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Review: New oral anticoagulants reduced stroke and systemic embolism compared with warfarin in AF.
Ann Intern Med. 2012 Sep 18;157(6):JC3-2
Authors: Klein L
Abstract
QUESTION In patients with atrial fibrillation (AF), are new oral anticoagulants effective and safe for preventing stroke and systemic embolism compared with warfarin? REVIEW SCOPE Included studies compared a new, non-vitamin K antagonist oral anticoagulant with warfarin in patients with AF, had > 1 year follow-up, and were published in peer-reviewed journals. Studies of ximelagatran were excluded. Primary efficacy outcome was a composite of stroke (including hemorrhagic stroke) and systemic embolism; secondary efficacy outcomes were ischemic and unidentified stroke, hemorrhagic stroke, all-cause mortality, vascular mortality, and myocardial infarction. Primary safety outcome was major bleeding; secondary safety outcomes were gastrointestinal bleeding and intracranial bleeding. REVIEW METHODS MEDLINE, EMBASE/Excerpta Medica, Cochrane Library, Science Citation Index Expanded, and ProQuest's Dissertations and Theses database (all to Jul 2011); clinical trials databases; reviews; and reference lists were searched for randomized controlled trials (RCTs). 3 noninferiority RCTs met the selection criteria ( n = 44 563, mean age 70 to 73 y, 60% to 65% men, median follow-up 657 to 730 d). ARISTOTLE ( n = 18 201) assessed apixaban, RE-LY ( n = 18 113) assessed dabigatran, and ROCKET-AF ( n = 14 264) assessed rivaroxaban. MAIN RESULTS The main results of the meta-analyses are in the Table. CONCLUSION In patients with atrial fibrillation, new oral anticoagulants (apixaban, dabigatran, and rivaroxaban) reduced a composite of stroke and systemic embolism, ischemic or unspecified stroke, hemorrhagic stroke, all-cause mortality, vascular mortality, and intracranial bleeding compared with warfarin.New oral anticoagulants (NOAs) (apixaban, dabigatran, or rivaroxaban) vs warfarin (war) in atrial fibrillation*OutcomesNumber of trials ( n)Weighted event ratesAt a median 657 to 730 dNOAWarRRR (95% CI)NNT (CI)All-cause stroke and systemic embolism3 (44 470)2.7%3.5%22% (8 to 33)131 (88 to 359)Ischemic or unspecified stroke3 (44 442)1.9%2.2%13% (1 to 23)349 (198 to 4537)Hemorrhagic stroke3 (44 442)0.4%0.8%55% (32 to 69)234 (186 to 401)All-cause mortality3 (44 442)5.6%6.3%12% (5 to 18)132 (88 to 316)Vascular mortality2 (26 241)3.4%3.9%13% (2 to 23)198 (112 to 1285)Myocardial infarction3 (44 442)1.3%1.4%4% (-26 to 27)Not significantMajor bleeding3 (44 474)5.0%5.7%12% (-9 to 29)Not significantIntracranial bleeding3 (44 474)0.7%1.3%51% (34 to 64)149 (119 to 223)RRI (CI)NNH (CI)Gastrointestinal bleeding3 (44 474)2.2%1.8%25% (-9 to 72)Not significant*Abbreviations defined in Glossary. RRR, RRI, NNT, NNH, and CI calculated from risk ratios and control event rates in article using a random-effects model.
PMID: 22986394 [PubMed - in process]