESILIENT randomized trial. Circ Cardiovasc Interv 2010;3:267-76. http://dx.doi.org/10.1161/CIRCINTERVENTIONS.109.903468
16. 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 Eng J Med 2006;354:1879-88. http://dx.doi.org/10.1056/NEJMoa051303.
17. Schillinger M, Sabeti S, Dick P, Amighi J, Mlekusch W, Schlager O, et al. Sustained benefit at 2 years of primary femoropopliteal stenting compared with balloon angioplasty with optional stenting. Circulation 2007;115:2745-9. http://dx.doi.org/10.1161/CIRCULATIONAHA.107.688341.
18. 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. http://dx.doi.org/10.1583/1545-1550(2007)14[431:QOLABA]2.0.CO;2.
19. Becquemin JP, Favre JP, Marzelle J, Nemoz C, Corsin C, Leizorovicz A. Systematic versus selective stent placement after superficial femoral artery balloon angioplasty: a multicenter prospective randomized study. J Vasc Surg 2003;37:487-94. http://dx.doi.org/10.1067/mva.2003.155.
20. Cejna M, Thurnher S, Illiasch H, Horvath W, Waldenberger P, Hornik K, et al. PTA versus Palmaz stent placement in femoropopliteal artery obstructions: a multicenter prospective randomized study. J Vasc Interv Radiol 2001;12:23-31. http://dx.doi.org/10.1016/S1051-0443(07)61397-9.
21. Grimm J, Muller-Hulsbeck S, Jahnke T, Hilbert C, Brossmann J, Heller M. Randomized study to compare PTA alone versus PTA with Palmaz stent placement for femoropopliteal lesions. J Vasc Interv Radiol 2001;12:935-42. http://dx.doi.org/10.1016/S1051-0443(07)61572-3.
22. Rand T, Basile A, Cejna M, Fleischmann D, Funovics M, Gschwendtner M, et al. PTA versus carbofilm-coated stents in infrapopliteal arteries: pilot study. Cardiovasc Interv Radiol 2006;29:29-38. http://dx.doi.org/10.1007/s00270-005-0276-9.
23. Vroegindeweij D, Vos LD, Tielbeek AV, Buth J, vd Bosch HC. Balloon angioplasty combined with primary stenting versus balloon angioplasty alone in femoropopliteal obstructions: a comparative randomized study. Cardiovasc Interv Radiol 1997;20:420-5. http://dx.doi.org/10.1007/s002709900186.
24. Zdanowski Z, Albrechtsson U, Lundin A, Jonung T, Ribbe E, Thorne J, et al. Percutaneous transluminal angioplasty with or without stenting for femoropopliteal occlusions? A randomized controlled study. Int Angiol 1999;18:251-5.
25. Dake M, Ansel G, Jaff M, Ohki T, Saxon R, Smouse HB, et al. Zilver PTX: a prospective, randomized trial of the polymer-free paditaxel-eluting stent compared to balloon angioplasty with provisional bare metal steating in patients with superficial femoral artery disease. Journal of the American College of Cardiology Conference, 22nd Annual Symposium of the Transcatheter Cardiovascular Therapeutics, Washington DC, 21-25 September 2010. J Am Coll Cardiol 2010;56(Suppl. B):xiii.
26. Ansel G. Zilver PTX randomized trial of paclitaxel-eluting stents for femoropopliteal artery disease: 24-month update. Catheterization and Cardiovascular Interventions Conference, 34th Annual Scientific Sessions of the Society for Cardiovascular Angiography and Interventions, Baltimore, MD, 4-7 May 2011.
27. Dake M, Ansel G, Ragheb A. Interim report on the Zilver PTX clinical trial. Cardiovascular and Interventional Radiological Society of Europe Annual Meeting Abstracts, Copenhagen, Denmark, 13-17 September 2008.
28. Duda SH, Pusich B, Richter G, Landwehr P, Oliva VL, Tielbeek A, et al. Sirolimus-eluting stents for the treatment of obstructive superficial femoral artery disease: six-month results. Circulation 2002;106:1505-9. http://dx.doi.org/10.1161/01.CIR.0000029746.10018.36
29. Duda SH, Bosiers M, Lammer J, Scheinert D, Zeller T, Tielbeek A, et al. Sirolimus-eluting versus bare nitinol stent for obstructive superficial femoral artery disease: the SIROCCO II trial. J Vasc Interv Radiol 2005;16:331-8. http://dx.doi.org/10.1097/01.RVI.0000151260.74519.CA
30. Duda SH, Bosiers M, Lammer J, Scheinert D, Zeller T, Oliva V, et al. Drug-eluting and bare nitinol stents for the treatment of atherosclerotic lesions in the superficial femoral artery: long-term results from the SIROCCO trial. J Endovasc Ther 2006;13:701-10. http://dx.doi.org/10.1583/05-1704.1.
31. Rastan A, Tepe G, Krankenberg H, Zahorsky R, Beschorner U, Noory E, et al. Sirolimus-eluting stents vs. bare-metal stents for treatment of focal lesions in infrapopliteal arteries: a double-blind, multi-centre, randomized clinical trial. Eur Heart J 2011;32:2274-81. http://dx.doi.org/10.1093/eurheartj/ehr144.
32. Saxon RR, Coffman JM, Gooding JM, Natuzzi E, Ponec DJ. Long-term results of ePTFE stent-graft versus angioplasty in the femoropopliteal artery: single center experience from a prospective, randomized trial. J Vasc Interv Radiol 2003;14:303-11. http://dx.doi.org/10.1097/01. RVI.0000058425.01661.d0.
33. Saxon RR, Dake MD, Volgelzang RL, Katzen BT, Becker GJ. Randomized, multicenter study comparing expanded polytetrafluoroethylene-covered endoprosthesis placement with percutaneous transluminal angioplasty in the treatment of superficial femoral artery occlusive disease. J Vasc Interv Radiol 2008;19:823-32. http://dx.doi.org/10.1016/j.jvir.2008.02.008.
34. Nakamura S, Conroy RM, Gordon IL, Deutsch LS, Maheswaran B, Antone CS, et al. A randomized trial of transcutaneous extraction atherectomy in femoral arteries: intravascular ultrasound observations. J Clin Ultrasound 1995;23:461-71. http://dx.doi.org/10.1002/jcu.1870230802.
35. Vroegindeweij D, Kemper FJ, Tielbeek AV, Buth J, Landman G. Recurrence of stenoses following balloon angioplasty and Simpson atherectomy of the femoro-popliteal segment. A randomised comparative 1-year follow-up study using colour flow duplex. Eur J Vasc Surg 1992;6:164-71. http://dx.doi.org/10.1016/S0950-821X(05)80235-X
36. Vroegindeweij D, Tielbeek AV, Buth J, Schol FP, Hop WC, Landman GH. Directional atherectomy versus balloon angioplasty in segmental femoropopliteal artery disease: two-year follow-up with color-flow duplex scanning. J Vasc Surg 1995;21:255-68. http://dx.doi.org/10.1016/S0741-5214(95)70267-9.
37. Tielbeek AV, Vroegindeweij D, Buth J, Landman GH. Comparison of balloon angioplasty and Simpson atherectomy for lesions in the femoropopliteal artery: angiographic and clinical results of a prospective randomized trial. J Vasc Interv Radiol 1996;7:837-44. http://dx.doi.org/10.1016/S1051-0443(96)70857-6.
38. Amighi J, Schillinger M, Dick P, Schlager O, Sabeti S, Mlekusch W, et al. De novo superficial femoropopliteal artery lesions: peripheral cutting balloon angioplasty and restenosis rates - randomized controlled trial. Radiology 2008;247:267-72. http://dx.doi.org/10.1148/radiol.2471070749.
39. Dick P, Sabeti S, Mlekusch W, Schlager O, Amighi J, Haumer M, et al. Conventional balloon angioplasty versus peripheral cutting balloon angioplasty for treatment of femoropopliteal artery in-stent restenosis: initial experience. Radiology 2008;248:297-302. http://dx.doi.org/10.1148/radiol.2481071159.
40. Jahnke T, Mueller-Huelsbeck S, Charalambous N, Trentmann J, Jamili A, Huemme TH, et al. Prospective, randomized single-center trial to compare cryoplasty versus conventional angioplasty in the popliteal artery: midterm results of the COLD study. J Vasc Interv Radiol 2010;21:186-94. http://dx.doi.org/10.1016/j.jvir.2009.10.021
41. Spiliopoulos S, Katsanos K, Karnabatidis D, Diamantopoulos A, Kagadis GC, Christeas N, et al. Cryoplasty versus conventional balloon angioplasty of the femoropopliteal artery in diabetic patients: long-term results from a prospective randomized single-center controlled trial. Cardiovasc Interv Radiol 2010;33:929-38. http://dx.doi.org/10.1007/s00270-010-9915-x
42. Gallino A, Do DD, Alerci M, Baumgartner I, Cozzi L, Segatto JM, et al. Effects of probucol versus aspirin and versus brachytherapy on restenosis after femoropopliteal angioplasty: the PAB randomized multicenter trial. J Endovasc Ther 2004;11:595-604. http://dx.doi.org/10.1583/04-1269MR.1.
43. Bonvini R, Baumgartner I, Do DD, Alerci M, Segatto JM, Tutta P, et al. Late acute thrombotic occlusion after endovascular brachytherapy and stenting of femoropopliteal arteries. J Am Coll Cardiol 2003;41:409-12. http://dx.doi.org/10.1016/S0735-1097(02)02684-0.
44. Diehm N, Silvestro A, Do DD, Greiner R, Triller J, Mahler F, et al. Endovascular brachytherapy after femoropopliteal balloon angioplasty fails to show robust clinical benefit over time. J Endovasc Ther 2005;12:723-30. http://dx.doi.org/10.1583/05-1583MR.1.
45. Zehnder T, von Briel C, Baumgartner I, Triller J, Greiner R, Mahler F, et al. Endovascular brachytherapy after percutaneous transluminal angioplasty of recurrent femoropopliteal obstructions. J Endovasc Ther 2003;10:304-11. http://dx.doi.org/10.1583/1545-1550(2003)0100304:EBAPTA2.0.CO;2.
46. Hagenaars T, If AP, van Sambeek MR, Coen VL, van Tongeren RB, Gescher FM, et al. Gamma radiation induces positive vascular remodeling after balloon angioplasty: a prospective, randomized intravascular ultrasound scan study. J Vasc Surg 2002;36:318-24. http://dx.doi.org/10.1067/mva.2002.124373.
47. Krueger K, Landwehr P, Bendel M, Nolte M, Stuetzer H, Bongartz R, et al. Endovascular gamma irradiation of femoropopliteal de novo stenoses immediately after PTA: interim results of prospective randomized controlled trial. Radiology 2002;224:519-28. http://dx.doi.org/10.1148/radiol.2242010882.
48. Krueger K, Zaehringer M, Bendel M, Stuetzer H, Strohe D, Nolte M, et al. De novo femoropopliteal stenoses: endovascular gamma irradiation following angioplasty - angiographic and clinical follow-up in a prospective randomized controlled trial. Radiology 2004;231:546-54. http://dx.doi.org/10.1148/radiol.2312030421.
49. Wolfram RM, Budinsky AC, Pokrajac B, Potter R, Minar E. Endovascular brachytherapy for prophylaxis of restenosis after femoropopliteal angioplasty: five-year follow-up - prospective randomized study. Radiology 2006;240:878-84. http://dx.doi.org/10.1148/radiol.2403050883.
50. Minar E, Pokrajac B, Maca T, Ahmadi R, Fellner C, Mittlbock M, et al. Endovascular brachytherapy for prophylaxis of restenosis after femoropopliteal angioplasty: results of a prospective randomized study. Circulation 2000;102:2694-9. http://dx.doi.org/10.1161/01.CIR.102.22.2694.
51. Wolfram RM, Budinsky AC, Pokrajac B, Potter R, Minar E. Endovascular brachytherapy: restenosis in de novo versus recurrent lesions of femoropopliteal artery - the Vienna experience. Radiology 2005;236:338-42. [Erratum published in Radiology 2006;239:613.] http://dx.doi.org/10.1148/radiol.2361040084.
52. Pokrajac B, Potter R, Wolfram RM, Budinsky AC, Kirisits C, Lileg B, et al. Endovascular brachytherapy prevents restenosis after femoropopliteal angioplasty: results of the Vienna-3 randomised multicenter study. Radiother Oncol 2005;74:3-9. http://dx.doi.org/10.1016/j.radonc.2004.08.015
53. Pokrajac B, Potter R, Maca T, Fellner C, Mittlbock M, Ahmadi R, et al. Intraarterial 192Ir high-doserate brachytherapy for prophylaxis of restenosis after femoropopliteal percutaneous transluminal angioplasty: the prospective randomized Vienna-2-trial radiotherapy parameters and risk factors analysis. Int J Radiat Oncol Biol Phys 2000;48:923-31. http://dx.doi.org/10.1016/S0360-3016(00)00716-1
54. van Tongeren RB, van Sambeek MR, van OH, Coen VL, Schmitz PI, Gescher FM, et al. Endovascular brachytherapy for the prevention of restenosis after femoropopliteal angioplasty. Results of the VARA Trial. J Cardiovasc Surg 2005;46:437-43.
55. Wyttenbach R, Corti R, Alerci M, Cozzi L, Di VM, Segatto JM, et al. Effects of percutaneous transluminal angioplasty and endovascular brachytherapy on vascular remodeling of human femoropopliteal artery: 2 years follow-up by noninvasive magnetic resonance imaging. Eur J Vasc Endovasc Surg 2007;34:416-23. http://dx.doi.org/10.1016/j.ejvs.2007.05.017
56. Wyttenbach R, Gallino A, Alerci M, Mahler F, Cozzi L, Di VM, et al. Effects of percutaneous transluminal angioplasty and endovascular brachytherapy on vascular remodeling of human femoropopliteal artery by noninvasive magnetic resonance imaging. Circulation 2004;110:1156-61. http://dx.doi.org/10.1161/01.CIR.0000140672.70862.5B
57. Fritz P, Stein U, Hasslacher C, Zierhut D, Wannenmacher M, Pritsch M. External beam radiotherapy fails to prevent restenosis after iliac or femoropopliteal percutaneous transluminal angioplasty: results of a prospective randomized double-blind study. Int J Radiat Oncol Biol Phys 2004;59:815-21. http://dx.doi.org/10.1016/j.ijrobp.2003.11.036
58. Therasse E, Donath D, Lesperance J, Tardif JC, Guertin MC, Oliva VL, et al. External beam radiation to prevent restenosis after superficial femoral artery balloon angioplasty. Circulation 2005;111:3310-15. http://dx.doi.org/10.1161/CIRCULATIONAHA.104.502179
59. Scheinert D, Zeller T, Duda S, Ricke J, Bosiers M. Six month follow-up from a prospective, randomized trial comparing a paclitaxel-coated balloon catheter to a noncoated balloon catheter in patients with femoropopliteal disease. Cardiovascular and Interventional Radiology Conference, Cardiovascular and Interventional Radiological Society of Europe, Valencia, Spain, 2-6 January 2010, p. 203.
60. Scheinert D, Zeller T, Duda S, Krankenberg H, Ricke J, Bosiers M. A prospective, multicenter, single blind, randomized, controlled trial comparing the Lutonix catheter vs. standard balloon angioplasty for treatment of femoropopliteal arteries with and without stenting(LEVANT I). Journal of the American College of Cardiology Conference, 22nd Annual Symposium of the Transcatheter Cardiovascular Therapeutics, Washington DC, 21-25 September 2010, p. xv.
61. Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwalder U, Beregi JP, et al. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Eng J Med 2008;358:689-99. http://dx.doi.org/10.1056/NEJMoa0706356
62. Tepe G, Zeller T, Albrecht T, Speck U. Drug-coated balloons for the prevention of restenosis in peripheral arteries. Angiographic and clinical two-year follow-up of the THUNDER trial. Am J Cardiol 2008;102:219I.
63. Tepe G, Zeller T, Albrecht T, Speck U. Persistent benefit of drug coated balloons for prevention of restenosis in peripheral arteries: angiographic follow-up after 6 and 12 months. Cardiovascular and Interventional Radiological Society of Europe Annual Meeting Abstracts, 13-17 September 2008, Copenhagen, Denmark.
64. 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;118:1358-1365. http://dx.doi.org/10.1161/CIRCULATIONAHA.107.735985.
65. Belli AM, Cumberland DC, Procter AE, Welsh CL. Follow-up of conventional angioplasty versus laser thermal angioplasty for total femoropopliteal artery occlusions: results of a randomized trial. J Vasc Interv Radiol 1991;2:485-488. http://dx.doi.org/10.1016/S1051-0443(91)72229-X
66. Belli AM, Cumberland DC, Procter AE, Welsh CL. Total peripheral artery occlusions: conventional versus laser thermal recanalization with a hybrid probe in percutaneous angioplasty - results of a randomized trial. Radiology 1991;181:57-60.
67. Fisher CM, Fletcher JP, May J, White GH, Lord RS, Crozier J, et al. No additional benefit from laser in balloon angioplasty of the superficial femoral artery. Eur J Vasc Endovasc Surg 1996;11: 349-52. http://dx.doi.org/10.1016/S1078-5884(96)80084-0.
68. Lammer J, Pilger E, Decrinis M, Quehenberger F, Klein GE, Stark G. Pulsed excimer laser versus continuous-wave Nd:YAG laser versus conventional angioplasty of peripheral arterial occlusions: prospective, controlled, randomised trial. Lancet 1992;340:1183-8.
69. Spies JB, LeQuire MH, Brantley SD, Williams JE, Beckett WC, Mills JL. Comparison of balloon angioplasty and laser thermal angioplasty in the treatment of femoropopliteal atherosclerotic disease: initial results of a prospective randomized trial. Work in progress. J Vasc Interv Radiol 1990;1:39-42. http://dx.doi.org/10.1016/S1051-0443(90)72500-6.
70. Tobis JM, Conroy R, Deutsch LS, Gordon I, Honye J, Andrews J, et al. Laser-assisted versus mechanical recanalization of femoral arterial occlusions. Am J Cardiol 1991;68:1079-86. http://dx.doi.org/10.1016/0002-9149(91)90499-B
71. Dake MD, Ansel G, Jaff M, Ohki T, Saxon R, Smouse HB, et al. Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: twelve month Zilver PTX randomized study results. Circulation 2011;4:495-504. http://dx.doi.org/10.1161/CIRCINTERVENTIONS.111.962324.
72. Bachoo P, Thorpe PA, Maxwell H, Welch K. Endovascular stents for intermittent claudication. Cochrane Database Syst Rev 2010;1:CD003228. http://dx.doi.org/10.1002/14651858.CD003228.
73. Twine CP, Coulston J, Shandall A, McLain AD. Angioplasty versus stenting for superficial femoral artery lesions. Cochrane Database Syst Rev 2009;2:CD006767. http://dx.doi.org/10.1002/14651858.CD006767.
74. Grenacher L, Saam T, Geier A, Muller-Hulsbeck S, Cejna M, Kauffmann GW, et al. [PTA versus Palmaz stent placement in femoropopliteal artery stenoses: results of a multicenter prospective randomized study(REFSA)]. Fortschr Rö ntgenstr 2004;176:1302-10.
75. 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. http://dx.doi.org/10.1093/eurheartj/ehn514.
76. Sculpher M, Michaels J, McKenna M, Minor J. A cost-utility analysis of laser-assisted angioplasty for peripheral arterial occlusions. Int J Technol Assess Health Care 1996;12:104-25. http://dx.doi.org/10.1017/S0266462300009430.
77. Hunink MG, Wong JB, Donaldson MC, Meyerovitz MF, de Vries J, Harrington DP. Revascularization for femoropopliteal disease. A decision and cost-effectiveness analysis. JAMA 1995;274:165-71.
78. de Vries SO, Visser K, de Vries JA, Wong JB, Donaldson MC, Hunink MG. Intermittent claudication: cost-effectiveness of revascularization versus exercise therapy. Radiology 2002;222:25-36.
79. Holler D, Claes C, Von Der SJM. Cost-utility analysis of treating severe peripheral arterial occlusive disease. Int J Angiol 2006;15:25-33. http://dx.doi.org/10.1007/s00547-006-2073-y
80. Muradin GS, Myriam Hunink MG. Cost and patency rate targets for the development of endovascular devices to treat femoropopliteal arterial disease. Radiology 2001;218:464-9.
81. Visser K, de Vries SO, Kitslaar PJ, van Engelshoven JM, Hunink MG. Cost-effectiveness of diagnostic imaging work-up and treatment for patients with intermittent claudication in the Netherlands. Eur J Vasc Endovasc Surg 2003;25:213-23. http://dx.doi.org/10.1053/ejvs.2002.1838.
82. Forbes JF, Adam DJ, Bell J, Fowkes FG, Gillespie I, Raab GM, et al. Bypass versus Angioplasty in Severe Ischaemia of the Leg(BASIL)trial: health-related quality of life outcomes, resource utilization, and cost-effectiveness analysis. J Vasc Surg 2010;51(Suppl. 5):43-51. http://dx.doi.org/10.1016/j.jvs.2010.01.076.
83. National Institute for Health and Care Excellence. Lower Limb Peripheral Arterial Disease: Diagnosis and Management.(Clinical Guideline 147). 2012. URL: http://guidance.nice.org.uk/CG147.(accessed 27 January 2014).
84. Bradbury AW, Ruckley CV, Fowkes FGR, Forbes JF, Gillespie I, Adam DJ, et al. Bypass versus angioplasty in severe ischaemia of the leg(BASIL): multicentre, randomised controlled trial. Lancet 2005;366:1925-34.
85. Bradbury AW, Adam DJ, Bell J, Forbes JF, Fowkes FG, Gillespie I, et al. Bypass versus Angioplasty in Severe Ischaemia of the Leg(BASIL)trial: an intention-to-treat analysis of amputation-free and overall survival in patients randomized to a bypass surgery-first or a balloon angioplasty-first revascularization strategy. J Vasc Surg 2010;51(Suppl. 5):5-17. http://dx.doi.org/10.1016/j.jvs.2010.01.073.
86. Bradbury AW, Adam DJ, Bell J, Forbes JF, Fowkes FG, Gillespie I, et al. Bypass versus Angioplasty in Severe Ischaemia of the Leg(BASIL)trial: analysis of amputation free and overall survival by treatment received. J Vasc Surg 2010;51(Suppl. 5):18-31. http://dx.doi.org/10.1016/j.jvs.2010.01.074.
87. Bradbury AW, Adam DJ, Bell J, Forbes JF, Fowkes FG, Gillespie I, et al. Bypass versus Angioplasty in Severe Ischaemia of the Leg(BASIL)trial: a survival prediction model to facilitate clinical decision making. J Vasc Surg 2010;51(Suppl. 5):52-68. http://dx.doi.org/10.1016/j. jvs.2010.01.077.
88. Bradbury AW, Adam DJ, Bell J, Forbes JF, Fowkes FG, Gillespie I, et al. Bypass versus Angioplasty in Severe Ischaemia of the Leg(BASIL)trial: A description of the severity and extent of disease using the Bollinger angiogram scoring method and the TransAtlantic Inter-Society Consensus II classification. J Vasc Surg 2010;51(Suppl. 5):32-42.[Erratum published in J Vasc Surg 2010;52:1751.] http://dx.doi.org/10.1016/j.jvs.2010.01.075.
89. Department of Health. 2010-11 reference costs publication. Department of Health; 2012. URL: www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_131140(accessed October 2013).
90. Personal Social Services Research Unit. Unit costs of health and social care 2010. Personal Social Services Research Unit; 2012. URL: www.pssru.ac.uk/project-pages/unit-costs/2010/index.php(accessed October 2013).
91. Axisa B, Fishwick G, Bolia A, Thompson MM, London NJM, Bell PRF, et al. Complications following peripheral angioplasty. Ann Royal Coll Surg Eng 2002;84:39-42.
92. White CJ, Gray WA. Endovascular therapies for peripheral arterial disease - an evidence-based review. Circulation 2007;116:2203-15. http://dx.doi.org/10.1161/CIRCULATIONAHA.106.621391.
93. Government Actuary's Department. Life Tables Index. Government Actuary's Department; 2012. URL: www.gad.gov.uk/Demography%20Data/Life%20Tables/(accessed October 2013).
94. Brass EP, Anthony R, Dormandy J, Hiatt WR, Jiao J, Nakanishi A, et al. Parenteral therapy with lipo-ecraprost, a lipid-based formulation of a PGE1 analog, does not alter six-month outcomes in patients with critical leg ischemia. J Vasc Surg 2006;43:752-9. http://dx.doi.org/10.1016/j.jvs.2005.11.041.
95. Briggs A, Sculpher M, Claxton K. Decision Modelling for Health Economic Evaluation. 1st edn. Oxford: Oxford University Press; 2006.
96. Bergqvist D, Troeng J, Elfstrom B, Hedberg K, Ljungstrom G, Norgren L, et al. Auditing surgical outcome: ten years with the Swedish vascular registry - Swedvasc. Eur J Surg 1998; 164(Suppl. 7):3-32.
97. Criqui MH, Langer RD, Fronek A, Feigelson HS, Klauber MR, McCann TJ, et al. Mortality over a period of 10 years in patients with peripheral arterial disease. N Eng J Med 1992;326:381-6. http://dx.doi.org/10.1056/NEJM199202063260605.
98. Hunink MG, Wong JB, Donaldson MC, Meyerovitz MF, Harrington DP. Patency results of percutaneous and surgical revascularization for femoropopliteal arterial disease. Med Decis Making 1994;14:71-81. http://dx.doi.org/10.1177/0272989X9401400109.
99. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FGR, et al. Inter-society consensus for the management of peripheral arterial disease. Int Angiol 2007;26:81-157.
100. de Vries SO, Magruder MC, Hunink MGM. Contralateral symptoms after unilateral intervention for peripheral occlusive disease. J Vasc Surg 1998;27:414-21. http://dx.doi.org/10.1016/S0741-5214(98)70315-5.
101. Ara R, Brazier JE. Populating an economic model with health state utility values: moving toward better practice. Value Health 2010;13:509-18. http://dx.doi.org/10.1111/j.1524- 4733.2010.00700.x
102. Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, et al. ACC/AHA 2005 practice guidelines for the management of patients with peripheral arterial disease(lower extremity, renal, mesenteric, and abdominal aortic): Executive summary - A collaborative report from the American association for vascular surgery/society for vascular surgery, society for cardiovascular angiography and interventions, society for vascular medicine and biology, society of interventional radiology, and the ACC/AHA task force on practice guidelines(Writing committee to develop guidelines for the management of patients with peripheral arterial disease). Circulation 2006;113:1474-547.
103. Spronk S, Bosch JL, den Hoed PT, Veen HF, Pattynama PM, Hunink MG. Cost-effectiveness of endovascular revascularization compared to supervised hospital-based exercise training in patients with intermittent claudication: a randomized controlled trial. J Vasc Surg 2008;48:1472-80. http://dx.doi.org/10.1016/j.jvs.2008.06.016.
104. Greenhalgh RM, Belch JJ, Brown LC, Gaines PA, Gao L, Reise JA, et al. The adjuvant benefit of angioplasty in patients with mild to moderate intermittent claudication(MIMIC)managed by supervised exercise, smoking cessation advice and best medical therapy: results from two randomised trials for stenotic femoropopliteal and aortoiliac arterial disease. Eur J Vasc Endovasc Surg 2008;36:680-8.
105. Gorenoi V, Dintsios CM, Schonermark MP, Hagen A. Intravascular brachytherapy for peripheral vascular disease. GMS Health Technol Assess 2008;4:Doc08.
106. Salman M, Asif A. Stent graft for nephrologists: concerns and consensus. Clin J Am Soc Nephrol 2010;5:1347-52. http://dx.doi.org/10.2215/CJN.02380310.
107. Schmieder GC, Carroll M, Panneton JM. Poor outcomes with cryoplasty for lower extremity arterial occlusive disease. J Vasc Surg 2010;52:362-8. http://dx.doi.org/10.1016/j.jvs.2010.03.012
108. Rastan A, Tepe G, Krankenberg H, Zahorsky R, Schwarzwalder U, Noory E, et al. Sirolimus-eluting stents versus bare-metal stents for treatment of infrapopliteal arteries: A double blind, multicentre randomised clinical trial. Journal of the American College of Cardiology, 22nd Annual Symposium of the Transcatheter Cardiovascular Therapeutics, Washington DC, 21-25 September 2010, pp. xv-xvi.
109. Claxton K, Possati G. An economic approach to clinical trial design and research priority-setting. Health Econ 1996;5:513-24. http://dx.doi.org/10.1002/(SICI)1099-1050(199611)5:6513::AIDHEC237 3.0.CO;2-9.
110. Agostoni P, Vermeersch P, Semeraro O, Verheye S, Van LG, Van den Heuvel P, et al. Intravascular ultrasound comparison of sirolimus-eluting stent versus bare metal stent implantation in diseased saphenous vein grafts(from the RRISC [reduction of restenosis in saphenous vein grafts with cypher sirolimus-eluting stent] trial). Am J Cardiol 2007;100:52-8. http://dx.doi.org/10.1016/j.amjcard.2007.02.052.
111. Ahn SS, Eton D, Yeatman LR, Deutsch LS, Moore WS. Intraoperative peripheral rotary atherectomy: early and late clinical results. Ann Vasc Surg 1992;6:272-80. http://dx.doi.org/10.1007/BF02000274.
112. Aldea GS, Gaudiani JA, Shapira OM, O'Gara P, Bao Y, Lazar HL, et al. Comparison of risk profile and outcomes in patients undergoing surgical and catheter-based revascularization. J Card Surg 1998;13:81-9.
113. Allaqaband S, Kirvaitis R, Jan F, Bajwa T. Endovascular treatment of peripheral vascular disease. Curr. Probl Cardiol 2009;34:359-476. http://dx.doi.org/10.1016/j.cpcardiol.2009.05.001.
114. Aoki J, Mintz GS, Weissman NJ, Mann JT, Cannon L, Greenberg J, et al. Chronic arterial responses to overlapping paclitaxel-eluting stents: insights from serial intravascular ultrasound analyses in the TAXUS-V and -VI trials. JACC Cardiovasc Interv 2008;1:161-7.
115. Carreira JM, Reyes R, Gude F, Gorriz E, Gallardo L, Pardo MD, et al. Long-term follow-up of Symphony nitinol stents in iliac arteriosclerosis obliterans. Minim Invasive Ther Allied Technol 2008;17:34-42. http://dx.doi.org/10.1080/13645700701800343.
116. Dalainas I, Nano G, Kashyap A, Anand KP, Kashyap S, Golledge J, et al. Balloon angioplasty or nitinol stents for peripheral-artery disease. N Eng J Med 2006;355:521-4.
117. Das TS. Percutaneous peripheral revascularisation with excimer laser: equipment, technique and results. Lasers Med Sci 2001;16:101-7. http://dx.doi.org/10.1007/PL00011338.
118. Diehm N, Baumgartner I, Juni P. Local paclitaxel delivery in peripheral vascular disease. N Engl J Med 2008;358:689-99. Comment and author reply: N Eng J Med 2008;358:2406-7.
119. Dieter RS, Nanjundappa A, Lopez JJ. Drug-eluting stents for critical limb ischemia. J Am Coll Cardiol 2010;56:1264. http://dx.doi.org/10.1016/j.jacc.2010.05.038.
120. Fleisher HLIII, Thompson BW, McCowan TC, Ferris EJ, Reifsteck JE, Barnes RW. Human percutaneous laser angioplasty. Patient selection criteria and early results. Am J Surg 1987;154:666-70.
121. Gaines PA, Schulte KL, Muller-Hulsbeck S, Seelen J, Maleux G, van Overhagen H, et al. A multicentre evaluation of the Medtronic AVE Flexible Iliac Bridge Stent in the iliac arteries(the first study). Eur J Vasc Endovasc Surg 2005;29:124-30. http://dx.doi.org/10.1016/j.ejvs.2004.12.004.
122. Hall P, Gaglione A, Giordano M, Colombo A. Peripheral angioplasty and interventions. Int Angiol 1993;12(Suppl. 3):32-9.
123. Hartnell GG, Jones AM, Murphy P. Do hydrophilic guidewires affect the technical success rates of percutaneous angioplasty? Angiology 1995;46:229-34. http://dx.doi.org/10.1177/000331979504600306
124. Hassan AK, Bergheanu SC, Stijnen T, van der Hoeven BL, Snoep JD, Plevier JW, et al. Late stent malapposition risk is higher after drug-eluting stent compared with bare-metal stent implantation and associates with late stent thrombosis. Eur Heart J 2010;31:1172-80. http://dx.doi.org/10.1093/eurheartj/ehn553
125. Kaneda H, Ako J, Terashima M, Waseda K, Yock PG, Fitzgerald PJ. Distribution pattern of neointimal hyperplasia following sirolimus-eluting stent implantation assessed by 3-dimensional intravascular ultrasound. Int J Cardiol 2009;135:243-5. http://dx.doi.org/10.1016/j.ijcard.2008.01.054
126. Killewich LA. Improving functional status and quality of life in elderly patients with peripheral arterial disease. J Am Coll Surg 2006;202:345-55. http://dx.doi.org/10.1016/j. jamcollsurg.2005.09.026
127. Jahnke T, Voshage G, Muller-Hulsbeck S, Grimm J, Heller M, Brossmann J. Endovascular placement of self-expanding nitinol coil stents for the treatment of femoropopliteal obstructive disease. J Vasc Interv Radiol 2002;13:257-66. http://dx.doi.org/10.1016/S1051-0443(07)61718-7
128. Jahnke T, Andresen R, Muller-Hulsbeck S, Schafer FK, Voshage G, Heller M, et al. Hemobahn stent-grafts for treatment of femoropopliteal arterial obstructions: midterm results of a prospective trial. J Vasc Interv Radiol 2003;14:41-51. http://dx.doi.org/10.1097/01. RVI.0000052290.26939.cb
129. Jeans WD, Murphy P, Hughes AO, Horrocks M, Baird RN. Randomized trial of laser-assisted passage through occluded femoro-popliteal arteries. Br J Radiol 1990;63:19-21. http://dx.doi.org/10.1259/0007-1285-63-745-19
130. Lammer J, Dake MD, Bleyn J, Katzen BT, Cejna M, Piquet P, et al. Peripheral arterial obstruction: prospective study of treatment with a transluminally placed self-expanding stent-graft. International Trial Study Group. Radiology 2000;217:95-104.
131. London NJ, Bolia A, Bell PR. Subintimal angioplasty for femoropopliteal artery occlusion. Lancet 1993;341:238. http://dx.doi.org/10.1016/0140-6736(93)90098-2
132. Nicholson T. Percutaneous transluminal angioplasty and enclosed thrombolysis versus percutaneous transluminal angioplasty in the treatment of femoropopliteal occlusions: results of a prospective randomized trial. Cardiovasc Interv Radiol 1998;21:470-4. http://dx.doi.org/10.1007/s002709900306
133. Randon C, Jacobs B, De Ryck F, Vermassen F. Angioplasty or primary stenting for infrapopliteal lesions: results of a prospective randomized trial. Cardiovasc Interv Radiol 2010;33:260-9. http://dx.doi.org/10.1007/s00270-009-9765-6
134. Roubin GS. Part II: endovascular therapy: revascularization/primary therapy. J Interv Cardiol 1997;10:481-3. http://dx.doi.org/10.1111/j.1540-8183.1997.tb00078.x
135. Sen SS, Khandker RK, Roth DA, Thomas J. A one-year comparison of cost and outcomes of angioplasty in stent and nonstent patients. Am J Ther 2005;12:210-17.
136. Sgura FA, Di Mario C, Liistro F, Montorfano M, Colombo A, Grube E. The lunar stent characteristics and clinical results. Herz 2002;27:514-17.
137. Tanabe K, Serruys PW, Degertekin M, Guagliumi G, Grube E, Chan C, et al. Chronic arterial responses to polymer-controlled paclitaxel-eluting stents: comparison with bare metal stents by serial intravascular ultrasound analyses: data from the randomized TAXUS-II trial. Circulation 2004;109:196-200. http://dx.doi.org/10.1161/01.CIR.0000109137.51122.49
138. Tay K, Taneja M, Irani F, Teo T, Khoo L, Burgmans M, et al. 'Angioplasty first' approach for limb salvage in patients with critical limb ischemia. J Vasc Interv Radiol 2011;22(Suppl. 3):S39abstract no. 85. http://dx.doi.org/10.1016/j.jvir.2011.01.094
139. Turco MA, Buchbinder M, Popma JJ, Weissman NJ, Mann T, Doucet S, et al. Pivotal, randomized U.S. study of the Symbiottrade mark covered stent system in patients with saphenous vein graft disease: eight-month angiographic and clinical results from the Symbiot III trial. Catheter Cardiovasc Interv 2006;68:379-88.
140. Whyman MR, Fowkes FG, Kerracher EM, Gillespie IN, Lee AJ, Housley E, et al. Is intermittent claudication improved by percutaneous transluminal angioplasty? A randomized controlled trial. J Vasc Surg 1997;26:551-7. http://dx.doi.org/10.1016/S0741-5214(97)70052-1
141. Wolfram RM, Budinsky AC, Pokrajac B, Potter R, Minar E. Vascular brachytherapy with 192Ir after femoropopliteal stent implantation in high-risk patients: twelve-month follow-up results from the Vienna-5 trial. Radiology 2005;236:343-51. http://dx.doi.org/10.1148/radiol.2361040696
142. Zabakis P, Kardamakis DM, Siablis D, Kalogeropoulou C, Karnabatidis D, Malatara G, et al. External beam radiation therapy reduces the rate of re-stenosis in patients treated with femoral stenting: results of a randomised study. Radiother Oncol 2005;74:11-16. http://dx.doi.org/10.1016/j.radonc.2004.09.010
143. Drummond M, Jefferson TO. Guidelines for authors and peer reviewers of economic submissions to the BMJ. BMJ 1996;313:275-83. http://dx.doi.org/10.1136/bmj.313.7052.275.
144. Evers S, Goossens M, De Vet H, Van Tulder M, Ament A. Criteria list for assessment of methodological quality of economic evaluations: Consensus on Health Economic Criteria. Int J Technol Assess Health Care 2005;21:240-5.
145. Dormandy J, Mahla E, Ascani A, Balsano F, de Leeuw PW, Blombery P, et al. Fate of patients with chronic leg ischaemia. J Cardiovasc Surg 1989;30:50-7.
146. Squires H, Simpson E, Meng Y, Harnan S, Stevens JW, Wong R, et al. A systematic review and economic evaluation of cilostazol, naftidrofuryl oxalate, pentoxifylline and inositol nicotinate for the treatment of intermittent claudication in people with peripheral arterial disease. Health Technol Assess 2011;15(40).
147. Jelnes R, Gaardsting O, Hougaard-Jensen K, Baekgaard N, Tonnesen KH, Schroeder T. Fate in intermittent claudication: outcome and risk factors. BMJ 1986;293:1137-40. http://dx.doi.org/10.1136/bmj.293.6555.1137
148. Levy PJ. Epidemiology and pathophysiology of peripheral arterial disease. Clin Cornerstone 2002;4:1-15. http://dx.doi.org/10.1016/S1098-3597(02)90012-8
149. Johnston KW. Femoral and popliteal arteries: reanalysis of results of balloon angioplasty. Radiology 1992;183:767-71.
150. Capek P, McLean GK, Berkowitz HD. Femoropopliteal angioplasty: factors influencing long-term success. Circulation 1991;83(Suppl. I):I70-80.
151. Hunink MG, Donaldson MC, Meyerovitz MF, Polak JF, Whittemore AD, Kandarpa K, et al. Risks and benefits of femoropopliteal percutaneous balloon angioplasty. J Vasc Surg 1993;17:183-92.
152. Jørgensen B, Henriksen LO, Karle A, Sager P, Holstein PE, Tonnesen KH. Percutaneous transluminal angioplasty of iliac and femoral arteries in severe lower-limb ischemia. Acta Chir Scand 1988;154:647-52.
153. Henriksen LO, Jørgensen B, Holstein PE, Tonnesen KH, Karle A, Sager P. Percutaneous transluminal angioplasty of infrarenal arteries in intermittent claudication. Acta Chir Scand 1988;154:573-6.
154. Walden R, Siegel Y, Rubinstein ZJ, Morag B, Bass A, Adar R. Percutaneous transluminal angioplasty. A suggested method for analysis of clinical, arteriographic, and hemodynamic factors affecting the results of treatment. J Vasc Surg 1986;3:583-90. http://dx.doi.org/10.1067/mva.1986.avs0030583
155. Jeans WD, Armstrong S, Cole SE, Horrocks M, Baird RN. Fate of patients undergoing transluminal angioplasty for lower-limb ischemia. Radiology 1990;177:559-64.
156. Krepel VM, van Andel GJ, van Erp WF, Breslau PJ. Percutaneous transluminal angioplasty of the femoropopliteal artery: initial and long-term results. Radiology 1985;156:325-8.
157. Samson RH, Sprayregen S, Veith FJ, Scher LA, Gupta SK, Ascer E. Management of angioplasty complications, unsuccessful procedures and early and late failures. Ann Surg 1984;199:234-40. http://dx.doi.org/10.1097/00000658-198402000-00017
158. Murray RR, Hewes RC, White RI, Jr, Mitchell SE, Auster M, Chang R, et al. Long-segment femoropopliteal stenoses: is angioplasty a boon or a bust? Radiology 1987;162:473-6.
159. Dumville JC, Lee AJ, Smith FB, Fowkes FGR. The health-related quality of life of people with peripheral arterial disease in the community: the Edinburgh Artery Study. Br J Gen Pract 2004;1:826-31.
160. Sprengers RW, Teraa M, Moll FL, de Wit GA, van der Graaf Y, Verhaar MC. Quality of life in patients with no-option critical limb ischemia underlines the need for new effective treatment. J Vasc Surg 2010;52:843-9. http://dx.doi.org/10.1016/j.jvs.2010.04.057
161. Sullivan PW, Slejko JF, Sculpher MJ, Ghushchyan V. Catalogue of EQ-5D Scores for the United Kingdom. Med Decis Making 2011;31:800-4. http://dx.doi.org/10.1177/0272989X11401031