Bleeding in Patients Treated With Anticoagulants and Potential Cancers
Bleeding in patients treated with anticoagulants may indicate an increased probability of cancer, according to late-breaking results from the COMPASS trial presented at the 2018 European Society of Cardiology Congress.
Principal investigator John Eikelboom, MD, of the Population Health Research Institute at McMaster University, Hamilton, Canada, said, “In patients with stable coronary artery disease or peripheral artery disease, the occurrence of major gastrointestinal bleeding predicts a substantial increase in new gastrointestinal cancer diagnoses, while major genitourinary bleeding predicts a substantial increase in new genitourinary tract cancer diagnoses.”
Up to 1 in 10 patients with cardiovascular disease have recurrent events each year. As previously reported, the COMPASS trial found that in patients with coronary artery disease or peripheral artery disease, the combination of rivaroxaban (Xarelto) at 2.5 mg twice daily and aspirin reduced cardiovascular events compared to aspirin alone, but there were more major bleeding events in the combined-drug group.
Bleeding and Cancer Risk
The COMPASS trial enrolled 27,395 patients with chronic stable coronary or peripheral artery disease from 602 centers in 33 countries. Patients were randomly allocated to one of three groups: rivaroxaban at 2.5 mg twice daily plus aspirin at 100 mg once daily; rivaroxaban at 5 mg twice daily; or aspirin at 100 mg once daily. Results in each of the rivaroxaban groups were compared with the aspirin-alone group. The mean duration of follow-up was 23 months.
The combination increased major bleeding, as defined by the International Society on Thrombosis and Hemostasis, compared with aspirin (3.1% vs 1.9%, hazard ratio [HR] = 1.70, 95% confidence interval [CI] = 1.40–2.05; P < .0001), but did not significantly increase intracranial bleeding (0.3% vs 0.3%, HR = 1.16, 95% CI = 0.67–2.00; P = .60) or fatal bleeding (0.2% vs 0.1%, HR = 1.49, 95% CI = 0.67–3.33, P = .32).
Major gastrointestinal bleeding was associated with a 20-fold increase in new diagnoses of gastrointestinal cancer (9.3% vs 0.7%, HR = 22.6, 95% CI = 14.9–34.3; P < .0001) and a 2-fold increase in nongastrointestinal cancer (4.6% vs 3.1%, HR = 2.55, 95% CI = 1.47–4.42; P < .0001). Major nongastrointestinal bleeding was associated with a 5-fold increase in new nongastrointestinal cancers (9.4% vs 3.0%, HR = 5.49, 95% CI = 3.95–7.62; P < .0001) but not with new gastrointestinal cancer (0.5% vs 0.8%, HR = 0.85, 95% CI = 0.21–3.45, P = .82).
Dr. Eikelboom concluded, “More than 1 in 10 patients with major bleeding were subsequently diagnosed with cancer, and more than 20% of new cancer diagnoses were in patients who experienced bleeding. By reducing major cardiovascular events and mortality, the combination of rivaroxaban and aspirin already produces a clear net benefit, and if bleeding unmasks cancer, it could potentially lead to the added benefit of improved cancer outcomes.”
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
