Incidence and risk factors for major bleeding among patients undergoing percutaneous coronary intervention: Findings from the Norwegian Coronary Stent Trial (NORSTENT)
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). NORSTENT was a randomized, double blind, pragmatic trial among pa...
Gespeichert in:
| Veröffentlicht in: | PloS one 2021-03, Vol.16 (3), p.e0247358-e0247358 |
|---|---|
| Hauptverfasser: | , , , , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | e0247358 |
|---|---|
| container_issue | 3 |
| container_start_page | e0247358 |
| container_title | PloS one |
| container_volume | 16 |
| creator | Samuelsen, Per-Jostein Eggen, Anne Elise Steigen, Terje Wilsgaard, Tom Kristensen, Andreas Skogsholm, Anne Holme, Elizabeth van den Heuvel, Christian Nordrehaug, Jan Erik Bendz, Bjørn Nilsen, Dennis W T Bønaa, Kaare Harald |
| description | 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).
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.
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).
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.
Unique identifier NCT00811772; http://www.clinicaltrial.gov. |
| doi_str_mv | 10.1371/journal.pone.0247358 |
| format | Article |
| fullrecord | <record><control><sourceid>gale_plos_</sourceid><recordid>TN_cdi_plos_journals_2497143534</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A653840709</galeid><doaj_id>oai_doaj_org_article_b5995d5634c74f7a844d2b76f1f11b35</doaj_id><sourcerecordid>A653840709</sourcerecordid><originalsourceid>FETCH-LOGICAL-c782t-e27f7b1af28326d64651659b341631825dc72dff2952c4da2553c950a970c27c3</originalsourceid><addsrcrecordid>eNqNk91u0zAUxyMEYqPwBggsIaHtosUfsZ1wgTRNG1SaOmkr3FqO46QuiV1sZ8AT8Zo4rB0r2gWK5Fj27_zPl0-WvURwhghH79Zu8FZ2s42zegZxzgktHmWHqCR4yjAkj-_tD7JnIawhpKRg7Gl2QAhjqETFYfZrbpWptVUaSFsDb8JX0EgVnQ-gcR70cp3WqtO6NrYFsndp3chotI0BDLbWvnXjzUZ7NURptRsCUM47K_1PYGzU_iaxxtn34NzYUSUpe9eDuNJg4fx33RppwenO5DomHCy9kR04WlxeXS_PFsvj59mTRnZBv9j-J9nn87Pl6afpxeXH-enJxVTxAsepxrzhFZINLghmNcsZRYyWFckRI6jAtFYc102DS4pVXktMKVElhbLkUGGuyCR7fau76VwQ2xoHgfOSo5xQkidifkvUTq7Fxps-RS2cNOLPgfOtkD4a1WlR0bKkNWUkVzxvuCzyvMYVZw1qEKqS2iT7sPU2VL2uVcrcy25PdP_GmpVo3Y3gqbOI4b_hqtS5aKywzkuBICRcYESL0cXR1oV33wYdouhNULrrbls1ZlZQCAtCEvrmH_Th_LdUK1OKxjYuRaZGUXHC0gPLIYdlomYPUOmrdW9UerKNSed7Bsd7BomJ-kds5RCCmF9f_T97-WWffXuPXWnZxVVw3TC-yLAP5rtSuhC8bu7agKAYJ25XDTFOnNhOXDJ7db-Fd0a7ESO_AZrrJfY</addsrcrecordid><sourcetype>Open Website</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2497143534</pqid></control><display><type>article</type><title>Incidence and risk factors for major bleeding among patients undergoing percutaneous coronary intervention: Findings from the Norwegian Coronary Stent Trial (NORSTENT)</title><source>NORA - Norwegian Open Research Archives</source><source>DOAJ Directory of Open Access Journals</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>Public Library of Science (PLoS) Journals Open Access</source><source>PubMed Central</source><source>Free Full-Text Journals in Chemistry</source><creator>Samuelsen, Per-Jostein ; Eggen, Anne Elise ; Steigen, Terje ; Wilsgaard, Tom ; Kristensen, Andreas ; Skogsholm, Anne ; Holme, Elizabeth ; van den Heuvel, Christian ; Nordrehaug, Jan Erik ; Bendz, Bjørn ; Nilsen, Dennis W T ; Bønaa, Kaare Harald</creator><contributor>De Rosa, Salvatore</contributor><creatorcontrib>Samuelsen, Per-Jostein ; Eggen, Anne Elise ; Steigen, Terje ; Wilsgaard, Tom ; Kristensen, Andreas ; Skogsholm, Anne ; Holme, Elizabeth ; van den Heuvel, Christian ; Nordrehaug, Jan Erik ; Bendz, Bjørn ; Nilsen, Dennis W T ; Bønaa, Kaare Harald ; De Rosa, Salvatore</creatorcontrib><description>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).
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.
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).
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.
Unique identifier NCT00811772; http://www.clinicaltrial.gov.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0247358</identifier><identifier>PMID: 33661918</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Acute coronary syndromes ; Angina ; Angina pectoris ; Angioplasty ; Antiplatelet therapy ; Arctic research ; Basale medisinske, odontologiske og veterinærmedisinske fag: 710 ; Basic medical, dental and veterinary science disciplines: 710 ; Bleeding ; Cardiology ; Cardiovascular disease ; Cardiovascular diseases ; Clinical medicine ; Complications and side effects ; Coronary artery ; Coronary artery disease ; Coronary vessels ; Demographic aspects ; Diabetes ; Drafting software ; Editing ; Funding ; Heart attacks ; Heart diseases ; Hemoglobin ; Hemorrhage ; Hospitals ; Implantation ; Implants ; Ischemia ; Kidney diseases ; Medical disciplines: 700 ; Medical imaging ; Medicine ; Medicine and Health Sciences ; Medisinske Fag: 700 ; Methodology ; Patients ; Pharmacovigilance ; Polar environments ; Risk analysis ; Risk factors ; Science and technology ; Stents ; Subgroups ; Surgical implants ; Transluminal angioplasty ; Validity ; VDP</subject><ispartof>PloS one, 2021-03, Vol.16 (3), p.e0247358-e0247358</ispartof><rights>COPYRIGHT 2021 Public Library of Science</rights><rights>2021 Samuelsen et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>info:eu-repo/semantics/openAccess</rights><rights>2021 Samuelsen et al 2021 Samuelsen et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c782t-e27f7b1af28326d64651659b341631825dc72dff2952c4da2553c950a970c27c3</citedby><cites>FETCH-LOGICAL-c782t-e27f7b1af28326d64651659b341631825dc72dff2952c4da2553c950a970c27c3</cites><orcidid>0000-0001-6675-3724 ; 0000-0002-7484-7488</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7932162/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7932162/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,2102,2928,23866,26567,27924,27925,53791,53793,79600,79601</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33661918$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>De Rosa, Salvatore</contributor><creatorcontrib>Samuelsen, Per-Jostein</creatorcontrib><creatorcontrib>Eggen, Anne Elise</creatorcontrib><creatorcontrib>Steigen, Terje</creatorcontrib><creatorcontrib>Wilsgaard, Tom</creatorcontrib><creatorcontrib>Kristensen, Andreas</creatorcontrib><creatorcontrib>Skogsholm, Anne</creatorcontrib><creatorcontrib>Holme, Elizabeth</creatorcontrib><creatorcontrib>van den Heuvel, Christian</creatorcontrib><creatorcontrib>Nordrehaug, Jan Erik</creatorcontrib><creatorcontrib>Bendz, Bjørn</creatorcontrib><creatorcontrib>Nilsen, Dennis W T</creatorcontrib><creatorcontrib>Bønaa, Kaare Harald</creatorcontrib><title>Incidence and risk factors for major bleeding among patients undergoing percutaneous coronary intervention: Findings from the Norwegian Coronary Stent Trial (NORSTENT)</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>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).
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.
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).
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.
Unique identifier NCT00811772; http://www.clinicaltrial.gov.</description><subject>Acute coronary syndromes</subject><subject>Angina</subject><subject>Angina pectoris</subject><subject>Angioplasty</subject><subject>Antiplatelet therapy</subject><subject>Arctic research</subject><subject>Basale medisinske, odontologiske og veterinærmedisinske fag: 710</subject><subject>Basic medical, dental and veterinary science disciplines: 710</subject><subject>Bleeding</subject><subject>Cardiology</subject><subject>Cardiovascular disease</subject><subject>Cardiovascular diseases</subject><subject>Clinical medicine</subject><subject>Complications and side effects</subject><subject>Coronary artery</subject><subject>Coronary artery disease</subject><subject>Coronary vessels</subject><subject>Demographic aspects</subject><subject>Diabetes</subject><subject>Drafting software</subject><subject>Editing</subject><subject>Funding</subject><subject>Heart attacks</subject><subject>Heart diseases</subject><subject>Hemoglobin</subject><subject>Hemorrhage</subject><subject>Hospitals</subject><subject>Implantation</subject><subject>Implants</subject><subject>Ischemia</subject><subject>Kidney diseases</subject><subject>Medical disciplines: 700</subject><subject>Medical imaging</subject><subject>Medicine</subject><subject>Medicine and Health Sciences</subject><subject>Medisinske Fag: 700</subject><subject>Methodology</subject><subject>Patients</subject><subject>Pharmacovigilance</subject><subject>Polar environments</subject><subject>Risk analysis</subject><subject>Risk factors</subject><subject>Science and technology</subject><subject>Stents</subject><subject>Subgroups</subject><subject>Surgical implants</subject><subject>Transluminal angioplasty</subject><subject>Validity</subject><subject>VDP</subject><issn>1932-6203</issn><issn>1932-6203</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>3HK</sourceid><sourceid>DOA</sourceid><recordid>eNqNk91u0zAUxyMEYqPwBggsIaHtosUfsZ1wgTRNG1SaOmkr3FqO46QuiV1sZ8AT8Zo4rB0r2gWK5Fj27_zPl0-WvURwhghH79Zu8FZ2s42zegZxzgktHmWHqCR4yjAkj-_tD7JnIawhpKRg7Gl2QAhjqETFYfZrbpWptVUaSFsDb8JX0EgVnQ-gcR70cp3WqtO6NrYFsndp3chotI0BDLbWvnXjzUZ7NURptRsCUM47K_1PYGzU_iaxxtn34NzYUSUpe9eDuNJg4fx33RppwenO5DomHCy9kR04WlxeXS_PFsvj59mTRnZBv9j-J9nn87Pl6afpxeXH-enJxVTxAsepxrzhFZINLghmNcsZRYyWFckRI6jAtFYc102DS4pVXktMKVElhbLkUGGuyCR7fau76VwQ2xoHgfOSo5xQkidifkvUTq7Fxps-RS2cNOLPgfOtkD4a1WlR0bKkNWUkVzxvuCzyvMYVZw1qEKqS2iT7sPU2VL2uVcrcy25PdP_GmpVo3Y3gqbOI4b_hqtS5aKywzkuBICRcYESL0cXR1oV33wYdouhNULrrbls1ZlZQCAtCEvrmH_Th_LdUK1OKxjYuRaZGUXHC0gPLIYdlomYPUOmrdW9UerKNSed7Bsd7BomJ-kds5RCCmF9f_T97-WWffXuPXWnZxVVw3TC-yLAP5rtSuhC8bu7agKAYJ25XDTFOnNhOXDJ7db-Fd0a7ESO_AZrrJfY</recordid><startdate>20210304</startdate><enddate>20210304</enddate><creator>Samuelsen, Per-Jostein</creator><creator>Eggen, Anne Elise</creator><creator>Steigen, Terje</creator><creator>Wilsgaard, Tom</creator><creator>Kristensen, Andreas</creator><creator>Skogsholm, Anne</creator><creator>Holme, Elizabeth</creator><creator>van den Heuvel, Christian</creator><creator>Nordrehaug, Jan Erik</creator><creator>Bendz, Bjørn</creator><creator>Nilsen, Dennis W T</creator><creator>Bønaa, Kaare Harald</creator><general>Public Library of Science</general><general>Public Library of Science (PLoS)</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>IOV</scope><scope>ISR</scope><scope>3V.</scope><scope>7QG</scope><scope>7QL</scope><scope>7QO</scope><scope>7RV</scope><scope>7SN</scope><scope>7SS</scope><scope>7T5</scope><scope>7TG</scope><scope>7TM</scope><scope>7U9</scope><scope>7X2</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FD</scope><scope>8FE</scope><scope>8FG</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABJCF</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>ARAPS</scope><scope>ATCPS</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BGLVJ</scope><scope>BHPHI</scope><scope>C1K</scope><scope>CCPQU</scope><scope>D1I</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>KB.</scope><scope>KB0</scope><scope>KL.</scope><scope>L6V</scope><scope>LK8</scope><scope>M0K</scope><scope>M0S</scope><scope>M1P</scope><scope>M7N</scope><scope>M7P</scope><scope>M7S</scope><scope>NAPCQ</scope><scope>P5Z</scope><scope>P62</scope><scope>P64</scope><scope>PATMY</scope><scope>PDBOC</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PTHSS</scope><scope>PYCSY</scope><scope>RC3</scope><scope>7X8</scope><scope>3HK</scope><scope>5PM</scope><scope>DOA</scope><orcidid>https://orcid.org/0000-0001-6675-3724</orcidid><orcidid>https://orcid.org/0000-0002-7484-7488</orcidid></search><sort><creationdate>20210304</creationdate><title>Incidence and risk factors for major bleeding among patients undergoing percutaneous coronary intervention: Findings from the Norwegian Coronary Stent Trial (NORSTENT)</title><author>Samuelsen, Per-Jostein ; Eggen, Anne Elise ; Steigen, Terje ; Wilsgaard, Tom ; Kristensen, Andreas ; Skogsholm, Anne ; Holme, Elizabeth ; van den Heuvel, Christian ; Nordrehaug, Jan Erik ; Bendz, Bjørn ; Nilsen, Dennis W T ; Bønaa, Kaare Harald</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c782t-e27f7b1af28326d64651659b341631825dc72dff2952c4da2553c950a970c27c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Acute coronary syndromes</topic><topic>Angina</topic><topic>Angina pectoris</topic><topic>Angioplasty</topic><topic>Antiplatelet therapy</topic><topic>Arctic research</topic><topic>Basale medisinske, odontologiske og veterinærmedisinske fag: 710</topic><topic>Basic medical, dental and veterinary science disciplines: 710</topic><topic>Bleeding</topic><topic>Cardiology</topic><topic>Cardiovascular disease</topic><topic>Cardiovascular diseases</topic><topic>Clinical medicine</topic><topic>Complications and side effects</topic><topic>Coronary artery</topic><topic>Coronary artery disease</topic><topic>Coronary vessels</topic><topic>Demographic aspects</topic><topic>Diabetes</topic><topic>Drafting software</topic><topic>Editing</topic><topic>Funding</topic><topic>Heart attacks</topic><topic>Heart diseases</topic><topic>Hemoglobin</topic><topic>Hemorrhage</topic><topic>Hospitals</topic><topic>Implantation</topic><topic>Implants</topic><topic>Ischemia</topic><topic>Kidney diseases</topic><topic>Medical disciplines: 700</topic><topic>Medical imaging</topic><topic>Medicine</topic><topic>Medicine and Health Sciences</topic><topic>Medisinske Fag: 700</topic><topic>Methodology</topic><topic>Patients</topic><topic>Pharmacovigilance</topic><topic>Polar environments</topic><topic>Risk analysis</topic><topic>Risk factors</topic><topic>Science and technology</topic><topic>Stents</topic><topic>Subgroups</topic><topic>Surgical implants</topic><topic>Transluminal angioplasty</topic><topic>Validity</topic><topic>VDP</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Samuelsen, Per-Jostein</creatorcontrib><creatorcontrib>Eggen, Anne Elise</creatorcontrib><creatorcontrib>Steigen, Terje</creatorcontrib><creatorcontrib>Wilsgaard, Tom</creatorcontrib><creatorcontrib>Kristensen, Andreas</creatorcontrib><creatorcontrib>Skogsholm, Anne</creatorcontrib><creatorcontrib>Holme, Elizabeth</creatorcontrib><creatorcontrib>van den Heuvel, Christian</creatorcontrib><creatorcontrib>Nordrehaug, Jan Erik</creatorcontrib><creatorcontrib>Bendz, Bjørn</creatorcontrib><creatorcontrib>Nilsen, Dennis W T</creatorcontrib><creatorcontrib>Bønaa, Kaare Harald</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>Gale In Context: Opposing Viewpoints</collection><collection>Gale In Context: Science</collection><collection>ProQuest Central (Corporate)</collection><collection>Animal Behavior Abstracts</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Biotechnology Research Abstracts</collection><collection>Nursing & Allied Health Database</collection><collection>Ecology Abstracts</collection><collection>Entomology Abstracts (Full archive)</collection><collection>Immunology Abstracts</collection><collection>Meteorological & Geoastrophysical Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Agricultural Science Collection</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Technology Research Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Technology Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Materials Science & Engineering Collection</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>Advanced Technologies & Aerospace Collection</collection><collection>Agricultural & Environmental Science Collection</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Technology Collection</collection><collection>Natural Science Collection</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>ProQuest Materials Science Collection</collection><collection>ProQuest Central Korea</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Materials Science Database</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Meteorological & Geoastrophysical Abstracts - Academic</collection><collection>ProQuest Engineering Collection</collection><collection>ProQuest Biological Science Collection</collection><collection>Agricultural Science Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biological Science Database</collection><collection>Engineering Database</collection><collection>Nursing & Allied Health Premium</collection><collection>Advanced Technologies & Aerospace Database</collection><collection>ProQuest Advanced Technologies & Aerospace Collection</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Environmental Science Database</collection><collection>Materials Science Collection</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>Engineering Collection</collection><collection>Environmental Science Collection</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><collection>NORA - Norwegian Open Research Archives</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>PloS one</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Samuelsen, Per-Jostein</au><au>Eggen, Anne Elise</au><au>Steigen, Terje</au><au>Wilsgaard, Tom</au><au>Kristensen, Andreas</au><au>Skogsholm, Anne</au><au>Holme, Elizabeth</au><au>van den Heuvel, Christian</au><au>Nordrehaug, Jan Erik</au><au>Bendz, Bjørn</au><au>Nilsen, Dennis W T</au><au>Bønaa, Kaare Harald</au><au>De Rosa, Salvatore</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Incidence and risk factors for major bleeding among patients undergoing percutaneous coronary intervention: Findings from the Norwegian Coronary Stent Trial (NORSTENT)</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2021-03-04</date><risdate>2021</risdate><volume>16</volume><issue>3</issue><spage>e0247358</spage><epage>e0247358</epage><pages>e0247358-e0247358</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>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).
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.
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).
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.
Unique identifier NCT00811772; http://www.clinicaltrial.gov.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>33661918</pmid><doi>10.1371/journal.pone.0247358</doi><tpages>e0247358</tpages><orcidid>https://orcid.org/0000-0001-6675-3724</orcidid><orcidid>https://orcid.org/0000-0002-7484-7488</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1932-6203 |
| ispartof | PloS one, 2021-03, Vol.16 (3), p.e0247358-e0247358 |
| issn | 1932-6203 1932-6203 |
| language | eng |
| recordid | cdi_plos_journals_2497143534 |
| source | NORA - Norwegian Open Research Archives; DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Public Library of Science (PLoS) Journals Open Access; PubMed Central; Free Full-Text Journals in Chemistry |
| subjects | Acute coronary syndromes Angina Angina pectoris Angioplasty Antiplatelet therapy Arctic research Basale medisinske, odontologiske og veterinærmedisinske fag: 710 Basic medical, dental and veterinary science disciplines: 710 Bleeding Cardiology Cardiovascular disease Cardiovascular diseases Clinical medicine Complications and side effects Coronary artery Coronary artery disease Coronary vessels Demographic aspects Diabetes Drafting software Editing Funding Heart attacks Heart diseases Hemoglobin Hemorrhage Hospitals Implantation Implants Ischemia Kidney diseases Medical disciplines: 700 Medical imaging Medicine Medicine and Health Sciences Medisinske Fag: 700 Methodology Patients Pharmacovigilance Polar environments Risk analysis Risk factors Science and technology Stents Subgroups Surgical implants Transluminal angioplasty Validity VDP |
| title | Incidence and risk factors for major bleeding among patients undergoing percutaneous coronary intervention: Findings from the Norwegian Coronary Stent Trial (NORSTENT) |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-29T00%3A18%3A33IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_plos_&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Incidence%20and%20risk%20factors%20for%20major%20bleeding%20among%20patients%20undergoing%20percutaneous%20coronary%20intervention:%20Findings%20from%20the%20Norwegian%20Coronary%20Stent%20Trial%20(NORSTENT)&rft.jtitle=PloS%20one&rft.au=Samuelsen,%20Per-Jostein&rft.date=2021-03-04&rft.volume=16&rft.issue=3&rft.spage=e0247358&rft.epage=e0247358&rft.pages=e0247358-e0247358&rft.issn=1932-6203&rft.eissn=1932-6203&rft_id=info:doi/10.1371/journal.pone.0247358&rft_dat=%3Cgale_plos_%3EA653840709%3C/gale_plos_%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2497143534&rft_id=info:pmid/33661918&rft_galeid=A653840709&rft_doaj_id=oai_doaj_org_article_b5995d5634c74f7a844d2b76f1f11b35&rfr_iscdi=true |