AMPLIFY Trial: Apixaban for acute VTE

amplify trial apixaban vte
2013 AMPLIFY TRIAL Oral Apixaban for the Treatment of Acute Venous Thromboembolism double-blind, multicenter, randomized controlled trial IM Objective: To determine if apixaban is non-inferior to conventional therapy with LMWH in patients with pulmonary embolism or proximal deep venous thrombosis Inclusion criteria: Patients ≥18 years with symptomatic VTE, 5,395 either DVT proximal to popliteal vein or PE with or without Patients any DVT, Confirmation of VTE on imaging, Unprovoked or provoked with a low risk of recurrence VS Apixaban (n=2,691) LMWH + Warfarin (n=2,704) PRIMARY OUTCOME 2.3 Recurrent symptomatic VTE or VTE mortality% RR 0.84; 95% HR 0.60-1.18; P<0.001 for non-inferiority 2.7 Major bleeding % 0.6 RR 0.31; 95% CI 0.17-0.55; 1.8 P<0.001 for superiority; NNT 100 4.3 Major bleeding or clinically-relevant non-major bleeding% RR 0.44; 95% CI 0.36-0.55; P<0.001 for superiority; NNT 19 9.7 SECONDARY OUTCOMES All-cause mortality % 1.5 1.9 RR 0.79; 95% CI 0.53-1.19 Conclusion: A fixed-dose regimen of apixaban alone was noninferior to conventional therapy for the treatment of acute venous thromboembolism and was associated with significantly less bleeding Agnelli et al. N Engl J Med 2013; 369:799-808 M Visualmed