Long-Term Results from the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Femoropopliteal Treatment: 3-Year Follow-up

Müller‐Hülsbeck, Stefan; Keirse, Koen; Zeller, Thomas; Schröe, Herman; Diaz‐Cartelle, Juan

doi:10.1007/s00270-017-1771-5

Cited by 67 publications

(43 citation statements)

References 20 publications

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“…A comparison of drug-eluting stents (DES) with PTA with bailout stenting [ 34 ] on SFA lesions showed better patency and event free survival with DES than with PTA. That study did not report on HRQoL and did not directly compare DES with BMS, but the reported 24-month primary patency of 74.8% of this trial [ 35 ] and of 83.5% of another recent DES trial [ 36 ] is comparable with our results.…”

Section: Discussionsupporting

confidence: 85%

Primary Stenting of the Superficial Femoral Artery in Patients with Intermittent Claudication Has Durable Effects on Health-Related Quality of Life at 24 Months: Results of a Randomized Controlled Trial

Lindgren

Qvarfordt

Bergman

et al. 2018

Cardiovasc Intervent Radiol

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BackgroundIntermittent claudication (IC) is commonly caused by lesions in the superficial femoral artery (SFA), yet invasive treatment is still controversial and longer term patient-reported outcomes are lacking. This prospective randomized trial assessed the 24-month impact of primary stenting with nitinol self-expanding stents compared to best medical treatment (BMT) alone in patients with stable IC due to SFA disease on health-related quality of life (HRQoL).MethodsOne hundred patients with stable IC due to SFA disease treated with BMT were randomized to either stent (n = 48) or control (n = 52) group. HRQoL assessed by Short Form 36 Health Survey (SF-36) and EuroQoL 5-dimensions (EQ5D) 24 months after treatment were primary outcome measures. Walking Impairment Questionnaire, ankle–brachial index (ABI), and walking distance were secondary outcomes.ResultsSignificantly better SF-36 Physical Component Summary (P = 0.024) and physical domain scores such as Physical Function (P = 0.012), Bodily Pain (P = 0.002), General Health (P = 0.037), and EQ5D (P = 0.010) were reported in intergroup comparison between the stent and the control group. Both ABI (from 0.58 ± 0.11 to 0.85 ± 0.18; P < 0.001 in the stent group and from 0.63 ± 0.17 to 0.69 ± 0.18; P = 0.036 in the control group) and walking distance (from 170 ± 90 m to 616 ± 375 m; P < 0.001 in the stent group and from 209 ± 111 m to 331 ± 304 m; P = 0.006 in the control group) improved significantly in intragroup comparisons.ConclusionsIn patients with IC caused by lesions in the SFA, primary stenting compared to BMT alone was associated with significant improvements in HRQoL, ABI, and walking distance durable up to 24 months of follow-up.Clinical Trial Registration http://www.clinicaltrials.gov. Unique Identifier: NCT01230229

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Section: Discussionsupporting

confidence: 85%

Primary Stenting of the Superficial Femoral Artery in Patients with Intermittent Claudication Has Durable Effects on Health-Related Quality of Life at 24 Months: Results of a Randomized Controlled Trial

Lindgren

Qvarfordt

Bergman

et al. 2018

Cardiovasc Intervent Radiol

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“…54 Two-year primary patency was 83%, and 3-year freedom from TLR was 85%. 56 No stent fractures were identified at 3 years, though this may be attributable to small sample size. 54,56 Given 2-year DCB patency rates close to 80%, DES compares favorably as DES trials included more highly calcified lesions and greater proportion of CTO.…”

Section: Superficial Femoral Arterymentioning

confidence: 93%

“…56 No stent fractures were identified at 3 years, though this may be attributable to small sample size. 54,56 Given 2-year DCB patency rates close to 80%, DES compares favorably as DES trials included more highly calcified lesions and greater proportion of CTO. 56 The IMPERIAL trial is ongoing to further evaluate Eluvia.…”

Section: Superficial Femoral Arterymentioning

confidence: 93%

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Drug-Eluting Balloons and Drug-Eluting Stents in the Treatment of Peripheral Vascular Disease

Lindquist¹,

Schramm²

2018

Semin intervent Radiol

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In the last 20 years, peripheral artery disease (PAD) has been increasingly recognized as a significant cause of morbidity and mortality in the United States. The endovascular treatment of PAD has seen a marked rise as minimally invasive techniques and devices have been refined. Two newer devices, drug-eluting stents and drug-eluting balloons, are on the forefront of the battle against limb loss from PAD. This review focuses on the data backing the use of drug-eluting technologies for use in the peripheral arterial system.

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“…TLR rate at 3‐years was estimated as 85.3%. This trial has promoted the long term durability in patients treated with paclitaxel eluting stents . The IMPERIAL trial, which is a head to head comparison of the Zilver and Eluvia platforms is currently ongoing (Clinical trial number: NCT02574481).…”

Section: Interventional Trials In Lower Extremity Padmentioning

confidence: 99%

Peripheral vascular interventional advances in 2017

Devanabanda

Tummala

Galmer

et al. 2018

J Interven Cardiology

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Long-Term Results from the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Femoropopliteal Treatment: 3-Year Follow-up

Abstract: Level 2b, cohort study.

Cited by 67 publications

References 20 publications

Primary Stenting of the Superficial Femoral Artery in Patients with Intermittent Claudication Has Durable Effects on Health-Related Quality of Life at 24 Months: Results of a Randomized Controlled Trial

Primary Stenting of the Superficial Femoral Artery in Patients with Intermittent Claudication Has Durable Effects on Health-Related Quality of Life at 24 Months: Results of a Randomized Controlled Trial

Drug-Eluting Balloons and Drug-Eluting Stents in the Treatment of Peripheral Vascular Disease

Peripheral vascular interventional advances in 2017

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