Safety and efficacy of oral factor-Xa inhibitors versus Vitamin K antagonist in patients with non-valvular atrial fibrillation: Meta-analysis of phase II and III randomized controlled trials

Jalaj Garg, Rahul Chaudhary, Parasuram Krishnamoorthy, Chandrasekar Palaniswamy, Neeraj Shah, Babak Bozorgnia, Andrea Natale

Research output: Contribution to journalArticlepeer-review

Abstract

Background Aim of our study was to assess the safety and efficacy on factor-Xa inhibitors (FXIs) in patients with non-valvular atrial fibrillation (NVAF) as compared to Vitamin K antagonist (VKA). Methods Phase II and III randomized controlled trials that reported clinical safety and efficacy of FXI in patients with NVAF were identified from MEDLINE, Embase, and Cochrane Central Register of Controlled Trials through December 10, 2015. The primary safety outcome of our study was composite of stroke and systemic embolic event. Secondary outcomes studied were individual endpoints of primary safety outcome, major bleeding, clinically relevant non-major bleed (CRNMB), and all-cause mortality. Results We included 11 RCTs with a total of 59,164 participants, of which 34,231 patients received oral FXI and 24,933 patients were on VKA with a mean follow-up of 369 days. There was a significant reduction in primary outcome with FXI compared to VKA, 1,112 (3.4%) versus 816 (3.6%) events, respectively (OR 0.82; 95% CI 0.68-0.99). Use of FXI significantly reduced major bleeding events compared to VKA, OR 0.74, 95% CI 0.58-0.96, test for heterogeneity (I2 = 74%). Incidence of CRNMB was not different between FXI and VKA groups, OR 0.84, 95% CI 0.68-1.04. There was a significant reduction in all-cause mortality in FXI group compared to VKA group, OR 0.88, 95% CI 0.83-0.94 with no significant heterogeneity. Conclusion Use of FXI was associated with a significant reduction in major bleeding events and all-cause mortality without increased risk of stroke or SEE compared to VKA.

Original languageEnglish (US)
Pages (from-to)235-239
Number of pages5
JournalInternational Journal of Cardiology
Volume218
DOIs
StatePublished - Sep 1 2016

Keywords

  • All-cause mortality
  • Atrial fibrillation
  • Bleeding
  • Factor X inhibitors
  • Stroke

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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