Evidence map›Paper›PMID 34984488›Full record

Trial reportCardiovascular and interventional radiology2022

Randomised Controlled Trial of Particles Used in Uterine fibRoid Embolisation (PURE): Non-Spherical Polyvinyl Alcohol Versus Calibrated Microspheres.

Raj Das, Anita Wale, Seyed Ameli Renani, Lakshmi Ratnam, Leto Mailli, Joo-Young Chun, Sourav Das, Balpreet Duggal, Isaac Manyonda, Anna-Maria Belli

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Cardiovascular and interventional radiology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
3.0field-weighted citation impact, top 9% 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

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Article
  5. Review
  6. BMJ case reports · 2024
    Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Nononcologic Embolization.Seminars in interventional radiology · 2022
    Review
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

10 authors at 1 institution in 1 country.

Raj DasDepartment of Radiology, St. George's Hospital, St George's Healthcare NHS Trust, London, SW17 0QT, UK. raj.das@stgeorges.nhs.uk.ORCID http://orcid.org/0000-0002-8353-2656
Anita WaleDepartment of Radiology, St. George's Hospital, St George's Healthcare NHS Trust, London, SW17 0QT, UK.
Seyed Ameli RenaniDepartment of Radiology, St. George's Hospital, St George's Healthcare NHS Trust, London, SW17 0QT, UK.
Lakshmi RatnamDepartment of Radiology, St. George's Hospital, St George's Healthcare NHS Trust, London, SW17 0QT, UK.
Leto MailliDepartment of Radiology, St. George's Hospital, St George's Healthcare NHS Trust, London, SW17 0QT, UK.
Joo-Young ChunDepartment of Radiology, St. George's Hospital, St George's Healthcare NHS Trust, London, SW17 0QT, UK.
Sourav DasDepartment of Gynaecology, St. George's Hospital, London, UK.
Balpreet DuggalDepartment of Gynaecology, St. George's Hospital, London, UK.
Isaac ManyondaDepartment of Gynaecology, St. George's Hospital, London, UK.
Anna-Maria BelliDepartment of Radiology, St. George's Hospital, St George's Healthcare NHS Trust, London, SW17 0QT, UK.
St George's Hospital · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe PURE study is a randomised controlled trial (RCT) comparing the clinical and MRI outcomes of patients treated with non-spherical polyvinyl alcohol, ns-PVA (Contour PVA-Boston Scientific-355-500 & 500-700 microns) versus calibrated hydrogel microspheres (Embozene-Varian Inc-700 & 900 microns) for symptomatic uterine fibroids. MATERIALS AND

methodsProspective, ethically approved non-sponsored RCT in 84 patients in a single UK tertiary IR unit, ISRCTN registry trial number ISRCTN18191539 in 2013 and 2014. All patients with symptomatic fibroid disease were eligible. UAE followed a standardised protocol with UFS-QOL and contrast-enhanced MRI before and 6 months post UAE. Outcome measures included: (1) Uterine Fibroid Symptom and Quality of Life questionnaire (UFS-QOL). (2) Percentage total and dominant fibroid infarction. (3) Uterine and dominant fibroid volume reduction. (4) Volume of embolics.

resultsSixty-three patients completed the QOL follow-up (33 ns-PVA vs 30 Embozenes), the groups were equivalent at baseline. Patients were followed up for 6 months following UAE. There was no significant difference in symptom scores or HR-QOL between ns-PVA and Embozenes, p = 0.67 and 0.21, respectively. 92.7% of patients treated with ns-PVA achieved > 90% dominant fibroid infarction versus 61.8% treated with Embozenes (p = 0.0016). 66% of patients treated with ns = PVA achieved > 90% total fibroid percentage infarction compared with 35% in the Embozene group (p = 0.011). The mean vials/syringes used were 5.2 with Embozenes versus 4.1 using PVA (p = 0.08).

conclusionThe PURE study informs IRs regarding the efficacy of embolic agents in UAE, with superior fibroid infarction on MRI using ns-PVA versus Embozenes however no significant difference in clinical outcomes at 6 months after UAE.

Indexed as

LeiomyomaUterine Artery EmbolizationUterine NeoplasmsFemaleHumansMicrospheresPolyvinyl AlcoholTreatment OutcomePolyvinyl AlcoholEmbolicEmbolisationFibroidInfarctionLeiomyomaParticle

Identifiers

PMID34984488
PMCPMC8807446
OpenAlexW4206050319

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.