Over the past decade, accumulated experience and considerable advances in percutaneous endovascular techniques have enabled their use with increasing frequency for the management of peripheral arterial occlusive disease. However, despite the established role of endoluminal approaches in many other arterial territories, their application for the treatment of femoropopliteal occlusive disease is still debatable due to unique unfavorable anatomical, functional, and flow characteristics of this area. Conventional balloon angioplasty in the femoral and popliteal arteries is frequently associated with suboptimal results and high restenosis rates. To overcome these limitations, emerging approaches have been introduced or are currently under investigation. These include angioplasty modifications, newer concepts in stent design, adjunctive pharmacotherapy, debulking devices, and the application of gamma radiation and freezing in an attempt to reduce intimal hyperplastic response and consequently to expand the application of minimal invasive techniques in the hostile femoropopliteal environment. This review article will present the current status and future trends of endovascular therapy of femoropopliteal artery occlusive disease.
Hertzer NR.The natural history of peripheral vascular disease. Implications for its management. Circulation.1991;83: 112-119.
2.
McDaniel MD, Cronenwett JL.Basic data related to the natural history of intermittent claudication. Ann Vasc Surg. 1989;3: 273-277.
3.
Long term mortality and its predictors in patients with critical leg ischemia. The I.C.A.I. Group. The Study Group of Critical Chronic Ischemia of the Lower Extremities. Eur J Vasc Endovasc Surg. 1997;14: 91-95.
4.
Weitz JI, Byrne J, Clagett GP, et al.Diagnosis and treatment of chronic arterial insufficiency of the lower extremities: a critical review. Circulation. 1996;94: 3026-3049.
5.
Anderson PL, Gelijns A, Moskowitz A, et al.Understanding trends in inpatient surgical volume: vascular interventions, 1980-2000. J Vasc Surg. 2004;39: 1200-1208.
6.
Nowygrod R, Egorova N, Greco G, et al.Trends, complications, and mortality in peripheral vascular surgery. J Vasc Surg. 2006;43: 205-216.
7.
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.
8.
Kudo T, Chandra FA, Kwun WH, Haas BT, Ahn SS.Changing pattern of surgical revascularization for critical limb ischemia over 12 years: endovascular vs. open bypass surgery. J Vasc Surg. 2006;44: 304-313.
9.
Keeling WB, Stone PA, Armstrong PA, et al.Increasing endovascular intervention for claudication: impact on vascular surgery resident training. J Endovasc Ther. 2006;13: 507-513.
10.
Wilson SE, Wolf GL, Cross AP.Percutaneous transluminal angioplasty versus operation for peripheral arteriosclerosis. Report of a prospective randomized trial in a selected group of patients. J Vasc Surg. 1989;9: 1-9.
11.
Holm J, Arfvidsson B, Jivegard L, et al.Chronic lower limb ischaemia. A prospective randomised controlled study comparing the 1-year results of vascular surgery and percutaneous transluminal angioplasty (PTA). Eur J Vasc Surg. 1991;5: 517-522.
12.
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: 132-137.
13.
Varty K, Nydahl S, Nasim A, Bolia A, Bell PR, London JM.Results of surgery and angioplasty for the treatment of chronic severe lower limb ischaemia. Eur J Vasc Endovasc Surg. 1998;16: 159-163.
14.
Hynes N, Akhtar Y, Manning B, et al.Subintimal angioplasty as a primary modality in the management of critical limb ischemia: comparison to bypass grafting for aortoiliac and femoropopliteal occlusive disease. J Endovasc Ther. 2004;11: 460-471.
15.
participants Bt.Bypass versus angioplasty in severe ischemia of the leg(BASIL): multicentre, randomized controlled trial. Lancet. 2005;366: 1925-1934.
16.
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: 165-171.
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: 1066-1071.
19.
Golledge J, Ferguson K, Ellis M, et al.Outcome of femoropopliteal angioplasty. Ann Surg. 1999;229: 146-153.
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: 325-332
24.
Clark TW, Groffsky JL, Soulen MC.Predictors of long-term patency after femoropopliteal angioplasty: results from the STAR registry. J Vasc Interv Radiol. 2001; 12: 923-993.
25.
Alback A, Biancari F, Schmidt S, et al.Haemodynamic results of femoropopliteal percutaneous transluminal angioplasty. Eur J Vasc Endovasc Surg. 1998;16: 7-12.
26.
Crawford DW, Barndt R, Jr., Back LH.Surface characteristics of normal and atherosclerotic human arteries including observations suggesting interaction between flow and intimal morphology. Lab Invest. 1976;34: 463-540.
27.
Davies PF, Polacek DC, Shi C, Helmke BP.The convergence of haemodynamics, genomics, and endothelial structure in studies of the focal origin of atherosclerosis. Biorheology. 2002;39: 299-306.
28.
Machan L.Drug eluting stents in the infrainguinal circulation. Tech Vasc Interv Radiol. 2004;7: 28-32.
29.
Surowiec SM, Davies MG, Eberly SW, et al.Percutaneous angioplasty and stenting of the superficial femoral artery. J Vasc Surg. 2005;41: 269-278.
30.
Kudo T, Chandra FA, Ahn SS.The effectiveness of percutaneous transluminal angioplasty for the treatment of critical limb ischemia: a 10-year experience. J Vasc Surg. 2005;41: 423-435; discussion 435.
31.
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: 330-335.
32.
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 Intervent Radiol. 1997;20: 420-425.
33.
Zdanowski Z, Albrechtsson U, Lundin A, et al.Percutaneous transluminal angioplasty with or without stenting for femoropopliteal occlusions? A randomized controlled study. Int Angiol. 1999;18: 251-255.
34.
Cejna M, Thurnher S, Illiasch H, et al.PTA versus Palmaz stent placement in femoropopliteal artery obstructions: a multicenter prospective randomized study. J Vasc Interv Radiol. 2001;12: 23-31.
35.
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: 935-942.
Grenacher L, Saam T, Geier A, et al.[PTA versus Palmaz stent placement in femoropopliteal artery stenoses: results of a multicenter prospective randomized study (REFSA)]. Rofo. 2004;176: 1302-1310.
38.
Muradin GS, Bosch JL, Stijnen T, Hunink MG.Balloon dilation and stent implantation for treatment of femoropopliteal arterial disease: meta-analysis. Radiology. 2001; 221: 137-145.
39.
Henry M, Henry I, Klonaris C, Hugel M.Clinical experience with the OptiMed sinus stent in the peripheral arteries. J Endovasc Ther. 2003;10: 772-779.
40.
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: 257-266.
41.
Vogel TR, Shindelman LE, Nackman GB, Graham AM.Efficacious use of nitinol stents in the femoral and popliteal arteries. J Vasc Surg. 2003;38: 1178-1184.
42.
Mewissen MW.Self-expanding nitinol stents in the femoropopliteal segment: technique and mid-term results. Tech Vasc Interv Radiol. 2004;7: 2-5.
43.
Lugmayr HF, Holzer H, Kastner M, Riedelsberger H, Auterith A.Treatment of complex arteriosclerotic lesions with nitinol stents in the superficial femoral and popliteal arteries: a midterm follow-up. Radiology. 2002;222: 37-43.
44.
Hayerizadeh R ZT, Krankenberg H.Long-term outcome of superficial femoral artery stenting using nitinol stents compared with stainless steel stents. A multicenter study. Am J Cardiol. 2003;92(Suppl): S157L-S157L.
45.
Sabeti S, Schillinger M, Amighi J, et al.Primary patency of femoropopliteal arteries treated with nitinol versus stainless steel self-expanding stents: propensity score-adjusted analysis. Radiology. 2004;232: 516-521.
46.
Duda SH, Pusich B, Richter G, et al.Sirolimus-eluting stents for the treatment of obstructive superficial femoral artery disease: six-month results. Circulation. 2002;106: 1505-1509.
47.
Duda SH, Bosiers M, Lammer J, et al.Sirolimus-eluting versus bare nitinol stent for obstructive superficial femoral artery disease: the SIROCCO II trial. J Vasc Interv Radiol. 2005;16: 331-338.
48.
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: 1879-1888.
49.
Scheinert D, Scheinert S, Sax J, et al.Prevalence and clinical impact of stent fractures after femoropopliteal stenting. J Am Coll Cardiol. 2005;45: 312-315.
50.
Schlager O, Dick P, Sabeti S, et al.Long-segment SFA stenting—the dark sides: in-stent restenosis, clinical deterioration, and stent fractures. J Endovasc Ther. 2005;12: 676-684.
51.
Cheng SW, Ting AC, Wong J.Endovascular stenting of superficial femoral artery stenosis and occlusions: results and risk factor analysis. Cardiovasc Surg. 2001;9: 133-140.
52.
Bolia A, Miles KA, Brennan J, Bell PR.Percutaneous transluminal angioplasty of occlusions of the femoral and popliteal arteries by subintimal dissection. Cardiovasc Intervent Radiol. 1990;13: 357-363.
53.
London NJ, Srinivasan R, Naylor AR, et al.Subintimal angioplasty of femoropopliteal artery occlusions: the long-term results. Eur J Vasc Surg. 1994;8: 148-155.
54.
Hynes N, Mahendran B, Manning B, Andrews E, Courtney D, Sultan S.The influence of subintimal angioplasty on level of amputation and limb salvage rates in lower limb critical ischaemia: a 15-year experience. Eur J Vasc Endovasc Surg. 2005;30: 291-299.
55.
Lipsitz EC, Ohki T, Veith FJ, et al.Does subintimal angioplasty have a role in the treatment of severe lower extremity ischemia? J Vasc Surg. 2003;37: 386-391.
56.
Smith BM, Stechman M, Gibson M, Torrie EP, Magee TR, Galland RB.Subintimal angioplasty for superficial femoral artery occlusion: poor patency in critical ischaemia. Ann R Coll Surg Engl. 2005;87: 361-365.
57.
Kim JS, Kang TS, Ahn CM, et al.Efficacy of subintimal angioplasty/stent implantation for long, multisegmental lower limb occlusive lesions in patients unsuitable for surgery. J Endovasc Ther. 2006;13: 514-521.
58.
Reekers JA.Percutaneous intentional extraluminal (subintimal) revascularization (PIER) for critical lower limb ischemia: too good to be true? J Endovasc Ther. 2002; 9: 419-421.
59.
Yilmaz S, Sindel T, Yegin A, Luleci E.Subintimal angioplasty of long superficial femoral artery occlusions. J Vasc Interv Radiol. 2003;14: 997-1010.
60.
Treiman GS, Treiman R, Whiting J.Results of percutaneous subintimal angioplasty using routine stenting. J Vasc Surg. 2006;43: 513-519.
61.
Walker SR, Papavassiliou VG, Bolia A, London N.Subintimal angioplasty of native vessels in the management of occluded vascular grafts. Eur J Vasc Endovasc Surg. 2001;22: 41-43.
62.
Hausegger KA, Georgieva B, Portugaller H, Tauss J, Stark G.The outback catheter: a new device for true lumen re-entry after dissection during recanalization of arterial occlusions. Cardiovasc Intervent Radiol. 2004;27: 26-30.
63.
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: 1291-1296.
64.
Balas P, Pangratis N, Ioannou N, Milas P, Klonaris C, Masouridou E.Open subintimal angioplasty of the superficial femoral and distal arteries. J Endovasc Ther. 2000;7: 68-71.
65.
Henry M, Amor M, Cragg A, et al.Occlusive and aneurysmal peripheral arterial disease: assessment of a stent-graft system. Radiology. 1996;201: 717-724.
66.
Cragg AH, Dake MD.Treatment of peripheral vascular disease with stent-grafts. Radiology. 1997;205: 307-314.
67.
Ahmadi R, Schillinger M, Maca T, Minar E.Femoropopliteal arteries: immediate and long-term results with a Dacron-covered stent-graft. Radiology. 2002;223: 345-350.
68.
Marin ML, Veith FJ, Cynamon J, et al.Human transluminally placed endovascular stented grafts: preliminary histopathologic analysis of healing grafts in aortoiliac and femoral artery occlusive disease. J Vasc Surg. 1995; 21: 595-603; discussion 603-604.
69.
Virmani R, Kolodgie FD, Dake MD, et al.Histopathologic evaluation of an expanded polytetrafluoroethylene-nitinol stent endoprosthesis in canine iliofemoral arteries. J Vasc Interv Radiol. 1999;10: 445-456.
70.
Lammer J, Dake MD, Bleyn J, 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.
71.
Fischer M, Schwabe C, Schulte KL.Value of the hemobahn/viabahn endoprosthesis in the treatment of long chronic lesions of the superficial femoral artery: 6 years of experience. J Endovasc Ther. 2006;13: 281-290.
72.
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: 303-311.
73.
Saxon RR, Coffman JM, Gooding JM, Ponec DJ.Endograft use in the femoral and popliteal arteries. Tech Vasc Interv Radiol. 2004;7: 6-15.
74.
Hartung O, Otero A, Dubuc M, et al.Efficacy of Hemobahn in the treatment of superficial femoral artery lesions in patients with acute or critical ischemia: a comparative study with claudicants. Eur J Vasc Endovasc Surg. 2005;30: 300-306.
75.
Wiesinger B, Beregi JP, Oliva VL, et al.PTFE-covered self-expanding nitinol stents for the treatment of severe iliac and femoral artery stenoses and occlusions: final results from a prospective study. J Endovasc Ther. 2005; 12: 240-246.
76.
Deutschmann HA, Schedlbauer P, Berczi V, Portugaller H, Tauss J, Hausegger KA.Placement of Hemobahn stent-grafts in femoropopliteal arteries: early experience and midterm results in 18 patients. J Vasc Interv Radiol. 2001;12: 943-950.
77.
Ansel GM, Botti CF, Jr., Silver MJ.The use of femoropopliteal stent-grafts for critical limb ischemia. Tech Vasc Interv Radiol. 2005;8: 140-145.
78.
Mewissen MW.Stenting in the femoropopliteal arterial segment. Tech Vasc Interv Radiol. 2005;8: 146-149.
79.
Moses JW, Leon MB, Popma JJ, et al.Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003;349: 1315-1323.
80.
Park SJ, Shim WH, Ho DS, et al.A paclitaxel-eluting stent for the prevention of coronary restenosis. N Engl J Med. 2003;348: 1537-1545.
81.
Minar E, Pokrajac B, Maca T, et al.Endovascular brachytherapy for prophylaxis of restenosis after femoropopliteal angioplasty: results of a prospective randomized study. Circulation. 2000;102: 2694-2699.
82.
Pokrajac B, Potter R, Wolfram RM, et al.Endovascular brachytherapy prevents restenosis after femoropopliteal angioplasty: results of the Vienna-3 randomised multi-center study. Radiother Oncol. 2005;74: 3-9.
83.
Diehm N, Silvestro A, Do DD, et al.Endovascular brachytherapy after femoropopliteal balloon angioplasty fails to show robust clinical benefit over time. J Endovasc Ther. 2005;12: 723-730.
84.
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: 878-884.
85.
Krueger K, Zaehringer M, Bendel 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: 546-554.
86.
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: 343-351.
87.
Wyttenbach R, Gallino A, Alerci M, 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: 1156-1161.
88.
Tatsutani KN, Joye JD, Virmani R, Taylor MJ.In vitro evaluation of vascular endothelial and smooth muscle cell survival and apoptosis in response to hypothermia and freezing. Cryo Lett. 2005;26: 55-64.
89.
Laird J, Jaff MR, Biamino G, et al.Cryoplasty for the treatment of femoropopliteal arterial disease: results of a prospective, multicenter registry. J Vasc Interv Radiol. 2005;16: 1067-1073.
90.
Laird JR, Biamino G, McNamara T, et al.Cryoplasty for the treatment of femoropopliteal arterial disease: extended follow-up results. J Endovasc Ther. 2006;13(Suppl 2): II52-II59.
Litvack F, Eigler N, Margolis J, et al.Percutaneous excimer laser coronary angioplasty: results in the first consecutive 3,000 patients. The ELCA Investigators. J Am Coll Cardiol. 1994;23: 323-329.
93.
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: 1183-1188.
94.
Biamino G.The excimer laser: science fiction fantasy or practical tool? J Endovasc Ther. 2004;11(Suppl 2): II207-II222.
95.
Das TS.Percutaneous peripheral revascularisation with excimer laser: equipment, technique and results. Lasers Med Sci. 2001;16: 101-107.
96.
Boccalandro F, Muench A, Sdringola S, Rosales OR.Wireless laser-assisted angioplasty of the superficial femoral artery in patients with critical limb ischemia who have failed conventional percutaneous revascularization. Catheter Cardiovasc Interv. 2004;63: 7-12.
97.
Laird JR, Zeller T, Gray BH, et al.Limb salvage following laser-assisted angioplasty for critical limb ischemia: results of the LACI multicenter trial. J Endovasc Ther. 2006;13: 1-11.
98.
Bosiers M, Peeters P, Elst FV, et al.Excimer laser assisted angioplasty for critical limb ischemia: results of the LACI Belgium Study. Eur J Vasc Endovasc Surg. 2005;29: 613-619.
99.
Tcheng JE, Volkert-Noethen AA.Current multicentre studies with the excimer laser: design and aims. Lasers Med Sci. 2001;16: 122-129.
100.
Steinkamp HJ, Rademaker J, Wissgott C, et al.Percutaneous transluminal laser angioplasty versus balloon dilation for treatment of popliteal artery occlusions. J Endovasc Ther. 2002;9: 882-888.
101.
Moussa I, Moses J, Di Mario C, et al.Stenting after optimal lesion debulking (sold) registry. Angiographic and clinical outcome. Circulation. 1998;98: 1604-1609.
102.
Bramucci E, Angoli L, Merlini PA, et al.Adjunctive stent implantation following directional coronary atherectomy in patients with coronary artery disease. J Am Coll Cardiol. 1998;32: 1855-1860.
103.
Wildenhain PM, Wholey MH, Jarmolowski CR, Hill KL.Infrainguinal directional atherectomy: long-term follow-up and comparison with percutaneous transluminal angioplasty. Cardiovasc Intervent Radiol. 1994;17: 305-311.
104.
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: 837-844.
105.
Kolvenbach R, Strosche H.Long term results after rotation angioplasty and catheter atherectomy. A retrospective analysis. J Cardiovasc Surg (Torino). 1998;39: 15-18.
106.
Zeller T, Rastan A, Schwarzwalder U, et al.Percutaneous peripheral atherectomy of femoropopliteal stenoses using a new-generation device: six-month results from a single-center experience. J Endovasc Ther.2004;11: 676-685.
