Advertisement

CardioVascular and Interventional Radiology

, Volume 41, Issue 7, pp 1008–1014 | Cite as

Two-Year Clinical Outcomes of the CONSEQUENT Trial: Can Femoropopliteal Lesions be Treated with Sustainable Clinical Results that are Economically Sound?

  • Thomas Albrecht
  • Matthias Waliszewski
  • Catherine Roca
  • Ulf Redlich
  • Jörg Tautenhahn
  • Maciej Pech
  • Zuhir Halloul
  • Özlem Gögebakan
  • Dirk-Roelfs Meyer
  • Ines Gemeinhardt
  • Thomas Zeller
  • Stefan Müller-Hülsbeck
  • Ilka Ott
  • Gunnar Tepe
Clinical Investigation

Abstract

Purpose

The previously reported 6-month angiographic and 12-month clinical outcomes of the CONSEQUENT trial demonstrated the safety and efficacy of a novel paclitaxel–resveratrol-coated balloon for the treatment of lesions in the femoropopliteal segment. The purpose of this report is to present the 2-year results including a cost-benefit analysis for Germany.

Materials and Methods

Patients with symptomatic peripheral artery occlusive disease in femoropopliteal lesions were randomized either to drug-coated balloon (DCB, n = 78) or plain old balloon angioplasty (POBA, n = 75). As secondary endpoints, the 2-year clinical results consisting of target lesion revascularization (TLR), patency and increase in walking distance were recorded. Based on the Kaplan–Meier analyses for TLR and other adverse events, a cost-benefit analysis was conducted for the German DRG system.

Results

There were no additional TLRs in both groups between 14 and 24 months so that the corresponding rates remained significantly different between the treatment groups (DCB: 19.1 vs. POBA 40.6%, p = 0.007). At 2 years, the patency rate was significantly higher in the DCB group (72.3 vs. 48.4%, p = 0.006). The walking distance increase was also significantly higher after DCB angioplasty (172 ± 103 vs. 52 ± 136 m, p = 0.001). We estimated 2-year cost savings of € 1111.97 per patient treated with DCB instead of POBA.

Conclusions

The use of paclitaxel–resveratrol matrix-coated peripheral balloons compared to POBA was associated with a significantly reduced TLR rate, superior patency and substantial cost savings at 2 years.

ClinicalTrials.gov Identifier NCT01970579.

Keywords

Drug-coated balloon catheter Peripheral artery occlusive disease Femoropopliteal lesions Target lesion revascularization Cost efficacy 

Notes

Acknowledgements

This research could not have been conducted without the help of Dr. Bettina Kelsch, Dr. Maren Kutschera and Dr. Beatrix Schnorr at InnoRa Berlin, Germany. For his statistical expertise, we wish to thank Dr. Ralf Degenhardt at the Herzkreislaufzentrum Rotenburg, Germany and Denny Herberger at Medical Scientific Affairs B.Braun, Berlin for his logistic support. We also wish to acknowledge Marco Fahrt and Steffen Kruse at B.Braun’s Government Affairs and Market Access department who provided their insights for the economic model of this work.

Funding

Based on a milestone system, all study participants received funding from B.Braun per included patient.

Compliance with Ethical Standards

Conflict of interest

TA and GT have received lecturer honoraria and research grants from B.Braun to conduct this trial. MW is a full-time employee in the Medical Scientific Affairs department of B.Braun Melsungen AG, Vascular Systems, Berlin/Germany. SMH received lecturer honoraria and travel grants from Terumo and Boston Scientific. TZ received honoraria from Abbott Vascular, Bard Peripheral Vascular, Veryan, Biotronik, Boston Scientific Corp., Cook Medical, Gore & Associates, Medtronic, Philips-Spectranetics, TriReme, Veryan, Shockwave, Biotronik, QT Medical and consulted for Boston Scientific Corp., Cook Medical, Gore & Associates, Medtronic, Spectranetics, B.Braun.

Ethical Approval

The study was approved by the Federal Institute for Drugs and Medical Devices (Ref. 95.05-5660-8211), by the Federal Agency for Radiation Protection (Ref. Z5-22462/2) and by all relevant ethics committees of participating centers. Patients gave written informed consent prior to inclusion. An independent critical event committee was installed to adjudicate event rates. Blinded quantitative angiographic analysis was conducted by an independent core laboratory. This trial was registered with the US National Institutes of Health (clinicaltrials.gov NCT01970579) prior to recruitment. This trial was conducted in accordance with the updated Declaration of Helsinki and other relevant guidance.

Informed Consent

Informed consent was obtained from all individual participants included in the study.

References

  1. 1.
    Tepe G, Gögebakan Ö, Redlich U, et al. Angiographic and clinical outcomes after treatment of femoro-popliteal lesions with a novel paclitaxel-matrix-coated balloon catheter. Cardiovasc Intervent Radiol. 2017;40(10):1535–44.CrossRefPubMedGoogle Scholar
  2. 2.
    Herten M, Torsello GB, Schönefeld E, Stahlhoff S. Critical appraisal of paclitaxel balloon angioplasty for femoral-popliteal arterial disease. Vasc Health Risk Manag. 2016;12:341–56.CrossRefPubMedPubMedCentralGoogle Scholar
  3. 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.CrossRefPubMedGoogle Scholar
  4. 4.
    Salisbury AC, Li H, Vilain KR, et al. Cost-effectiveness of endovascular femoropopliteal intervention using drug-coated balloons versus standard percutaneous transluminal angioplasty: results from the IN.PACT SFA II Trial. JACC Cardiovasc Interv. 2016;9(22):2343–52.CrossRefPubMedGoogle Scholar
  5. 5.
    Pietzsch JB, Geisler BP, Garner AM, Zeller T, Jaff MR. Economic analysis of endovascular interventions for femoropopliteal arterial disease: a systematic review and budget impact model for the United States and Germany. Catheter Cardiovasc Interv. 2014;84(4):546–54.CrossRefPubMedGoogle Scholar
  6. 6.
  7. 7.
    Roca C. Clinical and economic benefits of SeQuent® Please OTW: Masters Thesis. Welsh School of Pharmacy, Cardiff University in collaboration with Hochschule Fresenius, June 2017.Google Scholar
  8. 8.
    Diehm N, Diehm C, Kalka C, Dick F. Peripheral endovascular revascularization trials: high noon for uniform reporting standards. Acta Chir Belg. 2008;108(4):382–5.CrossRefPubMedGoogle Scholar
  9. 9.
    Byrne RA, Joner M, Alfonso F, Kastrati A. Drug-coated balloon therapy in coronary and peripheral artery disease. Nat Rev Cardiol. 2014;11(1):13–23.CrossRefPubMedGoogle Scholar
  10. 10.
    Tepe G, Zeller T, Albrecht T, et al. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. 2008;358(7):689–99.CrossRefPubMedGoogle Scholar
  11. 11.
    Werk M, Langner S, Reinkensmeier B, et al. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation. 2008;118(13):1358–65.CrossRefPubMedGoogle Scholar
  12. 12.
    Werk M, Albrecht T, Meyer DR, et al. Paclitaxel-coated balloons reduce restenosis after femoro-popliteal angioplasty: evidence from the randomized PACIFIER trial. Circ Cardiovasc Interv. 2012;5(6):831–40.CrossRefPubMedGoogle Scholar
  13. 13.
    Rosenfield K, Jaff MR, White CJ, et al. LEVANT 2 investigators. Trial of a paclitaxel-coated balloon for femoropopliteal artery disease. N Engl J Med. 2015;373(2):145–53.CrossRefPubMedGoogle Scholar
  14. 14.
    Scheinert D, Duda S, Zeller T, et al. The LEVANT I (Lutonix paclitaxel-coated balloon for the prevention of femoropopliteal restenosis) trial for femoropopliteal revascularization: first-in-human randomized trial of low-dose drug-coated balloon versus uncoated balloon angioplasty. JACC Cardiovasc Interv. 2014;7(1):10–9.CrossRefPubMedGoogle Scholar
  15. 15.
    Schroeder H, Meyer DR, Lux B, Ruecker F, Martorana M, Duda S. Two-year results of a low-dose drug-coated balloon for revascularization of the femoropopliteal artery: outcomes from the ILLUMENATE first-in-human study. Catheter Cardiovasc Interv. 2015;86(2):278–86.CrossRefPubMedGoogle Scholar
  16. 16.
    Schroeder H, Werner M, Meyer DR, et al. ILLUMENATE EU RCT investigators. Low-dose paclitaxel-coated versus uncoated percutaneous transluminal balloon angioplasty for femoropopliteal peripheral artery disease: one-year results of the ILLUMENATE European randomized clinical trial (randomized trial of a novel paclitaxel-coated percutaneous angioplasty balloon). Circulation. 2017;135(23):2227–36.CrossRefPubMedPubMedCentralGoogle Scholar
  17. 17.
    Scheinert D, Schulte KL, Zeller T, Lammer J, Tepe G. Paclitaxel-releasing balloon in femoropopliteal lesions using a BTHC excipient: twelve-month results from the BIOLUX P-I randomized trial. J Endovasc Ther. 2015;22(1):14–21.CrossRefPubMedGoogle Scholar
  18. 18.
    Jia X, Zhang J, Zhuang B, et al. Acotec drug-coated balloon catheter: randomized, multicenter, controlled clinical study in femoropopliteal arteries: evidence from the AcoArt I trial. JACC Cardiovasc Interv. 2016;9(18):1941–9.CrossRefPubMedGoogle Scholar
  19. 19.
    Katsanos K, Spiliopoulos S, Paraskevopoulos I, Diamantopoulos A, Karnabatidis D. Systematic review and meta-analysis of randomized controlled trials of paclitaxel-coated balloon angioplasty in the femoropopliteal arteries: role of paclitaxel dose and bioavailability. J Endovasc Ther. 2016;23(2):356–70.CrossRefPubMedGoogle Scholar
  20. 20.
    Krishnan P, Faries P, Niazi K, et al. Stellarex drug-coated balloon for treatment of femoropopliteal disease: twelve-month outcomes from the randomized ILLUMENATE pivotal and pharmacokinetic studies. Circulation. 2017;136(12):1102–13.CrossRefPubMedPubMedCentralGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2018

Authors and Affiliations

  • Thomas Albrecht
    • 1
  • Matthias Waliszewski
    • 2
    • 3
  • Catherine Roca
    • 4
    • 5
  • Ulf Redlich
    • 6
  • Jörg Tautenhahn
    • 6
  • Maciej Pech
    • 7
  • Zuhir Halloul
    • 8
  • Özlem Gögebakan
    • 1
  • Dirk-Roelfs Meyer
    • 9
  • Ines Gemeinhardt
    • 10
  • Thomas Zeller
    • 11
  • Stefan Müller-Hülsbeck
    • 12
  • Ilka Ott
    • 13
  • Gunnar Tepe
    • 14
  1. 1.Radiology and Interventional TherapyVivantes Hospital Berlin NeuköllnBerlinGermany
  2. 2.Medical Scientific AffairsB.Braun Melsungen AGBerlinGermany
  3. 3.Department of Internal Medicine and CardiologyCharité – Universitätsmedizin BerlinBerlinGermany
  4. 4.Welsh School of PharmacyCardiff UniversityCardiffUK
  5. 5.Hochschule FreseniusIdsteinGermany
  6. 6.Departments of Radiology and Vascular SurgeryKlinikum MagdeburgMagdeburgGermany
  7. 7.Department of Radiology and Nuclear MedicineUniversity Hospital MagdeburgMagdeburgGermany
  8. 8.Departments of Vascular SurgeryUniversity Hospital MagdeburgMagdeburgGermany
  9. 9.Department of Diagnostic and Interventional RadiologyHubertus HospitalBerlinGermany
  10. 10.Charité UniversitätsmedizinBerlinGermany
  11. 11.University Heart Center Bad KrozingenBad KrozingenGermany
  12. 12.Department of Diagnostic and Interventional Radiology and NeuroradiologyDiakonissenanstalt zu FlensburgFlensburgGermany
  13. 13.Heart Center MunichMunichGermany
  14. 14.Department of RadiologyRoMed Klinikum RosenheimRosenheimGermany

Personalised recommendations