Treatment of Atherosclerotic Disease of the Femoral Artery: Randomized Controlled Trials and Meta-Analyses. Should You Be Sceptical? — Oak Academic Publishing
Research ArticleOpen AccessGoogle Scholar indexed
Treatment of Atherosclerotic Disease of the Femoral Artery: Randomized Controlled Trials and Meta-Analyses. Should You Be Sceptical?
A narrative review of the data provided by Randomised Controlled clinical trials and meta-analyses was undertaken to assess how much reliance a clinician could place on these in selecting a treatment for patients with disease of the Femoral artery. An attempt was made to detect and review every clinical trial and meta-analysis published on treatments relating to disease of the femoral artery but not relating to drug treatment. Disease of the femoral artery in >65 years age group occurs in approximately 20% of the population but symptomatology was present in <2%. Associated morbidity was high and the 5-year mortality rate was >40%. In almost all trials the predominant (>90%) indication for treatment was intermittent claudication. In this setting, clinical benefit was limited and did not extend beyond 12 months. Mortality, from co-morbidities was high. The Basil Trial was the only one to examine intervention for critical limb ischemia. The results for Bypass surgery and Percutaneous transarterial balloon angioplasty (PTA) were equivalent. There is little evidence to support the use of PTA or stenting other than in the treatment of patients with critical limb ischemia.
Diehm, C., Schuster, A., Allenberg, J.R., Darius, H., Haberl, R., Lange, S., Pittrow, D., von Stritzky, B., Tephohl, G. and Trampisch, H.-J. (2004) High Prevalence of Peripheral Arterial Disease and Co-Morbidity in 6880 Primary Care Patients: Cross-Sectional Study. Atherosclerosis, 172, 95-105.
Meijer, W.T., Hoes, A.W., Rutgers, D., Bots, M.L., Hofman, A. and Grobbee, D.E. (1998) Peripheral Arterial Disease in the Elderly: The Rotterdam Study. Arteriosclerosis, Thrombosis, and Vascular Biology, 18, 185-192.
Hobbs, S.D. and Bradbury, A.W. (2006) The Exercise versus Angioplasty in Claudication Trial (EXACT): Reasons for Recruitment Failure and the Implications for Research into Treatment of Intermittent Claudication. Journal of Vascular Surgery,44, 432-433
Ratliff, D.A., Puttick, M., Libertiny, G., Hicks, R.C.J., Earby, L.E. and Richards, T. (2007) Supervised Exercise Training for Intermittent Claudication: Lasting Benefit at Three Years. European Journal of Vascular and Endovascular Surgery, 34, 322-326. https://doi.org/10.1016/j.ejvs.2007.04.014
Lane, R., Harwood, A., Watson, L. and Leng, G.C. (2017) Exercise for Intermittent Claudication. Cochrane Database of Systematic Reviews, No. 12, Article No. CD000990. https://doi.org/10.1002/14651858.CD000990.pub4
Mazari, F.A., Carradice, D., Norhisham, M.A., Rahman, A., Khan, J.A., Mockford, K., Mehta, T., McCollum, P.T. and Chetter, I.C. (2010) An Analysis of Relationship between Quality of Life Indices and Clinical Improvement Following Intervention in Patients with Intermittent Claudication Due to Femoropopliteal Disease. Journal of Vascular Surgery, 52, 77-84
Aherne, T., McHugh, S., Kheirelseid, E.A., Lee, M.J., McCaffrey, N., Moneley, D., Austin, L.L. and Naughton, P. (2015) Comparing Supervised Exercise Therapy to invasive Measures in the Management of Symptomatic Peripheral Arterial Disease. Surgical Research and Practice, 2015, Article ID: 960402. https://doi.org/10.1155/2015/960402
Creasy, T.S., McMillan, P.J., Fletcher, E.W.L., Collin, J. and Morris, P.J. (1990) Is Percutaneous Transluminal Angioplasty Better than Exercise for Claudication? -Preliminary Results from a Prospective Randomised Trial. European Journal of Vascular Surgery, 4, 135-140. https://doi.org/10.1016/S0950-821X(05)80427-X
Perkins, J.M.T., Collin, J., Creasy, T.S., Fletcher, E.W.L. and Morris, P.J. (1996) Exercise Training versus Angioplasty for Stable Claudication. Long and Medium-Term Results of a Prospective, Randomised Trial. European Journal of Vascular and Endovascular Surgery, 11, 409-413. https://doi.org/10.1016/S1078-5884(96)80171-7
Whyman, M.R., Fowkes, F.G.R., Kerraccher, E.M.G., Gillespie, I.N., Lee, A.J., Housley, E. and Ruckley, C.V. (1996) Randomised Controlled Trial of Percutaneous Transluminal Angioplasty for Intermittent Claudication. European Journal of Vascular and Endovascular Surgery, 12, 167-172. https://doi.org/10.1016/S1078-5884(96)80102-X
Whyman, M.R., Fowkes, F.G.R., Keracher, E.M.G., Gillespie, I.N., Lee, A.J., Housley, E. and Ruckley, C.V. (1997) Is Intermittent Claudication Improved by Percutaneous Transluminal Angioplasty? A Randomised Controlled Trial. Journal of Vascular Surgery, 26, 551-557.
Nylaende, M., Abdelnoor, M., Stranden, E., Morken, B., Sandaek, G., Risum, O., Jorgensen, J.J., Kindahl, A.K., Arnesen, H., Seljeflot, L. and Kroese, A.J. (2007) The Oslo Balloon Angioplasty versus Conservative Treatment Study(OBACT)-The 2-Year Results of a Single Centre, Prospective, Randomised Study in Patients with Intermittent Claudication. European Journal of Vascular and Endovascular Surgery, 33, 3-12.
Greenhalgh, R.M., Belch, J.J., Brown, L.C., Gaines, P.A., Gao, L. and Reise, J.A. (2008) The Adjuvant Benefit of Angioplasty in Patients with Mild to Moderate Intermittent Claudication (MIMIC). European Journal of Vascular and Endovascular Surgery, 36, 680-688.
Spronk, S., Boscch, J.L., den Hoed, P.T., Veen, H.F., Pattynama, P.M. and Hunink, M.G. (2008) Cost Effectiveness of Endovascular Revascularisation Compared to Supervised Hospital-Based Exercise Training in Patients with Intermittent Claudication: A Randomized Controlled Trial. Journal of Vascular Surgery, 48, 1472-1480. https://doi.org/10.1016/j.jvs.2008.06.016
Mazari, F.A., Khan, J.A., Carradice, D., Samuel, N., Abdul Rahman, M.N. and Gulati, S. (2012) Randomized Clinical Trial of Percutaneous Transluminal Angioplasty, Supervised Exercise Training and Combined Treatment for Intermittent Claudication Due to Femoropopliteal Arterial Disease. British Journal of Surgery, 99, 38-48. https://doi.org/10.1002/bjs.7710
Muradin, G.S., Bosch, J.L., Stijen, T. and Hunink, M.G. (2002) Balloon Dilation and Stent Implantation for Treatment of Femoropopliteal Artery Disease: Meta-Analysis. Radiology, 224, 137-145
YaJun, E., Neng, S.H., Wang, Y. and Fan, H. (2008) Percutaneous Transluminal Angioplasty (PTA) Alone versus PTA with Balloon-Expandable Stent Placement for Short Segment Femoropopliteal Artery Disease: A Meta-Analysis of Randomized Trials. Journal of Vascular and Interventional Radiology, 19, 499-503. https://doi.org/10.1016/j.jvir.2007.12.446
Mwipatayi, B.P., Hockings, A., Hoffman, M., Garbowski, M. and Sieunarine, K. (2008) Balloon Angioplasty Compared with Stenting for Treatment of Femoro-Popliteal Occlusive Disease: A Meta-Analysis. Journal of Vascular Surgery, 47, 461-469
Kasapis, C., Henke, P.K., Chetcuti, S.J., Koenig, G.C., Rectenwald, J.E., Krishnamrthy, V.N., Grossman, P.M. and Gurm, H.S. (2009) Routine Stent Implantation vs. Percutaneous Transluminal Angioplasty in Femoro-Popliteal Artery Disease: A Meta-Analysis of Randomised Controlled Trials. European Heart Journal, 30, 44-55. https://doi.org/10.1093/eurheartj/ehn514
Perrio, S., Holt, P.J.E., Patterson, B.O., Hinchliffe, R.J., Loftus, I.M. and Thompson, M.M. (2010) Role of Superficial Arterial Stents in the Management of Arterial Occlusive Disease: Review of the Current Evidence. Vascular, 18, 82-92.
Chowdhury, M.M., McLain, A.D. and Twine, C.P. (2014) Angioplasty versus Bare Metal Stenting for Superficial Femoral Artery Lesions. Cochrane Data Base of Systematic Reviews, No. 6, Article No. CD006767. https://doi.org/10.1002/14651858.CD006767.pub3
Vroegindeweij, D., Vos, L.D., Tielbeek, A.V., Buth, J. and vd Bosch, H.C. (1997) Balloon Angioplasty Combined with Primary Stenting versus Balloon Angioplasty Alone in Femoropopliteal Obstructions: A Comparative Randomized Study. CardioVascular and Interventional Radiology, 20, 420-425. https://doi.org/10.1007/s002709900186
Cheng, S.W., Ting, A.C. and Wong, J. (2001) Endovascular Stenting of Superficial Femoral Artery Stenosis and Occlusions: Results and Risk Factor Analysis. Cardiovascular Surgery, 9, 133-140.
Becquemin, J.-P., Favre, J.-P., Marzelle, J., Nemoz, C., Corsin, C. and Leizorovicz, A. (2003) Systematic versus Selective Stent Placement after Superficial Femoral Artery Balloon Angioplasty: A Multicentre Prospective Randomized Study. Journal of Vascular Surgery, 37, 487-494.
Tielbeek, A.V., Vroegindeweij, D., Buth, J., et al. (1996) Comparison of Balloon Angioplasty and Simpson Atherectomy for Lesions in the Femoropopliteal Artery: Angiographic and Clinical Results of a Prospective Randomized Trial. Journal of Vascular and Interventional Radiology, 7, 837-844. https://doi.org/10.1016/S1051-0443(96)70857-6
Henry, M., Amor, M., Ethevenot, G., et al. (1995) Palmaz Stent Placement in Iliac and Femoro-Popliteal Arteries: Primary and Secondary Patency in 310 Patients with 2-3 Years Follow Up. Radiology, 197, 167-174. https://doi.org/10.1148/radiology.197.1.7568818
Strecker, P., Boos, I.B. and Gottman, D. (1997) Femoropopliteal Sent Placement: Evaluation of Long Term Success. Radiology, 205, 375-383. https://doi.org/10.1148/radiology.205.2.9356617
Jeans, W.D., Cole, S.D., Horrocks, M., et al. (1994) Angioplasty Gives Good Results in Critical Lower Limb Ischemia. A 5-Year Follow Up in Patients with Known Ankle Pressure and Diabetic Status Having Femoropopliteal Dilations. The British Journal of Radiology, 67, 123-128. https://doi.org/10.1259/0007-1285-67-794-123
Murray, J.G., Apthorp, L.A. and Wilkins, R.A. (1995) Long Segment (>10cm) Femoropopliteal Angioplasty: Improved Technical Success and Long-Term Patency. Radiology, 195, 158-162. https://doi.org/10.1148/radiology.195.1.7892459
Stanley, B., Teague, B., Raptis, S., et al. (1996) Efficacy of Balloon Angioplasty of the Superficial Femoral Artery and Popliteal Artery in the Relief of Leg Ischemia. Journal of Vascular Surgery, 23, 679-685.
Martin, D.R., Katz, S.G., Kohl, R.D., et al. (1999) Percutaneous Transluminal Angioplasty of the Infra Inguinal Vessels. Annals of Vascular Surgery, 13, 184-187.
Golledge, J., Ferguson, K., Ellis, M., Sabharwal, T., Davies, A., Greenhalgh, R. and Powell, J. (1999) Outcome of Femororpopliteal Angioplasty. Annals of Surgery, 229, 146-153. https://doi.org/10.1097/00000658-199901000-00019
O’Donohoe, M.K., Sultan, S., Colgan, M.P., et al. (1999) Outcome of the First 100 Femoropopliteal Angioplasties Performed in the Operating Theatre. European Journal of Vascular and Endovascular Surgery, 17, 66-71.
Karch, L.A., Mattos, M.A., Henretta, J.P., et al. (2000) Clinical Failure after Percutaneous Transluminal Angioplasty of the Superficial Femoral and Popliteal Arteries. Journal of Vascular Surgery, 31, 880-887.
Martin, E.C., Katzen, B.T., Benenati, J.F., et al. (1995) Multicenter Trial of the Wall Stent in the Iliac and Femoral Arteries. Journal of Vascular and Interventional Radiology, 6, 843-849.
White, G., Liew, S.C., Waugh, R.C., et al. (1995) Early Outcome and Intermediate Follow Up of Vascular Stents in the Femoral and Popliteal Arteries without Long Term Anticoagulation. Journal of Vascular Surgery, 21, 270-281. https://doi.org/10.1016/S0741-5214(95)70268-7
Bergeron, P., Pinot, J.J., Poyen, V., et al. (1995) Long-Term Results with the Palmaz Stent in the Superficial Femoral Artery. Journal of Endovascular Therapy, 2, 161-167. https://doi.org/10.1583/1074-6218(1995)002 2.0.CO;2
Cejna, M., Thurnher, S., Illiasch, H., Horvath, W., Waldenberger, P., Hornik, K. and Lammer, J. (2001) PTA versus Palmaz Stent Placement in Femoro-Popliteal Artery Obstructions: A Multicentre Prospective Randomized Study. Journal of Vascular and Interventional Radiology, 12, 23-31. https://doi.org/10.1016/S1051-0443(07)61397-9
Cejna, M., Schoder, M. and Lammer, J. (1999) PTA vs Stent in Femoropopliteal Obstruction. Radiologe, 39, 144-150.
Zdanowski, Z., Albrechtsson, U., Lundin, A., Jonung, T., Ribbe, E., Thorne, J. and Norgren, L. (1999) Percutaneous Transluminal Angioplasty with or without Stenting for Femoropopliteal Occlusions? A Randomized Controlled Study. International Angiology, 18, 251-255.
Grimm, J., Muller-Hulsbeck, S., Janke, T., et al. (2001) Randomized Study to Compare PTA Alone versus PTA with Palmaz Stent Placement for Femoropopliteal Lesions. Journal of Vascular and Interventional Radiology, 12, 935-942.
Pozzi Mucelli, P., Fisicaro, M., Calderan, L., Malacrea, M., Mazzone, C., Cattin, L., Scardi, S. and Pozzi Mucelli, R. (2003) Percutaneous Revascularization of Femoropopliteal Artery Disease: PTA and PTA Plus Stent. Results after Six Years’ Follow-Up. La Radiologia Medica, 105, 339-349.
Grenacher, L., Saam, T., Geier, A., Muller-Hulsbeck, S., Cejna, M., Kauffman, G.W. and Richter, G.M. (2004) PTA versus Palmaz Stent Placement in Femororpopliteal Artery Stenosis: Results of a Multicentre Prospective Randomized Study (REFSA). Rofo, 176, 1302-1310.
Rand, T., Basile, A., Cejna, M., et al. (2006) PTA versus Carbofilm Coated Stents in Infrapopliteal Arteries: Pilot Study. CardioVascular and Interventional Radiology, 29, 29-38.
Saxon, R.R., Coffman, J.M., Gooding, J.M., Natuzzi, E. and Ponec, D.J. (2003) Long-Term Results of ePTFE Stent-Graft versus Angioplasty in the Femoropopliteal Artery: Single Center Experience from a Prospective, Randomized Trial. Journal of Vascular and Interventional Radiology, 14, 303-311.
Schillinger, M., Sabeti, S., Loewe, C., Dick, P., Amighi, J., Mlekusch, W., Schlager, O., Cejna, M., Lammer, J. and Minar, E. (2006) Balloonn Angioplasty versus Implantation of Nitinol Stents in the Superficial Femoral Artery. The New England Journal of Medicine, 354, 1879-1888. https://doi.org/10.1056/NEJMoa051303
Krankenberg, H., Schluter, M., Steinkamp, H.J., Burgelin, K., Scheinert, D., Schulte, K.-D., Minar, E., Peeters, P., Bosiers, M., Tepe, G., Reimers, B., Mahler, F., Tubler, T. and Zeller, T. (2007) 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, 285-292. https://doi.org/10.1161/CIRCULATIONAHA.107.689141
US Food and Drug Administration (2001) Center for Devices and Radiological Health. Intracoil Self Expanding Peripheral Stent-P00033. https://www.accessdata.fda.gov/cdrh_docs/pdf/P000033b.pdf.
Gray, B.H., Sullivan, T.M., Childs, M.B., Young, J.R. and Olin, J.W. (1997) High Incidence of Restenosis/Reocclusion of Stents in the Percutaneous Treatment of Long-Segment Superficial Femoral Artery Disease after Suboptimal Angioplasty. Journal of Vascular Surgery, 25, 74-83.
Conroy, R.M., Gordon, I.L., Tobis, J.M., Hiro, T., Kasaoka, S., Stemmer, E.A. and Wilson, S.E. (2000) Angioplasty and Stent Placement in chronic Occlusion of the Superficial Femoral Artery: Technique and Results. Journal of Vascular and Interventional Radiology, 11, 1009-1020.
Vogel, T.R., Shindelman, L.E., Nackman, G.B. and Graham, A.M. (2003) Efficacious Use of Nitinol Stents in the Femoral and Popliteal Artery. Journal of Vascular Surgery, 38, 1178-1184.
Sabeti, S., Schillinger, M., Amighi, J., Sherif, C., Mlekusch, W., Ahmadi, R. and Minar, E. (2004) Primary Patency of Femoro-Popliteal Arteries Treated with Nitinol versus Stainless Steel Self-Expanding Stents: Propensity Score Adjusted Analysis. Radiology, 232, 516-521.
Abahji, T.N., Tato, F., Rieger, J., Offner, A., Will, S., Hoelscher, G., Weiss, N. and Hoffmann, U. (2006) Stenting of the Superficial Femoral Artery after Suboptimal Balloon Angioplasty: One Year Results. International Angiology, 25, 184-189.
Lenti, M., Cieri, E., De Rango, P., Pozzilli, P., Coscarella, C., Bertoglio, C., Troiani, R. and Cao, P. (2007) Endovascular Treatment of Long Lesions of the Superficial Femoral Artery: Results from a Multicentre Registry of a Spiral, Covered Polytetrafluroethylene Stent. Journal of Vascular Surgery, 45, 32-39.
Duda, S.H., Bosiers, M., Lammer, J., Scheinert, D., Zeller, T., Oliva, V., Tielbeek, A., Anderson, J., Wiesinger, B., Tepe, G., Lansky, A, Jaff, M.R., Mudde, C., Tielemans, H. and Beregi, J.-P. (2006) Drug-Eluting and Bare Nitinol Stents for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery: Long-Term Results from the SIROCCO Trial. Journal of Endovascular Therapy, 13, 701-710. https://doi.org/10.1583/05-1704.1
Inhat, D.M., Duong, S.T. and Taylor, Z.T. (2008) Contemporary Outcomes after Superficial Femoral Artery Angioplasty and Stenting: the Influence of TASC Classification and Run off Score. Journal of Vascular Surgery, 47, 967-974.
Surowiec, S.M., Davies, M.G., Eberly, S.W., Rhodes, J.M., Illig, K.A., Shortell, C.K., Lee, D.E., Waldman, D.L. and Green, R.M. (2005) Percutaneous Angioplasty and Stenting of the Superficial Femoral Artery. Journal of Vascular Surgery, 41, 269-278.
Schmeider, G., Richardson, A., Scott, E., Stokes, G.K., Meier, G.H. and Panneton, J.M. (2008) Selective Stenting in Subintimal Angioplasty: Analysis of Primary Stent Outcomes. Journal of Vascular Surgery, 48, 1175-1181.
Ferriera, M., Lanziotti, L., Monteiro, M., Abuhadba, G., Capotorto, L.F., Nolte, L. and Fearnot, N. (2007) Superficial Femoral Artery Recanalization with Self-Expanding Nitinol Stents: Long Term Follow Up Results. European Journal of Vascular and Endovascular Surgery, 34, 702-708.
Dick, P., Wallner, H., Sabeti, S., et al. (2009) Balloon Angioplasty versus Stenting with Nitinol Stents in Intermediate Length Superficial Femoral Artery Lesions. Catheterization and Cardiovascular Interventions, 74, 1090-1095. https://doi.org/10.1002/ccd.22128
Bosiers, M., Peters, P., Krakenberg, H., et al. (2006) The Femoral Artery Stenting Trial (FAST): 12 Month Outcomes. Abstract from 2006 SVS Annual Meeting.
Chalmers, N., Walker, P.T., Belli, A.-M., Thorpe, A.P., Sidhu, P.S., Robinson, G., Van Ransbeeck, M. and Fearn, S.A. (2013) Randomized Trial of the SMART Stent versus Balloon Angioplasty in Long Superficial Femoral Artery Lesions: The SUPER Study. CardioVascular and Interventional Radiology, 36, 353-361. https://doi.org/10.1007/s00270-012-0492-z
Becquemin, J.-P., Cavillon, A. and Haiduc, F. (1994) Surgical Transluminal Angioplasty: Multivariate Analysis Outcome. Journal of Vascular Surgery, 19, 495-502. https://doi.org/10.1016/S0741-5214(94)70077-X
Laird, J.R., Jain, A., Zeller, T., Feldman, R., Scheinert, D., Popma, J.J., Armstrong, E.J., Jaff, M.R., et al. (2014) Nitinol Stent Implantation in the Superficial Femoral Artery and Proximal Popliteal Artery: Twelve-Month Results from the Complete SE Multicenter Trial. Journal of Endovascular Therapy, 21, 202-212. https://doi.org/10.1583/13-4548R.1
Laird, J.R., Katzen, B.T., Scheinert, D., Lammer, J., Carpenter, J., Buchbinder, M., Dave, R., Ansel, G., Lansky, A., Cristea, E., Collins, T.J., Goldstein, J., Cao, A.Y. and Jaff, M.R. (2012) Nitinol Stent Implantation vs. Balloon Angioplasty for Lesions in the Superficial Femoral and Proximal Popliteal Arteries with Claudication: Three-Year Follow-Up from the RESILIENT Randomized Trial. Journal of Endovascular Therapy, 19, 1-19.
Liistro, F., Grotti, S., Porto, I., Angioli, P., Ricci, L., Ducci, K., Falsini, G., Ventoruzzo, G., Turini, F., Bellandi, G. and Bolognese, L. (2013) 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). JACC: Cardiovascular Interventions, 6, 1295-302.
Lammer, J., Zeller, T., Hausegger, K.A., Schaefer, P.J., Gschwendtner, M., Mueller-Huelsbeck, S., Rand, T., Funovics, M., Wolf, F., Rastan, A., Gschwandtner, M., Puchner, S., Ristl, R. and Schoder, M. (2013) Heparin-Bonded Covered Stents Versus Bare-Metal Stents for Complex Femoropopliteal Artery Lesions. The Randomized VIA STAR Trial (Viabahn Endoprosthesis With PROPATEN Bioactive Surface [VIA] versus Bare Nitinol Stent in the Treatment of Long Lesions in Superficial Femoral Artery Occlusive Disease). JACC: Journal of the American College of Cardiology, 62, 1320-1327.
Dake, M.D., Ansel, G.M., Jaff, M.R., Ohki, T., Saxon, R.R., Smouse, B., Machan, L.S., Snyder, S.A., O’Leary, E.E., Ragheb, A.O., Zeller, T., et al. (2016) Durable Clinical Effectiveness with Paclitaxel-Eluting Stents in the Femoropopliteal Artery. Circulation, 133, 1472-1483.
Rosenfield, K., et al. (2015) Trial of a Paclitaxel-Coated Balloon for Femoropopliteal Artery Disease The New England Journal of Medicine, 373, 145-153.
Tepe, G., Laird, J., Schneider, P., et al. (2015) Drug-Coated Balloon versus Standard Percutaneous Transluminal Angioplasty for the Treatment of Superficial Femoral and Popliteal Peripheral Artery Disease, 12 Months Results from the IN. PACT SFA Randomized Trial. Circulation, 131, 495-502. https://doi.org/10.1161/CIRCULATIONAHA.114.011004
Banerjee, S., Das, T., Abu-Fadel, M., Dippel, E., Shammas, N., Tran, D., Zankar, A., Varghese, C., Kelly, K., Weideman, R., Little, B., Reilly, R., Addo, T. and Brilakis, E. (2012) Pilot Trial of Cryoplasty or Conventional Balloon Post-Dilation of Nitinol Stents for Revascularization of Peripheral Arterial Segments. Journal of the American College of Cardiology, 60, 1352-1359. https://doi.org/10.1016/j.jacc.2012.05.042
Lepantalo, M., Laurila, K., Roth, W., Rossi, P., Lavonen, J., Makinen, K., Manninen, H., Romsi, P., Perala, J., Bergqvist, D., et al. (2009) PTFE Bypass or Thrupass for Superficial Femoral Artery Occlusion? A Randomised Controlled Trial. European Journal of Vascular and Endovascular Surgery, 37, 578-584. https://doi.org/10.1016/j.ejvs.2009.01.003
van der Zaag, E., Legemate, D., Prins, M., Reekers, J. and Jacobs, M. (2004). Angioplasty or Bypass for Superficial Femoral Artery Disease? A Randomised Controlled Trial. European Journal of Vascular and Endovascular Surgery, 28, 132-137. https://doi.org/10.1016/j.ejvs.2004.04.003
Brancaccio, G. et al. (2012) Comparison of Embolic Load in Femoropopliteal Interventions: Percutaneous Transluminal Angioplasty versus Stenting. Vascular and Endovascular Surgery, 46, 229-235. https://doi.org/10.1177/1538574411422276
Diaz, M., Urtasun, F., Barberena, J., Aranzadi, C., Guillen-Grima, F. and Bilbao, J. (2011) Cryoplasty versus Conventional Angioplasty in Femoropopliteal Arterial Recanalization: 3-Year Analysis of Reintervention-Free Survival by Treatment Received. CardioVascular and Interventional Radiology, 34, 911-917. https://doi.org/10.1007/s00270-010-0032-7
Diehm, N. et al. (2005) Endovascular Brachytherapy after Femoropopliteal Balloon Angioplasty Fails to Show Robust Clinical Benefit over Time. Journal of Endovascular Therapy, 12, 723-730. https://doi.org/10.1583/05-1583MR.1
Fossaceca, R., Guzzardi, G., Di Terlizzi, M., Divenuto, I., Malatesta, E., Cerini, P., Cusaro, C. and Carriero, A. (2012) Comparison of Cryoplasty and Conventional Angioplasty for Treating Stenotic-Occlusive Lesions of the Femoropopliteal Arteries in Diabetic Patients: Immediate, Mid-Term and Long-Term Results. La Radiologia Medica, 117, 1176-1189. https://doi.org/10.1007/s11547-012-0793-7
Geraghty, P., Mewissen, M., Jaff, M. and Ansel, G. (2013) Three-Year Results of the VIBRANT Trial of VIABAHN Endoprosthesis versus Bare Nitinol Stent Implantation for Complex Superficial Femoral Artery Occlusive Disease. Journal of Vascular Surgery, 58, 386-395.e4. https://doi.org/10.1016/j.jvs.2013.01.050
Krueger, K., Zaehringer, M., Bendel, M., Stuetzer, H., Strohe, D., Nolte, M., Wittig, D., Mueller, R. and Lackner, K. (2004) De Novo Femoropopliteal Stenoses: Endovascular Gamma Irradiation Following Angioplasty—Angiographic and Clinical Follow-Up in a Prospective Randomized Controlled Trial. Radiology, 231, 546-554. https://doi.org/10.1148/radiol.2312030421
Pokrajac, B., Potter, R., Maca, T., Fellner, C., Mittlbock, M., Ahmadi, R., Seitz, W. and Minar, E. (2000) Intraarterial 192Ir High-Dose-Rate Brachytherapy for Prophylaxis of Restenosis after Femoropopliteal Percutaneous Transluminal Angioplasty: The Prospective Randomized Vienna-2-Trial Radiotherapy Parameters and Risk Factors Analysis. International Journal of Radiation Oncology Biology Physics, 48, 923-931. https://doi.org/10.1016/S0360-3016(00)00716-1
Pokrajac, B., Potter, R., Wolfram, R., Budinsky, A., Kirisits, C., Lileg, B., Mendel, H., Sabeti, S., Schmid, R. and Minar, E. (2005) Endovascular Brachytherapy Prevents Restenosis after Femoropopliteal Angioplasty: Results of the Vienna-3 Randomised Multicenter Study. Radiotherapy and Oncology, 74, 3-9. https://doi.org/10.1016/j.radonc.2004.08.015
Poncyljusz, W., Falkowski, A., Safranow, K., Rac, M. and Zawierucha, D. (2013) Cutting-Balloon Angioplasty Versus Balloon Angioplasty as Treatment for Short Atherosclerotic Lesions in the Superficial Femoral Artery: Randomized Controlled Trial. CardioVascular and Interventional Radiology, 36, 1500-1507. https://doi.org/10.1007/s00270-013-0603-5
Rastan, A., Krankenberg, H., Baumgartner, I., Blessing, E., Müller-Hülsbeck, S., Pilger, E., Scheinert, D., Lammer, J., Gißler, M., Noory, E., Neumann, F. and Zeller, T. (2013) Stent Placement versus Balloon Angioplasty for the Treatment of Obstructive Lesions of the Popliteal Artery. Circulation, 127, 2535-2541. https://doi.org/10.1161/CIRCULATIONAHA.113.001849
Scheinert, D., Duda, S., Zeller, T., Krankenberg, H., Ricke, J., Bosiers, M., Tepe, G., Naisbitt, S. and Rosenfield, K. (2014) The LEVANT I (Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis) Trial for Femoropopliteal Revascularization. JACC: Cardiovascular Interventions, 7, 10-19.
Spiliopoulos, S., Katsanos, K., Karnabatidis, D., Diamantopoulos, A., Kagadis, G., Christeas, N. and Siablis, D. (2010) Cryoplasty versus Conventional Balloon Angioplasty of the Femoropopliteal Artery in Diabetic Patients: Long-Term Results from a Prospective Randomized Single-Center Controlled Trial. CardioVascular and Interventional Radiology, 33, 929-938. https://doi.org/10.1007/s00270-010-9915-x
Tepe, G., Schnorr, B., Albrecht, T., Brechtel, K., Claussen, C., Scheller, B., Speck, U. and Zeller, T. (2015) Angioplasty of Femoral-Popliteal Arteries with Drug-Coated Balloons. JACC: Cardiovascular Interventions, 8, 102-108. https://doi.org/10.1016/j.jcin.2014.07.023
van Tongeren, R.B., van Sambeek, M.R., van Overhagen, H., Coen, V.L., Schmitz, P.I., Gescher, F.M., Wittens, C.H., Vernhout, R.M., van Urk, H., Levendag, P.C. and Bruijninckx, C.M. (2005) Endovascular Brachytherapy for the Prevention of Restenosis after Femoropopliteal Angioplasty. Results of the VARA Trial. The Journal of Cardiovascular Surgery, 46, 437-443.
Antonopoulos, C.N., Mylonas, S.N., Moulakakis, K.G., Sergentanis, T.N., Sfyroeras, G.S., Lazaris, A.M., Kakisis, J.D. and Vasdekis, S.N. (2017) A Network Meta-Analysis of Randomized Controlled Trials Comparing Treatment Modalities for De Novo Superficial Femoral Artery Occlusive Lesions. Journal of Vascular Surgery, 65, 234-245.
Kedora, J., Hohmann, S., Garrett, W., Munschaur, C., Theune, B. and Gable, D. (2007) Randomized Comparison of Percutaneous Viabahn Stent Grafts vs Prosthetic Femoral-Popliteal Bypass in the Treatment of Superficial Femoral Arterial Occlusive Disease. Journal of Vascular Surgery, 45, 10-16. https://doi.org/10.1016/j.jvs.2006.08.074
BASIL Trial Participants (2005) Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL): Multicentre, Randomised Controlled Trial. The Lancet, 366, 1925-1934. https://doi.org/10.1016/S0140-6736(05)67704-5
Bradbury, A.W., Adam, D.J., Bell, J., Forbes, J.F., Fowkes, G.R., Gillespie, I., Vaughan Ruckley, C. and Raab, G.M. (2010) Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) Trial: An Intention-to-Treat Analysis of Amputation-Free and Overall Survival in Patients Randomised to a Bypass Surgery First or a Balloon Angioplasty First Revascularization Strategy. Journal of Vascular Surgery, 51, 5s-17s.
Popplewell, M.A., Davies, H.O.B., Narayanswami, J., Renton, M., Sharp, A., Bate, G., Patel, S., Deeks, J., Bradbury, A.W. (2017) A Comparison of Outcomes in Patients with Infrapopliteal Disease Randomised to Vein Bypass or Plain Balloon Angioplasty in the Bypass vs. Angioplasty in Severe Ischaemia of the Leg (BASIL) Trial. European Journal of Vascular and Endovascular Surgery, 54,195-201.
Hunt, B.D., Popplewell, M.A., Davies, H., Meecham, L., Jarrett, H., Bate, G., Grant, M., Patel, S., Hewitt, C., Andronis, L., Deeks, J.J., Bradbury, A. and BASIL-3 Collaborative Group (2017) BAlloon versus Stenting in Severe Ischaemia of the Leg-3 (BASIL-3): Study Protocol for a Randomised Controlled Trial. Trials, 18, 224.
Zeller, T., Tiefenbacher, C., Steinkamp, H.J., Langhoff, R., Wittenberg, G., Schluter, M., Buergelin, K., Rastan, A., Krumsdorf, U., Sixt, S., Schulte, C.-L., Tubler, T. and Krankenberg, H. (2008) Nitinol Stent Implantation in TASC A and B Superficial Femoral Artery Lesions: The Femoral Artery Conformexx Trial (FACT). Journal of Endovascular Therapy, 15, 390-398. https://doi.org/10.1583/08-2461.1
Bosiers, M., Deloose, K., Callaert, J., Keirse, K., Virbst, J., Hendriks, J., Lauwers, P., D’Archambeau, O., Scheinert, D., Torsello, G. and Peeters, P. (2013) 4-French-Compatible Endovascular Material Is Safe and Effective in the Treatment of Femoropopliteal Occlusive Disease: Results of the 4-EVER Trial. Journal of Endovascular Therapy, 20, 746-756. https://doi.org/10.1583/13-4437MR.1
Matsumura, J.S., Yamanouchi, D., Goldstein, J.A., Pollock, C.W., Bosiers, M., Schultz, G.A., Scheinert, D. and Rocha-Singh, K.J. (2013) The United States Study for Evaluating Endovascular Treatments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By Using the Protégé Everflex NitInol Stent System II (DURABILITY II). Journal of Vascular Surgery, 58, 73-83.e1. https://doi.org/10.1016/j.jvs.2012.12.066
Clever, Y., Peters, D., Calisse, J., et al. (2016) Novel Sirolimus Coated Balloon Catheter. In Vivo Evaluation in a Porcine Coronary Model. Circulation: Cardiovascular Interventions, 9, e003543. http://circinterventions.ahajournals.org
Antoniou, G., Georgakarakos, E.I., Antoniou, S.A. and Georgiadis, G.S. (2014) Does Endovascular Treatment of Infra-Inguinal Arterial Disease with Drug-Eluting Stents Offer Better Results than Angioplasty with or without Bare Metal Stents? Interactive Cardiovascular and Thoracic Surgery, 19, 282-285.
Oransky, I. (2016) “Evidence-Based Medicine Has Been Hijacked:” A Confession from John Ioannidis. Retraction Watch.
Ioannidis, J. (2005) Why Most Published Research Findings Are False. PLoS Medicine, 2, e124. https://doi.org/10.1371/journal.pmed.0020124
Saxon, R.R., Dake, M.D., Volgelzang, R.L., Katzen, B. and Becker, G.J. (2008) Randomized, Multicenter Study Comparing Expanded Poly Tetrafluoroethylene-Covered Endoprothesis Placement with Percutaneous Transluminal Angioplasty in the treatment of Superficial Femoral Artery Occlusive Disease. Journal of Vascular and Interventional Radiology, 19, 823-832. https://doi.org/10.1016/j.jvir.2008.02.008
Reijen, M.M.P.J., van Walraven, L.A., Fritschy, W.M., et al. (2017) 1-Year Results of a Multicenter Randomized Controlled Trial Comparing Heparin-Bonded Endoluminal to Femoropopliteal Bypass. JACC: Cardiovascular Interventions, 10, 2320-2331. https://doi.org/10.1016/j.jcin.2017.09.013
Kinstner, C., Lammer, J., Willfort-Ehringer, A., Matzek, W., Gschwandtner, M., Javor, D., Funovics, M., Schoder, M., Koppensteiner, R., Loewe, C., Ristl, R. and Wolf, F. (2016) Paclitaxel-Eluting Balloon versus Standard Balloon Angioplasty in In-Stent Restenosis of the Superficial Femoral and Proximal Popliteal Artery. 1-year Results of the PACUBA Trial. JACC: Cardiovascular Interventions, 9, 1386-1392. https://doi.org/10.1016/j.jcin.2016.04.012
Muller-Hulsbek, S., Keirse, K., Zeller, T., et al. (2016) Twelve-Month Results from the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Treatment of Obstructive Femoropopliteal Disease. Journal of Endovascular Therapy, 23, 701-707. https://doi.org/10.1177/1526602816650206
Muller-Hulsbek, S., Keirse, K., Zeller, T., et al. (2017) Long-Term Results from the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Femoropopliteal Treatment: 3-Year Follow-Up. Cardiovascular and Interventional Radiology, 40, 1823-1838
Jongsma, H., van Mierlo-van den Broek, P., Imani, F., van den Heuvel, D., de Vries, J.-P. and Fioole, B. (2017) Randomized Comparison of Femoro-Popliteal Artery Drug-Eluting Balloons and Drug-Eluting-Stents (FOREST Trial): Study Protocol for a Randomised Controlled Trial. Journal of Vascular Surgery, 66, 1293-1298. https://doi.org/10.1016/j.jvs.2017.05.098
Bausback, Y., Willfort-Ehringer, A., Sievert, H., et al. (2017) Six-Month Results from the initial Randomized Study of the Ranger Paclitaxel-Coated Balloon in the Femoropopliteal Segment. Journal of Endovascular Therapy, 24, 459-467.
de Boer, S.W., van den Heuvel, D.A.F., de Vries-Werson, D.A.B., et al. (2017) Short-Term Results of the RAPID Randomized Trial of the Leg Flow Paclitaxel-Eluting Balloon with Supera Stenting vs Supera Stenting Alone for the Treatment of Intermediate and Long Superficial Femoral Artery Lesions. Journal of Endovascular Therapy, 24, 783-792.
Schroeder, H., Werner, M., Meyer, D.-R., Reimer, P., Kruger, K., Jaff, M.R., Brodman, M., et al. (2017) Low-Dose Paclitaxel-Coated Versus Uncoated Percutaneous Transluminal Balloon Angioplasty for Femoro-popliteal Peripheral Artery Disease. Circulation, 135, 2227-2236. https://doi.org/10.1161/CIRCULATIONAHA.116.026493
Gray, W.A., Keirse, K., Soga, Y., et al. (2018) A Polymer-Coated, Paclitaxel-Eluting Stent (Eluvia) versus a Polymer-Free, Paclitaxel-Coated Stent (Zilver PTX) for Endovascular Femororpopliteal Intervention (IMPERIAL): A Randomised, Non-Inferiority Trial. The Lancet, 392, 1541-1551.