Evidence map›Paper›PMID 33847862›Full record

Trial reportJournal of thrombosis and thrombolysis2021

Gender differences with short-term vs 12 months dual antiplatelet therapy in patients with acute coronary syndrome treated with the COMBO dual therapy stent: 2-years follow-up results of the REDUCE trial.

M Verdoia, H Suryapranata, S Damen, C Camaro, E Benit, L Barbieri, S Rasoul, H B Liew, J Polad, W A W Ahmad and 16 more

Abstract readMulticenter StudyRandomized Controlled TrialEquivalence Trial
PubMed Publisher
In one paragraph

Trial report in Journal of thrombosis and thrombolysis, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
1.9field-weighted citation impact, top 13% 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

9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Review
  6. Review
  7. Review
  8. Article
  9. Ideal P2Y12 Inhibitor in Acute Coronary Syndrome: A Review and Current Status.International journal of environmental research and public health · 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

26 authors at 13 institutions in 8 countries.

M VerdoiaAOU Maggiore Della Carità, Eastern Piedmont University, Novara, Italy.ORCID http://orcid.org/0000-0001-6506-8397
H SuryapranataRadboud University Medical Center, Nijmegen, The Netherlands.
S DamenRadboud University Medical Center, Nijmegen, The Netherlands.
C CamaroRadboud University Medical Center, Nijmegen, The Netherlands.
E BenitJessa Ziekenhuis, Hasselt, Belgium.
L BarbieriAOU Maggiore Della Carità, Eastern Piedmont University, Novara, Italy.
S RasoulAtrium Medical Center, Heerlen, The Netherlands.
H B LiewQueen Elizabeth II, Sabah, Malaysia.
J PoladJeroen Bosch Ziekenhuis, 's-Hertogenbosch, The Netherlands.
W A W AhmadUniversity Malaya, Kuala Lumpur, Malaysia.
R ZambahariNational Heart Institute, Kuala Lumpur, Malaysia.
J LalmandCentre Hospitalier Universitaire, Charleroi, Belgium.
R J van der SchaafOnze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
T H KohNational Heart Center, Singapore, Singapore.
P TimmermansJessa Ziekenhuis, Hasselt, Belgium.
D Dilling-BoerJessa Ziekenhuis, Hasselt, Belgium.
L F VeenstraAtrium Medical Center, Heerlen, The Netherlands.
A W J Van't HofIsala Hospital, Zwolle, The Netherlands.
S W L LeeQueen Mary Hospital, University of Hong Kong, Hong Kong, Hong Kong.
V RoolvinkIsala Hospital, Zwolle, The Netherlands.
E LigtenbergOrbusNeich Medical BV, Hoevelaken, The Netherlands.
S PostmaDiagram BV, Zwolle, The Netherlands.
E J J KolkmanRadboud University Medical Center, Nijmegen, The Netherlands.
M A BrouwerRadboud University Medical Center, Nijmegen, The Netherlands.
E KedhiErasmus Hospital, Bruxelles, Belgium.
G De LucaAOU Maggiore Della Carità, Eastern Piedmont University, Novara, Italy. giuseppe.deluca@med.uniupo.it.
Radboud University Nijmegen · NLJessa Hospital · BEUniversità degli Studi del Piemonte Orientale “Amedeo Avogadro” · ITAtrium Medisch Centrum Parkstad · NLIsala · NLDiagram (Netherlands) · NLErasmus Hospital · BEGrand Charleroi Hospital · BEJeroen Bosch Ziekenhuis · NLNational Heart Centre Singapore · SGNational Heart Institute · MYOLVG · NLQueen Mary Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGender differences in the thrombotic and bleeding risk have been suggested to condition the benefits of antithrombotic therapies in Acute Coronary Syndrome (ACS) patients, and mainly among those undergoing percutaneous coronary interventions with drug eluting stents (DES). The impact of gender on the optimal duration of dual antiplatelet therapy (DAPT) in ACS patients is still unexplored and was, therefore, the aim of the present sub-study.

methodsREDUCE was a prospective, multicenter, randomized investigator-initiated study designed to enroll 1500 ACS patients after treatment with the COMBO Dual Stent Therapy, based on a noninferiority design. Patients were randomized in a 1:1 fashion to either 3 or 12 months of DAPT. Primary study endpoint was a composite of all-cause mortality, myocardial infarction, definite/probable stent thrombosis (ST), stroke, target-vessel revascularization (TVR) and bleedings (BARC II, III, V) at 12 months. Secondary endpoints were cardiovascular mortality and the individual components of the primary endpoint within 24 months.

resultsFrom June 2014 to May 2016 300 women and 1196 men were included in the study. Among them, 43.7% of females and 51.9% of males were assigned to the 3 months DAPT treatment. Baseline characteristics were well matched between the two arms, with the exception of a lower rate of TIMI flow < 3 (p = 0.04), lower systolic blood pressure (p = 0.05) and use of spironolactone (p = 0.006) among women and a more advanced age (p = 0.05) among men receiving a short-term DAPT. At a mean follow-up of 525 (± 198) days, no difference in the primary endpoint was observed according to DAPT duration in both females [6.9% vs 5.9%, HR (95% CI) = 1.19 (0.48-2.9), p = 0.71] and males [8.2% vs 9%, HR (95% CI) = 0.92 (0.63-1.35), p = 0.67; p INT = 0.20]. Results were confirmed after correction for baseline differences [females: adjusted HR (95% CI) = 1.12 (0.45-2.78), p = 0.81; males: adjusted HR (95% CI) = 0.90 (0.61-1.32), p = 0.60]. Comparable rates of survival, thrombotic (MI, stent thrombosis, TVR, stroke) and bleeding events were observed with the two DAPT strategies, with no impact of gender.

conclusionsThe present study shows that among ACS patients randomized in the REDUCE trial, a 3 months DAPT strategy offers comparable results as compared to a standard 12 months DAPT at 2-years follow-up in both male and female gender.

Indexed as

Acute Coronary SyndromePercutaneous Coronary InterventionDrug Therapy, CombinationFemaleFollow-Up StudiesHemorrhageHumansMalePlatelet Aggregation InhibitorsProspective StudiesSex FactorsStentsStrokeThrombosisTreatment OutcomePlatelet Aggregation InhibitorsACSBleedingDAPT durationGenderMortalityPCIThrombosis

Identifiers

PMID33847862
OpenAlexW3153817800

What OpenQuestion holds

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Registered trials

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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.