Thrombosis

Thrombosis / 2013 / Article / Tab 3

Review Article

New Oral Anticoagulants in the Treatment of Pulmonary Embolism: Efficacy, Bleeding Risk, and Monitoring

Table 3

Outcomes of apixaban in AMPLIFY-EXT [34].

OutcomeApixaban 2.5 mg  
( ; 13 LTF)
Apixaban 5 mg  
( ; 20 LTF)
Placebo  
( ; 19 LTF)

Primary efficacy endpoint: composite of symptomatic recurrent vte or death from any cause32 (3.8%)34 (4.2%)96 (11.6%)
RR versus placeboRR versus placebo
0.33 (0.22–0.48)0.36 (0.25–0.53)

Secondary efficacy endpoint: symptomatic recurrent VTE or death related to VTE14 (1.7%)14 (1.7%)73 (8.8%)
RR versus placeboRR versus placebo
0.19 (0.11–0.33)0.20 (0.11–0.34)

Additional endpoint added after trial initiation: composite of symptomatic recurrent VTE, death related to VTE, myocardial infarction, stroke, or death related to cardiovascular cause18 (2.1%)19 (2.3%)83 (10%)
RR versus placeboRR versus placebo
0.21 (0.13–0.35)0.23 (0.14–0.38)

Primary safety endpoint: major bleeding2 (0.2%)1 (0.1%)4 (0.5%)
RR versus placeboRR versus placebo
0.49 (0.09–2.64)0.25 (0.03–2.24)

Secondary safety endpoint: major or clinically relevant nonmajor bleeding27 (3.2%)35 (4.3%)22 (2.7%)
RR versus placeboRR versus placebo
1.2 (0.69–2.10)1.62 (0.96–2.73)

Recurrent fatal PE or death where PE could not be excluded2 (0.2%)3 (0.4%)7 (0.8%)
RR versus placeboRR versus placebo
0.28 (0.06–1.35)0.43 (0.11–1.68)

Recurrent nonFatal PE8 (1%)4 (0.5%)15 (1.8%)
RR versus placeboRR versus placebo
0.53 (0.22–1.23)0.27 (0.09–0.82)

Study conclusion Extension with 12 months of apixaban 2.5 mg or 5 mg twice daily therapy reduced the risk of recurrent VTE and recurrent nonfatal PE, without increasing the risk of major bleeding.

NR: not reported, LTF: lost to follow (classified as having the primary efficacy endpoint).
Major bleeding as defined in AMPLIFY-EXT: clinical overt bleeding, with associated fall in hemoglobin of at least 2 g per deciliter, the need for transfusion of 2 or more units of red blood cells, involving a critical site or was fatal.
Nonmajor bleeding as defined in AMPLIFY-EXT: bleeding that did not meet criteria for major bleeding but AHT was associated with the need for medical intervention, unscheduled contact with a physician, interruption or discontinuation of the study drug, or discomfort or impairment of activities of daily living. In addition, any bleeding compromising hemodynamics, leading to hospitalization, development of subcutaneous hematoma larger than 25 cm2 or 100 cm2 if traumatic cause, intramuscular hematoma documented by ultrasonography, epistaxis of more than 5 minutes duration, or was repetitive, spontaneous gingival bleeding, spontaneous macroscopic hematuria lasting great than 24 hours, macroscopic gastrointestinal hemorrhage, and hemoptysis not occurring with PE.

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