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AMPLIFY-EXT shows benefits of extended VTE treatment

Results of a pre-specified secondary analysis of the apixaban phase 3 AMPLIFY-EXT trial (Apixaban after the initial Management of PuLmonary embolIsm and deep vein thrombosis with First-line therapY-EXTended Treatment) were presented during the European Society of Cardiology (ESC) Congress 2014, held recently in Barcelona, Spain.

The analysis evaluated clinical and demographic predictors of all-cause hospitalisation in patients with venous thromboembolism (VTE), presenting as deep vein thrombosis (DVT) and pulmonary embolism (PE). Results from this analysis showed that during the 12-month extended treatment of VTE, apixaban significantly reduced the risk of hospitalisation compared to placebo. This effect was independent of other variables including renal function, the only other significant predictor of hospitalisation in the AMPLIFY-EXT population.

“The results of this AMPLIFY-EXT secondary analysis showed that apixaban (Eliquis) significantly reduced the risk of hospitalisation, irrespective of other variables,” said Dr Alexander T Cohen, study investigator and consultant physician (Guy’s and St. Thomas’ Hospitals, King’s College, London). “The findings from this secondary analysis provide additional support for extended anticoagulation with apixaban in VTE patients.”

AMPLIFY-EXT design

Screen shot 2014-09-26 at 10.30.25

Dr Alexander T Cohen (King’s College, London)

AMPLIFY-EXT was a randomised, double-blind, placebo-controlled extended treatment superiority study with 12 months of treatment plus one month follow-up in patients with VTE who completed six to 12 months of anticoagulation therapy.

The secondary analysis presented at ESC showed that, compared with placebo, apixaban 2.5 mg (p=0.032) and 5 mg (p=0.004) were both associated with significant reduction in all-cause hospitalisation. Of the 2,486 patients included in the AMPLIFY-EXT trial, 138 patients were hospitalised at least once, including 62 (7.48%) in the placebo group (n=829), 42 (5.00%) in the apixaban 2.5 mg group (n=840), and 34 (4.18%) in the apixaban 5 mg group (n=813). Of the first hospitalisations in the placebo group, a total of 32 (51.6%) were attributed to VTE recurrence versus six (17.7%) in the apixaban 5 mg group and 11 (26.2%) in the apixaban 2.5 mg group.

The following factors were clinically significant and independent predictors of all-cause hospitalisation during the trial:

  • Apixaban 2.5 mg versus placebo (HR=0.65, 95% CI=0.43-0.96)
  • Apixaban 5 mg versus placebo (HR=0.54, 95% CI=0.36-0.83)
  • Severe or moderate renal impairment versus normal renal function (HR=2.26, 95% CI=1.30-3.92).

Sex, age, baseline body weight and type of VTE did not significantly predict hospitalisation.

Speaking to BJC Arrhythmia Watch, Dr Cohen said that the findings from AMPLIFY-EXT have provided us with “very reassuring safety data with respect to the 2.5 mg bid and 5 mg bid doses, and strengthening the efficacy/safety ratio in terms of extending secondary prevention.”

Asked whether there is really much between the NOACs in terms of effectiveness/efficacy, and convenience, Dr Cohen said: “It is hard to tell without head to head comparisons, but the network meta-analyses (NMAs) show that apixaban has a superior safety profile whilst maintaining efficacy. NMAs have been generally shown to conservatively estimate differences, and many have been validated in cardiovascular medicine”.

Asked whether he though newer strategies (longer-term) were likely to be adopted in primary care, given the cost constraints on the present commissioning system, Dr Cohen replied that they would not place too much strain on the present commissioning system, “as apixaban use was associated with reduced hospitalisations in the initial period (less bleeds vs. LMWH/warfarin) and the extended period (less recurrences, no increased clinically relevant bleeding vs. placebo). This should be very cost effective or cost saving,” he concluded.

Editors note

New guidelines on Acute Pulmonary Embolism were issued during the ESC Congress.

These can be accessed at: http://eurheartj.oxfordjournals.org/content/early/2014/09/17/eurheartj.ehu283.full.pdf+html

The guidelines provide the most comprehensive recommendations ever for the diagnosis and treatment of PE and include recommendations on the new oral anticoagulants. Clinicians can confidentially stratify risk in their patients with suspected PE and provide appropriate treatment.

Published on: September 26, 2014

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