Bayesian network meta-analysis of nitinol stents, covered stents, drug-eluting stents, and drug-coated balloons in the femoropopliteal artery

Journal of Vascular Surgery

Volumn 59, Issue 4, 2014, Pages

  Katsanos, Konstantinos ^a   Spiliopoulos, Stavros ^b   Karunanithy, Narayan ^a   Krokidis, Miltiadis ^c   Sabharwal, Tarun ^a   Taylor, Peter ^a  

^a KING'S COLLEGE LONDON   (United Kingdom)

^b UNIVERSITY HOSPITAL OF PATRAS   (Greece)

^c ADDENBROOKE S HOSPITAL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

NITINOL; PACLITAXEL; RAPAMYCIN;

AMPUTATION; ANALYSIS; ANGIOPLASTY; ARTERY; BALLOON; BARE NITINOL STENT; BAYESIAN LEARNING; BEHAVIOR; COMPARATIVE STUDY; COVERED NITINOL STENT; DRUG ELUTING STENT; FEMOROPOPLITEAL ARTERY; FOLLOW UP; HUMAN; INTENTION TO TREAT ANALYSIS; META ANALYSIS; NETWORK CONSISTENCY ANALYSIS; NITINOL STENT; PACLITAXEL COATED BALLOON; PACLITAXEL ELUTING STENT; PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RESTENOSIS; REVASCULARIZATION; REVIEW; SIROLIMUS ELUTING STENT; SYSTEMATIC REVIEW; TARGET LESION REVASCULARIZATION; VASCULAR RESTENOSIS;

ALLOYS; AMPUTATION; ANGIOPLASTY, BALLOON; BAYES THEOREM; CARDIOVASCULAR AGENTS; COATED MATERIALS, BIOCOMPATIBLE; CONSTRICTION, PATHOLOGIC; DRUG-ELUTING STENTS; EQUIPMENT DESIGN; FEMORAL ARTERY; HUMANS; LIMB SALVAGE; ODDS RATIO; PACLITAXEL; PERIPHERAL ARTERIAL DISEASE; POPLITEAL ARTERY; PROSTHESIS DESIGN; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RECURRENCE; RISK FACTORS; SIROLIMUS; STENTS; TREATMENT OUTCOME; VASCULAR ACCESS DEVICES;

EID: 84897837638     PISSN: 07415214     EISSN: 10976809     Source Type: Journal    
DOI: 10.1016/j.jvs.2014.01.041     Document Type: Review

References (80)

1. C. Kasapis, and H.S. Gurm Current approach to the diagnosis and treatment of femoral-popliteal arterial disease: a systematic review Curr Cardiol Rev 5 2009 296 311
2. L. Norgren, W.R. Hiatt, J.A. Dormandy, M.R. Nehler, K.A. Harris, and F.G. Fowkes Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) J Vasc Surg 45 Suppl S 2007 S5 67
3. T.W. Rooke, A.T. Hirsch, S. Misra, A.N. Sidawy, J.A. Beckman, and L.K. Findeiss 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: developed in collaboration with the Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society for Vascular Medicine, and Society for Vascular Surgery J Vasc Surg 54 2011 e32 e58
4. D. Tsetis, and A.M. Belli Guidelines for stenting in infrainguinal arterial disease Cardiovasc Intervent Radiol 27 2004 198 203
5. C. Kasapis, P.K. Henke, S.J. Chetcuti, G.C. Koenig, J.E. Rectenwald, and V.N. Krishnamurthy et al. Routine stent implantation vs. percutaneous transluminal angioplasty in femoropopliteal artery disease: a meta-analysis of randomized controlled trials Eur Heart J 30 2009 44 55
6. S. Cassese, R.A. Byrne, I. Ott, G. Ndrepepa, M. Nerad, and A. Kastrati et al. Paclitaxel-coated versus uncoated balloon angioplasty reduces target lesion revascularization in patients with femoropopliteal arterial disease: a meta-analysis of randomized trials Circ Cardiovasc Intervent 5 2012 582 589
7. S. Dias, A.J. Sutton, A.E. Ades, and N.J. Welton Evidence synthesis for decision making 2: a generalized linear modeling framework for pairwise and network meta-analysis of randomized controlled trials Med Decis Making 33 2013 607 617
8. T. Palmerini, G. Biondi-Zoccai, D. Della Riva, C. Stettler, D. Sangiorgi, and F. D'Ascenzo et al. Stent thrombosis with drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis Lancet 379 2012 1393 1402
9. D. Moher, A. Liberati, J. Tetzlaff, and D.G. Altman Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement BMJ 339 2009 b2535
10. J.P. Higgins, D.G. Altman, P.C. Gotzsche, P. Juni, D. Moher, and A.D. Oxman et al. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials BMJ 343 2011 d5928
11. D. Sacks, D.L. Marinelli, L.G. Martin, and J.B. Spies Reporting standards for clinical evaluation of new peripheral arterial revascularization devices J Vasc Interv Radiol 14 9 Pt 2 2003 S395 S404
12. J.R. Laird, B.T. Katzen, D. Scheinert, J. Lammer, J. Carpenter, and M. Buchbinder 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 19 2012 1 9
13. J.R. Laird, B.T. Katzen, D. Scheinert, J. Lammer, J. Carpenter, and M. Buchbinder et al. 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 Intervent 3 2010 267 276
14. M.D. Dake, G.M. Ansel, M.R. Jaff, T. Ohki, R.R. Saxon, and H.B. Smouse et al. Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: twelve-month Zilver PTX randomized study results Circ Cardiovasc Intervent 4 2011 495 504
15. Dias S, Welton NJ, Sutton AJ, Caldwell DM, Guobing L, Ades AE. NICE DSU technical support document 4: inconsistency in networks of evidence based on randomised controlled trials. 2011. Available at: http://www.nicedsu.org.uk.
16. Dias S, Welton NJ, Sutton AJ, Ades AE. NICE DSU technical support document 2: a generalised linear modelling framework for pairwise and network meta-analysis of randomized controlled trials. 2011. Available at: http://www.nicedsu.org.uk.
17. Dias S, Sutton AJ, Welton NJ, Ades AE. NICE DSU technical support document 3: heterogeneity: subgroups, meta-regression, bias and bias adjustment. 2011. Available at: http://www.nicedsu.org.uk.
18. F.A. Achana, N.J. Cooper, S. Dias, G. Lu, S.J. Rice, and D. Kendrick et al. Extending methods for investigating the relationship between treatment effect and baseline risk from pairwise meta-analysis to network meta-analysis Stat Med 32 2013 752 771
19. S. Dias, A.J. Sutton, N.J. Welton, and A.E. Ades Evidence synthesis for decision making 3: heterogeneity: subgroups, meta-regression, bias, and bias-adjustment Med Decis Making 33 2013 618 640
20. C. Guddat, U. Grouven, R. Bender, and G. Skipka A note on the graphical presentation of prediction intervals in random-effects meta-analyses Syst Rev 1 2012 34
21. G. Salanti, A.E. Ades, and J.P. Ioannidis Graphical methods and numerical summaries for presenting results from multiple-treatment meta-analysis: an overview and tutorial J Clin Epidemiol 64 2011 163 171
22. S. Dias, N.J. Welton, D.M. Caldwell, and A.E. Ades Checking consistency in mixed treatment comparison meta-analysis Stat Med 29 2010 932 944
23. H.C. Bucher, G.H. Guyatt, L.E. Griffith, and S.D. Walter The results of direct and indirect treatment comparisons in meta-analysis of randomized controlled trials J Clin Epidemiol 50 1997 683 691
24. GORE VIABAHN ENDOPROSTHESIS Peripheral Vascular Disease Study. Available at: http://www.clinicaltrials.gov/ct2/show/study/NCT00228384. Accessed January 2013.
25. Intracoil Self-expanding Peripheral Stent. Available at: http://www.accessdata.fda.gov/cdrh-docs/pdf/P000033bpdf. Accessed January 2013.
26. N. Chalmers, P.T. Walker, A.M. Belli, A.P. Thorpe, P.S. Sidhu, and G. Robinson et al. Randomized Trial of the SMART Stent versus Balloon Angioplasty in Long Superficial Femoral Artery Lesions: the SUPER Study Cardiovasc Intervent Radiol 2012
27. P. Dick, H. Wallner, S. Sabeti, C. Loewe, W. Mlekusch, and J. Lammer et al. Balloon angioplasty versus stenting with nitinol stents in intermediate length superficial femoral artery lesions Catheter Cardiovasc Interv 74 2009 1090 1095
28. S.H. Duda, M. Bosiers, J. Lammer, D. Scheinert, T. Zeller, and A. Tielbeek et al. Sirolimus-eluting versus bare nitinol stent for obstructive superficial femoral artery disease: the SIROCCO II trial J Vasc Interv Radiol 16 2005 331 338
29. F. Fanelli, A. Cannavale, E. Boatta, M. Corona, P. Lucatelli, and A. Wlderk et al. Lower limb multilevel treatment with drug-eluting balloons: 6-month results from the DEBELLUM randomized trial J Endovasc Ther 19 2012 571 580
30. Lammer J. One year results of the VIASTAR trial. Presented at IROS, Berlin, Germany. Available at: http://www.esir.org. Accessed February 2013.
31. R.R. Saxon, M.D. Dake, R.L. Volgelzang, B.T. Katzen, and G.J. Becker Randomized, multicenter study comparing expanded polytetrafluoroethylene-covered endoprosthesis placement with percutaneous transluminal angioplasty in the treatment of superficial femoral artery occlusive disease J Vasc Interv Radiol 19 2008 823 832
32. M. Schillinger, S. Sabeti, P. Dick, J. Amighi, W. Mlekusch, and O. Schlager et al. Sustained benefit at 2 years of primary femoropopliteal stenting compared with balloon angioplasty with optional stenting Circulation 115 2007 2745 2749
33. Schmidt A. Lessons learnt from LEVANT-1 first in human study: 24-month final analysis. Available at: http://www.esir.org. Presented at CIRSE 2012. Accessed January 2013.
34. G. Tepe, T. Zeller, T. Albrecht, S. Heller, U. Schwarzwalder, and J.P. Beregi et al. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg N Engl J Med 358 2008 689 699
35. M. Werk, T. Albrecht, D.R. Meyer, M.N. Ahmed, A. Behne, and U. Dietz et al. Paclitaxel-coated balloons reduce restenosis after femoro-popliteal angioplasty: evidence from the randomized PACIFIER trial Circ Cardiovasc Intervent 5 2012 831 840
36. M. Werk, S. Langner, B. Reinkensmeier, H.F. Boettcher, G. Tepe, and U. Dietz et al. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial Circulation 118 2008 1358 1365
37. M.D. Dake, G.M. Ansel, M.R. Jaff, T. Ohki, R.R. Saxon, and H.B. Smouse et al. Sustained safety and effectiveness of paclitaxel-eluting stents for femoropopliteal lesions: two-year follow-up from the Zilver PTX randomized and single-arm clinical studies J Am Coll Cardiol 61 2013 2417 2427
38. J. Lammer, T. Zeller, K.A. Hausegger, P.J. Schaefer, M. Gschwendtner, and S. Mueller-Huelsbeck et al. Heparin-bonded covered stents versus bare metal stents for complex femoro-popliteal artery lesions: the randomized VIASTAR trial J Am Coll Cardiol 62 2013 1320 1327
39. J.P. Higgins, D.G. Altman, P.C. Gotzsche, P. Juni, D. Moher, and A.D. Oxman et al. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials BMJ 343 2011 d5928
40. D. Moher, A. Liberati, J. Tetzlaff, and D.G. Altman Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement BMJ 339 2009 b2535
41. Dias S, Welton NJ, Sutton AJ, Caldwell DM, Guobing L, Ades AE. NICE DSU technical support document 4: inconsistency in networks of evidence based on randomised controlled trials. 2011. Available at: http://www.nicedsu.org.uk.
42. Dias S, Welton NJ, Sutton AJ, Ades AE. NICE DSU technical support document 2: a generalised linear modelling framework for pairwise and network meta-analysis of randomized controlled trials. 2011. Available at: http://www.nicedsu.org.uk.
43. Dias S, Sutton AJ, Welton NJ, Ades AE. NICE DSU technical support document 3: heterogeneity: subgroups, meta-regression, bias and bias adjustment. 2011. Available at: http://www.nicedsu.org.uk.
44. S. Dias, A.J. Sutton, A.E. Ades, and N.J. Welton Evidence synthesis for decision making 2: a generalized linear modeling framework for pairwise and network meta-analysis of randomized controlled trials Med Decis Making 33 2013 607 617
45. S.G. Thompson, T.C. Smith, and S.J. Sharp Investigating underlying risk as a source of heterogeneity in meta-analysis Stat Med 16 1997 2741 2758
46. F.A. Achana, N.J. Cooper, S. Dias, G. Lu, S.J. Rice, and D. Kendrick et al. Extending methods for investigating the relationship between treatment effect and baseline risk from pairwise meta-analysis to network meta-analysis Stat Med 32 2013 752 771
47. S. Dias, A.J. Sutton, N.J. Welton, and A.E. Ades Evidence synthesis for decision making 3: heterogeneity: subgroups, meta-regression, bias, and bias-adjustment Med Decis Making 33 2013 618 640
48. C. Guddat, U. Grouven, R. Bender, and G. Skipka A note on the graphical presentation of prediction intervals in random-effects meta-analyses Syst Rev 1 2012 34
49. G. Salanti, A.E. Ades, and J.P. Ioannidis Graphical methods and numerical summaries for presenting results from multiple-treatment meta-analysis: an overview and tutorial J Clin Epidemiol 64 2011 163 171
50. S.P. Brooks, and A. Gelman General methods for monitoring convergence of iterative simulations J Comput Graphic Stat 7 1998 434 455
51. J.P. Jansen, and H. Naci Is network meta-analysis as valid as standard pairwise meta-analysis? It all depends on the distribution of effect modifiers BMC Med 11 2013 159
52. J.P. Higgins, S.G. Thompson, J.J. Deeks, and D.G. Altman Measuring inconsistency in meta-analyses BMJ 327 2003 557 560
53. M. Egger, G. Davey Smith, M. Schneider, and C. Minder Bias in meta-analysis detected by a simple, graphical test BMJ 315 1997 629 634
54. S. Dias, N.J. Welton, D.M. Caldwell, and A.E. Ades Checking consistency in mixed treatment comparison meta-analysis Stat Med 29 2010 932 944
55. H.C. Bucher, G.H. Guyatt, L.E. Griffith, and S.D. Walter The results of direct and indirect treatment comparisons in meta-analysis of randomized controlled trials J Clin Epidemiol 50 1997 683 691
56. Intracoil Self-expanding Peripheral Stent. Available at: wwwaccessdatafdagov/cdrh-docs/pdf/P000033bpdf. 2013.
57. M. Schillinger, S. Sabeti, C. Loewe, P. Dick, J. Amighi, and W. Mlekusch et al. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery N Engl J Med 354 2006 1879 1888
58. M. Schillinger, S. Sabeti, P. Dick, J. Amighi, W. Mlekusch, and O. Schlager et al. Sustained benefit at 2 years of primary femoropopliteal stenting compared with balloon angioplasty with optional stenting Circulation 115 2007 2745 2749
59. H. Krankenberg, M. Schluter, H.J. Steinkamp, K. Burgelin, D. Scheinert, and K.L. Schulte 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 116 2007 285 292
60. P. Dick, H. Wallner, S. Sabeti, C. Loewe, W. Mlekusch, and J. Lammer et al. Balloon angioplasty versus stenting with nitinol stents in intermediate length superficial femoral artery lesions Catheter Cardiovasc Interv 74 2009 1090 1095
61. J.R. Laird, B.T. Katzen, D. Scheinert, J. Lammer, J. Carpenter, and M. Buchbinder 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 19 2012 1 9
62. J.R. Laird, B.T. Katzen, D. Scheinert, J. Lammer, J. Carpenter, and M. Buchbinder et al. 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 Intervent 3 2010 267 276
63. Mustapha J. The RESILIENT Randomized trial: three-year results. Presented at LINC 2012; 2013.
64. N. Chalmers, P.T. Walker, A.M. Belli, A.P. Thorpe, P.S. Sidhu, and G. Robinson et al. Randomized trial of the SMART Stent versus Balloon Angioplasty in Long Superficial Femoral Artery Lesions: the SUPER Study Cardiovasc Intervent Radiol 36 2013 353 361
65. R.R. Saxon, M.D. Dake, R.L. Volgelzang, B.T. Katzen, and G.J. Becker Randomized, multicenter study comparing expanded polytetrafluoroethylene-covered endoprosthesis placement with percutaneous transluminal angioplasty in the treatment of superficial femoral artery occlusive disease J Vasc Interv Radiol 19 2008 823 832
66. GORE VIABAHN ENDOPROSTHESIS Peripheral Vascular Disease Study. Available at: http://www.clinicaltrials.gov/ct2/show/study/NCT00228384. 2013.
67. GORE VIABAHN® endoprosthesis with bioactive propaten surface versus bare nitinol stent in the treatment of TASC B, C and D lesions in superficial femoral artery occlusive disease. Available at: http://www.clinical-trials.com/ ISRCTN48164244. 2013.
68. Lammer J. One year results of the VIASTAR trial. Presented at IROS, Berlin, Germany. Available at: http://www.esir.org. 2013.
69. J. Lammer, T. Zeller, K.A. Hausegger, P.J. Schaefer, M. Gschwendtner, and S. Mueller-Huelsbeck et al. Heparin-bonded covered stents versus bare metal stents for complex femoro-popliteal artery lesions: the randomized VIASTAR trial J Am Coll Cardiol 62 2013 1320 1327
70. S.H. Duda, M. Bosiers, J. Lammer, D. Scheinert, T. Zeller, and A. Tielbeek et al. Sirolimus-eluting versus bare nitinol stent for obstructive superficial femoral artery disease: the SIROCCO II trial J Vasc Interv Radiol 16 2005 331 338
71. S.H. Duda, B. Pusich, G. Richter, P. Landwehr, V.L. Oliva, and A. Tielbeek et al. Sirolimus-eluting stents for the treatment of obstructive superficial femoral artery disease: six-month results Circulation 106 2002 1505 1509
72. Scheinert D. Long-term outcomes of endovascular treatment in the SFA. Presented at LINC 2011. 2013.
73. M.D. Dake, G.M. Ansel, M.R. Jaff, T. Ohki, R.R. Saxon, and H.B. Smouse et al. Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: twelve-month Zilver PTX randomized study results Circ CardiovascIntervent 4 2011 495 504
74. Dake MD. The ZILVER-PTX randomized trial of paclitaxel-eluting stents for femoropopliteal disease: 3-year results. Vasc Intervent Adv Presented at VIVA 2012. 2012.
75. M.D. Dake, G.M. Ansel, M.R. Jaff, T. Ohki, R.R. Saxon, and H.B. Smouse et al. Sustained safety and effectiveness of paclitaxel-eluting stents for femoropopliteal lesions: two-year follow-up from the Zilver PTX randomized and single-arm clinical studies J Am Coll Cardiol 61 2013 2417 2427
76. G. Tepe, T. Zeller, T. Albrecht, S. Heller, U. Schwarzwalder, and J.P. Beregi et al. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg N Engl J Med 358 2008 689 699
77. M. Werk, S. Langner, B. Reinkensmeier, H.F. Boettcher, G. Tepe, and U. Dietz et al. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial Circulation 118 2008 1358 1365
78. M. Werk, T. Albrecht, D.R. Meyer, M.N. Ahmed, A. Behne, and U. Dietz et al. Paclitaxel-coated balloons reduce restenosis after femoro-popliteal angioplasty: evidence from the randomized PACIFIER trial Circ Cardiovasc Intervent 5 2012 831 840
79. F. Fanelli, A. Cannavale, E. Boatta, M. Corona, P. Lucatelli, and A. Wlderk et al. Lower limb multilevel treatment with drug-eluting balloons: 6-month results from the DEBELLUM randomized trial J Endovasc Ther 19 2012 571 580
80. Schmidt A. Lessons learnt from LEVANT-1 first in human study: 24-month final analysis. Available at: http://www.esir.org. Presented at CIRSE 2012. 2013.