Influence of CYP2C19 genotypes for the effect of 1-month dual antiplatelet therapy followed by clopidogrel monotherapy relative to 12-month dual ... View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2020-11-12

AUTHORS

Hirotoshi Watanabe, Takeshi Morimoto, Manabu Ogita, Satoru Suwa, Masahiro Natsuaki, Nobuhiro Suematsu, Yorihiko Koeda, Yoshihiro Morino, Akira Nikaido, Yoshiki Hata, Masayuki Doi, Kiyoshi Hibi, Kazuo Kimura, Shunsuke Yoda, Takeo Kaneko, Koji Nishida, Kazuya Kawai, Koji Yamaguchi, Tetsuzo Wakatsuki, Norimasa Tonoike, Masashi Yamamoto, Shogo Shimizu, Takao Shimohama, Junya Ako, Takeshi Kimura

ABSTRACT

The ultra-short dual antiplatelet therapy (DAPT) followed by P2Y12 inhibitor monotherapy might be promising after percutaneous coronary intervention (PCI). However, CYP2C19 loss-of-function (LOF) alleles have been reported to diminish the effect of clopidogrel, and clopidogrel monotherapy has a concern about the increased ischemic risk for patients with such alleles. STOPDAPT-2 is the multicenter prospective open-label, but adjudicator-blinded randomized control study comparing 1-month DAPT followed by clopidogrel monotherapy with the standard 12-month DAPT after PCI with cobalt–chromium everolimus-eluting stents. Among the participants of STOPDAPT-2, selected patients participated in a substudy of the CYP2C19 gene test. Patients with two CYP2C19*2 or *3 alleles were defined as the poor metabolizer (PM), one allele as the intermediate metabolizer (IM), and no allele as the extensive metabolizer (EM). The primary endpoint was the composite of cardiovascular and bleeding events, as defined in STOPDAPT-2. Among 750 (24.9%) patients with known CYP2C19 genotypes, 129 (17.2%) were PM, 367 (49.0%) were IM, and 254 (33.9%) were EM. The hazard ratios of 1-month DAPT relative to 12-month DAPT for the primary endpoint in PM, IM, and EM strata were 0.66 (95% CI 0.11–3.94), 1.94 (95% CI 0.60–6.31), and 0.21 (95% CI 0.02–1.78), respectively (P interaction = 0.17), and those for cardiovascular composite endpoint were 1.00 (95% CI 0.14–7.10), 6.10 (95% CI 0.75–49.55), and 0.26 (95% CI 0.03–2.34), respectively (P interaction = 0.12). In conclusion, for the selected patients in STOPDAPT-2 trial, CYP2C19 LOF alleles had no significant, consistent interaction with the effect of 1-month DAPT relative to 12-month DAPT for clinical outcomes, although the study was overtly underpowered.Trial registrySTOPDAPT-2 ClinicalTrials.gov number, NCT02619760. More... »

PAGES

403-415

Journal

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s12928-020-00719-6

DOI

http://dx.doi.org/10.1007/s12928-020-00719-6

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1132584809

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/33184726


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    "description": "The ultra-short dual antiplatelet therapy (DAPT) followed by P2Y12 inhibitor monotherapy might be promising after percutaneous coronary intervention (PCI). However, CYP2C19 loss-of-function (LOF) alleles have been reported to diminish the effect of clopidogrel, and clopidogrel monotherapy has a concern about the increased ischemic risk for patients with such alleles. STOPDAPT-2 is the multicenter prospective open-label, but adjudicator-blinded randomized control study comparing 1-month DAPT followed by clopidogrel monotherapy with the standard 12-month DAPT after PCI with cobalt\u2013chromium everolimus-eluting stents. Among the participants of STOPDAPT-2, selected patients participated in a substudy of the CYP2C19 gene test. Patients with two CYP2C19*2 or *3 alleles were defined as the poor metabolizer (PM), one allele as the intermediate metabolizer (IM), and no allele as the extensive metabolizer (EM). The primary endpoint was the composite of cardiovascular and bleeding events, as defined in STOPDAPT-2. Among 750 (24.9%) patients with known CYP2C19 genotypes, 129 (17.2%) were PM, 367 (49.0%) were IM, and 254 (33.9%) were EM. The hazard ratios of 1-month DAPT relative to 12-month DAPT for the primary endpoint in PM, IM, and EM strata were 0.66 (95% CI 0.11\u20133.94), 1.94 (95% CI 0.60\u20136.31), and 0.21 (95% CI 0.02\u20131.78), respectively (P interaction\u2009=\u20090.17), and those for cardiovascular composite endpoint were 1.00 (95% CI 0.14\u20137.10), 6.10 (95% CI 0.75\u201349.55), and 0.26 (95% CI 0.03\u20132.34), respectively (P interaction\u2009=\u20090.12). In conclusion, for the selected patients in STOPDAPT-2 trial, CYP2C19 LOF alleles had no significant, consistent interaction with the effect of 1-month DAPT relative to 12-month DAPT for clinical outcomes, although the study was overtly underpowered.Trial registrySTOPDAPT-2 ClinicalTrials.gov number, NCT02619760.", 
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336 grid-institutes:grid.410786.c schema:alternateName Department of Cardiovascular Medicine, Kitasato University School of Medicine, Sagamihara, Japan
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340 schema:name Division of Cardiology, Department of Internal Medicine, Memorial Heart Center, Iwate Medical University, Morioka, Japan
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342 grid-institutes:grid.412339.e schema:alternateName Department of Cardiovascular Medicine, Saga University, Saga, Japan
343 schema:name Department of Cardiovascular Medicine, Saga University, Saga, Japan
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345 grid-institutes:grid.412772.5 schema:alternateName Department of Cardiovascular Medicine, Tokushima University Hospital, Tokushima, Japan
346 schema:name Department of Cardiovascular Medicine, Tokushima University Hospital, Tokushima, Japan
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348 grid-institutes:grid.413045.7 schema:alternateName Division of Cardiology, Yokohama City University Medical Center, Yokohama, Japan
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351 grid-institutes:grid.414811.9 schema:alternateName Department of Cardiology, Kagawa Prefectural Central Hospital, Takamatsu, Japan
352 schema:name Department of Cardiology, Kagawa Prefectural Central Hospital, Takamatsu, Japan
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354 grid-institutes:grid.415753.1 schema:alternateName Department of Internal Medicine, Division of Cardiology, Shimonoseki City Hospital, Shimonoseki, Japan
355 schema:name Department of Internal Medicine, Division of Cardiology, Shimonoseki City Hospital, Shimonoseki, Japan
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357 grid-institutes:grid.416599.6 schema:alternateName Department of Cardiovascular Medicine, Saiseikai Fukuoka General Hospital, Fukuoka, Japan
358 schema:name Department of Cardiovascular Medicine, Saiseikai Fukuoka General Hospital, Fukuoka, Japan
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360 grid-institutes:grid.452236.4 schema:alternateName Department of Cardiology, Chikamori Hospital, Kochi, Japan
361 schema:name Department of Cardiology, Chikamori Hospital, Kochi, Japan
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363 grid-institutes:grid.482667.9 schema:alternateName Department of Cardiovascular Medicine, Juntendo University Shizuoka Hospital, Izunokuni, Japan
364 schema:name Department of Cardiovascular Medicine, Juntendo University Shizuoka Hospital, Izunokuni, Japan
365 rdf:type schema:Organization
 




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