Longer-term anticoagulation cuts thrombotic risk for patients with cancer, isolated DVT
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Key takeaways:
- Longer vs. shorter-duration anticoagulation reduces thrombotic event risk for patients with cancer and isolated DVT.
- There was no increased risk for major bleeding with 12-month anticoagulation therapy.
In the ONCO-DVT trial, patients with cancer and isolated distal deep vein thrombosis had fewer thrombotic events at 1 year with 12-month vs. 3-month edoxaban therapy, a finding that could change clinical guidance, according to a speaker.
Distal DVT is a common complication among patients with cancer, but recurrence can be prevented with anticoagulation therapy, Yugo Yamashita, MD, PhD, of Kyoto University Graduate School of Medicine, Japan, said during a press conference at the European Society of Cardiology Congress. However, there have been no randomized controlled trials assessing the optimal duration of anticoagulation therapy for these patients, Yamashita said.
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“The ONCO-DVT study is the first randomized clinical trial to investigate this issue,” Yamashita said during the press conference.
Yamashita and colleagues analyzed data from 604 adults living in Japan with active cancer and newly diagnosed isolated distal DVT confirmed with compression ultrasonography. The mean age of patients was 71 years; 72% were women. The most frequent site of cancer was the ovaries (14%), followed by the uterus (13%), lung (11%), colon (9%) and pancreas (8%). Researchers randomly assigned participants to 12 or 3 months of edoxaban (Savaysa, Daiichi Sankyo), at a fixed dose of 60 mg once daily or at a lower dose of 30 mg once daily for patients with a creatinine clearance of 30 to 50 mL/minute, a body weight of 60 kg or less or for those receiving concomitant treatment with a P-glycoprotein inhibitor.
The primary endpoint was symptomatic recurrent VTE or VTE-related death at 12 months. The secondary endpoint was a major bleeding event according to International Society on Thrombosis and Haemostasis criteria at 12 months.
Within 90 days, the incidence rate of the primary endpoint was about 1% in both groups. However, at 12 months, the primary endpoint occurred in 1.2% of patients in the 3-month edoxaban group and 8.5% of patients in the 12-month edoxaban group, for an OR of 0.13 (95% CI, 0.03-0.44; P < .001).
Major bleeding occurred in 10.2% of patients in the 12-month edoxaban group and 7.6% of patients in the 3-month edoxaban group, for an OR of 1.34 (95% CI, 0.75-2.41).
Researchers observed no differences in prespecified subgroup analyses stratified by age, body weight and renal function.
“This is the first and only randomized clinical trial to show the superiority of longer duration over shorter duration anticoagulation therapy for reducing thrombotic events in cancer patients with isolated distal DVT,” Yamashita said. “We believe these study results could change recommendations in clinical guidelines, maybe change daily clinical practice and could be new important evidence in the cardio-oncology field.”
Yamashita noted that since all participants were Japanese, the findings are likely not generalizable to people of other races and ethnicities.
Perspective
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In patients with isolated distal DVT, the best treatment strategy remains somewhat unclear. Patients with cancer are commonly found to have distal DVTs. This open-label, randomized trial found that 12 months of a non-vitamin K oral anticoagulant was significantly more effective than 3 months of therapy in reducing symptomatic VTE recurrence. There was a numerical increase in bleeding (as would be expected from a longer duration of therapy), though this was not statistically significant in this trial of approximately 600 patients. The effect size in terms of benefit was enormous. These results are very encouraging and will hopefully lead other investigators to try and replicate the results quickly, which should be easy if the degree of benefit observed in this modest-sized trial is real. It is always a bit of a challenge to know whether to immediately change practice on the basis of one open-label trial that is modest in size, but in patients at low risk for bleeding, it may be reasonable to implement these findings while waiting for larger trials on the topic.
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Yamashita Y, et al. Hot line 9. Presented at: European Society of Cardiology Congress; Aug. 25-28, 2023; Amsterdam (hybrid meeting).
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