Congresses

The ACC scientific sessions took place in Chicago and over the course of the virtual meeting, landmark trials including the CARAVAGGIO trial as well as many other studies were presented online with panel discussion and question and answer sessions. Please see below the highlight presentations from the scientific sessions.

Apixaban for the treatment of VTE associated with cancer: The CARAVAGGIO study

Oral apixaban has shown to be non-inferior to SC dalteparin for the treatment of cancer-associated VTE in the phase 3, multinational CARAVAGGIO trial presented by Prof. Giancarlo Agnelli (University of Perugia, Italy). The absence of an increase in the risk of MB at GI sites was of particular interest. These results, which were simultaneously presented at ACC 2020 and published in the New England Journal of Medicine, expand opportunities for patients with CAT who are eligible for treatment with DOACs, including patients with GI cancer^1,2. 

The CARAVAGGIO study

With a record-breaking audience of more than 116,000 delegates from 211 countries, the ESC Congress 2020 provided four days of live and on-demand scientific presentations covering a wide spectrum of topics relevant to cardiovascular medicine. The studio in Amsterdam hosted dozens of key opinion leaders on site, while ‘Hot Line’ trial presenters connected live from around the world and questions submitted by audience members were addressed in the discussions. Scientific CAT-related highlights from the congress are presented below.

Effectiveness and safety of apixaban, low-molecular weight heparin, and warfarin among high-risk subgroups of venous thromboembolism patients with active cancer

This study, presented by Alexander Thomas Cohen (London, UK), evaluated recurrent VTE and MB among VTE patients with active cancer within 6 months of initiating apixaban, LMWH, or warfarin stratified by cancer type, cancer treatment, and VTE characteristics. Across these high-risk subgroups of VTE cancer patients, apixaban generally had a lower risk of recurrent VTE and MB vs. LMWH and lower risk of recurrent VTE compared to warfarin. Warfarin patients generally had a similar risk of recurrent VTE and MB vs. LMWH. The findings are generally consistent with results from the overall population³.

Risk factors for major bleeding during prolonged anticoagulation therapy in cancer-associated venous thromboembolisms: From the COMMAND VTE Registry

In this study, presented by Yuji Nishimoto (Amagasaki, Japan), investigators aimed to identify the risk factors for MB during prolonged anticoagulation therapy in cancer-associated VTE patients. The study demonstrated that MB events were common during prolonged anticoagulation therapy in real world cancer-associated VTE patients. Terminal cancer, chronic kidney disease, and GI cancer were independent risk factors for MB⁴.

Patterns of anticoagulation for atrial fibrillation in cancer patients referred for cardio-oncological evaluation

This study, presented by Matteo Toma (Genova, Italy), retrospectively reviewed the records of patients referred to two cardio-oncology outpatient units between January 2017 and July 2019, and selected those presenting with nonvalvular atrial fibrillation (NVAF [CHA₂DS₂-VASc ≥1 for men and ≥2 for women]), and cancer on active treatment. In the setting of a dedicated cardio-oncology consultation, DOAC and VKA are most often appropriately prescribed to cancer patients with NVAF. However, the study indicated there is not-infrequent, residual use of LMWH at non-anticoagulant dosage. The presenters concluded that the non-evidence based use of LMWH at non-anticoagulant doses that is currently common practice in clinical oncology should be abandoned⁵.

Clinical course of pulmonary embolism patients treated with DOACs: comparing prognosis, recurrent thromboembolism, and major bleeding between patients with and without cancer

This study, presented by Yoshihisa Nakano (Nagoya, Japan), evaluated the clinical course of patients with PE treated primarily with DOACs. Conducted in a single centre, the data were collected from the medical records of consecutive patients who received inpatient treatment for PE. The investigators showed that although DOACs were used, the risk of recurrent VTE was still higher in cancer patients with PE compared to non-cancer patients with PE. The incidence of MB was comparable in both groups and the presenters concluded that the risk of bleeding associated with DOACs may be acceptable especially in cancer patients with PE⁵.

The ISTH 2020 Virtual Congress hosted State-of-the-Art sessions featuring world-renowned speakers on major topics including the clinical management of VTE in cancer patients and encompassed DOAC and new therapeutic tools for VTE treatment. Please see below the highlight presentations from the scientific sessions.

Anticoagulation therapy management in oncological patients: Experience in a centre

The aim of this study, presented by Dr. Feliciano, was to evaluate the efficacy and safety of DOACs in cancer patients. The presenters of this descriptive and retrospective observational study concluded that DOACs are a very interesting therapeutic option in patients with VTE and an active neoplasia⁶.

Risk of arterial thromboembolism in cancer patients: A population-based cohort study

This registry study, presented by Dr. Mulder, found substantial differences in the occurrence of arterial thromboembolism (ATE) between cancer patients and the general population. The presentation demonstrated that elderly patients were especially affected^7,8.

Apixaban levels in cancer-associated thrombosis in low-weight individuals

In this presentation, Dr. Bravo-Villa explains how investigators routinely treat patients with CAT weighing between 60–120 kg with full-dose apixaban and those below 60 kg receive full-dose anticoagulation for the first month and decrease to 2.5 mg BID thereafter. The study sought to determine whether low-weight individuals are being similarly anticoagulated as determined by apixaban plasma levels. Patients with CAT and low weight may be underrepresented in published studies and may be over-anticoagulated with regular therapeutic-dose apixaban. The authors concluded that prospective studies assessing thrombotic and bleeding risk in these individuals are warranted⁹.

Cancer associated thrombosis: Are DOACs a treatment option? Systematic review and meta-analysis of randomised controlled trials

The aim of this study presented by Dr. Alikhan, was to compare the efficacy and safety of DOACs to standard of care in the treatment of CAT. The study concluded that DOACs are associated with a reduced risk of recurrent VTE in patients with CAT when compared to LMWH ±VKA. There appears to be a non-statistically significant trend towards more bleeding with DOACs which may be related to cancer site or treatment related drug interactions. Further investigation is needed to identify patients with cancer with a low risk of bleeding who will benefit most from treatment with a DOAC¹⁰.

Are you up to date with the latest research regarding the use of anticoagulants? Watch the highlights from 2020’s pivotal studies focused on venous thromboembolism (VTE) prevention and management in cancer associated thrombosis (CAT) in an interview with Dr Cohen

Has there been any new research on the use of Direct Oral Anticoagulants (DOACs) for VTE in CAT in 2020?

Dr Cohen gives us a concise overview of publications that provide data to support decision making for the use of Factor Xa inhibitors in treating CAT. Gain key takeaways from the most recent studies that compare the use of Direct Oral Anticoagulants (DOACs) to low molecular weight heparin (LMWH).

Has 2020 seen improvement in our ability to stratify VTE risk among patients with cancer and identify those who may benefit from thromboprophylaxis?

A clear understanding of risk underpins clinical decision making.

• Further your insight into the identification of individuals with cancer at risk of VTE who could benefit from thromboprophylaxis, as Dr Cohen discusses a review undertaken with colleagues in 2020¹¹.
• Scores to assess risk and identify individuals for treatment include the COMPASS-CAT RAM risk assessment model, the Khorana score, the Vienna CATS score, the PROTECHT score, and the CONKO score. Risk factors broadly relate to tumour, treatment, patient, and biomarkers¹¹.
• Research provides continued refinement of risk-stratification methods. Listen to the latest understanding of which groups of patients might benefit, including for treatment with DOACs as trials for these factor Xa inhibitor undergo further sub-analysis.

How has our understanding of the safety and efficacy of DOACs in patients with cancer improved during 2020?

Dr Cohen relates real world evidence and trial data as he illustrates recent developments in understanding of the use of DOACs for CAT, key to using these drugs safely as well as with best effect for patients.

Familiarise yourself with knowledge underpinning clinical decision making around the use of DOACs, LMWH and vitamin K antagonists in this setting, with a focus on:

• Risk of bleeding
• Risk of recurrence
• The potential need for caution in gastrointestinal cancer

Which do you consider to be the most influential piece(s) of research in the field of CAT that has been published in 2020 and why?

• What do you need to know and understand in order to be confident your clinical decisions are underpinned by the latest evidence?
• Hear Dr Cohen shine a light on the CARAVAGGIO study, which compared apixaban and dalteparin for the treatment of patients with CAT, and explain the significance of its safety findings.

Which ongoing studies do you think are the ones to watch, and why?

• As developments occur in our understanding of how to manage CAT, it is important to keep abreast of the most recent research in order to make the right decisions when advising and treating patients.
• Dr Cohen highlights key studies likely to offer evidence-based support when making clinical decisions around the use of DOACs in the coming months and years.
• Listen to Dr Cohen’s overview of the evidence to ensure you are aware of the studies to watch for when considering rivaroxaban and apixaban treatment, including in relation to patient satisfaction, safety and dosing.

What are the major unmet needs that have been highlighted in research published in 2020?

• Dr Cohen brings his long-standing expertise in this area to call attention to the current unknowns and explains why unmet needs remain and in which populations of patients with cancer they mainly occur.
• Ultimately, awareness of unmet need keenly relates to the clinician’s provision of care to patients; being clear about what is and is not fully understood ensures a fair and balanced approach to decision-making. Dr Cohen looks to the future to consider research areas key to the effective prevention and management of CAT.

Meet Dr Ander Cohen

Vascular physician and epidemiologist in the Department of Haematology at Guy’s and St Thomas’ Hospital. King’s College London, United Kingdom.

Background

Limitations to the use of traditional vitamin K antagonists as anticoagulant therapy for treating and preventing thromboembolic disorders has led to the need for and development of newer oral therapies. With a predictable pharmacokinetic profile and limited need for monitoring, these novel treatments have a proven safety profile and a short half-life and are thus an attractive proposition for anticoagulation. Historically low molecular weight heparins have been used for the management of thromboembolic events in patients with cancer. 2020 has seen key developments in understanding of safety and efficacy of the Direct Oral Anticoagulants (DOACs) for use in cancer patients based on the outcomes of pivotal clinical trials and real-world evidence.

Now test your knowledge of why VTE can be common in cancer patients

Roundtable event 2021: The most impactful topics and data presented at International Conference on Thrombosis and Hemostasis Issues in Cancer (ICTHIC)

ICTHIC is an international conference that promotes recent advances in the understanding of thrombohemorrhagic complications in cancer patients. This roundtable event led by experts Professor Gary Lyman, Dr Alexander Cohen and Professor Anna Falanga covers various topics including updates to the guidelines and new recommendations for cancer associated thrombosis (CAT) prevention and treatment, the role of CAT prevention and prophylaxis treatments on CAT and the impact of COVID-19.

Introduction

Expert speakers Professor Gary Lyman, Dr Alexander Cohen and Professor Anna Falanga introduce themselves.

Latest ASCO guideline updates and discussions on new recommendations that are most impactful in clinical practice

An overview of the latest ASCO guideline updates¹ and the new recommendations for CAT that are most impactful in clinical practice. Our experts also cover ways to improve the timeliness and relevance of these guidelines by which adherence can also be improved.

The roles of thrombosis prophylaxis and risk assessment in cancer associated thrombosis (CAT)

A discussion on the role of a thromboprophylaxis approach in hospital patients with cancer and the surgical setting. Additionally, our experts discuss the role of risk assessment, the future direction in the field of CAT as well as the introduction of new biomarkers.

How to integrate a more patient-centric approach to cancer associated thrombosis (CAT) therapy and the effect of the pandemic on thrombotic issues in cancer patients

A discussion on how to discuss the most favourable therapeutic approaches with patients and how to involve them in a more patient-centric approach. Additionally, how has the pandemic further complicated thrombotic issues in cancer and its treatment, and what is the thrombotic risk associated with COVID-19 vaccines?

The impact of ongoing research on understanding cancer associated thrombosis (CAT), its prevention, and the treatment of patients

An update by our experts on ongoing research and how this may directly impact our understanding of CAT, its prevention and treatment. What is the current research on CAT, and what are the unmet medical needs in the field?

Professor Gary Lyman

Dr Lyman is Professor of Medicine in the Division of Medical Oncology at the University of Washington and Professor of the Public Health Sciences and Clinical Research at the Fred Hutchinson Cancer Research Centre where he serves as Senior Lead of Healthcare Quality and Policy of the Hutchinson Institute for Cancer Outcomes Research. He also is an adjunct Professor in the Schools of Public Health and Pharmacy at the University of Washington and at the School of Medicine at Duke University.

Dr Lyman received his undergraduate and medical degree from the State University of New York in Buffalo and completed his Internal Medicine Residency at the University of North Carolina in Chapel Hill and Hematology/Oncology Fellowship at the Roswell Park Memorial Institute. Dr Lyman subsequently pursued a Postdoctoral Fellowship in Biostatistics at the Harvard School of Public Health and the Dana Farber Cancer Centre in Boston.

He is active with the American Society of Clinical Oncology having served on the Board of Directors and chaired the American Society of Clinical Oncology (ASCO) Task Force on the Role of Observational Research in Clinical Practice, Guideline Methodology Committee and the ASCO Working Group on Biosimilars in Oncology. He has also a member of the ASCO Task Force on the Value of Cancer Care and the Task Force on Clinical Pathways along with chairing several clinical practice guidelines for the Society. At the same time, Dr Lyman serves as Chair of the Discovery Research and Publications Committee for the ASCO Big Data program (CancerLinQ).

Dr Alexander Cohen

Alexander (Ander) Cohen is a Vascular Physician and Epidemiologist at Guy’s and St Thomas’ Hospital, King’s College, London, UK. Dr Cohen graduated with honours in Medicine and honours in Surgery from the University of Melbourne, Australia, and became a fellow of the Royal Australasian College of Physicians in 1990. He was awarded an MSc in Epidemiology from the London School of Hygiene and Tropical Medicine, University of London, in 1991 with a thesis on the metabolic syndrome in South Asian populations. In 1998, he was awarded an MD with a thesis on the epidemiology of venous thromboembolism (VTE) and thromboprophylaxis. He is a Fellow of the European Society of Cardiology.

Dr Cohen is currently working on AF epidemiology, screening and has co-developed an AI-based algorithm. He is the Principal Investigator for a randomised controlled trial of the algorithm.

Dr Cohen has written and co-authored over 500 publications and is on the editorial board of several journals. He has over 40 publications in The Lancet and New England Journal of Medicine, as well as over 20 in the British Medical Journal, Blood, Circulation, Annals of Internal Medicine and JAMA Internal Medicine.

Professor Anna Falanga

Anna Falanga, MD, is full Professor of Hematology at the University of Milan Bicocca and Chief of the Department of Immunohematology and Transfusion Medicine and the Thrombosis and Hemostasis Center, at the Hospital Papa Giovanni XXIII, in Bergamo, Italy. She has authored more than 300 publications and is guest editor of 21 volumes. She is an expert in the field of cancer and thrombosis. For her experience in this field, she is a member of the panel of experts and co-chair for the preparation of the Guidelines for prophylaxis and treatment of venous thromboembolism in patients with cancer, for the Italian Society of Medical Oncology, the American Society of Clinical Oncology, and the European Society of Medical Oncology.

Anna Falanga has an active role in several professional societies, including the International Society of Thrombosis and Haemostasis (ISTH), the European Hematology Association (EHA), the Italian Society of Thrombosis and Hemostasis (SISET), the Italian Society of Hematology (SIE).

She received the BACH Investigator Award of the ISTH (2009), and the “Harold R. Roberts Medal 2015” of the SSC of ISTH (2015). Additionally, Anna Falanga is the organizer of 10 biennial International Conferences on “Thrombosis and Hemostasis Issues in Cancer” (ICTHIC), in Bergamo, Italy, and is co-editor-in-chief with Charles Francis of the online ICTHIC magazine.

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References

1. Streiff MB, Abutalib SA, Farge D, Murphy M, Connors JM, Piazza G. Update on Guidelines for the Management of Cancer-Associated Thrombosis. The Oncologist. 2020; 26(1):e24–e40.

References

1. Agnelli, G. et al. Apixaban for the Treatment of Venous Thromboembolism Associated with Cancer. N. Engl. J. Med. 2020;382:1599–1607.
2. Conference Highlights - ACC 2020. Available at: https://conferences.m3medical.com/acc-2020/ (accessed 18 September).
3. ESC Congress 2020 — The Digital Experience - Programme. Available at: https://programme.escardio.org/ESC2020/Abstracts/218535-effectiveness-and-safety-of-apixaban-low-molecular-weight-heparin-and-warfarin-among-high-risk-subgroups-of-venous-thromboembolism-patients-with-active-cancer?r=/ESC2020/On-Demand?s%3D%24expression%3Dapixaban (accessed 18 September).
4. ESC Congress 2020 — The Digital Experience - Programme. Available at: https://programme.escardio.org/ESC2020/Abstracts/219413-risk-factors-for-major-bleeding-during-prolonged-anticoagulation-therapy-in-cancer-associated-venous-thromboembolisms-from-the-command-vte-registry?r=/ESC2020/On-Demand?s%3D%24expression%3DCOMMAND (accessed 18 September).
5. ESC Congress 2020 — The Digital Experience - Programme. Available at: https://programme.escardio.org/ESC2020/Abstracts/219450-patterns-of-anticoagulation-for-atrial-fibrillation-in-cancer-patients-referred-for-cardio-oncological-evaluation?r=/ESC2020/On-Demand?s%3D%24expression%3Datrial fibrillation cancer (accessed 18 September).
6. Anticoagulation Therapy Management in Oncological Patients: Experience in a Center - ISTH Congress Abstracts. Available at: https://abstracts.isth.org/abstract/anticoagulation-therapy-management-in-oncological-patients-experience-in-a-center/ (accessed 18 September).
7. Conference Highlights - ISTH 2020. Available at: https://conferences.m3medical.com/isth-2020/ (accessed 18 September).
8. Risk of Arterial Thromboembolism in Cancer Patients: A Population-Based Cohort Study - ISTH Congress Abstracts. Available at: https://abstracts.isth.org/abstract/risk-of-arterial-thromboembolism-in-cancer-patients-a-population-based-cohort-study/ (accessed 18 September).
9. Apixaban Levels In Cancer-Associated Thrombosis In Low-Weight Individuals - ISTH Congress Abstracts. Available at: https://abstracts.isth.org/abstract/apixaban-levels-in-cancer-associated-thrombosis-in-low-weight-individuals/ (accessed 18 September).
10. Cancer Associated Thrombosis: Are DOACs a Treatment Option? Systematic Review and Meta-analysis of Randomised Controlled Trials - ISTH Congress Abstracts. Available at: https://abstracts.isth.org/abstract/cancer-associated-thrombosis-are-doacs-a-treatment-option-systematic-review-and-meta-analysis-of-randomised-controlled-trials/ (accessed 18 September).
11. Khorana AA, Cohen AT, Carrier M, Meyer G, Pabinger I, Kavan P, et al. Prevention of venous thromboembolism in ambulatory patients with cancer. ESMO Open. 2020;5(6):948.