Direct Xa inhibitors in addition to antiplatelet therapy in acute coronary syndrome: meta-analysis of randomized trials.
OBJECTIVE
We carried out a meta-analysis summarizing the efficacy and safety of direct factor Xa inhibitor (DXI) in patients receiving guideline-based antiplatelet therapy (GBAT) after an acute coronary syndrome.


BACKGROUND
Randomized-controlled trials have shown that the addition of a DXI to GBAT after acute coronary syndrome can reduce ischemic events, the trade-off being an increase in major bleeding complications.


METHODS
PubMed, Central, Embase, The Cochrane Register, Google Scholar databases, and the scientific session abstracts were searched for eligible randomized trials from 1 January 1990 through 31 December 2016.


RESULTS
Nine randomized-controlled trials were included in this meta-analysis enrolling a total of 45651 patients. There was a significant reduction in major adverse cardiovascular events with DXIs/GBAT compared with GBAT alone [odds ratio (OR): 0.88; 95% confidence interval (CI): 0.82-0.94, number needed to treat=52]. There were also significant reductions in two individual components of major adverse cardiovascular events: myocardial infarction (OR: 0.89; 95% CI: 0.81-0.98) and stent thrombosis (OR: 0.73; 95% CI: 0.59-0.90), favoring the DXI/GBAT group. There was an increased risk of major bleeding (OR: 2.51; 95% CI: 1.82-3.46) and intracranial hemorrhage (OR: 3.47; 95% CI: 1.76-6.86) compared with GBAT.


CONCLUSIONS
In acute coronary syndromes, the addition of a DXI to GBAT results in a significant reduction of major adverse cardiovascular events, myocardial infarction, and stent thrombosis, offset by an increased risk of bleeding.
aDepartment of Medicine, Division of Cardiovascular Diseases, Montefiore Medical Center bDepartment of Epidemiology and Population Health, Albert Einstein College of Medicine, New York, New York cDepartment of Medicine, Cardiovascular Division, Mayo Clinic College of Medicine, Rochester, Minnesota dDepartment of Internal Medicine, Cleveland Clinic, Cleveland, Ohio eDepartment of Anesthesiology and Perioperative Medicine, Division of Cardiovascular and Thoracic Anesthesiology fDepartment of Medicine, Cardiovascular Division, Mayo Clinic College of Medicine, Scottsdale, Arizona, USA gDepartment of Medicine, Cardiovascular Institute, Hospital Clínico San Carlos, Madrid, Spain.
Pedro A
PA
Villablanca
David
D
Holmes
Divyanshu
D
Mohananey
David F
DF
Briceno
Ivan J
IJ
Núñez Gil
Faraj
F
Kargoli
Tanush
T
Gupta
Jorge R
JR
Kizer
Anna E
AE
Bortnick
Jose
J
Wiley
Mark A
MA
Menegus
Robert
R
Pyo
Mario
M
García
Harish
H
Ramakrishna
Farouk
F
Mookadam
D054058:Acute Coronary Syndrome / Q000097:blood / Q000175:diagnosis / Q000628:therapy*; D000368:Aged; D016009:Chi-Square Distribution; D003328:Coronary Thrombosis / Q000209:etiology / Q000517:prevention & control; D065427:Factor Xa Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D016014:Linear Models; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000517:prevention & control; D016017:Odds Ratio; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D018570:Risk Assessment; D012307:Risk Factors; D015607:Stents; D016896:Treatment Outcome
D065427:Factor Xa Inhibitors; D010975:Platelet Aggregation Inhibitors