Idraparinux antithrombotics

Description Results

non fatal bleeding 2.50 [1.59; 3.91]

all bleeding 1.74 [1.49; 2.03]

major bleeding 2.67 [1.74; 4.08]

fatal bleeding 7.14 [1.61; 31.58]

fatal hemorrage other than intracranial 2.20 [0.20; 24.20]

all stroke or systemic embolism 0.73 [0.40; 1.32]

non vascular death 1.20 [0.67; 2.13]

all death 1.12 [0.79; 1.58]

fatal stroke(ischemic+hemorrhagic) 0.00 [0.00; NaN]

thrombo-embolic event (cerebral or systemic) 0.73 [0.40; 1.32]

ischemic stroke 0.71 [0.36; 1.43]

intracranial hemorrhage(hemorrhagic stroke+hematomas) 0.88 [0.24; 3.26]

thromboembolic event likes(TE event or ischemic stroke or systemic embolism) 0.73 [0.40; 1.32]

systemic thrombo-embolic complication 0.00 [0.00; NaN]

subcutaneous idraparinux 2·5 mg weekly (n=2283)

vs.

adjusted-dose vitamin K antagonists (target of an international normalised ratio of 2–3) (n=2293)

open

Parallel groups

Sample size: 2283/2293

Primary endpoint: all stroke and systemic embolism

FU duration: 10.7 months

All deaths 1.79 [1.17; 2.74]

non fatal PE 5.11 [1.48; 17.62]

recurrent VTE 2.10 [1.20; 3.67]

recurrent DVT only 1.02 [0.43; 2.45]

Major bleeding 0.51 [0.26; 1.02]

fatal PE 2.45 [0.87; 6.94]

subcutaneous idraparinux (2.5 mg once weekly) (n=1095)

vs.

heparin followed by an adjusted-dose vitamin K antagonist (n=1120)

open

Parallel groups

Sample size: 1095/1120

Primary endpoint: 3-month incidence of symptomatic recurrent venous thromboembolism (nonfatal or fatal)

FU duration: 3 mo (6 mo)

any bleeding 0.64 [0.48; 0.87]

recurrent DVT only 0.94 [0.49; 1.83]

All deaths 1.03 [0.64; 1.67]

Major bleeding 0.71 [0.34; 1.47]

non fatal PE 0.95 [0.53; 1.73]

fatal PE 1.00 [0.25; 3.99]

recurrent VTE during treatment 0.98 [0.64; 1.48]

recurrent VTE 0.98 [0.64; 1.48]

All deaths 1.79 [1.17; 2.74]

non fatal PE 5.11 [1.48; 17.62]

recurrent VTE 2.10 [1.20; 3.67]

recurrent DVT only 1.02 [0.43; 2.45]

Major bleeding 0.51 [0.26; 1.02]

fatal PE 2.45 [0.87; 6.94]

all bleeding 0.89 [0.50; 1.59]

deaths at 6 months 0.99 [0.66; 1.48]

Recurrent DVT/DVTextension (total) 0.38 [0.14; 1.06]

subcutaneous idraparinux (2.5 mg once weekly) (n=1452)

vs.

heparin followed by an adjusted-dose vitamin K antagonist (n=1452)

open

Parallel groups

Sample size: 1452/1452

Primary endpoint: 3-month incidence of symptomatic recurrent venous thromboembolism (nonfatal or fatal)

FU duration: 3 mo (6 mo)

subcutaneous idraparinux (2.5 mg once weekly) (n=1095)

vs.

heparin followed by an adjusted-dose vitamin K antagonist (n=1120)

open

Parallel groups

Sample size: 1095/1120

Primary endpoint: 3-month incidence of symptomatic recurrent venous thromboembolism (nonfatal or fatal)

FU duration: 3 mo (6 mo)

once-weekly subcutaneous injection of idraparinux (2.5 mg) for 6 months (n=220)

vs.

standard treatment for three months (8%) or six months (92%) (n=201)

Parallel groups

Sample size: 220/201

Primary endpoint:

FU duration: 6 months