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Statements

Subject Item
n2:RIV%2F00064203%3A_____%2F11%3A7107%21RIV12-MZ0-00064203
rdf:type
n7:Vysledek skos:Concept
rdfs:seeAlso
http://www.ncbi.nlm.nih.gov/pubmed/21780946
dcterms:description
Background Apixaban, an oral, direct factor Xa inhibitor, may reduce the risk of recurrent ischemic events when added to antiplatelet therapy after an acute coronary syndrome. Methods We conducted a randomized, double-blind, placebo-controlled clinical trial comparing apixaban, at a dose of 5 mg twice daily, with placebo, in addition to standard antiplatelet therapy, in patients with a recent acute coronary syndrome and at least two additional risk factors for recurrent ischemic events. Results The trial was terminated prematurely after recruitment of 7392 patients because of an increase in major bleeding events with apixaban in the absence of a counterbalancing reduction in recurrent ischemic events. With a median follow-up of 241 days, the primary outcome of cardiovascular death, myocardial infarction, or ischemic stroke occurred in 279 of the 3705 patients (7.5%) assigned to apixaban (13.2 events per 100 patient-years) and in 293 of the 3687 patients (7.9%) assigned to placebo (14.0 events per 100 patient-years) (hazard ratio with apixaban, 0.95; 95% confidence interval [CI], 0.80 to 1.11; P = 0.51). The primary safety outcome of major bleeding according to the Thrombolysis in Myocardial Infarction (TIMI) definition occurred in 46 of the 3673 patients (1.3%) who received at least one dose of apixaban (2.4 events per 100 patient-years) and in 18 of the 3642 patients (0.5%) who received at least one dose of placebo (0.9 events per 100 patient-years) (hazard ratio with apixaban, 2.59; 95% CI, 1.50 to 4.46; P = 0.001). A greater number of intracranial and fatal bleeding events occurred with apixaban than with placebo. Conclusions The addition of apixaban, at a dose of 5 mg twice daily, to antiplatelet therapy in high-risk patients after an acute coronary syndrome increased the number of major bleeding events without a significant reduction in recurrent ischemic events. (Funded by BristolMyers Squibb and Pfizer; APPRAISE-2 ClinicalTrials. gov number, NCT00831441.) Background Apixaban, an oral, direct factor Xa inhibitor, may reduce the risk of recurrent ischemic events when added to antiplatelet therapy after an acute coronary syndrome. Methods We conducted a randomized, double-blind, placebo-controlled clinical trial comparing apixaban, at a dose of 5 mg twice daily, with placebo, in addition to standard antiplatelet therapy, in patients with a recent acute coronary syndrome and at least two additional risk factors for recurrent ischemic events. Results The trial was terminated prematurely after recruitment of 7392 patients because of an increase in major bleeding events with apixaban in the absence of a counterbalancing reduction in recurrent ischemic events. With a median follow-up of 241 days, the primary outcome of cardiovascular death, myocardial infarction, or ischemic stroke occurred in 279 of the 3705 patients (7.5%) assigned to apixaban (13.2 events per 100 patient-years) and in 293 of the 3687 patients (7.9%) assigned to placebo (14.0 events per 100 patient-years) (hazard ratio with apixaban, 0.95; 95% confidence interval [CI], 0.80 to 1.11; P = 0.51). The primary safety outcome of major bleeding according to the Thrombolysis in Myocardial Infarction (TIMI) definition occurred in 46 of the 3673 patients (1.3%) who received at least one dose of apixaban (2.4 events per 100 patient-years) and in 18 of the 3642 patients (0.5%) who received at least one dose of placebo (0.9 events per 100 patient-years) (hazard ratio with apixaban, 2.59; 95% CI, 1.50 to 4.46; P = 0.001). A greater number of intracranial and fatal bleeding events occurred with apixaban than with placebo. Conclusions The addition of apixaban, at a dose of 5 mg twice daily, to antiplatelet therapy in high-risk patients after an acute coronary syndrome increased the number of major bleeding events without a significant reduction in recurrent ischemic events. (Funded by BristolMyers Squibb and Pfizer; APPRAISE-2 ClinicalTrials. gov number, NCT00831441.)
dcterms:title
Apixaban with Antiplatelet Therapy after Acute Coronary Syndrome Apixaban with Antiplatelet Therapy after Acute Coronary Syndrome
skos:prefLabel
Apixaban with Antiplatelet Therapy after Acute Coronary Syndrome Apixaban with Antiplatelet Therapy after Acute Coronary Syndrome
skos:notation
RIV/00064203:_____/11:7107!RIV12-MZ0-00064203
n7:predkladatel
n8:ico%3A00064203
n3:aktivita
n4:I
n3:aktivity
I
n3:cisloPeriodika
8
n3:dodaniDat
n14:2012
n3:domaciTvurceVysledku
n18:2467755
n3:druhVysledku
n9:J
n3:duvernostUdaju
n12:S
n3:entitaPredkladatele
n6:predkladatel
n3:idSjednocenehoVysledku
186572
n3:idVysledku
RIV/00064203:_____/11:7107
n3:jazykVysledku
n17:eng
n3:klicovaSlova
st-segment elevation; factor xa inhibitor; high-risk patients; acute myocardial-infarction; randomized controlled-trial; knee replacement; double-blind; aspirin; clopidogrel; warfarin
n3:klicoveSlovo
n11:randomized%20controlled-trial n11:high-risk%20patients n11:clopidogrel n11:warfarin n11:aspirin n11:st-segment%20elevation n11:acute%20myocardial-infarction n11:factor%20xa%20inhibitor n11:knee%20replacement n11:double-blind
n3:kodStatuVydavatele
US - Spojené státy americké
n3:kontrolniKodProRIV
[C7E9D18FF58B]
n3:nazevZdroje
New England Journal of Medicine
n3:obor
n16:FP
n3:pocetDomacichTvurcuVysledku
1
n3:pocetTvurcuVysledku
34
n3:rokUplatneniVysledku
n14:2011
n3:svazekPeriodika
365
n3:tvurceVysledku
Goodman, S. Wallentin, L. Diaz, R. Leiva-Pons, J. L. Vinereanu, D. Harrington, R. A. Kilaru, R. Parkhomenko, A. Flather, M. White, H. James, S. Cools, F. Verheugt, F. W. Alexander, J. H Liaw, D. De Caterina, R. Janský, Petr Husted, SE Bhatt, DL He, Y. H. Cornel, J. H Lopez-Sendon, J. Ruzyllo, W. Lawrence, J. Lopes, R. D. Mohan, P. Ogawa, H. Ruda, M. Geraldes, M. Huber, K. Darius, H. Pais, P. Atar, D. Keltai, M.
n3:wos
000294205300005
s:issn
0028-4793
s:numberOfPages
10