About Index

PLATO

"Ticagrelor versus Clopidogrel in Patients with Acute Coronary Syndromes". The New England Journal of Medicine. 2009. 361:1045-1057. PubMed•Full

Links to original sources: Wiki Journal Post Full Journal Article

Contents 1 Clinical Question 2 Bottom Line 3 Major Points 4 Guidelines 5 Design 6 Population 6.1 Inclusion Criteria 6.2 Exclusion Criteria 6.3 Baseline Characteristics 7 Interventions 8 Outcomes 8.1 Primary Outcome 8.2 Secondary Outcomes 8.3 Subgroup Analysis 9 Criticisms 10 Funding 11 Further Reading

Clinical Question


In patients admitted with an acute coronary syndrome, does ticagrelor reduce the risk of cardiovascular events compared to clopidogrel?

Bottom Line


In patients with an acute coronary syndrome, ticagrelor was superior to clopidogrel in reducing the risk of death from vascular causes, myocardial infarction, or stroke, without an increased risk of overall major bleeding but with an increase in non–procedure-related bleeding.

Major Points


Dual antiplatelet therapy with aspirin and clopidogrel is recommended for patients with an acute coronary syndrome. Ticagrelor, a new reversible direct-acting oral P2Y12 receptor antagonist, provides more consistent P2Y12 inhibition than clopidogrel. The PLATO trial compared ticagrelor with clopidogrel in 18,624 patients with acute coronary syndromes and found that ticagrelor reduced the risk of vascular death, myocardial infarction, or stroke, without an increased risk of overall major bleeding.

Guidelines


As of 2009, guidelines had not been published that reflect the results of this trial.

Design


Multicenter, randomized, double-blind, double-dummy trial N=18,624 Ticagrelor (n=9,333) Clopidogrel (n=9,291) Mean follow-up: 12 months

Population


Inclusion Criteria: Hospitalized patients within 24 hours of onset of acute coronary syndromes with or without ST-segment elevation Exclusion Criteria: Contraindications to clopidogrel, fibrinolytic therapy within 24 hours before randomization, need for oral anticoagulation, increased risk of bradycardia, strong cytochrome P-450 3A inhibitor or inducer therapy Baseline Characteristics: Well balanced across both groups

Interventions


Ticagrelor – 180 mg loading dose, followed by 90 mg twice daily Clopidogrel – 300-600 mg loading dose if not previously received, followed by 75 mg daily

Outcomes


Primary Outcome: Death from vascular causes, myocardial infarction, or stroke at 12 months 9.8% with ticagrelor vs. 11.7% with clopidogrel (hazard ratio, 0.84; 95% CI, 0.77 to 0.92; P<0.001)

Outcomes


Death from any cause: 4.5% with ticagrelor vs. 5.9% with clopidogrel (P<0.001) No significant difference in the rates of major bleeding between groups

Subgroup Analysis Benefit of ticagrelor appeared to be attenuated in patients under median weight, those not taking lipid-lowering drugs at randomization, and those enrolled in North America

Criticisms


Ticagrelor was associated with a higher rate of major bleeding not related to coronary-artery bypass grafting and more instances of fatal intracranial bleeding.

Funding


Supported by AstraZeneca.

Further Reading


Full text article available at NEJM.org