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Oral anticoagulant and antiplatelet therapy and peripheral arterial disease
1McMaster University, Hamilton, ON, Canada. anands@mcmaster.ca
Insights
Adding oral anticoagulants to antiplatelet therapy for peripheral arterial disease did not reduce major cardiovascular events. This combination significantly increased the risk of life-threatening bleeding compared to antiplatelet therapy alone.
Area of Science:
- Cardiology
- Vascular Medicine
- Pharmacology
Background:
- Peripheral arterial disease (PAD) increases risks of myocardial infarction, stroke, and cardiovascular death.
- Antiplatelet agents mitigate these risks, but the benefit of adding oral anticoagulants is uncertain.
Purpose of the Study:
- To evaluate the efficacy and safety of combined antiplatelet and oral anticoagulant therapy versus antiplatelet therapy alone in patients with PAD.
Main Methods:
- A randomized trial involving 2161 patients with PAD.
- Patients received either combination therapy (antiplatelet + oral anticoagulant, target INR 2.0-3.0) or antiplatelet therapy alone.
- Coprimary outcomes included major adverse cardiovascular events and a composite of events including severe ischemia or death.
Main Results:
- No significant difference in the rate of myocardial infarction, stroke, or cardiovascular death between the combination therapy group (12.2%) and the antiplatelet alone group (13.3%).
- No significant difference in the composite outcome including severe ischemia or death.
- Life-threatening bleeding occurred significantly more often in the combination therapy group (4.0%) compared to the antiplatelet alone group (1.2%).
Conclusions:
- Combination therapy with oral anticoagulants and antiplatelets is not more effective than antiplatelet therapy alone for preventing major cardiovascular complications in PAD patients.
- This combination therapy is associated with a substantially higher risk of life-threatening bleeding.
Background:
Atherosclerotic peripheral arterial disease is associated with an increased risk of myocardial infarction, stroke, and death from cardiovascular causes. Antiplatelet drugs reduce this risk, but the role of oral anticoagulant agents in the prevention of cardiovascular complications in patients with peripheral arterial disease is unclear.
Methods:
We assigned patients with peripheral arterial disease to combination therapy with an antiplatelet agent and an oral anticoagulant agent (target international normalized ratio [INR], 2.0 to 3.0) or to antiplatelet therapy alone. The first coprimary outcome was myocardial infarction, stroke, or death from cardiovascular causes; the second coprimary outcome was myocardial infarction, stroke, severe ischemia of the peripheral or coronary arteries leading to urgent intervention, or death from cardiovascular causes.
Results:
A total of 2161 patients were randomly assigned to therapy. The mean follow-up time was 35 months. Myocardial infarction, stroke, or death from cardiovascular causes occurred in 132 of 1080 patients receiving combination therapy (12.2%) and in 144 of 1081 patients receiving antiplatelet therapy alone (13.3%) (relative risk, 0.92; 95% confidence interval [CI], 0.73 to 1.16; P=0.48). Myocardial infarction, stroke, severe ischemia, or death from cardiovascular causes occurred in 172 patients receiving combination therapy (15.9%) as compared with 188 patients receiving antiplatelet therapy alone (17.4%) (relative risk, 0.91; 95% CI, 0.74 to 1.12; P=0.37). Life-threatening bleeding occurred in 43 patients receiving combination therapy (4.0%) as compared with 13 patients receiving antiplatelet therapy alone (1.2%) (relative risk, 3.41; 95% CI, 1.84 to 6.35; P<0.001).
Conclusions:
In patients with peripheral arterial disease, the combination of an oral anticoagulant and antiplatelet therapy was not more effective than antiplatelet therapy alone in preventing major cardiovascular complications and was associated with an increase in life-threatening bleeding. (ClinicalTrials.gov number, NCT00125671 [ClinicalTrials.gov].).
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