Peripheral Artery Disease

April 3, 2022 – Data presented at the 2022 American College of Cardiology (ACC) sessions showed that rivaroxaban reduced hospitalizations for thromboembolic events in patients with PAD after revascularization with or without chronic kidney disease (CKD). This was a sub-analysis of the VOYAGER-PAD trial, and it was important because the subset of population with CKD may be at even higher risk for hospitalization due to thrombosis after lower extremity revascularization (LER). The absolute benefit with rivaroxaban was higher among patients with CKD at baseline, without increasing the bleeding risk. In the trial, a total of 1327 (21%) patients had CKD at baseline.

More info on the results can be accessed here.

April 3, 2022 – Another sub-analysis of the VOYAGER-PAD trial showed that rivaroxaban vascular dose consistently reduced the composite of MACE (major adverse cardiovascular events) and MALE (major adverse limb events) in PAD patients with or without statin therapy. However, patients that received both rivaroxaban and statins had the lowest cumulative incidence of MALE events. This data suggest that adding statins to rivaroxaban 2.5mg may confer additional benefits for symptomatic PAD patients.

The full results of this sub-analysis can be accessed here.

April 3, 2022 – Connie Hess, MD, during a presentation at the 2022 American College of Cardiology – Vascular Year in Review, highlighted previously published data on the suboptimal use of lipid-lowering therapy (LLT) in patients with PAD. Low-density lipoprotein cholesterol (LDL-C) is an important causative driver of both major adverse cardiovascular events (MACE) and major adverse limb events (MALE) in PAD patients. However, a recent study showed that among 250,103 PAD patients, only 20.5% and 39.5% were treated at baseline with high and low-intensity LLT, respectively, and 40% were on no LLT at all. High-intensity LLT was defined as being on a high-intensity statin, statin + ezetimibe, or PCSK9 inhibitor, and low intensity LLT as any other lipid regimen. As a result, LDL-C goal achievement was suboptimal in these patients, including after a MACE or MALE event. This study highlights the missed opportunities for comprehensive secondary prevention in PAD patients and the increased residual risk for subsequent MACE and MALE events.

The full study can be accessed here.

August 27, 2021 – Results from a pre-specified subgroup analysis of the VOYAGER-PAD trial in patients with PAD and concomitant diabetes were presented at the 2021 European Society of Cardiology (ESC) meeting. The trial monitored the efficacy and safety of rivaroxaban in high-risk PAD patients after lower extremity revascularization (LER). The study result showed that patients with PAD and diabetes mellitus are at extremely high risk of adverse events of heart, limb, and brain after LER, and the efficacy of rivaroxaban 2.5 milligrams twice daily, in addition to low dose aspirin, with or without clopidogrel was similar in a patient with diabetes to the main trial population after LER for symptomatic PAD.

August 27, 2021 – The sex-based differences in the outcomes following peripheral artery revascularization in the VOYAGER-PAD trial were also discussed at the 2021 European Society of Cardiology (ESC) meeting. More than 1700 women had participated in the VOYAGER PAD study, and it was found that, compared to men, women are at higher risk for severe PAD and undergo lower extremity revascularization events. Furthermore, the efficacy and safety of rivaroxaban is similar in both men and women.

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August 27, 2021 – Results from a pre-specified sub-group analysis of the VOYAGER-PAD trial in fragile PAD patients after revascularization were presented at the 2021 European Society of Cardiology (ESC) meeting. The study found that rivaroxaban 2.5 milligram twice daily, in addition to low dose aspirin, with or without clopidogrel, is effective in reducing harmful events of limb, heart, and brain this subgroup of patients, an increase in bleeding (but not fatal bleeding) was also observed. As such, overall there was a net clinical benefit of administering rivaroxaban in these patients. Therefore, this agent can be considered in patients with symptomatic PAD and after LER regardless of age and fragility.

August 27, 2021 – The design and rationale of the STRIDE trial were also presented as a poster at the 2021 European Society of Cardiology (ESC) meeting.  This unique study is evaluating the effects of GLP-1RA semaglutide or other modern T2D drugs on clinical outcomes in patients with PAD and T2D.  The STRIDE study will monitor the impact of semaglutide on important outcomes in PAD patients that affect quality of life and everyday living.  Important outcomes will include walking ability, pain-free walking distance, as well as other PAD-specified and health-related patient-reported outcomes.  The ongoing study is the first and only dedicated PAD outcomes trial with a GLP-1 RA to date.

July 15, 2021 – In a new subgroup analysis of the COMPASS trial, the combination of low-dose rivaroxaban (2.5 mg twice/daily) and aspirin (100 mg once/daily) significantly reduced cardiovascular death compared to aspirin alone in patients with chronic CAD or PAD. Additionally, there were fewer deaths following MI, stroke, or cardiovascular procedures with the combination therapy, as well as fewer sudden cardiac, other, and unknown causes of CV deaths and coronary heart disease deaths. These mortality benefits were greater in patients with a higher baseline risk, supporting the results of the main study, which showed a greater benefit in patients with polyvascular disease, mild or moderate heart failure, chronic kidney disease, and diabetes. The results of this secondary analysis can better inform patient selection for dual pathway inhibition.

The full results of this study can be accessed here »

June 25, 2021 – In a new subgroup analysis of the VOYAGER-PAD trial presented at the 2021 American Diabetes Association (ADA) Scientific Sessions, authors reported that the benefits of rivaroxaban plus aspirin were consistent in PAD patients with critical limb ischemia (CLI) regardless of diabetes mellitus (DM) status. In this trial, 47% of CLI patients had comorbid DM, and the results of the analysis are important because the efficacy and safety of rivaroxaban in these patients was not established. However, because of baseline risk, the absolute benefit was greater in patients with both CLI and DM vs. those with CLI and without comorbid DM.