Use of apixaban and rivaroxaban in young adults with acute venous thromboembolism: a multi-center retrospective case series

DeCamillo, Deborah; Ellsworth, Stacy; Kaatz, Scott; Barnes, Geoffrey D.

doi:10.1007/s11239-020-02095-7

Cited by 7 publications

(4 citation statements)

References 7 publications

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“…24 For all patients treated with apixaban in the AMPLIFY trial, the 30-day rate of severe bleeding was ≈0.2% and the rate of clinically relevant nonmajor bleeding was 3.8%. 35,36 In comparison to data obtained from a more real-world setting, our findings are similar to the 14% rate of any bleeding that DeCamillo et al 37 found in retrospective chart review of VTE patients treated with either apixaban or rivaroxaban from 2 institutions. In a retrospective study of 671 VTE patients treated apixaban for 27 In the present work, in Table 4, question 3, it is likely that many of the 10.5% who had unscheduled care stated as "because of" bleeding also had other reasons that they sought unscheduled care, but we did not measure these possible confounders.…”

Section: Discussionsupporting

confidence: 85%

“…24 For all patients treated with apixaban in the AMPLIFY trial, the 30-day rate of severe bleeding was ≈0.2% and the rate of clinically relevant nonmajor bleeding was 3.8%. 35,36 In comparison to data obtained from a more real-world setting, our findings are similar to the 14% rate of any bleeding that DeCamillo et al 37 found in retrospective chart review of VTE patients treated with either apixaban or rivaroxaban from 2 institutions. In a retrospective study of 671 VTE patients treated apixaban for usual care, with 74% treated as outpatients, and outcomes assessed at 3 months, Hendriks et al 38 found a 0.3% (95% CI, 0.08%–1.1%) rate of VTE recurrence, but considerable higher 1.8% (95% CI, 0.9%–2.9%) rate of ISTH defined major bleeding.…”

Section: Discussionsupporting

confidence: 80%

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Monotherapy Anticoagulation to Expedite Home Treatment of Patients Diagnosed With Venous Thromboembolism in the Emergency Department: A Pragmatic Effectiveness Trial

Kline

Adler

Alanis

et al. 2021

Circ: Cardiovascular Quality and Outcomes

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BACKGROUND: The objective was to test if low-risk emergency department patients with vitamin K antagonist (venous thromboembolism [VTE]; including venous thrombosis and pulmonary embolism [PE]) can be safely and effectively treated at home with direct acting oral (monotherapy) anticoagulation in a large-scale, real-world pragmatic effectiveness trial. METHODS: This was a single-arm trial, conducted from 2016 to 2019 in accordance with the Standards for Reporting Implementation Studies guideline in 33 emergency departments in the United States. Participants had newly diagnosed VTE with low risk of death based upon either the modified Hestia criteria, or physician judgment plus the simplified PE severity index score of zero, together with nonhigh bleeding risk were eligible. Patients had to be discharged within 24 hours of triage and treated with either apixaban or rivaroxaban. Effectiveness was defined by the primary efficacy and safety outcomes, image-proven recurrent VTE and bleeding requiring hospitalization >24 hours, respectively, with an upper limit of the 95% CI for the 30-day frequency of VTE recurrence below 2.0% for both outcomes. RESULTS: We enrolled 1421 patients with complete outcomes data, including 903 with venous thrombosis and 518 with PE. The recurrent VTE requiring hospitalization occurred in 14/1421 (1.0% [95% CI, 0.5%–1.7%]), and bleeding requiring hospitalization occurred in 12/1421 (0.8% [0.4%–1.5%). The rate of severe bleeding using International Society for Thrombosis and Haemostasis criteria was 2/1421 (0.1% [0%–0.5%]). No patient died, and serious adverse events occurred in 2.5% of venous thrombosis patients and 2.3% of patients with PE. Medication nonadherence was reported by patients in 8.0% (6.6%–9.5%) and was associated with a risk ratio of 6.0 (2.3–15.2) for VTE recurrence. Among all patients diagnosed with VTE in the emergency department during the period of study, 18% of venous thrombosis patients and 10% of patients with PE were enrolled. CONCLUSIONS: Monotherapy treatment of low-risk patients with venous thrombosis or PE in the emergency department setting produced a low rate of bleeding and VTE recurrence, but may be underused. Patients with venous thrombosis and PE should undergo risk-stratification before home treatment. Improved patient adherence may reduce rate of recurrent VTE. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03404635

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Section: Discussionsupporting

confidence: 85%

“…24 For all patients treated with apixaban in the AMPLIFY trial, the 30-day rate of severe bleeding was ≈0.2% and the rate of clinically relevant nonmajor bleeding was 3.8%. 35,36 In comparison to data obtained from a more real-world setting, our findings are similar to the 14% rate of any bleeding that DeCamillo et al 37 found in retrospective chart review of VTE patients treated with either apixaban or rivaroxaban from 2 institutions. In a retrospective study of 671 VTE patients treated apixaban for usual care, with 74% treated as outpatients, and outcomes assessed at 3 months, Hendriks et al 38 found a 0.3% (95% CI, 0.08%–1.1%) rate of VTE recurrence, but considerable higher 1.8% (95% CI, 0.9%–2.9%) rate of ISTH defined major bleeding.…”

Section: Discussionsupporting

confidence: 80%

Monotherapy Anticoagulation to Expedite Home Treatment of Patients Diagnosed With Venous Thromboembolism in the Emergency Department: A Pragmatic Effectiveness Trial

Kline

Adler

Alanis

et al. 2021

Circ: Cardiovascular Quality and Outcomes

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“…DeCamillo et al confirmed a high incidence of vaginal/heavy menstrual bleeding (71.4% of all bleeding events) among young females treated with rivaroxaban or apixaban for acute VTE,; particularly, four patients out of five with abnormal uterine bleeding were undergoing rivaroxaban. 96 Thus, female patients should be alerted of this possible side effect when prescribing anticoagulation with factor Xa inhibitors. Possible options to reduce this complication may be (1) to recommend antifibrinolytic therapy during severe menstrual bleeding; (2) to consider changing anticoagulation therapy toward dabigatran; (3) to consider reducing anti-Xa inhibitors to low-dose (at least 3 months after the index event); (4) to consider changing anticoagulation therapy toward VKAs; (5) to combine estrogen–progestogen therapy while on full dose anticoagulation.…”

Section: Acute Management Of Vte and Secondary Prevention In Heredita...mentioning

confidence: 99%

Evolving Knowledge on Primary and Secondary Prevention of Venous Thromboembolism in Carriers of Hereditary Thrombophilia: A Narrative Review

Campello

Prandoni²

2022

Semin Thromb Hemost

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The association between heritability of venous thromboembolism (VTE) and thrombophilia was first reported clinically in 1956, later followed by the first description of a congenital cause of hypercoagulability—antithrombin deficiency—in 1965. Since then, our knowledge of hereditary causes of hypercoagulability, which may predispose carriers to VTE has improved greatly. Novel genetic defects responsible for severe thrombophilia have been recently identified and we have learned that a wide range of interactions between thrombophilia and other genetic and acquired risk factors are important determinants of the overall individual risk of developing VTE. Furthermore, therapeutic strategies in thrombophilic patients have benefited significantly from the introduction of direct oral anticoagulants. The present review is an overview of the current knowledge on the mechanisms underlying inherited thrombophilia, with a particular focus on the latest achievements in anticoagulation protocols and prevention strategies for thrombosis in carriers of this prothrombotic condition.

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“…Patients were ineligible if they had received unfractionated heparin (UFH), low-molecular-weight heparin (LMWH) or fondaparinux for over 48 h, or if they had creatinine clearance (CrCl) levels < 30 mL/min, a high risk of bleeding, or a life expectancy of <3 months. However, prior studies performed in patients with venous thromboembolism (VTE) [ 4 , 5 , 6 , 7 , 8 , 9 ] and atrial fibrillation [ 10 , 11 , 12 , 13 , 14 ] found that in clinical practice, the use of DOACs deviates from manufacturer prescribing information by rates of 17% to 50%. Although prescribers may have valid reasons for using off-label DOACs, no studies have yet demonstrated an association between this practice and improved outcomes.…”

Section: Introductionmentioning

confidence: 99%

Rivaroxaban Monotherapy in Patients with Pulmonary Embolism: Off-Label vs. Labeled Therapy

Micco¹,

Rosa

Capitán

et al. 2022

Life

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Background: The use of rivaroxaban in clinical practice often deviates from manufacturer prescribing information. No studies have demonstrated an association between this practice and improved outcomes. Methods: We used the RIETE registry to assess the clinical characteristics of patients with pulmonary embolism (PE) who received off-label rivaroxaban, and to compare their 3-month outcomes with those receiving the labeled therapy. The patients were classified into four subgroups: (1) labeled therapy; (2) delayed start; (3) low doses and (4) both conditions. Results: From May 2013 to May 2022, 2490 patients with PE received rivaroxaban: labeled therapy—1485 (58.6%); delayed start—808 (32.5%); low doses—143 (5.7%); both conditions—54 (2.2%). Patients with a delayed start were more likely to present with syncope, hypotension, raised troponin levels and more severe abnormalities on the echocardiogram than those on labeled therapy. Patients receiving low doses were most likely to have cancer, recent bleeding, anemia, thrombocytopenia or renal insufficiency. During the first 3 months, 3 patients developed PE recurrence, 4 had deep-vein thrombosis, 11 had major bleeding and 16 died. The rates of major bleeding (11 vs. 0; p < 0.001) or death (15 vs. 1; OR: 22.5; 95% CI: 2.97–170.5) were higher in patients receiving off-label rivaroxaban than in those on labeled therapy, with no differences in VTE recurrence (OR: 1.11; 95% CI: 0.25–6.57). Conclusions: In patients with severe PE, the start of rivaroxaban administration was often delayed. In those at increased risk for bleeding, it was often prescribed at low doses. Both subgroups had a worse outcome than those on labeled rivaroxaban.

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Use of apixaban and rivaroxaban in young adults with acute venous thromboembolism: a multi-center retrospective case series

Cited by 7 publications

References 7 publications

Monotherapy Anticoagulation to Expedite Home Treatment of Patients Diagnosed With Venous Thromboembolism in the Emergency Department: A Pragmatic Effectiveness Trial

Monotherapy Anticoagulation to Expedite Home Treatment of Patients Diagnosed With Venous Thromboembolism in the Emergency Department: A Pragmatic Effectiveness Trial

Evolving Knowledge on Primary and Secondary Prevention of Venous Thromboembolism in Carriers of Hereditary Thrombophilia: A Narrative Review

Rivaroxaban Monotherapy in Patients with Pulmonary Embolism: Off-Label vs. Labeled Therapy

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