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Long-Term Mortality of Matched Patients with Intermittent Claudication Treated by High-Dose Paclitaxel-Coated Balloon Versus Plain Balloon Angioplasty: A Real-World Study

  • Clinical Investigation
  • Arterial Interventions
  • Published:
CardioVascular and Interventional Radiology Aims and scope Submit manuscript

Abstract

Purpose

The aim of this study was to assess the long-term mortality of patients treated by the IN.PACT Admiral (Medtronic, Dublin, Ireland) paclitaxel-coated balloon angioplasty (PCBA) compared with standard plain balloon angioplasty (POBA).

Materials and Methods

Between January 2013 and January 2014, 238 patients met the inclusion criteria. A two-step analysis was performed. In step 1, the 5-year mortality of the whole patient population was evaluated regardless of possible differences in the patient demographics. In step 2, a matched paired analysis was performed using propensity scores. In addition, for those patients who were treated with PCBA, a possible correlation between dose of paclitaxel and mortality was evaluated.

Results

Univariate analysis for the whole group of patients (POBA group A, n = 84 and PCBA group B, n = 121) showed a 5-year mortality rate of 26.2% versus 14.0%, p = 0.02, respectively. Univariate analysis of 77 pairs of propensity score-matched patients resulted in mortality of 26.0% versus 20.8%, p = 0.4, of group A and B, respectively (median follow-up of 61.7 and 61.8 months, p = 0.8, respectively). Comparison of the patients of group B who died versus those who survived showed no correlation between the dose of paclitaxel with increased mortality (p = 0.4).

Conclusion

The 5-year findings of the present real-world study showed no increased mortality for the matched patients who underwent PCBA versus POBA. In addition, there was no correlation between mortality and the dose of paclitaxel used.

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References

  1. Katsanos K, Tepe G, Tsetis D, et al. Standards of practice for superficial femoral and popliteal artery angioplasty and stenting. Cardiovasc Intervent Radiol. 2014;37:592–603.

    Article  Google Scholar 

  2. 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.e8–33.e8.

    Article  Google Scholar 

  3. Laird JR, Schneider PA, Tepe G, et al. IN.PACT SFA trial investigators. Durability of treatment effect using a drug-coated balloon for femoropopliteal lesions: 24-month results of IN.PACT SFA. J Am Coll Cardiol. 2015;66(21):2329–38.

    Article  Google Scholar 

  4. Albrecht T, Ukrow A, Werk M, et al. Correction to: impact of patient and lesion characteristics on drug-coated balloon angioplasty in the femoropopliteal artery: a pooled analysis of four randomized controlled multicenter trials. Cardiovasc Intervent Radiol. 2019;42(7):1055. https://doi.org/10.1007/s00270-019-02203-y.

    Article  PubMed  Google Scholar 

  5. Albrecht T, Ukrow A, Werk M, et al. Impact of patient and lesion characteristics on drug-coated balloon angioplasty in the femoropopliteal artery: a pooled analysis of four randomized controlled multicenter trials. Cardiovasc Intervent Radiol. 2019;42(4):495–504. https://doi.org/10.1007/s00270-018-2137-3Epub 2018 Dec 11.

    Article  PubMed  Google Scholar 

  6. Katsanos K, Spiliopoulos S, Kitrou P, et al. 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.

    Article  Google Scholar 

  7. Fanelli F, Cortese B, Zeller T. Use of paclitaxel-eluting technologies in the femoropopliteal segment under scrutiny over possible link to late all-cause mortality: time to panic or an opportunity to resurge? J Endovasc Ther. 2019;26(1):41–3.

    Article  Google Scholar 

  8. Bisdas T, Beropoulis E, Argyriou A, et al. 1-Year all-comers analysis of the eluvia drug-eluting stent for long femoropopliteal lesions after suboptimal angioplasty. JACC. 2018;11:957–66.

    PubMed  Google Scholar 

  9. Shishehbor MH, Secemsky EA, Varcoe R. Is there a real association between paclitaxel devices and mortality? Time to pause and re-evaluate what we know about this statistical finding. J Am Heart Assoc. 2019;8:e012524.

    Article  Google Scholar 

  10. Schneider PA, Laird JR, Doros G, Gao Q, Ansel G, Brodmann M, Micari A, Shishehbor MH, Tepe G, Zeller T. Mortality not correlated with paclitaxel exposure: an independent patient-level meta-analysis of a drug-coated balloon. J Am Coll Cardiol. 2019;73(20):2550–63.

    Article  Google Scholar 

  11. Gerhard-Herman MD, Gornik HL, Barrett C, et al. 2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: executive summary: a report of the American college of cardiology/American heart association task force on clinical practice guidelines. Circulation. 2017;135:e686–725.

    PubMed  Google Scholar 

  12. Olin JW, Allie DE, Belkin M, American College of Cardiology Foundation, American Heart Association, American College of Radiology, Society for Cardiac Angiography Interventions, Society for Interventional Radiology, Society for Vascular Medicine, Society for Vascular Nursing, Society for Vascular Surgery, et al. ACCF/AHA/ACR/SCAI/SIR/SVM/SVN/SVS 2010 performance measures for adults with peripheral artery disease: a report of the American college of cardiology foundation/American heart association task force on performance measures, the American college of radiology, the society for cardiac angiography and interventions, the society for interventional radiology, the society for vascular medicine, the society for vascular nursing, and the society for vascular surgery (writing committee to develop clinical performance measures for peripheral artery disease). J Am Coll Cardiol. 2010;56:2147–81.

    Article  Google Scholar 

  13. Dake MD, Ansel GM, Jaff MR, et al. Durable clinical effectiveness with paclitaxel-eluting stents in the femoropopliteal artery: 5-year results of the Zilver PTX randomized trial. Circulation. 2016;133:1472–83 (discussion 1483).

    Article  CAS  Google Scholar 

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Author notes

  1. Konstantinos P. Donas and Anne Sohr have contributed equally to this work.

Authors and Affiliations

  1. Department of Vascular Surgery, St. Franziskus Hospital Münster, Hohenzollernring 72, 48145, Münster, Germany

    Konstantinos P. Donas, Anne Sohr & Giovanni Torsello

  2. Department of Surgery, Division of Vascular Surgery, Aristotle University of Thessaloniki, Thessaloniki, Greece

    Georgios A. Pitoulias

  3. Department of Cardiology, La Princesa University Hospital, Madrid, Spain

    Fernando Alfonso

Authors
  1. Konstantinos P. Donas
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  2. Anne Sohr
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  3. Georgios A. Pitoulias
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  4. Fernando Alfonso
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Correspondence to Konstantinos P. Donas.

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Donas, K.P., Sohr, A., Pitoulias, G.A. et al. Long-Term Mortality of Matched Patients with Intermittent Claudication Treated by High-Dose Paclitaxel-Coated Balloon Versus Plain Balloon Angioplasty: A Real-World Study. Cardiovasc Intervent Radiol 43, 2–7 (2020). https://doi.org/10.1007/s00270-019-02329-z

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  • DOI: https://doi.org/10.1007/s00270-019-02329-z

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