In this linked registry claims study (Vascular Quality Initiative registry and Medicare
claims data), Mao et al. report the outcomes of 11 452 patients with femoropopliteal atherosclerotic disease
treated with either paclitaxel coated devices (PCD) or non-PCD.
1
The primary outcome was all cause mortality and the secondary outcome was major amputation
within three years after the index intervention. The treatment effect was analysed
using inverse probability weighting (IPW). In order to identify differential effects
and increase the understanding of previous conflicting results, the authors created
three subgroups: (A) patients treated for femoropopliteal or infrapopliteal occlusive
disease with or without any other concurrent treatment; (B) patients treated for isolated
superficial femoral or popliteal artery disease; and (C) patients with inclusion criteria
designed to approximate randomised clinical trial (RCT) populations. In this large
and robust study based on real world data, with very few missing and a low dropout
rate, the authors did not observe increased all cause mortality (even a potential
protective effect) or major amputation at three years after the intervention with
PCD in any of the groups.To read this article in full you will need to make a payment
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References
- Real-world study of mortality after the use of paclitaxel-coated devices in peripheral vascular intervention.Eur J Vasc Endovasc Surg. 2023; 65: 131-140
- 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.J Am Heart Assoc. 2018; 7: e011245
- Mortality rates after paclitaxel-coated device use in patients with occlusive femoropopliteal disease: an updated systematic review and meta-analysis of randomized controlled trials.J Endovasc Ther. 2021; 28: 755-777
- Paclitaxel and mortality following peripheral angioplasty: an adjusted and case matched multicentre analysis.Eur J Vasc Endovasc Surg. 2020; 60: 220-229
- Mortality with paclitaxel-coated devices in peripheral artery disease.N Engl J Med. 2020; 383: 2538-2546
- Comparison of propensity score methods and covariate adjustment: evaluation in 4 cardiovascular studies.J Am Coll Cardiol. 2017; 69: 345-357
- Systematic review and narrative synthesis of randomised controlled trials supporting implantable devices for vascular and endovascular procedures.Eur J Vasc Endovasc Surg. 2022; 64: 57-64
Article info
Publication history
Published online: August 31, 2022
Accepted:
August 26,
2022
Received:
August 24,
2022
Identification
Copyright
© 2022 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.
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- Editor's Choice – Real World Study of Mortality After the Use of Paclitaxel Coated Devices in Peripheral Vascular InterventionEuropean Journal of Vascular and Endovascular SurgeryVol. 65Issue 1
