Evidence map›Paper›PMID 33008407›Full record

ArticleCardiovascular diabetology2020

Everolimus-eluting bioresorbable scaffolds and metallic stents in diabetic patients: a patient-level pooled analysis of the prospective ABSORB DM Benelux Study, TWENTE and DUTCH PEERS.

T M Hommels, R S Hermanides, B Berta, E Fabris, G De Luca, E H Ploumen, C von Birgelen, E Kedhi

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Cardiovascular diabetology, 2020. 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 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 44% 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.

NCT01066650 phase4completednot on this map

The Real-World Endeavor Resolute Versus XIENCE V Drug-Eluting SteNt Study: Head-to-head Comparison of Clinical Outcome After Implantation of Second Generation Drug-eluting Stents in a Real World Scenario

TypeinterventionalSponsorFoundation of Cardiovascular Research and Education EnschedeRan2008 to 2012Enrolled1,391ConditionsCoronary Artery Disease, Angina Pectoris, Unstable Angina Pectoris, Coronary StenosisArmsEndeavor Resolute (Biolinx-based Zotarolimus-eluting stent), Xience V (Everolimus-eluting stent)
NCT01331707 phase4completednot on this map

DUrable Polymer-based STent CHallenge of Promus Element Versus ReSolute Integrity (DUTCH PEERS): Randomized Multicenter Trial in All Comers Population Treated Within Eastern NeThErlands-2 (TWENTE-2)

TypeinterventionalSponsorFoundation of Cardiovascular Research and Education EnschedeRan2010 to 2013Enrolled1,811ConditionsAcute Coronary Syndrome, Angina Pectoris, Angina, Unstable, Myocardial InfarctionArmsResolute Integrity (Zotarolimus-eluting stent), Promus Element (Everolimus-eluting stent)
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. 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

8 authors at 5 institutions in 3 countries.

T M HommelsIsala Hospital, Zwolle, The Netherlands.ORCID 0000-0002-8527-6254
R S HermanidesIsala Hospital, Zwolle, The Netherlands.
B BertaIsala Hospital, Zwolle, The Netherlands.
E FabrisCardiovascular Department, University of Trieste, Trieste, Italy.
G De LucaAOU Maggiore della Carità, Eastern Piedmont University, Novara, Italy.
E H PloumenMedisch Spectrum Twente, Thoraxcentrum & University of Twente, Thoraxcentrum, The Netherlands.
C von BirgelenMedisch Spectrum Twente, Thoraxcentrum & University of Twente, Thoraxcentrum, The Netherlands.
E KedhiDepartment of Cardiology, Hôpital Erasme Université Libre de Bruxelles, Brussels, Belgium. ekedhi@me.com.
Isala · NLMedisch Spectrum Twente · NLUniversità degli Studi del Piemonte Orientale “Amedeo Avogadro” · ITUniversité Libre de Bruxelles · BEUniversity of Trieste · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSeveral studies compared everolimus-eluting bioresorbable scaffolds (EE-BRS) with everolimus-eluting stents (EES), but only few assessed these devices in patients with diabetes mellitus.

aimTo evaluate the safety and efficacy outcomes of all-comer patients with diabetes mellitus up to 2 years after treatment with EE-BRS or EES.

methodsWe performed a post hoc pooled analysis of patient-level data in diabetic patients who were treated with EE-BRS or EES in 3 prospective clinical trials: The ABSORB DM Benelux Study (NTR5447), TWENTE (NTR1256/NCT01066650) and DUTCH PEERS (NTR2413/NCT01331707). Primary endpoint of the analysis was target lesion failure (TLF): a composite of cardiac death, target vessel myocardial infarction or clinically driven target lesion revascularization. Secondary endpoints included major adverse cardiac events (MACE): a composite of all-cause death, any myocardial infarction or clinically driven target vessel revascularization, as well as definite or probable device thrombosis (ST).

resultsA total of 499 diabetic patients were assessed, of whom 150 received EE-BRS and 249 received EES. Total available follow-up was 222.6 patient years (PY) in the EE-BRS and 464.9 PY in the EES group. The adverse events rates were similar in both treatment groups for TLF (7.2 vs. 5.2 events per 100 PY, p = 0.39; adjusted hazard ratio (HR) = 1.48 (95% confidence interval (CI): 0.77-2.87), p = 0.24), MACE (9.1 vs. 8.3 per 100 PY, p = 0.83; adjusted HR = 1.23 (95% CI: 0.70-2.17), p = 0.47), and ST (0.9 vs. 0.6 per 100 PY, p > 0.99).

conclusionIn this patient-level pooled analysis of patients with diabetes mellitus from 3 clinical trials, EE-BRS showed clinical outcomes that were quite similar to EES.

Indexed as

Absorbable ImplantsDiabetes MellitusDrug-Eluting StentsAgedCardiovascular AgentsClinical Trials as TopicCoronary Artery DiseaseEverolimusFemaleHumansMaleMiddle AgedPercutaneous Coronary InterventionProsthesis DesignRisk AssessmentRisk FactorsCardiovascular AgentsEverolimusBioresorbable scaffoldsCoronary artery diseaseDevice thrombosisDiabetes mellitusDrug-eluting stentsPercutaneous coronary intervention

Identifiers

PMID33008407
PMCPMC7532086
OpenAlexW3089974227

What Socratic holds

Textmetadata
LicenceCC BY
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 Socratic graph.