Table 1.
Study | No. of study patients | No. of patientsa in meta-analysis | Duration | Agec | Per cent women | Study treatment | Antiplatelet drugs |
Bleeding events used in the present study | |
---|---|---|---|---|---|---|---|---|---|
Single (%) | Dual (%) | ||||||||
ESTEEM11 | 1900 | 1883 | 6 months | 68 | 32 | Ximelagatran 24, 36, 48, or 60 mg b.i.d., or placebo | 100 | – | ISTH major and clinically relevant non-major bleeds |
APPRAISE-112 | 1715 | 1210b | 6 months | 61 | 24 | Apixaban 2.5 mg b.i.d., 10 mg o.d., or placebo | 24 | 76 | ISTH major and clinically relevant non-major bleeds |
ATLAS ACS-TIMI4613 | 3462 | 1997b | 6 months | 57 | 23 | Rivaroxaban 5 mg o.d., 5 mg b.i.d., 10 mg o.d., or placebo | 25 | 75 | TIMI clinically significant bleeding (TIMI major bleeding, TIMI minor bleeding, or bleeding requiring medical attention) |
REDEEM14 | 1878 | 1861 | 6 months | 62 | 24 | Dabigatran 50, 75, 110. or 150 mg b.i.d. or placebo | 2 | 98 | ISTH major and clinically relevant non-major bleeds |
RUBY-115 | 1279 | 1258 | 6 months | 57 | 20 | Darexaban 5, 15 or 30 mg b.i.d., 10, 30 or 60 mg o.d., or placebo | 5 | 95 | ISTH major and clinically relevant non-major bleeds |
APPRAISE-216 | 7392 | 7315 | 8 months | 67 | 32 | Apixaban 5 mg (or 2.5 mgd) b.i.d., or placebo | 19 | 81 | TIMI major bleeds; ISTH major and clinically relevant non-major bleeds |
ATLAS ACS2-TIMI5117 | 15 526 | 15 342 | 13 months | 62 | 25 | Rivaroxaban 2.5 or 5 mg b.i.d., or placebo | 7 | 93 | TIMI major (non-CABG related) bleeds, TIMI bleeding requiring medical attention |
o.d., once daily; b.i.d., twice daily; ISTH, International Society on Thrombosis and Haemostasis; TIMI, Thrombolysis in Myocardial Infarction.
See Methods for description of inclusion and exclusion criteria. Single antiplatelet therapy includes patients not receiving any antiplatelet medication at randomization, dual antiplatelet treatment consists of aspirin and clopidogrel at randomization.
aNo. of patients who received at least one dose of study drug.
bNo. of patients treated with daily doses also evaluated in phase III study.
cMean or median.
dApixaban 2.5 mg b.i.d. in 8.5% of the patients with estimated creatinine clearance <40 mL/min.