Evidence map›Paper›PMID 35981821›Full record

Trial reportJournal of the American College of Cardiology2022

Impact of Medication Nonadherence in a Clinical Trial of Dual Antiplatelet Therapy.

Marco Valgimigli, Enrico Frigoli, Pascal Vranckx, Yukio Ozaki, Marie-Claude Morice, Bernard Chevalier, Yoshinobu Onuma, Stephan Windecker, Laurent Delorme, Petr Kala and 18 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of the American College of Cardiology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03023020 (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
3.2field-weighted citation impact, top 7% 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.

NCT03023020 nacompletednot on this map

Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen

TypeinterventionalSponsorECRI bvRan2017 to 2021Enrolled4,579ConditionsHigh Bleeding Risk, Coronary Artery Disease, PCIArmsAspirin, P2Y12 inhibitor
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. Review
  6. Long-term antithrombotic therapy in patients with atrial fibrillation and PCI: antiplatelets are fired.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2024
    Article
  7. Review
  8. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

28 authors at 20 institutions in 15 countries.

Marco ValgimigliCardiocentro Institute, Ente Ospedaliero Cantonale, Università della Svizzera Italiana (USI), CH-6900 Lugano, Switzerland. Electronic address: marco.valgimigli@eoc.ch.
Enrico FrigoliCTU Bern, University of Bern, Bern, Switzerland.
Pascal VranckxDepartment of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, and Faculty of Medicine and Life Sciences, Hasselt University, Hasselt, Belgium.
Yukio OzakiDepartment of Cardiology, School of Medicine, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.
Marie-Claude MoriceCardiovascular European Research Center (CERC), and ICPS Ramsay General de santé, Massy, France.
Bernard ChevalierRamsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud, Massy, France.
Yoshinobu OnumaNational University of Ireland, Galway, Ireland.
Stephan WindeckerDepartment of Cardiology, Bern University Hospital, Bern, Switzerland.
Laurent DelormeCardiologie et Maladies Vasculaires, AIHP-ACCAHP, Clinique du Pont De Chaume, Montauban Cedex, France.
Petr KalaUniversity Hospital Brno and Medical Faculty of Masaryk University, Brno, Czech Republic.
Sasko KedevUniversity Clinic of Cardiology, Medical Faculty, University "St. Cyril and Methodius", Skopje, Macedonia.
Rajpal K AbhaichandG. Kuppuswamy Naidu Memorial Hospital, Coimbatore, India.
Vasil VelchevCardiology Clinic, St. Anna University Hospital Sofia, Sofia Medical University, Sofia, Bulgaria.
Willem DewildeImelda Hospital, Bonheiden, Belgium.
Jakub PodolecJagiellonian University Medical College Institute of Cardiology Department of Interventional Cardiology and the John Paul II Hospital, Krakow, Poland.
Gregor LeibundgutCardiology, Cantonal Hospital Baselland, Liestal, Switzerland.
Dragan TopicDepartment of Invasive Diagnostic and Therapy, Institute for Cardiovascular Diseases "Dedinje," Belgrade, Republic of Serbia.
Carl SchultzDepartment of Cardiology, Royal Perth Hospital Campus, University of Western Australia, Perth, Western Australia, Australia.
Goran StankovicDepartment of Cardiology, Clinical Center of Serbia and Faculty of Medicine, University of Belgrade, Belgrade, Serbia.
Astin LeeDepartment of Cardiology, The Wollongong Hospital, Wollongong, New South Wales, Australia.
Thomas JohnsonUniversity Hospitals Bristol and Weston NHS Foundation Trust, Bristol, United Kingdom.
Pim A L ToninoDepartment of Cardiology, Catharina Hospital, Eindhoven, the Netherlands.
Aneta Klotzka1st Department of Cardiology, University of Medical Sciences, Poznan, Poland.
Maciej Lesiak1st Department of Cardiology, University of Medical Sciences, Poznan, Poland.
Renato D LopesDuke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.
Pieter C SmitsDepartment of Cardiology, Maasstad Hospital, Rotterdam, the Netherlands.
Dik HegCTU Bern, University of Bern, Bern, Switzerland.
MASTER DAPT Investigators
Poznan University of Medical Sciences · PLUniversity of Bern · CHDuke University · USEau de Paris (France) · FREnte Ospedaliero Cantonale · CHFujita Health University · JPGénérale de Santé · FRG. Kuppuswamy Naidu Memorial Hospital · INHartcentrum Hasselt · BEImelda Hospital · BEInstitut Cardiovasculaire Paris Sud · FRInstitute for Cardiovascular Diseases of Vojvodina · RSJagiellonian University · PLMaasstad Ziekenhuis · NLMasaryk University · CZMedical University of Sofia · BGOllscoil na Gaillimhe – University of Galway · IERadboud University Nijmegen · NLSs. Cyril and Methodius University in Skopje · MKThe University of Western Australia · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNonadherence to antiplatelet therapy after percutaneous coronary intervention (PCI) is common, even in clinical trials.

objectivesThe purpose of this study was to investigate the impact of nonadherence to study protocol regimens in the MASTER DAPT (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen) trial.

methodsAt 1-month after PCI, 4,579 high bleeding risk patients were randomized to single antiplatelet therapy (SAPT) for 11 months (or 5 months in patients on oral anticoagulation [OAC]) or dual antiplatelet therapy (DAPT) for ≥2 months followed by SAPT. Coprimary outcomes included net adverse clinical events (NACE), major adverse cardiac and cerebral events (MACE), and major or clinically relevant nonmajor bleeding (MCB) at 335 days. Inverse probability-of-censoring weights were used to correct for nonadherence Academic Research Consortium type 2 or 3.

resultsIn total, 464 (20.2%) patients in the abbreviated-treatment and 214 (9.4%) in the standard-treatment groups incurred nonadherence Academic Research Consortium type 2 or 3. At inverse probability-of-censoring weights analyses, NACE (HR: 1.01; 95% CI: 0.88-1.27) or MACE (HR: 1.07; 95% CI: 0.83-1.40) did not differ, and MCB was lower with abbreviated compared with standard treatment (HR: 0.51; 95% CI: 0.60-0.73) consistently across OAC subgroups; among OAC patients, SAPT discontinuation 6 months after PCI was associated with similar MACE and lower MCB (HR: 0.47; 95% CI: 0.22-0.99) compared with SAPT continuation.

conclusionsIn the MASTER DAPT adherent population, 1-month compared with ≥3-month DAPT was associated with similar NACE or MACE and lower MCB. Among OAC patients, SAPT discontinuation after 6 months was associated with similar MACE and lower MCB than SAPT continuation (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen [MASTER DAPT]; NCT03023020).

Indexed as

Drug-Eluting StentsPercutaneous Coronary InterventionDrug Therapy, CombinationHemorrhageHumansMedication AdherencePlatelet Aggregation InhibitorsPolymersTreatment OutcomePlatelet Aggregation InhibitorsPolymersacetylsalicylic aciddrug-eluting stentdual antiplatelet therapyhigh bleeding riskP2Y(12) inhibitor

Identifiers

PMID35981821
OpenAlexW4291810627

What OpenQuestion holds

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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.