Economic analysis of endovascular drug-eluting treatments for femoropopliteal artery disease in the UK

BMJ Open

Volumn 6, Issue 5, 2016, Pages

  Katsanos, Konstantinos ^a   Geisler, Benjamin P ^b,c   Garner, Abigail M ^b   Zayed, Hany ^a   Cleveland, Trevor ^d   Pietzsch, Jan B ^b  

^a GUY'S AND ST THOMAS' NHS FOUNDATION TRUST   (United Kingdom)

^b Wing Tech Inc   (United States)

^c MASSACHUSETTS GENERAL HOSPITAL   (United States)

^d SHEFFIELD TEACHING HOSPITALS NHS FOUNDATION TRUST   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BALLOON; BARE METAL STENT; BARE METAL STENTING; CARDIOVASCULAR PARAMETERS; CLINICAL TRIAL (TOPIC); COMPARATIVE EFFECTIVENESS; COST CONTROL; COST EFFECTIVENESS ANALYSIS; DEVICE ECONOMICS; DRUG COATED BALLOON; DRUG ELUTING CARDIOVASCULAR STENT; EMBASE; EVIDENCE BASED PRACTICE; FEMOROPOPLITEAL ARTERY DISEASE; HEALTH CARE COST; HEALTH CARE QUALITY; HUMAN; MEDLINE; MULTICENTER STUDY (TOPIC); NATIONAL HEALTH SERVICE; PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY; PERIPHERAL OCCLUSIVE ARTERY DISEASE; PRACTICE GUIDELINE; QUALITY ADJUSTED LIFE YEAR; RANDOMIZED CONTROLLED TRIAL (TOPIC); REIMBURSEMENT; REVASCULARIZATION; SUSTAINED RELEASE PREPARATION; SYSTEMATIC REVIEW; TARGET LESION REVASCULARZATION; TREATMENT OUTCOME; UNITED KINGDOM; COMPARATIVE STUDY; COST BENEFIT ANALYSIS; DEVICES; DRUG ELUTING STENT; ECONOMICS; FEMORAL ARTERY; NUMBERS NEEDED TO TREAT; POPLITEAL ARTERY; STATISTICS AND NUMERICAL DATA; VASCULAR SURGERY;

ANGIOPLASTY, BALLOON; COST-BENEFIT ANALYSIS; DRUG-ELUTING STENTS; FEMORAL ARTERY; HEALTH CARE COSTS; HUMANS; NUMBERS NEEDED TO TREAT; PERIPHERAL ARTERIAL DISEASE; POPLITEAL ARTERY; QUALITY-ADJUSTED LIFE YEARS; STATE MEDICINE; UNITED KINGDOM; VASCULAR SURGICAL PROCEDURES;

EID: 84971326516     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2016-011245     Document Type: Article

References (51)

1. Kearns BC, Michaels JA, Stevenson MD, et al. Cost-effectiveness analysis of enhancements to angioplasty for infrainguinal arterial disease. Br J Surg 2013;100:1180-8.
2. Fowkes FGR, Rudan D, Rudan I, et al. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet 2013;382:1329-40.
3. National Institute for Health and Care Excellence. Peripheral arterial disease: diagnosis and management. 2012. https://www.nice.org.uk/guidance/cg147
4. Bosiers M, Torsello G, Gissler HM, et al. Nitinol stent implantation in long superficial femoral artery lesions: 12-month results of the DURABILITY I study. J Endovasc Ther 2009;16:261-9.
5. Katsanos K, Spiliopoulos S, Karunanithy N, et al. Bayesian network meta-analysis of nitinol stents, covered stents, drug-eluting stents, and drug-coated balloons in the femoropopliteal artery. J Vasc Surg 2014;59:1123-33.e8.
6. Pietzsch JB, Geisler BP, Garner AM, et al. Economic analysis of endovascular interventions for femoropopliteal arterial disease: a systematic review and budget impact model for the United States and Germany. Catheter Cardiovasc Interv 2014;84:546-54.
7. Laird JR, Schneider PA, Tepe G, et al. Durability of treatment effect using a drug-coated balloon for femoropopliteal lesions: 24-month results of IN.PACT SFA. J Am Coll Cardiol 2015;66:2329-38.
8. Laird JR, Katzen BT, Scheinert D, 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.
9. Laird JR, Jain A, Zeller T, et al. Nitinol stent implantation in the superficial femoral artery and proximal popliteal artery: twelve-month results from the complete SE multicenter trial. J Endovasc Ther 2014;21:202-12.
10. Litsky J, Chanda A, Stilp E, et al. Critical evaluation of stents in the peripheral arterial disease of the superficial femoral artery - focus on the paclitaxel eluting stent. Med Devices (Auckl) 2014;7:149-56.
11. Tepe G, Laird J, Schneider P, et al. Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease: 12-month results from the IN.PACT SFA randomized trial. Circulation 2015;131:495-502.
12. Schillinger M, Sabeti S, Loewe C, et al. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med 2006;354:1879-88.
13. Chalmers N, Walker PT, Belli AM, et al. Randomized trial of the SMART stent versus balloon angioplasty in long superficial femoral artery lesions: the SUPER study. Cardiovasc Intervent Radiol 2013;36:353-61.
14. Gongora CA, Shibuya M, Wessler JD, et al. Impact of paclitaxel dose on tissue pharmacokinetics and vascular healing: a comparative drug-coated balloon study in the familial hypercholesterolemic swine model of superficial femoral in-stent restenosis. JACC Cardiovasc Interv 2015;8:1115-23.
15. Granada JF, Stenoien M, Buszman PP, et al. Mechanisms of tissue uptake and retention of paclitaxel-coated balloons: impact on neointimal proliferation and healing. Open Heart 2014;1:e000117.
16. Katsanos K, Spiliopoulos S, Paraskevopoulos I, et al. Systematic review and meta-analysis of randomized controlled trials of paclitaxel-coated balloon angioplasty in the femoropopliteal artery: role of paclitaxel dose and bioavailability. J Endovasc Ther 2016;23:356-70.
17. Tepe G, Zeller T, Albrecht T, et al. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med 2008;358:689-99.
18. Werk M, Langner S, Reinkensmeier B, et al. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation 2008;118:1358-65.
19. Laird JR, Katzen BT, Scheinert D, et al. Nitinol stent implantation vs. balloon angioplasty for lesions in the superficial femoral and proximal popliteal arteries of patients with claudication: three-year follow-up from the RESILIENT randomized trial. J Endovasc Ther 2012;19:1-9.
20. Krankenberg H, Schlüter M, Steinkamp HJ, 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.
21. Dake MD, Ansel GM, Jaff MR, et al. Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: twelve-month Zilver PTX randomized study results. Circ Cardiovasc Interv 2011;4:495-504.
22. Dake MD, Ansel GM, Jaff MR, et al. Sustained safety and effectiveness of paclitaxel-eluting stents for femoropopliteal lesions: 2-year follow-up from the Zilver PTX randomized and single-arm clinical studies. J Am Coll Cardiol 2013;61:2417-27.
23. Werk M, Albrecht T, Meyer DR, et al. Paclitaxel-coated balloons reduce restenosis after femoro-popliteal angioplasty: evidence from the randomized PACIFIER trial. Circ Cardiovasc Interv 2012;5:831-40.
24. Scheinert D, Schulte KL, Zeller T, et al. Paclitaxel-releasing balloon in femoropopliteal lesions using a BTHC excipient: twelve-month results from the BIOLUX P-I randomized trial. J Endovasc Ther 2015;22:14-21.
25. Scheinert D, Duda S, Zeller T, et al. The LEVANT I (Lutonix paclitaxel-coated balloon for the prevention of femoropopliteal restenosis) trial for femoropopliteal revascularization: first-in-human randomized trial of low-dose drug-coated balloon versus uncoated balloon angioplasty. JACC Cardiovasc Interv 2014;7:10-19.
26. Rosenfield K, Jaff MR, White CJ, et al. Trial of a paclitaxel-coated balloon for femoropopliteal artery disease. N Engl J Med 2015;373:145-53.
27. Dattilo R, Himmelstein SI, Cuff RF. The COMPLIANCE 360 degrees Trial: a randomized, prospective, multicenter, pilot study comparing acute and long-term results of orbital atherectomy to balloon angioplasty for calcified femoropopliteal disease. J Invasive Cardiol 2014;26:355-60.
28. Duda SH, Bosiers M, Lammer J, 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.
29. Diehl SJ, Gerblich F, Jochum S, et al. Twelve-month results of the EverFlex stent in the superficial femoral artery. J Vasc Interv Radiol 2012;23:1317-22.
30. Banerjee S, Das TS, Abu-Fadel MS, et al. Pilot trial of cryoplasty or conventional balloon post-dilation of nitinol stents for revascularization of peripheral arterial segments: the COBRA trial. J Am Coll Cardiol 2012;60:1352-9.
31. Kralj I, Boos I, Müller-Bühl U. Three year results of endovascular therapy with a new generation nitinol stent for femoro-popliteal artery lesions - a single-center outcome analysis of a subcohort of MISAGO 2 study. Vasa 2013;42:340-9.
32. Rastan A, Krankenberg H, Baumgartner I, et al. Stent placement versus balloon angioplasty for the treatment of obstructive lesions of the popliteal artery: a prospective, multicenter, randomized trial. Circulation 2013;127:2535-41.
33. Tadros RO, Faries PL, Rocha-Singh KJ, et al. The impact of sex on angioplasty and primary stenting for femoropopliteal occlusive disease: results of the DURABILITY II trial. Ann Vasc Surg 2014;28:1-9.
34. Werner M, Piorkowski M, Thieme M, et al. SUMMIT registry: one-year outcomes after implantation of the EPIC self-expanding nitinol stent in the femoropopliteal segment. J Endovasc Ther 2013;20:759-66.
35. Gabrielli R, Rosati MS, Chiappa R, et al. First clinical experience with the Innova versus the Protege EverFlex self-expanding bare metal stents in superficial femoral artery occlusions. Thorac Cardiovasc Surg 2015;63:158-63.
36. Garcia L, Jaff MR, Metzger C, et al. Wire-interwoven nitinol stent outcome in the superficial femoral and proximal popliteal arteries: twelve-month results of the SUPERB trial. Circ Cardiovasc Interv 2015;8:e000937.
37. Krankenberg H, Tübler T, Sixt S, et al. German multicenter real-world registry of stenting for superficial femoral artery disease: clinical results and predictive factors for revascularization. J Endovasc Ther 2014;21:463-71.
38. Werner M, Paetzold A, Banning-Eichenseer U, et al. Treatment of complex atherosclerotic femoropopliteal artery disease with a self-expanding interwoven nitinol stent: midterm results from the Leipzig SUPERA 500 registry. EuroIntervention 2014;10:861-8.
39. Micari A, Cioppa A, Vadalà G, et al. Clinical evaluation of a paclitaxel-eluting balloon for treatment of femoropopliteal arterial disease: 12-month results from a multicenter Italian registry. JACC Cardiovasc Interv 2012;5:331-8.
40. Micari A, Cioppa A, Vadalà G, et al. 2-year results of paclitaxel-eluting balloons for femoropopliteal artery disease: evidence from a multicenter registry. JACC Cardiovasc Interv 2013;6:282-9.
41. Schroeder H, Meyer DR, Lux B, et al. Two-year results of a low-dose drug-coated balloon for revascularization of the femoropopliteal artery: Outcomes from the ILLUMENATE first-in-human study. Catheter Cardiovasc Interv 2015;86:278-86.
42. Dake MD, Ansel GM, Jaff MR, et al. Sustained safety and effectiveness of paclitaxel-eluting stents for femoropopliteal lesions: 2-year follow-up from the Zilver PTX randomized and single-arm clinical studies. J Am Coll Cardiol 2013;61:2417-27.
43. Lammer J, Bosiers M, Zeller T, et al. First clinical trial of nitinol self-expanding everolimus-eluting stent implantation for peripheral arterial occlusive disease. J Vasc Surg 2011;54:394-401.
44. Cortese B, Granada JF, Scheller B, et al. Drug-coated balloon treatment for lower extremity vascular disease intervention: an international positioning documentdagger. Eur Heart J 2016;37:1096-103.
45. Katsanos K, Tepe G, Tsetis D, et al. Standards of practice for superficial femoral and popliteal artery angioplasty and stenting. Cardiovasc Intervent Radiol 2014;37:592-603.
46. Diamantopoulos A, Katsanos K. Treating femoropopliteal disease: established and emerging technologies. Semin Intervent Radiol 2014;31:345-52.
47. Pietzsch JB, Weber SA, Pietzsch ML, et al. The impact of new endovascular therapies for femoropopliteal arterial disease on therapy utilization and case volumes in Germany, 2009-2013. Value Health 2015;18:A366.
48. Diehm N, Schneider H. Cost-effectiveness analysis of paclitaxel-coated balloons for endovascular therapy of femoropopliteal arterial obstructions. J Endovasc Ther 2013;20:819-25.
49. Dake MD. The Zilver PTX randomized trial of treating femoropopliteal artery disease: 5-year results. Las Veags, NV, USA: Vascular Interventional Advances (VIVA), 2014.
50. Tepe G, Schnorr B, Albrecht T, et al. Angioplasty of femoral-popliteal arteries with drug-coated balloons: 5-year follow-up of the THUNDER trial. JACC Cardiovasc Interv 2015;8(Pt A):102-8.
51. Cohen DJ. IN.PACT SF a health-economic study. Las Vegas, NV, USA: VIVA, 2015.