Evidence map›Paper›PMID 38170246›Full record

ArticleClinical research in cardiology : official journal of the German Cardiac Society2024

Safety and efficacy of everolimus-eluting bioresorbable vascular scaffold for cardiac allograft vasculopathy (CART).

Michele Pighi, Fabrizio Tomai, Simone Fezzi, Gabriele Pesarini, Alessandro Petrolini, Leonardo Spedicato, Giuseppe Tarantini, Marco Ferlini, Paolo Calabrò, Bruno Loi and 4 more

Registry-linked trialAbstract readMulticenter Study
PubMed Publisher
In one paragraph

Article in Clinical research in cardiology : official journal of the German Cardiac Society, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02377648 (Everolimus-eluting Bioresorbable Vascular Scaffold System in the Treatment of Cardiac Allograft Vasculopathy in Heart Transplant Recipients), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT02377648 phase4completednot on this map

Everolimus-eluting Bioresorbable Vascular Scaffold System in the Treatment of Cardiac Allograft Vasculopathy in Heart Transplant Recipients: A Prospective Multicenter Pilot Study

TypeinterventionalSponsorUniversita di VeronaRan2015 to 2020Enrolled34ConditionsCardiac Allograft VasculopathyArmsEverolimus-Eluting Bioresorbable Vascular Scaffold (ABSORB)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
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

14 authors.

Michele PighiDivision of Cardiology, Department of Medicine, University of Verona, Piazzale Aristide Stefani, 1, 37126, Verona, Italy.
Fabrizio TomaiDepartment of Cardiovascular Sciences, European Hospital, Rome, Italy.
Simone FezziDivision of Cardiology, Department of Medicine, University of Verona, Piazzale Aristide Stefani, 1, 37126, Verona, Italy.
Gabriele PesariniDivision of Cardiology, Department of Medicine, University of Verona, Piazzale Aristide Stefani, 1, 37126, Verona, Italy. gabriele.pesarini@aovr.veneto.it.ORCID http://orcid.org/0000-0002-2770-8231
Alessandro PetroliniDepartment of Cardiovascular Sciences, European Hospital, Rome, Italy.
Leonardo SpedicatoDepartment of Cardiovascular Sciences, Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy.
Giuseppe TarantiniDepartment of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Padua, Italy.
Marco FerliniDivision of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Paolo CalabròDepartment of Translational Medical Sciences, University of Campania "Luigi Vanvitelli", Naples, Italy.
Bruno LoiDivision of Cardiology, Azienda Ospedaliera Brotzu, Cagliari, Italy.
Valeria FerreroDivision of Cardiology, Department of Medicine, University of Verona, Piazzale Aristide Stefani, 1, 37126, Verona, Italy.
Maria Natalia Tovar ForeroDepartment of Cardiology, Erasmus University Medical Center, Rotterdam, The Netherlands.
Joost DaemenDepartment of Cardiology, Erasmus University Medical Center, Rotterdam, The Netherlands.
Flavio RibichiniDivision of Cardiology, Department of Medicine, University of Verona, Piazzale Aristide Stefani, 1, 37126, Verona, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCardiac allograft vasculopathy (CAV) is still the main drawback of heart transplantation (HTx) and percutaneous coronary intervention (PCI) is a palliative measure because of the high incidence of failure.

objectiveThis study aimed to investigate the safety and efficacy of bioresorbable scaffolds (BRSs) as potential novel therapeutic tool for the treatment of coronary stenoses in CAV.

methodsThis is a multicenter, single-arm, prospective, open-label study (CART, NCT02377648), that included patients affected by advanced CAV treated with PCI and second-generation ABSORB BRS (Abbott Vascular). The primary endpoint was the incidence of 12-month angiographic in-segment scaffold restenosis (ISSR). Secondary endpoints were the incidence of major adverse cardiac events (MACEs) at 12- and 36-month follow-up and the incidence of ISSR at 36 months. A paired intracoronary imaging analysis at baseline and follow-up was also performed.

resultsBetween 2015 and 2017 35 HTx patients were enrolled and treated for 44 coronary lesions with 51 BRSs. The primary endpoint occurred in 13.5% of the lesions (5/37), with a cumulative ISSR rate up to 3 years of 16.2% (6/37). Angiographic lumen loss was 0.40 ± 0.62 mm at 12 months and 0.53 ± 0.57 mm at 36 months. Overall survival rate was 91.4% and 74.3%, and MACEs incidence 14.2% and 31.4% at 12 and 36 months, respectively. At the paired intracoronary imaging analysis, a significant increase of the vessel external elastic membrane area in the treated segment and some progression of CAV proximally to the BRS were detected.

conclusionsBRS-based PCI for the treatment of CAV is feasible and safe, with an ISSR incidence similar to what reported in retrospective studies with drug-eluting stents.

Indexed as

Absorbable ImplantsCoronary AngiographyEverolimusHeart TransplantationPercutaneous Coronary InterventionAgedAllograftsCoronary Artery DiseaseCoronary StenosisCoronary VesselsDrug-Eluting StentsFemaleFollow-Up StudiesHumansImmunosuppressive AgentsMaleEverolimusImmunosuppressive AgentsBioresorbable vascular scaffoldCardiac allograft vasculopathyHeart transplantationIntravascular ultrasoundOptical coherence tomographyPercutaneous coronary intervention

Identifiers

PMID38170246

What OpenQuestion holds

Textmetadata
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 OpenQuestion graph.