Evidence map›Paper›PMID 33025243›Full record

ArticleCardiovascular and interventional radiology2021

Prediction Model for Freedom from TLR from a Multi-study Analysis of Long-Term Results with the Zilver PTX Drug-Eluting Peripheral Stent.

Michael D Dake, Fabrizio Fanelli, Aaron E Lottes, Erin E O'Leary, Heidi Reichert, Xiaohui Jiang, Weiguo Fu, Osamu Iida, Kan Zen, Marc Schermerhorn and 2 more

5 registry-linked trialsOpen access · hybridAbstract read
In one paragraph

Article in Cardiovascular and interventional radiology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.6field-weighted citation impact, top 16% 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
NCT01094678 nacompletednot on this map

Evaluation of the Safety and Performance of the Zilver® PTX™ Drug-Eluting Stent for Treating De Novo or Restenotic Lesions of the Above-the-knee Femoropopliteal Artery

TypeinterventionalSponsorCook Group IncorporatedRan2006 to 2011Enrolled788ConditionsPeripheral Arterial Disease, Peripheral Vascular DiseaseArmsZilver® PTX™ Stent
NCT01901289 nacompletednot on this map

Zilver® PTX® Drug-Eluting Peripheral Stent Post-Approval Study

TypeinterventionalSponsorCook Research IncorporatedRan2013 to 2021Enrolled200ConditionsPeripheral Arterial DiseaseArmsZilver® PTX® Drug-Eluting Peripheral Stent
NCT02171962 nacompletednot on this map

Evaluation of the Zilver® PTX® Drug-Eluting Peripheral Stent for Treatment of Lesions of the Above-the-Knee Femoropopliteal Artery

TypeinterventionalSponsorCook Group IncorporatedRan2014 to 2017Enrolled178ConditionsPeripheral Artery DiseaseArmsZilver® PTX® Drug-Eluting Peripheral Stent
NCT02254837 nacompletednot on this map

Zilver PTX Post-Market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan

TypeinterventionalSponsorCook Group IncorporatedRan2012 to 2018Enrolled909ConditionsPeripheral Arterial Disease (PAD)ArmsZilver PTX Drug-Eluting Stent
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 14 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 10 institutions in 5 countries.

Michael D DakeThe University of Arizona, Health Sciences Innovation Building, 1670 East Drachman Street, 9th Floor SVP Suite, P.O. Box 210216, Tucson, AZ, 85721-0216, USA. mddake@email.arizona.edu.
Fabrizio FanelliDepartment of Vascular and Interventional Radiology, "Careggi" University Hospital, Florence, Italy.
Aaron E LottesPurdue University, West Lafayette, IN, USA.
Erin E O'LearyCook Research Incorporated, West Lafayette, IN, USA.
Heidi ReichertEpidStrategies, Ann Arbor, MI, USA.
Xiaohui JiangEpidStrategies, Ann Arbor, MI, USA.
Weiguo FuDepartment of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.
Osamu IidaCardiovascular Center, Kansai Rosai Hospital, Amagasaki, Japan.
Kan ZenDepartment of Cardiovascular Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Marc SchermerhornDivision of Vascular Surgery, Department of Surgery, Beth Israel Deaconess Medical Center, Boston, MA, USA.
Thomas ZellerUniversitaets-Herz-Zentrum Freiburg - Bad Krozingen, Bad Krozingen, Germany.
Gary M AnselDepartment of Medicine, Ohio Health/Riverside Methodist Hospital, Columbus, OH, USA.
Azienda Ospedaliero-Universitaria Careggi · ITBeth Israel Deaconess Medical Center · USCook Research (United States) · USKansai Rosai Hospital · JPKyoto Prefectural University of Medicine · JPPurdue University West Lafayette · USRiverside Methodist Hospital · USUniversitäts-Herzzentrum Freiburg-Bad Krozingen · DEUniversity of Arizona · USZhongshan Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeDevelop a prediction model to determine the impact of patient and lesion factors on freedom from target lesion revascularization (ffTLR) for patients who are candidates for Zilver PTX drug-eluting stent (DES) treatment for femoropopliteal lesions.

methodsPatient factors, lesion characteristics, and TLR results from five global studies were utilized for model development. Factors potentially associated with TLR (sex, age, diabetes, hypertension, hypercholesterolemia, renal disease, smoking status, Rutherford classification, lesion length, reference vessel diameter (RVD), popliteal involvement, total occlusion, calcification severity, prior interventions, and number of runoff vessels) were analyzed in a Cox proportional hazards model. Probability of ffTLR was generated for three example patient profiles via combinations of patient and lesion factors. TLR was defined as reintervention performed for ≥ 50% diameter stenosis after recurrent clinical symptoms.

resultsThe model used records from 2227 patients. The median follow-up time was 23.9 months (range: 0.03-60.8). The Kaplan-Meier estimates for ffTLR were 90.5% through 1 year and 75.2% through 5 years. In a multivariate analysis, sex, age, Rutherford classification, lesion length, RVD, total occlusion, and prior interventions were significant factors. The example patient profiles have predicted 1-year ffTLRs of 97.4, 92.3, and 86.0% and 5-year predicted ffTLRs of 92.8, 79.5, and 64.8%. The prediction model is available as an interactive web-based tool ( https://cooksfa.z13.web.core.windows.net ).

conclusionsThis is the first prediction model that uses an extensive dataset to determine the impact of patient and lesion factors on ffTLR through 5 years and provides an interactive web-based tool for expected patient outcomes with the Zilver PTX DES. CLINICAL TRIAL REGISTRATIONS: Zilver PTX RCT unique identifier: NCT00120406; Zilver PTX single-arm study unique identifier: NCT01094678; Zilver PTX China study unique identifier: NCT02171962; Zilver PTX US post-approval study unique identifier: NCT01901289; Zilver PTX Japan post-market surveillance study unique identifier: NCT02254837. LEVELS OF EVIDENCE: Zilver PTX RCT: Level 2, randomized controlled trial; Single-arm study: Level 4, large case series; China study: Level 4, case series; US post-approval study: Level 4, case series Japan PMS study: Level 4, large case series.

Indexed as

Drug-Eluting StentsAgedAged, 80 and overDatasets as TopicEndovascular ProceduresFemaleFemoral ArteryFollow-Up StudiesHumansMaleMiddle AgedPaclitaxelPeripheral Arterial DiseasePopliteal ArteryProspective StudiesRecurrencePaclitaxelTubulin ModulatorsDrug-eluting stentPaclitaxelPeripheral artery diseasePrediction modelTarget lesion revascularization

Identifiers

PMID33025243
PMCPMC7806559
OpenAlexW3091888319

What Socratic holds

Textmetadata
LicenceCC BY
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.