Objective: To compare hemorrhagic events between clopidogrel and ticagrelor in the Platelet Inhibition and Patient Outcomes (PLATO) trial. Methods: We examined the FDA Medical Review. Results: Compared to clopidogrel, ticagrelor significantly increased spontaneous bleeds, major bleeds, major plus minor bleeds, and major plus minor plus minimal bleeds. Ticagrelor also increased both major and fatal/life-threatening bleeds versus clopidogrel when CABG was performed between 24 and 96 h after stopping medication, which was also accompanied by a larger volume of chest tube drainage and transfusions. Moreover, ticagrelor increased CABG-related bleeding versus clopidogrel in those patients who did not wait until day 5 after stopping treatment to have CABG. Additionally, compared to clopidogrel, ticagrelor increased the risk of hematuria (RR = 1.91; 95% CI: 0.95-3.83), intracranial hemorrhage or subdural or other hematoma (RR 1.87; 95% CI: 1.02-3.42), subcutaneous hemorrhage, ecchymosis, hematoma (RR = 1.63; 95% CI: 0.84-3.17), epistaxis (RR = 1.49; 95% CI: 0.67-3.32), retroperitoneal hematoma or hemorrhage (RR = 1.49; 95% CI: 0.53-4.19), gastrointestinal/anal bleed (RR = 1.23; 95% CI: 0.93-1.64) and bleed/hematoma (RR = 1.21, 95% CI: 1.02-1.43). Conclusions: Clopidogrel is safer than ticagrelor in regard to bleeding. Additionally, ticagrelor's purported faster antiplatelet 'offset' is substantially longer than its pharmacokinetics indicate. Considering the fact that the mortality, stent thrombosis and myocardial infarction 'benefit' of ticagrelor have recently been challenged, and that the increase in stroke on ticagrelor has recently been shown to be worse than originally published, the decision to use ticagrelor over clopidogrel in the face of a higher risk for bleeds is not advised. (C) 2013 Elsevier Ireland Ltd. All rights reserved.

Clopidogrel is safer than ticagrelor in regard to bleeds: A closer look at the PLATO trial / James J., Dinicolantonio; Fabrizio, D'Ascenzo; Ales, Tomek; Saurav, Chatterjee; Asfandyar K., Niazi; BIONDI ZOCCAI, Giuseppe. - In: INTERNATIONAL JOURNAL OF CARDIOLOGY. - ISSN 0167-5273. - STAMPA. - 168:3(2013), pp. 1739-1744. [10.1016/j.ijcard.2013.06.135]

Clopidogrel is safer than ticagrelor in regard to bleeds: A closer look at the PLATO trial

BIONDI ZOCCAI, GIUSEPPE
2013

Abstract

Objective: To compare hemorrhagic events between clopidogrel and ticagrelor in the Platelet Inhibition and Patient Outcomes (PLATO) trial. Methods: We examined the FDA Medical Review. Results: Compared to clopidogrel, ticagrelor significantly increased spontaneous bleeds, major bleeds, major plus minor bleeds, and major plus minor plus minimal bleeds. Ticagrelor also increased both major and fatal/life-threatening bleeds versus clopidogrel when CABG was performed between 24 and 96 h after stopping medication, which was also accompanied by a larger volume of chest tube drainage and transfusions. Moreover, ticagrelor increased CABG-related bleeding versus clopidogrel in those patients who did not wait until day 5 after stopping treatment to have CABG. Additionally, compared to clopidogrel, ticagrelor increased the risk of hematuria (RR = 1.91; 95% CI: 0.95-3.83), intracranial hemorrhage or subdural or other hematoma (RR 1.87; 95% CI: 1.02-3.42), subcutaneous hemorrhage, ecchymosis, hematoma (RR = 1.63; 95% CI: 0.84-3.17), epistaxis (RR = 1.49; 95% CI: 0.67-3.32), retroperitoneal hematoma or hemorrhage (RR = 1.49; 95% CI: 0.53-4.19), gastrointestinal/anal bleed (RR = 1.23; 95% CI: 0.93-1.64) and bleed/hematoma (RR = 1.21, 95% CI: 1.02-1.43). Conclusions: Clopidogrel is safer than ticagrelor in regard to bleeding. Additionally, ticagrelor's purported faster antiplatelet 'offset' is substantially longer than its pharmacokinetics indicate. Considering the fact that the mortality, stent thrombosis and myocardial infarction 'benefit' of ticagrelor have recently been challenged, and that the increase in stroke on ticagrelor has recently been shown to be worse than originally published, the decision to use ticagrelor over clopidogrel in the face of a higher risk for bleeds is not advised. (C) 2013 Elsevier Ireland Ltd. All rights reserved.
File allegati a questo prodotto
Non ci sono file associati a questo prodotto.

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/525095
 Attenzione

Attenzione! I dati visualizzati non sono stati sottoposti a validazione da parte dell'ateneo

Citazioni
  • ???jsp.display-item.citation.pmc??? 15
  • Scopus 50
  • ???jsp.display-item.citation.isi??? 44
social impact