Efficacy and safety of apixaban for primary prevention of thromboembolism in patients with cancer and a central venous catheter: A subgroup analysis of the AVERT Trial

Willem Brandt; Cameron Brown; Tzu Fei Wang; Vicky Tagalakis; Sudeep Shivakumar; Leonardo A. Ciuffini; Ranjeeta Mallick; Phil S. Wells; Marc Carrier

doi:10.1016/j.thromres.2022.05.014

Efficacy and safety of apixaban for primary prevention of thromboembolism in patients with cancer and a central venous catheter: A subgroup analysis of the AVERT Trial

Willem Brandt, Cameron Brown, Tzu Fei Wang, Vicky Tagalakis, Sudeep Shivakumar, Leonardo A. Ciuffini, Ranjeeta Mallick, Phil S. Wells, Marc Carrier

Medicine

Research output: Contribution to journal › Letter › peer-review

18 Citations (Scopus)

Abstract

Introduction: Central venous catheters (CVC) are associated with an increased risk of venous thromboembolism (VTE) in patients with cancer. Primary thromboprophylaxis using a direct oral anticoagulant decreases the risk of VTE in intermediate-to-high risk ambulatory cancer patients. We assessed the efficacy and safety of thromboprophylaxis with apixaban in the subpopulation of patients with cancer and a CVC in the AVERT trial. Methods: The AVERT study was a randomized, placebo-controlled, double-blind clinical trial assessing the efficacy and safety of apixaban for primary thromboprophylaxis in patients with cancer initiating chemotherapy who were at intermediate to high risk of VTE. The primary efficacy outcome was objectively confirmed VTE within 180 days of randomization and the primary safety outcome was major bleeding. The hazard ratios (HRs) were calculated using a Cox regression model controlling for age, gender, and center. Results: A total of 217 patients had a CVC and were included in the subgroup analyses with 126 and 91 patients receiving apixaban or placebo, respectively. VTE occurred in 6 (4.8%) patients in the apixaban group and 17 (18.7%) patients in the placebo group (HR 0.26; 95% CI, 0.14–0.47; p < 0.0001). Major bleeding occurred in 2 (1.6%) patients in the apixaban group and 2 (2.2%) patients in the placebo group (HR 0.69; 95% CI, 0.20–2.35; p = 0.556). Conclusions: Primary thromboprophylaxis with apixaban in patients with cancer and a CVC was associated with a reduced risk of VTE in the AVERT study population, without an increased risk of bleeding. (Funded by the CIHR and Bristol-Myers Squibb-Pfizer Alliance; NCT02048865).

Original language	English
Pages (from-to)	8-10
Number of pages	3
Journal	Thrombosis Research
Volume	216
DOIs	https://doi.org/10.1016/j.thromres.2022.05.014
Publication status	Published - Aug 2022

Bibliographical note

Funding Information:
M. Carrier has received research funding from BMS , Pfizer , and LEO Pharma , and honoraria from Bayer, Pfizer, BMS, Servier, and LEO Pharma. P. Wells received research funding from BMS / Pfizer , and honoraria from BMS/Pfizer, Bayer, Sanofi, and Daiichi Sankyo. T-F. Wang received honorarium from Servier. W Brandt, C Brown, L Ciuffini and R. Mallick have no relevant conflicts of interest to disclose. V. Tagalakis received consulting honoraria from Pfizer - BMS and Daiichi-Sankyo and has received research funding from Sanofi .

Funding Information:
The AVERT trial was funded by the Canadian Institutes of Health Research and the Bristol-Myers Squibb– Pfizer Alliance . M Carrier is the recipient of a Research Chair from the University of Ottawa and the Department of Medicine on Venous Thromboembolism and Cancer . P Wells is the recipient of a Distinguished Research Chair from the University of Ottawa and the Department of Medicine, and of a University Research Chair.

Publisher Copyright:
© 2022 Elsevier Ltd

ASJC Scopus Subject Areas

Hematology

PubMed: MeSH publication types

Letter
Randomized Controlled Trial

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.thromres.2022.05.014

Cite this

Brandt, W., Brown, C., Wang, T. F., Tagalakis, V., Shivakumar, S., Ciuffini, L. A., Mallick, R., Wells, P. S., & Carrier, M. (2022). Efficacy and safety of apixaban for primary prevention of thromboembolism in patients with cancer and a central venous catheter: A subgroup analysis of the AVERT Trial. Thrombosis Research, 216, 8-10. https://doi.org/10.1016/j.thromres.2022.05.014

Brandt, W, Brown, C, Wang, TF, Tagalakis, V, Shivakumar, S, Ciuffini, LA, Mallick, R, Wells, PS & Carrier, M 2022, 'Efficacy and safety of apixaban for primary prevention of thromboembolism in patients with cancer and a central venous catheter: A subgroup analysis of the AVERT Trial', Thrombosis Research, vol. 216, pp. 8-10. https://doi.org/10.1016/j.thromres.2022.05.014

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title = "Efficacy and safety of apixaban for primary prevention of thromboembolism in patients with cancer and a central venous catheter: A subgroup analysis of the AVERT Trial",

abstract = "Introduction: Central venous catheters (CVC) are associated with an increased risk of venous thromboembolism (VTE) in patients with cancer. Primary thromboprophylaxis using a direct oral anticoagulant decreases the risk of VTE in intermediate-to-high risk ambulatory cancer patients. We assessed the efficacy and safety of thromboprophylaxis with apixaban in the subpopulation of patients with cancer and a CVC in the AVERT trial. Methods: The AVERT study was a randomized, placebo-controlled, double-blind clinical trial assessing the efficacy and safety of apixaban for primary thromboprophylaxis in patients with cancer initiating chemotherapy who were at intermediate to high risk of VTE. The primary efficacy outcome was objectively confirmed VTE within 180 days of randomization and the primary safety outcome was major bleeding. The hazard ratios (HRs) were calculated using a Cox regression model controlling for age, gender, and center. Results: A total of 217 patients had a CVC and were included in the subgroup analyses with 126 and 91 patients receiving apixaban or placebo, respectively. VTE occurred in 6 (4.8%) patients in the apixaban group and 17 (18.7%) patients in the placebo group (HR 0.26; 95% CI, 0.14–0.47; p < 0.0001). Major bleeding occurred in 2 (1.6%) patients in the apixaban group and 2 (2.2%) patients in the placebo group (HR 0.69; 95% CI, 0.20–2.35; p = 0.556). Conclusions: Primary thromboprophylaxis with apixaban in patients with cancer and a CVC was associated with a reduced risk of VTE in the AVERT study population, without an increased risk of bleeding. (Funded by the CIHR and Bristol-Myers Squibb-Pfizer Alliance; NCT02048865).",

author = "Willem Brandt and Cameron Brown and Wang, {Tzu Fei} and Vicky Tagalakis and Sudeep Shivakumar and Ciuffini, {Leonardo A.} and Ranjeeta Mallick and Wells, {Phil S.} and Marc Carrier",

note = "Funding Information: M. Carrier has received research funding from BMS , Pfizer , and LEO Pharma , and honoraria from Bayer, Pfizer, BMS, Servier, and LEO Pharma. P. Wells received research funding from BMS / Pfizer , and honoraria from BMS/Pfizer, Bayer, Sanofi, and Daiichi Sankyo. T-F. Wang received honorarium from Servier. W Brandt, C Brown, L Ciuffini and R. Mallick have no relevant conflicts of interest to disclose. V. Tagalakis received consulting honoraria from Pfizer - BMS and Daiichi-Sankyo and has received research funding from Sanofi . Funding Information: The AVERT trial was funded by the Canadian Institutes of Health Research and the Bristol-Myers Squibb– Pfizer Alliance . M Carrier is the recipient of a Research Chair from the University of Ottawa and the Department of Medicine on Venous Thromboembolism and Cancer . P Wells is the recipient of a Distinguished Research Chair from the University of Ottawa and the Department of Medicine, and of a University Research Chair. Publisher Copyright: {\textcopyright} 2022 Elsevier Ltd",

year = "2022",

month = aug,

doi = "10.1016/j.thromres.2022.05.014",

language = "English",

volume = "216",

pages = "8--10",

journal = "Thrombosis Research",

issn = "0049-3848",

publisher = "Elsevier Limited",

}

TY - JOUR

T1 - Efficacy and safety of apixaban for primary prevention of thromboembolism in patients with cancer and a central venous catheter

T2 - A subgroup analysis of the AVERT Trial

AU - Brandt, Willem

AU - Brown, Cameron

AU - Wang, Tzu Fei

AU - Tagalakis, Vicky

AU - Shivakumar, Sudeep

AU - Ciuffini, Leonardo A.

AU - Mallick, Ranjeeta

AU - Wells, Phil S.

AU - Carrier, Marc

N1 - Funding Information: M. Carrier has received research funding from BMS , Pfizer , and LEO Pharma , and honoraria from Bayer, Pfizer, BMS, Servier, and LEO Pharma. P. Wells received research funding from BMS / Pfizer , and honoraria from BMS/Pfizer, Bayer, Sanofi, and Daiichi Sankyo. T-F. Wang received honorarium from Servier. W Brandt, C Brown, L Ciuffini and R. Mallick have no relevant conflicts of interest to disclose. V. Tagalakis received consulting honoraria from Pfizer - BMS and Daiichi-Sankyo and has received research funding from Sanofi . Funding Information: The AVERT trial was funded by the Canadian Institutes of Health Research and the Bristol-Myers Squibb– Pfizer Alliance . M Carrier is the recipient of a Research Chair from the University of Ottawa and the Department of Medicine on Venous Thromboembolism and Cancer . P Wells is the recipient of a Distinguished Research Chair from the University of Ottawa and the Department of Medicine, and of a University Research Chair. Publisher Copyright: © 2022 Elsevier Ltd

PY - 2022/8

Y1 - 2022/8

N2 - Introduction: Central venous catheters (CVC) are associated with an increased risk of venous thromboembolism (VTE) in patients with cancer. Primary thromboprophylaxis using a direct oral anticoagulant decreases the risk of VTE in intermediate-to-high risk ambulatory cancer patients. We assessed the efficacy and safety of thromboprophylaxis with apixaban in the subpopulation of patients with cancer and a CVC in the AVERT trial. Methods: The AVERT study was a randomized, placebo-controlled, double-blind clinical trial assessing the efficacy and safety of apixaban for primary thromboprophylaxis in patients with cancer initiating chemotherapy who were at intermediate to high risk of VTE. The primary efficacy outcome was objectively confirmed VTE within 180 days of randomization and the primary safety outcome was major bleeding. The hazard ratios (HRs) were calculated using a Cox regression model controlling for age, gender, and center. Results: A total of 217 patients had a CVC and were included in the subgroup analyses with 126 and 91 patients receiving apixaban or placebo, respectively. VTE occurred in 6 (4.8%) patients in the apixaban group and 17 (18.7%) patients in the placebo group (HR 0.26; 95% CI, 0.14–0.47; p < 0.0001). Major bleeding occurred in 2 (1.6%) patients in the apixaban group and 2 (2.2%) patients in the placebo group (HR 0.69; 95% CI, 0.20–2.35; p = 0.556). Conclusions: Primary thromboprophylaxis with apixaban in patients with cancer and a CVC was associated with a reduced risk of VTE in the AVERT study population, without an increased risk of bleeding. (Funded by the CIHR and Bristol-Myers Squibb-Pfizer Alliance; NCT02048865).

AB - Introduction: Central venous catheters (CVC) are associated with an increased risk of venous thromboembolism (VTE) in patients with cancer. Primary thromboprophylaxis using a direct oral anticoagulant decreases the risk of VTE in intermediate-to-high risk ambulatory cancer patients. We assessed the efficacy and safety of thromboprophylaxis with apixaban in the subpopulation of patients with cancer and a CVC in the AVERT trial. Methods: The AVERT study was a randomized, placebo-controlled, double-blind clinical trial assessing the efficacy and safety of apixaban for primary thromboprophylaxis in patients with cancer initiating chemotherapy who were at intermediate to high risk of VTE. The primary efficacy outcome was objectively confirmed VTE within 180 days of randomization and the primary safety outcome was major bleeding. The hazard ratios (HRs) were calculated using a Cox regression model controlling for age, gender, and center. Results: A total of 217 patients had a CVC and were included in the subgroup analyses with 126 and 91 patients receiving apixaban or placebo, respectively. VTE occurred in 6 (4.8%) patients in the apixaban group and 17 (18.7%) patients in the placebo group (HR 0.26; 95% CI, 0.14–0.47; p < 0.0001). Major bleeding occurred in 2 (1.6%) patients in the apixaban group and 2 (2.2%) patients in the placebo group (HR 0.69; 95% CI, 0.20–2.35; p = 0.556). Conclusions: Primary thromboprophylaxis with apixaban in patients with cancer and a CVC was associated with a reduced risk of VTE in the AVERT study population, without an increased risk of bleeding. (Funded by the CIHR and Bristol-Myers Squibb-Pfizer Alliance; NCT02048865).

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U2 - 10.1016/j.thromres.2022.05.014

DO - 10.1016/j.thromres.2022.05.014

M3 - Letter

C2 - 35660801

AN - SCOPUS:85131430941

SN - 0049-3848

VL - 216

SP - 8

EP - 10

JO - Thrombosis Research

JF - Thrombosis Research

ER -

Efficacy and safety of apixaban for primary prevention of thromboembolism in patients with cancer and a central venous catheter: A subgroup analysis of the AVERT Trial

Abstract

Bibliographical note

ASJC Scopus Subject Areas

PubMed: MeSH publication types

UN SDGs

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