TY - JOUR
T1 - Efficacy and Safety of the Use of Non-vitamin K Antagonist Oral Anticoagulants in Patients with Ischemic Heart Disease
T2 - A Meta-Analysis of Phase III Randomized Trials
AU - Fu, Linghua
AU - Zhu, Wengen
AU - Huang, Lin
AU - Hu, Jinzhu
AU - Ma, Jianyong
AU - Lip, Gregory Y H
AU - Hong, Kui
PY - 2019
Y1 - 2019
N2 - BACKGROUND: There are conflicting published data on non-vitamin K antagonist oral anticoagulants (NOACs), with varying evidence of benefit or harm in acute coronary syndrome (ACS) and non-ACS cohorts. To explore the efficacy and safety of NOAC use in patients with ischemic heart disease (IHD), we conducted a meta-analysis of phase III randomized controlled trials (RCTs).METHODS: We systematically searched the Cochrane Library, PubMed, and Embase databases. A random-effect model was selected to pool the effect measurement estimates (hazard ratios [HRs] and 95% confidence intervals [CIs]).RESULTS: Three RCTs with 39,492 enrolled IHD patients were included. Compared with placebo, NOACs were associated with reduced risks of major adverse cardiac events (MACE) (HR 0.83, 95% CI 0.76-0.90), cardiovascular death (HR 0.82, 95% CI 0.72-0.93), and myocardial infarction (HR 0.87, 95% CI 0.78-0.97) accompanied by increased risks of major bleeding (HR 2.46, 95% CI 1.42-4.26), but not fatal bleeding (HR 1.35, 95% CI 0.76-2.39) or intracranial hemorrhage (HR 2.19, 95% CI 0.91-5.27). Subgroup analysis revealed that NOACs were associated with an increased risk of major bleeding in patients who received dual antiplatelet therapy compared with patients who received single antiplatelet therapy (3.01, 1.82-4.98 vs. 1.66, 1.37-2.03; P for interaction 0.03) and patients with ACS compared with patients with non-ACS (3.27, 2.16-4.95 vs. 1.66, 1.36-2.02; P for interaction 0.004).CONCLUSIONS: In patients with IHD, NOACs confer protection against thrombosis-related complications, but at the cost of an increased hazard of major bleeding. NOACs plus a single antiplatelet drug seem to be a good choice for patients with IHD.
AB - BACKGROUND: There are conflicting published data on non-vitamin K antagonist oral anticoagulants (NOACs), with varying evidence of benefit or harm in acute coronary syndrome (ACS) and non-ACS cohorts. To explore the efficacy and safety of NOAC use in patients with ischemic heart disease (IHD), we conducted a meta-analysis of phase III randomized controlled trials (RCTs).METHODS: We systematically searched the Cochrane Library, PubMed, and Embase databases. A random-effect model was selected to pool the effect measurement estimates (hazard ratios [HRs] and 95% confidence intervals [CIs]).RESULTS: Three RCTs with 39,492 enrolled IHD patients were included. Compared with placebo, NOACs were associated with reduced risks of major adverse cardiac events (MACE) (HR 0.83, 95% CI 0.76-0.90), cardiovascular death (HR 0.82, 95% CI 0.72-0.93), and myocardial infarction (HR 0.87, 95% CI 0.78-0.97) accompanied by increased risks of major bleeding (HR 2.46, 95% CI 1.42-4.26), but not fatal bleeding (HR 1.35, 95% CI 0.76-2.39) or intracranial hemorrhage (HR 2.19, 95% CI 0.91-5.27). Subgroup analysis revealed that NOACs were associated with an increased risk of major bleeding in patients who received dual antiplatelet therapy compared with patients who received single antiplatelet therapy (3.01, 1.82-4.98 vs. 1.66, 1.37-2.03; P for interaction 0.03) and patients with ACS compared with patients with non-ACS (3.27, 2.16-4.95 vs. 1.66, 1.36-2.02; P for interaction 0.004).CONCLUSIONS: In patients with IHD, NOACs confer protection against thrombosis-related complications, but at the cost of an increased hazard of major bleeding. NOACs plus a single antiplatelet drug seem to be a good choice for patients with IHD.
KW - Acute Coronary Syndrome/drug therapy
KW - Administration, Oral
KW - Anticoagulants/adverse effects
KW - Clinical Trials, Phase III as Topic
KW - Hemorrhage/drug therapy
KW - Humans
KW - Intracranial Hemorrhages/drug therapy
KW - Myocardial Ischemia/drug therapy
KW - Platelet Aggregation Inhibitors/adverse effects
KW - Randomized Controlled Trials as Topic
UR - http://www.scopus.com/inward/record.url?scp=85053423481&partnerID=8YFLogxK
U2 - 10.1007/s40256-018-0299-7
DO - 10.1007/s40256-018-0299-7
M3 - Review article
C2 - 30182350
SN - 1175-3277
VL - 19
SP - 37
EP - 47
JO - American Journal of Cardiovascular Drugs
JF - American Journal of Cardiovascular Drugs
IS - 1
ER -