Evidence map›Paper›PMID 25787199›Full record

Trial reportJournal of the American College of Cardiology2015

Benefits and Risks of Extended Duration Dual Antiplatelet Therapy After PCI in Patients With and Without Acute Myocardial Infarction.

Robert W Yeh, Dean J Kereiakes, Philippe Gabriel Steg, Stephan Windecker, Michael J Rinaldi, Anthony H Gershlick, Donald E Cutlip, David J Cohen, Jean-Francois Tanguay, Alice Jacobs and 5 more

Registry-linked trialAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of the American College of Cardiology, 2015. 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 77 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
77citing papers in PubMed, 7 pooled it
32.3field-weighted citation impact, top 1% 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

77 citing papers in PubMed, 7 syntheses or guidelines pooled it, 275 citations in OpenAlex.

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  17. Should We Use Aspirin or P2YCurrent atherosclerosis reports · 2024
    Review
  18. Thrombogenicity of biodegradable metals.Bioactive materials · 2024
    Article
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17 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 12 institutions in 6 countries.

Robert W YehMassachusetts General Hospital, Boston, Massachusetts; Harvard Clinical Research Institute, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts.
Dean J KereiakesThe Christ Hospital Heart and Vascular Center and The Lindner Center for Research and Education, Cincinnati, Ohio.
Philippe Gabriel StegUniversité Paris-Diderot, Paris, France, INSERM U-1148, Paris, France; Hôpital Bichat, Département Hospitalo-Universitaire FIRE, Assistance Publique-Hôpitaux de Paris, Paris, France; NHLI, Imperial College, Royal Brompton Hospital, London, United Kingdom.
Stephan WindeckerBern University Hospital, Bern, Switzerland.
Michael J RinaldiThe Sanger Heart and Vascular Institute, Carolinas HealthCare System, Charlotte, North Carolina.
Anthony H GershlickDepartment of Cardiovascular Sciences, University of Leicester and National Institute of Health Research Leicester Cardiovascular Biomedical Research Unit, University Hospitals of Leicester, Leicester, United Kingdom.
Donald E CutlipHarvard Clinical Research Institute, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts; Beth Israel Deaconess Medical Center, Boston, Massachusetts.
David J CohenSaint Luke's Mid-America Heart Institute, University of Missouri-Kansas City School of Medicine, Kansas City, Missouri.
Jean-Francois TanguayMontreal Heart Institute, Université de Montréal, Montreal, Canada.
Alice JacobsBoston Medical Center, Boston University School of Medicine, Boston, Massachusetts.
Stephen D WiviottHarvard Medical School, Boston, Massachusetts; Brigham and Women's Hospital, Boston, Massachusetts.
Joseph M MassaroHarvard Clinical Research Institute, Boston, Massachusetts; Boston University School of Public Health, Boston, Massachusetts.
Adrian C IancuHeart Institute, University of Medicine Iuliu Hatieganu, Cluj Napoca, Romania.
Laura MauriHarvard Clinical Research Institute, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts; Brigham and Women's Hospital, Boston, Massachusetts. Electronic address: lmauri1@partners.org.
DAPT Study Investigators
Boston University · USBrigham and Women's Hospital · USBeth Israel Deaconess Medical Center · USCarolinas Healthcare System · USChrist Hospital · USHarvard University · USInserm · FRIuliu Hațieganu University of Medicine and Pharmacy · ROMontreal Heart Institute · CASaint Luke's Hospital · USUniversity Hospital of Bern · CHUniversity of Leicester · GB

Funding

HARVARD CLINICAL AND TRANSLATIONAL SCIENCE CENTER (UL1)UL1RR025758 · NCRR · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2008 to 2011
$91.4M
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 1R01FD003870-01FDA HHS R01 FD003870NCRR NIH HHS UL1 RR025758NHLBI NIH HHS K23 HL118138
6 · The paper itself

Abstract

backgroundThe benefits and risks of prolonged dual antiplatelet therapy may be different for patients with acute myocardial infarction (MI) compared with more stable presentations.

objectivesThis study sought to assess the benefits and risks of 30 versus 12 months of dual antiplatelet therapy among patients undergoing coronary stent implantation with and without MI.

methodsThe Dual Antiplatelet Therapy Study, a randomized double-blind, placebo-controlled trial, compared 30 versus 12 months of dual antiplatelet therapy after coronary stenting. The effect of continued thienopyridine on ischemic and bleeding events among patients initially presenting with versus without MI was assessed. The coprimary endpoints were definite or probable stent thrombosis and major adverse cardiovascular and cerebrovascular events (MACCE). The primary safety endpoint was GUSTO (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries) moderate or severe bleeding.

resultsOf 11,648 randomized patients (9,961 treated with drug-eluting stents, 1,687 with bare-metal stents), 30.7% presented with MI. Between 12 and 30 months, continued thienopyridine reduced stent thrombosis compared with placebo in patients with and without MI at presentation (MI group, 0.5% vs. 1.9%, p < 0.001; no MI group, 0.4% vs. 1.1%, p < 0.001; interaction p = 0.69). The reduction in MACCE for continued thienopyridine was greater for patients with MI (3.9% vs. 6.8%; p < 0.001) compared with those with no MI (4.4% vs. 5.3%; p = 0.08; interaction p = 0.03). In both groups, continued thienopyridine reduced MI (2.2% vs. 5.2%, p < 0.001 for MI; 2.1% vs. 3.5%, p < 0.001 for no MI; interaction p = 0.15) but increased bleeding (1.9% vs. 0.8%, p = 0.005 for MI; 2.6% vs. 1.7%, p = 0.007 for no MI; interaction p = 0.21).

conclusionsCompared with 12 months of therapy, 30 months of dual antiplatelet therapy reduced the risk of stent thrombosis and MI in patients with and without MI, and increased bleeding. (The Dual Antiplatelet Therapy Study [The DAPT Study]; NCT00977938).

Indexed as

Percutaneous Coronary InterventionStentsAspirinDouble-Blind MethodFemaleHumansMaleMiddle AgedMyocardial InfarctionPlatelet Aggregation InhibitorsPostoperative ComplicationsPyridinesRisk AssessmentThrombosisTime FactorsAspirinPlatelet Aggregation InhibitorsPyridinesthienopyridineacute coronary syndromesantiplatelet therapymyocardial infarctionpercutaneous coronary interventionrandomized clinical trial

Identifiers

PMID25787199
PMCPMC4678101
OpenAlexW1972901101

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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.