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Efficacy and safety of apixaban vs warfarin in patients with atrial fibrillation and prior bioprosthetic valve replacement or valve repair : Insights from the ARISTOTLE trial

Guimaraes, Patricia O. (author)
Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA
Pokorney, Sean D. (author)
Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA
Lopes, Renato D. (author)
Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA
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Wojdyla, Daniel M. (author)
Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA
Gersh, Bernard J. (author)
Mayo Clin, Div Cardiovasc Dis, Coll Med, Rochester, MN USA
Giczewska, Anna (author)
Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA;Gdansk Univ Technol, Dept Biomed Engn, Fac Elect Telecommun & Informat, Gdansk, Poland
Carnicelli, Anthony (author)
Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA
Lewis, Basil S. (author)
Lady Davis Carmel Med Ctr, Dept Cardiovasc Med, Haifa, Israel
Hanna, Michael (author)
Bristol Myers Squibb, Princeton, NJ USA
Wallentin, Lars, 1943- (author)
Uppsala universitet,Kardiologi,Uppsala kliniska forskningscentrum (UCR)
Vinereanu, Dragos (author)
Univ & Emergency Hosp, Dept Cardiol, Univ Med & Pharm Carol Davila, Bucharest, Romania
Alexander, John H. (author)
Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA
Granger, Christopher B. (author)
Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA
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 (creator_code:org_t)
2019-04-09
2019
English.
In: Clinical Cardiology. - : Wiley. - 0160-9289 .- 1932-8737. ; 42:5, s. 568-571
  • Journal article (peer-reviewed)
Abstract Subject headings
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  • Background The optimal anticoagulation strategy for patients with atrial fibrillation (AF) and bioprosthetic valve (BPV) replacement or native valve repair remains uncertain.HypothesisWe evaluated the safety and efficacy of apixaban vs warfarin in patients with AF and a history of BPV replacement or native valve repair.MethodsUsing data from Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) (n = 18 201), a randomized trial comparing apixaban with warfarin in patients with AF, we analyzed the subgroup of patients (n = 251) with prior valve surgery. We contacted sites by telephone to obtain additional data about prior valve surgery. Full data were available for 156 patients. The primary efficacy endpoint was stroke/systemic embolism. The primary safety endpoint was major bleeding. Treatment groups were compared using a Cox regression model.ResultsIn ARISTOTLE, 104 (0.6%) patients had a history of BPV replacement (n = 73 [aortic], n = 26 [mitral], n = 5 [mitral and aortic]) and 52 (0.3%) had a history of valve repair (n = 50 [mitral], n = 2 [aortic]). Among patients with BPVs, 55 were randomized to apixaban and 49 to warfarin. Among those with a history of native valve repair, 32 were randomized to apixaban and 20 to warfarin. Overall clinical event rates were low, with no significant differences between apixaban and warfarin for any outcomes.ConclusionsIn patients with AF and a history of BPV replacement or repair, the safety and efficacy of apixaban compared with warfarin was consistent with results from ARISTOTLE. These data suggest that apixaban may be reasonable for patients with BPVs or prior valve repair, though future larger randomized trials are needed.ClinicalTrials.govNCT00412984.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Kardiologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)

Keyword

apixaban
atrial fibrillation
bioprosthetic valves
valve repair

Publication and Content Type

ref (subject category)
art (subject category)

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