AMPLIFY trial results
September 1, 2013
Currently, there are three novel oral anticoagulants on the market — dabigatran, rivaroxaban, and apixaban. All are approved for stroke prevention in patients with nonvalvular atrial fibrillation, but only rivaroxaban is approved for deep vein thrombosis/pulmonary embolism (PE) prevention and treatment. That may change with the publication of the AMPLIFY trial, which compared apixaban with conventional anticoagulant therapy in patients with acute venous thromboembolism (VTE). In a randomized, double-blind study, apixaban was compared with enoxaparin/warfarin (conventional therapy) in nearly 5400 patients with acute VTE. The primary outcome was recurrent symptomatic VTE or death related to VTE. The principal safety outcomes were major bleeding alone and major bleeding plus clinically relevant nonmajor bleeding. The primary outcome (recurrent VTE) occurred in 59 of 2609 patients (2.3%) in the apixaban group compared with 71 of 2635 (2.7%) in the conventional therapy group (relative risk [RR] 0.84; 95% CI, 0.60-1.18). Major bleeding occurred in 0.6% of those in the apixaban group and 1.8% in the conventional therapy group (RR, 0.31; 95% CI, 0.17-0.55; P < 0.001 for superiority). The composite outcome of major bleeding and nonmajor bleeding occurred more than twice as often in the conventional therapy group. Rates of adverse events were similar. The authors conclude that a fixed-dose regimen of apixaban alone was noninferior to conventional therapy for the treatment of acute VTE and was associated with less bleeding. The findings were the same for patients with PE or extensive disease (N Engl J Med published online July 1, 2013. DOI: 10.1056/NEJMoa1302507). An accompanying editorial states that this is “an exciting time in thrombosis care,” although more information is needed on reversal strategies and monitoring of these new agents (N Engl J Med July 1, 2013. DOI: 10.1056/NEJMe1307413). The option to safely treat VTE with fixed-dose oral options is very appealing. Both dabigatran and apixaban are expected to be reviewed for these indications in the near future.
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