1-Year All-Comers Analysis of the Eluvia Drug-Eluting Stent for Long Femoropopliteal Lesions After Suboptimal Angioplasty

Bisdas, Theodosios; Beropoulis, Efthymios; Argyriou, Angeliki; Torsello, Giovanni; Stavroulakis, Konstantinos

doi:10.1016/j.jcin.2018.03.046

Cited by 74 publications

(62 citation statements)

References 28 publications

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“…However, these studies provide a range of reference and context for the IMPERIAL study results. In a registry of Eluvia use at a single European center, a 12-month primary patency rate of 87% in patients with a mean lesion length of 20 cm (48% with CLTI) was reported, 13 further supporting the notion of independence between patency and lesion length for patients treated with Eluvia. Treatment of long lesions with the paclitaxelcoated Zilver PTX stent yielded 1-year primary patency rates of 52.5% in a single-center registry in France (mean lesion length 25 cm, 51% with CLTI at baseline) 14 and 86.4% in a multicenter registry in Japan (mean lesion length 14.7 cm, 21.5% with CLTI).…”

Section: Discussionmentioning

confidence: 69%

Effectiveness and Safety of a Paclitaxel-Eluting Stent for Superficial Femoral Artery Lesions up to 190 mm: One-Year Outcomes of the Single-Arm IMPERIAL Long Lesion Substudy of the Eluvia Drug-Eluting Stent

et al. 2020

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Purpose: To report the clinical effect of a drug-eluting stent on femoropopliteal occlusive disease in patients with long lesions. Materials and Methods: The global IMPERIAL Long Lesion substudy ( ClinicalTrials.gov identifier NCT02574481) is a prospective, single-arm, multicenter trial of the Eluvia Drug-Eluting Vascular Stent for treating femoropopliteal lesions >140 mm and ≤190 mm in length. Fifty patients (mean age 68.2 years; 32 men) with long lesions (mean length 162.8±34.7 mm) were enrolled; 20 patients had diabetes. Fourteen of the lesions were severely calcified and 16 were occluded. Primary patency (duplex ultrasound peak systolic velocity ratio ≤2.4 in the absence of clinically-driven target lesion revascularization or bypass of the target lesion) and major adverse events [30-day all-cause death and 1-year target limb major amputation or target lesion revascularization (TLR)] were assessed at 12 months. Results: At 12 months, no deaths, target limb amputations, or stent thrombosis had occurred. The Kaplan-Meier estimate of primary patency was 91.0% (95% CI 82.5% to 99.6%). The MAE-free rate at 12 months was 93.5% due to 3 clinically-driven TLRs. The corresponding Kaplan-Meier estimate of freedom from TLR was 93.9% (95% CI 87.2% to 100%). Conclusion: The IMPERIAL Long Lesion substudy demonstrated excellent patency and safety through 1 year among patients with long femoropopliteal occlusive disease treated with the Eluvia stent.

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Section: Discussionmentioning

confidence: 69%

Effectiveness and Safety of a Paclitaxel-Eluting Stent for Superficial Femoral Artery Lesions up to 190 mm: One-Year Outcomes of the Single-Arm IMPERIAL Long Lesion Substudy of the Eluvia Drug-Eluting Stent

et al. 2020

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“…The causes of vessel injury included oversized balloons, high-pressure inflation, stent fracture, or infection [13]. Although the precise pathophysiology is unknown, paclitaxel may be implicated due to a combination of cytotoxic effects on the vascular wall, hypersensitivity-related extensive inflammation, and delayed neointimal healing [6,[16][17].…”

Section: Discussionmentioning

confidence: 99%

Superficial Femoral Artery Pseudoaneurysm and Arterial Wall Destruction After Drug-Coated Balloon Treatment

Golouh¹,

Kobilica²,

Breznik³

2020

Cureus

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Drug-coated balloon angioplasty may present an efficient alternative to traditional balloon angioplasty and stenting, which suffer from high rates of restenosis and increased risk of stent fractures in the anatomically unfavorable regions, such as the superficial femoral artery in the adductor canal. Although pseudoaneurysms are the most common vascular access site complications, they are considerably rarer at the site of the endovascular treatment. They can be caused by several mechanisms, including stent fractures, usage of oversized balloons, high-pressure inflations, and infections. In addition, paclitaxel, the drug released from drug-coated balloons, may also play a significant role in the formation and exacerbation of pseudoaneurysms. The exact pathophysiology remains unclear, but it may be due to a combination of paclitaxel's suppression of neointimal healing and immune response, cytotoxic properties, and hypersensitivity-related inflammation.

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“…In this study, negative LLL was observed in 23% patients (8 of 35) of the Eluvia group, wherein the vessel diameter during the chronic phase was larger than that at the final imaging. To investigate previously reported information on aneurysmal degeneration 15) , we performed duplex ultrasound for all cases, but aneurysmal degeneration was not observed in the present study. Similarly, for angiographic follow-up, there was no aneurysmal change exceeding the stent diameter.…”

Section: Baselinementioning

confidence: 95%

One-Year Late Lumen Loss between A Polymer-Coated Paclitaxel-Eluting Stent (Eluvia) and a Polymer-Free Paclitaxel-Coated Stent (Zilver PTX) for Femoropopliteal Disease

Soga

Fujihara

Tomoi

et al. 2020

JAT

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Paclitaxel-eluting stents' (Eluvia and Zilver PTX) effectiveness has been recently reported for femoropopliteeal (FP) lesions. However, there is no evaluation of one-year late lumen loss (LLL). Therefore, we evaluated one-year LLL after implantation with Eluvia or Zilver PTX. Methods: This was a multicenter, prospective study. Patients who had symptomatic de novo lesions in the native FP artery were enrolled. The primary endpoint was one-year angiographic LLL, and the secondary endpoints were binary restenosis and target lesion revascularization (TLR) at one year. Results: From December 2015 to December 2016, 48 patients (Eluvia, 36 patients; Zilver PTX, 12 patients) were enrolled. No significant difference was found in baseline and lesion characteristics between both groups. One-year, LLL was significantly lower in the Eluvia group (0.60 {plus minus}0.80 mm) than in the Zilver PTX group (1.74 {plus minus}0.89 mm) (P 0.0003). Negative LLL was observed only in the Eluvia group (0% vs. 23%, p 0.096). The binary restenosis rate was significantly lower than in the Zilver PTX group (0% vs. 16.7%, P 0.012). The one-year TLR in the Eluvia group tended to be lower (0% vs. 8.3%, P 0.08). Stent thrombosis was not observed in either group. Conclusion: One-year LLL in the Eluvia group was significantly lower than that in the Zilver PTX group for FP lesions. tion (TLR) have decreased 7, 8). However, successful initial vessel preparation using standard PTA is necessary in order to proceed with treatment using a DCB; therefore, it difficult to make DCBs the first-choice treatment. In recent years, a polymer-coated paclitaxel-eluting stent (Eluvia) has become available, and revascularization strategies for FP lesions are changing. In the MAJESTIC trial 9) , an international, multicenter single-arm study, the primary patency in the first year was 96.4% and in the second year was 83.5%, which are very high patency rates. The IMPE

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1-Year All-Comers Analysis of the Eluvia Drug-Eluting Stent for Long Femoropopliteal Lesions After Suboptimal Angioplasty

Abstract: The fluoropolymer-based PES showed promising 1-year clinical and angiographic outcomes in real-world long femoropopliteal lesions. The long-term impact of aneurysm formation remains to be further investigated.

Cited by 74 publications

References 28 publications

Effectiveness and Safety of a Paclitaxel-Eluting Stent for Superficial Femoral Artery Lesions up to 190 mm: One-Year Outcomes of the Single-Arm IMPERIAL Long Lesion Substudy of the Eluvia Drug-Eluting Stent

Effectiveness and Safety of a Paclitaxel-Eluting Stent for Superficial Femoral Artery Lesions up to 190 mm: One-Year Outcomes of the Single-Arm IMPERIAL Long Lesion Substudy of the Eluvia Drug-Eluting Stent

Superficial Femoral Artery Pseudoaneurysm and Arterial Wall Destruction After Drug-Coated Balloon Treatment

One-Year Late Lumen Loss between A Polymer-Coated Paclitaxel-Eluting Stent (Eluvia) and a Polymer-Free Paclitaxel-Coated Stent (Zilver PTX) for Femoropopliteal Disease

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