Evidence map›Paper›PMID 27576774›Full record

Trial reportCirculation2016

Impact of Optimal Medical Therapy in the Dual Antiplatelet Therapy Study.

Charles D Resor, Ashwin Nathan, Dean J Kereiakes, Robert W Yeh, Joseph M Massaro, Donald E Cutlip, P Gabriel Steg, Wen-Hua Hsieh, Laura Mauri, Dual Antiplatelet Therapy Study Investigators

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Circulation, 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 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 11% 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

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 4 institutions in 1 country.

Charles D ResorFrom Division of Cardiology and Center for Clinical Biometrics, Department of Medicine, Brigham and Women's Hospital, Boston, MA (C.D.R., L.M.); Harvard Clinical Research Institute, Boston, MA (R.W.Y., D.E.C., W.-H.H., L.M.); Harvard Medical School, Boston, MA (R.W.Y., L.M.); Division of Cardiology, University of Pennsylvania Medical Center, Philadelphia (A.N.); Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, MA (R.W.Y., D.E.C.); Department of Biostatistics, Boston University School of Public Heath, MA (J.M.M.); The Christ Hospital Heart and Vascular Center and The Lindner Center for Research and Education, Cincinnati, OH (D.J.K.); Université Paris-Diderot, INSERM U-1148, Hôpital Bichat, Département Hospitalo-Universitaire Fibrosis, Inflammation, and Remodeling, Assistance Publique-Hôpitaux de Paris, Paris, France (P.G.S.); and National Heart and Lung Institute, Institute of Cardiovascular Medicine and Science, Royal Brompton Hospital, Imperial College, London, UK (P.G.S.).
Ashwin NathanFrom Division of Cardiology and Center for Clinical Biometrics, Department of Medicine, Brigham and Women's Hospital, Boston, MA (C.D.R., L.M.); Harvard Clinical Research Institute, Boston, MA (R.W.Y., D.E.C., W.-H.H., L.M.); Harvard Medical School, Boston, MA (R.W.Y., L.M.); Division of Cardiology, University of Pennsylvania Medical Center, Philadelphia (A.N.); Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, MA (R.W.Y., D.E.C.); Department of Biostatistics, Boston University School of Public Heath, MA (J.M.M.); The Christ Hospital Heart and Vascular Center and The Lindner Center for Research and Education, Cincinnati, OH (D.J.K.); Université Paris-Diderot, INSERM U-1148, Hôpital Bichat, Département Hospitalo-Universitaire Fibrosis, Inflammation, and Remodeling, Assistance Publique-Hôpitaux de Paris, Paris, France (P.G.S.); and National Heart and Lung Institute, Institute of Cardiovascular Medicine and Science, Royal Brompton Hospital, Imperial College, London, UK (P.G.S.).
Dean J KereiakesFrom Division of Cardiology and Center for Clinical Biometrics, Department of Medicine, Brigham and Women's Hospital, Boston, MA (C.D.R., L.M.); Harvard Clinical Research Institute, Boston, MA (R.W.Y., D.E.C., W.-H.H., L.M.); Harvard Medical School, Boston, MA (R.W.Y., L.M.); Division of Cardiology, University of Pennsylvania Medical Center, Philadelphia (A.N.); Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, MA (R.W.Y., D.E.C.); Department of Biostatistics, Boston University School of Public Heath, MA (J.M.M.); The Christ Hospital Heart and Vascular Center and The Lindner Center for Research and Education, Cincinnati, OH (D.J.K.); Université Paris-Diderot, INSERM U-1148, Hôpital Bichat, Département Hospitalo-Universitaire Fibrosis, Inflammation, and Remodeling, Assistance Publique-Hôpitaux de Paris, Paris, France (P.G.S.); and National Heart and Lung Institute, Institute of Cardiovascular Medicine and Science, Royal Brompton Hospital, Imperial College, London, UK (P.G.S.).
Robert W YehFrom Division of Cardiology and Center for Clinical Biometrics, Department of Medicine, Brigham and Women's Hospital, Boston, MA (C.D.R., L.M.); Harvard Clinical Research Institute, Boston, MA (R.W.Y., D.E.C., W.-H.H., L.M.); Harvard Medical School, Boston, MA (R.W.Y., L.M.); Division of Cardiology, University of Pennsylvania Medical Center, Philadelphia (A.N.); Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, MA (R.W.Y., D.E.C.); Department of Biostatistics, Boston University School of Public Heath, MA (J.M.M.); The Christ Hospital Heart and Vascular Center and The Lindner Center for Research and Education, Cincinnati, OH (D.J.K.); Université Paris-Diderot, INSERM U-1148, Hôpital Bichat, Département Hospitalo-Universitaire Fibrosis, Inflammation, and Remodeling, Assistance Publique-Hôpitaux de Paris, Paris, France (P.G.S.); and National Heart and Lung Institute, Institute of Cardiovascular Medicine and Science, Royal Brompton Hospital, Imperial College, London, UK (P.G.S.).
Joseph M MassaroFrom Division of Cardiology and Center for Clinical Biometrics, Department of Medicine, Brigham and Women's Hospital, Boston, MA (C.D.R., L.M.); Harvard Clinical Research Institute, Boston, MA (R.W.Y., D.E.C., W.-H.H., L.M.); Harvard Medical School, Boston, MA (R.W.Y., L.M.); Division of Cardiology, University of Pennsylvania Medical Center, Philadelphia (A.N.); Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, MA (R.W.Y., D.E.C.); Department of Biostatistics, Boston University School of Public Heath, MA (J.M.M.); The Christ Hospital Heart and Vascular Center and The Lindner Center for Research and Education, Cincinnati, OH (D.J.K.); Université Paris-Diderot, INSERM U-1148, Hôpital Bichat, Département Hospitalo-Universitaire Fibrosis, Inflammation, and Remodeling, Assistance Publique-Hôpitaux de Paris, Paris, France (P.G.S.); and National Heart and Lung Institute, Institute of Cardiovascular Medicine and Science, Royal Brompton Hospital, Imperial College, London, UK (P.G.S.).
Donald E CutlipFrom Division of Cardiology and Center for Clinical Biometrics, Department of Medicine, Brigham and Women's Hospital, Boston, MA (C.D.R., L.M.); Harvard Clinical Research Institute, Boston, MA (R.W.Y., D.E.C., W.-H.H., L.M.); Harvard Medical School, Boston, MA (R.W.Y., L.M.); Division of Cardiology, University of Pennsylvania Medical Center, Philadelphia (A.N.); Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, MA (R.W.Y., D.E.C.); Department of Biostatistics, Boston University School of Public Heath, MA (J.M.M.); The Christ Hospital Heart and Vascular Center and The Lindner Center for Research and Education, Cincinnati, OH (D.J.K.); Université Paris-Diderot, INSERM U-1148, Hôpital Bichat, Département Hospitalo-Universitaire Fibrosis, Inflammation, and Remodeling, Assistance Publique-Hôpitaux de Paris, Paris, France (P.G.S.); and National Heart and Lung Institute, Institute of Cardiovascular Medicine and Science, Royal Brompton Hospital, Imperial College, London, UK (P.G.S.).
P Gabriel StegFrom Division of Cardiology and Center for Clinical Biometrics, Department of Medicine, Brigham and Women's Hospital, Boston, MA (C.D.R., L.M.); Harvard Clinical Research Institute, Boston, MA (R.W.Y., D.E.C., W.-H.H., L.M.); Harvard Medical School, Boston, MA (R.W.Y., L.M.); Division of Cardiology, University of Pennsylvania Medical Center, Philadelphia (A.N.); Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, MA (R.W.Y., D.E.C.); Department of Biostatistics, Boston University School of Public Heath, MA (J.M.M.); The Christ Hospital Heart and Vascular Center and The Lindner Center for Research and Education, Cincinnati, OH (D.J.K.); Université Paris-Diderot, INSERM U-1148, Hôpital Bichat, Département Hospitalo-Universitaire Fibrosis, Inflammation, and Remodeling, Assistance Publique-Hôpitaux de Paris, Paris, France (P.G.S.); and National Heart and Lung Institute, Institute of Cardiovascular Medicine and Science, Royal Brompton Hospital, Imperial College, London, UK (P.G.S.).
Wen-Hua HsiehFrom Division of Cardiology and Center for Clinical Biometrics, Department of Medicine, Brigham and Women's Hospital, Boston, MA (C.D.R., L.M.); Harvard Clinical Research Institute, Boston, MA (R.W.Y., D.E.C., W.-H.H., L.M.); Harvard Medical School, Boston, MA (R.W.Y., L.M.); Division of Cardiology, University of Pennsylvania Medical Center, Philadelphia (A.N.); Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, MA (R.W.Y., D.E.C.); Department of Biostatistics, Boston University School of Public Heath, MA (J.M.M.); The Christ Hospital Heart and Vascular Center and The Lindner Center for Research and Education, Cincinnati, OH (D.J.K.); Université Paris-Diderot, INSERM U-1148, Hôpital Bichat, Département Hospitalo-Universitaire Fibrosis, Inflammation, and Remodeling, Assistance Publique-Hôpitaux de Paris, Paris, France (P.G.S.); and National Heart and Lung Institute, Institute of Cardiovascular Medicine and Science, Royal Brompton Hospital, Imperial College, London, UK (P.G.S.).
Laura MauriFrom Division of Cardiology and Center for Clinical Biometrics, Department of Medicine, Brigham and Women's Hospital, Boston, MA (C.D.R., L.M.); Harvard Clinical Research Institute, Boston, MA (R.W.Y., D.E.C., W.-H.H., L.M.); Harvard Medical School, Boston, MA (R.W.Y., L.M.); Division of Cardiology, University of Pennsylvania Medical Center, Philadelphia (A.N.); Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, MA (R.W.Y., D.E.C.); Department of Biostatistics, Boston University School of Public Heath, MA (J.M.M.); The Christ Hospital Heart and Vascular Center and The Lindner Center for Research and Education, Cincinnati, OH (D.J.K.); Université Paris-Diderot, INSERM U-1148, Hôpital Bichat, Département Hospitalo-Universitaire Fibrosis, Inflammation, and Remodeling, Assistance Publique-Hôpitaux de Paris, Paris, France (P.G.S.); and National Heart and Lung Institute, Institute of Cardiovascular Medicine and Science, Royal Brompton Hospital, Imperial College, London, UK (P.G.S.). lmauri1@partners.org.
Dual Antiplatelet Therapy Study Investigators
Boston University · USChrist Hospital · USDeaconess Hospital · USBaim Institute for Clinical Research · US

Funding

TRAINING PROGRAM IN CARDIOVASCULAR RESEARCHT32HL007604 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI MARK W FEINBERG · 1985 to 2026
$19.0M
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 R01 FD003870NHLBI NIH HHS K23 HL118138NHLBI NIH HHS T32 HL007604
6 · The paper itself

Abstract

backgroundContinued dual antiplatelet therapy and optimal medical therapy (OMT) improve outcomes in selected patient populations with established coronary heart disease, but whether OMT modifies the treatment effect of dual antiplatelet therapy is unknown.

methodsThe DAPT (Dual Antiplatelet Therapy) Study, a double-blind trial, randomly assigned 11 648 patients who had undergone coronary stenting and completed 1 year of dual antiplatelet therapy without major bleeding or ischemic events to an additional 18 months of continued thienopyridine or placebo. OMT was defined as a combination of statin, β-blocker, and angiotensin-converting enzyme inhibitor/angiotensin receptor blocker use in patients with an American College of Cardiology/American Heart Association class I indication for each medication. Per protocol, all patients were treated with 75 to 325 mg aspirin daily. End points included myocardial infarction, major adverse cardiovascular and cerebrovascular events, and Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries moderate or severe bleeding events.

resultsOf 11 643 randomly assigned patients with complete medication data, 63% were on OMT. Between 12 and 30 months, continued thienopyridine reduced myocardial infarction in comparison with placebo in both groups (on OMT 2.1% versus 3.3%, hazard ratio [HR], 0.64; 95% confidence interval [CI], 0.48-0.86; P=0.003; off OMT 2.2% versus 5.2%, HR, 0.41; CI, 0.29-0.58; P<0.001; interaction P=0.103). Comparing continued thienopyridine versus placebo, rates of major adverse cardiovascular and cerebrovascular events were 4.2% versus 5.0% among patients on OMT (HR, 0.82; CI, 0.66-1.02; P=0.077) and 4.5% versus 7.0% among those off OMT (HR, 0.63; CI, 0.49-0.82; P<0.001; interaction P=0.250); rates of bleeding for thienopyridine versus placebo in patients on OMT were 2.2% versus 1.0% (HR, 2.13; CI, 1.43-3.17; P<0.001), and in patients off OMT were 2.8% versus 2.2% (HR, 1.30; CI, 0.88-1.92; P=0.189; interaction P=0.073). Overall, patients on OMT had lower rates of myocardial infarction (2.7% versus 3.7%, P=0.003), major adverse cardiovascular and cerebrovascular events (4.6% versus 5.7%, P=0.007), and bleeding (1.6% versus 2.5%, P<0.001) in comparison with patients off OMT. Rates of stent thrombosis (0.8% versus 1.0%, P=0.171) and death (1.6% versus 1.9%, P=0.155) did not differ.

conclusionsContinued thienopyridine therapy reduced the rate of myocardial infarction regardless of OMT status and had consistent effects on reduction in major adverse cardiovascular and cerebrovascular events and increased bleeding. CLINICAL

trial registrationURL: http://clinicaltrials.gov. Unique identifier: NCT00977938.

Indexed as

AdultAgedAngiotensin-Converting Enzyme InhibitorsAspirinCoronary Artery DiseaseDouble-Blind MethodDrug-Eluting StentsDrug Therapy, CombinationFemaleHemorrhageHumansMaleMiddle AgedMyocardial InfarctionPercutaneous Coronary InterventionPlatelet Aggregation InhibitorsAngiotensin-Converting Enzyme InhibitorsAspirinPlatelet Aggregation Inhibitorsantiplatelet agentsmedical therapystents

Identifiers

PMID27576774
PMCPMC5421387
OpenAlexW2509510125

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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.