AMPLIFY (Apixaban for initial management of PE DVT as first line therapy

Question 1

AMPLIFY clinical question?

Answer 1

Among patients with acute VTE, is apixaban non-inferior to conventional therapy with LMWH and vitamin K antagonists for symptomatic VTE recurrence, VTE mortality, or rates of bleeding?

Question 2

AMPLIFY bottom line

Answer 2

Apixaban is noninferior to LMWH and vitamin K antagonist-based therapy for VTE recurrence and VTE mortality. Apixiban therapy has a greater reduction in rates of bleeding

Question 3

AMPLIFY design and n

Answer 3

Prospective, randomized, double-blind trial, 5395

Question 4

AMPLIFY primary outcome

Answer 4

• Recurrent symptomatic VTE or VTE mortality
• Major bleeding
• Major bleeding or clinically-relevant non-major bleeding

Question 5

AMPLIFY inclusion criteria

Answer 5

• Age ≥18 years with symptomatic VTE, either DVT proximal to popliteal vein or PE with or without any DVT
• Confirmation of VTE on imaging
• Unprovoked or provoked with a low risk of recurrence

Question 6

AMPLIFY interventions

Answer 6

-Apixaban - Apixaban 10 mg PO bid for 7 days then 5 mg po BID along with placebo LMWH and warfarin (a sham INR result was given to simulate routine adjustments)

-Conventional therapy - Enoxaparin 1 mg/kg q12h for ≥5 days then warfarin adjusted to an INR of 2-3
Both groups treated for 6 months

Question 7

AMPLIFY criticisms

Answer 7

• Unclear if these outcomes would remain unchanged in patients with cancer, underweight, or creatinine clearance <50 mL/min
• No analysis based upon geographic location