Anticoagulants plus NSAIDs or aspirin increased bleeding risk in VTE

Concomitant use of aspirin or an NSAID during anticoagulant therapy was associated with an increased risk for clinically relevant and major bleeding in patients with venous thromboembolism, according to study results.

The prospective analysis included data from the EINSTEIN deep vein thrombosis and pulmonary embolism clinical trials. The trials compared combined treatment with anticoagulants — either rivaroxaban (Xarelto, Janssen), or a regimen of enoxaparin(Lovenox, Sanofi Aventis) and vitamin K antagonist — and NSAID or aspirin therapy in 8,246 patients between 2007 and 2009.

Researchers compared bleeding rates during concomitant treatment with those observed during anticoagulation therapy alone.

Among patients treated with NSAIDs, the results showed significantly higher rates of clinically relevant bleeding (37.5 per 100 patient-years vs. 16.6 per 100 patient-years; HR=1.77; 95% CI, 1.46-2.14) and major bleeding (6.5 per 100 patient-years vs. 2 per 100 patient-years; HR=2.37; 95% CI, 1.51-3.75) during concomitant treatment than during anticoagulation therapy alone.

Among patients treated with aspirin, results showed higher rates of clinically relevant bleeding (36.6 per 100 patient-years vs. 16.9 per 100 patient-years; HR=1.7; 95% CI, 1.38-2.11) and major bleeding (4.8 per 100 patient-years vs. 2.2 per 100 patient-years; HR=1.5; 95% CI, 0.86-2.62) during concomitant treatment than during anticoagulation alone.

“The doubled risk for bleeding should urge physicians to combine anticoagulation with either NSAID or aspirin therapy with caution and only if genuinely indicated, with no similarly effective and safer alternative treatment available,” the researchers concluded. “If indicated, patients treated with VKAs should be monitored carefully to avoid prolonged periods in the supratherapeutic zone, especially in those with an a priori enhanced bleeding risk.”

Disclosure: The researchers reported payment from Bayer for steering committee and other work related to the EINSTEIN study; travel support from and employment relationships with Bayer; and paid speaker roles with Janssen.

Source: www.healio.com