Log in to MyACC
Peripheral Artery Disease Revascularization With Rivaroxaban and Clopidogrel
Quick Takes
- The efficacy of rivaroxaban 2.5 mg plus aspirin following PAD revascularization was similar with and without clopidogrel use.
- Bleeding risk can likely be minimized if shorter courses of clopidogrel are used in addition to rivaroxaban and aspirin after PAD revascularization.
Study Questions:
How does use of clopidogrel following peripheral artery disease (PAD) revascularization modify the efficacy and safety of rivaroxaban plus aspirin use?
Methods:
The authors performed a subgroup analysis of the VOYAGER PAD randomized trial. This trial randomized patients with symptomatic PAD undergoing lower extremity revascularization to receive rivaroxaban 2.5 mg twice daily plus aspirin 100 mg daily or placebo plus aspirin. The primary efficacy outcome was a composite of acute limb ischemia, major amputation from a vascular cause, myocardial infarction, ischemic stroke, or cardiovascular death. The primary safety outcome was Thrombolysis in Myocardial Infarction (TIMI) major bleeding. International Society on Thrombosis and Haemostasis (ISTH) major bleeding was a secondary safety outcome. Clopidogrel use was allowed at the discretion of the investigator (up to 6 months). Comparisons between patients using and not using clopidogrel were performed using interaction p values and logistic regression.
Results:
Clopidogrel use was documented in 3,313/6,547 (50.6%) patients for a median duration of 29.0 days. Over 3 years, hazard ratios (HRs) for the primary efficacy were similar in both patients taking clopidogrel (HR, 0.85; 95% confidence interval [CI], 0.71-1.01) and patients not taking clopidogrel (HR, 0.86; 95% CI, 0.73-1.01) without evidence of statistical heterogeneity (p for interaction = 0.92). Reductions in early acute limb ischemia (within 30 days) were seen in patients randomized to rivaroxaban in both those taking clopidogrel (HR, 0.45; 95% CI, 0.14-1.46) and those not taking clopidogrel (HR, 0.48; 95% CI, 0.22-1.01; p for interaction = 0.93). The risk of TIMI major bleeding was similar between patients taking and not taking clopidogrel who were randomized to receive rivaroxaban (p for interaction = 0.71). ISTH-defined major bleeding was more common in patients randomized to rivaroxaban versus placebo if clopidogrel was used for >30 days (HR, 3.20; 95% CI, 1.44-7.13) but not if clopidogrel use was <30 days (HR, 1.30; 95% CI, 0.68-2.47).
Conclusions:
The authors concluded that the safety of rivaroxaban plus aspirin following PAD revascularization was consistent regardless of clopidogrel use. They also concluded that major bleeding may be more prevalent among patients with longer courses of clopidogrel use.
Perspective:
The VOYAGER PAD study provided critical safety and efficacy data around the use of a dual pathway approach to managing patients with PAD. This analysis provides further support that dual pathway inhibition can be safely used in addition to more potent antiplatelet therapy. This is critical for many proceduralists and surgeons who feel that dual antiplatelet therapy is necessary immediately following PAD revascularization. The study suggests that if rivaroxaban 2.5 mg twice daily and dual antiplatelet regimens are to be used concurrently, they should be limited to <30 days following revascularization. After that time, continued use of rivaroxaban plus aspirin is probably best given the results of both the VOYAGER PAD and COMPASS studies.
Clinical Topics: Anticoagulation Management, Cardiac Surgery, Cardiovascular Care Team, Invasive Cardiovascular Angiography and Intervention, Vascular Medicine, Atherosclerotic Disease (CAD/PAD), Interventions and Vascular Medicine
Keywords: Anticoagulants, Aspirin, Hemorrhage, Myocardial Infarction, Myocardial Ischemia, Myocardial Revascularization, Peripheral Arterial Disease, Peripheral Vascular Diseases, Platelet Aggregation Inhibitors, Stroke, Vascular Diseases
< Back to Listings
