A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial

IMPERIAL investigators

Research output: Contribution to journalArticle

29 Citations (Scopus)

Abstract

Background: The clinical effect of a drug-eluting stent in the femoropopliteal segment has not been investigated in a randomised trial with a contemporary comparator. The IMPERIAL study sought to compare the safety and efficacy of the polymer-coated, paclitaxel-eluting Eluvia stent with the polymer-free, paclitaxel-coated Zilver PTX stent for treatment of femoropopliteal artery segment lesions. Methods: In this randomised, single-blind, non-inferiority study, patients with symptomatic lower-limb ischaemia manifesting as claudication (Rutherford category 2, 3, or 4) with atherosclerotic lesions in the native superficial femoral artery or proximal popliteal artery were enrolled at 65 centres in Austria, Belgium, Canada, Germany, Japan, New Zealand, and the USA. Patients were randomly assigned (2:1) with a site-specific, web-based randomisation schedule to receive treatment with Eluvia or Zilver PTX. All patients, site personnel, and investigators were masked to treatment assignment until all patients had completed 12 months of follow-up. The primary efficacy endpoint was primary patency (defined as a peak systolic velocity ratio ≤2·4, without clinically driven target lesion revascularisation or bypass of the target lesion) and the primary safety endpoint was major adverse events (ie, all causes of death through 1 month, major amputation of target limb through 12 months, and target lesion revascularisation through 12 months). We set a non-inferiority margin of −10% at 12 months. Primary non-inferiority analyses were done when the minimum sample size required for adequate statistical power had completed 12 months of follow-up. The primary safety non-inferiority analysis included all patients who had completed 12 months of follow-up or had a major adverse event through 12 months. This trial is registered with ClinicalTrials.gov, number NCT02574481. Findings: Between Dec 2, 2015, and Feb 15, 2017, 465 patients were randomly assigned to Eluvia (n=309) or to Zilver PTX (n=156). Non-inferiority was shown for both efficacy and safety endpoints at 12 months: primary patency was 86·8% (231/266) in the Eluvia group and 81·5% (106/130) in the Zilver PTX group (difference 5·3% [one-sided lower bound of 95% CI −0·66]; p<0·0001). 259 (94·9%) of 273 patients in the Eluvia group and 121 (91·0%) of 133 patients in the Zilver PTX group had not had a major adverse event at 12 months (difference 3·9% [one-sided lower bound of 95% CI −0·46]; p<0.0001). No deaths were reported in either group. One patient in the Eluvia group had a major amputation and 13 patients in each group required target lesion revascularisation. Interpretation: The Eluvia stent was non-inferior to the Zilver PTX stent in terms of primary patency and major adverse events at 12 months after treatment of patients for femoropopliteal peripheral artery disease. Funding: Boston Scientific.

Original languageEnglish (US)
Pages (from-to)1541-1551
Number of pages11
JournalThe Lancet
Volume392
Issue number10157
DOIs
StatePublished - Oct 27 2018

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Paclitaxel
Stents
Polymers
Safety
Amputation
Popliteal Artery
Drug-Eluting Stents
Austria
Peripheral Arterial Disease
Belgium
Femoral Artery
Therapeutics
Random Allocation
New Zealand
Sample Size
Canada
Germany
Cause of Death
Lower Extremity
Appointments and Schedules

ASJC Scopus subject areas

  • Medicine(all)

Cite this

@article{cb81e583579d4b209dc87913f769a773,
title = "A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial",
abstract = "Background: The clinical effect of a drug-eluting stent in the femoropopliteal segment has not been investigated in a randomised trial with a contemporary comparator. The IMPERIAL study sought to compare the safety and efficacy of the polymer-coated, paclitaxel-eluting Eluvia stent with the polymer-free, paclitaxel-coated Zilver PTX stent for treatment of femoropopliteal artery segment lesions. Methods: In this randomised, single-blind, non-inferiority study, patients with symptomatic lower-limb ischaemia manifesting as claudication (Rutherford category 2, 3, or 4) with atherosclerotic lesions in the native superficial femoral artery or proximal popliteal artery were enrolled at 65 centres in Austria, Belgium, Canada, Germany, Japan, New Zealand, and the USA. Patients were randomly assigned (2:1) with a site-specific, web-based randomisation schedule to receive treatment with Eluvia or Zilver PTX. All patients, site personnel, and investigators were masked to treatment assignment until all patients had completed 12 months of follow-up. The primary efficacy endpoint was primary patency (defined as a peak systolic velocity ratio ≤2·4, without clinically driven target lesion revascularisation or bypass of the target lesion) and the primary safety endpoint was major adverse events (ie, all causes of death through 1 month, major amputation of target limb through 12 months, and target lesion revascularisation through 12 months). We set a non-inferiority margin of −10{\%} at 12 months. Primary non-inferiority analyses were done when the minimum sample size required for adequate statistical power had completed 12 months of follow-up. The primary safety non-inferiority analysis included all patients who had completed 12 months of follow-up or had a major adverse event through 12 months. This trial is registered with ClinicalTrials.gov, number NCT02574481. Findings: Between Dec 2, 2015, and Feb 15, 2017, 465 patients were randomly assigned to Eluvia (n=309) or to Zilver PTX (n=156). Non-inferiority was shown for both efficacy and safety endpoints at 12 months: primary patency was 86·8{\%} (231/266) in the Eluvia group and 81·5{\%} (106/130) in the Zilver PTX group (difference 5·3{\%} [one-sided lower bound of 95{\%} CI −0·66]; p<0·0001). 259 (94·9{\%}) of 273 patients in the Eluvia group and 121 (91·0{\%}) of 133 patients in the Zilver PTX group had not had a major adverse event at 12 months (difference 3·9{\%} [one-sided lower bound of 95{\%} CI −0·46]; p<0.0001). No deaths were reported in either group. One patient in the Eluvia group had a major amputation and 13 patients in each group required target lesion revascularisation. Interpretation: The Eluvia stent was non-inferior to the Zilver PTX stent in terms of primary patency and major adverse events at 12 months after treatment of patients for femoropopliteal peripheral artery disease. Funding: Boston Scientific.",
author = "{IMPERIAL investigators} and Gray, {William A.} and Koen Keirse and Yoshimitsu Soga and Andrew Benko and Anvar Babaev and Yoshiaki Yokoi and Henrik Schroeder and Prem, {Jeffery T.} and Andrew Holden and Jeffrey Popma and Jaff, {Michael R.} and Juan Diaz-Cartelle and Stefan M{\"u}ller-H{\"u}lsbeck and Thomas Albrecht and Kenji Ando and Anvar Babaev and Bacharach, {Michael J.} and William Bachinsky and Danielle Bajakian and Robert Beasley and James Benenati and Andrew Benko and Mark Burket and Joseph Cardenas and Tony Das and {De Martino}, {Randall R} and Hannes Deutschmann and Daniel Dulas and Robert Feldman and Mark Fugate and Lawrence Garcia and Jaafer Golzar and Rao Gutta and Patrick Hall and Stewart Hawkins and Steve Henao and Benjamin Herdrich and Keisuke Hirano and Andrew Holden and Safwan Jaalouk and Sean Janzer and Daizo Kawasaki and Koen Keirse and Yazan Khatib and Kimihiko Kichikawa and Ethan Korngold and Christian Loewe and Louis Lopez and Henry Lui and Toshiaki Mano",
year = "2018",
month = "10",
day = "27",
doi = "10.1016/S0140-6736(18)32262-1",
language = "English (US)",
volume = "392",
pages = "1541--1551",
journal = "The Lancet",
issn = "0140-6736",
publisher = "Elsevier Limited",
number = "10157",

}

TY - JOUR

T1 - A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL)

T2 - a randomised, non-inferiority trial

AU - IMPERIAL investigators

AU - Gray, William A.

AU - Keirse, Koen

AU - Soga, Yoshimitsu

AU - Benko, Andrew

AU - Babaev, Anvar

AU - Yokoi, Yoshiaki

AU - Schroeder, Henrik

AU - Prem, Jeffery T.

AU - Holden, Andrew

AU - Popma, Jeffrey

AU - Jaff, Michael R.

AU - Diaz-Cartelle, Juan

AU - Müller-Hülsbeck, Stefan

AU - Albrecht, Thomas

AU - Ando, Kenji

AU - Babaev, Anvar

AU - Bacharach, Michael J.

AU - Bachinsky, William

AU - Bajakian, Danielle

AU - Beasley, Robert

AU - Benenati, James

AU - Benko, Andrew

AU - Burket, Mark

AU - Cardenas, Joseph

AU - Das, Tony

AU - De Martino, Randall R

AU - Deutschmann, Hannes

AU - Dulas, Daniel

AU - Feldman, Robert

AU - Fugate, Mark

AU - Garcia, Lawrence

AU - Golzar, Jaafer

AU - Gutta, Rao

AU - Hall, Patrick

AU - Hawkins, Stewart

AU - Henao, Steve

AU - Herdrich, Benjamin

AU - Hirano, Keisuke

AU - Holden, Andrew

AU - Jaalouk, Safwan

AU - Janzer, Sean

AU - Kawasaki, Daizo

AU - Keirse, Koen

AU - Khatib, Yazan

AU - Kichikawa, Kimihiko

AU - Korngold, Ethan

AU - Loewe, Christian

AU - Lopez, Louis

AU - Lui, Henry

AU - Mano, Toshiaki

PY - 2018/10/27

Y1 - 2018/10/27

N2 - Background: The clinical effect of a drug-eluting stent in the femoropopliteal segment has not been investigated in a randomised trial with a contemporary comparator. The IMPERIAL study sought to compare the safety and efficacy of the polymer-coated, paclitaxel-eluting Eluvia stent with the polymer-free, paclitaxel-coated Zilver PTX stent for treatment of femoropopliteal artery segment lesions. Methods: In this randomised, single-blind, non-inferiority study, patients with symptomatic lower-limb ischaemia manifesting as claudication (Rutherford category 2, 3, or 4) with atherosclerotic lesions in the native superficial femoral artery or proximal popliteal artery were enrolled at 65 centres in Austria, Belgium, Canada, Germany, Japan, New Zealand, and the USA. Patients were randomly assigned (2:1) with a site-specific, web-based randomisation schedule to receive treatment with Eluvia or Zilver PTX. All patients, site personnel, and investigators were masked to treatment assignment until all patients had completed 12 months of follow-up. The primary efficacy endpoint was primary patency (defined as a peak systolic velocity ratio ≤2·4, without clinically driven target lesion revascularisation or bypass of the target lesion) and the primary safety endpoint was major adverse events (ie, all causes of death through 1 month, major amputation of target limb through 12 months, and target lesion revascularisation through 12 months). We set a non-inferiority margin of −10% at 12 months. Primary non-inferiority analyses were done when the minimum sample size required for adequate statistical power had completed 12 months of follow-up. The primary safety non-inferiority analysis included all patients who had completed 12 months of follow-up or had a major adverse event through 12 months. This trial is registered with ClinicalTrials.gov, number NCT02574481. Findings: Between Dec 2, 2015, and Feb 15, 2017, 465 patients were randomly assigned to Eluvia (n=309) or to Zilver PTX (n=156). Non-inferiority was shown for both efficacy and safety endpoints at 12 months: primary patency was 86·8% (231/266) in the Eluvia group and 81·5% (106/130) in the Zilver PTX group (difference 5·3% [one-sided lower bound of 95% CI −0·66]; p<0·0001). 259 (94·9%) of 273 patients in the Eluvia group and 121 (91·0%) of 133 patients in the Zilver PTX group had not had a major adverse event at 12 months (difference 3·9% [one-sided lower bound of 95% CI −0·46]; p<0.0001). No deaths were reported in either group. One patient in the Eluvia group had a major amputation and 13 patients in each group required target lesion revascularisation. Interpretation: The Eluvia stent was non-inferior to the Zilver PTX stent in terms of primary patency and major adverse events at 12 months after treatment of patients for femoropopliteal peripheral artery disease. Funding: Boston Scientific.

AB - Background: The clinical effect of a drug-eluting stent in the femoropopliteal segment has not been investigated in a randomised trial with a contemporary comparator. The IMPERIAL study sought to compare the safety and efficacy of the polymer-coated, paclitaxel-eluting Eluvia stent with the polymer-free, paclitaxel-coated Zilver PTX stent for treatment of femoropopliteal artery segment lesions. Methods: In this randomised, single-blind, non-inferiority study, patients with symptomatic lower-limb ischaemia manifesting as claudication (Rutherford category 2, 3, or 4) with atherosclerotic lesions in the native superficial femoral artery or proximal popliteal artery were enrolled at 65 centres in Austria, Belgium, Canada, Germany, Japan, New Zealand, and the USA. Patients were randomly assigned (2:1) with a site-specific, web-based randomisation schedule to receive treatment with Eluvia or Zilver PTX. All patients, site personnel, and investigators were masked to treatment assignment until all patients had completed 12 months of follow-up. The primary efficacy endpoint was primary patency (defined as a peak systolic velocity ratio ≤2·4, without clinically driven target lesion revascularisation or bypass of the target lesion) and the primary safety endpoint was major adverse events (ie, all causes of death through 1 month, major amputation of target limb through 12 months, and target lesion revascularisation through 12 months). We set a non-inferiority margin of −10% at 12 months. Primary non-inferiority analyses were done when the minimum sample size required for adequate statistical power had completed 12 months of follow-up. The primary safety non-inferiority analysis included all patients who had completed 12 months of follow-up or had a major adverse event through 12 months. This trial is registered with ClinicalTrials.gov, number NCT02574481. Findings: Between Dec 2, 2015, and Feb 15, 2017, 465 patients were randomly assigned to Eluvia (n=309) or to Zilver PTX (n=156). Non-inferiority was shown for both efficacy and safety endpoints at 12 months: primary patency was 86·8% (231/266) in the Eluvia group and 81·5% (106/130) in the Zilver PTX group (difference 5·3% [one-sided lower bound of 95% CI −0·66]; p<0·0001). 259 (94·9%) of 273 patients in the Eluvia group and 121 (91·0%) of 133 patients in the Zilver PTX group had not had a major adverse event at 12 months (difference 3·9% [one-sided lower bound of 95% CI −0·46]; p<0.0001). No deaths were reported in either group. One patient in the Eluvia group had a major amputation and 13 patients in each group required target lesion revascularisation. Interpretation: The Eluvia stent was non-inferior to the Zilver PTX stent in terms of primary patency and major adverse events at 12 months after treatment of patients for femoropopliteal peripheral artery disease. Funding: Boston Scientific.

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UR - http://www.scopus.com/inward/citedby.url?scp=85056359256&partnerID=8YFLogxK

U2 - 10.1016/S0140-6736(18)32262-1

DO - 10.1016/S0140-6736(18)32262-1

M3 - Article

C2 - 30262332

AN - SCOPUS:85056359256

VL - 392

SP - 1541

EP - 1551

JO - The Lancet

JF - The Lancet

SN - 0140-6736

IS - 10157

ER -