Evidence map›Paper›PMID 37460061›Full record

Trial reportJournal of vascular and interventional radiology : JVIR2023

IN.PACT AV Access Randomized Trial of Drug-Coated Balloons for Dysfunctional Arteriovenous Fistulae: Clinical Outcomes through 36 Months.

Robert Lookstein, Hiroaki Haruguchi, Kotaro Suemitsu, Naoko Isogai, Vincent Gallo, Sreekumar Madassery, Sanjay Misra, Hong Wang, Phally S Roffe, Andrew Holden and 1 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of vascular and interventional radiology : JVIR, 2023. 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
5.4field-weighted citation impact, top 4% 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

6 citing papers in PubMed, 16 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

11 authors at 8 institutions in 3 countries.

Robert LooksteinDepartment of Diagnostic, Molecular, and Interventional Radiology, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: Robert.Lookstein@mountsinai.org.
Hiroaki HaruguchiHaruguchi Vascular Access Clinic, Tokyo, Japan.
Kotaro SuemitsuKansai Rosai Hospital, Hyogo, Japan.
Naoko IsogaiShonan Kamakura General Hospital, Kanagawa, Japan.
Vincent GalloVascular and Interventional Radiology, Staten Island University Hospital/Northwell Health, New York, New York.
Sreekumar MadasseryVascular Interventional Services, Rush University Medical Center, Chicago, Illinois.
Sanjay MisraDepartment of Radiology, Division of Vascular and Interventional Radiology, Mayo Clinic, Rochester, Minnesota.
Hong WangMedtronic, Plymouth, Minnesota.
Phally S RoffeMedtronic, Plymouth, Minnesota.
Andrew HoldenDepartment of Interventional Radiology, Auckland Hospital, Auckland, New Zealand.
IN.PACT AV Access Investigators
Medtronic (United States) · USAuckland City Hospital · NZIcahn School of Medicine at Mount Sinai · USKansai Rosai Hospital · JPMayo Clinic · USNorthwell Health · USRush University Medical Center · USShonan Kamakura General Hospital · JP

Funding

The Role of Hypoxia In Venous Neointimal Hyperplasia In Hemodialysis GraftsR01HL098967 · NHLBI · MAYO CLINIC ROCHESTER · PI Sanjay Misra · 2010 to 2026
$10.4M
NHLBI NIH HHS R01 HL098967
6 · The paper itself

Abstract

purposeTo present the 36-month outcomes of the prospective randomized IN.PACT AV Access study of participants with obstructive de novo or restenotic native upper extremity arteriovenous dialysis fistula lesions treated with drug-coated balloon (DCBs) or standard percutaneous transluminal angioplasty (PTA) following successful high-pressure PTA. MATERIALS AND

methodsParticipants at 29 international sites were randomized 1:1 to receive an IN.PACT AV DCB (n = 170) or undergo PTA (n = 160). The outcomes through 36 months included target lesion primary patency (TLPP) and access circuit primary patency (ACPP) (composites of clinically driven target lesion or access circuit revascularization and/or access circuit thrombosis), number of reinterventions, and serious adverse events involving the access circuit.

resultsTLPP was 52.1% in the DCB group compared with 36.7% in the PTA group through 24 months and 43.1% in the DCB group compared with 28.6% in the PTA group through 36 months (both log-rank P < .001). ACPP was 39.4% in the DCB group compared with 25.3% in the PTA group through 24 months and 26.4% in the DCB group compared with 16.6% in the PTA group through 36 months (both log-rank P < .001). Cumulative incidence of access circuit thrombosis through 36 months was 8.2% in the DCB group compared with 18.3% in the PTA group (log-rank P = .040). Cumulative incidence of mortality through 36 months was 26.6% in the DCB group compared with 30.8% in the PTA group (log-rank P = .71).

conclusionsThis study demonstrated superior TLPP and ACPP with DCBs compared with PTA, with no difference in mortality through 3 years. Access circuit thrombosis was statistically significantly higher in the PTA group at 3 years.

Indexed as

Angioplasty, BalloonPeripheral Arterial DiseaseThrombosisVascular Access DevicesCoated Materials, BiocompatibleFemoral ArteryHumansPopliteal ArteryProspective StudiesSingle-Blind MethodTime FactorsTreatment OutcomeVascular PatencyCoated Materials, Biocompatible

Identifiers

PMID37460061
PMCPMC11702510
OpenAlexW4384562783

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.