Rivaroxaban in Peripheral Artery Disease after Revascularization

Bonaca, Marc P.; Bauersachs, Rupert; Anand, Sonia S.; Debus, Eike Sebastian; Nehler, Mark R.; Patel, Manesh R.; Fanelli, Fabrizio; Capell, Warren H.; Diao, Lihong; Jaeger, Nicole; Hess, Connie N.; Pap, Á; Kittelson, John M.; Gudz, Ivan; Mátyás, Lajos; Krieviņš, Dainis; Dı́az, Rafael; Brodmann, Marianne; Muehlhofer, Eva; Haskell, Lloyd; Berkowitz, Scott D.; Hiatt, William R.

doi:10.1056/nejmoa2000052

Cited by 614 publications

(310 citation statements)

References 29 publications

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“…In patients with established PAD, the COMPASS-PAD study [50] demonstrated a relevant reduction in major adverse limb events (1.5% for rivaroxaban plus aspirin vs. 2.6% for aspirin alone), but again with a significant increase in major bleeding (3.0 vs. 2.0%). Similar observations were reported from the recent VOYAGER PAD trial in patients with symptomatic PAD who had undergone lower extremity revascularization [51].…”

Section: Heart Failuresupporting

confidence: 87%

Necessity of Antiaggregation and Anticoagulation and Its Prognostic Impact: A Cardiologist’s View

Hink

Voigtländer

2020

Visc Med

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Background: In modern cardiology, anticoagulation and antiaggregation are key components of current treatment strategies. However, in patients treated with anticoagulation and antiplatelet substances, bleeding is a major risk. Findings: In all major cardiovascular diseases, a multitude of studies have shown a positive impact of antithrombotic treatment on cardiovascular death. In patients with higher bleeding risks, recent studies showed the safety of reducing the period of dual antiplatelet therapy (DAPT), i.e., after percutaneous coronary intervention. In patients with coronary artery disease and atrial fibrillation (AF), triple therapy including DAPT and anticoagulation is associated with very high bleeding risks. However, recently published data showed the safety of direct oral anticoagulants (DOACs) and P2Y12 inhibitors only compared to vitamin K antagonist (VKA) and DAPT. Anticoagulation in nonvalvular AF reduces major cerebrovascular ischemic events. However, the inherent cerebrovascular bleeding risk is an important concern of this treatment. With the advent of DOACs, this risk could be reduced compared to VKA. Furthermore, anticoagulation and antiaggregation are crucial after treatment of valve disease, both after surgical and interventional procedures. Even in heart failure, new data show benefits using antithrombot-ic substances. Conclusions: Anticoagulation and antiaggregation are of major prognostic relevance in cardiovascular diseases. However, the inherent bleeding risk has to be considered.

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Section: Heart Failuresupporting

confidence: 87%

Necessity of Antiaggregation and Anticoagulation and Its Prognostic Impact: A Cardiologist’s View

Hink

Voigtländer

2020

Visc Med

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“…Given the slight differences in each of the four trials, the authors provided three different grouped analyses of the data. When assessing the [26][27][28][29][30] EINSTEIN [32][33][34][35] ROCKET AF [36] COMPASS [38] VOYAGER-PAD [39] Study population effects of weight on the primary outcomes across the four trials, the "total treatment duration pool" was used. From this pool, the safety population, which excluded patients who were randomized but did not receive any study medication, included 12,383 patients (6183 in the rivaroxaban group and 6200 in the enoxaparin group) and was used for this analysis [30].…”

Section: Prophylaxis Of Deep Vein Thrombosis (Dvt) After Hip or Knee mentioning

confidence: 99%

“…Further expanding the knowledge of rivaroxaban use in PAD, another phase III study assessed the use of rivaroxaban in patients with PAD who underwent lower-extremity revascularization [39]. VOYAGER-PAD was a randomized, double-blind clinical trial in which 6564 patients received either rivaroxaban 2.5 mg twice daily plus aspirin (N = 3286) or placebo plus aspirin (N = 3278).…”

Section: Reduction Of Risk Of Major Adverse Cardiovascular Events (Mamentioning

confidence: 99%

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The Pharmacology, Efficacy, and Safety of Rivaroxaban in Obese Patient Populations

Ashton

Mudarris

Moore

2020

Am J Cardiovasc Drugs

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Cardiovascular disease (CVD) remains the leading cause of death in the USA. Several risk factors have been identified, and obesity has become one of prominent concern. Excessive weight is considered a risk factor for CVD based on evidence linking it to a hypercoagulable state. Considering the prevalence of CVD and obesity in the USA, along with the increased risk for thrombus-related events, anticoagulation plays a significant role in prevention and treatment. Direct oral anticoagulants have taken the place of many traditional anticoagulants. Considering the recently approved indications and continued postmarketing studies conducted with rivaroxaban, this updated review provides data on the overall impact of obesity on this compound. This includes data obtained from both healthy obese volunteers and obese patients with various CVD conditions enrolled in rivaroxaban clinical trials, along with data obtained from postmarketing real-world evidence studies. Assessment of the clinical pharmacology and population pharmacokinetics in obese individuals revealed no clinically relevant effects of increased weight. Additionally, subgroup analyses from each of the pivotal phase III trials supporting the current approved labeling also demonstrated consistent efficacy and safety results in obese patients. Lastly, these findings are further supported by several recent real-world evidence studies assessing the continued effectiveness and safety of rivaroxaban. In conclusion, rivaroxaban's overall pharmacological and clinical profile remained consistent in obese adults when assessed in both drug development and postmarketing studies, supporting the premise that higher weight does not necessitate adjustment in either dose strength or regimen. Key Points Obesity is a prominent risk factor for cardiovascular disease (CVD) in the USA, and anticoagulation plays a significant role in the prevention and treatment of cardiovascular conditions.

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“…Bleeding was mainly gastrointestinal (1.6% versus 0.7%; p=0.03) with few intracranial (0.2% versus 0.4%) or fatal haemorrhages (0.2% versus 0.1%). 20 In this trial, 6,564 patients were recruited and blindly randomised with 3,286 assigned to the rivaroxaban group and 3,278 assigned to the placebo group. Results showed acute limb ischaemia and limb loss for vascular causes were significantly lower in the rivaroxaban group at 28 months (acute limb ischaemia: 4.7% versus 6.9%; major amputation: 3.1% versus 3.5% for rivaroxaban versus placebo group, respectively; p<0.001).…”

Section: Warfarin and Other Coumarinsmentioning

confidence: 99%

Anticoagulation in Peripheral Artery Disease: Are We There Yet?

Cannavale

Santoni

Cannavale

et al. 2020

Vascular and Endovascular Review

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Thromboembolism in patients with peripheral artery disease (PAD) represents a common cause of morbidity and mortality. In this article, the authors analyse the use of anticoagulants for patients with PAD. Anticoagulants have been used to reduce the risk of venous thromboembolism, but have recently been applied to the arterial circulation. Heparins were introduced to reduce short-term major adverse limb events in patients undergoing arterial revascularisation. Low molecular weight heparins have allowed easier management and carry a lower risk of bleeding than unfractioned heparin. Vitamin K anticoagulants have been tested in trials that included patients with PAD, showing an increased risk of bleeding when compared with aspirin alone, but longer patency rates for venous surgical bypass, although the evidence remains weak. Those anticoagulants are currently recommended only in patients with PAD who need anticoagulation for other diseases. Direct oral anticoagulants have only recently been investigated for use in patients with PAD. Promising results from low dose rivaroxaban plus aspirin have been recently outlined by a randomised controlled trial and supported by international guidelines.

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Rivaroxaban in Peripheral Artery Disease after Revascularization

Cited by 614 publications

References 29 publications

Necessity of Antiaggregation and Anticoagulation and Its Prognostic Impact: A Cardiologist’s View

Necessity of Antiaggregation and Anticoagulation and Its Prognostic Impact: A Cardiologist’s View

The Pharmacology, Efficacy, and Safety of Rivaroxaban in Obese Patient Populations

Anticoagulation in Peripheral Artery Disease: Are We There Yet?

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