Abstract
Purpose
To report the 3-year results of the MAJESTIC first-in-human study of the Eluvia Drug-Eluting Vascular Stent System for treating femoropopliteal artery lesions.
Methods
The prospective, single-arm, multicenter clinical trial enrolled 57 patients with symptomatic lower limb ischemia (Rutherford category 2, 3, or 4) and lesions in the superficial femoral artery or proximal popliteal artery. Mean lesion length was 70.8 ± 28.1 mm, and 46% of lesions were occluded. Efficacy measures at 2 years included primary patency, defined as duplex ultrasound peak systolic velocity ratio of ≤2.5 and the absence of target lesion revascularization (TLR) or bypass. Safety monitoring through 3 years included adverse events and TLR.
Results
Primary patency was estimated as 83.5% (Kaplan–Meier analysis) at 24 months, and 90.6% (48/53) of patients maintained an improvement in Rutherford class. At 36 months, the Kaplan–Meier estimate of freedom from TLR was 85.3%. No stent fractures were identified, and no major target limb amputations occurred.
Conclusion
MAJESTIC results demonstrated long-term treatment durability among patients whose femoropopliteal arteries were treated with the paclitaxel-eluting Eluvia stent.
Level of Evidence
Level 2b, cohort study
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Acknowledgements
The authors thank the following Boston Scientific employees for their assistance: Lieve Cornelis, Lisa Melchior, and Teri Takle-Flach for clinical program management, H. Terry Liao, PhD, for statistical analysis, and Elizabeth J. Davis, PhD, for medical writing. This study was funded by Boston Scientific Corporation (Marlborough, MA).
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Stefan Müller-Hülsbeck serves as a consultant for Boston Scientific and has received consulting fees, speaker honorarium, and support for accommodation and traveling when presenting BSC-related data. Thomas Zeller serves as a consultant for Boston Scientific, Cook, Medtronic, W. L. Gore, Veryan, Spectranetics, Trireme, and Terumo and has received consulting fees, speaker honoraria, and support for accommodation and traveling from the same companies. Herman Schroë serves as a consultant for Boston Scientific and has received consulting fees, speaker honorarium, and support for accommodation and traveling when presenting BSC-related data. Juan Diaz-Cartelle is an employee of and owns stock in Boston Scientific Corporation. Koen Keirse declares no conflicts of interest.
Ethical Approval
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.
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Informed consent was obtained from all individual participants included in the study.
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Müller-Hülsbeck, S., Keirse, K., Zeller, T. et al. Long-Term Results from the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Femoropopliteal Treatment: 3-Year Follow-up. Cardiovasc Intervent Radiol 40, 1832–1838 (2017). https://doi.org/10.1007/s00270-017-1771-5
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DOI: https://doi.org/10.1007/s00270-017-1771-5