Evidence map›Paper›PMID 30143879›Full record

Trial reportCardiovascular drugs and therapy2018

High Bleeding Risk Patients Treated with Very Thin-Strut Biodegradable Polymer or Thin-Strut Durable Polymer Drug-Eluting Stents in the BIO-RESORT Trial.

Paolo Zocca, Marlies M Kok, Liefke C van der Heijden, Peter W Danse, Carl E Schotborgh, Martijn Scholte, Marc Hartmann, Gerard C M Linssen, Carine J M Doggen, Clemens von Birgelen

2 registry-linked trialsOpen access · hybridAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Cardiovascular drugs and therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 24% 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.

NCT01674803 nacompletednot on this map

Comparison of BIOdegradable Polymer and DuRablE Polymer Drug-eluting Stents in an All COmeRs PopulaTion: Randomized Multicenter Trial in an All Comers Population Treated Within thE NeThErlands 3 (TWENTE 3)

TypeinterventionalSponsorFoundation of Cardiovascular Research and Education EnschedeRan2012 to 2020Enrolled3,514ConditionsAcute Coronary Syndrome, Angina Pectoris, Angina, Unstable, Myocardial InfarctionArmsOrsiro, Synergy, Resolute Integrity
NCT04885816 naterminatednot on this mapstarted 2021, after this paper: background citation

Drug-Eluting Balloon Versus Drug-eluting Stent On de Novo coRonary Artery Disease in Patients With High Bleeding Risk

TypeinterventionalSponsorInstituto Nacional de Cardiologia Ignacio ChavezRan2021 to 2021Enrolled5ConditionsHigh Bleeding Risk, Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI)ArmsDrug Eluting Balloon (DEB), Drug Eluting Stents (DES)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  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

10 authors at 6 institutions in 1 country.

Paolo ZoccaDepartment of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Postbus 50.000, 7500, KA, Enschede, the Netherlands.
Marlies M KokDepartment of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Postbus 50.000, 7500, KA, Enschede, the Netherlands.
Liefke C van der HeijdenDepartment of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Postbus 50.000, 7500, KA, Enschede, the Netherlands.
Peter W DanseDepartment of Cardiology, Rijnstate Hospital, Arnhem, the Netherlands.
Carl E SchotborghDepartment of Cardiology, Haga Hospital, Den Haag, the Netherlands.
Martijn ScholteDepartment of Cardiology, Albert Schweitzer Hospital, Dordrecht, the Netherlands.
Marc HartmannDepartment of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Postbus 50.000, 7500, KA, Enschede, the Netherlands.
Gerard C M LinssenDepartment of Cardiology, Ziekenhuisgroep Twente, Almelo and Hengelo, the Netherlands.
Carine J M DoggenDepartment of Health Technology and Services Research, Faculty of Behavioural, Management and Social Sciences, Technical Medical Centre, University of Twente, Enschede, the Netherlands.
Clemens von BirgelenDepartment of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Postbus 50.000, 7500, KA, Enschede, the Netherlands. c.vonbirgelen@mst.nl.ORCID 0000-0002-5128-2832
Medisch Spectrum Twente · NLAlbert Schweitzer Ziekenhuis · NLHaga Hospital · NLRijnstate Hospital · NLUniversity of Twente · NLZiekenhuis Groep Twente · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposePatients with high bleeding risk (HBR) who undergo percutaneous coronary intervention also have an increased risk of ischemic events and represent an overall high-risk population. The coating of durable polymer drug-eluting stents (DP-DES) may induce inflammation and delay arterial healing, which might be reduced by novel biodegradable polymer DES (BP-DES). We aimed to evaluate the safety and efficacy of treating HBR patients with very thin-strut BP-DES versus thin-strut DP-DES.

methodsParticipants in BIO-RESORT (NCT01674803), an investigator-initiated multicenter, randomized all-comers trial, were treated with very thin-strut BP-DES (Synergy or Orsiro) or thin-strut DP-DES (Resolute Integrity). For the present analysis, patients were classified following HBR criteria based on previous trials. The primary endpoint was target vessel failure: a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization at 1 year.

resultsOf all 3514 patients, 1009 (28.7%) had HBR. HBR patients were older (p < 0.001) and had more co-morbidities than non-HBR patients (p < 0.001). At 1-year follow-up, HBR patients had significantly higher rates of target vessel failure (6.7 vs. 4.2%, p = 0.003), cardiac death (1.9 vs. 0.4%, p < 0.001), and major bleeding (3.3 vs. 1.5%, p = 0.001). Of all 1009 HBR patients, 673 (66.7%) received BP-DES and 336 (33.3%) had DP-DES. The primary endpoint was met by 43/673 (6.5%) patients treated with BP-DES and 24/336 (7.3%) treated with DP-DES (HR 0.88 [95%CI 0.54-1.46], p = 0.63). There were no significant between-group differences in the most global patient-oriented clinical endpoint (9.7 vs. 10.5%, HR 0.92 [95%CI 0.61-1.39], p = 0.69) and other secondary endpoints.

conclusionsAt 1-year follow-up, very thin-strut BP-DES showed similar safety and efficacy for treating HBR patients as thin-strut DP-DES.

Indexed as

Absorbable ImplantsDrug-Eluting StentsAgedAged, 80 and overCoronary Artery DiseaseFemaleHemorrhageHumansMaleMiddle AgedNetherlandsPercutaneous Coronary InterventionPlatelet Aggregation InhibitorsPolymersProsthesis DesignRisk AssessmentPlatelet Aggregation InhibitorsPolymersBiodegradable polymerDrug-eluting stentDurable polymerHigh bleeding riskPercutaneous coronary intervention

Identifiers

PMID30143879
PMCPMC6267643
OpenAlexW2888471566

What OpenQuestion holds

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LicenceCC BY
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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.