Xarelto plus Acetylsalicylic acid: Treatment patterns and Outcomes in patients with Atherosclerosis (XATOA): Rationale and design of a prospective registry study to assess rivaroxaban 2.5 mg twice daily plus aspirin for prevention of atherothrombotic events in coronary artery disease, peripheral artery disease, or both

Fox, Keith A; Anand, Sonia S.; Aboyans, Victor; Cowie, Martin R.; Debus, Eike Sebastian; Zeymer, Uwe; Monje, Danja; Vogtländer, Kai; Lawatscheck, Robert

doi:10.1016/j.ahj.2020.01.015

Cited by 15 publications

(12 citation statements)

References 22 publications

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“…However, other studies will assess ischemic and bleeding outcomes in patients with CAD, PAD, or both, receiving rivaroxaban 2.5 mg twice daily plus ASA. This is the case of the 'Xarelto plus Acetylsalicylic acid: Treatment patterns and Outcomes in patients with Atherosclerosis (XATOA)' registry, which will include up to 10,000 patients from at least 400 centers in 22 countries [65].…”

Section: Where Are We Now? Using Rivaroxaban In Peripheral Artery Diseasementioning

confidence: 99%

Antithrombotic Therapy in Patients with Peripheral Artery Disease: A Focused Review on Oral Anticoagulation

Rivera‐Caravaca

Camelo-Castillo

Ramírez-Macías

et al. 2021

IJMS

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Peripheral artery disease (PAD) is a major cause of morbidity and mortality but it is usually underdiagnosed and undertreated. Patients with PAD present dysregulated procoagulant, anticoagulant, and fibrinolytic pathways leading to arterial and venous thrombosis. The risk of several ischemic-related complications could be mitigated with appropriate antithrombotic therapy, which plays a central role in all types of PAD. For years, antiplatelets have been indicated in patients with symptomatic PAD or those who have undergone revascularization. Unfortunately, a non-negligible proportion of patients with PAD will suffer from adverse events during the follow-up, even despite proper medical therapies for the prevention of PAD complications. Thus, there is room for improving clinical outcomes in these patients. Given the implication of both, primary and secondary hemostasis in arterial thrombosis and the pathophysiology of PAD, the combination of antiplatelets and anticoagulants has emerged as a potential antithrombotic alternative to antiplatelets alone. In this narrative review article, we have highlighted the most recent evidence about antithrombotic therapy in PAD patients, with a special focus on oral anticoagulation. Certainly, COMPASS and VOYAGER PAD trials have shown promising results. Thus, rivaroxaban in combination with aspirin seem to reduce cardiovascular outcomes with a similar bleeding risk compared to aspirin alone. Nevertheless, results from real-world studies are needed to confirm these observations, and other trials will provide novel evidence about the safety and efficacy of emerging anticoagulant agents.

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Section: Where Are We Now? Using Rivaroxaban In Peripheral Artery Diseasementioning

confidence: 99%

Antithrombotic Therapy in Patients with Peripheral Artery Disease: A Focused Review on Oral Anticoagulation

Rivera‐Caravaca

Camelo-Castillo

Ramírez-Macías

et al. 2021

IJMS

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“…17 RWD can complement the results of phase III RCTs by providing insight into their applicability to clinical practice and informing health technology assessment bodies and payers. 16 In the present study, only 30.1% of the COPART evaluable cohort was eligible for the rivaroxaban 2.5 mg twice daily plus aspirin regimen. VOYAGER-PAD criteria did not allow more patients to be eligible for this regimen than COMPASS criteria alone.…”

Section: Discussionmentioning

confidence: 96%

“…This is an aim of the prospective post-approval XATOA registry study (Xarelto plus Acetylsalicylic acid: Treatment patterns and Outcomes in patients with Atherosclerosis). 16 There are limitations to this analysis. Because the COPART registry recruited patients from 2006 to 2015 (recent data being entered), the management and prognosis of some patients could be different from what is currently observed.…”

Section: Discussionmentioning

confidence: 97%

“…1,9,10 Moreover, new therapies may be used in a broader patient population in clinical practice than that enrolled in the RCTs, and the regulatory approval may also extend beyond the inclusion and exclusion criteria of the trials. 16 The application of real world data (RWD), mostly drawn from registries, to support drug approvals is now accepted by regulatory authorities such as the EMA and the U.S. Food and Drug Administration. 17 RWD can complement the results of phase III RCTs by providing insight into their applicability to clinical practice and informing health technology assessment bodies and payers.…”

Section: Discussionmentioning

confidence: 99%

“…Patients with lower extremity artery disease (LEAD) are at heightened risk of major adverse cardiovascular events (MACE), including cardiovascular (CV) death, myocardial infarction (MI), and stroke, and are also at increased risk of all cause mortality. Despite antithrombotic therapy, the one year cumulative incidence of MACE is at least 12%, and is as high as 16.8% after revascularisation for chronic limb threatening ischaemia (CLTI). 1,2 Limb related event rates are also high.…”

Section: Introductionmentioning

confidence: 99%

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Editor's Choice – External Applicability of the COMPASS and VOYAGER-PAD Trials on Patients with Symptomatic Lower Extremity Artery Disease in France: The COPART Registry

Lapébie

Aboyans

Lacroix

et al. 2021

European Journal of Vascular and Endovascular Surgery

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WHAT THIS PAPER ADDS Only 30.1% of patients hospitalised for symptomatic lower extremity artery disease are eligible for rivaroxaban 2.5 mg twice daily plus aspirin, based on the COMPASS or VOYAGER-PAD criteria. These patients have higher rates of ischaemic events than those in these trials. The one year cumulative incidences were 6.0% (95% confidence interval [CI] 4.3 e 8.1) in the COMPASS eligible subset vs. 3.5% (95% CI 2.9 e 4.3) in the COMPASS control arm for major adverse cardiovascular events, and 27.9% (95% CI 19.9 e 38.3) in the VOYAGER-PAD eligible subset vs. 6.0% (95% CI 5.3 e 6.9) in the VOYAGER-PAD control arm for major adverse limb events. This regimen may have greater benefits in the real world population.Objective: The aim of this study was to examine the external applicability of the COMPASS and the VOYAGER-PAD trials in patients with lower extremity artery disease (LEAD) in the real world. Methods: This was a multicentre retrospective analysis of prospectively collected COPART data, a French multicentre registry of patients hospitalised for symptomatic LEAD. The proportion of patients eligible for the combination of rivaroxaban 2.5 mg twice daily plus aspirin based on either COMPASS or VOYAGER-PAD criteria is reported. The one year cumulative incidence of outcomes between eligible and non-eligible patients, as well as eligible patients vs. control arms of the COMPASS (LEAD patient subgroup) and the VOYAGER-PAD trials were compared. Analyses were performed using Cox models. Results: Of 2 259 evaluable patients, only 679 (30.1%) were eligible for a low dose rivaroxaban plus aspirin regimen. Others were not eligible because of the need for anticoagulant (48.5% and 38.9% of patients meeting COMPASS and VOYAGER-PAD exclusion criteria, respectively) or dual antiplatelet therapy use (15.7% and 16.5%, respectively), high bleeding risk (14.4% and 11.6%, respectively), malignancy (26.1% and 21.0%, respectively), history of ischaemic/haemorrhagic stroke (21.1% and 19.8%, respectively), and severe renal failure (13.2% and 10.5%, respectively). COMPASS and VOYAGER-PAD eligible and ineligible patients were at higher risk of ischaemic events than participants in these trials. The one year cumulative incidences were 6.0% (95% CI 4.3 e 8.1) in the COMPASS eligible subset vs. 3.5% (95% CI 2.9 e 4.3) in the COMPASS control arm for major adverse cardiovascular events, and 27.9% (95% CI 19.9 e 38.3) in the VOYAGER-PAD eligible subset vs. 6.0% (95% CI 5.3 e 6.9) in the VOYAGER-PAD control arm for major adverse limb events.

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Rivaroxaban: A Review for Secondary CV Prevention in CAD and PAD

Scott

2020

Drugs

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Cited by 15 publications

References 22 publications

Antithrombotic Therapy in Patients with Peripheral Artery Disease: A Focused Review on Oral Anticoagulation

Antithrombotic Therapy in Patients with Peripheral Artery Disease: A Focused Review on Oral Anticoagulation

Editor's Choice – External Applicability of the COMPASS and VOYAGER-PAD Trials on Patients with Symptomatic Lower Extremity Artery Disease in France: The COPART Registry

Rivaroxaban: A Review for Secondary CV Prevention in CAD and PAD

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