Endovascular stents for intermittent claudication
- PMID: 20091540
- PMCID: PMC7144684
- DOI: 10.1002/14651858.CD003228.pub2
Endovascular stents for intermittent claudication
Abstract
Background: Endovascular stents have been suggested as a means to improve the patency of arteries after angioplasty in patients with intermittent claudication. This is an update of a Cochrane review published in 2002.
Objectives: The null hypothesis to be tested by this review is that for individuals with claudication the use of an endovascular stent, in addition to percutaneous transluminal angioplasty, does not improve symptoms of life-style limiting claudication when compared to percutaneous angioplasty alone.
Search strategy: For this update the Cochrane Peripheral Vascular Diseases Group searched their Specialised Register (last searched August 2009) and the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (last searched 2009, Issue 3).
Selection criteria: Randomised trials comparing angioplasty alone versus angioplasty with endovascular stents in patients with intermittent claudication.
Data collection and analysis: Two authors independently assessed trial quality and extracted the data. Only published trial data were used but unpublished data were sought for the update. Effectiveness was measured by the pre-defined primary outcome measures restenosis or reocclusion rates and maximum walking distance.
Main results: Two studies were included involving a total of 104 participants. Both studies included only individuals with femoro-popliteal disease. They compared angioplasty and stenting with the Palmaz stent against angioplasty alone. Although one study showed a slight statistical advantage in arterial patency after angioplasty alone, this was not found when the two studies were combined. No differences in the secondary outcomes were detected in either study.
Authors' conclusions: The small number of relevant studies identified together with the small sample sizes and methodological weaknesses severely limit the usefulness of this review in guiding practice. The results from larger multicentre trials are needed.
Conflict of interest statement
None known.
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Update of
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Endovascular stents for intermittent claudication.Cochrane Database Syst Rev. 2003;(1):CD003228. doi: 10.1002/14651858.CD003228. Cochrane Database Syst Rev. 2003. Update in: Cochrane Database Syst Rev. 2010 Jan 20;(1):CD003228. doi: 10.1002/14651858.CD003228.pub2. PMID: 12535463 Updated.
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References
References to studies included in this review
Grimm 2001 {published data only}
-
- 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. Journal of Vascular and Interventional Radiology 2001;12(8):935‐41. - PubMed
Vroegindeweij 1997 {published data only}
-
- Vroegindeweij D, Vos LD, Tielbeek AV, Buth J, Harrie CM, vd Bosch HC. Balloon angioplasty combined with primary stenting versus balloon angioplasty alone in femoropopliteal obstructions: A comparative randomized study. Cardiovascular and Interventional Radiology 1997;20(6):420‐5. - PubMed
References to studies excluded from this review
Becquemin 2003 {published data only}
-
- Becquemin JP, Favre JP, Marzelle J, Nemoz C, Corsin C, Leizorovicz A. Systematic versus selective stent placement after superficial femoral artery balloon angioplasty: a multicenter prospective randomized study. Journal of Vascular Surgery 2003;37(3):487‐94. - PubMed
Cejna 2001 {published data only}
-
- Cejna M, Thunher S, Illiasch H, Horvath W, Waldenberger P, Hornik K, et al. PTA versus Palmaz stent placement in femoropopliteal artery obstructions: a multicenter prospective randomized study. Journal of Vascular and Interventional Radiology 2001;12(1):23‐31. - PubMed
Conroy 2000 {published data only}
-
- Conroy RM, Gordon IL, Tobis JM, Hirot T, Kasaoka S, Stemmer EA, et al. Angioplasty and stent placement in chronic occlusion of the superficial femoral artery: technique and results. Journal of Vascular and Interventional Radiology 2000;11(8):1009‐20. - PubMed
Do‐dai‐Do 1992 {published data only}
-
- Do‐dai‐Do, Triller J, Walpoth BH, Stirnemann P, Mahler F. A comparison study of self‐expandable stents vs balloon angioplasty alone in femoropopliteal artery occlusions. Cardiovascular and Interventional Radiology 1992;15(5):306‐12. - PubMed
-
- Klein WM, Graaf Y, Seegers J, Spithoven JH, Buskens E, van, et al. Dutch iliac stent trial: long‐term results in patients randomized for primary or selective stent placement. Radiology 2006;238(2):734‐44. - PubMed
Dutch Trial 1998 {published data only}
-
- Bosch JL, Tetteroo E, Mali WP, Hunink MG. Iliac arterial occlusive disease: Cost effectiveness analysis of stent placement versus percutaneous transluminal angioplasty. Radiology 1998;208(3):641‐8. - PubMed
-
- Bosch JL, Graaf Y, Hunink MG. Health related quality of life after angioplasty and stent placement in patients with iliac artery occlusive disease: results of a randomized controlled clinical trial. The Dutch Iliac Stent Trial Group. Circulation 1999;99(24):3155‐60. - PubMed
-
- Kamphuis AG, Engelen AD, Tetteroo E, Hunink MG, Mali WP. Impact of different haemodynamic criteria for stent placement after suboptimal iliac angioplasty. Dutch Iliac Stent Trial Study Group. Journal of Vascular and Interventional Radiology 1999;10(6):741‐6. - PubMed
-
- Klein WM, Graaf Y, Seegers J, Spithoven JH, Buskens E, van, et al. Dutch iliac stent trial: long‐term results in patients randomized for primary or selective stent placement. Radiology 2006;238(2):734‐44. - PubMed
-
- Klein WM, van‐der Graaf Y, Seegers J, Moll FL, Mali WP. Long‐term cardiovascular morbidity, mortality, and reintervention after endovascular treatment in patients with iliac artery disease: The Dutch Iliac Stent Trial Study. Radiology 2004;232:491‐8. - PubMed
Fast 2007 {published data only}
-
- Bosiers M, Peeters P, Krankenberg H. The Femoral Artery Stenting Trial (FAST): 12‐month outcomes. Abstracts from the 2006 Vascular Annual Meeting 2006.
-
- Krankenberg H. FAST (Femoral Artery Stenting Trial): Current evidence in femoral stenting: insights from the FAST trial acute results and 6‐month outcomes. Leipzig Interventional Course; Jan 26‐28; Leipzig. 2006.
-
- Krankenberg H. FAST: No advantage to nitinol stents in short lesions. Transcatheter Cardiovascular Therapeutics; 2006 Oct 22‐27; Washington DC, USA. 2006.
-
- Krankenberg H. Randomized comparison of PTA versus femoral artery stenting (FAST): Acute results. Journal of Endovascular Therapy 2005; Vol. 12 Suppl 1:21‐2.
-
- Krankenberg H, Schluter M, Steinkamp HJ, Burgelin K, Scheinert D, Schulte KL, et al. Nitinol stent implantation versus percutaneous transluminal angioplasty in superficial femoral artery lesions up to 10 cm in length: the femoral artery stenting trial (FAST). Circulation 2007;116(3):285‐92. - PubMed
Grenacher 2004 {published data only}
-
- Grenacher L, Saam T, Geier A, Muller‐Hulsbeck S, Cejna M, Kauffmann, et al. [PTA versus Palmaz stent placement in femoropopliteal artery stenoses: results of a multicenter prospective randomized study (REFSA)]. ROFO: Fortschritte auf dem Gebiete der Rontgenstrahlen und der Nuklearmedizin 2004;176(9):1302‐10. - PubMed
Palmaz 1992 {published data only}
-
- Palmaz JC, Laborde JC, Rivera FJ, Encarnacion CE, Lutz JD, Moss JG. Stenting of the iliac arteries with the Palmaz stent: experience from a multicenter trial. Cardiovascular and Interventional Radiology 1992;15(5):291‐7. - PubMed
Richter 1991 {published data only}
-
- Richter GM, Roeren TK, Noeldge G, Landwehr P, Brambs HJ, Kauffmann GW, et al. Iliac balloon expandable stent placement versus regular PTA: Long term results of a randomized multicenter trial. Journal of Vascular and Interventional Radiology 1991;2(1):6.
Richter 1992 {published data only}
-
- Richter GM, Roeren T, Noeldge G, Landwehr P, Allenberg JJ, Kauffmann GW, et al. Prospective randomized trial: Iliac stenting versus PTA. Angiology 1992;43(3):268.
Richter 1993 {published data only}
-
- Richter GM, Roeren T, Brado M, Noeldge G. Further update of the randomized trial: iliac stent placement versus PTA ‐ Morphology, clinical success rates, and failure analysis. Journal of Vascular and Interventional Radiology 1993;4(1):30‐1.
Saxon 2008 {published data only}
-
- 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. Journal of Vascular and Interventional Radiology 2003;14(3):303‐11. - PubMed
-
- Saxon RR, Dake MD, Volgelzang RL, Katzen BT, Becker GJ. Randomized, multicenter study comparing expanded polytetrafluoroethylene‐covered endoprosthesis placement with percutaneous transluminal angioplasty in the treatment of superficial femoral artery occlusive disease. Journal of Vascular and Interventional Radiology 2008;19(6):823‐32. - PubMed
Van Rij 1991 {published data only}
-
- Van Rij, Packer SGK, Morrison N. A randomized controlled study of percutaneous angioplasty for claudicants with femoro‐popliteal disease. Journal of Cardiovascular Surgery 1991;32:34.
Vienna Absolute 2007 {published data only}
-
- Minar E, Schillinger M. Stenting vs PTA for complex femoro‐popliteal obstructions: Results from a randomized trial. Leipzig Interventional Course; 2006 Jan 26‐28; Leipzig. 2006.
-
- Sabeti S, Czerwenka‐Wenkstetten A, Dick P, Schlager O, Amighi J, Mlekusch I, et al. Quality of life after balloon angioplasty versus stent implantation in the superficial femoral artery: findings from a randomized controlled trial. Journal of Endovascular Therapy: Official Journal of the International Society of Endovascular Specialists 2007;14(4):431‐7. - PubMed
-
- Schillinger M. Long‐term SFA stenting trial results are encouraging. Vascular News 2007; Vol. 34:2‐4.
-
- Schillinger M. Vienna Absolute trial: Balloon angioplasty versus stenting in the superficial femoral artery. http://clinicaltrials.gov/ct/show/NCT00281060?order=1 [accessed Feb 09] 2006.
-
- Schillinger M, Sabeti S, Dick P, Amighi J, Mlekusch W, Schlager O, et al. Sustained benefit at 2 years of primary femoropopliteal stenting compared with balloon angioplasty with optional stenting. Circulation 2007;115(21):2745‐9. - PubMed
Zdanowski 1999 {published data only}
-
- Zdanowski Z, Albrechtsson U, Lundin A, Jonung T, Ribbe E, Thorne J, et al. Percutaneous transluminal angioplasty with or without stenting for femoropopliteal occlusions? A randomized controlled study. International Angiology 1999;18(4):251‐5. - PubMed
References to ongoing studies
Baumgartner 2007 {published data only}
-
- Baumgartner I, Amann B. The SIT‐UP Study: Swiss Investigation of the S.M.A.R.T. Nitinol Self‐Expandable Stent in Superficial Femoral Artery Occlusions Versus Balloon Angioplasty. http://clinicaltrials.gov/ct2/show/NCT00309595?term=NCT00309595&rank=1 [accessed 2 Sep 2009].
Chalmers 2007 {published data only}
-
- Chalmers N, Cowling M. SUPER UK: The Super Study ‐ Superficial Femoral Artery Stent Versus Angioplasty Study. http://clinicaltrials.gov/ct2/show/NCT00232843?term=NCT00232843&rank=1 [accessed 2 Sep 2009].
Dake 2007 {published data only}
-
- Dake M. Evaluation of the Zilver PTX Drug‐Eluting Stent in the Above‐the‐Knee Femoropopliteal Artery. www.http://clinicaltrials.gov/ct/show/NCT00120406?order=1 [accessed 2 Sep 2009].
Reekers 2007 {published data only}
-
- Reekers J. The Duravest Study: Dutch Randomised Angioplasty Versus Stent Trial for the Treatment of Superficial Femoral Artery Occlusions. http://clinicaltrials.gov/ct2/show/NCT00289055?term=NCT00289055&rank=1 [accessed 2 Sep 2009].
Additional references
Ahn 1992
Axisa 2002
Belli 1993
-
- Belli AM, Jackson JE, Allison DJ. Interventional radiological procedures. In: Clement DL, Shepherd JT editor(s). Vascular disease in the limbs. Mechanisms and principles of treatment. St. Louis: Mosby Year Book, 1993:239‐58.
Blum 1993
-
- Blum U, Gabelmann A, Redecker M, Noldge G, Dornberg W, Grosser G, et al. Percutaneous recanalization of iliac artery occlusions: results of a prospective study. Radiology 1993;189(2):536‐40. - PubMed
Cochrane 2008
-
- Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1 [updated September 2008]. The Cochrane Collaboration, 2008. Available from www.cochrane‐handbook.org.
Dewhurst 1991
-
- Dewhurst G, Wood DA, Walker F, Lampe FC, Jeffreys M, Cooper M, et al. A population survey of cardiovascular disease in elderly people: design, methods and prevalence results. Age and Ageing 1991;20(5):353‐60. - PubMed
Dotter 1989
-
- Dotter CT, Judkins MP. Transluminal treatment of arteriosclerotic obstruction. Description of a new technic and a preliminary report of its application. Radiology 1989;172(3 part 2):904‐20. - PubMed
el‐Bayar 1992
-
- el‐Bayar H, Roberts A, Hye R, Davis G, Freischlag J. Determinants of failure in superficial femoral artery angioplasty. Angiology 1992;43(11):877‐85. - PubMed
Fowkes 1991
-
- Fowkes FG, Housley E, Cawood EH, Macintyre CC, Ruckley CV, Prescott RJ. Edinburgh Artery Study: prevalence of asymptomatic and symptomatic peripheral arterial disease in the general population. International Journal of Epidemiology 1991;20(2):384‐92. - PubMed
Hughson 1978
Leng 1992
-
- Leng GC, Fowkes FG. The Edinburgh claudication questionnaire: An improved version of the WHO/Rose questionnaire for use in epidemiological surveys. Journal of Clinical Epidemiology 1992;45(10):1101‐9. - PubMed
Leng 1996
-
- Leng GC, Lee AJ, Fowkes FG, Whiteman M, Dunbar J, Housley E, et al. Incidence, natural history and cardiovascular events in symptomatic and asymptomatic peripheral arterial disease in the general population. International Journal of Epidemiology 1996;25:1172‐81. - PubMed
O'Keeffe 1991
-
- O`Keeffe ST, Woods BO, Beckmann CF. Percutaneous transluminal angioplasty of the peripheral arteries. In: Breslin DJ editor(s). Cardiology Clinics. Peripheral Vascular Disease in the Elderly. Philadelphia: Saunders, 1991:519‐21. - PubMed
Price 1996
-
- Price JF, Fowkes FGR. Effectiveness of percutaneous angioplasty for lower limb atherosclerosis. In: Greenhalgh RM, Fowkes FGR editor(s). Trials and tribulations in vascular surgery. London: WB Saunders, 1996.
PVD Group 2009
-
- Fowkes FGR, Fletcher J, Hiatt WR, Kleijnen J, Leng GC, Maxwell H, Middeldorp S, Moneta G, Price JF, Prins MH, Stansby G, Tisi P, Wakefield TW, Watson L, Welch K. Cochrane Peripheral Vascular Diseases Group. About The Cochrane Collaboration (Cochrane Review Groups (CRGs)). 2009, Issue 3. Art. No.: PVD.
Schwarzenberg 1998
-
- Schwarzenberg H, Muller‐Hulsbeck S, Gluer CC, Wesner F, Heller M. Restenosis of peripheral stents and stent grafts as revealed by intravascular sonography: in vivo comparison with angiography. American Journal of Roentgenology 1998;170(5):1181‐5. - PubMed
SIGN 2006
-
- Diagnosis and management of peripheral arterial disease. A national clinical guideline. No. 89. Scottish Intercollegiate Guidelines Network (SIGN) October 2006.
Tegtmeyer 1991
-
- Tegtmeyer CJ, Hartwell GD, Selby JB, Robertson R Jr, Kron IL, Tribble CG. Results and complications of angioplasty in aortoiliac disease. Circulation 1991;83(2 Suppl):153‐60. - PubMed
Vorwerk 1995
-
- Vorwerk D, Gunther RW, Schurmann K, Wendt G, Peters I. Primary stent placement for chronic iliac artery occlusions: follow‐up results in 103 patients. Radiology 1995;194(3):745‐49. - PubMed
Ware 1993
-
- Ware JE, Snow KK, Kosinski M, Gandek B. SF‐36 Health survey manual interpretation guide. New England Medical Center, Health Institute, Boston MA 1993.
Whyman 1996
-
- Whyman MR, Fowkes FG, Kerracher EM, Gillespie IN, Lee AJ, Housley E, et al. Randomised controlled trial of percutaneous transluminal angioplasty for intermittent claudication. European Journal of Vascular and Endovascular Surgery 1996;12(2):167‐72. - PubMed
References to other published versions of this review
Cochrane 2003
-
- Bachoo P, Thorpe PA. Endovascular stents for intermittent claudication.. Cochrane Database of Systematic Reviews 2003, Issue Issue 1 . Art. No.: CD003228. DOI: 10.1002/14651858.CD003228. - PubMed
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