Evidence map›Paper›PMID 28228427›Full record

Trial reportCirculation2017

Myocardial Infarction Risk After Discontinuation of Thienopyridine Therapy in the Randomized DAPT Study (Dual Antiplatelet Therapy).

Ada C Stefanescu Schmidt, Dean J Kereiakes, Donald E Cutlip, Robert W Yeh, Ralph B D'Agostino, Joseph M Massaro, Wen-Hua Hsieh, Laura Mauri, DAPT Investigators

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

Trial report in Circulation, 2017. 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 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
2.3field-weighted citation impact, top 10% 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

7 citing papers in PubMed, 21 citations in OpenAlex.

  1. Article
  2. Review
  3. Drug-eluting stent thrombosis: current and future perspectives.Cardiovascular intervention and therapeutics · 2021
    Review
  4. Article
  5. Article
  6. Article
  7. Article
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

9 authors at 3 institutions in 1 country.

Ada C Stefanescu SchmidtFrom Massachusetts General Hospital, Boston (A.C.S.S.); Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute), Boston, MA (A.C.S.S., D.E.C., R.W.Y., R.B.D'A., J.M.M., W.-H.H., L.M.); Brigham and Women's Hospital, Boston, MA (A.C.S.S., L.M.); Christ Hospital, Heart and Vascular Center and Lindner Center for Research and Education, Cincinnati, OH (D.J.K.); and Beth Israel Deaconess Medical Center, Boston, MA (D.E.C., R.W.Y.).
Dean J KereiakesFrom Massachusetts General Hospital, Boston (A.C.S.S.); Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute), Boston, MA (A.C.S.S., D.E.C., R.W.Y., R.B.D'A., J.M.M., W.-H.H., L.M.); Brigham and Women's Hospital, Boston, MA (A.C.S.S., L.M.); Christ Hospital, Heart and Vascular Center and Lindner Center for Research and Education, Cincinnati, OH (D.J.K.); and Beth Israel Deaconess Medical Center, Boston, MA (D.E.C., R.W.Y.).
Donald E CutlipFrom Massachusetts General Hospital, Boston (A.C.S.S.); Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute), Boston, MA (A.C.S.S., D.E.C., R.W.Y., R.B.D'A., J.M.M., W.-H.H., L.M.); Brigham and Women's Hospital, Boston, MA (A.C.S.S., L.M.); Christ Hospital, Heart and Vascular Center and Lindner Center for Research and Education, Cincinnati, OH (D.J.K.); and Beth Israel Deaconess Medical Center, Boston, MA (D.E.C., R.W.Y.).
Robert W YehFrom Massachusetts General Hospital, Boston (A.C.S.S.); Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute), Boston, MA (A.C.S.S., D.E.C., R.W.Y., R.B.D'A., J.M.M., W.-H.H., L.M.); Brigham and Women's Hospital, Boston, MA (A.C.S.S., L.M.); Christ Hospital, Heart and Vascular Center and Lindner Center for Research and Education, Cincinnati, OH (D.J.K.); and Beth Israel Deaconess Medical Center, Boston, MA (D.E.C., R.W.Y.).
Ralph B D'AgostinoFrom Massachusetts General Hospital, Boston (A.C.S.S.); Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute), Boston, MA (A.C.S.S., D.E.C., R.W.Y., R.B.D'A., J.M.M., W.-H.H., L.M.); Brigham and Women's Hospital, Boston, MA (A.C.S.S., L.M.); Christ Hospital, Heart and Vascular Center and Lindner Center for Research and Education, Cincinnati, OH (D.J.K.); and Beth Israel Deaconess Medical Center, Boston, MA (D.E.C., R.W.Y.).
Joseph M MassaroFrom Massachusetts General Hospital, Boston (A.C.S.S.); Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute), Boston, MA (A.C.S.S., D.E.C., R.W.Y., R.B.D'A., J.M.M., W.-H.H., L.M.); Brigham and Women's Hospital, Boston, MA (A.C.S.S., L.M.); Christ Hospital, Heart and Vascular Center and Lindner Center for Research and Education, Cincinnati, OH (D.J.K.); and Beth Israel Deaconess Medical Center, Boston, MA (D.E.C., R.W.Y.).
Wen-Hua HsiehFrom Massachusetts General Hospital, Boston (A.C.S.S.); Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute), Boston, MA (A.C.S.S., D.E.C., R.W.Y., R.B.D'A., J.M.M., W.-H.H., L.M.); Brigham and Women's Hospital, Boston, MA (A.C.S.S., L.M.); Christ Hospital, Heart and Vascular Center and Lindner Center for Research and Education, Cincinnati, OH (D.J.K.); and Beth Israel Deaconess Medical Center, Boston, MA (D.E.C., R.W.Y.).
Laura MauriFrom Massachusetts General Hospital, Boston (A.C.S.S.); Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute), Boston, MA (A.C.S.S., D.E.C., R.W.Y., R.B.D'A., J.M.M., W.-H.H., L.M.); Brigham and Women's Hospital, Boston, MA (A.C.S.S., L.M.); Christ Hospital, Heart and Vascular Center and Lindner Center for Research and Education, Cincinnati, OH (D.J.K.); and Beth Israel Deaconess Medical Center, Boston, MA (D.E.C., R.W.Y.). lmauri1@partners.org.
DAPT Investigators
Brigham and Women's Hospital · USChrist Hospital · USMassachusetts General Hospital · US

Funding

TRAINING PROGRAM IN CARDIOVASCULAR RESEARCHT32HL007604 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI MARK W FEINBERG · 1985 to 2026
$19.0M
Balancing the Risks of Ischemia and Bleeding in Percutaneous Coronary InterventioK23HL118138 · NHLBI · MASSACHUSETTS GENERAL HOSPITAL · PI YEH, ROBERT · 2013 to 2017
$740k
NHLBI NIH HHS K23 HL118138NHLBI NIH HHS T32 HL007604
6 · The paper itself

Abstract

backgroundThienopyridine plus aspirin beyond 1 year after coronary stenting reduces myocardial infarction (MI) risk and increases bleeding risk in comparison with aspirin alone. The hazard associated with late thienopyridine discontinuation and risk factors for MI after discontinuation are poorly defined.

methodsIn the DAPT Study (Dual Antiplatelet Therapy), after percutaneous coronary intervention and 12 months of thienopyridine (clopidogrel or prasugrel) plus aspirin, eligible patients remained on aspirin and were randomly assigned to continued thienopyridine versus placebo for 18 months. At 30 months, patients stopped the study drug and were observed for 3 months. Cumulative incidence of MI was assessed over 3 months after randomization (months 12-15) and 3 months after study drug discontinuation (months 30-33). The MI hazard for each of these periods was assessed across randomized treatment arms and by DAPT score values <2 or ≥2.

resultsAmong the 11 648 randomly assigned patients, the monthly cumulative incidence of MI was lower with continued thienopyridine versus placebo at 12 to 15 months (0.12% versus 0.37%,

conclusionsDiscontinuing thienopyridine after either 12 or 30 months is associated with an early increase in MI risk, mainly unrelated to stent thrombosis; the magnitude of risk is highest in the earlier time frame, and lower in patients not treated with paclitaxel-eluting stents. Although higher DAPT scores identify patients with greater absolute ischemic benefit (relative to bleeding harm) with continued thienopyridine therapy, discontinuation at 12 months increases MI hazard regardless of DAPT score group. CLINICAL

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

Indexed as

Percutaneous Coronary InterventionAcute Coronary SyndromeAgedAngina, StableAspirinClopidogrelCoronary ThrombosisDouble-Blind MethodDrug Administration ScheduleDrug-Eluting StentsDrug Therapy, CombinationFemaleHumansIncidenceIntention to Treat AnalysisMaleAspirinClopidogrelPlatelet Aggregation InhibitorsPrasugrel HydrochlorideTiclopidinecoronary artery diseasemyocardial infarctionplatelet aggregation inhibitorsstentsthienopyridines

Identifiers

PMID28228427
PMCPMC5469374
OpenAlexW2893887857

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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.