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dc.contributor.authorSamuelsen, Per-Jostein
dc.contributor.authorEggen, Anne Elise
dc.contributor.authorSteigen, Terje
dc.contributor.authorWilsgaard, Tom
dc.contributor.authorKristensen, Andreas
dc.contributor.authorSkogsholm, Anne
dc.contributor.authorHolme, Elizabeth
dc.contributor.authorvan den Heuvel, Christian
dc.contributor.authorNordrehaug, Jan Erik
dc.contributor.authorBendz, Bjørn
dc.contributor.authorNilsen, Dennis W.T.
dc.contributor.authorBønaa, Kaare Harald
dc.date.accessioned2021-06-28T09:50:27Z
dc.date.available2021-06-28T09:50:27Z
dc.date.created2021-06-25T13:31:01Z
dc.date.issued2021
dc.identifier.citationPLOS ONE. 2021, 16 (3), .en_US
dc.identifier.issn1932-6203
dc.identifier.urihttps://hdl.handle.net/11250/2761567
dc.description.abstractIntroduction Bleeding 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 methods NORSTENT 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. Results The 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). Conclusions The 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 registration Unique identifier NCT00811772; http://www.clinicaltrial.gov.en_US
dc.language.isoengen_US
dc.publisherPublic Library of Science, PLOSen_US
dc.rightsNavngivelse 4.0 Internasjonal*
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/deed.no*
dc.titleIncidence and risk factors for major bleeding among patients undergoing percutaneous coronary intervention: Findings from the Norwegian Coronary Stent Trial (NORSTENT)en_US
dc.typePeer revieweden_US
dc.typeJournal articleen_US
dc.description.versionpublishedVersionen_US
dc.source.pagenumber0en_US
dc.source.volume16en_US
dc.source.journalPLOS ONEen_US
dc.source.issue3en_US
dc.identifier.doi10.1371/journal.pone.0247358
dc.identifier.cristin1918517
dc.description.localcodeCopyright: © 2021 Samuelsen et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.en_US
dc.source.articlenumbere0247358en_US
cristin.ispublishedtrue
cristin.fulltextoriginal
cristin.qualitycode1


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