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Randomized Controlled Trial
. 2020 Feb 6;55(2):1901697.
doi: 10.1183/13993003.01697-2019. Print 2020 Feb.

Clinical implications of incidental venous thromboembolism in cancer patients

Frits I Mulder  1   2 , Marcello Di Nisio  3 , Cihan Ay  4 , Marc Carrier  5 , Floris T M Bosch  6   2 , Annelise Segers  7 , Noémie Kraaijpoel  6 , Michael A Grosso  8 , George Zhang  8 , Peter Verhamme  9 , Tzu-Fei Wang  10 , Jeffrey I Weitz  11 , Saskia Middeldorp  6 , Gary Raskob  12 , Ludo F M Beenen  13 , Harry R Büller  6 , Nick van Es  6
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Free article
Randomized Controlled Trial

Clinical implications of incidental venous thromboembolism in cancer patients

Frits I Mulder et al. Eur Respir J. .
Free article

Abstract

Introduction: In cancer patients, current guidance suggests similar treatment for incidental and symptomatic venous thromboembolism (VTE), mainly based on retrospective data. We aimed to evaluate anticoagulant therapy in cancer patients with incidental and symptomatic VTE.

Methods: The Hokusai VTE Cancer Study was a randomised controlled trial comparing edoxaban with dalteparin for cancer-associated VTE. The primary outcome was the composite of first recurrent VTE or major bleeding. Secondary outcomes included major bleeding, recurrent VTE and mortality. Outcomes in patients with incidental and symptomatic VTE were evaluated during the 12-month study period.

Results: 331 patients with incidental VTE and 679 patients with symptomatic VTE were enrolled, of whom the index event was confirmed by an independent radiologist. Median durations of anticoagulant treatment were 195 and 189 days, respectively. In patients with incidental VTE, the primary outcome occurred in 12.7% of patients, major bleeding in 6.6% of patients and recurrent VTE in 7.9% of patients. Out of the 26 VTE recurrences in patients with incidental VTE, five (31%) were incidental, seven (44%) were symptomatic and four (25%) were deaths for which pulmonary embolism could not be ruled out. In patients with symptomatic VTE, the primary outcome occurred in 13.8% of patients, major bleeding in 4.9% of patients and recurrent VTE in 10.9% of patients. All-cause mortality was similar in both groups.

Conclusion: Clinical adverse outcomes are substantial in both cancer patients with incidental and symptomatic VTE, supporting current guideline recommendations that suggest treating incidental VTE in the same manner as symptomatic VTE.

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Conflict of interest statement

Conflict of interest: F.I. Mulder has nothing to disclose. Conflict of interest: M. Di Nisio reports personal fees from Daiichi Sankyo outside the submitted work. Conflict of interest: C. Ay reports personal fees from Bayer, Daiichi Sankyo, Pfizer and BMS, outside the submitted work. Conflict of interest: M. Carrier reports personal fees from Daiichi Sankyo during the conduct of the study; grants and personal fees from BMS, LEO Pharma; personal fees from Pfizer, Sanofi and Bayer outside the submitted work. Conflict of interest: F.T.M. Bosch has nothing to disclose. Conflict of interest: A. Segers reports grants from Daiichi Sankyo during the conduct of the study; grants from Ionis Pharmaceuticals, Daiichi Sankyo and Janssen Pharmaceuticals outside the submitted work. Conflict of interest: N. Kraaijpoel has nothing to disclose. Conflict of interest: M.A. Grosso reports personal fees from Daiichi Sankyo outside the submitted work. Conflict of interest: G. Zhang reports personal fees from Daiichi Sankyo outside the submitted work. Conflict of interest: P. Verhamme reports grants and personal fees from Daiichi Sankyo, during the conduct of the study; grants and personal fees from Bayer Healthcare, Boehringer Ingelheim and LEO Pharma; personal fees from BMS, Portola, Medscape, Medtronic and Pfizer; and grants from Sanofi outside the submitted work. Conflict of interest: T-Z. Wang reports nonfinancial support from Daiichi Sankyo during the conduct of the study. Conflict of interest: J.I. Weitz reports personal fees from Daiichi Sankyo, during the conduct of the study; personal fees from Bayer Healthcare, BMS, Boehringer Ingelheim, Ionis Pharmaceuticals, Janssen, Johnson & Johnson, Pfizer, Portola, Medscape and Novartis outside the submitted work. Conflict of interest: S. Middeldorp reports grants and personal fees from GSK, BMS/Pfizer, Aspen, Daiichi Sankyo; personal fees from Bayer, Boehringer Ingelheim; and grants from Sanquin. Conflict of interest: G. Raskob reports personal fees from Daiichi Sankyo during the conduct of the study; personal fees from Bayer Healthcare, BMS, Boehringer Ingelheim, Eli Lilly, Janssen, Johnson & Johnson, Pfizer, Portola, Merck and Medscape outside the submitted work. Conflict of interest: L.F.M. Beenen has nothing to disclose. Conflict of interest: H.R. Büller reports personal fees from Daiichi Sankyo, during the conduct of the study; personal fees from Bayer Healthcare, BMS/Pfizer, Boehringer Ingelheim, Portola, Medscape, Eli Lilly, Sanofi Aventis and Ionis outside the submitted work. Conflict of interest: N. van Es reports personal fees from Daiichi Sankyo during the conduct of the study; and personal fees from Pfizer outside the submitted work.

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