Evidence map›Paper›PMID 25399847›Full record

Trial reportCirculation. Cardiovascular quality and outcomes2015

Evaluating the generalizability of a large streamlined cardiovascular trial: comparing hospitals and patients in the dual antiplatelet therapy study versus the National Cardiovascular Data Registry.

Robert W Yeh, Matthew J Czarny, Sharon-Lise T Normand, Dean J Kereiakes, David R Holmes, Ralph G Brindis, W Douglas Weaver, John S Rumsfeld, Matthew T Roe, Sunghee Kim and 2 more

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

Trial report in Circulation. Cardiovascular quality and outcomes, 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 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
1.8field-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.

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

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.

  1. Pooled it
  2. External validity of the "all-comers" design: insights from the BIOSCIENCE trial.Clinical research in cardiology : official journal of the German Cardiac Society · 2016
    Trial
  3. Trial
  4. Article
  5. Outcomes of stroke events during transcatheter aortic valve implantation.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2022
    Article
  6. Article
  7. Article
  8. Article
  9. Demonstrating the Value of Outcomes in Echocardiography: Imaging-Based Registries in Improving Patient Care.Journal of the American Society of Echocardiography : official publication of the American Society of Echocardiography · 2019
    Review
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 7 institutions in 1 country.

Robert W YehFrom the Cardiology Division, Department of Medicine, Massachusetts General Hospital (R.W.Y), Department of Health Care Policy (Biostatistics) (S.-L.T.N.), and Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital (L.M.), Harvard Medical School, Boston, MA (R.W.Y., S.-L.T.N., L.M.); Harvard Clinical Research Institute, Boston, MA (R.W.Y., P.D.S., L.M.); Cardiology Division, Department of Medicine, Johns Hopkins Hospital, Johns Hopkins University School of Medicine, Baltimore, MD (M.J.C.); Department of Biostatistics, Harvard University School of Public Health, Boston, MA (S.-L.T.N.); The Christ Hospital Heart and Vascular Center/The Lindner Research Center, Cincinnati, OH (D.J.K.); Cardiology Division, Mayo Clinic, Rochester, MN (D.R.H., Jr); Philip R. Lee Institute for Health Policy Studies, Department of Medicine, University of California, San Francisco (R.G.B.); Heart and Vascular Institute, Henry Ford Health System, Detroit, MI (W.D.W.); Cardiology Division, Denver VA Medical Center/Veterans Health Administration, CO (J.S.R.); and Duke Clinical Research Institute, Durham, NC (M.T.R., S.K.). ryeh@partners.org.
Matthew J CzarnyFrom the Cardiology Division, Department of Medicine, Massachusetts General Hospital (R.W.Y), Department of Health Care Policy (Biostatistics) (S.-L.T.N.), and Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital (L.M.), Harvard Medical School, Boston, MA (R.W.Y., S.-L.T.N., L.M.); Harvard Clinical Research Institute, Boston, MA (R.W.Y., P.D.S., L.M.); Cardiology Division, Department of Medicine, Johns Hopkins Hospital, Johns Hopkins University School of Medicine, Baltimore, MD (M.J.C.); Department of Biostatistics, Harvard University School of Public Health, Boston, MA (S.-L.T.N.); The Christ Hospital Heart and Vascular Center/The Lindner Research Center, Cincinnati, OH (D.J.K.); Cardiology Division, Mayo Clinic, Rochester, MN (D.R.H., Jr); Philip R. Lee Institute for Health Policy Studies, Department of Medicine, University of California, San Francisco (R.G.B.); Heart and Vascular Institute, Henry Ford Health System, Detroit, MI (W.D.W.); Cardiology Division, Denver VA Medical Center/Veterans Health Administration, CO (J.S.R.); and Duke Clinical Research Institute, Durham, NC (M.T.R., S.K.).
Sharon-Lise T NormandFrom the Cardiology Division, Department of Medicine, Massachusetts General Hospital (R.W.Y), Department of Health Care Policy (Biostatistics) (S.-L.T.N.), and Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital (L.M.), Harvard Medical School, Boston, MA (R.W.Y., S.-L.T.N., L.M.); Harvard Clinical Research Institute, Boston, MA (R.W.Y., P.D.S., L.M.); Cardiology Division, Department of Medicine, Johns Hopkins Hospital, Johns Hopkins University School of Medicine, Baltimore, MD (M.J.C.); Department of Biostatistics, Harvard University School of Public Health, Boston, MA (S.-L.T.N.); The Christ Hospital Heart and Vascular Center/The Lindner Research Center, Cincinnati, OH (D.J.K.); Cardiology Division, Mayo Clinic, Rochester, MN (D.R.H., Jr); Philip R. Lee Institute for Health Policy Studies, Department of Medicine, University of California, San Francisco (R.G.B.); Heart and Vascular Institute, Henry Ford Health System, Detroit, MI (W.D.W.); Cardiology Division, Denver VA Medical Center/Veterans Health Administration, CO (J.S.R.); and Duke Clinical Research Institute, Durham, NC (M.T.R., S.K.).
Dean J KereiakesFrom the Cardiology Division, Department of Medicine, Massachusetts General Hospital (R.W.Y), Department of Health Care Policy (Biostatistics) (S.-L.T.N.), and Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital (L.M.), Harvard Medical School, Boston, MA (R.W.Y., S.-L.T.N., L.M.); Harvard Clinical Research Institute, Boston, MA (R.W.Y., P.D.S., L.M.); Cardiology Division, Department of Medicine, Johns Hopkins Hospital, Johns Hopkins University School of Medicine, Baltimore, MD (M.J.C.); Department of Biostatistics, Harvard University School of Public Health, Boston, MA (S.-L.T.N.); The Christ Hospital Heart and Vascular Center/The Lindner Research Center, Cincinnati, OH (D.J.K.); Cardiology Division, Mayo Clinic, Rochester, MN (D.R.H., Jr); Philip R. Lee Institute for Health Policy Studies, Department of Medicine, University of California, San Francisco (R.G.B.); Heart and Vascular Institute, Henry Ford Health System, Detroit, MI (W.D.W.); Cardiology Division, Denver VA Medical Center/Veterans Health Administration, CO (J.S.R.); and Duke Clinical Research Institute, Durham, NC (M.T.R., S.K.).
David R HolmesFrom the Cardiology Division, Department of Medicine, Massachusetts General Hospital (R.W.Y), Department of Health Care Policy (Biostatistics) (S.-L.T.N.), and Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital (L.M.), Harvard Medical School, Boston, MA (R.W.Y., S.-L.T.N., L.M.); Harvard Clinical Research Institute, Boston, MA (R.W.Y., P.D.S., L.M.); Cardiology Division, Department of Medicine, Johns Hopkins Hospital, Johns Hopkins University School of Medicine, Baltimore, MD (M.J.C.); Department of Biostatistics, Harvard University School of Public Health, Boston, MA (S.-L.T.N.); The Christ Hospital Heart and Vascular Center/The Lindner Research Center, Cincinnati, OH (D.J.K.); Cardiology Division, Mayo Clinic, Rochester, MN (D.R.H., Jr); Philip R. Lee Institute for Health Policy Studies, Department of Medicine, University of California, San Francisco (R.G.B.); Heart and Vascular Institute, Henry Ford Health System, Detroit, MI (W.D.W.); Cardiology Division, Denver VA Medical Center/Veterans Health Administration, CO (J.S.R.); and Duke Clinical Research Institute, Durham, NC (M.T.R., S.K.).
Ralph G BrindisFrom the Cardiology Division, Department of Medicine, Massachusetts General Hospital (R.W.Y), Department of Health Care Policy (Biostatistics) (S.-L.T.N.), and Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital (L.M.), Harvard Medical School, Boston, MA (R.W.Y., S.-L.T.N., L.M.); Harvard Clinical Research Institute, Boston, MA (R.W.Y., P.D.S., L.M.); Cardiology Division, Department of Medicine, Johns Hopkins Hospital, Johns Hopkins University School of Medicine, Baltimore, MD (M.J.C.); Department of Biostatistics, Harvard University School of Public Health, Boston, MA (S.-L.T.N.); The Christ Hospital Heart and Vascular Center/The Lindner Research Center, Cincinnati, OH (D.J.K.); Cardiology Division, Mayo Clinic, Rochester, MN (D.R.H., Jr); Philip R. Lee Institute for Health Policy Studies, Department of Medicine, University of California, San Francisco (R.G.B.); Heart and Vascular Institute, Henry Ford Health System, Detroit, MI (W.D.W.); Cardiology Division, Denver VA Medical Center/Veterans Health Administration, CO (J.S.R.); and Duke Clinical Research Institute, Durham, NC (M.T.R., S.K.).
W Douglas WeaverFrom the Cardiology Division, Department of Medicine, Massachusetts General Hospital (R.W.Y), Department of Health Care Policy (Biostatistics) (S.-L.T.N.), and Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital (L.M.), Harvard Medical School, Boston, MA (R.W.Y., S.-L.T.N., L.M.); Harvard Clinical Research Institute, Boston, MA (R.W.Y., P.D.S., L.M.); Cardiology Division, Department of Medicine, Johns Hopkins Hospital, Johns Hopkins University School of Medicine, Baltimore, MD (M.J.C.); Department of Biostatistics, Harvard University School of Public Health, Boston, MA (S.-L.T.N.); The Christ Hospital Heart and Vascular Center/The Lindner Research Center, Cincinnati, OH (D.J.K.); Cardiology Division, Mayo Clinic, Rochester, MN (D.R.H., Jr); Philip R. Lee Institute for Health Policy Studies, Department of Medicine, University of California, San Francisco (R.G.B.); Heart and Vascular Institute, Henry Ford Health System, Detroit, MI (W.D.W.); Cardiology Division, Denver VA Medical Center/Veterans Health Administration, CO (J.S.R.); and Duke Clinical Research Institute, Durham, NC (M.T.R., S.K.).
John S RumsfeldFrom the Cardiology Division, Department of Medicine, Massachusetts General Hospital (R.W.Y), Department of Health Care Policy (Biostatistics) (S.-L.T.N.), and Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital (L.M.), Harvard Medical School, Boston, MA (R.W.Y., S.-L.T.N., L.M.); Harvard Clinical Research Institute, Boston, MA (R.W.Y., P.D.S., L.M.); Cardiology Division, Department of Medicine, Johns Hopkins Hospital, Johns Hopkins University School of Medicine, Baltimore, MD (M.J.C.); Department of Biostatistics, Harvard University School of Public Health, Boston, MA (S.-L.T.N.); The Christ Hospital Heart and Vascular Center/The Lindner Research Center, Cincinnati, OH (D.J.K.); Cardiology Division, Mayo Clinic, Rochester, MN (D.R.H., Jr); Philip R. Lee Institute for Health Policy Studies, Department of Medicine, University of California, San Francisco (R.G.B.); Heart and Vascular Institute, Henry Ford Health System, Detroit, MI (W.D.W.); Cardiology Division, Denver VA Medical Center/Veterans Health Administration, CO (J.S.R.); and Duke Clinical Research Institute, Durham, NC (M.T.R., S.K.).
Matthew T RoeFrom the Cardiology Division, Department of Medicine, Massachusetts General Hospital (R.W.Y), Department of Health Care Policy (Biostatistics) (S.-L.T.N.), and Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital (L.M.), Harvard Medical School, Boston, MA (R.W.Y., S.-L.T.N., L.M.); Harvard Clinical Research Institute, Boston, MA (R.W.Y., P.D.S., L.M.); Cardiology Division, Department of Medicine, Johns Hopkins Hospital, Johns Hopkins University School of Medicine, Baltimore, MD (M.J.C.); Department of Biostatistics, Harvard University School of Public Health, Boston, MA (S.-L.T.N.); The Christ Hospital Heart and Vascular Center/The Lindner Research Center, Cincinnati, OH (D.J.K.); Cardiology Division, Mayo Clinic, Rochester, MN (D.R.H., Jr); Philip R. Lee Institute for Health Policy Studies, Department of Medicine, University of California, San Francisco (R.G.B.); Heart and Vascular Institute, Henry Ford Health System, Detroit, MI (W.D.W.); Cardiology Division, Denver VA Medical Center/Veterans Health Administration, CO (J.S.R.); and Duke Clinical Research Institute, Durham, NC (M.T.R., S.K.).
Sunghee KimFrom the Cardiology Division, Department of Medicine, Massachusetts General Hospital (R.W.Y), Department of Health Care Policy (Biostatistics) (S.-L.T.N.), and Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital (L.M.), Harvard Medical School, Boston, MA (R.W.Y., S.-L.T.N., L.M.); Harvard Clinical Research Institute, Boston, MA (R.W.Y., P.D.S., L.M.); Cardiology Division, Department of Medicine, Johns Hopkins Hospital, Johns Hopkins University School of Medicine, Baltimore, MD (M.J.C.); Department of Biostatistics, Harvard University School of Public Health, Boston, MA (S.-L.T.N.); The Christ Hospital Heart and Vascular Center/The Lindner Research Center, Cincinnati, OH (D.J.K.); Cardiology Division, Mayo Clinic, Rochester, MN (D.R.H., Jr); Philip R. Lee Institute for Health Policy Studies, Department of Medicine, University of California, San Francisco (R.G.B.); Heart and Vascular Institute, Henry Ford Health System, Detroit, MI (W.D.W.); Cardiology Division, Denver VA Medical Center/Veterans Health Administration, CO (J.S.R.); and Duke Clinical Research Institute, Durham, NC (M.T.R., S.K.).
Priscilla Driscoll-ShemppFrom the Cardiology Division, Department of Medicine, Massachusetts General Hospital (R.W.Y), Department of Health Care Policy (Biostatistics) (S.-L.T.N.), and Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital (L.M.), Harvard Medical School, Boston, MA (R.W.Y., S.-L.T.N., L.M.); Harvard Clinical Research Institute, Boston, MA (R.W.Y., P.D.S., L.M.); Cardiology Division, Department of Medicine, Johns Hopkins Hospital, Johns Hopkins University School of Medicine, Baltimore, MD (M.J.C.); Department of Biostatistics, Harvard University School of Public Health, Boston, MA (S.-L.T.N.); The Christ Hospital Heart and Vascular Center/The Lindner Research Center, Cincinnati, OH (D.J.K.); Cardiology Division, Mayo Clinic, Rochester, MN (D.R.H., Jr); Philip R. Lee Institute for Health Policy Studies, Department of Medicine, University of California, San Francisco (R.G.B.); Heart and Vascular Institute, Henry Ford Health System, Detroit, MI (W.D.W.); Cardiology Division, Denver VA Medical Center/Veterans Health Administration, CO (J.S.R.); and Duke Clinical Research Institute, Durham, NC (M.T.R., S.K.).
Laura MauriFrom the Cardiology Division, Department of Medicine, Massachusetts General Hospital (R.W.Y), Department of Health Care Policy (Biostatistics) (S.-L.T.N.), and Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital (L.M.), Harvard Medical School, Boston, MA (R.W.Y., S.-L.T.N., L.M.); Harvard Clinical Research Institute, Boston, MA (R.W.Y., P.D.S., L.M.); Cardiology Division, Department of Medicine, Johns Hopkins Hospital, Johns Hopkins University School of Medicine, Baltimore, MD (M.J.C.); Department of Biostatistics, Harvard University School of Public Health, Boston, MA (S.-L.T.N.); The Christ Hospital Heart and Vascular Center/The Lindner Research Center, Cincinnati, OH (D.J.K.); Cardiology Division, Mayo Clinic, Rochester, MN (D.R.H., Jr); Philip R. Lee Institute for Health Policy Studies, Department of Medicine, University of California, San Francisco (R.G.B.); Heart and Vascular Institute, Henry Ford Health System, Detroit, MI (W.D.W.); Cardiology Division, Denver VA Medical Center/Veterans Health Administration, CO (J.S.R.); and Duke Clinical Research Institute, Durham, NC (M.T.R., S.K.).
Johns Hopkins University · USDenver VA Medical Center · USHenry Ford Health System · USMayo Clinic in Arizona · USJohns Hopkins Hospital · USJohns Hopkins Medicine · USLee University · US

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 1K23HL118138NHLBI NIH HHS K23 HL118138
6 · The paper itself

Abstract

backgroundThe Dual Antiplatelet Therapy Study is large streamlined clinical trial designed to evaluate antiplatelet treatment strategies in a broadly inclusive population of subjects treated with coronary stents. Whether large streamlined trials can successfully include a representative group of study sites and patients has not been formally assessed. METHODS AND

resultsWithin the National Cardiovascular Data Registry CathPCI Registry, we compared characteristics and outcomes of hospitals participating versus not participating in the Dual Antiplatelet Therapy Study. We also compared clinical and procedural characteristics of trial subjects undergoing percutaneous coronary intervention (PCI) with drug-eluting stents to contemporaneous patients within the National Cardiovascular Data Registry CathPCI Registry. Standardized differences between groups were estimated. Between September 2009 and July 2011, 1.1 million PCIs were performed among 1276 hospitals, of which 309 (24.2%) participated in the Dual Antiplatelet Therapy Study. Participating hospitals were larger (468 versus 311 beds), more frequently located in urban settings (61.2% versus 42.6%), and had higher annual PCI volumes (858 versus 378) compared with nonparticipating hospitals, although hospital case mix and procedural outcomes were similar. Compared with CathPCI patients, trial patients undergoing PCI with drug-eluting stents were similar with respect to race, sex, and rates of diabetes mellitus, hypertension, and smoking, although they had lower rates of prior cardiovascular disease.

conclusionsWithin the Dual Antiplatelet Therapy Study, clinical trial sites had similar patient case mix and clinical outcomes as nonparticipating sites. Although trial participants were representative of PCI patients with respect to race, sex and most comorbidities, they had a lower prevalence of chronic cardiovascular disease compared with registry patients. Although a streamlined cardiovascular clinical trial may successfully involve a large number of hospitals and rapidly enroll a diverse population of patients, differences between eligible patients and those actually enrolled remained. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00977938.

Indexed as

Percutaneous Coronary InterventionRegistriesResearch DesignAgedComorbidityCoronary Artery DiseaseDrug-Eluting StentsDrug Therapy, CombinationFemaleHospital Bed CapacityHospitalsHospitals, High-VolumeHospitals, UrbanHumansMaleMiddle AgedPlatelet Aggregation Inhibitorsclinical trialcoronary diseasemethodsstents

Identifiers

PMID25399847
PMCPMC4303486
OpenAlexW2885748118

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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.