Bleeding complications with the P2Y12 receptor antagonists clopidogrel and ticagrelor in the PLATelet inhibition and patient Outcomes (PLATO) trial
Identifieur interne : 006C98 ( Main/Exploration ); précédent : 006C97; suivant : 006C99Bleeding complications with the P2Y12 receptor antagonists clopidogrel and ticagrelor in the PLATelet inhibition and patient Outcomes (PLATO) trial
Auteurs : Richard C. Becker [États-Unis] ; Jean Pierre Bassand [France] ; Andrzej Budaj [Pologne] ; Daniel M. Wojdyla [États-Unis] ; Stefan K. James [Suède] ; Jan H. Corner [Pays-Bas] ; John French [Australie] ; Claes Held [Suède] ; Jay Horrow [États-Unis] ; Steen Husted [Danemark] ; Jose Lopez-Sendon [Espagne] ; Riitta Lassila [Finlande] ; Kenneth W. Mahaffey [États-Unis] ; Robert F. Storey [Royaume-Uni] ; Robert A. Harrington [États-Unis] ; Lars Wallentin [Suède]Source :
- European heart journal [ 0195-668X ] ; 2011.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
English descriptors
- KwdEn :
Abstract
Aims More intense platelet-directed therapy for acute coronary syndrome (ACS) may increase bleeding risk. The aim of the current analysis was to determine the rate, clinical impact, and predictors of major and fatal bleeding complications in the PLATO study. Methods PLATO was a randomized, double-blind, active control international, phase 3 clinical trial in patients with acute ST and results elevation and non-ST-segment elevation ACS. A total of 18 624 patients were randomized to either ticagrelor, a nonthienopyridine, reversibly binding platelet P2Y12 receptor antagonist, or clopidogrel in addition to aspirin. Patients randomized to ticagrelor and clopidogrel had similar rates of PLATO major bleeding (11.6 vs. 11.2%; P=0.43). TIMI major bleeding (7.9 vs. 7.7%, P = 0.56) and GUSTO severe bleeding (2.9 vs. 3.1%, P = 0.22). Procedure-related bleeding rates were also similar. Non-CABG major bleeding (4.5 vs. 3.8%, P = 0.02) and non-procedure-related major bleeding (3.1 vs. 2.3%, P = 0.05) were more common in ticagrelor-treated patients, primarily after 30 days on treatment. Fatal bleeding and transfusion rates did not differ between groups. There were no significant interactions for major bleeding or combined minor plus major bleeding between treatment groups and age ≥75 years, weight <60 kg, region, chronic kidney disease, creatinine clearance <60 mL/min, aspirin dose >325 mg on the day of randomization, pre-randomization clopidogrel administration, or clopidogrel loading dose. Conclusion Ticagrelor compared with clopidogrel was associated with similar total major bleeding but increased non-CABG and non-procedure-retated major bleeding, primarily after 30 days on study drug treatment. Fatal bleeding was low and did not differ between groups.
Affiliations:
- Australie, Danemark, Espagne, Finlande, France, Pays-Bas, Pologne, Royaume-Uni, Suède, États-Unis
- Bourgogne-Franche-Comté, Communauté de Madrid, East Middle Sweden, Franche-Comté, Nouvelle-Galles du Sud, Svealand
- Besançon, Madrid, Sydney, Uppsala
- Université d'Uppsala
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">Bleeding complications with the P<sub>2</sub>Y<sub>12</sub> receptor antagonists clopidogrel and ticagrelor in the PLATelet inhibition and patient Outcomes (PLATO) trial</title><author><name sortKey="Becker, Richard C" sort="Becker, Richard C" uniqKey="Becker R" first="Richard C." last="Becker">Richard C. Becker</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Duke University School of Medicine, Duke Clinical Research Institute, 2400 Pratt Street</s1><s2>Durham, NC 27715</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>4 aut.</sZ><sZ>13 aut.</sZ><sZ>15 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Durham, NC 27715</wicri:noRegion></affiliation></author><author><name sortKey="Pierre Bassand, Jean" sort="Pierre Bassand, Jean" uniqKey="Pierre Bassand J" first="Jean" last="Pierre Bassand">Jean Pierre Bassand</name><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>University of Besançon</s1><s2>Besançon</s2><s3>FRA</s3><sZ>2 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Bourgogne-Franche-Comté</region><region type="old region">Franche-Comté</region><settlement type="city">Besançon</settlement></placeName></affiliation></author><author><name sortKey="Budaj, Andrzej" sort="Budaj, Andrzej" uniqKey="Budaj A" first="Andrzej" last="Budaj">Andrzej Budaj</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Post-Graduate Medical School, Department of Cardiology, Grochowski Hospital</s1><s2>Warsaw</s2><s3>POL</s3><sZ>3 aut.</sZ></inist:fA14><country>Pologne</country><wicri:noRegion>Warsaw</wicri:noRegion></affiliation></author><author><name sortKey="Wojdyla, Daniel M" sort="Wojdyla, Daniel M" uniqKey="Wojdyla D" first="Daniel M." last="Wojdyla">Daniel M. Wojdyla</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Duke University School of Medicine, Duke Clinical Research Institute, 2400 Pratt Street</s1><s2>Durham, NC 27715</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>4 aut.</sZ><sZ>13 aut.</sZ><sZ>15 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Durham, NC 27715</wicri:noRegion></affiliation></author><author><name sortKey="James, Stefan K" sort="James, Stefan K" uniqKey="James S" first="Stefan K." last="James">Stefan K. James</name><affiliation wicri:level="4"><inist:fA14 i1="04"><s1>Uppsala Clinical Research Centre, Uppsala University</s1><s2>Uppsala</s2><s3>SWE</s3><sZ>5 aut.</sZ><sZ>8 aut.</sZ><sZ>16 aut.</sZ></inist:fA14><country>Suède</country><placeName><settlement type="city">Uppsala</settlement><region nuts="1">Svealand</region><region nuts="1">East Middle Sweden</region></placeName><orgName type="university">Université d'Uppsala</orgName></affiliation></author><author><name sortKey="Corner, Jan H" sort="Corner, Jan H" uniqKey="Corner J" first="Jan H." last="Corner">Jan H. Corner</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Medisch Centrum Alkmaar</s1><s2>Alkmaar</s2><s3>NLD</s3><sZ>6 aut.</sZ></inist:fA14><country>Pays-Bas</country><wicri:noRegion>Medisch Centrum Alkmaar</wicri:noRegion></affiliation></author><author><name sortKey="French, John" sort="French, John" uniqKey="French J" first="John" last="French">John French</name><affiliation wicri:level="3"><inist:fA14 i1="06"><s1>Liverpool Hospital</s1><s2>Sydney</s2><s3>AUS</s3><sZ>7 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation></author><author><name sortKey="Held, Claes" sort="Held, Claes" uniqKey="Held C" first="Claes" last="Held">Claes Held</name><affiliation wicri:level="4"><inist:fA14 i1="04"><s1>Uppsala Clinical Research Centre, Uppsala University</s1><s2>Uppsala</s2><s3>SWE</s3><sZ>5 aut.</sZ><sZ>8 aut.</sZ><sZ>16 aut.</sZ></inist:fA14><country>Suède</country><placeName><settlement type="city">Uppsala</settlement><region nuts="1">Svealand</region><region nuts="1">East Middle Sweden</region></placeName><orgName type="university">Université d'Uppsala</orgName></affiliation></author><author><name sortKey="Horrow, Jay" sort="Horrow, Jay" uniqKey="Horrow J" first="Jay" last="Horrow">Jay Horrow</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>AstraZeneca Research and Development</s1><s2>Wilmington, DE</s2><s3>USA</s3><sZ>9 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>AstraZeneca Research and Development</wicri:noRegion></affiliation></author><author><name sortKey="Husted, Steen" sort="Husted, Steen" uniqKey="Husted S" first="Steen" last="Husted">Steen Husted</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Århus Univeristy Hospital</s1><s2>Århus</s2><s3>DNK</s3><sZ>10 aut.</sZ></inist:fA14><country>Danemark</country><wicri:noRegion>Århus Univeristy Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Lopez Sendon, Jose" sort="Lopez Sendon, Jose" uniqKey="Lopez Sendon J" first="Jose" last="Lopez-Sendon">Jose Lopez-Sendon</name><affiliation wicri:level="3"><inist:fA14 i1="09"><s1>Cardiology Department, Universidad Autonoma de Madrid, Hospital Universitario La Paz</s1><s2>Madrid</s2><s3>ESP</s3><sZ>11 aut.</sZ></inist:fA14><country>Espagne</country><placeName><settlement type="city">Madrid</settlement><region nuts="2" type="region">Communauté de Madrid</region></placeName></affiliation></author><author><name sortKey="Lassila, Riitta" sort="Lassila, Riitta" uniqKey="Lassila R" first="Riitta" last="Lassila">Riitta Lassila</name><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Helsinki University Central Hospital Division of Hematology and Laboratory Services Coagulation Disorders</s1><s2>Helsinki</s2><s3>FIN</s3><sZ>12 aut.</sZ></inist:fA14><country>Finlande</country><wicri:noRegion>Helsinki University Central Hospital Division of Hematology and Laboratory Services Coagulation Disorders</wicri:noRegion></affiliation></author><author><name sortKey="Mahaffey, Kenneth W" sort="Mahaffey, Kenneth W" uniqKey="Mahaffey K" first="Kenneth W." last="Mahaffey">Kenneth W. 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Harrington</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Duke University School of Medicine, Duke Clinical Research Institute, 2400 Pratt Street</s1><s2>Durham, NC 27715</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>4 aut.</sZ><sZ>13 aut.</sZ><sZ>15 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Durham, NC 27715</wicri:noRegion></affiliation></author><author><name sortKey="Wallentin, Lars" sort="Wallentin, Lars" uniqKey="Wallentin L" first="Lars" last="Wallentin">Lars Wallentin</name><affiliation wicri:level="4"><inist:fA14 i1="04"><s1>Uppsala Clinical Research Centre, Uppsala University</s1><s2>Uppsala</s2><s3>SWE</s3><sZ>5 aut.</sZ><sZ>8 aut.</sZ><sZ>16 aut.</sZ></inist:fA14><country>Suède</country><placeName><settlement type="city">Uppsala</settlement><region nuts="1">Svealand</region><region nuts="1">East Middle Sweden</region></placeName><orgName type="university">Université d'Uppsala</orgName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">12-0014256</idno><date when="2011">2011</date><idno type="stanalyst">PASCAL 12-0014256 INIST</idno><idno type="RBID">Pascal:12-0014256</idno><idno type="wicri:Area/PascalFrancis/Corpus">001744</idno><idno type="wicri:Area/PascalFrancis/Curation">004765</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">001D07</idno><idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">001D07</idno><idno type="wicri:doubleKey">0195-668X:2011:Becker R:bleeding:complications:with</idno><idno type="wicri:Area/Main/Merge">007158</idno><idno type="wicri:Area/Main/Curation">006C98</idno><idno type="wicri:Area/Main/Exploration">006C98</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Bleeding complications with the P<sub>2</sub>Y<sub>12</sub> receptor antagonists clopidogrel and ticagrelor in the PLATelet inhibition and patient Outcomes (PLATO) trial</title><author><name sortKey="Becker, Richard C" sort="Becker, Richard C" uniqKey="Becker R" first="Richard C." last="Becker">Richard C. Becker</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Duke University School of Medicine, Duke Clinical Research Institute, 2400 Pratt Street</s1><s2>Durham, NC 27715</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>4 aut.</sZ><sZ>13 aut.</sZ><sZ>15 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Durham, NC 27715</wicri:noRegion></affiliation></author><author><name sortKey="Pierre Bassand, Jean" sort="Pierre Bassand, Jean" uniqKey="Pierre Bassand J" first="Jean" last="Pierre Bassand">Jean Pierre Bassand</name><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>University of Besançon</s1><s2>Besançon</s2><s3>FRA</s3><sZ>2 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Bourgogne-Franche-Comté</region><region type="old region">Franche-Comté</region><settlement type="city">Besançon</settlement></placeName></affiliation></author><author><name sortKey="Budaj, Andrzej" sort="Budaj, Andrzej" uniqKey="Budaj A" first="Andrzej" last="Budaj">Andrzej Budaj</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Post-Graduate Medical School, Department of Cardiology, Grochowski Hospital</s1><s2>Warsaw</s2><s3>POL</s3><sZ>3 aut.</sZ></inist:fA14><country>Pologne</country><wicri:noRegion>Warsaw</wicri:noRegion></affiliation></author><author><name sortKey="Wojdyla, Daniel M" sort="Wojdyla, Daniel M" uniqKey="Wojdyla D" first="Daniel M." last="Wojdyla">Daniel M. Wojdyla</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Duke University School of Medicine, Duke Clinical Research Institute, 2400 Pratt Street</s1><s2>Durham, NC 27715</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>4 aut.</sZ><sZ>13 aut.</sZ><sZ>15 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Durham, NC 27715</wicri:noRegion></affiliation></author><author><name sortKey="James, Stefan K" sort="James, Stefan K" uniqKey="James S" first="Stefan K." last="James">Stefan K. James</name><affiliation wicri:level="4"><inist:fA14 i1="04"><s1>Uppsala Clinical Research Centre, Uppsala University</s1><s2>Uppsala</s2><s3>SWE</s3><sZ>5 aut.</sZ><sZ>8 aut.</sZ><sZ>16 aut.</sZ></inist:fA14><country>Suède</country><placeName><settlement type="city">Uppsala</settlement><region nuts="1">Svealand</region><region nuts="1">East Middle Sweden</region></placeName><orgName type="university">Université d'Uppsala</orgName></affiliation></author><author><name sortKey="Corner, Jan H" sort="Corner, Jan H" uniqKey="Corner J" first="Jan H." last="Corner">Jan H. Corner</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Medisch Centrum Alkmaar</s1><s2>Alkmaar</s2><s3>NLD</s3><sZ>6 aut.</sZ></inist:fA14><country>Pays-Bas</country><wicri:noRegion>Medisch Centrum Alkmaar</wicri:noRegion></affiliation></author><author><name sortKey="French, John" sort="French, John" uniqKey="French J" first="John" last="French">John French</name><affiliation wicri:level="3"><inist:fA14 i1="06"><s1>Liverpool Hospital</s1><s2>Sydney</s2><s3>AUS</s3><sZ>7 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation></author><author><name sortKey="Held, Claes" sort="Held, Claes" uniqKey="Held C" first="Claes" last="Held">Claes Held</name><affiliation wicri:level="4"><inist:fA14 i1="04"><s1>Uppsala Clinical Research Centre, Uppsala University</s1><s2>Uppsala</s2><s3>SWE</s3><sZ>5 aut.</sZ><sZ>8 aut.</sZ><sZ>16 aut.</sZ></inist:fA14><country>Suède</country><placeName><settlement type="city">Uppsala</settlement><region nuts="1">Svealand</region><region nuts="1">East Middle Sweden</region></placeName><orgName type="university">Université d'Uppsala</orgName></affiliation></author><author><name sortKey="Horrow, Jay" sort="Horrow, Jay" uniqKey="Horrow J" first="Jay" last="Horrow">Jay Horrow</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>AstraZeneca Research and Development</s1><s2>Wilmington, DE</s2><s3>USA</s3><sZ>9 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>AstraZeneca Research and Development</wicri:noRegion></affiliation></author><author><name sortKey="Husted, Steen" sort="Husted, Steen" uniqKey="Husted S" first="Steen" last="Husted">Steen Husted</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Århus Univeristy Hospital</s1><s2>Århus</s2><s3>DNK</s3><sZ>10 aut.</sZ></inist:fA14><country>Danemark</country><wicri:noRegion>Århus Univeristy Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Lopez Sendon, Jose" sort="Lopez Sendon, Jose" uniqKey="Lopez Sendon J" first="Jose" last="Lopez-Sendon">Jose Lopez-Sendon</name><affiliation wicri:level="3"><inist:fA14 i1="09"><s1>Cardiology Department, Universidad Autonoma de Madrid, Hospital Universitario La Paz</s1><s2>Madrid</s2><s3>ESP</s3><sZ>11 aut.</sZ></inist:fA14><country>Espagne</country><placeName><settlement type="city">Madrid</settlement><region nuts="2" type="region">Communauté de Madrid</region></placeName></affiliation></author><author><name sortKey="Lassila, Riitta" sort="Lassila, Riitta" uniqKey="Lassila R" first="Riitta" last="Lassila">Riitta Lassila</name><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Helsinki University Central Hospital Division of Hematology and Laboratory Services Coagulation Disorders</s1><s2>Helsinki</s2><s3>FIN</s3><sZ>12 aut.</sZ></inist:fA14><country>Finlande</country><wicri:noRegion>Helsinki University Central Hospital Division of Hematology and Laboratory Services Coagulation Disorders</wicri:noRegion></affiliation></author><author><name sortKey="Mahaffey, Kenneth W" sort="Mahaffey, Kenneth W" uniqKey="Mahaffey K" first="Kenneth W." last="Mahaffey">Kenneth W. Mahaffey</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Duke University School of Medicine, Duke Clinical Research Institute, 2400 Pratt Street</s1><s2>Durham, NC 27715</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>4 aut.</sZ><sZ>13 aut.</sZ><sZ>15 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Durham, NC 27715</wicri:noRegion></affiliation></author><author><name sortKey="Storey, Robert F" sort="Storey, Robert F" uniqKey="Storey R" first="Robert F." last="Storey">Robert F. Storey</name><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Department of Cardiovascular Science, University of Sheffield</s1><s2>Sheffield</s2><s3>GBR</s3><sZ>14 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Sheffield</wicri:noRegion></affiliation></author><author><name sortKey="Harrington, Robert A" sort="Harrington, Robert A" uniqKey="Harrington R" first="Robert A." last="Harrington">Robert A. Harrington</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Duke University School of Medicine, Duke Clinical Research Institute, 2400 Pratt Street</s1><s2>Durham, NC 27715</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>4 aut.</sZ><sZ>13 aut.</sZ><sZ>15 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Durham, NC 27715</wicri:noRegion></affiliation></author><author><name sortKey="Wallentin, Lars" sort="Wallentin, Lars" uniqKey="Wallentin L" first="Lars" last="Wallentin">Lars Wallentin</name><affiliation wicri:level="4"><inist:fA14 i1="04"><s1>Uppsala Clinical Research Centre, Uppsala University</s1><s2>Uppsala</s2><s3>SWE</s3><sZ>5 aut.</sZ><sZ>8 aut.</sZ><sZ>16 aut.</sZ></inist:fA14><country>Suède</country><placeName><settlement type="city">Uppsala</settlement><region nuts="1">Svealand</region><region nuts="1">East Middle Sweden</region></placeName><orgName type="university">Université d'Uppsala</orgName></affiliation></author></analytic><series><title level="j" type="main">European heart journal</title><title level="j" type="abbreviated">Eur. heart j.</title><idno type="ISSN">0195-668X</idno><imprint><date when="2011">2011</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">European heart journal</title><title level="j" type="abbreviated">Eur. heart j.</title><idno type="ISSN">0195-668X</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Acute coronary syndrome</term><term>Antagonist</term><term>Antiplatelet agent</term><term>Biological receptor</term><term>Cardiology</term><term>Circulatory system</term><term>Clopidogrel</term><term>Complication</term><term>Hemorrhage</term><term>Human</term><term>Inhibition</term><term>Patient</term><term>Platelet</term><term>Prognosis</term><term>Ticagrelor</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Hémorragie</term><term>Complication</term><term>Récepteur biologique</term><term>Antagoniste</term><term>Clopidogrel</term><term>Inhibiteur thromboagrégation</term><term>Ticagrélor</term><term>Thrombocyte</term><term>Inhibition</term><term>Homme</term><term>Malade</term><term>Pronostic</term><term>Appareil circulatoire</term><term>Cardiologie</term><term>Syndrome coronaire aigu</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Aims More intense platelet-directed therapy for acute coronary syndrome (ACS) may increase bleeding risk. The aim of the current analysis was to determine the rate, clinical impact, and predictors of major and fatal bleeding complications in the PLATO study. Methods PLATO was a randomized, double-blind, active control international, phase 3 clinical trial in patients with acute ST and results elevation and non-ST-segment elevation ACS. A total of 18 624 patients were randomized to either ticagrelor, a nonthienopyridine, reversibly binding platelet P2Y<sub>12</sub> receptor antagonist, or clopidogrel in addition to aspirin. Patients randomized to ticagrelor and clopidogrel had similar rates of PLATO major bleeding (11.6 vs. 11.2%; P=0.43). TIMI major bleeding (7.9 vs. 7.7%, P = 0.56) and GUSTO severe bleeding (2.9 vs. 3.1%, P = 0.22). Procedure-related bleeding rates were also similar. Non-CABG major bleeding (4.5 vs. 3.8%, P = 0.02) and non-procedure-related major bleeding (3.1 vs. 2.3%, P = 0.05) were more common in ticagrelor-treated patients, primarily after 30 days on treatment. Fatal bleeding and transfusion rates did not differ between groups. There were no significant interactions for major bleeding or combined minor plus major bleeding between treatment groups and age ≥75 years, weight <60 kg, region, chronic kidney disease, creatinine clearance <60 mL/min, aspirin dose >325 mg on the day of randomization, pre-randomization clopidogrel administration, or clopidogrel loading dose. Conclusion Ticagrelor compared with clopidogrel was associated with similar total major bleeding but increased non-CABG and non-procedure-retated major bleeding, primarily after 30 days on study drug treatment. Fatal bleeding was low and did not differ between groups.</div></front></TEI><affiliations><list><country><li>Australie</li><li>Danemark</li><li>Espagne</li><li>Finlande</li><li>France</li><li>Pays-Bas</li><li>Pologne</li><li>Royaume-Uni</li><li>Suède</li><li>États-Unis</li></country><region><li>Bourgogne-Franche-Comté</li><li>Communauté de Madrid</li><li>East Middle Sweden</li><li>Franche-Comté</li><li>Nouvelle-Galles du Sud</li><li>Svealand</li></region><settlement><li>Besançon</li><li>Madrid</li><li>Sydney</li><li>Uppsala</li></settlement><orgName><li>Université d'Uppsala</li></orgName></list><tree><country name="États-Unis"><noRegion><name sortKey="Becker, Richard C" sort="Becker, Richard C" uniqKey="Becker R" first="Richard C." last="Becker">Richard C. Becker</name></noRegion><name sortKey="Harrington, Robert A" sort="Harrington, Robert A" uniqKey="Harrington R" first="Robert A." last="Harrington">Robert A. Harrington</name><name sortKey="Horrow, Jay" sort="Horrow, Jay" uniqKey="Horrow J" first="Jay" last="Horrow">Jay Horrow</name><name sortKey="Mahaffey, Kenneth W" sort="Mahaffey, Kenneth W" uniqKey="Mahaffey K" first="Kenneth W." last="Mahaffey">Kenneth W. Mahaffey</name><name sortKey="Wojdyla, Daniel M" sort="Wojdyla, Daniel M" uniqKey="Wojdyla D" first="Daniel M." last="Wojdyla">Daniel M. Wojdyla</name></country><country name="France"><region name="Bourgogne-Franche-Comté"><name sortKey="Pierre Bassand, Jean" sort="Pierre Bassand, Jean" uniqKey="Pierre Bassand J" first="Jean" last="Pierre Bassand">Jean Pierre Bassand</name></region></country><country name="Pologne"><noRegion><name sortKey="Budaj, Andrzej" sort="Budaj, Andrzej" uniqKey="Budaj A" first="Andrzej" last="Budaj">Andrzej Budaj</name></noRegion></country><country name="Suède"><region name="Svealand"><name sortKey="James, Stefan K" sort="James, Stefan K" uniqKey="James S" first="Stefan K." last="James">Stefan K. James</name></region><name sortKey="Held, Claes" sort="Held, Claes" uniqKey="Held C" first="Claes" last="Held">Claes Held</name><name sortKey="Wallentin, Lars" sort="Wallentin, Lars" uniqKey="Wallentin L" first="Lars" last="Wallentin">Lars Wallentin</name></country><country name="Pays-Bas"><noRegion><name sortKey="Corner, Jan H" sort="Corner, Jan H" uniqKey="Corner J" first="Jan H." last="Corner">Jan H. Corner</name></noRegion></country><country name="Australie"><region name="Nouvelle-Galles du Sud"><name sortKey="French, John" sort="French, John" uniqKey="French J" first="John" last="French">John French</name></region></country><country name="Danemark"><noRegion><name sortKey="Husted, Steen" sort="Husted, Steen" uniqKey="Husted S" first="Steen" last="Husted">Steen Husted</name></noRegion></country><country name="Espagne"><region name="Communauté de Madrid"><name sortKey="Lopez Sendon, Jose" sort="Lopez Sendon, Jose" uniqKey="Lopez Sendon J" first="Jose" last="Lopez-Sendon">Jose Lopez-Sendon</name></region></country><country name="Finlande"><noRegion><name sortKey="Lassila, Riitta" sort="Lassila, Riitta" uniqKey="Lassila R" first="Riitta" last="Lassila">Riitta Lassila</name></noRegion></country><country name="Royaume-Uni"><noRegion><name sortKey="Storey, Robert F" sort="Storey, Robert F" uniqKey="Storey R" first="Robert F." last="Storey">Robert F. 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