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Apixaban, an Oral, Direct, Selective Factor Xa Inhibitor, in Combination With Antiplatelet Therapy After Acute Coronary Syndrome: Results of the Apixaban for Prevention of Acute Ischemic and Safety Events (APPRAISE) Trial

Alexander, John H ; Becker, Richard C ; Bhatt, Deepak L ; Cools, Frank ; Crea, Filippo ; Dellborg, Mikael ; Fox, Keith A A ; Goodman, Shaun G ; Harrington, Robert A ; Huber, Kurt ; Husted, Steen ; Lewis, Basil S ; Lopez-Sendon, Jose ; Mohan, Puneet ; Montalescot, Gilles ; Ruda, Mikhail ; Ruzyllo, Witold ; Verheugt, Freek ; Wallentin, Lars

Circulation (New York, N.Y.), 2009-06, Vol.119 (22), p.2877-2885 [Periódico revisado por pares]

Hagerstown, MD: Lippincott Williams & Wilkins

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Título:
Apixaban, an Oral, Direct, Selective Factor Xa Inhibitor, in Combination With Antiplatelet Therapy After Acute Coronary Syndrome: Results of the Apixaban for Prevention of Acute Ischemic and Safety Events (APPRAISE) Trial
Autor: Alexander, John H ; Becker, Richard C ; Bhatt, Deepak L ; Cools, Frank ; Crea, Filippo ; Dellborg, Mikael ; Fox, Keith A A ; Goodman, Shaun G ; Harrington, Robert A ; Huber, Kurt ; Husted, Steen ; Lewis, Basil S ; Lopez-Sendon, Jose ; Mohan, Puneet ; Montalescot, Gilles ; Ruda, Mikhail ; Ruzyllo, Witold ; Verheugt, Freek ; Wallentin, Lars
Assuntos: Acute Coronary Syndrome - complications ; Acute Coronary Syndrome - drug therapy ; Adolescent ; Adult ; Aged ; Aged, 80 and over ; Aspirin - therapeutic use ; Biological and medical sciences ; Blood and lymphatic vessels ; Blood. Blood coagulation. Reticuloendothelial system ; Cardiology. Vascular system ; Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug Therapy, Combination ; Factor Xa Inhibitors ; Female ; Hemorrhage - chemically induced ; Humans ; Male ; MEDICAL AND HEALTH SCIENCES ; Medical sciences ; MEDICIN ; MEDICIN OCH HÄLSOVETENSKAP ; MEDICINE ; Middle Aged ; Myocardial Ischemia - prevention & control ; Pharmacology. Drug treatments ; Platelet Aggregation Inhibitors - therapeutic use ; Pyrazoles - administration & dosage ; Pyrazoles - toxicity ; Pyridones - administration & dosage ; Pyridones - toxicity ; Ticlopidine - analogs & derivatives ; Ticlopidine - therapeutic use ; Young Adult
É parte de: Circulation (New York, N.Y.), 2009-06, Vol.119 (22), p.2877-2885
Notas: ObjectType-Article-2
SourceType-Scholarly Journals-1
ObjectType-Feature-1
ObjectType-News-3
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Descrição: After an acute coronary syndrome, patients remain at risk of recurrent events. Apixaban, an oral direct factor Xa inhibitor, is a novel anticoagulant that may reduce these events but also poses a risk of bleeding. Apixaban for Prevention of Acute Ischemic and Safety Events (APPRAISE) was a phase 2, double-blind, placebo-controlled, dose-ranging study. Patients (n=1715) with recent ST-elevation or non-ST-elevation acute coronary syndrome were randomized to 6 months of placebo (n=611) or 1 of 4 doses of apixaban: 2.5 mg twice daily (n=317), 10 mg once daily (n=318), 10 mg twice daily (n=248), or 20 mg once daily (n=221). Nearly all patients received aspirin; 76% received clopidogrel. The primary outcome was International Society of Thrombosis and Hemostasis major or clinically relevant nonmajor bleeding. A secondary outcome was cardiovascular death, myocardial infarction, severe recurrent ischemia, or ischemic stroke. At the recommendation of the Data Monitoring Committee, the 2 higher-dose apixaban arms were discontinued because of excess total bleeding. Compared with placebo, apixaban 2.5 mg twice daily (hazard ratio, 1.78; 95% confidence interval, 0.91 to 3.48; P=0.09) and 10 mg once daily (hazard ratio, 2.45; 95% confidence interval, 1.31 to 4.61; P=0.005) resulted in a dose-dependent increase in major or clinically relevant nonmajor bleeding. Apixaban 2.5 mg twice daily (hazard ratio, 0.73; 95% confidence interval, 0.44 to 1.19; P=0.21) and 10 mg once daily (hazard ratio, 0.61; 95% confidence interval, 0.35 to 1.04; P=0.07) resulted in lower rates of ischemic events compared with placebo. The increase in bleeding was more pronounced and the reduction in ischemic events was less evident in patients taking aspirin plus clopidogrel than in those taking aspirin alone. We observed a dose-related increase in bleeding and a trend toward a reduction in ischemic events with the addition of apixaban to antiplatelet therapy in patients with recent acute coronary syndrome. The safety and efficacy of apixaban may vary depending on background antiplatelet therapy. Further testing of apixaban in patients at risk of recurrent ischemic events is warranted.
Editor: Hagerstown, MD: Lippincott Williams & Wilkins
Idioma: Inglês

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Apixaban, an Oral, Direct, Selective Factor Xa Inhibitor, in Combination With Antiplatelet Therapy After Acute Coronary Syndrome: Results of the Apixaban for Prevention of Acute Ischemic and Safety Events (APPRAISE) Trial

Hagerstown, MD: Lippincott Williams & Wilkins

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