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
