Endovascular treatment of lower extremity peripheral arterial disease

Trends in Cardiovascular Medicine

Volumn 26, Issue 6, 2016, Pages 495-512

  Klein, Andrew J ^a,b   Ross, Charles B ^c  

^a PIEDMONT HOSPITAL   (United States)

^b SAINT LOUIS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c Piedmont Atlanta Hospital   (United States)

Author keywords

Claudication; Critical limb ischemia; Endovascular therapy; Peripheral arterial disease

Indexed keywords

ATHERECTOMY; CLINICAL TRIAL (TOPIC); DRUG ELUTING STENT; ENDOVASCULAR SURGERY; FEMORAL ARTERY; HUMAN; ILIAC ARTERY; LEG ISCHEMIA; LEG REVASCULARIZATION; LIFESTYLE; LIMB ISCHEMIA; LOWER LIMB; META ANALYSIS (TOPIC); MULTICENTER STUDY (TOPIC); PERIPHERAL OCCLUSIVE ARTERY DISEASE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; ADVERSE EFFECTS; CRITICAL ILLNESS; DEVICES; INTERMITTENT CLAUDICATION; ISCHEMIA; PATHOPHYSIOLOGY; PATIENT SELECTION; PERIPHERAL ARTERIAL DISEASE; RISK FACTOR; TREATMENT OUTCOME; VASCULAR PATENCY; VASCULARIZATION;

CRITICAL ILLNESS; ENDOVASCULAR PROCEDURES; HUMANS; INTERMITTENT CLAUDICATION; ISCHEMIA; LOWER EXTREMITY; PATIENT SELECTION; PERIPHERAL ARTERIAL DISEASE; RISK FACTORS; TREATMENT OUTCOME; VASCULAR PATENCY;

EID: 84977523449     PISSN: 10501738     EISSN: 18732615     Source Type: Journal    
DOI: 10.1016/j.tcm.2016.02.007     Document Type: Review

References (144)

1. [1] Fowkes, F.G., 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 382 (2013), 1329–1340.
2. [2] Mahoney, E.M., Wang, K., Keo, H.H., et al. Vascular hospitalization rates and costs in patients with peripheral artery disease in the United States. Circ Cardiovasc Qual Outcomes 3 (2010), 642–651.
3. [3] Pande, R.L., Perlstein, T.S., Beckman, J.A., Creager, M.A., Secondary prevention and mortality in peripheral artery disease: National Health and Nutrition Examination Study, 1999–2004. Circulation 124 (2011), 17–23.
4. [4] Smith, G.D., Shipley, M.J., Rose, G., Intermittent claudication, heart disease risk factors, and mortality. The Whitehall Study. Circulation 82 (1990), 1925–1931.
5. [5] Ankle Brachial Index, C., Fowkes, F.G., Murray, G.D., et al. Ankle brachial index combined with Framingham Risk Score to predict cardiovascular events and mortality: a meta-analysis. J Am Med Assoc 300 (2008), 197–208.
6. [6] Regensteiner, J.G., Hiatt, W.R., Coll, J.R., et al. The impact of peripheral arterial disease on health-related quality of life in the peripheral arterial disease awareness, risk, and treatment: New Resources for Survival (PARTNERS) Program. Vasc Med 13 (2008), 15–24.
7. [7] McDermott, M.M., Guralnik, J.M., Tian, L., et al. Baseline functional performance predicts the rate of mobility loss in persons with peripheral arterial disease. J Am Coll Cardiol 50 (2007), 974–982.
8. [8] McDermott, M.M., Liu, K., Greenland, P., et al. Functional decline in peripheral arterial disease: associations with the ankle brachial index and leg symptoms. J Am Med Assoc 292 (2004), 453–461.
9. [9] Klevsgard, R., Froberg, B.L., Risberg, B., Hallberg, I.R., Nottingham Health Profile and Short-Form 36 health survey questionnaires in patients with chronic lower limb ischemia: before and after revascularization. J Vasc Surg 36 (2002), 310–317.
10. [10] Spronk, S., Bosch, J.L., den Hoed, P.T., Veen, H.F., Pattynama, P.M., Hunink, M.G., Intermittent claudication: clinical effectiveness of endovascular revascularization versus supervised hospital-based exercise training—randomized controlled trial. Radiology 250 (2009), 586–595.
11. [11] Stewart, K.J., Hiatt, W.R., Regensteiner, J.G., Hirsch, A.T., Exercise training for claudication. N Engl J Med 347 (2002), 1941–1951.
12. [12] Fakhry, F., Spronk, S., van der Laan, L., et al. Endovascular revascularization and supervised exercise for peripheral artery disease and intermittent claudication: a randomized clinical trial. J Am Med Assoc 314 (2015), 1936–1944.
13. [13] McDermott, M.M., Guralnik, J.M., Criqui, M.H., et al. Home-based walking exercise in peripheral artery disease: 12-month follow-up of the GOALS randomized trial. J Am Heart Assoc, 3, 2014, e000711.
14. [14] McDermott, M.M., Liu, K., Guralnik, J.M., et al. Home-based walking exercise intervention in peripheral artery disease: a randomized clinical trial. J Am Med Assoc 310 (2013), 57–65.
15. [15] Pande, R.L., Hiatt, W.R., Zhang, P., Hittel, N., Creager, M.A., A pooled analysis of the durability and predictors of treatment response of cilostazol in patients with intermittent claudication. Vasc Med 15 (2010), 181–188.
16. [16] Harris, T.J., Zafar, A.M., Murphy, T.P., Utilization of lower extremity arterial disease diagnostic and revascularization procedures in Medicare beneficiaries 2000-2007. Am J Roentgenol 197 (2011), W314–W317.
17. [17] McFalls, E.O., Ward, H.B., Moritz, T.E., et al. Coronary-artery revascularization before elective major vascular surgery. N Engl J Med 351 (2004), 2795–2804.
18. [18] Cheng, S.W., Wu, L.L., Ting, A.C., Lau, H., Wong, J., Screening for asymptomatic carotid stenosis in patients with peripheral vascular disease: a prospective study and risk factor analysis. Cardiovasc Surg 7 (1999), 303–309.
19. [19] Norgren, L., Hiatt, W.R., Dormandy, J.A., Nehler, M.R., Harris, K.A., Fowkes, F.G., Inter-society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg 45:Suppl. S (2007), S5–67.
20. [20] Rooke, T.W., Hirsch, A.T., Misra, S., et al. 2011 ACCF/AHA focused update of the guideline for the management of patients with peripheral artery disease (updating the 2005 guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines: developed in collaboration with the Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society for Vascular Medicine, and Society for Vascular Surgery. Catheter Cardiovasc Interv 79 (2011), 501–531.
21. [21] Armstrong, E.J., Chen, D.C., Westin, G.G., et al. Adherence to guideline-recommended therapy is associated with decreased major adverse cardiovascular events and major adverse limb events among patients with peripheral arterial disease. J Am Heart Assoc, 3, 2014, e000697.
22. [22] Westin, G.G., Armstrong, E.J., Bang, H., et al. Association between statin medications and mortality, major adverse cardiovascular event, and amputation-free survival in patients with critical limb ischemia. J Am Coll Cardiol 63 (2014), 682–690.
23. [23] Hirsch, A.T., Criqui, M.H., Treat-Jacobson, D., et al. Peripheral arterial disease detection, awareness, and treatment in primary care. J Am Med Assoc 286 (2001), 1317–1324.
24. [24] McDermott, M.M., Greenland, P., Liu, K., et al. Leg symptoms in peripheral arterial disease: associated clinical characteristics and functional impairment. J Am Med Assoc 286 (2001), 1599–1606.
25. [25] Boyd, A.M., The natural course of arteriosclerosis of the lower extremities. Proc R Soc Med 55 (1962), 591–593.
26. [26] Imparato, A.M., Kim, G.E., Davidson, T., Crowley, J.G., Intermittent claudication: its natural course. Surgery 78 (1975), 795–799.
27. [27] McAllister, F.F., The fate of patients with intermittent claudication managed nonoperatively. Am J Surg 132 (1976), 593–595.
28. [28] Zeller, T., Current state of endovascular treatment of femoro-popliteal artery disease. Vasc Med 12 (2007), 223–234.
29. [29] Klein, A.J., Chen, S.J., Messenger, J.C., et al. Quantitative assessment of the conformational change in the femoropopliteal artery with leg movement. Catheter Cardiovasc Interv 74 (2009), 787–798.
30. [30] Scheinert, D., Scheinert, S., Sax, J., et al. Prevalence and clinical impact of stent fractures after femoropopliteal stenting. J Am Coll Cardiol 45 (2005), 312–315.
31. [31] Connors, G., Todoran, T.M., Engelson, B.A., Sobieszczyk, P.S., Eisenhauer, A.C., Kinlay, S., Percutaneous revascularization of long femoral artery lesions for claudication: patency over 2.5 years and impact of systematic surveillance. Catheter Cardiovasc Interv 77 (2011), 1055–1062.
32. [32] Gray, B.H., Diaz-Sandoval, L.J., Dieter, R.S., et al. SCAI expert consensus statement for infrapopliteal arterial intervention appropriate use. Catheter Cardiovasc Interv 84 (2014), 539–545.
33. [33] Klein, A.J., Feldman, D.N., Aronow, H.D., et al. SCAI expert consensus statement for aorto-iliac arterial intervention appropriate use. Catheter Cardiovasc Interv 84 (2014), 520–528.
34. [34] Klein, A.J., Pinto, D.S., Gray, B.H., et al. SCAI expert consensus statement for femoral-popliteal arterial intervention appropriate use. Catheter Cardiovasc Interv 84 (2014), 529–538.
35. [35] Lepantalo, M., Matzke, S., Outcome of unreconstructed chronic critical leg ischaemia. Eur J Vasc Endovasc Surg 11 (1996), 153–157.
36. [36] Wolfe, J.H., Wyatt, M.G., Critical and subcritical ischaemia. Eur J Vasc Endovasc Surg 13 (1997), 578–582.
37. [37] Bertele, V., Roncaglioni, M.C., Pangrazzi, J., Terzian, E., Tognoni, E.G., Clinical outcome and its predictors in 1560 patients with critical leg ischaemia. Chronic Critical Leg Ischaemia Group. Eur J Vasc Endovasc Surg 18 (1999), 401–410.
38. [38] Conte, M.S., Bandyk, D.F., Clowes, A.W., et al. Results of PREVENT III: a multicenter, randomized trial of edifoligide for the prevention of vein graft failure in lower extremity bypass surgery. J Vasc Surg 43 (2006), 742–751 [discussion 751].
39. [39] Schanzer, A., Mega, J., Meadows, J., Samson, R.H., Bandyk, D.F., Conte, M.S., 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 48 (2008), 1464–1471.
40. [40] Shah, A.P., Klein, A.J., Sterrett, A., et al. Clinical outcomes using aggressive approach to anatomic screening and endovascular revascularization in a veterans affairs population with critical limb ischemia. Catheter Cardiovasc Interv 74 (2009), 11–19.
41. [41] Rueda, C.A., Nehler, M.R., Perry, D.J., et al. Patterns of artery disease in 450 patients undergoing revascularization for critical limb ischemia: implications for clinical trial design. J Vasc Surg 47 (2008), 995–999 [discussion 999–1000].
42. [42] DeRubertis, B.G., Pierce, M., Ryer, E.J., Trocciola, S., Kent, K.C., Faries, P.L., Reduced primary patency rate in diabetic patients after percutaneous intervention results from more frequent presentation with limb-threatening ischemia. J Vasc Surg 47 (2008), 101–108.
43. [43] Romiti, M., Albers, M., Brochado-Neto, F.C., Durazzo, A.E., Pereira, C.A., De Luccia, N., Meta-analysis of infrapopliteal angioplasty for chronic critical limb ischemia. J Vasc Surg 47 (2008), 975–981.
44. [44] Adam, D.J., Beard, J.D., Cleveland, T., et al. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Lancet 366 (2005), 1925–1934.
45. [45] Biancari, F., Juvonen, T., Angiosome-targeted lower limb revascularization for ischemic foot wounds: systematic review and meta-analysis. Eur J Vasc Endovasc Surg 47 (2014), 517–522.
46. [46] Mills, J.L. Sr., Conte, M.S., Armstrong, D.G., et al. The society for vascular surgery lower extremity threatened limb classification system: risk stratification based on wound, ischemia, and foot infection (WIfI). J Vasc Surg 59 (2014), e1–e2.
47. [47] Zhan, L.X., Branco, B.C., Armstrong, D.G., Mills, J.L. Sr, The society for vascular surgery lower extremity threatened limb classification system based on wound, ischemia, and foot infection (WIfI) correlates with risk of major amputation and time to wound healing. J Vasc Surg 61 (2015), 939–944.
48. [48] Rutherford, R.B., Baker, J.D., Ernst, C., et al. Recommended standards for reports dealing with lower extremity ischemia: revised version. J Vasc Surg 26 (1997), 517–538.
49. [49] Creager, M.A., Kaufman, J.A., Conte, M.S., Clinical practice. Acute limb ischemia. N Engl J Med 366 (2012), 2198–2206.
50. [50] Earnshaw, J.J., Whitman, B., Foy, C., National audit of thrombolysis for acute leg ischemia (NATALI): clinical factors associated with early outcome. J Vasc Surg 39 (2004), 1018–1025.
51. [51] Eliason, J.L., Wainess, R.M., Proctor, M.C., et al. A national and single institutional experience in the contemporary treatment of acute lower extremity ischemia. Ann Surg 238 (2003), 382–389 [discussion 389–90].
52. [52] Thukkani, A.K., Kinlay, S., Endovascular intervention for peripheral artery disease. Circ Res 116 (2015), 1599–1613.
53. [53] de Vries, S.O., Hunink, M.G., Results of aortic bifurcation grafts for aortoiliac occlusive disease: a meta-analysis. J Vasc Surg 26 (1997), 558–569.
54. [54] Jongkind, V., Akkersdijk, G.J., Yeung, K.K., Wisselink, W., A systematic review of endovascular treatment of extensive aortoiliac occlusive disease. J Vasc Surg 52 (2010), 1376–1383.
55. [55] Ye, W., Liu, C.W., Ricco, J.B., Mani, K., Zeng, R., Jiang, J., Early and late outcomes of percutaneous treatment of transatlantic inter-society consensus class C and D aorto-iliac lesions. J Vasc Surg 53 (2011), 1728–1737.
56. [56] Kashyap, V.S., Pavkov, M.L., Bena, J.F., et al. The management of severe aortoiliac occlusive disease: endovascular therapy rivals open reconstruction. J Vasc Surg, 48, 2008 1451-7, 1457 e1-3.
57. [57] Leville, C.D., Kashyap, V.S., Clair, D.G., et al. Endovascular management of iliac artery occlusions: extending treatment to TransAtlantic Inter-Society Consensus class C and D patients. J Vasc Surg 43 (2006), 32–39.
58. [58] Mwipatayi, B.P., Thomas, S., Wong, J., et al. A comparison of covered vs bare expandable stents for the treatment of aortoiliac occlusive disease. J Vasc Surg 54 (2011), 1561–1570.
59. [59] Sabri, S.S., Choudhri, A., Orgera, G., et al. Outcomes of covered kissing stent placement compared with bare metal stent placement in the treatment of atherosclerotic occlusive disease at the aortic bifurcation. J Vasc Interv Radiol 21 (2010), 995–1003.
60. [60] Grimme, F., Goverde, P., Van Oostayen, J., Zeebregts, C., Reijnen, M., Covered stents for aortoiliac reconstruction of chronic occlusive lesions. J Cardiovasc Surg (Torino) 53 (2012), 279–289.
61. [61] Bjorses, K., Ivancev, K., Riva, L., Manjer, J., Uher, P., Resch, T., Kissing stents in the aortic bifurcation—a valid reconstruction for aorto-iliac occlusive disease. Eur J Vasc Endovasc Surg 36 (2008), 424–431.
62. [62] Dyet, J.F., Gaines, P.A., Nicholson, A.A., et al. Treatment of chronic iliac artery occlusions by means of percutaneous endovascular stent placement. J Vasc Interv Radiol 8 (1997), 349–353.
63. [63] Henry, M., Amor, M., Ethevenot, G., Henry, I., Mentre, B., Tzvetanov, K., Percutaneous endoluminal treatment of iliac occlusions: long-term follow-up in 105 patients. J Endovasc Surg 5 (1998), 228–235.
64. [64] Scheinert, D., Schroder, M., Ludwig, J., et al. Stent-supported recanalization of chronic iliac artery occlusions. Am J Med 110 (2001), 708–715.
65. [65] Vorwerk, D., Guenther, R.W., Schurmann, K., Wendt, G., Peters, I., Primary stent placement for chronic iliac artery occlusions: follow-up results in 103 patients. Radiology 194 (1995), 745–749.
66. [66] Kang, J.L., Patel, V.I., Conrad, M.F., Lamuraglia, G.M., Chung, T.K., Cambria, R.P., Common femoral artery occlusive disease: contemporary results following surgical endarterectomy. J Vasc Surg 48 (2008), 872–877.
67. [67] Bonvini, R.F., Rastan, A., Sixt, S., et al. Endovascular treatment of common femoral artery disease: medium-term outcomes of 360 consecutive procedures. J Am Coll Cardiol 58 (2011), 792–798.
68. [68] Dattilo, P.B., Tsai, T.T., Kevin Rogers, R., Casserly, I.P., Acute and medium-term outcomes of endovascular therapy of obstructive disease of diverse etiology of the common femoral artery. Catheter Cardiovasc Interv 81 (2013), 1013–1022.
69. [69] Klein, A.J., Messenger, J.C., Casserly, I.P., Contemporary management of acute lower extremity ischemia following percutaneous coronary and cardiac interventional procedures using femoral access—a case series and discussion. Catheter Cardiovasc Interv 70 (2007), 129–137.
70. [70] Klein, A.J., Casserly, I.P., Messenger, J.C., Carroll, J.D., Chen, S.Y., In vivo 3D modeling of the femoropopliteal artery in human subjects based on x-ray angiography: methodology and validation. Med Phys 36 (2009), 289–310.
71. [71] Dorrucci, V., Treatment of superficial femoral artery occlusive disease. J Cardiovasc Surg (Torino) 45 (2004), 193–201.
72. [72] Gray, B.H., Olin, J.W., Limitations of percutaneous transluminal angioplasty with stenting for femoropopliteal arterial occlusive disease. Semin Vasc Surg 10 (1997), 8–16.
73. [73] Laird, J.R., Limitations of percutaneous transluminal angioplasty and stenting for the treatment of disease of the superficial femoral and popliteal arteries. J Endovasc Ther 13:Suppl. 2 (2006), II30–II40.
74. [74] Bausback, Y., Botsios, S., Flux, J., et al. Outback catheter for femoropopliteal occlusions: immediate and long-term results. J Endovasc Ther 18 (2011), 13–21.
75. [75] Schmidt, A., Bausback, Y., Piorkowski, M., et al. Retrograde recanalization technique for use after failed antegrade angioplasty in chronic femoral artery occlusions. J Endovasc Ther 19 (2012), 23–29.
76. [76] Soga, Y., Iida, O., Hirano, K., Yokoi, H., Nanto, S., Nobuyoshi, M., Mid-term clinical outcome and predictors of vessel patency after femoropopliteal stenting with self-expandable nitinol stent. J Vasc Surg 52 (2010), 608–615.
77. [77] Hong, S.J., Ko, Y.G., Shin, D.H., et al. Outcomes of spot stenting versus long stenting after intentional subintimal approach for long chronic total occlusions of the femoropopliteal artery. J Am Coll Cardiol Cardiovasc Interv 8 (2015), 472–480.
78. [78] Krankenberg, H., Schluter, M., Steinkamp, H.J., 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 116 (2007), 285–292.
79. [79] Rocha-Singh, K.J., Jaff, M.R., Crabtree, T.R., Bloch, D.A., Ansel, G., Viva Physicians I, Performance goals and endpoint assessments for clinical trials of femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease. Catheter Cardiovasc Interv 69 (2007), 910–919.
80. [80] Schillinger, M., Sabeti, S., Loewe, C., et al. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med 354 (2006), 1879–1888.
81. [81] Geraghty, P.J., Mewissen, M.W., Jaff, M.R., Ansel, G.M., Three-year results of the VIBRANT trial of VIABAHN endoprosthesis vs bare nitinol stent implantation for complex superficial femoral artery occlusive disease. J Vasc Surg 58 (2013), 386–395 e4.
82. [82] Saxon, R.R., Chervu, A., Jones, P.A., et al. Heparin-bonded, expanded polytetrafluoroethylene-lined stent graft in the treatment of femoropopliteal artery disease: 1-year results of the VIPER (Viabahn Endoprosthesis with Heparin Bioactive Surface in the Treatment of Superficial Femoral Artery Obstructive Disease) trial. J Vasc Interv Radiol 24 (2013), 165–173 [quiz 174].
83. [83] Lammer, J., Zeller, T., Hausegger, K.A., et al. Heparin-bonded covered stents versus bare-metal stents for complex femoropopliteal artery lesions: the randomized VIASTAR trial (Viabahn endoprosthesis with PROPATEN bioactive surface [VIA] versus bare nitinol stent in the treatment of long lesions in superficial femoral artery occlusive disease). J Am Coll Cardiol 62 (2013), 1320–1327.
84. [84] Johnston, P.C., Vartanian, S.M., Runge, S.J., et al. Risk factors for clinical failure after stent graft treatment for femoropopliteal occlusive disease. J Vasc Surg 56 (2012), 998–1006 [1007 e1; discussion 1006–7].
85. [85] Shackles, C., Rundback, J.H., Herman, K., David, Y., Barkarma, R., Above and below knee femoropopliteal VIABAHN(R). Catheter Cardiovasc Interv 85 (2015), 859–867.
86. [86] Ullery, B.W., Tran, K., Itoga, N., Casey, K., Dalman, R.L., Lee, J.T., Safety and efficacy of antiplatelet/anticoagulation regimens after Viabahn stent graft treatment for femoropopliteal occlusive disease. J Vasc Surg 61 (2015), 1479–1488.
87. [87] Dake, M.D., Ansel, G.M., Jaff, M.R., 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 4 (2011), 495–504.
88. [88] Dake, M.D., Ansel, G.M., Jaff, M.R., 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 61 (2013), 2417–2427.
89. [89] Fanelli, F., Di Primo, M., Boatta, E., Johnston, K., Sapoval, M., Drug-eluting nitinol stent treatment of the superficial femoral artery and above-the-knee popliteal artery (the Zilver PTX single-arm clinical study): a comparison between diabetic and nondiabetic patients. Cardiovasc Intervent Radiol 36 (2013), 1232–1240.
90. [90] Rastan, A., Noory, E., Zeller, T., Drug-eluting stents for treatment of focal infrapopliteal lesions. Vasa 41 (2012), 90–95.
91. [91] Yokoi, H., Ohki, T., Kichikawa, K., et al. Zilver PTX post-market surveillance study of paclitaxel-eluting stents for treating femoropopliteal artery disease in japan: 12-month results. J Am Coll Cardiol Cardiovasc Interv Feb 8 (2016), 271–277.
92. [92] Iida, O., Takahara, M., Soga, Y., et al. 1-year results of the ZEPHYR Registry (Zilver PTX for the femoral artery and proximal popliteal artery): predictors of restenosis. J Am Coll Cardiol Cardiovasc Interv 8 (2015), 1105–1112.
93. [93] De Cock, E., Sapoval, M., Julia, P., de Lissovoy, G., Lopes, S., A budget impact model for paclitaxel-eluting stent in femoropopliteal disease in France. Cardiovasc Intervent Radiol 36 (2013), 362–370.
94. [94] Speck, U., Scheller, B., Abramjuk, C., et al. Neointima inhibition: comparison of effectiveness of non-stent-based local drug delivery and a drug-eluting stent in porcine coronary arteries. Radiology 240 (2006), 411–418.
95. [95] Tepe, G., Zeller, T., Albrecht, T., et al. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med 358 (2008), 689–699.
96. [96] Werk, M., Albrecht, T., Meyer, D.R., et al. Paclitaxel-coated balloons reduce restenosis after femoro-popliteal angioplasty: evidence from the randomized PACIFIER trial. Circ Cardiovasc Interv 5 (2012), 831–840.
97. [97] Fanelli, F., Cannavale, A., Corona, M., Lucatelli, P., Wlderk, A., Salvatori, F.M., The DEBELLUM—lower limb multilevel treatment with drug eluting balloon—randomized trial: 1-year results. J Cardiovasc Surg (Torino) 55 (2014), 207–216.
98. [98] 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. J Am Coll Cardiol Cardiovasc Interv 7 (2014), 10–19.
99. [99] Rosenfield, K., Jaff, M.R., White, C.J., et al. Trial of a paclitaxel-coated balloon for femoropopliteal artery disease. N Engl J Med 373 (2015), 145–153.
100. [100] 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 131 (2015), 495–502.
101. [101] Laird, J.R., Schneider, P.A., Tepe, G., et al. Sustained Durability of treatment effect using a drug-coated balloon for femoropopliteal lesions: 24-month results of IN.PACT SFA. J Am Coll Cardiol, 2015.
102. [102] Liistro, F., Grotti, S., Porto, I., et al. Drug-eluting balloon in peripheral intervention for the superficial femoral artery: the DEBATE-SFA randomized trial (drug eluting balloon in peripheral intervention for the superficial femoral artery). J Am Coll Cardiol Cardiovasc Interv 6 (2013), 1295–1302.
103. [103] Scheinert, D., Schulte, K.L., Zeller, T., Lammer, J., Tepe, G., Paclitaxel-releasing balloon in femoropopliteal lesions using a BTHC excipient: twelve-month results from the BIOLUX P-I randomized trial. J Endovasc Ther 22 (2015), 14–21.
104. [104] Zeller, T., Rastan, A., Macharzina, R., et al. Drug-coated balloons vs. drug-eluting stents for treatment of long femoropopliteal lesions. J Endovasc Ther 21 (2014), 359–368.
105. [105] Liistro, F., Angioli, P., Porto, I., et al. Paclitaxel-eluting balloon vs. standard angioplasty to reduce recurrent restenosis in diabetic patients with in-stent restenosis of the superficial femoral and proximal popliteal arteries: the DEBATE-ISR study. J Endovasc Ther 21 (2014), 1–8.
106. [106] Stabile, E., Virga, V., Salemme, L., et al. Drug-eluting balloon for treatment of superficial femoral artery in-stent restenosis. J Am Coll Cardiol 60 (2012), 1739–1742.
107. [107] Werner, M., Micari, A., Cioppa, A., et al. Evaluation of the biodegradable peripheral Igaki-Tamai stent in the treatment of de novo lesions in the superficial femoral artery: the GAIA study. J Am Coll Cardiol Cardiovasc Interv 7 (2014), 305–312.
108. [108] Lipsitz, E.C., Veith, F.J., 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 (Torino) 45 (2004), 231–237.
109. [109] Iida, O., Nakamura, M., Yamauchi, Y., et al. Endovascular treatment for infrainguinal vessels in patients with critical limb ischemia: OLIVE registry, a prospective, multicenter study in Japan with 12-month follow-up. Circ Cardiovasc Interv 6 (2013), 68–76.
110. [110] Schmidt, A., Ulrich, M., Winkler, B., et al. Angiographic patency and clinical outcome after balloon-angioplasty for extensive infrapopliteal arterial disease. Catheter Cardiovasc Interv 76 (2010), 1047–1054.
111. [111] Schmidt, A., Piorkowski, M., Werner, M., et al. First experience with drug-eluting balloons in infrapopliteal arteries: restenosis rate and clinical outcome. J Am Coll Cardiol 58 (2011), 1105–1109.
112. [112] Liistro, F., Porto, I., Angioli, P., et al. Drug-eluting balloon in peripheral intervention for below the knee angioplasty evaluation (DEBATE-BTK): a randomized trial in diabetic patients with critical limb ischemia. Circulation 128 (2013), 615–621.
113. [113] Zeller, T., Baumgartner, I., Scheinert, D., et al. Drug-eluting balloon versus standard balloon angioplasty for infrapopliteal arterial revascularization in critical limb ischemia: 12-month results from the IN.PACT DEEP randomized trial. J Am Coll Cardiol 64 (2014), 1568–1576.
114. [114] Laird, J.R., Armstrong, E.J., Drug-coated balloons for infrapopliteal disease: digging deep to understand the impact of a negative trial. J Am Coll Cardiol 64 (2014), 1577–1579.
115. [115] Feiring, A.J., Krahn, M., Nelson, L., Wesolowski, A., Eastwood, D., Szabo, A., Preventing leg amputations in critical limb ischemia with below-the-knee drug-eluting stents: the PaRADISE (PReventing Amputations using Drug eluting StEnts) trial. J Am Coll Cardiol 55 (2010), 1580–1589.
116. [116] Rastan, A., Brechtel, K., Krankenberg, H., et al. Sirolimus-eluting stents for treatment of infrapopliteal arteries reduce clinical event rate compared to bare-metal stents: long-term results from a randomized trial. J Am Coll Cardiol 60 (2012), 587–591.
117. [117] Bosiers, M., Scheinert, D., Peeters, P., et al. Randomized comparison of everolimus-eluting versus bare-metal stents in patients with critical limb ischemia and infrapopliteal arterial occlusive disease. J Vasc Surg 55 (2012), 390–398.
118. [118] Scheinert, D., Katsanos, K., Zeller, T., et al. A prospective randomized multicenter comparison of balloon angioplasty and infrapopliteal stenting with the sirolimus-eluting stent in patients with ischemic peripheral arterial disease: 1-year results from the ACHILLES trial. J Am Coll Cardiol 60 (2012), 2290–2295.
119. [119] McKinsey, J.F., Zeller, T., Rocha-Singh, K.J., Jaff, M.R., Garcia, L.A., Investigators DL. Lower extremity revascularization using directional atherectomy: 12-month prospective results of the DEFINITIVE LE study. J Am Coll Cardiol Cardiovasc Interv 7 (2014), 923–933.
120. [120] Lee, M.S., Yang, T., Adams, G., Pooled analysis of the CONFIRM registries: safety outcomes in diabetic patients treated with orbital atherectomy for peripheral artery disease. J Endovasc Ther 21 (2014), 258–265.
121. [121] Safian, R.D., Niazi, K., Runyon, J.P., et al. Orbital atherectomy for infrapopliteal disease: device concept and outcome data for the OASIS trial. Catheter Cardiovasc Interv 73 (2009), 406–412.
122. [122] Shammas, N.W., Weissman, N.J., Coiner, D., Shammas, G.A., Dippel, E., Jerin, M., Treatment of subacute and chronic thrombotic occlusions of lower extremity peripheral arteries with the excimer laser: a feasibility study. Cardiovasc Revasc Med 13 (2012), 211–214.
123. [123] Sultan, S., Tawfick, W., Hynes, N., Cool excimer laser-assisted angioplasty (CELA) and tibial balloon angioplasty (TBA) in management of infragenicular arterial occlusion in critical lower limb ischemia (CLI). Vasc Endovascular Surg 47 (2013), 179–191.
124. [124] Diamantopoulos, A., Katsanos, K., Atherectomy of the femoropopliteal artery: a systematic review and meta-analysis of randomized controlled trials. J Cardiovasc Surg (Torino) 55 (2014), 655–665.
125. [125] Ouriel, K., Shortell, C.K., DeWeese, J.A., et al. A comparison of thrombolytic therapy with operative revascularization in the initial treatment of acute peripheral arterial ischemia. J Vasc Surg 19 (1994), 1021–1030.
126. [126] Ouriel, K., Veith, F.J., Sasahara, A.A., A comparison of recombinant urokinase with vascular surgery as initial treatment for acute arterial occlusion of the legs. Thrombolysis or peripheral arterial surgery (TOPAS) investigators. N Engl J Med 338 (1998), 1105–1111.
127. [127] Weaver, F.A., Comerota, A.J., Youngblood, M., Froehlich, J., Hosking, J.D., Papanicolaou, G., Surgical revascularization versus thrombolysis for nonembolic lower extremity native artery occlusions: results of a prospective randomized trial. The STILE Investigators. Surgery versus Thrombolysis for Ischemia of the Lower Extremity. J Vasc Surg 24 (1996), 513–521 [discussion 521–3].
128. [128] Yilmaz, S., Sindel, T., Golbasi, I., Turkay, C., Mete, A., Luleci, E., Aortoiliac kissing stents: long-term results and analysis of risk factors affecting patency. J Endovasc Ther 13 (2006), 291–301.
129. [129] Soga, Y., Iida, O., Kawasaki, D., et al. Contemporary outcomes after endovascular treatment for aorto-iliac artery disease. Circ J 76 (2012), 2697–2704.
130. [130] Laird, J.R., Katzen, B.T., 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 19 (2012), 1–9.
131. [131] Laird, J.R., Katzen, B.T., 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 3 (2010), 267–276.
132. [132] Matsumura, J.S., Yamanouchi, D., Goldstein, J.A., et al. The United States study for evaluating endovascular treatments of lesions in the superficial femoral artery and proximal popliteal by using the protege everflex nitinol stent system II (DURABILITY II). J Vasc Surg, 58, 2013, e1.
133. [133] Rocha-Singh, K.J., Bosiers, M., Schultz, G., et al. A single stent strategy in patients with lifestyle limiting claudication: 3-year results from the Durability II trial. Catheter Cardiovasc Interv 86 (2015), 164–170.
134. [134] Davaine, J.M., Azema, L., Guyomarch, B., et al. One-year clinical outcome after primary stenting for Trans-Atlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions (the STELLA STEnting Long de L׳Artere femorale superficielle cohort). Eur J Vasc Endovasc Surg 44 (2012), 432–441.
135. [135] Scheinert, D., Grummt, L., Piorkowski, M., et al. A novel self-expanding interwoven nitinol stent for complex femoropopliteal lesions: 24-month results of the SUPERA SFA registry. J Endovasc Ther 18 (2011), 745–752.
136. [136] Laird, J.R., 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 21 (2014), 202–212.
137. [137] Lammer, J., Zeller, T., Hausegger, K.A., et al. Sustained benefit at 2 years for covered stents versus bare-metal stents in long SFA lesions: the VIASTAR trial. Cardiovasc Intervent Radiol 38 (2015), 25–32.
138. [138] Dave, R.M., Patlola, R., Kollmeyer, K., et al. Excimer laser recanalization of femoropopliteal lesions and 1-year patency: results of the CELLO registry. J Endovasc Ther 16 (2009), 665–675.
139. [139] Dattilo, R., Himmelstein, S.I., Cuff, R.F., 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 26 (2014), 355–360.
140. [140] Sixt, S., Rastan, A., Scheinert, D., et al. The 1-year clinical impact of rotational aspiration atherectomy of infrainguinal lesions. Angiology 62 (2011), 645–656.
141. [141] Banerjee, S., Brilakis, E.S., Das, T.S., Lichtenwalter, C.S., Treatment of complex superficial femoral artery lesions with PolarCath cryoplasty. Am J Cardiol 104 (2009), 447–449.
142. [142] Banerjee, S., Das, T.S., Abu-Fadel, M.S., 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 60 (2012), 1352–1359.
143. [143] Gandini, R., Del Giudice, C., Merolla, S., Morosetti, D., Pampana, E., Simonetti, G., Treatment of chronic SFA in-stent occlusion with combined laser atherectomy and drug-eluting balloon angioplasty in patients with critical limb ischemia: a single-center, prospective, randomized study. J Endovasc Ther 20 (2013), 805–814.
144. [144] Laird, J.R. Jr., Yeo, K.K., Rocha-Singh, K., et al. Excimer laser with adjunctive balloon angioplasty and heparin-coated self-expanding stent grafts for the treatment of femoropopliteal artery in-stent restenosis: twelve-month results from the SALVAGE study. Catheter Cardiovasc Interv 80 (2012), 852–859.