ximelagatran trial summary

Acute coronary syndrome

All ACS (including AMI): 1 trials - ESTEEM

No demonstrated result

Endpoint	TE [95% CI]	p val	I2	n	k	trials
cardiac event (fatal and non fatal )	no data
cardiovascular events	no data
Cardiovascular death	no data
myocardial infarction (fatal and non fatal)	no data
ischemic stroke	no data
All cause death	no data
stent thrombosis	no data
major or minor bleeding	no data
any bleedings	no data
major or clinically relevant non-major bleeding	no data
Major bleeding	no data
Fatal bleeding	no data

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

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All type of patients: 1 trials - ESTEEM

ximelagatran vs placebo

No demonstrated result

Endpoint	TE [95% CI]	p val	I2	n	k	trials
cardiac event (fatal and non fatal )	no data
cardiovascular events	no data
Cardiovascular death	no data
myocardial infarction (fatal and non fatal)	no data
ischemic stroke	no data
All cause death	no data
stent thrombosis	no data
major or minor bleeding	no data
any bleedings	no data
major or clinically relevant non-major bleeding	no data
Major bleeding	no data
Fatal bleeding	no data

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

Patients with a recent ACS: 1 trials - ESTEEM

ximelagatran vs placebo

No demonstrated result

Endpoint	TE [95% CI]	p val	I2	n	k	trials
cardiac event (fatal and non fatal )	no data
cardiovascular events	no data
Cardiovascular death	no data
myocardial infarction (fatal and non fatal)	no data
ischemic stroke	no data
All cause death	no data
stent thrombosis	no data
major or minor bleeding	no data
any bleedings	no data
major or clinically relevant non-major bleeding	no data
Major bleeding	no data
Fatal bleeding	no data

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

Atrial fibrillation

All type of patients: 3 trials - SPORTIF II (ximelagatran vs warfarin standard dose) - SPORTIF III - SPORTIF V

ximelagatran vs warfarin standard dose

No demonstrated result

hypertransaminasemia by 681% (harmful effect)

suggested Major bleeding by 27% (not demonstrated)

Endpoint	TE [95% CI]	p val	I2	n	k	trials
systemic thrombo-embolic complication	2.47 [0.70 8.67]	p=1.00	0	7583	3	SPORTIF II (ximelagatran vs warfarin standard dose),SPORTIF III,SPORTIF V,
thrombo-embolic event (cerebral or systemic)	0.98 [0.73 1.32]	p=1.00	0	7329	2	SPORTIF III,SPORTIF V,
TE event or ischemic stroke or systemic embolism	0.94 [0.68 1.29]	p=1.00	0	7329	2	SPORTIF III,SPORTIF V,
ischemic stroke	0.94 [0.69 1.29]	p=1.00	0	7583	3	SPORTIF II (ximelagatran vs warfarin standard dose),SPORTIF III,SPORTIF V,
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	7.81 [4.54 13.42]	p=0.04	0	3922	1	SPORTIF V,
Major bleeding	0.73 [0.55 0.95]	p=0.04	0	7583	3	SPORTIF II (ximelagatran vs warfarin standard dose),SPORTIF III,SPORTIF V,
Haemmorhagic stroke	0.54 [0.20 1.43]	p=1.00	0	7583	3	SPORTIF II (ximelagatran vs warfarin standard dose),SPORTIF III,SPORTIF V,
Fatal bleeding	no data
Cardiovascular death	1.21 [0.76 1.93]	p=1.00	0	3407	1	SPORTIF III,
stroke (fatal and non fatal)	0.91 [0.67 1.23]	p=1.00	0	7583	3	SPORTIF II (ximelagatran vs warfarin standard dose),SPORTIF III,SPORTIF V,
Coronary event	0.99 [0.66 1.49]	p=1.00	0	7329	2	SPORTIF III,SPORTIF V,
All cause death	0.96 [0.79 1.18]	p=1.00	0	7583	3	SPORTIF II (ximelagatran vs warfarin standard dose),SPORTIF III,SPORTIF V,
Fatal stroke	1.51 [0.73 3.13]	p=1.00	0	7583	3	SPORTIF II (ximelagatran vs warfarin standard dose),SPORTIF III,SPORTIF V,
Non fatal stroke	no data

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

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Primary prevention of thromboembolic events: 3 trials - SPORTIF II (ximelagatran vs warfarin standard dose) - SPORTIF III - SPORTIF V

ximelagatran vs warfarin standard dose

No demonstrated result

hypertransaminasemia by 681% (harmful effect)

suggested Major bleeding by 27% (not demonstrated)

Endpoint	TE [95% CI]	p val	I2	n	k	trials
systemic thrombo-embolic complication	2.47 [0.70 8.67]	p=1.00	0	7583	3	SPORTIF II (ximelagatran vs warfarin standard dose),SPORTIF III,SPORTIF V,
thrombo-embolic event (cerebral or systemic)	0.98 [0.73 1.32]	p=1.00	0	7329	2	SPORTIF III,SPORTIF V,
TE event or ischemic stroke or systemic embolism	0.94 [0.68 1.29]	p=1.00	0	7329	2	SPORTIF III,SPORTIF V,
ischemic stroke	0.94 [0.69 1.29]	p=1.00	0	7583	3	SPORTIF II (ximelagatran vs warfarin standard dose),SPORTIF III,SPORTIF V,
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	7.81 [4.54 13.42]	p=0.04	0	3922	1	SPORTIF V,
Major bleeding	0.73 [0.55 0.95]	p=0.04	0	7583	3	SPORTIF II (ximelagatran vs warfarin standard dose),SPORTIF III,SPORTIF V,
Haemmorhagic stroke	0.54 [0.20 1.43]	p=1.00	0	7583	3	SPORTIF II (ximelagatran vs warfarin standard dose),SPORTIF III,SPORTIF V,
Fatal bleeding	no data
Cardiovascular death	1.21 [0.76 1.93]	p=1.00	0	3407	1	SPORTIF III,
stroke (fatal and non fatal)	0.91 [0.67 1.23]	p=1.00	0	7583	3	SPORTIF II (ximelagatran vs warfarin standard dose),SPORTIF III,SPORTIF V,
Coronary event	0.99 [0.66 1.49]	p=1.00	0	7329	2	SPORTIF III,SPORTIF V,
All cause death	0.96 [0.79 1.18]	p=1.00	0	7583	3	SPORTIF II (ximelagatran vs warfarin standard dose),SPORTIF III,SPORTIF V,
Fatal stroke	1.51 [0.73 3.13]	p=1.00	0	7583	3	SPORTIF II (ximelagatran vs warfarin standard dose),SPORTIF III,SPORTIF V,
Non fatal stroke	no data

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

Thrombosis prevention

Elective hip replacement: 3 trials - Platinum (Colwell) - METHRO III - EXPRESS

ximelagatran vs Enoxaparin

No demonstrated result

Major bleeding by 49% (harmful effect)

Endpoint	TE [95% CI]	p val	I2	n	k	trials
Acute coronary syndrome	no data
Venous thromboembolism	0.99 [0.88 1.13]	p=1.00	0	6150	3	Platinum (Colwell),METHRO III,EXPRESS,
Major bleeding	1.49 [1.02 2.19]	p=0.04	0	7369	3	Platinum (Colwell),METHRO III,EXPRESS,

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

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Elective major knee surgery : 4 trials - Phase II (Heit) - METHRO I - METHRO III - EXPRESS

ximelagatran vs Dalteparin

No demonstrated result

Endpoint	TE [95% CI]	p val	I2	n	k	trials
Acute coronary syndrome	no data
Venous thromboembolism	0.83 [0.20 3.51]	p=1.00	0	53	1	METHRO I,
Major bleeding	0.97 [0.02 50.39]	p=1.00	0	67	1	METHRO I,

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

ximelagatran vs Enoxaparin

No demonstrated result

Major bleeding by 59% (harmful effect)

Endpoint	TE [95% CI]	p val	I2	n	k	trials
Acute coronary syndrome	no data
Venous thromboembolism	0.93 [0.82 1.06]	p=1.00	0	4785	3	Phase II (Heit),METHRO III,EXPRESS,
Major bleeding	1.59 [1.05 2.40]	p=0.04	0	5805	3	Phase II (Heit),METHRO III,EXPRESS,

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

Orthopedic surgery: 6 trials - Phase II (Heit) - Platinum (Colwell) - METHRO I - METHRO II - METHRO III - EXPRESS

ximelagatran vs Dalteparin

No demonstrated result

suggested Venous thromboembolism by 45% (not demonstrated)

Endpoint	TE [95% CI]	p val	I2	n	k	trials
Acute coronary syndrome	no data
Venous thromboembolism	0.55 [0.37 0.82]	p=0.04	0	646	2	METHRO I,METHRO II,
Major bleeding	1.95 [0.88 4.33]	p=1.00	0	827	2	METHRO I,METHRO II,

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

ximelagatran vs Enoxaparin

No demonstrated result

Endpoint	TE [95% CI]	p val	I2	n	k	trials
Acute coronary syndrome	no data
Venous thromboembolism	0.98 [0.87 1.11]	p=1.00	0	6342	4	Phase II (Heit),Platinum (Colwell),METHRO III,EXPRESS,
Major bleeding	1.46 [1.00 2.14]	p=1.00	0	7621	4	Phase II (Heit),Platinum (Colwell),METHRO III,EXPRESS,

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

Venous thrombosis

secondary prevention of VTE : 1 trials - THRIVE III

ximelagatran vs discontinuation

No demonstrated result

suggested VTE by 76% (not demonstrated)

Endpoint	TE [95% CI]	p val	I2	n	k	trials
recurrent DVT	no data
VTE	0.24 [0.14 0.41]	p=0.04	0	1223	1	THRIVE III,
fatal pulmonary embolism	no data
non-fatal pulmonary embolism	no data
Major bleeding	1.20 [0.36 3.95]	p=1.00	0	1223	1	THRIVE III,
any bleedings	1.21 [0.91 1.60]	p=1.00	0	1223	1	THRIVE III,
Fatal bleeding	no data
All cause death	0.86 [0.29 2.56]	p=1.00	0	1223	1	THRIVE III,

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

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All type of patients: 3 trials - THRIVE III - THRIVE I - Fiessinger

ximelagatran vs discontinuation

No demonstrated result

suggested VTE by 76% (not demonstrated)

Endpoint	TE [95% CI]	p val	I2	n	k	trials
recurrent DVT	no data
VTE	0.24 [0.14 0.41]	p=0.04	0	1223	1	THRIVE III,
fatal pulmonary embolism	no data
non-fatal pulmonary embolism	no data
Major bleeding	1.20 [0.36 3.95]	p=1.00	0	1223	1	THRIVE III,
any bleedings	1.21 [0.91 1.60]	p=1.00	0	1223	1	THRIVE III,
Fatal bleeding	no data
All cause death	0.86 [0.29 2.56]	p=1.00	0	1223	1	THRIVE III,

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

ximelagatran vs LMWH/VKA

No demonstrated result

Endpoint	TE [95% CI]	p val	I2	n	k	trials
recurrent DVT	no data
VTE	no data
fatal pulmonary embolism	no data
non-fatal pulmonary embolism	no data
Major bleeding	no data
any bleedings	no data
Fatal bleeding	no data
All cause death	no data

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

ximelagatran (without LMWH) vs LMWH/VKA

No demonstrated result

Endpoint	TE [95% CI]	p val	I2	n	k	trials
recurrent DVT	no data
VTE	no data
fatal pulmonary embolism	no data
non-fatal pulmonary embolism	no data
Major bleeding	no data
any bleedings	no data
Fatal bleeding	no data
All cause death	no data

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

All types of patients: 2 trials - THRIVE III - THRIVE I

ximelagatran vs discontinuation

No demonstrated result

suggested VTE by 76% (not demonstrated)

Endpoint	TE [95% CI]	p val	I2	n	k	trials
recurrent DVT	no data
VTE	0.24 [0.14 0.41]	p=0.04	0	1223	1	THRIVE III,
fatal pulmonary embolism	no data
non-fatal pulmonary embolism	no data
Major bleeding	1.20 [0.36 3.95]	p=1.00	0	1223	1	THRIVE III,
any bleedings	1.21 [0.91 1.60]	p=1.00	0	1223	1	THRIVE III,
Fatal bleeding	no data
All cause death	0.86 [0.29 2.56]	p=1.00	0	1223	1	THRIVE III,

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

ximelagatran (without LMWH) vs LMWH/VKA

No demonstrated result

Endpoint	TE [95% CI]	p val	I2	n	k	trials
recurrent DVT	no data
VTE	no data
fatal pulmonary embolism	no data
non-fatal pulmonary embolism	no data
Major bleeding	no data
any bleedings	no data
Fatal bleeding	no data
All cause death	no data

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

Patients with cancer: 1 trials - Schulman (subgroup)

ximelagatran vs placebo

No demonstrated result

Endpoint	TE [95% CI]	p val	I2	n	k	trials
Recurrent thromboembolic event	no data
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	no data
All cause death	no data
Bleeding	no data
Major bleeding	no data
Fatal bleeding	no data

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

Ximelagatran antithrombotics

H 376-95 - H 376 95 - Exanta - xi-melagatran - ximelagatran

Acute coronary syndrome

Atrial fibrillation

Thrombosis prevention

Venous thrombosis