Abstract 15835: Use of Factor Xa Inhibitors in Addition to Antiplatelet Therapy in Patients With a Recent Acute Coronary Syndrome: A Systematic Review and Meta-Analysis of Randomized Trials
Background: Patients with a history of acute coronary syndrome (ACS) continue to have significant risk for recurrent thrombotic events. Randomized controlled trials (RCT) have shown that addition of a direct factor Xa inhibitor (FXAI) to standard therapy after ACS can yield a reduction of future ischemic events with an increase in major bleeding complications. Our objective was to evaluate the efficacy and safety of FXAIs by conducting a meta-analysis of all RCT comparing FXAI with placebo in patients receiving antiplatelet therapy after ACS.
Methods and Results: Electronic databases were searched to identify RCT that evaluated the effects of FXAIs in patients receiving antiplatelet therapy after an ACS. The primary endpoint was major adverse cardiovascular events (MACE) defined as the composite of all-cause mortality, new myocardial infarction (MI), recurrent ischemia or stroke. Secondary end points included individual analysis of new MI, all-cause mortality, stroke and stent thrombosis. Major bleeding complications were recorded as a safety endpoint. The net clinical benefit was calculated as the sum of composite ischemic events and major bleeding events. Eight RCT were included in the meta-analysis enrolling a total of 42,898 patients. There was a significant reduction in MACE with FXAIs compared with standard therapy (I2 = 35.03%; odds ratio (OR) 0.892 [95% confidence interval (CI) 0.828-0.961], p=0.003), number needed to treat (NNT) = 62. There were also significant reductions in MI (I2 = 20.15%; OR 0.893 [95% CI 0.811-0.983], p=0.002) NNT = 105 and stent thrombosis (I2 = 0%; OR 0,726 [95% CI 0.587-0.897], p=003) NNT = 315. There was a trend toward reduction in all cause mortality (I2 = 0%; OR 0.916 [95% CI 0.798-1.051], p=0.21) and strokes (I2 = 0%; OR 0.867 [95% CI 0.658-1.141], p=0.308) with FXAIs. There was an increased risk of major bleeding compared with the standard treatment (I2 = 33.85%; OR 2.793 [95% CI 2.207-3.536], p <0.000), number needed to harm (NNH) = 98 and minor bleedings.
Conclusions: In patient with recent ACS, the addition of a direct FXAI on top of standard therapy in the setting of ACS results in significant reduction of MACE, MI and stent thrombosis with overall favorable clinical benefit.
Author Disclosures: P.A. Villablanca Spinetto: None. O. Maitas: None. A. Joseph: None. I. Yang: None. M.S. Salih: None. J. Somberg: None.
- © 2014 by American Heart Association, Inc.