Evidence map›Paper›PMID 35961692›Full record

Trial reportOpen heart2022

Real-world bleeding in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) and prescribed different combinations of dual antiplatelet therapy (DAPT) in England: a population-based cohort study emulating a 'target trial'.

Maria Pufulete, Jessica Harris, Koen Pouwels, Barney C Reeves, Daniel Lasserson, Yoon K Loke, Andrew Mumford, Kalaivani Mahadevan, Thomas W Johnson

Open access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Open heart, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 4 pooled it
2.8field-weighted citation impact, top 8% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 4 syntheses or guidelines pooled it, 18 citations in OpenAlex.

  1. [Efficacy and safety of dual anti-platelet aggregation short post-pharmacologic stent].Revista medica del Instituto Mexicano del Seguro Social · 2026
    Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Article
  6. P2YOpen heart · 2026
    Observational
  7. Review
  8. Antiplatelet Therapy in Heart Disease.Reviews in cardiovascular medicine · 2025
    Review
  9. Article
  10. Article
  11. Article
  12. Review
  13. Review
  14. Article
  15. 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 4 institutions in 1 country.

Maria PufuleteBristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK maria.pufulete@bristol.ac.uk.ORCID 0000-0002-1775-1949
Jessica HarrisBristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK.
Koen PouwelsHealth Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
Barney C ReevesBristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK.
Daniel LassersonWarwick Medical School, University of Warwick, Coventry, UK.
Yoon K LokeNorwich Medical School, University of East Anglia, Norfolk, UK.
Andrew MumfordSchool of Cellular and Molecular Medicine, Bristol Medical School, University of Bristol, Bristol, UK.
Kalaivani MahadevanSchool of Cellular and Molecular Medicine, Bristol Medical School, University of Bristol, Bristol, UK.ORCID 0000-0002-9414-6945
Thomas W JohnsonSchool of Cellular and Molecular Medicine, Bristol Medical School, University of Bristol, Bristol, UK.
University of Bristol · GBUniversity of East Anglia · GBUniversity of Oxford · GBUniversity of Warwick · GB

Funding

British Heart FoundationDepartment of Health 14/192/89
6 · The paper itself

Abstract

objectiveTo estimate the incidence and HRs for bleeding for different dual antiplatelet therapies (DAPT) in a real-world population with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) in England.

designA retrospective, population-based cohort study emulating a target randomised controlled trial (tRCT). DATA SOURCES: Linked Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES).

settingPrimary and secondary care.

participantsPatients ≥18 years old with ACS undergoing emergency PCI.

interventionsAspirin and clopidogrel (AC, reference) versus aspirin and prasugrel (AP) or aspirin and ticagrelor (AT); AP evaluated only in patients with ST-elevation myocardial infarction (STEMI).

main outcome measuresPrimary: any bleeding up to 12 months after the index event (HES- or CPRD- recorded). Secondary: HES-recorded bleeding, CPRD-recorded bleeding, all-cause and cardiovascular mortality, mortality from bleeding, myocardial infarction, stroke, additional coronary intervention and major adverse cardiovascular and cerebrovascular events (MACCE).

resultsIn ACS, the rates of any bleeding for AC and AT were 89 per 1000 person years and 134 per 1000 person years, respectively. In STEMI, rates for AC, AP and AT were 93 per 1000 person years, 138 per 1000 person years and 143 per 100 person years, respectively. In ACS, compared with AC, AT increased the hazard of any bleeding (HR: 1.47, 95% CI 1.19 to 1.82) but did not reduce MACCE (HR: 1.06, 95% CI 0.89 to 1.27). In STEMI, compared with AC, AP and AT increased the hazard of any bleeding (HR: 1.77, 95% CI 1.21 to 2.59 and HR: 1.50, 95% CI 1.10 to 2.05, respectively) but did not reduce MACCE (HR: 1.10, 95% CI 0.80 to 1.51 and HR: 1.21, 95% CI 0.94 to 1.51, respectively). Non-adherence to the prescribed DAPT regimen was 28% in AC (29% in STEMI only), 31% in AP (STEMI only) and 33% in AT (32% in STEMI only).

conclusionsIn a real-world population with ACS, DAPT with ticagrelor or prasugrel are associated with increased bleeding compared with DAPT with clopidogrel. TRIAL REGISTRATION NUMBER: ISRCTN76607611.

Indexed as

Acute Coronary SyndromePercutaneous Coronary InterventionST Elevation Myocardial InfarctionAdolescentAspirinClopidogrelCohort StudiesDinucleoside PhosphatesHemorrhageHumansPlatelet Aggregation InhibitorsPrasugrel HydrochlorideRetrospective StudiesTicagrelor2'-deoxythymidylyl-(3'-5')-2'-deoxyadenosineAspirinClopidogrelDinucleoside PhosphatesPlatelet Aggregation InhibitorsPrasugrel HydrochlorideTicagreloracute coronary syndromeelectronic health recordsepidemiologypercutaneous coronary interventionpharmacology, clinical

Identifiers

PMID35961692
PMCPMC9379532
OpenAlexW4290840724

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.