
Researchers reported that “assessing total arterial and venous thrombotic events, not just first events, provides more complete information about disease burden and absolute on-treatment impact” in patients with peripheral arterial disease (PAD) after they undergo lower extremity revascularization (LER). The data was collected in the VOYAGER PAD trial and published in the Journal of Thrombosis and Haemostasis. Primary investigator, Scott D. Berkowitz, further reported that “following LER, judicious modulation of more than one coagulation pathway can provide broader benefit than intensifying inhibition of one hemostatic system component.”
The VOYAGER PAD trial randomized 6,564 patients with symptomatic PAD undergoing LER to groups receiving either rivaroxaban 2.5 mg twice-daily or a placebo with aspirin background. Hazard ratios (HR) were calculated for first and total thrombotic events and incidence rate was calculated in number of events per 100 patient-years of follow-up.
PAD After Lower Extremity Revascularization Findings
Reportedly, over a median of 2.5 years of follow-up, the rate of first and total arterial and venous thrombotic event was 5.4 and 7.9 per 100 patients-years, respectively, for the rivaroxaban and aspirin group, compared to 7.1 and 10.3 respective first and total events per 100 patient-years in the control group. Authors provided that this was a 23% reduction in total thrombotic events versus aspirin (HR = 0.77; 95% confidence interval [CI], 0.67–0.89; p = 0.0005), “preventing 6.1 total arterial and venous thrombotic events at 3 years.”
Additionally, Berkowitz and colleagues noted that “two-thirds (925/1372) of total thrombotic events (arterial 95%, venous 5%) were nonfatal first events,” and that “nearly one-third of patients with first event had a second arterial or venous thrombotic event.”
The authors provided a list of “essential” takeaways, highlighting the observed efficacy of rivaroxaban and aspirin, the value of analyzing total thrombotic events, and that “more than one hemostatic pathway is involved in atherosclerotic vessel thrombotic events.”
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