US Food and Drug Administration Perspective on "Mortality and Paclitaxel-Coated Devices: An Individual Patient Data Meta-Analysis".

Sara Royce, Adrijo Chakraborty, Yu Zhao

Abstract readEditorialComment

In one paragraph

Article in Circulation, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it

0cells of the map it votes in

6citing papers in PubMed

–field-weighted citation impact

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

6 citing papers in PubMed.

When should clinical practice guidelines change? A critical appraisal of the ESVS focused update on paclitaxel-coated devices after SWEDEPAD 2.CVIR endovascular · 2026
Article
The ups and downs of paclitaxel-coated balloons and paclitaxel eluting stents: do the conclusions of SWEDEPAD 2 change our practice? Should we be concerned about mortality (again)?CVIR endovascular · 2026
Article
Re-analysis of Old Data and New Outcomes Data Do Not Support a Link Between Paclitaxel Coated Balloons and Paclitaxel Eluting Stents and Mortality: These Devices Should be Used in PAD (Peripheral Arterial Disease) Treatment in Femoropopliteal Disease on the Basis of Their Published Efficacy.Cardiovascular and interventional radiology · 2023
Article
ATIC-Associated De Novo Purine Synthesis Is Critically Involved in Proliferative Arterial Disease.Circulation · 2022
Article
Clinical Use of Hydrogen Sulfide to Protect Against Intimal Hyperplasia.Frontiers in cardiovascular medicine · 2022
Review
Vascular smooth muscle cells in intimal hyperplasia, an update.Frontiers in physiology · 2022
Review

4 · The record

Corrections and comments

Comment on
Mortality and Paclitaxel-Coated Devices: An Individual Patient Data Meta-Analysis.2020

5 · Who and what money

Authors and funding

3 authors.

Sara RoyceOffice of Cardiovascular Devices (S.R.), Office of Product Evaluation and Quality, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD.

Adrijo ChakrabortyOffice of Clinical Evidence and Analysis (A.C., Y.Z.), Office of Product Evaluation and Quality, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD.

Yu ZhaoOffice of Clinical Evidence and Analysis (A.C., Y.Z.), Office of Product Evaluation and Quality, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

PubMed holds no abstract for this paper.

Indexed as

Angioplasty, BalloonPeripheral Arterial DiseaseHumansPaclitaxelUnited StatesUnited States Food and Drug AdministrationPaclitaxelEditorialspaclitaxelperipheral arterial diseaserisk

Identifiers

PMID32511000

DOI10.1161/CIRCULATIONAHA.120.047376

What OpenQuestion holds

Textmetadata

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.