In a recent systematic review and meta-analysis of randomised controlled trials,
1
Katsanos et al. investigated the long term risk of major amputation associated with the use of paclitaxel drug coated balloons (DCBs) in the lower limbs. A significantly higher long term risk of major limb loss using DCBs was found. The authors must be congratulated for this very valuable work and the concerns raised must be confirmed or refuted by specific trials.- Katsanos K.
- Spiliopoulos S.
- Teichgräber U.
- Kitrou P.
- Del Giudice C.
- Björkman P.
- et al.
Risk of major amputation following application of paclitaxel coated balloons in the lower limb arteries: a systematic review and meta-analysis of randomised controlled trials.
Eur J Vasc Endovasc Surg. 2022; 63: 60-71
It should be emphasised that the comparator arm used in one of the trials included in the analysis was not standard plain balloon angioplasty. In the PACUS trial,
2
whose results were significantly against DCBs (hazard ratio 7.96; 1.38–46.00, the worst of all the included studies), uncoated balloon angioplasty was followed by local intravascular ultrasound energy treatment. A balloon was then inflated distal to the lesion to create flow cessation, and a paclitaxel iodinated contrast mixture was injected into the stagnant blood column and allowed to absorb into the vessel wall for 60 seconds. The readers of the journal should be aware that the control arm of this study also received paclitaxel using a different method.Conflict of interest
Raphaël COSCAS had received speaking honoraria from Becton Dickinson, Medtronic, Boston Scientific.
References
- Risk of major amputation following application of paclitaxel coated balloons in the lower limb arteries: a systematic review and meta-analysis of randomised controlled trials.Eur J Vasc Endovasc Surg. 2022; 63: 60-71
- Local ultrasound to enhance paclitaxel delivery after femoral-popliteal treatment in critical limb ischemia: the PACUS trial.JACC Cardiovasc Interv. 2016; 9: 2147-2153
Article info
Publication history
Published online: March 02, 2022
Accepted:
November 12,
2021
Received:
November 6,
2021
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© 2022 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.
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- Editor's Choice – Risk of Major Amputation Following Application of Paclitaxel Coated Balloons in the Lower Limb Arteries: A Systematic Review and Meta-Analysis of Randomised Controlled TrialsEuropean Journal of Vascular and Endovascular SurgeryVol. 63Issue 1
- PreviewThere have been concerns about the long term safety of paclitaxel coated devices in the lower limbs. A formal systematic review and meta-analysis of randomised controlled trials (RCTs) was performed to examine the long term risk of major amputation using paclitaxel coated balloons in peripheral arterial disease (PAD).
- Full-Text
- Preview
- Response to “Re Risk of Major Amputation Following Application of Paclitaxel Coated Balloons in the Lower Limb Arteries: a Systematic Review and Meta-Analysis of Randomised Controlled Trials”European Journal of Vascular and Endovascular SurgeryVol. 63Issue 4
- PreviewWe thank Dr Coscas and colleagues for their interest in our recent paper documenting a substantially higher risk of major amputation following use of paclitaxel coated balloons in the infra-inguinal arteries.1 The authors discuss the fact that the control arm in the PACUS trial had also received liquid paclitaxel at the treatment site. We would like to clarify that this has been noted and accounted for in our meta-analysis. First, as explained in the legend of Table 1, in the PACUS trial, DCB were randomised vs.
- Full-Text
- Preview
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