Atherectomy for peripheral arterial disease

Cochrane Database of Systematic Reviews

Volumn 2020, Issue 9, 2020, Pages

  Wardle, Bethany G ^a   Ambler, Graeme K ^a,c   Radwan, Rami W ^b   Hinchliffe, Robert J ^a,c   Twine, Christopher P ^a,c  

^a NORTH BRISTOL NHS TRUST   (United Kingdom)

^b CARDIFF UNIVERSITY   (United Kingdom)

^c UNIVERSITY OF BRISTOL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ACUTE CORONARY SYNDROME; ALL CAUSE MORTALITY; ARTICLE; ATHERECTOMY; CAUSE OF DEATH; CLAUDICATION; CLINICAL EFFECTIVENESS; CLINICAL OUTCOME; CRITICAL LIMB ISCHEMIA; EVIDENCE BASED MEDICINE; HEART FAILURE; HUMAN; MORTALITY RATE; PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY; PERIPHERAL OCCLUSIVE ARTERY DISEASE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); SYSTEMATIC REVIEW; TARGET VESSEL REVASCULARIZATION; VASCULAR PATENCY; META ANALYSIS; MORTALITY; PROCEDURES; STENT;

ACUTE CORONARY SYNDROME; ANGIOPLASTY, BALLOON; ATHERECTOMY; CAUSE OF DEATH; HEART FAILURE; HUMANS; PERIPHERAL ARTERIAL DISEASE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; STENTS;

EID: 85091768256     PISSN: 14651858     EISSN: None     Source Type: Journal    
DOI: 10.1002/14651858.CD006680.pub3     Document Type: Article

References (80)

1. Dattilo R, Himmelstein SI, Cuff RF. The COMPLIANCE 360 trial: a randomized, prospective, multicenter, pilot study comparing acute and long-term results of orbital atherectomy to balloon angioplasty for calcified femoropopliteal disease. Journal of Invasive Cardiology 2014;26(8):355-60. x-wiley/crsRef/14641225
2. Nakamura S, Conroy RM, Gordon IL, Deutsch LS, Maheswaran B, Antone CS, et al. A randomized trial of transcutaneous extraction atherectomy in femoral arteries: intravascular ultrasound observations. Journal of Clinical Ultrasound 1995;23(8):461-71. x-wiley/crsRef/3069220
3. NCT00986752. Efficacy study of stenting, paclitaxel eluting balloon or atherectomy to treat peripheral artery disease (ISAR-STATH). clinicaltrials.gov/show/NCT00986752 (first posted 30 September 2009). x-wiley/crsRef/14641227
4. Ott I, Cassese S, Groha P, Steppich B, Hadamitzky M, Ibrahim T, et al. Randomized comparison of Paclitaxel-eluting balloon and stenting versus plain balloon plus stenting versus directional atherectomy for femoral artery disease (ISAR-STATH). Circulation 2017;135(23):2218-26. x-wiley/crsRef/14641228
5. Coiner D, Dippel E, Jerin M, Shammas G, Shammas N. Percutaneous lower extremity arterial interventions using balloon angioplasty versus silverhawk atherectomy: results of the SMARTHAWK randomized trial. Catheterization and Cardiovascular Interventions 2009;73:S21. x-wiley/crsRef/3069222
6. Coiner D, Dippel E, Jerin M, Shammas G, Shammas N. Walking impairment questionnaire, ankle-brachial index and Rutherford-Baker class in patients undergoing angioplasty versus Silverhawk atherectomy: results from the smarthawk randomized trial. Catheterization and Cardiovascular Interventions 2009;73:S42. x-wiley/crsRef/3069223
7. Shammas NW, Coiner D, Shammas G, Jerin M. Predictors of provisional stenting in patients undergoing lower extremity arterial interventions. International Journal of Angiology 2011;20(2):95-100. x-wiley/crsRef/3069224
8. Shammas NW, Coiner D, Shammas GA, Dippel EJ, Christensen L, Jerin M. Percutaneous lower-extremity arterial interventions with primary balloon angioplasty versus Silverhawk atherectomy and adjunctive balloon angioplasty: randomized trial. Journal of Vascular and Interventional Radiology 2011;22(9):1223-8. x-wiley/crsRef/3069225
9. Shammas NW, Lam R, Mustapha J, Ellichman J, Aggarwala G, Rivera E, et al. Comparison of orbital atherectomy plus balloon angioplasty vs. balloon angioplasty alone in patients with critical limb ischemia: results of the calcium 360 randomized pilot trial. Journal of Endovascular Therapy 2012;19(4):480-8. x-wiley/crsRef/3069227
10. Shammas NW, Lam R, Mustapha J, Ellichman J, Aggarwala G, Rivera E. Orbital atherectomy and balloon angioplasty vs. balloon angioplasty alone in critical limb ischemia: results of the CALCIUM 360 trial. Journal of Vascular and Interventional Radiology 2013;24(1):145.e2-3. x-wiley/crsRef/3069228
11. Shammas NWM. Six-month outcomes of prospective, randomized CALCIUM 360 study demonstrate the advantages of plaque modification with the orbital technology versus treatment with balloon angioplasty in patients with critical limb ischemia. Journal of the American College of Cardiology 2011;58(20 Suppl 1):B154. x-wiley/crsRef/3069229
12. 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. Journal of Vascular and Interventional Radiology 1996;7(6):837-44. x-wiley/crsRef/3069231
13. Tielbeek AV, Vroegindeweij D, Buth J, Schol FP, Mali WP. Comparison of intravascular ultrasonography and intraarterial digital subtraction angiography after directional atherectomy of short lesions in femoropopliteal arteries. Journal of Vascular Surgery 1996;23(3):436-45. x-wiley/crsRef/3069232
14. Vroegindeweij D, Kemper FJ, Tielbeek AV, Buth J, Landman G. Recurrence of stenoses following balloon angioplasty and Simpson atherectomy of the femoro-popliteal segment. A randomised comparative 1-year follow-up study using colour flow duplex. European Journal of Vascular Surgery 1992;6(2):164-71. x-wiley/crsRef/3069233
15. Vroegindeweij D, Kemper FJ, Tielbeek AV, Landman G, Buth J. Recurrence of stenoses following balloon angioplasty and atherectomy of the femoropopliteal segment. A randomized comparative one year follow-up study using color flow duplex. In: European Society for Vascular Surgery 5th Annual Meeting. Warsaw, Poland, 1991:72. x-wiley/crsRef/3069234
16. Vroegindeweij D, Tielbeek AV, Buth J, Schol FP, Hop WC, Landman GH. Directional atherectomy versus balloon angioplasty in segmental femoropopliteal artery disease: two-year follow-up with color-flow duplex scanning. Journal of Vascular Surgery 1995;21(2):255-68; discussion 268-9. x-wiley/crsRef/3069235
17. NCT01366482. Atherectomy followed by a drug coated balloon to treat peripheral arterial disease (DEFINITIVE AR). clinicaltrials.gov/show/NCT01366482 (first posted 6 June 2011). x-wiley/crsRef/14641230
18. Zeller T, Langhoff R, Rocha-Singh KJ, Jaff MR, Blessing E, Amann-Vesti B, et al. Directional atherectomy followed by a Paclitaxel-coated balloon to inhibit restenosis and maintain vessel patency: twelve-month results of the DEFINITIVE AR Study. Circulation: Cardiovascular Interventions 2017;10(9):e004848. x-wiley/crsRef/14641231 [DOI: 10.1161/circinterventions.116.004848]
19. Brodmann M, Rief P, Froehlich H, Dorr A, Gary T, Eller P, et al. Neointimal hyperplasia after Silverhawk atherectomy versus percutaneous transluminal angioplasty (PTA) in femoropopliteal stent reobstructions: a controlled, randomized pilot trial. Cardiovascular and Interventional Radiology 2013;36(1):69-74. x-wiley/crsRef/3069237
20. Del Giudice C. Synergistic strategy of laser atherectomy and drug-eluting balloon angioplasty for treatment of in-stent restenosis in the superficial femoral artery: a randomised study. In: EuroPCR Abstracts and Posters. 2014. x-wiley/crsRef/14641233 [DOI: 10.1007/978-1-4471-5220-0_14]
21. Dippel EJ, Makam P, Kovach R, George JC, Patlola R, Metzger DC, et al. Randomized controlled study of excimer laser atherectomy for treatment of femoropopliteal in-stent restenosis: Initial results from the EXCITE ISR Trial (EXCImer laser randomized controlled study for treatment of FemoropopliTEal in-stent restenosis). JACC: Cardiovascular Interventions 2015;8(1):95-101. x-wiley/crsRef/14641235
22. Dippel EJ, Makam P, Kovach RC, George JC, Patlola RR, Metzger DC, et al. Excite ISR: a prospective, randomized controlled trial of excimer laser atherectomy vs balloon angioplasty for the treatment of femoropopliteal in-stent restenosis. Journal of the American College of Cardiology 2014;64(11 suppl 1):B155. x-wiley/crsRef/14641236
23. Gabrielli R, Rosati MS, Vitale S, Baciarello G, Siani A, et al. Randomized controlled trial of remote endarterectomy versus endovascular intervention for TransAtlantic Inter-Society Consensus II D femoropopliteal lesions. Journal of Vascular Surgery 2012;56(6):1598-605. x-wiley/crsRef/3069239
24. 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. Journal of Endovascular Therapy 2013;20:805-14. x-wiley/crsRef/14641238
25. Gisbertz SS, Ramzan M, Tutein Nolthenius RP, van der Laan L, Overtoom TT, Moll FL, et al. Short-term results of a randomized trial comparing remote endarterectomy and supragenicular bypass surgery for long occlusions of the superficial femoral artery (the REVAS Trial). European Journal of Vascular and Endovascular Surgery 2009;37(1):68-76. x-wiley/crsRef/3069241
26. Gisbertz SS, Tutein Nolthenius RP, de Borst GJ, van der Laan L, Overtoom TT, Moll FL, et al. Remote endarterectomy versus supragenicular bypass surgery for long occlusions of the superficial femoral artery: medium-term results of a randomized controlled trial (the REVAS trial). Annals of Vascular Surgery 2010;24(8):1015-23. x-wiley/crsRef/3069242
27. NCT02730234. JetStream atherectomy for the treatment of in-stent restenosis (JET-ISR). clinicaltrials.gov/show/NCT02730234 (first received 6 April 2016). x-wiley/crsRef/14641240
28. NCT02832024. Clinical study of stent versus direct atherectomy versus angioplasty to treat lower limb in-stent restenosis. clinicaltrials.gov/ct2/show/NCT02832024 (first received 13 July 2016). x-wiley/crsRef/14641242
29. Schwindt AG, Bennett JG Jr, Crowder WH, Dohad S, Janzer SF, George JC, et al. Lower extremity revascularization using optical coherence tomography-guided directional atherectomy: final results of the evaluatIon of the pantheris optIcal coherence tomography imaging atherectomy system for use in the peripheral vasculature (VISION) Study. Journal of Endovascular Therapy 2017;24(3):355-66. x-wiley/crsRef/14641244
30. ChiCTR-IOR-17012486x. Drug-coated balloon versus drug-coated balloon with atherectomy for the treatment of femoral-popliteal calcified occlusive disease: a randomized, controlled and prospective study. www.chictr.org.cn/showprojen.aspx?proj=21256 (first received 28 August 2017). x-wiley/crsRef/14641246
31. Martinsen BJ, Weber SA, Pietzsch ML, Behrens A, Weatherspoon M, Igyarto Z, et al. Economic study design for the optimize study on orbital atherectomy and drug-coated balloon devices for the treatment of below-the-knee peripheral arterial disease. Value in Health 2015;18(7):A723. x-wiley/crsRef/14641248
32. NCT01579123. Laser atherectomy versus angioplasty for the treatment of critical limb ischemia. clinicaltrials.gov/ct2/show/NCT01579123 (first received 17 April 2012). x-wiley/crsRef/3069244
33. NCT01763476. Atherectomy and drug-coated balloon angioplasty in treatment of long infrapopliteal lesions. clinicaltrials.gov/ct2/show/NCT01763476 (first received 9 January 2013). x-wiley/crsRef/14641250
34. NCT02514460. Clinical study of stent versus direct atherectomy to treat lower limb ischemia. clinicaltrials.gov/ct2/show/NCT02514460 (first received 3 August 2015). x-wiley/crsRef/14641252
35. NCT02517827. Percutaneous intervention versus surgery in the treatment of common femoral artery lesions. clinicaltrials.gov/ct2/show/NCT02517827 (first received 7 August 2015). x-wiley/crsRef/14641254
36. NCT02561299. Orbital vessel preparation to maximize dcb efficacy in calcified below the knee (BTK) lesions - a pilot study. clinicaltrials.gov/ct2/show/NCT02561299 (first received 28 September 2015). x-wiley/crsRef/14641256
37. NCT02840786. Clinical study of stent versus direct atherectomy to treat arteriosclerosis occlusive disease of lower extremity. clinicaltrials.gov/ct2/show/NCT02840786 (first received 26 July 2016). x-wiley/crsRef/14641258
38. NCT03206762. JET-RANGER Trial - JETStream atherectomy with adjunctive Paclitaxel-coated balloon angioplasty vs plain old balloon angioplasty followed by Paclitaxel-coated balloon. clinicaltrials.gov/ct2/show/NCT03206762 (first received 2 July 2017). x-wiley/crsRef/14641260
39. NCT03380650. Study of DA+LDD in the treatment of femoropopliteal occlusive disease. clinicaltrials.gov/ct2/show/NCT03380650 (first received 21 December 2017). x-wiley/crsRef/14641262
40. NCT03495453. Directional versus orbital atherectomy plaque modification and luminal area assessment of the femoro-popliteal artery via intravascular ultrasound. clinicaltrials.gov/ct2/show/NCT03495453 (first received 12 April 2018). x-wiley/crsRef/14641264
41. Abdel-Wahab M, Richardt G, Joachim Buttner H, Toelg R, Geist V, Meinertz T, et al. High-speed rotational atherectomy before paclitaxel-eluting stent implantation in complex calcified coronary lesions: the randomized ROTAXUS (Rotational Atherectomy Prior to Taxus Stent Treatment for Complex Native Coronary Artery Disease) trial. ACC Cardiovascular Intervention January 2013;6:10-9.
42. Akkus NI, Abdulbaki A, Jimenez E, Tandon N. Atherectomy devices: technology update. Med Devices (Auckl) 2014;8:1-10. [DOI: 10.2147/MDER.S50594]
43. Briguori C, DiMario C, Colombo A. Distal embolization during directional coronary atherectomy. Journal of Invasive Cardiology 2003;15(8):448-50.
44. Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, et al, Zilver PTX Investigators. Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: twelve-month Zilver PTX randomized study results. Circulation. Cardiovascular Interventions 2011;4(5):495-504.
45. DerSimonian R, Laird N. Meta-analysis in clinical trials. Controlled Clinical Trials 1986;7(3):177-88.
46. Reifart N, Vandormael M, Krajcar M, Göhring S, Preusler W, Schwarz F, et al. Randomized comparison of angioplasty of complex coronary lesions at a single center. Excimer Laser, Rotational Atherectomy, and Balloon Angioplasty Comparison (ERBAC) Study. Circulation 1997;96(1):91-8.
47. European Consensus. European consensus on critical limb ischaemia. Lancet 1989;333(8640):737-8.
48. Fowkes G, Gillespie IN. Angioplasty (versus non surgical management) for intermittent claudication. Cochrane Database of Systematic Reviews 1998, Issue 2. Art. No: CD000017. [DOI: 10.1002/14651858.CD000017]
49. Fowkes F, Leng GC. Bypass surgery for chronic lower limb ischaemia. Cochrane Database of Systematic Reviews 2008, Issue 2. Art. No: CD002000. [DOI: 10.1002/14651858.CD002000.pub2]
50. Frans FA, Bipat S, Reekers JA, Legemate DA, Koelemay MJ. Systematic review of exercise training or percutaneous transluminal angioplasty for intermittent claudication. British Journal of Surgery 2012;99(1):16-28.
51. Fu X, Zhang Z, Liang K, Shi S, Wang G, Zhang K, et al. Angioplasty versus bypass surgery in patients with critical limb ischemia: a meta-analysis. International Journal of Clinical and Experimental Medicine 2015;8:10595-602.
52. Garcia LA, Lyden SP. Atherectomy for infrainguinal peripheral artery disease. Journal of Endovascular Therapy 2009;16(2 Suppl 2):II105-15.
53. Guyatt GH, Oxman AD, Kunz R, Vist GE, Falck-Ytter Y, Schunemann HJ. What is "quality of evidence" and why is it important to clinicians? BMJ 2008;336:995-8.
54. Heuser RR. Treatment of lower extremity vascular disease: the Diamondback 360 degrees Orbital Atherectomy System. Expert Review of Medical Devices 2008;5(3):279-86.
55. Higgins JP, Green S, editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from handbook.cochrane.org.
56. Indes JE, Shah HJ, Jonker FH, Ohki T, Veith FJ, Lipsitz EC. Subintimal angioplasty is superior to SilverHawk atherectomy for the treatment of occlusive lesions of the lower extremities. Journal of Endovascular Therapy 2010;17(2):243-50.
57. Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, Karnabatidis D. Risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the leg: a systematic review and meta-analysis of randomized controlled trials. Journal of American Heart Association 2018;7(24):e011245.
58. Kayssi A, Al-Atassi T, Oreopoulos G, Roche-Nagle G, Tan KT, Rajan DK. Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs. Cochrane Database of Systematic Reviews 2016, Issue 8. Art. No: CD011319. [DOI: 10.1002/14651858.CD011319.pub2]
59. Kim TH, Katsetos M, Dahal K, Azrin M, Lee J. Use of rotational atherectomy for reducing significant dissection in treating de novo femoropopliteal steno-occlusive disease after balloon angioplasty. Journal of Geriatric Cardiology 2018;15:254-60.
60. Laird JR, Katzen BT, Scheinert D, Lammer J, Carpenter J, Buchbinder M, et al, on behalf of the 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. Circulation. Cardiovascular Interventions 2010;3(3):267-76.
61. Lee M, Genereux P, Shlofmitz R, Phillipson D, Anose BM, Martinsen BJ, et al. Orbital atherectomy for treating de novo, severely calcified coronary lesions: 3-year results of the pivotal ORBIT II trial. Cardiovascular Revascularization Medicine 2017;18:261-4.
62. Lefebvre C, Manheimer E, Glanville J. Chapter 6: Searching for studies. In: Higgins JP, Green S, editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration. Available from handbook.cochrane.org.
63. McKinsey JF, Goldstein L, Khan HU, Graham A, Rezeyat C, Morrissey NJ, et al. Novel treatment of patients with lower extremity ischemia: use of percutaneous atherectomy in 579 lesions. Annals of Surgery 2008;248(4):519-28.
64. Murphy TP, Cutlip DE, Regensteiner JG, Mohler ER, Cohen DJ, Reynolds MR, et al. Supervised exercise, stent revascularization, or medical therapy for claudication due to aortoiliac peripheral artery disease: a randomized clinical trial. Journal of the American College of Cardiology 2015;65:999-1009.
65. National Institute for Health and Care Excellence. Percutaneous atherectomy of femoropopliteal arterial lesions with plaque excision devices [IPG380]. Available at: www.nice.org.uk/guidance/IPG380 2011.
66. Ramkumar N, Martinez-Camblor P, Columbo JA, Osborne NH, Goodney PP, O'Malley AJ. Adverse events after atherectomy: analyzing long-term outcomes of endovascular lower extremity revascularization techniques. Journal of the American Heart Association 2019;8(12):e012081.
67. Rerkasem K, Rothwell PM. Meta-analysis of small randomised controlled trials in surgery may be unreliable. British Journal of Surgery 2010;97(4):466-9.
68. Nordic Cochrane Centre, The Cochrane Collaboration Review Manager 5 (RevMan 5). Version 5.3. Copenhagen: Nordic Cochrane Centre, The Cochrane Collaboration, 2014.
69. Robertson L, Ghouri MA, Kovacs F. Antiplatelet and anticoagulant drugs for prevention of restenosis/reocclusion following peripheral endovascular treatment. Cochrane Database of Systematic Reviews 2012, Issue 8. Art. No: CD002071. [DOI: 10.1002/14651858.CD002071.pub3]
70. Schillinger M, Sabeti S, Loewe C, Dick P, Amighi J, Mlekusch W, et al. Balloon angioplasty versus implantation of Nitinol stents in the superficial femoral artery. New England Journal of Medicine 2006;354(18):1879-88.
71. Schroeder H, Werner M, Meyer DR, Reimer P, Kruger K, Jaff MR, et al. Low-dose Paclitaxel-coated versus uncoated percutaneous transluminal balloon angioplasty for femoropopliteal peripheral artery disease: one-year results of the ILLUMENATE European randomized clinical trial (randomized trial of a novel paclitaxel-coated percutaneous angioplasty balloon). Circulation 2017;135:2227-36.
72. Schwarzwälder U, Zeller T. Debulking procedures: potential device specific indications. Techniques in Vascular Interventional Radiology 2010;13(1):43-53.
73. Simpson JB, Selmon MR, Robertson GC, Cipriano PR, Hayden WG, Johnson DE, et al. Transluminal atherectomy for occlusive peripheral vascular disease. American Journal of Cardiology 1988;16(14):96G-101G.
74. Spreen MI, Martens JM, Knippenberg B, van Dijk LC, de Vries JPM, Vos JA, et al. Long-term follow-up of the PADI trial: percutaneous transluminal angioplasty versus drug-eluting stents for infrapopliteal lesions in critical limb ischemia. Journal of the American Heart Association 2017;6(4):e004877.
75. Stack RS, Califf RM, Phillips HR, Pryor DB, Quigley PJ, Bauman RP, et al. Interventional Cardiac Catheterization at Duke Medical Center. American Journal of Cardiology 1988;62(10 Pt2):3F-24F.
76. Ramaiah V, Gammon R, Kiesz S, Cardenas J, Runyon JP, Fail P, et al, on behalf of the TALON Registry. Midterm outcomes from the TALON Registry: treating peripherals with SilverHawk: outcomes collection. Journal of Endovascular Therapy 2006;13(5):592-602.
77. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG, et al, on behalf of the TASC II Working Group. Inter-society consensus for the management of peripheral arterial disease. International Angiology 2007;26(2):81-157.
78. Watson L, Ellis B, Leng GC. Exercise for intermittent claudication. Cochrane Database of Systematic Reviews 2008, Issue 4. Art. No: CD000990. [DOI: 10.1002/14651858.CD000990.pub2]
79. Ambler GK, Radwan R, Hayes PD, Twine CP. Atherectomy for peripheral arterial disease. Cochrane Database of Systematic Reviews 2014, Issue 3. Art. No: CD006680. [DOI: 10.1002/14651858.CD006680.pub2]
80. Viswanathan G, Navaneethan SD. Atherectomy for peripheral arterial disease. Cochrane Database of Systematic Reviews 2007, Issue 3. Art. No: CD006680. [DOI: 10.1002/14651858.CD006680]