Evidence map›Paper›PMID 26586780›Full record

Trial reportEuropean heart journal2016

Causes of late mortality with dual antiplatelet therapy after coronary stents.

Laura Mauri, Sammy Elmariah, Robert W Yeh, Donald E Cutlip, P Gabriel Steg, Stephan Windecker, Stephen D Wiviott, David J Cohen, Joseph M Massaro, Ralph B D'Agostino and 3 more

Registry-linked trialOpen access · bronzeAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in European heart journal, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00977938 (A Prospective, Multi-center, Randomized, Double-blind Trial to Assess the Effectiveness and Safety of 12 Versus 30 Months of Dual Antiplatelet Therapy in Subjects Undergoing Percutaneous Coronary Intervention With Either Drug-eluting Stent or Bare Metal Stent Placement for the Treatment of Coronary Artery Lesions), which is not on this map. Cited by 21 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 2 pooled it
6.2field-weighted citation impact, top 3% 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.

NCT00977938 phase4completednot on this map

A Prospective, Multi-center, Randomized, Double-blind Trial to Assess the Effectiveness and Safety of 12 Versus 30 Months of Dual Antiplatelet Therapy in Subjects Undergoing Percutaneous Coronary Intervention With Either Drug-eluting Stent or Bare Metal Stent Placement for the Treatment of Coronary Artery Lesions

TypeinterventionalSponsorBaim Institute for Clinical ResearchRan2009 to 2014Enrolled25,682ConditionsCoronary Artery DiseaseArmsPlacebo & Aspirin, Clopidogrel & Aspirin, Prasugrel & Aspirin
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 2 syntheses or guidelines pooled it, 50 citations in OpenAlex.

  1. Mortality after bleeding versus myocardial infarction in coronary artery disease: a systematic review and meta-analysis.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2021
    Pooled it
  2. Pooled it
  3. Trial
  4. Guideline for Chronic Coronary Syndrome - 2025.Arquivos brasileiros de cardiologia · 2025
    Article
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  16. Optimal duration of dual antiplatelet therapy for coronary artery disease.Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation · 2018
    Review
  17. Article
  18. Review
  19. Optimal duration of dual antiplatelet therapy after percutaneous coronary intervention or after acute coronary syndrome : Practical lessons from a review.Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation · 2017
    Review
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 8 institutions in 4 countries.

Laura MauriHarvard Clinical Research Institute, Boston, USA Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA Harvard Medical School , Boston, USA lmauri1@partners.org.
Sammy ElmariahHarvard Clinical Research Institute, Boston, USA Harvard Medical School , Boston, USA Massachusetts General Hospital, Boston, USA.
Robert W YehHarvard Clinical Research Institute, Boston, USA Harvard Medical School , Boston, USA Massachusetts General Hospital, Boston, USA.
Donald E CutlipHarvard Clinical Research Institute, Boston, USA Harvard Medical School , Boston, USA Beth Israel Deaconess Medical Center, Boston, USA.
P Gabriel StegDépartement Hospitalo-Universitaire Fibrosis, Inflammation, and Remodeling, Assistance Publique - Hôpitaux de Paris, Paris, France National Heart and Lung Institute, Imperial College, Royal Brompton Hospital, London, UK.
Stephan WindeckerBern University Hospital, Bern, Switzerland.
Stephen D WiviottDivision of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA Harvard Medical School , Boston, USA.
David J CohenSaint Luke's Mid America Heart Institute, Kansas City, MO, USA University of Missouri-Kansas City School of Medicine, Kansas City, MO, USA.
Joseph M MassaroHarvard Clinical Research Institute, Boston, USA Boston University School of Public Health, Boston, USA Université Paris-Diderot, INSERM U-1148, Hôpital Bichat, Paris, France.
Ralph B D'AgostinoHarvard Clinical Research Institute, Boston, USA Boston University School of Public Health, Boston, USA.
Eugene BraunwaldDivision of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA Harvard Medical School , Boston, USA.
Dean J KereiakesThe Christ Hospital Heart and Vascular Center, The Lindner Center for Research and Education, Cincinnati, OH, USA.
DAPT Study Investigators
Baim Institute for Clinical Research · USHarvard University · USBoston University · USChrist Hospital · USMassachusetts General Hospital · USRoyal Brompton Hospital · GBUniversity Hospital of Bern · CHUniversity of Missouri–Kansas City · US

Funding

DUAL ANTIPLATELET THERAPY TRIAL: Research Project Grant (R01)R01FD003870 · FDA · HARVARD CLINICAL RESEARCH INSTITUTE · PI MAURI, LAURA · 2009 to 2009
$1.5M
Balancing the Risks of Ischemia and Bleeding in Percutaneous Coronary InterventioK23HL118138 · NHLBI · MASSACHUSETTS GENERAL HOSPITAL · PI YEH, ROBERT · 2013 to 2017
$740k
FDA HHS 1R01FD003870-01NHLBI NIH HHS K23 HL118138
6 · The paper itself

Abstract

aimsIn the dual antiplatelet therapy (DAPT) study, continued thienopyridine beyond 12 months after drug-eluting stent placement was associated with increased mortality compared with placebo. We sought to evaluate factors related to mortality in randomized patients receiving either drug-eluting or bare metal stents in the DAPT study. METHODS AND

resultsPatients were enrolled after coronary stenting, given thienopyridine and aspirin for 12 months, randomly assigned to continued thienopyridine or placebo for an additional 18 months (while taking aspirin), and subsequently treated with aspirin alone for another 3 months. A blinded independent adjudication committee evaluated deaths. Among 11 648 randomized patients, rates of all-cause mortality rates were 1.9 vs. 1.5% (continued thienopyridine vs. placebo, P = 0.07), cardiovascular mortality, 1.0 vs. 1.0% (P = 0.97), and non-cardiovascular mortality, 0.9 vs. 0.5% (P = 0.01) over the randomized period (Months 12-30). Rates of fatal bleeding were 0.2 vs. 0.1% (P = 0.81), and deaths related to any prior bleeding were 0.3 vs. 0.2% (P = 0.36), Months 12-33). Cancer incidence did not differ (2.0 vs. 1.6%, P = 0.12). Cancer-related deaths occurred in 0.6 vs. 0.3% (P = 0.02) and were rarely related to bleeding (0.1 vs. 0, P = 0.25). After excluding those occurring in patients with cancer diagnosed before enrolment, rates were 0.4 vs. 0.3% (P = 0.16).

conclusionBleeding accounted for a minority of deaths among patients treated with continued thienopyridine. Cancer-related death in association with thienopyridine therapy was mainly not related to bleeding and may be a chance finding. Caution is warranted when considering extended thienopyridine in patients with advanced cancer.

trial registrationclinicaltrials.gov Identifier: NCT00977938.

Indexed as

Drug-Eluting StentsAspirinCause of DeathDrug Therapy, CombinationFemaleHemorrhageHumansMaleMiddle AgedMyocardial InfarctionNeoplasmsPercutaneous Coronary InterventionPlatelet Aggregation InhibitorsPyridinesTreatment OutcomeAspirinPlatelet Aggregation InhibitorsPyridinesthienopyridineCancerDual antiplatelet therapyMortalityThienopyridine

Identifiers

PMID26586780
PMCPMC4751218
OpenAlexW2195530205

What OpenQuestion holds

Textmetadata
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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.