RT Journal Article
T1 Apixaban for the Treatment of Venous Thromboembolism Associated with Cancer
A1 Agnelli, Giancarlo
A1 Muñoz Martín, Andrés Jesús
A1 Verso, Melina
AB BACKGROUND Recent guidelines recommend consideration of the use of oral edoxaban or rivaroxaban for the treatment of venous thromboembolism in patients with cancer. However, the benefit of these oral agents is limited by the increased risk of bleeding associated with their use. METHODS This was a multinational, randomized, investigatorinitiated, openlabel, noninferiority trial with blinded central outcome adjudication. We randomly assigned consecutive patients with cancer who had symptomatic or incidental acute proximal deepvein thrombosis or pulmonary embolism to receive oral apixaban (at a dose of 10 mg twice daily for the first 7 days, followed by 5 mg twice daily) or subcutaneous dalteparin (at a dose of 200 IU per kilogram of body weight once daily for the first month, followed by 150 IU per kilogram once daily). The treatments were administered for 6 months. The primary outcome was objectively confirmed recurrent venous thromboembolism during the trial period. The principal safety outcome was major bleeding. RESULTS Recurrent venous thromboembolism occurred in 32 of 576 patients (5.6%) in the apixaban group and in 46 of 579 patients (7.9%) in the dalteparin group (hazard ratio, 0.63; 95% confidence interval [CI], 0.37 to 1.07; P<0.001 for noninferiority). Major bleeding occurred in 22 patients (3.8%) in the apixaban group and in 23 patients (4.0%) in the dalteparin group (hazard ratio, 0.82; 95% CI, 0.40 to 1.69; P=0.60). CONCLUSIONS Oral apixaban was noninferior to subcutaneous dalteparin for the treatment of cancerassociated venous thromboembolism without an increased risk of major bleeding.
PB Massachusetts Medical Society
SN 1533-4406
YR 2020
FD 2020
LK https://hdl.handle.net/20.500.14352/126239
UL https://hdl.handle.net/20.500.14352/126239
LA eng
NO Agnelli G, Becattini C, Meyer G, Muñoz A, Huisman MV, Connors JM, Cohen A, Bauersachs R, Brenner B, Torbicki A, Sueiro MR, Lambert C, Gussoni G, Campanini M, Fontanella A, Vescovo G, Verso M; Caravaggio Investigators. Apixaban for the Treatment of Venous Thromboembolism Associated with Cancer. N Engl J Med. 2020 Apr 23;382(17):1599-1607.
NO El ensayo clínico Caravaggio ha publicado diferentes subanálisis, analizando distintos subgrupos de pacientes (por tipo de tumor, estadio, insuficiencia renal, patrón temporal y análisis de interacciones, entre otros), siendo todos los resultados consistentes con los resultados globales del ensayo clínico.
NO BristolMyers Squibb-Pfizer Alliance
NO Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti
DS Docta Complutense
RD 24 mar 2026