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Antiplatelet therapy with or without anticoagulant therapy for lower extremity peripheral artery disease: A
Donna Rahmatian1, Arden R Barry2
1(PharmD for Pharmacists student), Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Canada, and St. Paul's Hospital, Lower Mainland Pharmacy Services, Vancouver, Canada.
Insights
Dual-pathway inhibition using low-dose rivaroxaban and aspirin may reduce adverse events in peripheral artery disease (PAD) patients. However, increased bleeding risk suggests questionable net clinical benefit, warranting careful consideration.
Area of Science:
- Cardiovascular Medicine
- Vascular Surgery
- Pharmacology
Background:
- Lower extremity peripheral artery disease (PAD) affects millions globally.
- Optimal medical therapy for PAD, particularly post-revascularization, remains an area of active research.
- Balancing thrombotic and bleeding risks is crucial in PAD management.
Purpose of the Study:
- To systematically review randomized controlled trials (RCTs) comparing antiplatelet monotherapy with combination antiplatelet plus anticoagulant therapy.
- To evaluate the efficacy and safety of these strategies regarding major adverse cardiovascular events (MACE), major adverse limb events (MALE), death, and bleeding in patients with lower extremity PAD.
Main Methods:
- Systematic literature search of MEDLINE, Embase, and CENTRAL databases.
- Inclusion of 5 RCTs: 2 in stable PAD, 3 in PAD post-revascularization.
- Analysis of outcomes including MACE, MALE, death (cardiovascular, all-cause), and bleeding events.
Main Results:
- Combination therapy with warfarin and antiplatelets did not reduce MACE/MALE or death but increased bleeding in stable PAD.
- Low-dose rivaroxaban plus antiplatelets reduced MACE/MALE in stable PAD but increased major bleeding.
- In PAD post-revascularization, warfarin plus antiplatelets showed no MACE/MALE benefit and increased bleeding/death.
- Low-dose rivaroxaban plus aspirin reduced MACE/MALE in PAD post-revascularization but increased bleeding.
Conclusions:
- Dual-pathway inhibition with low-dose rivaroxaban and aspirin demonstrates potential for reducing MACE and MALE in both stable and revascularized PAD.
- The observed increase in major bleeding necessitates careful evaluation of the net clinical benefit.
- Further research may be needed to optimize antithrombotic strategies in PAD while minimizing bleeding complications.
Purpose:
To identify randomized controlled trials that compared antiplatelet monotherapy to combination antiplatelet plus anticoagulant therapy and evaluated major adverse cardiovascular events (MACE) or major adverse limb events (MALE), death, or bleeding in patients with lower extremity peripheral artery disease (PAD).
Summary:
A systematic search of MEDLINE, Embase, and CENTRAL databases revealed 5 trials. Two trials consisted of patients with stable PAD, while 3 trials examined patients with PAD post revascularization. Antiplatelet therapy was mostly aspirin (81-325 mg daily), and anticoagulation included rivaroxaban 2.5 mg twice daily or warfarin. Duration of follow-up ranged from 12 to 38 months. Two trials had low risk of bias, whereas 3 trials had high/unclear risk of bias. For patients with stable PAD, one trial showed that use of warfarin (or acenocoumarol) with antiplatelet therapy did not reduce MACE, MALE, or cardiovascular or all-cause death but increased the risk of life-threatening bleeding. A second trial demonstrated that low-dose rivaroxaban plus antiplatelet therapy lowered the risk of MACE and MALE, with no effect in preventing cardiovascular or all-cause death, but increased the risk of major bleeding. For patients with PAD post revascularization receiving warfarin and antiplatelet therapy, 2 trials showed no benefit in MACE or MALE but increased or similar rates of all-cause death and major bleeding. In a third trial, low-dose rivaroxaban plus aspirin reduced occurrence of the composite of MACE and MALE but increased major bleeding, with no effect on cardiovascular or all-cause death.
Conclusion:
Dual-pathway inhibition with low-dose rivaroxaban and aspirin reduced MACE and MALE in patients with stable or revascularized PAD, but net clinical benefit is questionable.
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