When choosing an OAP, consider these select differences
*PLATO included both medical and invasive (PCI or CABG) treatment approaches. Patients who received fibrinolytic therapy within the previous 24 hours or who had a need for chronic oral anticoagulation therapy were excluded.5
†Clopidogrel is not indicated in patients with acute ischemic stroke. Clopidogrel is only indicated in patients with established peripheral arterial disease or with a history of recent myocardial infarction (MI) or recent stroke.2
‡CYP3A4 is the major enzyme responsible for ticagrelor metabolism and the formation of its major active metabolite.1
§CYP2C19 poor metabolizers are defined as patients who are homozygous for nonfunctional alleles (ie, 2 loss-of-function alleles) of the CYP2C19 gene. In a genetic substudy cohort of PLATO, the risk of thrombotic CV events in the BRILINTA arm did not depend on CYP2C19 loss of function status.1
FDA narrowed the ACS indication for clopidogrel4
- FDA has removed the reduction of CV death and death from the ACS indication for Plavix® (clopidogrel bisulfate) tablets
- Plavix is not indicated in patients with STEMI undergoing PCI
2016 revisions to Plavix ACS indications‖
Plavix is indicated to reduce the rate of myocardial infarction and stroke For in patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)], including patients who are to be managed medically and those who are to be managed with coronary revascularization. Plavix should be administered in conjunction with aspirin. Plavix has been shown to decrease the rate of a combined endpoint of cardiovascular death, myocardial infarction (MI), or stroke as well as the rate of a combined endpoint of cardiovascular death, MI, stroke, or refractory ischemia.
Plavix is indicated to reduce the rate of myocardial infarction and stroke For in patients with acute ST-elevation myocardial infarction (STEMI) who are to be managed medically. Plavix should be administered in conjunction with aspirin. Plavix has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction, or stroke. The benefit for patients who undergo primary percutaneous coronary intervention is unknown. The optimal duration of Plavix therapy in ACS is unknown.
||Additions are shown as underlined text; deletions are shown as strikethrough text.
Plavix is a registered trademark of sanofi-aventis.
ACC=American College of Cardiology; ACS=acute coronary syndrome; AHA=American Heart Association; CABG=coronary artery bypass graft; CAD=coronary artery disease; CV=cardiovascular; DAPT=dual antiplatelet therapy; FDA=Food and Drug Administration; MI=myocardial infarction; NIHSS=National Institutes of Health Stroke Scale; NSTE-ACS=non–ST-elevation acute coronary syndrome; OAP=oral antiplatelet; PCI=percutaneous coronary intervention; PLATO=PLATelet inhibition and patient Outcomes; STEMI=ST-elevation myocardial infarction; TIA=transient ischemic attack.
- BRILINTA® (ticagrelor) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2021.
- Plavix® (clopidogrel bisulfate) [package insert]. Bridgewater, NJ: Sanofi-Aventis US LLC; 2021.
- Effient® (prasugrel) [package insert]. Indianapolis, IN: Eli Lilly and Company; 2019.
- Department of Health and Human Services. US Food and Drug Administration. Revised Plavix labeling. Published September 16, 2016. Accessed May 27, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020839Orig1s062,s064ltr.pdf
- Wallentin L, Becker RC, Budaj A, et al; for the PLATO Investigators. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009;361(11):1045-1057 and Supplementary Appendix.