Efficacy and Safety of Rivaroxaban in Patients with Venous Thromboembolism and Active Malignancy

A Single-center Registry

Dalene M. Bott-Kitslaar, Rayya A. Saadiq, Robert D. McBane, Charles Lawrence Loprinzi, Aneel Arjun Ashrani, Teresa R. Ransone, Alissa A. Wolfgram, Michelle M. Berentsen, Waldemar E. Wysokinski

Research output: Contribution to journalArticle

43 Citations (Scopus)

Abstract

Objective: The purpose of this study is to evaluate the efficacy and safety of rivaroxaban in patients with venous thromboembolism and active malignancy, given the paucity of clinical data with the use of direct Xa inhibitors in this high-risk population. Patients and Methods: Consecutive patients treated with rivaroxaban for deep vein thrombosis or pulmonary embolism, enrolled into Mayo Thrombophilia Clinic Direct Oral Anticoagulants Registry between March 1, 2013, and April 30, 2015, were followed prospectively to evaluate the efficacy and safety of this therapy. Results: Of the 404 venous thromboembolism patients in the registry, 296 received rivaroxaban and had at least 3 months of follow-up. Of these, 118 (40%) had active malignancy (51% female, mean age 66 ± 10 years) and 178 had no cancer (47% female, mean age 55 ± 15 years). The 3 most common cancer locations were genitourinary (23.6%), gastrointestinal (20.3%), and lung (13.5%). There was no difference in venous thromboembolism recurrence between the malignant (3.3%) and the nonmalignant (2.8%) venous thromboembolism groups (P = .533). Borderline higher rates for major bleeding (P = .06) and nonmajor clinically relevant bleeding (P = .08) were observed in patients with cancer. Conclusions: The "real world" effectiveness and safety of rivaroxaban is similar for venous thromboembolism patients with and without active malignancy.

Original languageEnglish (US)
JournalAmerican Journal of Medicine
DOIs
StateAccepted/In press - 2016

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Venous Thromboembolism
Registries
Safety
Neoplasms
Hemorrhage
Thrombophilia
Pulmonary Embolism
Venous Thrombosis
Anticoagulants
Rivaroxaban
Recurrence
Lung
Population

Keywords

  • Direct oral anticoagulants
  • Malignancy
  • Rivaroxaban venous thromboembolism

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Efficacy and Safety of Rivaroxaban in Patients with Venous Thromboembolism and Active Malignancy : A Single-center Registry. / Bott-Kitslaar, Dalene M.; Saadiq, Rayya A.; McBane, Robert D.; Loprinzi, Charles Lawrence; Ashrani, Aneel Arjun; Ransone, Teresa R.; Wolfgram, Alissa A.; Berentsen, Michelle M.; Wysokinski, Waldemar E.

In: American Journal of Medicine, 2016.

Research output: Contribution to journalArticle

Bott-Kitslaar, Dalene M. ; Saadiq, Rayya A. ; McBane, Robert D. ; Loprinzi, Charles Lawrence ; Ashrani, Aneel Arjun ; Ransone, Teresa R. ; Wolfgram, Alissa A. ; Berentsen, Michelle M. ; Wysokinski, Waldemar E. / Efficacy and Safety of Rivaroxaban in Patients with Venous Thromboembolism and Active Malignancy : A Single-center Registry. In: American Journal of Medicine. 2016.
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abstract = "Objective: The purpose of this study is to evaluate the efficacy and safety of rivaroxaban in patients with venous thromboembolism and active malignancy, given the paucity of clinical data with the use of direct Xa inhibitors in this high-risk population. Patients and Methods: Consecutive patients treated with rivaroxaban for deep vein thrombosis or pulmonary embolism, enrolled into Mayo Thrombophilia Clinic Direct Oral Anticoagulants Registry between March 1, 2013, and April 30, 2015, were followed prospectively to evaluate the efficacy and safety of this therapy. Results: Of the 404 venous thromboembolism patients in the registry, 296 received rivaroxaban and had at least 3 months of follow-up. Of these, 118 (40{\%}) had active malignancy (51{\%} female, mean age 66 ± 10 years) and 178 had no cancer (47{\%} female, mean age 55 ± 15 years). The 3 most common cancer locations were genitourinary (23.6{\%}), gastrointestinal (20.3{\%}), and lung (13.5{\%}). There was no difference in venous thromboembolism recurrence between the malignant (3.3{\%}) and the nonmalignant (2.8{\%}) venous thromboembolism groups (P = .533). Borderline higher rates for major bleeding (P = .06) and nonmajor clinically relevant bleeding (P = .08) were observed in patients with cancer. Conclusions: The {"}real world{"} effectiveness and safety of rivaroxaban is similar for venous thromboembolism patients with and without active malignancy.",
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T1 - Efficacy and Safety of Rivaroxaban in Patients with Venous Thromboembolism and Active Malignancy

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AU - Bott-Kitslaar, Dalene M.

AU - Saadiq, Rayya A.

AU - McBane, Robert D.

AU - Loprinzi, Charles Lawrence

AU - Ashrani, Aneel Arjun

AU - Ransone, Teresa R.

AU - Wolfgram, Alissa A.

AU - Berentsen, Michelle M.

AU - Wysokinski, Waldemar E.

PY - 2016

Y1 - 2016

N2 - Objective: The purpose of this study is to evaluate the efficacy and safety of rivaroxaban in patients with venous thromboembolism and active malignancy, given the paucity of clinical data with the use of direct Xa inhibitors in this high-risk population. Patients and Methods: Consecutive patients treated with rivaroxaban for deep vein thrombosis or pulmonary embolism, enrolled into Mayo Thrombophilia Clinic Direct Oral Anticoagulants Registry between March 1, 2013, and April 30, 2015, were followed prospectively to evaluate the efficacy and safety of this therapy. Results: Of the 404 venous thromboembolism patients in the registry, 296 received rivaroxaban and had at least 3 months of follow-up. Of these, 118 (40%) had active malignancy (51% female, mean age 66 ± 10 years) and 178 had no cancer (47% female, mean age 55 ± 15 years). The 3 most common cancer locations were genitourinary (23.6%), gastrointestinal (20.3%), and lung (13.5%). There was no difference in venous thromboembolism recurrence between the malignant (3.3%) and the nonmalignant (2.8%) venous thromboembolism groups (P = .533). Borderline higher rates for major bleeding (P = .06) and nonmajor clinically relevant bleeding (P = .08) were observed in patients with cancer. Conclusions: The "real world" effectiveness and safety of rivaroxaban is similar for venous thromboembolism patients with and without active malignancy.

AB - Objective: The purpose of this study is to evaluate the efficacy and safety of rivaroxaban in patients with venous thromboembolism and active malignancy, given the paucity of clinical data with the use of direct Xa inhibitors in this high-risk population. Patients and Methods: Consecutive patients treated with rivaroxaban for deep vein thrombosis or pulmonary embolism, enrolled into Mayo Thrombophilia Clinic Direct Oral Anticoagulants Registry between March 1, 2013, and April 30, 2015, were followed prospectively to evaluate the efficacy and safety of this therapy. Results: Of the 404 venous thromboembolism patients in the registry, 296 received rivaroxaban and had at least 3 months of follow-up. Of these, 118 (40%) had active malignancy (51% female, mean age 66 ± 10 years) and 178 had no cancer (47% female, mean age 55 ± 15 years). The 3 most common cancer locations were genitourinary (23.6%), gastrointestinal (20.3%), and lung (13.5%). There was no difference in venous thromboembolism recurrence between the malignant (3.3%) and the nonmalignant (2.8%) venous thromboembolism groups (P = .533). Borderline higher rates for major bleeding (P = .06) and nonmajor clinically relevant bleeding (P = .08) were observed in patients with cancer. Conclusions: The "real world" effectiveness and safety of rivaroxaban is similar for venous thromboembolism patients with and without active malignancy.

KW - Direct oral anticoagulants

KW - Malignancy

KW - Rivaroxaban venous thromboembolism

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