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The surgery was a success, but what else can be done to protect Roberto?
Unfortunately, ignoring the symptoms of lower limb ischaemia will not make the pain go away. As many as 1 in 20 patients suffering from PAD-induced claudication experience a worsening of their lower limb pain within 2 years, with a similar number of these patients requiring a peripheral angioplasty or stenting over the same timeframe.
Furthermore, patients like Roberto will often need another procedure, given that 1 in 7 patients who have already undergone a revascularization procedure will require a re‑intervention within 2 years.1 Revascularization has also been associated with increased risks of acute limb ischaemia and major amputation.2 This risk suggests that patients undergoing revascularization will require enhanced protection from ischaemic events.
Patients following revascularization are at a high risk of needing re-intervention1
Although the need for enhanced protection from ischaemic events in patients like Roberto is clear, there is a clinical uncertainty surrounding antithrombotic treatment in patients with symptomatic PAD.3 However, recent data from the VOYAGER PAD study have shown that dual pathway inhibition with rivaroxaban vascular dose 2.5 mg twice daily (bid) plus low-dose aspirin may offer a new option for antithrombotic therapy for patients with PAD after revascularization.
VOYAGER PAD was an international, phase III, randomized, placebo‑controlled, double‑blind clinical trial.4 It evaluated the efficacy and safety of rivaroxaban 2.5 mg bid plus aspirin compared with aspirin alone in patients with symptomatic PAD undergoing lower-extremity peripheral revascularization. The study recruited 6564 patients with a history of symptomatic PAD who had undergone a lower-extremity peripheral revascularization within 10 days before the treatment initiation. Of these patients, 3286 received rivaroxaban 2.5 mg bid plus aspirin and 3278 received aspirin alone. Clopidogrel was administered per investigators’ discretion.
Rivaroxaban 2.5 mg bid plus aspirin was associated with a significant 15% risk reduction in the primary outcome (composite of myocardial infarction, ischaemic stroke, cardiovascular death, acute limb ischaemia and major amputation of vascular aetiology) compared with aspirin alone (19.9% vs 17.3%; HR=0.85; 95% CI 0.76–0.96; p=0.0085). This represents a clear benefit in reducing the risk of major cardiovascular and limb events in this high-risk patient group.
Importantly, no statistically significant difference in TIMI major bleeding was observed between the two study arms (HR=1.43; 95% CI 0.97–2.10; p=0.0695).5
Primary efficacy outcome and safety outcome in VOYAGER PAD trial5
The results of VOYAGER PAD complement those of the COMPASS trial, in which rivaroxaban 2.5 mg bid plus aspirin reduced the risk of atherothrombotic events in patients with chronic PAD compared with aspirin.6
What does that mean for patients like Roberto? Previously, there was a lack of evidence-based treatment regimens to protect him from devastating cardiovascular and limb events. However, following VOYAGER PAD, there is compelling new evidence that dual pathway inhibition is an effective treatment option for patients with a recent lower-extremity revascularization. Therefore, dual pathway inhibition can continue to offer protection from atherothrombotic events after the patients have left the surgeons’ care.