Comparative Effectiveness of Plain Balloon Angioplasty, Bare Metal Stents, Drug-Coated Balloons, and Drug-Eluting Stents for the Treatment of Infrapopliteal Artery Disease: Systematic Review and Bayesian Network Meta-analysis of Randomized Controlled Trials

Journal of Endovascular Therapy

Volumn 23, Issue 6, 2016, Pages 851-863

  Katsanos, Konstantinos ^a   Kitrou, Panagiotis ^b   Spiliopoulos, Stavros ^c   Diamantopoulos, Athanasios ^a   Karnabatidis, Dimitris ^b  

^a KING'S COLLEGE LONDON   (United Kingdom)

^b UNIVERSITY HOSPITAL OF PATRAS   (Greece)

^c UNIVERSITY OF ATHENS   (Greece)

Author keywords

amputation; balloon angioplasty; bare metal stents; critical limb ischemia; drug eluting stents; infrapopliteal arteries; network meta analysis; paclitaxel coated balloons; randomized controlled trial; restenosis; target lesion revascularization; wound healing

Indexed keywords

PACLITAXEL; BIOCOMPATIBLE COATED MATERIAL; CARDIOVASCULAR AGENT; METAL;

ANGIOGRAPHY; ARTERY DISEASE; ARTICLE; BALLOON; BARE METAL STENT; COMPUTER ASSISTED TOMOGRAPHY; DRUG COATED BALLOON; DRUG ELUTING STENT; ECHOGRAPHY; HUMAN; LIMB AMPUTATION; META ANALYSIS; OUTCOME ASSESSMENT; PACLITAXEL ELUTING CORONARY STENT; PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RESTENOSIS; REVASCULARIZATION; SYSTEMATIC REVIEW; WOUND HEALING; AMPUTATION; BAYES THEOREM; COMPARATIVE EFFECTIVENESS; DEVICES; LIMB SALVAGE; MARKOV CHAIN; NETWORK META-ANALYSIS; ODDS RATIO; PATHOPHYSIOLOGY; PERIPHERAL OCCLUSIVE ARTERY DISEASE; POPLITEAL ARTERY; PROSTHESIS DESIGN; RECURRENT DISEASE; RISK FACTOR; STENOSIS, OCCLUSION AND OBSTRUCTION; STENT; TIME FACTOR; TREATMENT OUTCOME; VASCULAR ACCESS DEVICE; VASCULAR PATENCY;

AMPUTATION; ANGIOPLASTY, BALLOON; BAYES THEOREM; CARDIOVASCULAR AGENTS; COATED MATERIALS, BIOCOMPATIBLE; COMPARATIVE EFFECTIVENESS RESEARCH; CONSTRICTION, PATHOLOGIC; DRUG-ELUTING STENTS; HUMANS; LIMB SALVAGE; MARKOV CHAINS; METALS; NETWORK META-ANALYSIS; ODDS RATIO; PERIPHERAL ARTERIAL DISEASE; POPLITEAL ARTERY; PROSTHESIS DESIGN; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RECURRENCE; RISK FACTORS; STENTS; TIME FACTORS; TREATMENT OUTCOME; VASCULAR ACCESS DEVICES; VASCULAR PATENCY; WOUND HEALING;

EID: 85009111599     PISSN: 15266028     EISSN: 15451550     Source Type: Journal    
DOI: 10.1177/1526602816671740     Document Type: Article

References (50)

1. van Overhagen H, Spiliopoulos S, Tsetis D,. Below-the-knee interventions. Cardiovasc Intervent Radiol. 2013; 36: 302-311.
2. Conte MS., Diabetic revascularization: endovascular versus open bypass-do we have the answer? Semin Vasc Surg. 2012; 25: 108-114.
3. Romiti M, Albers M, Brochado-Neto FC, et al. Meta-analysis of infrapopliteal angioplasty for chronic critical limb ischemia. J Vasc Surg. 2008; 47: 975-981.
4. Katsanos K, Spiliopoulos S, Diamantopoulos A, et al. Systematic review of infrapopliteal drug-eluting stents: a meta-analysis of randomized controlled trials. Cardiovasc Intervent Radiol. 2013; 36: 645-658.
5. Siablis D, Kitrou PM, Spiliopoulos S, et al. Paclitaxel-coated balloon angioplasty versus drug-eluting stenting for the treatment of infrapopliteal long-segment arterial occlusive disease: the IDEAS randomized controlled trial. JACC Cardiovasc Interv. 2014; 7: 1048-1056.
6. Zeller T, Baumgartner I, Scheinert D, et al. Drug-eluting balloon versus standard balloon angioplasty for infrapopliteal arterial revascularization in critical limb ischemia: 12-month results from the IN.PACT DEEP randomized trial. J Am Coll Cardiol. 2014; 64: 1568-1576.
7. Katsanos K, Spiliopoulos S, Krokidis M, et al. Does below-the-knee placement of drug-eluting stents improve clinical outcomes? J Cardiovasc Surg (Torino). 2012; 53: 195-203.
8. Biondi-Zoccai GG, Sangiorgi G, Lotrionte M, et al. Infragenicular stent implantation for below-the-knee atherosclerotic disease: clinical evidence from an international collaborative meta-analysis on 640 patients. J Endovasc Ther. 2009; 16: 251-260.
9. TASC Steering Committee, Jaff MR, White CJ, et al. An update on methods for revascularization and expansion of the TASC lesion classification to include below-the-knee arteries: a supplement to the Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Endovasc Ther. 2015; 22: 663-677.
10. Antoniou GA, Chalmers N, Kanesalingham K, et al. Meta-analysis of outcomes of endovascular treatment of infrapopliteal occlusive disease with drug-eluting stents. J Endovasc Ther. 2013; 20: 131-144.
11. Jens S, Conijn AP, Koelemay MJ, et al. Randomized trials for endovascular treatment of infrainguinal arterial disease: systematic review and meta-analysis (Part 2: Below the knee). Eur J Vasc Endovasc Surg. 2014; 47: 536-544.
12. Moher D, Liberati A, Tetzlaff J, et al. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ. 2009; 339: b2535.
13. Higgins JP, Altman DG, Gotzsche PC, et al. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials. BMJ. 2011; 343: d5928.
14. Jansen JP, Trikalinos T, Cappelleri JC, et al. Indirect treatment comparison/network meta-analysis study questionnaire to assess relevance and credibility to inform health care decision making: an ISPOR-AMCP-NPC Good Practice Task Force report. Value Health. 2014; 17: 157-173.
15. Guyatt GH, Oxman AD, Vist GE, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ. 2008; 336: 924-926.
16. Puhan MA, Schunemann HJ, Murad MH, et al. A GRADE Working Group approach for rating the quality of treatment effect estimates from network meta-analysis. BMJ. 2014; 349: g5630.
17. Dias S, Sutton AJ, Ades AE, et al. Evidence synthesis for decision making 2: a generalized linear modeling framework for pairwise and network meta-analysis of randomized controlled trials. Med Decis Making. 2013; 33: 607-617.
18. Dias S, Sutton AJ, Welton NJ, et al. Evidence synthesis for decision making 3: heterogeneity-subgroups, meta-regression, bias, and bias-adjustment. Med Decis Making. 2013; 33: 618-640.
19. Dias S, Welton NJ, Sutton AJ, et al. Evidence synthesis for decision making 4: inconsistency in networks of evidence based on randomized controlled trials. Med Decis Making. 2013; 33: 641-656.
20. Salanti G, Ades AE, Ioannidis JP., Graphical methods and numerical summaries for presenting results from multiple-treatment meta-analysis: an overview and tutorial. J Clin Epidemiol. 2011; 64: 163-171.
21. Chaimani A, Higgins JP, Mavridis D, et al. Graphical tools for network meta-analysis in STATA. PLoS One. 2013; 8: e76654.
22. Achana FA, Cooper NJ, Dias S, et al. Extending methods for investigating the relationship between treatment effect and baseline risk from pairwise meta-analysis to network meta-analysis. Stat Med. 2013; 32: 752-771.
23. Jansen JP, Naci H., Is network meta-analysis as valid as standard pairwise meta-analysis? It all depends on the distribution of effect modifiers. BMC Med. 2013; 11: 159.
24. Dias S, Welton NJ, Caldwell DM, et al. Checking consistency in mixed treatment comparison meta-analysis. Stat Med. 2010; 29: 932-944.
25. Brown S, Hutton B, Clifford T, et al. A Microsoft-Excel-based tool for running and critically appraising network meta-analyses-an overview and application of NetMetaXL. Syst Rev. 2014; 3: 110.
26. Turner RM, Davey J, Clarke MJ, et al. Predicting the extent of heterogeneity in meta-analysis, using empirical data from the Cochrane Database of Systematic Reviews. Int J Epidemiol. 2012; 41: 818-827.
27. Bosiers M, Peeters P, D'Archambeau O, et al. AMS INSIGHT-absorbable metal stent implantation for treatment of below-the-knee critical limb ischemia: 6-month analysis. Cardiovasc Intervent Radiol. 2009; 32: 424-435.
28. Bosiers M, Scheinert D, Peeters P, et al. Randomized comparison of everolimus-eluting versus bare-metal stents in patients with critical limb ischemia and infrapopliteal arterial occlusive disease. J Vasc Surg. 2012; 55: 390-398.
29. Brodmann M, Froehlich H, Dorr A, et al. Percutaneous transluminal angioplasty versus primary stenting in infrapopliteal arteries in critical limb ischemia. Vasa. 2011; 40: 482-490.
30. Falkowski A, Poncyljusz W, Wilk G, et al. The evaluation of primary stenting of sirolimus-eluting versus bare-metal stents in the treatment of atherosclerotic lesions of crural arteries. Eur Radiol. 2009; 19: 966-974.
31. Liistro F, Porto I, Angioli P, et al. Drug-eluting balloon in peripheral intervention for below the knee angioplasty evaluation (DEBATE-BTK): a randomized trial in diabetic patients with critical limb ischemia. Circulation. 2013; 128: 615-621.
32. Martens JM, Knippenberg B, Vos JA, et al. Update on PADI trial: percutaneous transluminal angioplasty and drug-eluting stents for infrapopliteal lesions in critical limb ischemia. J Vasc Surg. 2009; 50: 687-689.
33. Rand T, Basile A, Cejna M, et al. PTA versus carbofilm-coated stents in infrapopliteal arteries: pilot study. Cardiovasc Intervent Radiol. 2006; 29: 29-38.
34. Rand T, Lammer J, Rabbia C, et al. Percutaneous transluminal angioplasty versus turbostatic carbon-coated stents in infrapopliteal arteries: InPeria II trial. Radiology. 2011; 261: 634-642.
35. Randon C, Jacobs B, De Ryck F, et al. Angioplasty or primary stenting for infrapopliteal lesions: results of a prospective randomized trial. Cardiovasc Intervent Radiol. 2010; 33: 260-269.
36. Rastan A, Brechtel K, Krankenberg H, et al. Sirolimus-eluting stents for treatment of infrapopliteal arteries reduce clinical event rate compared to bare-metal stents: long-term results from a randomized trial. J Am Coll Cardiol. 2012; 60: 587-591.
37. Rastan A, Tepe G, Krankenberg H, et al. Sirolimus-eluting stents vs. bare-metal stents for treatment of focal lesions in infra-popliteal arteries: a double-blind, multi-centre, randomized clinical trial. Eur Heart J. 2011; 32: 2274-2281.
38. Scheinert D, Katsanos K, Zeller T, et al. A prospective randomized multicenter comparison of balloon angioplasty and infra-popliteal stenting with the sirolimus-eluting stent in patients with ischemic peripheral arterial disease: 1-year results from the ACHILLES trial. J Am Coll Cardiol. 2012; 60: 2290-2295.
39. Schulte KL, Pilger E, Schellong S, et al. Primary self-EXPANDing nitinol stenting vs balloon angioplasty with optional bailout stenting for the treatment of infrapopliteal artery disease in patients with severe intermittent claudication or critical limb ischemia (EXPAND Study). J Endovasc Ther. 2015; 22: 690-697.
40. Tepe G, Schmehl J, Heller S, et al. Drug eluting stents versus PTA with GP IIb/IIIa blockade below the knee in patients with current ulcers-the BELOW study. J Cardiovasc Surg (Torino). 2010; 51: 203-212.
41. van Overhagen H,. Morphological results of PADI trial: Percutaneous transluminal angioplasty versus drug-eluting stents for infrapopliteal lesions in critical limb ischemia. Paper presented at: Annual meeting of the CIRSE; September 26-30, 2015; Lisbon, Portugal.
42. Zeller T, Beschorner U, Pilger E, et al. Paclitaxel-coated balloon in infrapopliteal arteries: 12-month results from the BIOLUX P-II randomized trial (Biotronik's-first in man study of the Passeo-18 LUX drug releasing PTA balloon catheter vs. the uncoated Passeo-18 PTA balloon catheter in subjects requiring revascularization of infrapopliteal arteries). JACC Cardiovasc Interv. 2015; 8: 1614-1622.
43. Spreen MI, Martens JM, Hansen BE, et al. Percutaneous transluminal angioplasty and drug-eluting stents for infra-popliteal lesions in critical limb ischemia (PADI) trial. Circ Cardiovasc Interv. 2016; 9: e002376.
44. Rucker G, Schwarzer G., Ranking treatments in frequentist network meta-analysis works without resampling methods. BMC Med Res Methodol. 2015; 15: 58.
45. Fusaro M, Cassese S, Ndrepepa G, et al. Drug-eluting stents for revascularization of infrapopliteal arteries: updated meta-analysis of randomized trials. JACC Cardiovasc Interv. 2013; 6: 1284-1293.
46. Katsanos K, Spiliopoulos S, Saha P, et al. Comparative efficacy and safety of different antiplatelet agents for prevention of major cardiovascular events and leg amputations in patients with peripheral arterial disease: a systematic review and network meta-analysis. PLoS One. 2015; 10: e0135692.
47. Katsanos K, Spiliopoulos S, Karunanithy N, et al. Bayesian network meta-analysis of nitinol stents, covered stents, drug-eluting stents, and drug-coated balloons in the femoropopliteal artery. J Vasc Surg. 2014; 59: 1123-1133.e8.
48. Baumann F, Fust J, Engelberger RP, et al. Early recoil after balloon angioplasty of tibial artery obstructions in patients with critical limb ischemia. J Endovasc Ther. 2014; 21: 44-51.
49. Laird JR, Armstrong EJ., Drug-coated balloons for infrapopliteal disease: digging deep to understand the impact of a negative trial. J Am Coll Cardiol. 2014; 64: 1577-1579.
50. Katsanos K, Spiliopoulos S, Diamantopoulos A, et al. Wound healing outcomes and health-related quality-of-life changes in the ACHILLES trial: 1-year results from a prospective randomized controlled trial of infrapopliteal balloon angioplasty versus sirolimus-eluting stenting in patients with ischemic peripheral arterial disease. JACC Cardiovasc Interv. 2016; 9: 259-267.