Download Data Supplement - Circulation: Cardiovascular Interventions

SUPPLEMENTAL MATERIAL
MS ID#: CIRCCVINT/2012/969972
Paclitaxel-coated versus uncoated balloon angioplasty reduces target lesion revascularization
in patients with femoro-popliteal arterial disease. A meta-analysis of randomized trials.
Supplemental Table 1. Endpoints definitions of included trials
Trial
THUNDER1
FemPac2
LEVANT I3
PACIFIER4
TLR
Any repeat revascularization
of the target lesion
Any repeat revascularization
of the target lesion
Any repeat revascularization
of the target lesion
Any repeat revascularization
of the target lesion
Angiographic
Restenosis*
Stenosis of ≥50% of the
diameter of the referencevessel segment
Stenosis ≥50% in the treated
lesion
n/a†
Binary restenosis‡
LLL§
Difference between the
minimum lumen diameters
after dilation and at the 6month follow-up
Difference between
the minimal luminal
diameter after the procedure
and at 6 months by
quantitative angiography
n/r
n/r
Death
n/r
n/r
n/r
Death of any cause
TLR: Target lesion revascularization; LLL: Late lumen loss. n/r: not reported; n/a: not available.
*
Percent of diameter stenosis is calculated as [1-(MLD/reference vessel diameter)/100]. MLD: Minimum lumen diameter. †Cumulative TLR/>50%
diameter stenosis data at 6-month follow-up available. ‡Stenosis of ≥50% of the diameter of the reference-vessel segment. §Late lumen loss is
calculated as MLD at index procedure - MLD at angiographic follow-up, within the stent. Trial acronyms: THUNDER: Local Taxane with Short
Exposure for Reduction of Restenosis in Distal Arteries trial; FemPac: Femoral Paclitaxel trial; LEVANT I: Lutonix Paclitaxel-Coated Balloon for
the Prevention of Femoropoliteal Restenosis; PACIFIER: Paclitaxel-coated Balloons in Femoral Indication to Defeat Restenosis.
2
Table 2 – Supplementary Data. Records identified and selected citations
Records identified through database searching
1. Mazari FA. Randomized clinical trial of percutaneous transluminal angioplasty, supervised exercise and combined
treatment for intermittent claudication due to femoropopliteal arterial disease. Br J Surg. 2012;99:39-48
2. Dake MD. Zilver PTXInvestigators. Paclitaxel-eluting stents show superiority to balloon angioplasty and bare
metal stents in femoropopliteal disease: twelve-month Zilver PTX randomized study results. Circ Cardiovasc
Interv. 2011;4:495-504.
3. Frans FA. Systematic review of exercise training or percutaneous transluminal angioplasty for intermittent
claudication. Br J Surg. 2012;99:16-28. Review.
4. Diaz ML. Cardiovasc Intervent Radiol. 2011;34:911-7.
5. Chalmers N. Letter by Chalmers regarding article "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:e22; author reply e23.
6. Brechtel K. [Endovascular therapy options in femoro-popliteal PAD]. Rofo. 2010;182:755-63. Review. German.
7. Spiliopoulos S. Cryoplasty versus conventional balloon angioplasty of the femoropopliteal artery in diabetic
patients: long-term results from a prospective randomized single-center controlled trial. Cardiovasc Intervent
Radiol. 2010;33:929-38.
8. Laird JR; 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.
9. Bradbury AW; BASIL trial Participants. Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial:
A description of the severity and extent of disease using the Bollinger angiogram scoring method and the
TransAtlantic Inter-Society Consensus II classification. J Vasc Surg. 2010;51(5 Suppl):32S-42S.
10. Willenberg T. An angiographic analysis of atherosclerosis progression in below-the-knee arteries after
femoropopliteal angioplasty in claudicants. J Endovasc Ther. 2010;17:39-45.
11. Diehm N. Routine stent implantation vs. percutaneous transluminal angioplasty in femoropopliteal artery disease: a
meta-analysis of randomized controlled trials. Eur Heart J. 2009;30:3083; author reply 3083-4.
12. Mazari FA. Early outcomes from a randomized, controlled trial of supervised exercise, angioplasty, and combined
therapy in intermittent claudication. Ann Vasc Surg. 2010;24:69-79.
13. Ansel GM. Evolving modalities for femoropopliteal interventions. J Endovasc Ther. 2009;16(2 Suppl 2):II82-97.
Review.
Inclusion
No
No
No
No
No
No
No
No
No
No
No
No
No
14. Soga Y. Efficacy of cilostazol after endovascular therapy for femoropopliteal artery disease in patients with
intermittent claudication. J Am Coll Cardiol. 2009;53:48-53.
15. Kasapis C. Routine stent implantation vs. percutaneous transluminal angioplasty in femoropopliteal artery disease:
a meta-analysis of randomized controlled trials. Eur Heart J. 2009;30:44-55.
16. Greenhalgh RM; MIMIC Trial Participants. The adjuvant benefit of angioplasty in patients with mild to moderate
intermittent claudication (MIMIC) managed by supervised exercise, smoking cessation advice and best medical
therapy: results from two randomised trials for stenotic femoropopliteal and aortoiliac arterial disease. Eur J Vasc
Endovasc Surg. 2008;36:680-8.
17. Werk M. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral
paclitaxel randomized pilot trial. Circulation. 2008;118:1358-65.
18. Husmann M. Successful lower extremity angioplasty improves brachial artery flow-mediated dilation in patients
with peripheral arterial disease. J Vasc Surg. 2008;48:1211-6.
19. Dick P. Conventional balloon angioplasty versus peripheral cutting balloon angioplasty for treatment of
femoropopliteal artery in-stent restenosis: initial experience. Radiology. 2008;248:297-302.
20. Iida O. Cilostazol reduces restenosis after endovascular therapy in patients with femoropopliteal lesions. J Vasc
Surg. 2008;48:144-9.
21. E Y. Percutaneous transluminal angioplasty (PTA) alone versus PTA with balloon-expandable stent placement for
short-segment femoropopliteal artery disease: a metaanalysis of randomized trials. J Vasc Interv Radiol.
2008;19:499-503.
22. Ihnat DM. Contemporary outcomes after superficial femoral artery angioplasty and stenting: the influence of TASC
classification and runoff score. J Vasc Surg. 2008;47:967-74.
23. Tepe G. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med.
2008;358:689-99.
24. Amighi J. De novo superficial femoropopliteal artery lesions: peripheral cutting balloon angioplasty and restenosis
rates--randomized controlled trial. Radiology.2008;247:267-72.
25. Wohlgemuth WA. Endovascular brachytherapy in the femoropopliteal segment using 192Ir and 188Re. Cardiovasc
Intervent Radiol. 2008;31:698-708.
26. Wyttenbach R. Effects of percutaneous transluminal angioplasty and endovascular brachytherapy on vascular
remodeling of human femoropopliteal artery: 2 years follow-up by noninvasive magnetic resonance imaging. Eur J
Vasc Endovasc Surg. 2007;34:416-23.
27. Schillinger M. Sustained benefit at 2 years of primary femoropopliteal stenting compared with balloon angioplasty
with optional stenting. Circulation. 2007;115:2745-9.
28. Rocha-Singh KJ; VIVA Physicians. Performance goals and endpoint assessments for clinical trials of
No
No
No
Yes
No
No
No
No
No
Yes
No
No
No
No
No
femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease. Catheter Cardiovasc
Interv. 2007;69:910-9.
29. Koppensteiner R. Low-molecular-weight heparin for prevention of restenosis after femoropopliteal percutaneous
transluminal angioplasty: a randomized controlled trial. J Vasc Surg. 2006;44:1247-53.
30. Pokrovskiĭ AV. Carotid artery dissection (literature review and a case report). Angiol Sosud Khir. 2005;11:130-40.
Review. English, Russian.
31. Lyden SP. Contemporary endovascular treatment for disease of the superficial femoral and popliteal arteries: an
integrated device-based strategy. J Endovasc Ther. 2006;13 Suppl 2:II41-51. Review.
32. Laird JR. Limitations of percutaneous transluminal angioplasty and stenting for the treatment of disease of the
superficial femoral and popliteal arteries. J Endovasc Ther. 2006;13 Suppl 2:II30-40. Review.
33. Diehm N. Endovascular brachytherapy after femoropopliteal balloon angioplasty fails to show robust clinical
benefit over time. J Endovasc Ther. 2005;12:723-30.
34. Rigatelli G. Endovascular therapies for noncoronary atherosclerosis in the elderly: aortoiliac and femorotibial
lesions. Am J Geriatr Cardiol. 2005;14:195-9. Review.
35. Wolfram RM. Vascular brachytherapy with 192Ir after femoropopliteal stent implantation in high-risk patients:
twelve-month follow-up results from the VIENNA-5 trial. Radiology. 2005;236:343-51.
36. Therasse E. External beam radiation to prevent restenosis after superficial femoral artery balloon angioplasty.
Circulation. 2005;111:3310-5.
37. Pokrajac B. Endovascular brachytherapy prevents restenosis after femoropopliteal angioplasty: results of the
VIENNA-3 randomised multicenter study. Radiother Oncol. 2005;74:3-9.
38. Gallino A. Effects of probucol versus aspirin and versus brachytherapy on restenosis after femoropopliteal
angioplasty: the PAB randomized multicenter trial. J Endovasc Ther. 2004;11:595-604.
39. Greenberg D. In-hospital costs of self-expanding nitinol stent implantation versus balloon angioplasty in the
femoropopliteal artery (the VascuCoil Trial). J Vasc Interv Radiol. 2004;15:1065-9.
40. Mongiardo A. Molecular mechanisms of restenosis after percutaneous peripheral angioplasty and approach to
endovascular therapy. Curr Drug Targets Cardiovasc Haematol Disord. 2004;4:275-87. Review.
41. Grenacher L. [PTA versus Palmaz stent placement in femoropopliteal artery stenoses: results of a multicenter
prospective randomized study (REFSA)]. Rofo. 2004;176:1302-10. German.
42. Wyttenbach R. Effects of percutaneous transluminal angioplasty and endovascular brachytherapy on vascular
remodeling of human femoropopliteal artery by noninvasive magnetic resonance imaging. Circulation.
2004;110:1156-61.
43. Fritz P. External beam radiotherapy fails to prevent restenosis after iliac or femoropopliteal percutaneous
transluminal angioplasty: results of a prospective randomized double-blind study. Int J Radiat Oncol Biol Phys.
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
2004;59:815-21.
44. Zehnder T. Endovascular brachytherapy after percutaneous transluminal angioplasty of recurrent femoropopliteal
obstructions. J Endovasc Ther. 2003;10:304-11.
45. Strecker EP. Clopidogrel plus long-term aspirin after femoro-popliteal stenting. The CLAFS project: 1- and 2-year
results. Eur Radiol. 2004;14:302-8.
46. Roeren T. [Stents in peripheral arterial occlusive diseases (PAOD)]. Ther Umsch. 2003;60:199-203. Review.
German.
47. Saxon RR. Long-term results of ePTFE stent-graft versus angioplasty in the femoropopliteal artery: single center
experience from a prospective, randomized trial. J Vasc Interv Radiol. 2003;14:303-11.
48. Bonvini R. Late acute thrombotic occlusion after endovascular brachytherapy and stenting of femoropopliteal
arteries. J Am Coll Cardiol. 2003;41:409-12.
49. Wagner HJ. [Current status of endovascular therapy in the femoropopliteal vascular segment in chronic peripheral
arterial occlusive disease]. Vasa. 2002;31:153-61. Review. German.
50. Hagenaars T. Gamma radiation induces positive vascular remodeling after balloon angioplasty: a prospective,
randomized intravascular ultrasound scan study. J Vasc Surg. 2002;36:318-24.
51. Krueger K. Endovascular gamma irradiation of femoropopliteal de novo stenoses immediately after PTA: interim
results of prospective randomized controlled trial. Radiology. 2002;224:519-28.
52. Ansel GM; IntraCoil Femoralpopliteal Stent Trial Investigators. Clinical results for the training-phase roll-in
patients in the Intracoil femoralpopliteal stent trial. Catheter Cardiovasc Interv. 2002;56:443-9.
53. Pokrajac B. Possible impact of iridium-192 source centering on restenosis rate after femoro-popliteal angioplasty
and endovascular brachytherapy in VIENNA-2 study. Radiother Oncol. 2002;63:97-102.
54. Hofmann WJ. Preliminary observations on the need for control angiography after peripheral endovascular
brachytherapy using a centering balloon. J Endovasc Ther. 2002;9:241-5.
55. Pokrajac B. Present status of endovascular brachytherapy in peripheral arteries. Herz. 2002;27:56-61. Review.
56. Zorger N. Peripheral arterial balloon angioplasty: effect of short versus long balloon inflation times on the
morphologic results. J Vasc Interv Radiol. 2002;13:355-9.
57. Grimm J. Randomized study to compare PTA alone versus PTA with Palmaz stent placement for femoropopliteal
lesions. J Vasc Interv Radiol. 2001;12:935-42.
58. Cejna M. PTA versus Palmaz stent placement in femoropopliteal artery obstructions: a multicenter prospective
randomized study. J Vasc Interv Radiol. 2001;12:23-31.
59. Minar E. Endovascular brachytherapy for prophylaxis of restenosis after femoropopliteal angioplasty: results of a
prospective study. Circulation. 2000;102:2694-9.
60. Pokrajac B. Intraarterial (192)Ir high-dose-rate brachytherapy for prophylaxis of restenosis after femoropopliteal
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
percutaneous transluminal angioplasty: the prospective randomized VIENNA-2-trial radiotherapy parameters and
risk factors analysis. Int J Radiat Oncol Biol Phys. 2000;48:923-31.
61. Zdanowski Z, Albrechtsson U, Lundin A, Jonung T, Ribbe E, Thörne J, Norgren L. Percutaneous transluminal
angioplasty with or without stenting for femoropopliteal occlusions? A randomized controlled study. Int Angiol.
1999;18:251-5.
62. Suggs WD. When is urokinase treatment an effective sole or adjunctive treatment for acute limb ischemia
secondary to native artery occlusion? Am J Surg. 1999;178:103-6.
63. Nicholson T. Percutaneous transluminal angioplasty and enclosed thrombolysis versus percutaneous transluminal
angioplasty in the treatment of femoropopliteal occlusions: results of a prospective randomized trial. Cardiovasc
Intervent Radiol. 1998;21:470-4.
64. Vroegindeweij D. Balloon angioplasty combined with primary stenting versus balloon angioplasty alone in
femoropopliteal obstructions: A comparative randomized study. Cardiovasc Intervent Radiol. 1997;20:420-5.
65. Minar E. Comparison of effects of high-dose and low-dose aspirin on restenosis after femoropopliteal percutaneous
transluminal angioplasty. Circulation. 1995 Apr;91:2167-73.
66. Hartnell GG. Do hydrophilic guidewires affect the technical success rates of percutaneous angioplasty? Angiology.
1995;46:229-34.
67. Wolf GL. Surgery or balloon angioplasty for peripheral vascular disease: a randomized clinical trial. Principal
investigators and their Associates of Veterans Administration Cooperative Study Number 199. J Vasc Interv
Radiol. 1993;4:639-48.
68. Siegel RJ. Clinical trial of percutaneous peripheral ultrasound angioplasty. J Am Coll Cardiol. 1993;22:480-8.
69. London NJ. Subintimal angioplasty for femoropopliteal artery occlusion. Lancet. 1993;341:238.
70. Vroegindeweij D. Recurrence of stenoses following balloon angioplasty and Simpson atherectomy of the femoropopliteal segment. A randomised comparative 1-year follow-up study using colour flow duplex. Eur J Vasc Surg.
1992;6:164-71.
71. Belli AM. Follow-up of conventional angioplasty versus laser thermal angioplasty for total femoropopliteal artery
occlusions: results of a randomized trial. J Vasc Interv Radiol. 1991;2:485-8.
72. Minar E. [Randomized comparative study of the recurrence rate following femoro-popliteal PTA: high g/die) vs
low (0.1 g/die) acetylsalicylic acid dose]. Vasa Suppl. 1991;33:167. German.
73. Spies JB. Comparison of balloon angioplasty and laser thermal angioplasty in the treatment of femoropopliteal
atherosclerotic disease: initial results of a prospective randomized trial. Work in progress. J Vasc Interv Radiol.
1990;1:39-42.
74. Jeans WD. Randomized trial of laser-assisted passage through occluded femoro-popliteal arteries. Br J Radiol.
1990;63:19-21.
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Additional records identified through other sources
1. Banerjee S, COBRA Trial: Cryoplasty Or conventional Balloon postdilation of nitinol stents for Revascularization
of peripheral Arterial segments. December 01, 2011
2. Dattilo R, COMPLIANCE 360°: A Prospective, Randomized, Multicenter Trial Comparing Balloon Angioplasty to
Diamondback 360° Orbital Atherectomy System in Calcified Femoropopliteal Disease. November 08, 2011
3. van der Schaaf R, Paclitaxel-eluting Balloon in Primary Percutaneous Coronary Intervention in Amsterdam
(PAPPA): Short Term Outcome of a Pilot Study. November 08, 2011
4. Werk M, The PACIFIER Trial. A Randomized Multicenter Trial Evaluating Prevention of Restenosis with
Paclitaxel-Coated PTA Balloon Catheters in Stenosis or Occlusion of Femoropopliteal Arteries. September 09,
2011
5. Micari A, Drug Eluting Balloon for the Treatment of Femoro-Popliteal Arterial Disease: Mid-Term Results from a
Multicenter Italian Registry. May 18, 2011
6. O`Donnell T, A Randomized Controlled Double-Blinded Pilot Trial of Autologous Bone Marrow Concentrate for
No-Option Critical Limb Ischemia. January 20, 2011
7. Zeller T, DES-BTK: A Prospective, Double-Blind, Randomized Trial of Polymer-Free Sirolimus-Eluting Stents
Compared to Bare Metal Stents in Patients with Infrapopliteal Disease. September 24, 2010
8. Werner G, PEPCAD-CTO: A Prospective Nonrandomized Study of Paclitaxel-Eluting Balloons After Bare Metal
Stent Placement in Successfully Recanalized Chronic Total Coronary Occlusions. September 24, 2010
9. Wöhrle J, PERfECT STENT: A Prospective, Randomized Trial Evaluating a Paclitaxel-Eluting Balloon in Patients
Treated with Endothelial Progenitor Cell Capturing Stents for De Novo Coronary Artery Disease. September 23,
2010
10. Scheinert D, LEVANT I: A Prospective Randomized Trial of a Paclitaxel-Eluting Balloon Compared to a NonDrug-Eluting Balloon With and Without Stenting in Patients with Diseased Femoropopliteal Arteries. September
23, 2010
11. Detlef M, The PEPCAD V Bifurcation Study: Results from a Paclitaxel-Eluting Balloon for Bifurcation Coronary
Lesions. September 22, 2009
12. Scheinert D, LASER ROCKS: Randomized Comparison of Turbo-Booster Laser Atherectomy Prior to Stenting vs.
Stenting Alone in Complex SFA Lesions. September 21, 2009
13. Cortese B, Paclitaxel-eluting balloon versus paclitaxel-eluting stent in small coronary vessel disease: The
PICCOLETO Trial. May 21, 2009
14. Scheller B, The BRAUN Paclitaxel-Eluting Balloon Program: Device Characteristics, Experimental Findings, and
Inclusion
No
No
No
Yes
No
No
No
No
No
Yes
No
No
No
No
Clinical Outcomes In Patients with In-Stent Restenosis and For Small Vessels (PEPCAD I and II). October 13,
2008
15. Stella P, The DIOR Paclitaxel-Eluting Balloon For Bifurcation Lesions: Device Characteristics and Results from
the DEBIUT Registry and Ongoing Randomized Trial. October 13, 2008
16. Wahr D, The LUTONIX Paclitaxel-Eluting Balloon Program: Design Specifications, Experimental Observations,
and Clinical Trial Plans. October 13, 2008
17. Scheller P, PACCOCATH ISR 1 and 2: A Prospective, Randomized Trial of a Paclitaxel-Eluting Balloon in InStent Restenosis: 2-Year Results. October 24, 2007
18. Bosiers M, MELOPEE-study: 6-month data clinical, duplex and x-ray outcome of the triple helix designed
LifeStent in popliteal lesions. June 15, 2007
19. Krankenberg H, FAST LATE: Femoral Artery Stenting Trial: 12-Month Final Analysis. October 23, 2006
20. Krankenberg H, FAST: (Femoral Artery Stenting Trial) - Acute Results and 6-Month Outcomes. October 18, 2005
21. Duda S, Role of Drug-eluting Stents for Peripheral de novo Lesions – SIROCCO. January 03, 2003
No
No
No
No
No
No
Supplemental Table 3. Main features of devices used
Trial
Drug dose/Balloon surface
Drug/Balloon loading component
Elution excipient
Excipient hydrophilicity
Manufacturer
THUNDER1
FemPac2
LEVANT I3
PACIFIER4
3 μg/mm2
3 μg/mm2
2 μg/mm2
3 μg/mm2
Ethyl acetate/Acetone
Ethyl acetate/Acetone
Unknown*
Urea†
Iopromide
None
Unknown*
Urea†
+
-
n/a
+++
Bavaria
Medizin
Technologie/Bayer AG
Bavaria
Medizin
Technologie/Bayer AG
Lutonix Inc.
Medtronic-Invatec Inc.
Trial acronyms: THUNDER: Local Taxane with Short Exposure for Reduction of Restenosis in Distal Arteries trial; FemPac: Femoral Paclitaxel
trial; LEVANT I: Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropoliteal Restenosis; PACIFIER: Paclitaxel-coated Balloons in
Femoral Indication to Defeat Restenosis. *Drug carrier is a molecular entity on the Food and Drug Administration IV-approved list. (Informations
at http://www.lutonix.com/product/technology/moxy. Last access performed on January 2012). †Dosage 0.5 µg/mm2; n/a: not assessable.
10
Supplemental References
1. Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwalder 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.
2. Werk M, Langner S, Reinkensmeier B, Boettcher HF, Tepe G, Dietz U, Hosten N, Hamm B, Speck U, Ricke J.
Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel
randomized pilot trial. Circulation 2008;118:1358-65.
3. Scheinert D. LEVANT I Trial 6-month results - A Comparison of the Moxy™ Drug Coated Balloon Catheter vs
Standard PTA for Femoropopliteal Disease. Transcatheter Cardiovascular Therapeutics Congress, 2010 September,
Washington, DC 2010;Oral presentation available at: http://www.tctmd.com/show.aspx?id=102034.
4. Werk M, Albrecht T, Meyer DR, Stiepani H, Schnorr B, Dietz U, Lopez Hänninen E. The PACIFIER trial. A
randomized multicenter trial evaluating prevention of restenosis with paclitaxel-coated PTA balloon catheters in
stenosis or occlusion of femoropopliteal arteries. Cardiovascular and Interventional Radiological Society of Europe
Congress, 2011 September, Munich 2011;Oral presentation available at:
http://www.esir.org/cslide/library/esir/mylibrary/authors/W/M.+Werk