Eric R. Bates, MD
In patients with acute coronary syndromes (ACSs), what are the relative efficacy and safety of ticagrelor and clopidogrel?
Randomized controlled trial (Study of Platelet Inhibition and Patient Outcomes [PLATO]). ClinicalTrials.gov NCT00391872.
Blinded (patients, clinicians, data collectors, outcome adjudication committee, data analysts, and manuscript writers).*
Median 9 months.
862 centers in 43 countries worldwide.
18 624 patients ≥ 18 years of age (median age 62 y, 72% men) who were hospitalized for an ACS, with or without ST-segment elevation, with onset of symptoms within 24 hours. Exclusion criteria included fibrinolytic therapy in ≤ 24 hours, need for oral anticoagulation therapy, increased risk for bradycardia, and concomitant therapy with a strong cytochrome P-450 3A inhibitor or inducer.
Ticagrelor, loading dose 180 mg and then 90 mg twice/d (n = 9333), or clopidogrel, loading dose 300 mg and then 75 mg/d (n = 9291), for 6 to 12 months. An additional dose of the study drug (90 mg of ticagrelor/placebo if > 24 h or 300 mg of clopidogrel/placebo at the investigator’s discretion) was given to patients having percutaneous coronary intervention, and study drugs were recommended to be withheld for a few days in patients having coronary artery bypass grafting (CABG). All patients received aspirin.
Primary composite endpoint (myocardial infarction [MI], stroke, or death from vascular causes), secondary composite endpoint (MI, stroke, or death from any cause), components of the composite endpoints, major bleeding, and other adverse effects.
100% (intention-to-treat analysis).
Ticagrelor reduced risk for the composite endpoints, vascular and all-cause death, and MI, but not stroke (Table). Groups did not differ for major bleeding overall (Table), but ticagrelor increased risk for non–CABG-related major bleeding (4.5% vs 3.8%), dyspnea (14% vs 7.8%), and ventricular pauses ≥ 3 seconds (5.8% vs 3.6%).
In patients with acute coronary syndromes, ticagrelor prevented more major adverse cardiovascular events at 1 year than clopidogrel, with no increase in major bleeding.
Ticagrelor vs clopidogrel for acute coronary syndromes†
†MI = myocardial infarction; other abbreviations defined in Glossary. RRR, RRI, NNT, NNH, and CI calculated from data in article.
Bates ER. Ticagrelor was more effective than clopidogrel, with no increase in major bleeding in acute coronary syndromes. Ann Intern Med. ;151:JC6–4. doi: 10.7326/0003-4819-151-12-200912150-02004
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Published: Ann Intern Med. 2009;151(12):JC6-4.
Acute Coronary Syndromes, Cardiology, Coronary Heart Disease, Emergency Medicine.
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