Two-Year Efficacy and Safety Results from the IMPERIAL Randomized Study of the Eluvia Polymer-Coated Drug-Eluting Stent and the Zilver PTX Polymer-free Drug-Coated Stent

Müller‐Hülsbeck, Stefan; Benko, Andrew; Soga, Yoshimitsu; Fujihara, Masahiko; Iida, Osamu; Babaev, Anvar; O’Connor, David; Zeller, Thomas; Dulas, Daniel; Diaz‐Cartelle, Juan; Gray, William A.

doi:10.1007/s00270-020-02693-1

Cited by 71 publications

(59 citation statements)

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“…Here, we report a patient with exacerbated aneurysmal degeneration assessed by serial angiography and IVUS 50 months after Eluvia™ implantation for an SFA lesion. Although several clinical studies reported instances of aneurysmal degeneration 12 or 24 months after Eluvia™ implantation [4][5][6], there have been no reports of complications with exacerbated aneurysmal degeneration assessed by serial imaging device beyond 24 months after implantation. To the best of our knowledge, this is the rst report showing worsening of aneurysmal degeneration assessed by serial angiography and intravascular ultrasound 50 months after Eluvia™ implantation.…”

Section: Discussionmentioning

confidence: 99%

“…With the development of anti-restenotic devices, endovascular therapy (EVT) has become the rst-line treatment for femoropopliteal lesions. The IMPERIAL randomized trial compared a novel uoropolymercoated paclitaxel-eluting stent (Eluvia™; Boston Scienti c, Marlborough, MA, USA) with a polymer-free paclitaxel-coated stent (Zilver PTX™; Cook Corporation, Bloomington, IN, USA), demonstrating a durable patency rate after Eluvia™ implantation [4,5]. However, the problem of aneurysmal degeneration after Eluvia™ implantation has been raised as a clinical issue in several reports [4][5][6].…”

Section: Introductionmentioning

confidence: 99%

“…The IMPERIAL randomized trial compared a novel uoropolymercoated paclitaxel-eluting stent (Eluvia™; Boston Scienti c, Marlborough, MA, USA) with a polymer-free paclitaxel-coated stent (Zilver PTX™; Cook Corporation, Bloomington, IN, USA), demonstrating a durable patency rate after Eluvia™ implantation [4,5]. However, the problem of aneurysmal degeneration after Eluvia™ implantation has been raised as a clinical issue in several reports [4][5][6]. Here, we report a case with exacerbated aneurysmal degeneration on serial angiography and intravascular ultrasound 50 months after Eluvia™ implantation for a super cial femoral artery (SFA) lesion.…”

Section: Introductionmentioning

confidence: 99%

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Aneurysmal Degeneration of Fluoropolymer-Coated Paclitaxel-Eluting Stent in the Superficial Femoral Artery. A Rising Concern

Tsujimura

Iida

Asai

et al. 2021

Preprint

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Background: Although several clinical reports demonstrated a durable patency rate after a novel fluoropolymer-coated paclitaxel-eluting stent (Eluvia™; Boston Scientific, Marlborough, MA, USA) implantation, aneurysmal degeneration after implanting Eluvia™ has raised clinical concerns. Here, we report a case with exacerbated aneurysmal degeneration on serial angiography and intravascular ultrasound 50 months after Eluvia™ implantation for a superficial femoral artery lesion.Case presentation: A 79-year-old woman with claudication in the right lower extremity decreasing her quality of life was referred to our hospital. Pre-procedural angiography showed severe stenosis from the middle-to-distal part of the right superficial femoral artery, and Eluvia™ was implanted with optimal expansion. However, the patient had a recurrence of intermittent claudication in the right lower extremity 25 months thereafter. Angiography revealed de novo stenosis in the distal part of the popliteal artery and proximal stent edge restenosis at the Eluvia™ implantation site. Subsequently, the patient underwent endovascular therapy for these lesions. In addition, intravascular ultrasound at the time of endovascular therapy revealed vessel enlargement with a mean vessel diameter of 7.2-9.9 mm at the distal edge of the Eluvia™ implantation site. However, intermittent claudication on the right side recurred again 50 months after Eluvia™ implantation. Angiography demonstrated de novo severe stenosis from the distal part of the superficial femoral artery to the middle part of the popliteal artery. Furthermore, peri-stent contrast staining was found at the distal part of the Eluvia™ implantation site. Intravascular ultrasound showed a further enlargement of mean vessel diameter to 11.9 mm at the distal edge of the Eluvia™ stent. Moreover, enlargement of the lumen and stent malapposition were also found, suggesting exacerbated aneurysmal degeneration 50 months after Eluvia™ implantation.Conclusions: We report a case with exacerbated aneurysmal degeneration on serial angiography and intravascular ultrasound 50 months after Eluvia™ implantation for an SFA lesion. Long-term follow-up should be mandatory for patients receiving Eluvia™ implants.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Aneurysmal Degeneration of Fluoropolymer-Coated Paclitaxel-Eluting Stent in the Superficial Femoral Artery. A Rising Concern

Tsujimura

Iida

Asai

et al. 2021

Preprint

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“…Primary safety and key clinical outcomes and resource-use parameters from the IMPERIAL trial included in the model[4,6] AEs adverse events, CD-TLR clinically driven target lesion revascularisation…”

mentioning

confidence: 99%

“…a Adapted from Table3and TableA6of Gray et al[4] b Adapted from Müller-Hülsbeck, Benko[6] and data on file (hospitalisation outcomes)cThe average length of hospital stay for AE was calculated as 5.5 days for Eluvia DES group and 6.8 days for Zilver PTX group at 12 months (where average hospital stay = hospital days for AE * n/N), representing a 19% reduction for eluvia DES group at 12 months *The price of Eluvia and Zilver PTX stents (difference = $0) were referenced from the 2019 Australian Prostheses List (Part A) available at https://www.health.gov.au/resources/publications/prostheses-list N. Altaf et al: A Budget Impact Model for the use of Drug-Eluting… translating to an average reduction of 7707 days per year in the length of stay.Australian State PerspectiveThe BIM investigated the 5-year budget impact of Eluvia versus Zilver PTX at the Australian state/territory level for DES usage rates from low (10%) to the average base-case rate (28%) (Table5). At the Australian state/territory level, the potential healthcare system budget savings were driven by the reduction of diagnostic related group (DRG) payments for AEs, as a result of events avoided through use of Eluvia DES.…”

mentioning

confidence: 99%

A Budget Impact Model for the use of Drug-Eluting Stents in Patients with Symptomatic Lower-Limb Peripheral Arterial Disease: An Australian Perspective

Altaf

Ariyaratne²,

Peacock³

et al. 2021

Cardiovasc Intervent Radiol

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Purpose Improvement in long-term outcomes through innovative, cost-effective medical technologies is a focus for endovascular procedures aimed at treating symptomatic lower-limb peripheral arterial disease (PAD). The advent of drug-eluting stents (DES) has improved symptomatic PAD treatment via a reduction in high rates of target lesion revascularisation (TLR). The present study aimed to compare the 5-year financial impact of treatment with Eluvia, a new paclitaxel-eluting stent, versus treatment with Zilver PTX, a drug-coated stent, among patients in Australia by developing a budget impact model (BIM). Methods A BIM was developed from an Australian public hospital payer perspective using Australian national cost weights (AUD), published literature, and public hospital audit data. Clinical outcomes, including clinically driven TLRs (CD-TLRs), adverse events, and length of stay, were based on the 2-year results of the IMPERIAL trial, which compared Eluvia DES to Zilver PTX. Results Assuming EVP eligibility rate of 80% and DES uses rate ranging from 10 to 28% (superficial femoral artery lesions only), the 5-year model forecasted a treatment population between 14,428 and 40,399 patients. The model estimated 1499–4198 fewer CD-TLRs and 16,515–46,243 fewer hospital days with Eluvia DES use. This translated to 5-year potential savings of $4.3–$12.1 million to the Australian public hospital payer attributable to reduced CD-TLRs for Eluvia DES and $33.1–$92.6 million to Australian public hospitals owing to reduced adverse events and hospital bed days. Conclusion Eluvia DES use as treatment for symptomatic lower-limb PAD could lead to potential savings for the Australian public healthcare system based on improved patient outcomes.

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Predictors of recurrent restenosis after repeat drug‐coated balloon therapy for drug‐coated balloon restenosis in femoropopliteal lesions: Results of the RECURRENCE study

Yanagiuchi,

Fukai,

Sogabe

et al. 2024

Cathet Cardio Intervent

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BackgroundDespite the widespread use of drug‐coated balloons (DCBs) for femoropopliteal (FP) lesions, there is still no consensus on treatment strategies for DCB restenosis. This study aimed to determine the risk factors for recurrent restenosis after repeat DCB therapy for DCB restenosis in FP lesions.MethodsThis multicenter retrospective study assessed 1176 consecutive limbs in 860 patients who successfully received initial DCB therapy for FP lesions at four cardiovascular centers between May 2018 and December 2022. Among these patients, 118 consecutive limbs of 104 patients treated via repeat DCB for primary DCB restenosis were enrolled.ResultsThe Kaplan–Meier estimate of freedom from recurrent restenosis was 74.6% at 1 year. Cox proportional hazard multivariate analysis revealed that recurrent restenosis was independently associated with the time from initial DCB to primary restenosis (hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.79–0.92; p < 0.001), history of ≥2 endovascular therapies (EVTs) (HR, 3.11; 95%CI, 1.36–7.12; p = 0.007), and PACSS grade 3 or 4 (HR, 2.76; 95%CI, 1.15–6.63; p = 0.023). Furthermore, receiver operating characteristic curve analysis showed that the cutoff value of the time from initial DCB to primary restenosis to prevent recurrent restenosis was 12.6 months, with an area under the curve of 0.841 (p < 0.001).ConclusionRepeat DCB therapy for DCB restenosis might be an acceptable strategy, particularly for restenosis that occurred more than 12.6 months after initial DCB, given the rate of freedom from recurrent restenosis.

show abstract

Two-Year Efficacy and Safety Results from the IMPERIAL Randomized Study of the Eluvia Polymer-Coated Drug-Eluting Stent and the Zilver PTX Polymer-free Drug-Coated Stent

Cited by 71 publications

References 11 publications

Aneurysmal Degeneration of Fluoropolymer-Coated Paclitaxel-Eluting Stent in the Superficial Femoral Artery. A Rising Concern

Aneurysmal Degeneration of Fluoropolymer-Coated Paclitaxel-Eluting Stent in the Superficial Femoral Artery. A Rising Concern

A Budget Impact Model for the use of Drug-Eluting Stents in Patients with Symptomatic Lower-Limb Peripheral Arterial Disease: An Australian Perspective

Predictors of recurrent restenosis after repeat drug‐coated balloon therapy for drug‐coated balloon restenosis in femoropopliteal lesions: Results of the RECURRENCE study

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