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