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The Journal of Cardiovascular Surgery 2019 Apr 15

DOI: 10.23736/S0021-9509.19.10830-0

Copyright © 2019 EDIZIONI MINERVA MEDICA

lingua: Inglese

One-year outcome of the everolimus eluting, balloon expandable Promus Element and Promus Element Plus stent in the treatment of below-the-knee lesions in patients with critical limb ischemia

Kim TAEYMANS 1, Marc BOSIERS 1 , Koen DELOOSE 1, Joren CALLAERT 1, Koen KEIRSE 2, Jürgen VERBIST 3, Wouter van der EYNDE 3, Giovanni TORSELLO 4, Jeroen WAUTERS 5

1 A.Z. Sint-Blasius, Dendermonde, Belgium; 2 RZ Heilig Hart Hospital, Tienen, Belgium; 3 Imelda Hospital, Bonheiden, Belgium; 4 Sint-Franziskus Hospital, Münster, Germany; 5 Flanders Medical Research Program, Dendermonde, Belgium


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BACKGROUND: To investigate the efficacy of the balloon expandable Promus Element and Promus Element Plus stent , coated with everolimus, in the treatment of short, focal infrapopliteal lesions.
METHODS: The PREVENT study was a prospective, multi-center, non-randomized, single arm study evaluating the safety and efficacy of the Promus Element and Promus Element Plus stent in the treatment of stenotic or occlusive lesions ≤40 mm long in the tibioperoneal arteries of patients with critical limb ischemia (CLI). A total of 70 study subjects were enrolled in a period of 26 months, between November 2012 and December 2014. The mean age was 77,84 (62-90; ± 6,62) years and 47 patients were men (67.1%). Mean lesion length was 22.83 (5-40; ± 8.78) mm. 44.3% of the lesions were occluded, whereas 55.7% were stenotic. Primary endpoint was primary patency at 12 months, defined as absence of restenosis (≥50% stenosis) or occlusion within the originally treated lesion based on angiography. Secondary outcomes included hemodynamic primary patency on duplex ultrasound (PSV ratio ≤2.4 ), limb salvage and freedom from target lesion revascularization (TLR).
RESULTS: Technical and procedural success (<30% residual angiographic stenosis without major complications) was achieved in all 70 cases (100%). Primary patency was 93.8 % at 6 months and 86.2% at 1 year. Freedom from TLR was 93% at 1 year. Limb salvage rate at 12 month follow-up, defined as absence of major amputation, was 100%.
CONCLUSIONS: This study shows the safety and efficacy of the everolimus eluting, balloon expandable Promus Element and Promus Element Plus stent in the treatment of below-the-knee lesions in patients with critical limb ischemia.


KEY WORDS: Below-the-knee arteries - Critical limb ischemia - Drug-eluting stent - Infrapopliteal arteries - Lower limb - Everolimus - Peroneal artery - Balloon expandable stent - Tibial artery

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