High-sensitivity C-reactive protein and clopidogrel treatment in patients at high risk of cardiovascular events: a substudy from the CHARISMA trial
Identifieur interne : 006266 ( Main/Exploration ); précédent : 006265; suivant : 006267High-sensitivity C-reactive protein and clopidogrel treatment in patients at high risk of cardiovascular events: a substudy from the CHARISMA trial
Auteurs : Michael Weber [Allemagne] ; Deepak L. Bhatt [États-Unis] ; Danielle M. Brennan [États-Unis] ; Graeme J. Hankey [Australie] ; Steven R. Steinhubl [Suisse] ; S Claiborne Johnston [États-Unis] ; Gilles Montalescot [France] ; Koon-Hou Mak [République populaire de Chine] ; Keith A A. Fox [Royaume-Uni] ; Donald J. Easton [États-Unis] ; Eric J. Topol [États-Unis] ; Christian W. Hamm [Allemagne]Source :
- Heart [ 1355-6037 ] ; 2011-04-15.
Descripteurs français
- Wicri :
- topic : Maladie cardio-vasculaire.
English descriptors
- KwdEn :
- Angiotensin, Angiotensin antagonist, Artery disease, Aspirin, Aspirin dose, Atherosclerotic, Atherosclerotic disease, Baseline, Baseline characteristics, Body mass index, Bristol myers squibb, Broad population, Cardiovascular, Cardiovascular death, Cardiovascular disease, Cardiovascular events, Charisma, Charisma trial, Clopidogrel, Clopidogrel group, Clopidogrel treatment, Consulting fees, Coronary artery disease, Coronary disease table, Current smoker, Diabetes mellitus, Endpoint, Engl, Heart disease, High hscrp levels, High risk, Hscrp, Hscrp levels, Hypercholesterolaemia, Hypertension, Infarction, Inhibitor medication, Ischaemic events, Lecture fees, Median, Myocardial infarction, Placebo, Placebo group, Platelet, Platelet activation, Predictive value, Previous statins, Primary endpoint, Quartile, Risk factors, Secondary prevention, Smoker, Squibb, Statin, Statin treatment, Study entry, Substudy, Treatment effect, Treatment group, Treatment groups, Unstable angina.
- Teeft :
- Angiotensin, Angiotensin antagonist, Artery disease, Aspirin, Aspirin dose, Atherosclerotic, Atherosclerotic disease, Baseline, Baseline characteristics, Body mass index, Bristol myers squibb, Broad population, Cardiovascular, Cardiovascular death, Cardiovascular disease, Cardiovascular events, Charisma, Charisma trial, Clopidogrel, Clopidogrel group, Clopidogrel treatment, Consulting fees, Coronary artery disease, Coronary disease table, Current smoker, Diabetes mellitus, Endpoint, Engl, Heart disease, High hscrp levels, High risk, Hscrp, Hscrp levels, Hypercholesterolaemia, Hypertension, Infarction, Inhibitor medication, Ischaemic events, Lecture fees, Median, Myocardial infarction, Placebo, Placebo group, Platelet, Platelet activation, Predictive value, Previous statins, Primary endpoint, Quartile, Risk factors, Secondary prevention, Smoker, Squibb, Statin, Statin treatment, Study entry, Substudy, Treatment effect, Treatment group, Treatment groups, Unstable angina.
Abstract
Aims This study investigated the effect of clopidogrel treatment on inflammatory activity as evidenced by the change in high-sensitivity C-reactive protein (hsCRP) levels in a broad population of patients who are at high risk of atherothrombotic events. The predictive value of hsCRP levels for a treatment benefit of clopidogrel was also explored. Methods The study included 8021 patients with established atherosclerotic disease or multiple cardiovascular risk factors enrolled in the CHARISMA trial. Patients were randomly assigned either to clopidogrel plus aspirin or placebo plus aspirin. HsCRP was measured at study entry and at study termination (median 28 months). The predefined primary composite endpoint was myocardial infarction, stroke, or death from cardiovascular causes. Results There was a stepwise increase in the event rate of the combined primary endpoint with increasing quartiles of hsCRP at baseline (4.0%, 6.1%, 7.4% and 8.7% for the highest quartile). In both treatment groups the changes in hsCRP levels over time were identical. In patients with low hsCRP levels (<3 mg/l) clopidogrel treatment was associated with a lower event rate compared with placebo (4.0% vs 6.0%, log rank p=0.005). In contrast no treatment effect was observed in patients with high hsCRP levels (8.1% vs 8.0%, ns). Conclusions In this broad population, hsCRP is a powerful predictor of ischaemic events. Compared with placebo, clopidogrel was without effect on inflammatory markers. The reduction in cardiovascular events by antiplatelet treatment with clopidogrel was isolated to patients with low levels of hsCRP.
Url:
DOI: 10.1136/hrt.2010.210419
Affiliations:
- Allemagne, Australie, France, Royaume-Uni, République populaire de Chine, Suisse, États-Unis
- Californie, Massachusetts, Ohio, Rhode Island, Écosse, Île-de-France
- Paris, Édimbourg
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Bhatt</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Brigham and Women's Hospital, Boston, Massachusetts</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Brennan, Danielle M" sort="Brennan, Danielle M" uniqKey="Brennan D" first="Danielle M" last="Brennan">Danielle M. Brennan</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Cleveland Clinic, Cleveland, Ohio</wicri:regionArea><placeName><region type="state">Ohio</region></placeName></affiliation></author><author><name sortKey="Hankey, Graeme J" sort="Hankey, Graeme J" uniqKey="Hankey G" first="Graeme J" last="Hankey">Graeme J. Hankey</name><affiliation wicri:level="1"><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Neurology, University of Western Australia, Perth</wicri:regionArea><wicri:noRegion>Perth</wicri:noRegion></affiliation></author><author><name sortKey="Steinhubl, Steven R" sort="Steinhubl, Steven R" uniqKey="Steinhubl S" first="Steven R" last="Steinhubl">Steven R. Steinhubl</name><affiliation wicri:level="1"><country xml:lang="fr">Suisse</country><wicri:regionArea>The Medicines Company, Zurich</wicri:regionArea><wicri:noRegion>Zurich</wicri:noRegion></affiliation></author><author><name sortKey="Johnston, S Claiborne" sort="Johnston, S Claiborne" uniqKey="Johnston S" first="S Claiborne" last="Johnston">S Claiborne Johnston</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, University of California, San Francisco, California</wicri:regionArea><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Montalescot, Gilles" sort="Montalescot, Gilles" uniqKey="Montalescot G" first="Gilles" last="Montalescot">Gilles Montalescot</name><affiliation wicri:level="3"><country xml:lang="fr">France</country><wicri:regionArea>Institut de Cardiologie, Centre Hospitalier Universitaire Pitié-Salpêtrière, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Mak, Koon Hou" sort="Mak, Koon Hou" uniqKey="Mak K" first="Koon-Hou" last="Mak">Koon-Hou Mak</name><affiliation wicri:level="1"><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Mak Heart Clinic and Yong Loo Lin School of Medicine, Singapore</wicri:regionArea><wicri:noRegion>Singapore</wicri:noRegion></affiliation></author><author><name sortKey="Fox, Keith A A" sort="Fox, Keith A A" uniqKey="Fox K" first="Keith A A" last="Fox">Keith A A. Fox</name><affiliation wicri:level="3"><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>University and Royal Infirmary, Edinburgh</wicri:regionArea><placeName><settlement type="city">Édimbourg</settlement><region type="country">Écosse</region></placeName></affiliation></author><author><name sortKey="Easton, Donald J" sort="Easton, Donald J" uniqKey="Easton D" first="Donald J" last="Easton">Donald J. Easton</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, Rhode Island Hospital and Brown University, Providence, Rhode Island</wicri:regionArea><placeName><region type="state">Rhode Island</region></placeName></affiliation></author><author><name sortKey="Topol, Eric J" sort="Topol, Eric J" uniqKey="Topol E" first="Eric J" last="Topol">Eric J. Topol</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>The Scripps Research Institute and Scripps Clinic, La Jolla, California</wicri:regionArea><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Hamm, Christian W" sort="Hamm, Christian W" uniqKey="Hamm C" first="Christian W" last="Hamm">Christian W. Hamm</name><affiliation wicri:level="1"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Kerckhoff Heart Center, Department of Cardiology, Bad Nauheim</wicri:regionArea><wicri:noRegion>Bad Nauheim</wicri:noRegion><wicri:noRegion>Bad Nauheim</wicri:noRegion></affiliation></author></analytic><monogr></monogr><series><title level="j">Heart</title><title level="j" type="abbrev">Heart</title><idno type="ISSN">1355-6037</idno><idno type="eISSN">1468-201X</idno><imprint><publisher>BMJ Publishing Group Ltd and British Cardiovascular Society</publisher><date type="published" when="2011-04-15">2011-04-15</date><biblScope unit="volume">97</biblScope><biblScope unit="issue">8</biblScope><biblScope unit="page" from="626">626</biblScope></imprint><idno type="ISSN">1355-6037</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">1355-6037</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Angiotensin</term><term>Angiotensin antagonist</term><term>Artery disease</term><term>Aspirin</term><term>Aspirin dose</term><term>Atherosclerotic</term><term>Atherosclerotic disease</term><term>Baseline</term><term>Baseline characteristics</term><term>Body mass index</term><term>Bristol myers squibb</term><term>Broad population</term><term>Cardiovascular</term><term>Cardiovascular death</term><term>Cardiovascular disease</term><term>Cardiovascular events</term><term>Charisma</term><term>Charisma trial</term><term>Clopidogrel</term><term>Clopidogrel group</term><term>Clopidogrel treatment</term><term>Consulting fees</term><term>Coronary artery disease</term><term>Coronary disease table</term><term>Current smoker</term><term>Diabetes mellitus</term><term>Endpoint</term><term>Engl</term><term>Heart disease</term><term>High hscrp levels</term><term>High risk</term><term>Hscrp</term><term>Hscrp levels</term><term>Hypercholesterolaemia</term><term>Hypertension</term><term>Infarction</term><term>Inhibitor medication</term><term>Ischaemic events</term><term>Lecture fees</term><term>Median</term><term>Myocardial infarction</term><term>Placebo</term><term>Placebo group</term><term>Platelet</term><term>Platelet activation</term><term>Predictive value</term><term>Previous statins</term><term>Primary endpoint</term><term>Quartile</term><term>Risk factors</term><term>Secondary prevention</term><term>Smoker</term><term>Squibb</term><term>Statin</term><term>Statin treatment</term><term>Study entry</term><term>Substudy</term><term>Treatment effect</term><term>Treatment group</term><term>Treatment groups</term><term>Unstable angina</term></keywords><keywords scheme="Teeft" xml:lang="en"><term>Angiotensin</term><term>Angiotensin antagonist</term><term>Artery disease</term><term>Aspirin</term><term>Aspirin dose</term><term>Atherosclerotic</term><term>Atherosclerotic disease</term><term>Baseline</term><term>Baseline characteristics</term><term>Body mass index</term><term>Bristol myers squibb</term><term>Broad population</term><term>Cardiovascular</term><term>Cardiovascular death</term><term>Cardiovascular disease</term><term>Cardiovascular events</term><term>Charisma</term><term>Charisma trial</term><term>Clopidogrel</term><term>Clopidogrel group</term><term>Clopidogrel treatment</term><term>Consulting fees</term><term>Coronary artery disease</term><term>Coronary disease table</term><term>Current smoker</term><term>Diabetes mellitus</term><term>Endpoint</term><term>Engl</term><term>Heart disease</term><term>High hscrp levels</term><term>High risk</term><term>Hscrp</term><term>Hscrp levels</term><term>Hypercholesterolaemia</term><term>Hypertension</term><term>Infarction</term><term>Inhibitor medication</term><term>Ischaemic events</term><term>Lecture fees</term><term>Median</term><term>Myocardial infarction</term><term>Placebo</term><term>Placebo group</term><term>Platelet</term><term>Platelet activation</term><term>Predictive value</term><term>Previous statins</term><term>Primary endpoint</term><term>Quartile</term><term>Risk factors</term><term>Secondary prevention</term><term>Smoker</term><term>Squibb</term><term>Statin</term><term>Statin treatment</term><term>Study entry</term><term>Substudy</term><term>Treatment effect</term><term>Treatment group</term><term>Treatment groups</term><term>Unstable angina</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Maladie cardio-vasculaire</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract">Aims This study investigated the effect of clopidogrel treatment on inflammatory activity as evidenced by the change in high-sensitivity C-reactive protein (hsCRP) levels in a broad population of patients who are at high risk of atherothrombotic events. The predictive value of hsCRP levels for a treatment benefit of clopidogrel was also explored. Methods The study included 8021 patients with established atherosclerotic disease or multiple cardiovascular risk factors enrolled in the CHARISMA trial. Patients were randomly assigned either to clopidogrel plus aspirin or placebo plus aspirin. HsCRP was measured at study entry and at study termination (median 28 months). The predefined primary composite endpoint was myocardial infarction, stroke, or death from cardiovascular causes. Results There was a stepwise increase in the event rate of the combined primary endpoint with increasing quartiles of hsCRP at baseline (4.0%, 6.1%, 7.4% and 8.7% for the highest quartile). In both treatment groups the changes in hsCRP levels over time were identical. In patients with low hsCRP levels (<3 mg/l) clopidogrel treatment was associated with a lower event rate compared with placebo (4.0% vs 6.0%, log rank p=0.005). In contrast no treatment effect was observed in patients with high hsCRP levels (8.1% vs 8.0%, ns). Conclusions In this broad population, hsCRP is a powerful predictor of ischaemic events. Compared with placebo, clopidogrel was without effect on inflammatory markers. The reduction in cardiovascular events by antiplatelet treatment with clopidogrel was isolated to patients with low levels of hsCRP.</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>France</li><li>Royaume-Uni</li><li>République populaire de Chine</li><li>Suisse</li><li>États-Unis</li></country><region><li>Californie</li><li>Massachusetts</li><li>Ohio</li><li>Rhode Island</li><li>Écosse</li><li>Île-de-France</li></region><settlement><li>Paris</li><li>Édimbourg</li></settlement></list><tree><country name="Allemagne"><noRegion><name sortKey="Weber, Michael" sort="Weber, Michael" uniqKey="Weber M" first="Michael" last="Weber">Michael Weber</name></noRegion><name sortKey="Hamm, Christian W" sort="Hamm, Christian W" uniqKey="Hamm C" first="Christian W" last="Hamm">Christian W. Hamm</name><name sortKey="Weber, Michael" sort="Weber, Michael" uniqKey="Weber M" first="Michael" last="Weber">Michael Weber</name></country><country name="États-Unis"><region name="Massachusetts"><name sortKey="Bhatt, Deepak L" sort="Bhatt, Deepak L" uniqKey="Bhatt D" first="Deepak L" last="Bhatt">Deepak L. Bhatt</name></region><name sortKey="Brennan, Danielle M" sort="Brennan, Danielle M" uniqKey="Brennan D" first="Danielle M" last="Brennan">Danielle M. Brennan</name><name sortKey="Easton, Donald J" sort="Easton, Donald J" uniqKey="Easton D" first="Donald J" last="Easton">Donald J. Easton</name><name sortKey="Johnston, S Claiborne" sort="Johnston, S Claiborne" uniqKey="Johnston S" first="S Claiborne" last="Johnston">S Claiborne Johnston</name><name sortKey="Topol, Eric J" sort="Topol, Eric J" uniqKey="Topol E" first="Eric J" last="Topol">Eric J. Topol</name></country><country name="Australie"><noRegion><name sortKey="Hankey, Graeme J" sort="Hankey, Graeme J" uniqKey="Hankey G" first="Graeme J" last="Hankey">Graeme J. Hankey</name></noRegion></country><country name="Suisse"><noRegion><name sortKey="Steinhubl, Steven R" sort="Steinhubl, Steven R" uniqKey="Steinhubl S" first="Steven R" last="Steinhubl">Steven R. Steinhubl</name></noRegion></country><country name="France"><region name="Île-de-France"><name sortKey="Montalescot, Gilles" sort="Montalescot, Gilles" uniqKey="Montalescot G" first="Gilles" last="Montalescot">Gilles Montalescot</name></region></country><country name="République populaire de Chine"><noRegion><name sortKey="Mak, Koon Hou" sort="Mak, Koon Hou" uniqKey="Mak K" first="Koon-Hou" last="Mak">Koon-Hou Mak</name></noRegion></country><country name="Royaume-Uni"><region name="Écosse"><name sortKey="Fox, Keith A A" sort="Fox, Keith A A" uniqKey="Fox K" first="Keith A A" last="Fox">Keith A A. 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