Evidence map›Paper›PMID 33661918›Full record

Trial reportPloS one2021

Incidence and risk factors for major bleeding among patients undergoing percutaneous coronary intervention: Findings from the Norwegian Coronary Stent Trial (NORSTENT).

Per-Jostein Samuelsen, Anne Elise Eggen, Terje Steigen, Tom Wilsgaard, Andreas Kristensen, Anne Skogsholm, Elizabeth Holme, Christian van den Heuvel, Jan Erik Nordrehaug, Bjørn Bendz and 2 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled TrialPragmatic Clinical Trial
In one paragraph

Trial report in PloS one, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00811772 (Comparison of the Long-term Effects on Mortality and Cardiovascular Morbidity of Percutaneous Coronary Intervention With Drug-eluting Stent Versus Bare-metal Stent. Randomized, Five-year Prospective, Multicenter Clinical Trial), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.3field-weighted citation impact, top 20% 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.

NCT00811772 nacompletednot on this map

Comparison of the Long-term Effects on Mortality and Cardiovascular Morbidity of Percutaneous Coronary Intervention With Drug-eluting Stent Versus Bare-metal Stent. Randomized, Five-year Prospective, Multicenter Clinical Trial

TypeinterventionalSponsorUniversity of TromsoRan2008 to 2015Enrolled9,013ConditionsCoronary Atherosclerosis, Angina Pectoris, Myocardial InfarctionArmsPercutaneous coronary intervention (PCI)
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 13 citations in OpenAlex.

  1. Article
  2. Article
  3. The Negative Influence and Adverse Outcome of Red Blood Cell Transfusion in Contemporary Percutaneous Coronary Interventions.Indian journal of hematology & blood transfusion : an official journal of Indian Society of Hematology and Blood Transfusion · 2025
    Review
  4. Review
  5. Article
  6. Observational
  7. Article
  8. Article
  9. Article
  10. Article
  11. 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

12 authors at 6 institutions in 1 country.

Per-Jostein SamuelsenRegional Medicines Information and Pharmacovigilance Centre (RELIS), University Hospital of North Norway, Tromsø, Norway.ORCID 0000-0002-7484-7488
Anne Elise EggenDepartment of Community Medicine, UiT The Arctic University of Norway, Tromsø, Norway.
Terje SteigenDepartment of Cardiology, University Hospital of North Norway, Tromsø, Norway.
Tom WilsgaardDepartment of Community Medicine, UiT The Arctic University of Norway, Tromsø, Norway.
Andreas KristensenDepartment of Cardiology, University Hospital of North Norway, Tromsø, Norway.
Anne SkogsholmDepartment of Cardiology, University Hospital of North Norway, Tromsø, Norway.
Elizabeth HolmeDepartment of Cardiology, University Hospital of North Norway, Tromsø, Norway.
Christian van den HeuvelDepartment of Cardiology, University Hospital of North Norway, Tromsø, Norway.
Jan Erik NordrehaugDepartment of Clinical Science, University of Bergen, Bergen, Norway.
Bjørn BendzDepartment of Cardiology, Rikshospitalet, Oslo University Hospital, Oslo, Norway.
Dennis W T NilsenDepartment of Clinical Science, University of Bergen, Bergen, Norway.
Kaare Harald BønaaClinic for Heart Disease, St. Olav's University Hospital, Trondheim, Norway.ORCID 0000-0001-6675-3724
University Hospital of North Norway · NOUiT The Arctic University of Norway · NONorwegian University of Science and Technology · NOOslo University Hospital · NOStavanger University Hospital · NOUniversity of Bergen · NO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionBleeding is a concern after percutaneous coronary intervention (PCI) and subsequent dual antiplatelet therapy (DAPT). We herein report the incidence and risk factors for major bleeding in the Norwegian Coronary Stent Trial (NORSTENT). MATERIALS AND

methodsNORSTENT was a randomized, double blind, pragmatic trial among patients with acute coronary syndrome or stable coronary disease undergoing PCI during 2008-11. The patients (N = 9,013) were randomized to receive either a drug-eluting stent or a bare-metal stent, and were treated with at least nine months of DAPT. The patients were followed for a median of five years, with Bleeding Academic Research Consortium (BARC) 3-5 major bleeding as one of the safety endpoints. We estimated cumulative incidence of major bleeding by a competing risks model and risk factors through cause-specific Cox models.

resultsThe 12-month cumulative incidence of major bleeding was 2.3%. Independent risk factors for major bleeding were chronic kidney disease, low bodyweight (< 60 kilograms), diabetes mellitus, and advanced age (> 80 years). A myocardial infarction (MI) or PCI during follow-up increased the risk of major bleeding (HR = 1.67, 95% CI 1-29-2.15).

conclusionsThe 12-month cumulative incidence of major bleeding in NORSTENT was higher than reported in previous, explanatory trials. This analysis strengthens the role of chronic kidney disease, advanced age, and low bodyweight as risk factors for major bleeding among patients receiving DAPT after PCI. The presence of diabetes mellitus or recurrent MI among patients is furthermore a signal of increased bleeding risk. CLINICAL

trial registrationUnique identifier NCT00811772; http://www.clinicaltrial.gov.

Indexed as

Myocardial InfarctionPostoperative HemorrhageAgedAged, 80 and overAge FactorsDrug-Eluting StentsFemaleHumansIncidenceMaleMiddle AgedPercutaneous Coronary InterventionPlatelet Aggregation InhibitorsRisk FactorsPlatelet Aggregation Inhibitors

Identifiers

PMID33661918
PMCPMC7932162
OpenAlexW3134267993

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.