ESC 23: ONCO DVT: Optimal Duration of DOAC Therapy for IDDVT Patients with Cancer
Published: 28 Aug 2023
ESC 23 — In this concise interview, Dr Yugo Yamashita (Kyoto University Graduate School of Medicine, JP) reveals the findings of the ONCO DVT Study (NCT03895502).
The ONCO DVT study (Takeshi Morimoto) aimed to determine the ideal duration of anticoagulation therapy with the direct oral anticoagulant (DOAC) edoxaban for the treatment of isolated distal deep vein thrombosis (IDDVT) in patients with active cancer. 605 participants were enrolled in the trial, and were randomly assigned to receive either edoxaban for 3 months (short DOAC group) or edoxaban for 12 months (long DOAC group).
- What are the unmet needs of cancer patients with IVDDT?
- What was the study design and the patient population?
- What were the key outcomes?
- How should these findings impact care?
- What further study is needed?
Recorded on-site at ESC Congress 2023, Amsterdam.
For more content from ESC Congress 2023 head to the Hot Line & Late-breaking Science Video Collection.
Editors: Mirjam Boros and Jordan Rance
Video Specialists: Dan Brent, Tom Green, Mike Knight, Oliver Miles
"I'm Yugo Yamashita from the department of cardiovascular medicine, Kyoto University. I'm a cardiologist, and I'm a researcher of venous thromboembolism, and the current ONCO-DVT study was a study investigating the optimal duration of anticoagulation therapy for isolated distal DVT in the field of onco-cardiology.
Unmet Needs of Cancer Patients with DVT
Recently, the cancer patient is surviving longer due to the improvement of the treatment of cancer. And thus, cardiovascular complications during the treatment course of cancer are becoming more clinically relevant in terms of cardio-oncology. So among the cardiovascular complications, isolated distal DVT is one of the more common cardiovascular complications. However, there has been no randomized clinical trial in investigating the issue. So we conducted the ONCO-DVT study.
The ONCO-DVT study was a physician-initiated, multicenter superiority, educated, blinded randomized clinical trial.
Study Design and Patient Population
So the included patient was randomly assigned to receive either twelve months of edoxaban treatment or three months of edoxaban treatment for isolated distal DVT and evaluated the primary endpoint of a composite of a symptomatic recurrent VTE or VTE-related death at twelve months. Based on the intention-to-treat population analysis.
Actually, we found the superiority of a twelve-month edoxaban treatment group to the three months edoxaban treatment group. So the event rate is about 1% in the twelve months edoxaban group, and on the other hand, about 8% in the three months edoxaban treatment group. So we successfully demonstrated the superiority of a longer duration of anticoagulant therapy for isolated distal DVT with active cancer.
As for the major secondary endpoint of major bleeding events, there was no significant difference between the two groups, although the incidence of major bleeding was numerically slightly higher in the twelve months edoxaban group as expected. But there was no significant difference, so there was no safety concern overall.
Generalisation of Results to Global Population
I think from the ONCO-DVT study's basic concept that thrombotic risk is higher in the patient with isolated distal DVT. But the important thing in the cancer patient is there is a variety of cancer types and, of course, there is a racial difference. So the generalizability of the current study to other populations should be carried out carefully.
Impact on Patient Care
The important message from the ONCO-DVT study is if you find the minor DVT isolated distal DVT in your patient and if they have active cancer, you should be careful because the risk of thrombotic risk is not low. That is a key message from the ONCO-DVT study.
So I believe that the current ONCO-DVT study result could change practice guidelines as well as daily clinical practice. Maybe there are some patients who can get more benefit. On the other hand, there are some patients who get less benefit. So it is important to find out more beneficial patient the risk-beneficial patient through the maybe sub-analysis of the ONCO-DVT study.”