Evidence map›Paper›PMID 26969758›Full record

Trial reportCirculation2016

Durable Clinical Effectiveness With Paclitaxel-Eluting Stents in the Femoropopliteal Artery: 5-Year Results of the Zilver PTX Randomized Trial.

Michael D Dake, Gary M Ansel, Michael R Jaff, Takao Ohki, Richard R Saxon, H Bob Smouse, Lindsay S Machan, Scott A Snyder, Erin E O'Leary, Anthony O Ragheb and 2 more

Erratum issued 2 registry-linked trialsOpen access · greenAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Circulation, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 138 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
138citing papers in PubMed, 13 pooled it
59.9field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00120406 nacompletednot on this map

Evaluation of the Zilver PTX Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery

TypeinterventionalSponsorCook Group IncorporatedRan2005 to 2014Enrolled474ConditionsPeripheral Vascular DiseasesArmsZilver® PTX™ Drug Eluting Vascular Stent, Angioplasty
NCT05780359 narecruitingnot on this mapstarted 2022, after this paper: background citation

A Multicenter, Randomized, Controlled, Superiority Clinical Trial to Evaluate the Safety and Efficacy of Drug-eluting Peripheral Arterial Stent System（G-stream） in the Treatment of the Above-the-knee Femoropopliteal Artery Stenosis or Occlusion

TypeinterventionalSponsorShenzhen Salubris Pharmaceuticals Co., Ltd.Ran2022 to 2026Enrolled280ConditionsPeripheral Artery DiseaseArmsDrug eluting stent, drug coating balloon
3 · Its place in the literature

Who cites it

138 citing papers in PubMed, 13 syntheses or guidelines pooled it, 511 citations in OpenAlex.

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  19. Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort.Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists · 2020
    Trial
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78 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 8 institutions in 3 countries.

Michael D DakeFrom Department of Cardiothoracic Surgery, Stanford University Medical Center, Stanford, CA (M.D.D.); Department of Medicine, Ohio Health/Riverside Methodist Hospital, Columbus (G.M.A.); The Vascular Center, Massachusetts General Hospital, Boston (M.R.J.); Department of Surgery, Jikei University Hospital, Tokyo, Japan (T.O.); Department of Diagnostic Imaging and Interventional Radiology, Tri-City Medical Center, Oceanside, CA (R.R.S.); Department of Radiology, OSF St. Francis Medical Center, Peoria, IL (H.B.S.); Department of Radiology, The University of British Columbia, Vancouver, Canada (L.S.M.); Cook Research Incorporated, West Lafayette, IN (S.A.S., E.E.O'L., A.O.R.); and Department of Angiology, Herz Zentrum, Bad Krozingen, Germany (T.Z.). mddake@stanford.edu.
Gary M AnselFrom Department of Cardiothoracic Surgery, Stanford University Medical Center, Stanford, CA (M.D.D.); Department of Medicine, Ohio Health/Riverside Methodist Hospital, Columbus (G.M.A.); The Vascular Center, Massachusetts General Hospital, Boston (M.R.J.); Department of Surgery, Jikei University Hospital, Tokyo, Japan (T.O.); Department of Diagnostic Imaging and Interventional Radiology, Tri-City Medical Center, Oceanside, CA (R.R.S.); Department of Radiology, OSF St. Francis Medical Center, Peoria, IL (H.B.S.); Department of Radiology, The University of British Columbia, Vancouver, Canada (L.S.M.); Cook Research Incorporated, West Lafayette, IN (S.A.S., E.E.O'L., A.O.R.); and Department of Angiology, Herz Zentrum, Bad Krozingen, Germany (T.Z.).
Michael R JaffFrom Department of Cardiothoracic Surgery, Stanford University Medical Center, Stanford, CA (M.D.D.); Department of Medicine, Ohio Health/Riverside Methodist Hospital, Columbus (G.M.A.); The Vascular Center, Massachusetts General Hospital, Boston (M.R.J.); Department of Surgery, Jikei University Hospital, Tokyo, Japan (T.O.); Department of Diagnostic Imaging and Interventional Radiology, Tri-City Medical Center, Oceanside, CA (R.R.S.); Department of Radiology, OSF St. Francis Medical Center, Peoria, IL (H.B.S.); Department of Radiology, The University of British Columbia, Vancouver, Canada (L.S.M.); Cook Research Incorporated, West Lafayette, IN (S.A.S., E.E.O'L., A.O.R.); and Department of Angiology, Herz Zentrum, Bad Krozingen, Germany (T.Z.).
Takao OhkiFrom Department of Cardiothoracic Surgery, Stanford University Medical Center, Stanford, CA (M.D.D.); Department of Medicine, Ohio Health/Riverside Methodist Hospital, Columbus (G.M.A.); The Vascular Center, Massachusetts General Hospital, Boston (M.R.J.); Department of Surgery, Jikei University Hospital, Tokyo, Japan (T.O.); Department of Diagnostic Imaging and Interventional Radiology, Tri-City Medical Center, Oceanside, CA (R.R.S.); Department of Radiology, OSF St. Francis Medical Center, Peoria, IL (H.B.S.); Department of Radiology, The University of British Columbia, Vancouver, Canada (L.S.M.); Cook Research Incorporated, West Lafayette, IN (S.A.S., E.E.O'L., A.O.R.); and Department of Angiology, Herz Zentrum, Bad Krozingen, Germany (T.Z.).
Richard R SaxonFrom Department of Cardiothoracic Surgery, Stanford University Medical Center, Stanford, CA (M.D.D.); Department of Medicine, Ohio Health/Riverside Methodist Hospital, Columbus (G.M.A.); The Vascular Center, Massachusetts General Hospital, Boston (M.R.J.); Department of Surgery, Jikei University Hospital, Tokyo, Japan (T.O.); Department of Diagnostic Imaging and Interventional Radiology, Tri-City Medical Center, Oceanside, CA (R.R.S.); Department of Radiology, OSF St. Francis Medical Center, Peoria, IL (H.B.S.); Department of Radiology, The University of British Columbia, Vancouver, Canada (L.S.M.); Cook Research Incorporated, West Lafayette, IN (S.A.S., E.E.O'L., A.O.R.); and Department of Angiology, Herz Zentrum, Bad Krozingen, Germany (T.Z.).
H Bob SmouseFrom Department of Cardiothoracic Surgery, Stanford University Medical Center, Stanford, CA (M.D.D.); Department of Medicine, Ohio Health/Riverside Methodist Hospital, Columbus (G.M.A.); The Vascular Center, Massachusetts General Hospital, Boston (M.R.J.); Department of Surgery, Jikei University Hospital, Tokyo, Japan (T.O.); Department of Diagnostic Imaging and Interventional Radiology, Tri-City Medical Center, Oceanside, CA (R.R.S.); Department of Radiology, OSF St. Francis Medical Center, Peoria, IL (H.B.S.); Department of Radiology, The University of British Columbia, Vancouver, Canada (L.S.M.); Cook Research Incorporated, West Lafayette, IN (S.A.S., E.E.O'L., A.O.R.); and Department of Angiology, Herz Zentrum, Bad Krozingen, Germany (T.Z.).
Lindsay S MachanFrom Department of Cardiothoracic Surgery, Stanford University Medical Center, Stanford, CA (M.D.D.); Department of Medicine, Ohio Health/Riverside Methodist Hospital, Columbus (G.M.A.); The Vascular Center, Massachusetts General Hospital, Boston (M.R.J.); Department of Surgery, Jikei University Hospital, Tokyo, Japan (T.O.); Department of Diagnostic Imaging and Interventional Radiology, Tri-City Medical Center, Oceanside, CA (R.R.S.); Department of Radiology, OSF St. Francis Medical Center, Peoria, IL (H.B.S.); Department of Radiology, The University of British Columbia, Vancouver, Canada (L.S.M.); Cook Research Incorporated, West Lafayette, IN (S.A.S., E.E.O'L., A.O.R.); and Department of Angiology, Herz Zentrum, Bad Krozingen, Germany (T.Z.).
Scott A SnyderFrom Department of Cardiothoracic Surgery, Stanford University Medical Center, Stanford, CA (M.D.D.); Department of Medicine, Ohio Health/Riverside Methodist Hospital, Columbus (G.M.A.); The Vascular Center, Massachusetts General Hospital, Boston (M.R.J.); Department of Surgery, Jikei University Hospital, Tokyo, Japan (T.O.); Department of Diagnostic Imaging and Interventional Radiology, Tri-City Medical Center, Oceanside, CA (R.R.S.); Department of Radiology, OSF St. Francis Medical Center, Peoria, IL (H.B.S.); Department of Radiology, The University of British Columbia, Vancouver, Canada (L.S.M.); Cook Research Incorporated, West Lafayette, IN (S.A.S., E.E.O'L., A.O.R.); and Department of Angiology, Herz Zentrum, Bad Krozingen, Germany (T.Z.).
Erin E O'LearyFrom Department of Cardiothoracic Surgery, Stanford University Medical Center, Stanford, CA (M.D.D.); Department of Medicine, Ohio Health/Riverside Methodist Hospital, Columbus (G.M.A.); The Vascular Center, Massachusetts General Hospital, Boston (M.R.J.); Department of Surgery, Jikei University Hospital, Tokyo, Japan (T.O.); Department of Diagnostic Imaging and Interventional Radiology, Tri-City Medical Center, Oceanside, CA (R.R.S.); Department of Radiology, OSF St. Francis Medical Center, Peoria, IL (H.B.S.); Department of Radiology, The University of British Columbia, Vancouver, Canada (L.S.M.); Cook Research Incorporated, West Lafayette, IN (S.A.S., E.E.O'L., A.O.R.); and Department of Angiology, Herz Zentrum, Bad Krozingen, Germany (T.Z.).
Anthony O RaghebFrom Department of Cardiothoracic Surgery, Stanford University Medical Center, Stanford, CA (M.D.D.); Department of Medicine, Ohio Health/Riverside Methodist Hospital, Columbus (G.M.A.); The Vascular Center, Massachusetts General Hospital, Boston (M.R.J.); Department of Surgery, Jikei University Hospital, Tokyo, Japan (T.O.); Department of Diagnostic Imaging and Interventional Radiology, Tri-City Medical Center, Oceanside, CA (R.R.S.); Department of Radiology, OSF St. Francis Medical Center, Peoria, IL (H.B.S.); Department of Radiology, The University of British Columbia, Vancouver, Canada (L.S.M.); Cook Research Incorporated, West Lafayette, IN (S.A.S., E.E.O'L., A.O.R.); and Department of Angiology, Herz Zentrum, Bad Krozingen, Germany (T.Z.).
Thomas ZellerFrom Department of Cardiothoracic Surgery, Stanford University Medical Center, Stanford, CA (M.D.D.); Department of Medicine, Ohio Health/Riverside Methodist Hospital, Columbus (G.M.A.); The Vascular Center, Massachusetts General Hospital, Boston (M.R.J.); Department of Surgery, Jikei University Hospital, Tokyo, Japan (T.O.); Department of Diagnostic Imaging and Interventional Radiology, Tri-City Medical Center, Oceanside, CA (R.R.S.); Department of Radiology, OSF St. Francis Medical Center, Peoria, IL (H.B.S.); Department of Radiology, The University of British Columbia, Vancouver, Canada (L.S.M.); Cook Research Incorporated, West Lafayette, IN (S.A.S., E.E.O'L., A.O.R.); and Department of Angiology, Herz Zentrum, Bad Krozingen, Germany (T.Z.).
Zilver PTX Investigators
Cook Research (United States) · USSt. Francis Medical Center · USMassachusetts General Hospital · USOhioHealth · USStanford Medicine · USStanford University · USSt Francis Medical Center · USThe Jikei University Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis randomized controlled trial evaluated clinical durability of Zilver PTX, a paclitaxel-coated drug-eluting stent (DES), for femoropopliteal artery lesions. Outcomes compare primary DES versus percutaneous transluminal angioplasty (PTA), overall DES (primary and provisional) versus standard care (PTA and provisional Zilver bare metal stent [BMS]), and provisional DES versus provisional BMS. METHODS AND

resultsPatients with symptomatic femoropopliteal artery disease were randomly assigned to DES (n=236) or PTA (n=238). Approximately 91% had claudication; 9% had critical limb ischemia. Patients experiencing acute PTA failure underwent secondary randomization to provisional BMS (n=59) or DES (n=61). The 1-year primary end points of event-free survival and patency showed superiority of primary DES in comparison with PTA; these results were sustained through 5 years. Clinical benefit (freedom from persistent or worsening symptoms of ischemia; 79.8% versus 59.3%, P<0.01), patency (66.4% versus 43.4%, P<0.01), and freedom from reintervention (target lesion revascularization, 83.1% versus 67.6%, P<0.01) for the overall DES group were superior to standard care in nonrandomized comparisons. Similarly, clinical benefit (81.8% versus 63.8%, P=0.02), patency (72.4% versus 53.0%, P=0.03), and freedom from target lesion revascularization (84.9% versus 71.6%, P=0.06) with provisional DES were improved over provisional BMS. These results represent >40% relative risk reduction for restenosis and target lesion revascularization through 5 years for the overall DES in comparison with standard care and for provisional DES in comparison with provisional BMS.

conclusionsThe 5-year results from this large study provide long-term information previously unavailable regarding endovascular treatment of femoropopliteal artery disease. The Zilver PTX DES provided sustained safety and clinical durability in comparison with standard endovascular treatments. CLINICAL

trial registrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT00120406.

Indexed as

AngioplastyDrug-Eluting StentsFemoral ArteryPopliteal ArteryAdultAgedAnticoagulantsArterial Occlusive DiseasesAspirinClopidogrelCombined Modality TherapyDisease-Free SurvivalDisease ProgressionEquipment FailureFemaleFollow-Up StudiesAnticoagulantsAspirinClopidogrelPaclitaxelTiclopidineangioplastydrug-eluting stentspaclitaxelperipheral artery diseasestents

Identifiers

PMID26969758
PMCPMC4823823
OpenAlexW2295508527

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.