Evidence map›Paper›PMID 36007713›Full record

ArticleEuropean journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery2023

Editor's Choice - Real World Study of Mortality After the Use of Paclitaxel Coated Devices in Peripheral Vascular Intervention.

Jialin Mao, Art Sedrakyan, Philip P Goodney, Misti Malone, Kenneth J Cavanaugh, Danica Marinac-Dabic, Jens Eldrup-Jorgensen, Daniel J Bertges, Society for Vascular Surgery Vascular Quality Initiative and the Vascular Implant Surveillance and Interventional Outcomes Network

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PubMed Full text at PMC Publisher
In one paragraph

Article in European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
2.2field-weighted citation impact, top 12% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 10 citations in OpenAlex.

  1. Observational
  2. Drug-eluting devices for lower limb peripheral arterial disease.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2024
    Review
  3. Device regulation and surveillance in vascular care: Challenges and opportunities.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2024
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 5 institutions in 1 country.

Jialin MaoDepartment of Population Health Sciences, Weill Cornell Medicine, New York, USA.
Art SedrakyanDepartment of Population Health Sciences, Weill Cornell Medicine, New York, USA.
Philip P GoodneySection of Vascular Surgery and the Dartmouth Institute, Dartmouth-Hitchcock Medical Centre, Lebanon, USA.
Misti MaloneU.S. Food and Drug Administration, Centre for Devices and Radiological Health, Silver Spring, USA.
Kenneth J CavanaughU.S. Food and Drug Administration, Centre for Devices and Radiological Health, Silver Spring, USA.
Danica Marinac-DabicU.S. Food and Drug Administration, Centre for Devices and Radiological Health, Silver Spring, USA.
Jens Eldrup-JorgensenDivision of Vascular Surgery, Maine Medical Centre, Portland, USA.
Daniel J BertgesDivision of Vascular Surgery, University of Vermont Medical Centre, Division of Vascular Surgery, Burlington, USA. Electronic address: daniel.bertges@uvmhealth.org.
Society for Vascular Surgery Vascular Quality Initiative and the Vascular Implant Surveillance and Interventional Outcomes Network
United States Food and Drug Administration · USCornell University · USDartmouth–Hitchcock Medical Center · USMaine Medical Center · USUniversity of Vermont Medical Center · US

Funding

Novel Approaches to Advance Coordinated Registry Networks (CRNs).U01FD006936 · FDA · WEILL MEDICAL COLL OF CORNELL UNIV · PI SEDRAKYAN, ART · 2020 to 2022
$2.1M
Leveraging linked registry and electronic health records to examine long-term patient outcomes after peripheral vascular intervention"K01HL159315 · NHLBI · WEILL MEDICAL COLL OF CORNELL UNIV · PI MAO, JIALIN · 2021 to 2025
$810k
FDA HHS U01 FD006936NHLBI NIH HHS K01 HL159315
6 · The paper itself

Abstract

objectiveThis observational cohort study examined outcomes after peripheral vascular intervention (PVI) with paclitaxel coated devices (PCD) and non-PCD, and evaluated heterogeneity of treatment effect in populations of interest.

methodsThe study included patients undergoing percutaneous transluminal angioplasty and or stent placement between 1 October 2015 and 31 December 2018 in the Vascular Quality Initiative Registry linked to Medicare claims. It determined differences in patient mortality and ipsilateral major amputation after PVI with PCD and non-PCD using Kaplan-Meier analyses and Cox regressions with inverse probability weighting in three cohorts: (A) patients treated for femoropopliteal or infrapopliteal occlusive disease with or without any other concurrent treatment (n = 11 452); (B) those treated for isolated superficial femoral or popliteal artery disease (n = 5 519); and (C) patients with inclusion criteria designed to approximate RCT populations (n = 2 278).

resultsThe mean age of patients was 72.3 (SD = 10.9) years, and 40.6% were female. In cohort A, patients receiving PCD had a lower mortality rate (HR 0.88, 95% CI 0.79 - 0.98) than those receiving non-PCD. There was no significant difference in mortality between groups in cohort B (HR 0.91, 95% CI 0.80 - 1.04) and cohort C (HR 1.10, 95% CI 0.84 - 1.43). Patients receiving PCD did not have a significantly elevated risk of major amputation compared with those receiving non-PCD (cohort A: HR 0.84, 95% CI 0.70 - 1.00; cohort B: HR 0.84, 95% CI 0.67 - 1.06; and cohort C: HR 1.05, 95% CI 0.51 - 2.14).

conclusionNo increased patient mortality or major amputation was found at three years after PVI with PCD vs. non-PCD in this large, linked registry claims study, after accounting for heterogeneity of treatment effect by population. The analysis and results from three cohorts intended to mirror the cohorts of previous studies provide robust and niche real world evidence on PCD safety and help to understand and reconcile previously discrepant findings.

Indexed as

Device safetyDrug-coated balloonDrug eluting stentPaclitaxelPeripheral arterial occlusive diseasePeripheral vascular intervention

Identifiers

PMID36007713
PMCPMC9839562
OpenAlexW4292821391

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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 OpenQuestion graph.