Long-Term Results from the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Femoropopliteal Treatment: 3-Year Follow-up
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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.
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.
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.
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
KeywordsClaudication Drug-eluting stent Paclitaxel Peripheral artery disease Popliteal artery Superficial femoral artery
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).
Compliance with Ethical Standards
Conflict of interest
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.
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.
Informed consent was obtained from all individual participants included in the study.
- 8.Tepe G, Laird J, Schneider P, et al. Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and/or popliteal peripheral artery disease: 12-month results from the In PACT SFA randomized trial. Circulation. 2015;131:495–502.CrossRefPubMedPubMedCentralGoogle Scholar
- 17.Stone GW, Teirstein PS, Meredith IT, et al. A prospective, randomized evaluation of a novel everolimus-eluting coronary stent: the platinum (a prospective, randomized, multicenter trial to assess an everolimus-eluting coronary stent system [Promus element] for the treatment of up to two de novo coronary artery lesions) trial. J Am Coll Cardiol. 2011;57:1700–8.CrossRefPubMedGoogle Scholar
- 19.Gasior P, Cheng Y, Valencia AF, et al. Impact of fluoropolymer-based paclitaxel delivery on neointimal proliferation and vascular healing: a comparative peripheral drug-eluting stent study in the familial hypercholesterolemic swine model of femoral restenosis. Circ Cardiovasc Interv. 2017;10:e004450.CrossRefPubMedGoogle Scholar