Evaluation of acute thrombus regression effect of edoxaban for deep vein thrombosis in patients with cancer: a single-center prospective observational study.
Cancer
Deep vein thrombosis
Direct oral anticoagulant
Frailty
Venous thromboembolism
Journal
Heart and vessels
ISSN: 1615-2573
Titre abrégé: Heart Vessels
Pays: Japan
ID NLM: 8511258
Informations de publication
Date de publication:
21 May 2024
21 May 2024
Historique:
received:
22
01
2024
accepted:
15
05
2024
medline:
21
5
2024
pubmed:
21
5
2024
entrez:
21
5
2024
Statut:
aheadofprint
Résumé
Although there are reports on the recurrence prevention in the chronic phase using direct oral anticoagulants (DOACs) for deep vein thrombosis (DVT) in patients with cancer, acute thrombus regression effect using DOACs has not been assessed. This study aimed to assess the thrombus regression effect of initial treatment using edoxaban for acute lower-extremity DVT in patients with active cancer. In this observational study, among the inpatients with cancer and lower-extremity DVT who underwent initial treatment with edoxaban at our hospital from November 2019 to December 2021, 34 consenting patients were recruited in this study. The quantitative ultrasound thrombus (QUT) score of thrombus volume was calculated at baseline (before administration) and 7-14 days after the start of edoxaban administration, using lower-extremity venous ultrasound to evaluate changes in thrombus volume. The primary and secondary endpoints were the acute thrombus regression effect of edoxaban and the impact of patients' clinical frailty on the thrombus regression effect, respectively. Anticoagulant therapy with edoxaban significantly reduced QUT score (p < 0.001). In addition, regardless of the Clinical Frailty Scale scores, QUT score decreased significantly. Initial treatment with edoxaban was effective for lower-extremity DVT in patients with cancer. In addition, the effect was the same independent of the degree of frailty.
Sections du résumé
BACKGROUND
BACKGROUND
Although there are reports on the recurrence prevention in the chronic phase using direct oral anticoagulants (DOACs) for deep vein thrombosis (DVT) in patients with cancer, acute thrombus regression effect using DOACs has not been assessed. This study aimed to assess the thrombus regression effect of initial treatment using edoxaban for acute lower-extremity DVT in patients with active cancer.
METHODS AND RESULTS
RESULTS
In this observational study, among the inpatients with cancer and lower-extremity DVT who underwent initial treatment with edoxaban at our hospital from November 2019 to December 2021, 34 consenting patients were recruited in this study. The quantitative ultrasound thrombus (QUT) score of thrombus volume was calculated at baseline (before administration) and 7-14 days after the start of edoxaban administration, using lower-extremity venous ultrasound to evaluate changes in thrombus volume. The primary and secondary endpoints were the acute thrombus regression effect of edoxaban and the impact of patients' clinical frailty on the thrombus regression effect, respectively. Anticoagulant therapy with edoxaban significantly reduced QUT score (p < 0.001). In addition, regardless of the Clinical Frailty Scale scores, QUT score decreased significantly.
CONCLUSION
CONCLUSIONS
Initial treatment with edoxaban was effective for lower-extremity DVT in patients with cancer. In addition, the effect was the same independent of the degree of frailty.
Identifiants
pubmed: 38771333
doi: 10.1007/s00380-024-02418-1
pii: 10.1007/s00380-024-02418-1
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2024. Springer Nature Japan KK, part of Springer Nature.
Références
Gervaso L, Dave H, Khorana AA (2021) Venous and arterial thromboembolism in patients with cancer: JACC: cardiooncology state-of-the-art review. JACC CardioOncol 3(2):173–190
doi: 10.1016/j.jaccao.2021.03.001
pubmed: 34396323
pmcid: 8352228
Khorana AA, Francis CW, Culakova E, Kuderer NM, Lyman GH (2007) Thromboembolism is a leading cause of death in cancer patients receiving outpatient chemotherapy. J Thromb Haemost 5(3):632–634
doi: 10.1111/j.1538-7836.2007.02374.x
pubmed: 17319909
Connolly GC, Francis CW (2013) Cancer-associated thrombosis. Hematology Am Soc Hematol Educ Program 2013:684–691
doi: 10.1182/asheducation-2013.1.684
pubmed: 24319253
Cronin-Fenton DP, Søndergaard F, Pedersen LA, Fryzek JP, Cetin K, Acquavella J, Baron JA, Sørensen HT (2010) Hospitalisation for venous thromboembolism in cancer patients and the general population: a population-based cohort study in Denmark, 1997–2006. Br J Cancer 103(7):947–953
doi: 10.1038/sj.bjc.6605883
pubmed: 20842120
pmcid: 2965880
Heit JA, Silverstein MD, Mohr DN, Petterson TM, O’Fallon WM, Melton LJ 3rd (2000) Risk factors for deep vein thrombosis and pulmonary embolism: a population-based case-control study. Arch Intern Med 160(6):809–815
doi: 10.1001/archinte.160.6.809
pubmed: 10737280
Abdol Razak NB, Jones G, Bhandari M, Berndt MC, Metharom P (2018) Cancer-Associated Thrombosis: An Overview of Mechanisms, Risk Factors, and Treatment. Cancers (Basel) 10(10):380
doi: 10.3390/cancers10100380
pubmed: 30314362
Lyman GH (2011) Venous thromboembolism in the patient with cancer: focus on burden of disease and benefits of thromboprophylaxis. Cancer 117(7):1334–1349
doi: 10.1002/cncr.25714
pubmed: 21425133
Tapson VF (2004) Acute pulmonary embolism. Cardiol Clin 22(3):353–365
doi: 10.1016/j.ccl.2004.04.002
pubmed: 15302356
Khorana AA, Noble S, Lee AYY, Soff G, Meyer G, O’Connell C, Carrier M (2018) Role of direct oral anticoagulants in the treatment of cancer-associated venous thromboembolism: guidance from the SSC of the ISTH. J Thromb Haemost 16(9):1891–1894
doi: 10.1111/jth.14219
pubmed: 30027649
Key NS, Khorana AA, Kuderer NM, Bohlke K, Lee AYY, Arcelus JI, Wong SL, Balaban EP, Flowers CR, Francis CW, Gates LE, Kakkar AK, Levine MN, Liebman HA, Tempero MA, Lyman GH, Falanga A (2020) Venous thromboembolism prophylaxis and treatment in patients with cancer: ASCO clinical practice guideline update. J Clin Oncol 38(5):496–520
doi: 10.1200/JCO.19.01461
pubmed: 31381464
Stevens SM, Woller SC, Kreuziger LB, Bounameaux H, Doerschug K, Geersing GJ, Huisman MV, Kearon C, King CS, Knighton AJ, Lake E, Murin S, Vintch JRE, Wells PS, Moores LK (2021) Antithrombotic therapy for VTE disease: second update of the CHEST guideline and expert panel report. Chest 160(6):e545–e608
doi: 10.1016/j.chest.2021.07.055
pubmed: 34352278
Streiff MB, Holmstrom B, Angelini D, Ashrani A, Elshoury A, Fanikos J, Fertrin KY, Fogerty AE, Gao S, Goldhaber SZ, Gundabolu K, Ibrahim I, Kraut E, Leavitt AD, Lee A, Lee JT, Lim M, Mann J, Martin K, McMahon B, Moriarty J, Morton C, Ortel TL, Paschal R, Schaefer J, Shattil S, Siddiqi T, Sudheendra D, Williams E, Hollinger L, Nguyen MQ (2021) Cancer-Associated Venous Thromboembolic Disease, Version 2.2021, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw 19(10):1181–1201
pubmed: 34666313
Falanga A, Ay C, Di Nisio M, Gerotziafas G, Jara-Palomares L, Langer F, Lecumberri R, Mandala M, Maraveyas A, Pabinger I, Sinn M, Syrigos K, Young A, Jordan K (2023) Venous thromboembolism in cancer patients: ESMO clinical practice guideline. Ann Oncol 34(5):452–467
doi: 10.1016/j.annonc.2022.12.014
pubmed: 36638869
Yamashita Y, Morimoto T, Muraoka N, Oyakawa T, Umetsu M, Akamatsu D, Nishimoto Y, Sato Y, Takada T, Jujo K, Minami Y, Ogihara Y, Dohi K, Fujita M, Nishikawa T, Ikeda N, Hashimoto G, Otsui K, Mori K, Sueta D, Tsubata Y, Shoji M, Shikama A, Hosoi Y, Tanabe Y, Chatani R, Tsukahara K, Nakanishi N, Kim K, Ikeda S, Mo M, Yoshikawa Y, Kimura T (2023) Edoxaban for 12 months versus 3 months in patients with cancer with isolated distal deep vein thrombosis (ONCO DVT Study): an open-label, multicenter. Randomized Clinical Trial Circulation 148(21):1665–1676
pubmed: 37638968
Prins MH, Lensing AW, Brighton TA, Lyons RM, Rehm J, Trajanovic M, Davidson BL, Beyer-Westendorf J, Pap ÁF, Berkowitz SD, Cohen AT, Kovacs MJ, Wells PS, Prandoni P (2014) Oral rivaroxaban versus enoxaparin with vitamin K antagonist for the treatment of symptomatic venous thromboembolism in patients with cancer (EINSTEIN-DVT and EINSTEIN-PE): a pooled subgroup analysis of two randomised controlled trials. Lancet Haematol 1(1):e37-46
doi: 10.1016/S2352-3026(14)70018-3
pubmed: 27030066
Young AM, Marshall A, Thirlwall J, Chapman O, Lokare A, Hill C, Hale D, Dunn JA, Lyman GH, Hutchinson C, MacCallum P, Kakkar A, Hobbs FDR, Petrou S, Dale J, Poole CJ, Maraveyas A, Levine M (2018) Comparison of an oral factor xa inhibitor with low molecular weight heparin in patients with cancer with venous thromboembolism: results of a randomized trial (SELECT-D). J Clin Oncol 36(20):2017–2023
doi: 10.1200/JCO.2018.78.8034
pubmed: 29746227
Raskob GE, van Es N, Verhamme P, Carrier M, Di Nisio M, Garcia D, Grosso MA, Kakkar AK, Kovacs MJ, Mercuri MF, Meyer G, Segers A, Shi M, Wang TF, Yeo E, Zhang G, Zwicker JI, Weitz JI, Büller HR (2018) Edoxaban for the treatment of cancer-associated venous thromboembolism. N Engl J Med 378(7):615–624
doi: 10.1056/NEJMoa1711948
pubmed: 29231094
Agnelli G, Becattini C, Meyer G, Muñoz A, Huisman MV, Connors JM, Cohen A, Bauersachs R, Brenner B, Torbicki A, Sueiro MR, Lambert C, Gussoni G, Campanini M, Fontanella A, Vescovo G, Verso M (2020) Apixaban for the treatment of venous thromboembolism associated with cancer. N Engl J Med 382(17):1599–1607
doi: 10.1056/NEJMoa1915103
pubmed: 32223112
McBane RD 2nd, Wysokinski WE, Le-Rademacher JG, Zemla T, Ashrani A, Tafur A, Perepu U, Anderson D, Gundabolu K, Kuzma C, Perez Botero J, Leon Ferre RA, Henkin S, Lenz CJ, Houghton DE, Vishnu P, Loprinzi CL (2020) Apixaban and dalteparin in active malignancy-associated venous thromboembolism: The ADAM VTE trial. J Thromb Haemost 18(2):411–421
doi: 10.1111/jth.14662
pubmed: 31630479
Planquette B, Bertoletti L, Charles-Nelson A, Laporte S, Grange C, Mahé I, Pernod G, Elias A, Couturaud F, Falvo N, Sevestre MA, Ray V, Burnod A, Brebion N, Roy PM, Timar-David M, Aquilanti S, Constans J, Bura-Rivière A, Brisot D, Chatellier G, Sanchez O, Meyer G, Girard P, Mismetti P (2022) Rivaroxaban vs dalteparin in cancer-associated thromboembolism: a randomized trial. Chest 161(3):781–790
doi: 10.1016/j.chest.2021.09.037
pubmed: 34627853
Rockwood K, Theou O (2020) Using the clinical frailty scale in allocating scarce health care resources. Can Geriatr J 23(3):210–215
doi: 10.5770/cgj.23.463
pubmed: 32904824
pmcid: 7458601
Dauzat M, Laroche JP, Deklunder G, Ayoub J, Quére I, Lopez FM, Janbon C (1997) Diagnosis of acute lower limb deep venous thrombosis with ultrasound: trends and controversies. J Clin Ultrasound 25(7):343–358
doi: 10.1002/(SICI)1097-0096(199709)25:7<343::AID-JCU1>3.0.CO;2-A
pubmed: 9282799
Hisatake S, Kabuki T, Kiuchi S, Oka T, Dobashi S, Fujii T, Iwasaki Y, Ikeda T (2017) Short-term subcutaneous fondaparinux and oral edoxaban for acute venous thromboembolism. Circ J 81(6):855–861
doi: 10.1253/circj.CJ-16-1012
pubmed: 28239036
Kabuki T, Nakanishi R, Hisatake S, Fujii T, Dobashi S, Wakakura S, Kiuchi S, Fujino T, Ikeda T (2017) A treatment strategy using subcutaneous fondaparinux followed by oral rivaroxaban is effective for treating acute venous thromboembolism. J Cardiol 70(2):163–168
doi: 10.1016/j.jjcc.2016.10.013
pubmed: 27979674
Schulman S, Angerås U, Bergqvist D, Eriksson B, Lassen MR, Fisher W (2010) Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients. J Thromb Haemost 8(1):202–204
doi: 10.1111/j.1538-7836.2009.03678.x
pubmed: 19878532
Nakamura M, Okano Y, Minamiguchi H, Munemasa M, Sonoda M, Yamada N, Hanzawa K, Aoyagi N, Tsujimoto H, Sarai N, Nakajima H, Kunieda T (2011) Multidetector-row computed tomography-based clinical assessment of fondaparinux for treatment of acute pulmonary embolism and acute deep vein thrombosis in Japanese patients. Circ J 75(6):1424–1432
doi: 10.1253/circj.CJ-10-1036
pubmed: 21512258
Kanda Y (2013) Investigation of the freely available easy-to-use software ‘EZR’ for medical statistics. Bone Marrow Transplant 48(3):452–458
doi: 10.1038/bmt.2012.244
pubmed: 23208313
Khorana AA, Kuderer NM, Culakova E, Lyman GH, Francis CW (2008) Development and validation of a predictive model for chemotherapy-associated thrombosis. Blood 111(10):4902–4907
doi: 10.1182/blood-2007-10-116327
pubmed: 18216292
pmcid: 2384124
Ruíz-Giménez N, Suárez C, González R, Nieto JA, Todolí JA, Samperiz AL, Monreal M (2008) Predictive variables for major bleeding events in patients presenting with documented acute venous thromboembolism. Findings from the RIETE Registry. Thromb Haemost 100(1):26–31
doi: 10.1160/TH08-03-0193
pubmed: 18612534
Klok FA, Hösel V, Clemens A, Yollo WD, Tilke C, Schulman S, Lankeit M, Konstantinides SV (2016) Prediction of bleeding events in patients with venous thromboembolism on stable anticoagulation treatment. Eur Respir J 48(5):1369–1376
doi: 10.1183/13993003.00280-2016
pubmed: 27471209
Yamashita A, Hisatake S, Kiuchi S, Kabuki T, Ikeda T (2023) Effectiveness of fondaparinux in the japanese population with acute venous thromboembolism -a study comparing patients with and without cancer. Intern Med 62(6):821–831
doi: 10.2169/internalmedicine.0296-22
pubmed: 36328572
Nakamura M, Ishiguro A, Dazai M, Kawamoto Y, Yuki S, Sogabe S, Hosokawa A, Sawada K, Muto O, Izawa N, Nakashima K, Horie Y, Yagisawa M, Kajiura S, Ando T, Mitsuhashi Y, Sunakawa Y, Kikuchi Y, Komatsu Y (2022) Feasibility of edoxaban for asymptomatic cancer-associated thrombosis in Japanese patients with gastrointestinal cancer: ExCAVE study. BMC Cancer 22(1):1322
doi: 10.1186/s12885-022-10403-y
pubmed: 36526992
pmcid: 9757916
Piazza G, Mani V, Goldhaber SZ, Grosso MA, Mercuri M, Lanz HJ, Schussler S, Hsu C, Chinigo A, Ritchie B, Nadar V, Cannon K, Pullman J, Concha M, Schul M, Fayad ZA (2016) Magnetic resonance venography to assess thrombus resolution with edoxaban monotherapy versus parenteral anticoagulation/warfarin for symptomatic deep vein thrombosis: a multicenter feasibility study. Vasc Med 21(4):361–368
doi: 10.1177/1358863X16645853
pubmed: 27165711
pmcid: 4963800
Takai S, Nakanishi N, Yokota I, Imai K, Yamada A, Kawasaki T, Kasahara T, Okada T, Sawada T, Matoba S (2022) Clot-regression effects of rivaroxaban in venous thromboembolism treatment in cancer patients-a prospective interventional study. Sci Rep 12(1):21569
doi: 10.1038/s41598-022-26150-w
pubmed: 36513734
pmcid: 9747974
Sato D, Ikeda S, Koga S, Yamagata Y, Eguchi M, Yonekura T, Tsuneto A, Yoshimuta T, Koide Y, Kawano H, Maemura K (2019) Effectiveness and safety of oral direct factor Xa inhibitors for the treatment of venous thromboembolism in patients with cancer and/or older age. Heart Vessels 34(4):678–687
doi: 10.1007/s00380-018-1283-5
pubmed: 30341629
Scotté F, Leroy P, Chastenet M, Aumont L, Benatar V, Elalamy I (2019) Treatment and prevention of cancer-associated thrombosis in frail patients: tailored management. Cancers (Basel) 11(1):48
doi: 10.3390/cancers11010048
pubmed: 30621020