Anticoagulant therapy and outcomes in patients with prior or acute heart failure and acute coronary syndromes: Insights from the APixaban for PRevention of Acute ISchemic Events 2 trial - 28/03/15
, Renato D. Lopes, MD, PhD b, Stefan James, MD, PhD c, Susanna R. Stevens, MS b, Megan L. Neely, PhD b, Danny Liaw, MD, PhD d, Julie Miller, MD e, Puneet Mohan, MD, PhD d, John Amerena, MD f, Dimitar Raev, MD g, Yong Huo, MD h, Miguel Urina-Triana, MD i, Alex Gallegos Cazorla, MD j, Dragos Vinereanu, MD k, Viliam Fridrich, MD l, Robert A. Harrington, MD m, Lars Wallentin, MD, PhD c, John H. Alexander, MD, MHS bfor the
APPRAISE-2 Study Group
Riassunto |
Background |
Clinical outcomes and the effects of oral anticoagulants among patients with acute coronary syndrome (ACS) and either a history of or acute heart failure (HF) are largely unknown. We aimed to assess the relationship between prior HF or acute HF complicating an index ACS event and subsequent clinical outcomes and the efficacy and safety of apixaban compared with placebo in these populations.
Methods |
High-risk patients were randomly assigned post-ACS to apixaban 5.0 mg or placebo twice daily. Median follow-up was 8 (4-12) months. The primary outcome was cardiovascular death, myocardial infarction, or stroke. The main safety outcome was thrombolysis in myocardial infarction major bleeding.
Results |
Heart failure was reported in 2,995 patients (41%), either as prior HF (2,076 [28%]) or acute HF (2,028 [27%]). Patients with HF had a very high baseline risk and were more often managed medically. Heart failure was associated with a higher rate of the primary outcome (prior HF: adjusted hazard ratio [HR] 1.73, 95% CI 1.42-2.10, P < .0001, acute HF: adjusted HR 1.65, 95% CI 1.35-2.01, P < .0001) and cardiovascular death (prior HF: HR 2.54, 95% CI 1.82-3.54, acute HF: adjusted HR 2.52, 95% CI 1.82-3.50). Patients with acute HF also had significantly higher rates of thrombolysis in myocardial infarction major bleeding (prior HF: adjusted HR 1.22, 95% CI 0.65-2.27, P = .54, acute HF: adjusted HR 1.78, 95% CI 1.03-3.08, P = .04). There was no statistical evidence of a differential effect of apixaban on clinical events or bleeding in patients with or without prior HF; however, among patients with acute HF, there were numerically fewer events with apixaban than placebo (14.8 vs 19.3, HR 0.76, 95% CI 0.57-1.01, interaction P = .13), a trend that was not seen in patients with prior HF or no HF.
Conclusions |
In high-risk patients post-ACS, both prior and acute HFs are associated with an increased risk of subsequent clinical events. Apixaban did not significantly reduce clinical events and increased bleeding in patients with and without HF; however, there was a tendency toward fewer clinical events with apixaban in patients with acute HF.
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| Funding source: APPRAISE-2 was funded by Bristol Myers Squibb and Pfizer, Inc. |
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| Presented as an abstract at the European Society of Cardiology Congress 2012 Scientific Sessions (August 25-29, 2012) in Munich, Germany. |
Vol 169 - N° 4
P. 531-538 - Aprile 2015 Ritorno al numero
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