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01-04-2017 | Review Article

How should recent endovascular trials for femoropopliteal artery disease be interpreted?

Author: Yoshiaki Yokoi

Published in: Cardiovascular Intervention and Therapeutics | Issue 2/2017

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Abstract

Most cases of femoral–popliteal disease require aggressive medical treatment, but patients with severe lifestyle-limiting symptoms and limb-threatening disease are increasingly receiving endovascular treatment. The femoropopliteal artery is the longest vessel in the thigh and the unique physical forces involved in this vessel are considered to cause high rates of restenosis and stent fracture. Endovascular therapy for superficial artery (SFA) disease is still a challenge in terms of long-term patency and clinical effectiveness. The purpose of this brief review is to reexamine previously published key trials in order to identify and compare the differences of each study. Discussion of how to interpret the results of these studies is vital for the incorporation of the data into actual real-life cases.
Literature
2.
go back to reference Rooke TW, Hirsch AT, 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. J Am Coll Cardiol. 2011;58(19):2020–45.CrossRefPubMed Rooke TW, Hirsch AT, 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. J Am Coll Cardiol. 2011;58(19):2020–45.CrossRefPubMed
3.
go back to reference ) Norgren L, Hiatt WR, Dormandy JA, et al. Inter-society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg. 2007;45 Suppl S:S5–S67. ) Norgren L, Hiatt WR, Dormandy JA, et al. Inter-society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg. 2007;45 Suppl S:S5–S67.
4.
go back to reference Cheng CP, Wilson NM, Hallett RL, Herfkens RJ, Taylor CA. In vivo MR angiographic quantification of axial and twisting deformations of the superficial femoral artery resulting from maximum hip and knee flexion. J Vasc Interv Radiol. 2006;17(6):979–87.CrossRefPubMed Cheng CP, Wilson NM, Hallett RL, Herfkens RJ, Taylor CA. In vivo MR angiographic quantification of axial and twisting deformations of the superficial femoral artery resulting from maximum hip and knee flexion. J Vasc Interv Radiol. 2006;17(6):979–87.CrossRefPubMed
5.
go back to reference Schienert D, Schienert S, Sax J, et al. Prevalence and clinical impact of stent fractures after femoropopliteal stenting. J Am Coll Cardiol. 2005;45(2):312–5.CrossRef Schienert D, Schienert S, Sax J, et al. Prevalence and clinical impact of stent fractures after femoropopliteal stenting. J Am Coll Cardiol. 2005;45(2):312–5.CrossRef
6.
go back to reference Schillinger M, Exner M, Mlekusch W, et al. Inflammatory response to stent implantation: differences in femoropopliteal, iliac, and carotid arteries. Radiology. 2002;224(2):529–35.CrossRefPubMed Schillinger M, Exner M, Mlekusch W, et al. Inflammatory response to stent implantation: differences in femoropopliteal, iliac, and carotid arteries. Radiology. 2002;224(2):529–35.CrossRefPubMed
7.
go back to reference Schillinger M, Sabeti S, Loewe C, Dick P, Amighi J, Mlekusch W, Schlager O, Cejna M, Lammer J, Minar E. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006;354:1879–88.CrossRefPubMed Schillinger M, Sabeti S, Loewe C, Dick P, Amighi J, Mlekusch W, Schlager O, Cejna M, Lammer J, Minar E. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006;354:1879–88.CrossRefPubMed
8.
go back to reference Schillinger M, Sabeti S, Dick P, Amighi J, Mlekusch W, Schlager O, Loewe C, Cejna M, Lammer J, Minar E. Sustained benefit a 2 years of primary femoropopliteal stenting compared with balloon angioplasty with optional stenting. Circulation. 2007;115:2745–9.CrossRefPubMed Schillinger M, Sabeti S, Dick P, Amighi J, Mlekusch W, Schlager O, Loewe C, Cejna M, Lammer J, Minar E. Sustained benefit a 2 years of primary femoropopliteal stenting compared with balloon angioplasty with optional stenting. Circulation. 2007;115:2745–9.CrossRefPubMed
9.
go back to reference Schlager O, Dick P, Sabeti S, Amighi J, Miekusch W, Minar E, Schillinger M. Long-segment SFA stenting—the dark sides: in-stent restenosis, clinical deterioration, and stent fractures. J Endovasc Ther. 2005;12:676–84.CrossRefPubMed Schlager O, Dick P, Sabeti S, Amighi J, Miekusch W, Minar E, Schillinger M. Long-segment SFA stenting—the dark sides: in-stent restenosis, clinical deterioration, and stent fractures. J Endovasc Ther. 2005;12:676–84.CrossRefPubMed
10.
go back to reference Laird J, Katzen BT, Scheinert D, et al. RESILIENT Investigators. 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. Laird J, Katzen BT, Scheinert D, et al. RESILIENT Investigators. 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.
11.
go back to reference 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;1:1–9.CrossRef 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;1:1–9.CrossRef
12.
go back to reference Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002;346(23):1773–80.CrossRefPubMed Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002;346(23):1773–80.CrossRefPubMed
13.
go back to reference Duda SH, Pusich B, Richter G, Landwehr P, Oliva VL, Tielbeek A, Wiesinger B, Hak JB, Tielemans H, Ziemer G, Cristea E, Lansky A, Bérégi JP. Sirolimus-eluting stents for the treatment of obstructive superficial femoral artery disease: six-month results. Circulation. 2002;106(12):1505–9.CrossRefPubMed Duda SH, Pusich B, Richter G, Landwehr P, Oliva VL, Tielbeek A, Wiesinger B, Hak JB, Tielemans H, Ziemer G, Cristea E, Lansky A, Bérégi JP. Sirolimus-eluting stents for the treatment of obstructive superficial femoral artery disease: six-month results. Circulation. 2002;106(12):1505–9.CrossRefPubMed
14.
go back to reference Duda SH, Bosiers M, Lammer J, Scheinert D, Zeller T, Oliva V, et al. Drug-eluting and bare nitinol stents for the treatment of atherosclerotic lesions in the superficial femoral artery: long-term results from the SIROCCO trial. J Endovasc Ther. 2006;13:701–10.CrossRefPubMed Duda SH, Bosiers M, Lammer J, Scheinert D, Zeller T, Oliva V, et al. Drug-eluting and bare nitinol stents for the treatment of atherosclerotic lesions in the superficial femoral artery: long-term results from the SIROCCO trial. J Endovasc Ther. 2006;13:701–10.CrossRefPubMed
15.
go back to reference Dake MD, Ansel GM, Jaff MR, et al., For the Zilver PTX Investigators. Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: twelvemonth Zilver PTX randomized study results. Circ Cardiovasc Interv 2011;4:495–504. Dake MD, Ansel GM, Jaff MR, et al., For the Zilver PTX Investigators. Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: twelvemonth Zilver PTX randomized study results. Circ Cardiovasc Interv 2011;4:495–504.
16.
17.
go back to reference Iida O, Takahara M, Soga Y, et al., For the ZEPHYR Investigators. 1-year results of the ZEPHYR registry (Zilver PTX for the femoral artery and proximal popliteal artery): predictors of restenosis. J Am Coll Cardiol Interv 2015;8:1105–12. Iida O, Takahara M, Soga Y, et al., For the ZEPHYR Investigators. 1-year results of the ZEPHYR registry (Zilver PTX for the femoral artery and proximal popliteal artery): predictors of restenosis. J Am Coll Cardiol Interv 2015;8:1105–12.
18.
go back to reference Hwang CW, Wu D, Edelman ER. Physiological transport forces govern drug distribution for stentbased delivery. Circulation. 2001;104:600–5.CrossRefPubMed Hwang CW, Wu D, Edelman ER. Physiological transport forces govern drug distribution for stentbased delivery. Circulation. 2001;104:600–5.CrossRefPubMed
20.
go back to reference Cassese S, Byrne RA, Ott I, et al. Paclitaxelcoated versus uncoated balloon angioplasty reduces target lesion revascularization in patients with femoropopliteal arterial disease: a metaanalysis of randomized trials. Circ Cardiovasc Interv. 2012;5:582–9.CrossRefPubMed Cassese S, Byrne RA, Ott I, et al. Paclitaxelcoated versus uncoated balloon angioplasty reduces target lesion revascularization in patients with femoropopliteal arterial disease: a metaanalysis of randomized trials. Circ Cardiovasc Interv. 2012;5:582–9.CrossRefPubMed
21.
go back to reference Schroeder H, Meyer DR, Lux B, Ruecker F, Martorana M, Duda S. 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.CrossRefPubMed Schroeder H, Meyer DR, Lux B, Ruecker F, Martorana M, Duda S. 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.CrossRefPubMed
22.
go back to reference Rosenfield K, Jaff MR, White CJ, LEVANT 2 Investigators, et al. Trial of a paclitaxel-coated balloon for femoropopliteal artery disease. N Engl J Med. 2015;373(2):145–53.CrossRefPubMed Rosenfield K, Jaff MR, White CJ, LEVANT 2 Investigators, et al. Trial of a paclitaxel-coated balloon for femoropopliteal artery disease. N Engl J Med. 2015;373(2):145–53.CrossRefPubMed
23.
go back to reference Tepe G, Laird J, Schneider P, IN.PACT SFA Trial Investigators, 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(5):495–502.CrossRefPubMedPubMedCentral Tepe G, Laird J, Schneider P, IN.PACT SFA Trial Investigators, 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(5):495–502.CrossRefPubMedPubMedCentral
24.
go back to reference European Stroke Organisation, Tendera M, Aboyans V, et al. ESC Committee for Practice Guidelines. ESC Guidelines on the diagnosis and treatment of peripheral artery diseases: document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries: the task force on the diagnosis and treatment of peripheral artery diseases of the European Society of Cardiology (ESC). Eur Heart J. 2011;32(22):2851–906.CrossRef European Stroke Organisation, Tendera M, Aboyans V, et al. ESC Committee for Practice Guidelines. ESC Guidelines on the diagnosis and treatment of peripheral artery diseases: document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries: the task force on the diagnosis and treatment of peripheral artery diseases of the European Society of Cardiology (ESC). Eur Heart J. 2011;32(22):2851–906.CrossRef
25.
go back to reference Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwälder U, Beregi JP, Claussen CD, Oldenburg A, Scheller B, Speck U. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. 2008;358:689–99.CrossRefPubMed Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwälder U, Beregi JP, Claussen CD, Oldenburg A, Scheller B, Speck U. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. 2008;358:689–99.CrossRefPubMed
26.
go back to reference 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. J Am Coll Cardiol Intv. 2015;8:102–8.CrossRef 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. J Am Coll Cardiol Intv. 2015;8:102–8.CrossRef
27.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
28.
go back to reference Rocha-Singh KJ, Jaff MR, Crabtree TR, et al. Performance goals and endpoint assessments for clinical trials of femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease. Catheter Cardiovasc Interv. 2007;69:910–9.CrossRefPubMed Rocha-Singh KJ, Jaff MR, Crabtree TR, et al. Performance goals and endpoint assessments for clinical trials of femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease. Catheter Cardiovasc Interv. 2007;69:910–9.CrossRefPubMed
Metadata
Title
How should recent endovascular trials for femoropopliteal artery disease be interpreted?
Author
Yoshiaki Yokoi
Publication date
01-04-2017
Publisher
Springer Japan
Published in
Cardiovascular Intervention and Therapeutics / Issue 2/2017
Print ISSN: 1868-4300
Electronic ISSN: 1868-4297
DOI
https://doi.org/10.1007/s12928-017-0463-z