Bleeding complications with the P2Y12 receptor antagonists clopidogrel and ticagrelor in the PLATelet inhibition and patient Outcomes (PLATO) trial

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 AND RESULTS PLATO was a randomize...

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Published in:	European heart journal Vol. 32; no. 23; p. 2933
Main Authors:	Becker, Richard C, Bassand, Jean Pierre, Budaj, Andrzej, Wojdyla, Daniel M, James, Stefan K, Cornel, Jan H, French, John, Held, Claes, Horrow, Jay, Husted, Steen, Lopez-Sendon, Jose, Lassila, Riitta, Mahaffey, Kenneth W, Storey, Robert F, Harrington, Robert A, Wallentin, Lars
Format:	Journal Article
Language:	English
Published:	England 01.12.2011
Subjects:	Acute Coronary Syndrome - mortality Acute Coronary Syndrome - prevention & control Adenosine - adverse effects Adenosine - analogs & derivatives Aged Aspirin - therapeutic use Coronary Artery Bypass - adverse effects Coronary Artery Bypass - mortality Double-Blind Method Female Hemorrhage - chemically induced Humans Male Middle Aged Platelet Aggregation Inhibitors - adverse effects Purinergic P2 Receptor Antagonists - adverse effects Stroke - chemically induced Ticlopidine - adverse effects Ticlopidine - analogs & derivatives Treatment Outcome
ISSN:	1522-9645, 1522-9645
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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 AND RESULTS PLATO was a randomized, double-blind, active control international, phase 3 clinical trial in patients with acute ST elevation and non-ST-segment elevation ACS. A total of 18 624 patients were randomized to either ticagrelor, a non-thienopyridine, reversibly binding platelet P2Y(12) 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-related major bleeding, primarily after 30 days on study drug treatment. Fatal bleeding was low and did not differ between groups.
AbstractList	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 AND RESULTS PLATO was a randomized, double-blind, active control international, phase 3 clinical trial in patients with acute ST elevation and non-ST-segment elevation ACS. A total of 18 624 patients were randomized to either ticagrelor, a non-thienopyridine, reversibly binding platelet P2Y(12) 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-related major bleeding, primarily after 30 days on study drug treatment. Fatal bleeding was low and did not differ between groups. 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 AND RESULTS PLATO was a randomized, double-blind, active control international, phase 3 clinical trial in patients with acute ST elevation and non-ST-segment elevation ACS. A total of 18 624 patients were randomized to either ticagrelor, a non-thienopyridine, reversibly binding platelet P2Y(12) 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-related major bleeding, primarily after 30 days on study drug treatment. Fatal bleeding was low and did not differ between groups.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 AND RESULTS PLATO was a randomized, double-blind, active control international, phase 3 clinical trial in patients with acute ST elevation and non-ST-segment elevation ACS. A total of 18 624 patients were randomized to either ticagrelor, a non-thienopyridine, reversibly binding platelet P2Y(12) 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-related major bleeding, primarily after 30 days on study drug treatment. Fatal bleeding was low and did not differ between groups.
Author	Lassila, Riitta Lopez-Sendon, Jose Mahaffey, Kenneth W Bassand, Jean Pierre James, Stefan K Becker, Richard C Held, Claes Harrington, Robert A Wallentin, Lars Husted, Steen Horrow, Jay Budaj, Andrzej Cornel, Jan H French, John Storey, Robert F Wojdyla, Daniel M
Author_xml	– sequence: 1 givenname: Richard C surname: Becker fullname: Becker, Richard C email: becke021@mc.duke.edu organization: Duke University School of Medicine, Duke Clinical Research Institute, Durham, NC 27715, USA. becke021@mc.duke.edu – sequence: 2 givenname: Jean Pierre surname: Bassand fullname: Bassand, Jean Pierre – sequence: 3 givenname: Andrzej surname: Budaj fullname: Budaj, Andrzej – sequence: 4 givenname: Daniel M surname: Wojdyla fullname: Wojdyla, Daniel M – sequence: 5 givenname: Stefan K surname: James fullname: James, Stefan K – sequence: 6 givenname: Jan H surname: Cornel fullname: Cornel, Jan H – sequence: 7 givenname: John surname: French fullname: French, John – sequence: 8 givenname: Claes surname: Held fullname: Held, Claes – sequence: 9 givenname: Jay surname: Horrow fullname: Horrow, Jay – sequence: 10 givenname: Steen surname: Husted fullname: Husted, Steen – sequence: 11 givenname: Jose surname: Lopez-Sendon fullname: Lopez-Sendon, Jose – sequence: 12 givenname: Riitta surname: Lassila fullname: Lassila, Riitta – sequence: 13 givenname: Kenneth W surname: Mahaffey fullname: Mahaffey, Kenneth W – sequence: 14 givenname: Robert F surname: Storey fullname: Storey, Robert F – sequence: 15 givenname: Robert A surname: Harrington fullname: Harrington, Robert A – sequence: 16 givenname: Lars surname: Wallentin fullname: Wallentin, Lars
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/22090660$$D View this record in MEDLINE/PubMed
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PublicationTitle	European heart journal
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References	Eur Heart J. 2012 Nov;33(21):2750 22096089 - Eur Heart J. 2011 Dec;32(23):2919-21
References_xml	– reference: - Eur Heart J. 2012 Nov;33(21):2750 – reference: 22096089 - Eur Heart J. 2011 Dec;32(23):2919-21
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Snippet	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...
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SubjectTerms	Acute Coronary Syndrome - mortality Acute Coronary Syndrome - prevention & control Adenosine - adverse effects Adenosine - analogs & derivatives Aged Aspirin - therapeutic use Coronary Artery Bypass - adverse effects Coronary Artery Bypass - mortality Double-Blind Method Female Hemorrhage - chemically induced Humans Male Middle Aged Platelet Aggregation Inhibitors - adverse effects Purinergic P2 Receptor Antagonists - adverse effects Stroke - chemically induced Ticlopidine - adverse effects Ticlopidine - analogs & derivatives Treatment Outcome
Title	Bleeding complications with the P2Y12 receptor antagonists clopidogrel and ticagrelor in the PLATelet inhibition and patient Outcomes (PLATO) trial
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