idraparinux trial summary

No demonstrated result

Endpoint	TE [95% CI]	p val	I2	n	k	trials
systemic thrombo-embolic complication	0.22 [0.01 4.57]	p=1.00	0	4029	1	AMADEUS,
thrombo-embolic event (cerebral or systemic)	0.73 [0.40 1.33]	p=1.00	0	4029	1	AMADEUS,
TE event or ischemic stroke or systemic embolism	0.73 [0.40 1.33]	p=1.00	0	4029	1	AMADEUS,
ischemic stroke	0.71 [0.35 1.44]	p=1.00	0	4029	1	AMADEUS,
Lifethreatening major bleeding	no data
Non-lifethreatening major bleeding	no data
Gastrointestinal major bleeding	no data
major or clinically relevant non-major bleeding	no data
hypertransaminasemia	no data
Major bleeding	2.67 [1.73 4.12]	p=0.04	0	3902	1	AMADEUS,
Haemmorhagic stroke	no data
Fatal bleeding	7.14 [1.61 31.66]	p=0.04	0	4072	1	AMADEUS,
Cardiovascular death	no data
stroke (fatal and non fatal)	no data
Coronary event	no data
All cause death	1.12 [0.78 1.60]	p=1.00	0	4072	1	AMADEUS,
Fatal stroke	0.37 [0.01 8.99]	p=1.00	0	4072	1	AMADEUS,
Non fatal stroke	no data

TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients

Primary prevention of thromboembolic events: 2 trials - idraparinux BOREALIS-AF - AMADEUS

No demonstrated result

Endpoint	TE [95% CI]	p val	I2	n	k	trials
systemic thrombo-embolic complication	0.22 [0.01 4.57]	p=1.00	0	4029	1	AMADEUS,
thrombo-embolic event (cerebral or systemic)	0.73 [0.40 1.33]	p=1.00	0	4029	1	AMADEUS,
TE event or ischemic stroke or systemic embolism	0.73 [0.40 1.33]	p=1.00	0	4029	1	AMADEUS,
ischemic stroke	0.71 [0.35 1.44]	p=1.00	0	4029	1	AMADEUS,
Lifethreatening major bleeding	no data
Non-lifethreatening major bleeding	no data
Gastrointestinal major bleeding	no data
major or clinically relevant non-major bleeding	no data
hypertransaminasemia	no data
Major bleeding	2.67 [1.73 4.12]	p=0.04	0	3902	1	AMADEUS,
Haemmorhagic stroke	no data
Fatal bleeding	7.14 [1.61 31.66]	p=0.04	0	4072	1	AMADEUS,
Cardiovascular death	no data
stroke (fatal and non fatal)	no data
Coronary event	no data
All cause death	1.12 [0.78 1.60]	p=1.00	0	4072	1	AMADEUS,
Fatal stroke	0.37 [0.01 8.99]	p=1.00	0	4072	1	AMADEUS,
Non fatal stroke	no data

TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients

All type of patients: 1 trials - VanGogh PE

No demonstrated result

suggested VTE by 110% (not demonstrated)

suggested All cause death by 79% (not demonstrated)

Endpoint	TE [95% CI]	p val	I2	n	k	trials
VTE	2.10 [1.19 3.72]	p=0.04	0	2215	1	VanGogh PE,
recurrent VTE during treatment	no data
Symptomatic deep-vein thrombosis	no data
Death related to venous thromboembolism	no data
symptomatic pulmonary embolism	no data
fatal pulmonary embolism	2.45 [0.86 6.99]	p=1.00	0	2215	1	VanGogh PE,
non-fatal pulmonary embolism	5.11 [1.48 17.72]	p=0.04	0	2215	1	VanGogh PE,
All cause death	1.79 [1.15 2.79]	p=0.04	0	2215	1	VanGogh PE,
Major bleeding	0.51 [0.25 1.03]	p=1.00	0	2215	1	VanGogh PE,
major or clinically relevant non-major bleeding	no data
Bleeding	no data

TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients

No demonstrated result

suggested All cause death by 40% (not demonstrated)

suggested Major bleeding by 41% (not demonstrated)

suggested Bleeding by 36% (not demonstrated)

Endpoint	TE [95% CI]	p val	I2	n	k	trials
VTE	1.29 [0.92 1.82]	p=1.00	0	5119	2	VanGogh DVT,VanGogh PE,
recurrent VTE during treatment	0.98 [0.63 1.50]	p=1.00	0	2904	1	VanGogh DVT,
Symptomatic deep-vein thrombosis	no data
Death related to venous thromboembolism	no data
symptomatic pulmonary embolism	no data
fatal pulmonary embolism	1.77 [0.77 4.09]	p=1.00	0	5119	2	VanGogh DVT,VanGogh PE,
non-fatal pulmonary embolism	1.31 [0.76 2.26]	p=1.00	0	5119	2	VanGogh DVT,VanGogh PE,
All cause death	1.40 [1.01 1.94]	p=0.04	0	5119	2	VanGogh DVT,VanGogh PE,
Major bleeding	0.59 [0.36 0.99]	p=0.04	0	5119	2	VanGogh DVT,VanGogh PE,
major or clinically relevant non-major bleeding	no data
Bleeding	0.64 [0.47 0.89]	p=0.04	0	2904	1	VanGogh DVT,

TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients

No demonstrated result

Endpoint	TE [95% CI]	p val	I2	n	k	trials
Recurrent thromboembolic event	0.38 [0.13 1.10]	p=1.00	0	421	1	Van Gogh (subgroup),
recurrent VTE	no data
fatal pulmonary embolism	no data
non-fatal pulmonary embolism	no data
Recurrent DVT/DVT extension (symptomatic)	no data
Thrombocytopenia	no data
death at 3 months	no data
Long term death	0.99 [0.66 1.48]	p=1.00	0	421	1	Van Gogh (subgroup),
All cause death	no data
Bleeding	0.89 [0.50 1.59]	p=1.00	0	421	1	Van Gogh (subgroup),
Major bleeding	no data
Fatal bleeding	no data

TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients

Idraparinux antithrombotics