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A Genotype-Guided Strategy for Oral P2Y 12 Inhibitors in Primary PCI

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Název: A Genotype-Guided Strategy for Oral P2Y 12 Inhibitors in Primary PCI
Autoři: Johannes C. Kelder, Carmine Morisco, Jean-Paul R. Herrman, Daniel M.F. Claassens, Richard M. Tjon Joe Gin, Willem Dewilde, Arend Mosterd, Emanuele Barbato, Maarten J. Postma, C. Boersma, Folkert W. Asselbergs, Arnoud W J van 't Hof, Pim van der Harst, Jurrien M Ten Berg, Thomas O. Bergmeijer, Renicus S Hermanides, Gerrit J.A. Vos, Vera H.M. Deneer, Anthonius de Boer, Paul W.A. Janssen
Přispěvatelé: Arts Assistenten Cardiologie, Team Medisch, Circulatory Health, Cardiovasculaire Immunologie, Apotheek Klinische Farmacie, Pharmacoepidemiology and Clinical Pharmacology, Afd Pharmacoepi & Clinical Pharmacology, PECP – Centre for Clinical Therapeutics, PECP - Centre for Pharmacoepidemiology
Zdroj: New England Journal of Medicine. 381:1621-1631
Informace o vydavateli: Massachusetts Medical Society, 2019.
Rok vydání: 2019
Témata: Male, Ticagrelor, Genotype, ST Elevation Myocardial Infarction/drug therapy, PERCUTANEOUS CORONARY INTERVENTION, MULTICENTER, Administration, Oral, Hemorrhage, Clopidogrel/adverse effects, 03 medical and health sciences, Percutaneous Coronary Intervention, 0302 clinical medicine, Hemorrhage/chemically induced, Taverne, STENT THROMBOSIS, Journal Article, Humans, ST-SEGMENT ELEVATION, Single-Blind Method, Precision Medicine, Aged, Medicine(all), OUTCOMES, Research Support, Non-U.S. Gov't, Coronary Thrombosis, ELEVATION MYOCARDIAL-INFARCTION, DUAL ANTIPLATELET THERAPY, General Medicine, Middle Aged, Prasugrel Hydrochloride/adverse effects, OPEN-LABEL, Clopidogrel, Intention to Treat Analysis, 3. Good health, Coronary Thrombosis/prevention & control, Multicenter Study, Cytochrome P-450 CYP2C19, PCI, P2Y12, Ticagrelor/adverse effects, CYP2C19 GENOTYPE, CLOPIDOGREL, Purinergic P2Y Receptor Antagonists/adverse effects, Randomized Controlled Trial, Purinergic P2Y Receptor Antagonists, ST Elevation Myocardial Infarction, Female, Stents, Cytochrome P-450 CYP2C19/genetics, Prasugrel Hydrochloride
Popis: It is unknown whether patients undergoing primary percutaneous coronary intervention (PCI) benefit from genotype-guided selection of oral P2Y12 inhibitors.We conducted a randomized, open-label, assessor-blinded trial in which patients undergoing primary PCI with stent implantation were assigned in a 1:1 ratio to receive either a P2Y12 inhibitor on the basis of early CYP2C19 genetic testing (genotype-guided group) or standard treatment with either ticagrelor or prasugrel (standard-treatment group) for 12 months. In the genotype-guided group, carriers of CYP2C19*2 or CYP2C19*3 loss-of-function alleles received ticagrelor or prasugrel, and noncarriers received clopidogrel. The two primary outcomes were net adverse clinical events - defined as death from any cause, myocardial infarction, definite stent thrombosis, stroke, or major bleeding defined according to Platelet Inhibition and Patient Outcomes (PLATO) criteria - at 12 months (primary combined outcome; tested for noninferiority, with a noninferiority margin of 2 percentage points for the absolute difference) and PLATO major or minor bleeding at 12 months (primary bleeding outcome).For the primary analysis, 2488 patients were included: 1242 in the genotype-guided group and 1246 in the standard-treatment group. The primary combined outcome occurred in 63 patients (5.1%) in the genotype-guided group and in 73 patients (5.9%) in the standard-treatment group (absolute difference, -0.7 percentage points; 95% confidence interval [CI], -2.0 to 0.7; P
Druh dokumentu: Article
Popis souboru: application/pdf; image/pdf
Jazyk: English
ISSN: 1533-4406
0028-4793
DOI: 10.1056/nejmoa1907096
Přístupová URL adresa: https://pubmed.ncbi.nlm.nih.gov/31479209
http://hdl.handle.net/11588/758723
https://hdl.handle.net/11370/650391a9-784b-433f-a595-a7bf8062502a
https://doi.org/10.1056/NEJMoa1907096
https://research.rug.nl/en/publications/650391a9-784b-433f-a595-a7bf8062502a
https://cris.maastrichtuniversity.nl/en/publications/bb73e8c6-3735-412e-9308-2d05f5549d34
https://doi.org/10.1056/NEJMoa1907096
https://pubmed.ncbi.nlm.nih.gov/31479209/
https://europepmc.org/article/MED/31479209
https://www.rug.nl/research/portal/publications/a-genotypeguided-strategy-for-oral-p2y12-inhibitors-in-primary-pci(650391a9-784b-433f-a595-a7bf8062502a).html
https://www.ncbi.nlm.nih.gov/pubmed/31479209/
https://www.narcis.nl/publication/RecordID/oai%3Acris.maastrichtuniversity.nl%3Apublications%2Fbb73e8c6-3735-412e-9308-2d05f5549d34
https://research.rug.nl/en/publications/a-genotype-guided-strategy-for-oral-p2y12-inhibitors-in-primary-p
https://dspace.library.uu.nl/handle/1874/453165
https://dspace.library.uu.nl/handle/1874/389963
https://dspace.library.uu.nl/handle/1874/390371
Rights: taverne
URL: http://www.nejmgroup.org/legal/terms-of-use.htm
Přístupové číslo: edsair.doi.dedup.....733c98faebcd29c4b96c53bc67fcb7de
Databáze: OpenAIRE
Popis
Abstrakt:It is unknown whether patients undergoing primary percutaneous coronary intervention (PCI) benefit from genotype-guided selection of oral P2Y12 inhibitors.We conducted a randomized, open-label, assessor-blinded trial in which patients undergoing primary PCI with stent implantation were assigned in a 1:1 ratio to receive either a P2Y12 inhibitor on the basis of early CYP2C19 genetic testing (genotype-guided group) or standard treatment with either ticagrelor or prasugrel (standard-treatment group) for 12 months. In the genotype-guided group, carriers of CYP2C19*2 or CYP2C19*3 loss-of-function alleles received ticagrelor or prasugrel, and noncarriers received clopidogrel. The two primary outcomes were net adverse clinical events - defined as death from any cause, myocardial infarction, definite stent thrombosis, stroke, or major bleeding defined according to Platelet Inhibition and Patient Outcomes (PLATO) criteria - at 12 months (primary combined outcome; tested for noninferiority, with a noninferiority margin of 2 percentage points for the absolute difference) and PLATO major or minor bleeding at 12 months (primary bleeding outcome).For the primary analysis, 2488 patients were included: 1242 in the genotype-guided group and 1246 in the standard-treatment group. The primary combined outcome occurred in 63 patients (5.1%) in the genotype-guided group and in 73 patients (5.9%) in the standard-treatment group (absolute difference, -0.7 percentage points; 95% confidence interval [CI], -2.0 to 0.7; P
ISSN:15334406
00284793
DOI:10.1056/nejmoa1907096