Rivaroxaban antithrombotics

BAY 59-7939 - Xarelto

Acute coronary syndrome

All ACS (including AMI):  4 trials  - ATLAS ACS 2 - TIMI 51 (2.5mg) - ATLAS ACS 2 - TIMI 51 (5mg) - ATLAS ACS-TIMI 46 (5mg) - ATLAS ACS-TIMI 46 (2.5mg)

rivaroxaban 2.5mg vs placebo

No demonstrated result

major or minor bleeding by 75% (harmful effect)

any bleedings by 75% (harmful effect)

major or clinically relevant non-major bleeding by 75% (harmful effect)

Major bleeding by 244% (harmful effect)

suggested cardiovascular events by 18% (not demonstrated)

suggested Cardiovascular death by 34% (not demonstrated)

suggested All cause death by 33% (not demonstrated)

rivaroxaban 5mg vs placebo

No demonstrated result

any bleedings by 127% (harmful effect)

major or clinically relevant non-major bleeding by 136% (harmful effect)

Major bleeding by 369% (harmful effect)

suggested cardiovascular events by 49% (not demonstrated)

suggested Cardiovascular death by 58% (not demonstrated)

suggested myocardial infarction (fatal and non fatal) by 47% (not demonstrated)

suggested All cause death by 58% (not demonstrated)

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All type of patients:  4 trials  - ATLAS ACS 2 - TIMI 51 (2.5mg) - ATLAS ACS 2 - TIMI 51 (5mg) - ATLAS ACS-TIMI 46 (5mg) - ATLAS ACS-TIMI 46 (2.5mg)

rivaroxaban 2.5mg vs placebo

No demonstrated result

major or minor bleeding by 75% (harmful effect)

any bleedings by 75% (harmful effect)

major or clinically relevant non-major bleeding by 75% (harmful effect)

Major bleeding by 244% (harmful effect)

suggested cardiovascular events by 18% (not demonstrated)

suggested Cardiovascular death by 34% (not demonstrated)

suggested All cause death by 33% (not demonstrated)

rivaroxaban 5mg vs placebo

No demonstrated result

any bleedings by 127% (harmful effect)

major or clinically relevant non-major bleeding by 136% (harmful effect)

Major bleeding by 369% (harmful effect)

suggested cardiovascular events by 49% (not demonstrated)

suggested Cardiovascular death by 58% (not demonstrated)

suggested myocardial infarction (fatal and non fatal) by 47% (not demonstrated)

suggested All cause death by 58% (not demonstrated)

Patients with a recent ACS:  2 trials  - ATLAS ACS 2 - TIMI 51 (2.5mg) - ATLAS ACS 2 - TIMI 51 (5mg)

rivaroxaban 2.5mg vs placebo

No demonstrated result

major or minor bleeding by 75% (harmful effect)

any bleedings by 75% (harmful effect)

major or clinically relevant non-major bleeding by 75% (harmful effect)

Major bleeding by 243% (harmful effect)

suggested cardiovascular events by 17% (not demonstrated)

suggested Cardiovascular death by 34% (not demonstrated)

suggested All cause death by 33% (not demonstrated)

rivaroxaban 5mg vs placebo

No demonstrated result

any bleedings by 127% (harmful effect)

major or clinically relevant non-major bleeding by 127% (harmful effect)

Major bleeding by 333% (harmful effect)

suggested cardiovascular events by 50% (not demonstrated)

suggested Cardiovascular death by 58% (not demonstrated)

suggested myocardial infarction (fatal and non fatal) by 47% (not demonstrated)

suggested All cause death by 58% (not demonstrated)

Atrial fibrillation

All type of patients :  2 trials  - ROCKET-AF - ROCKET J

rivaroxaban vs warfarin standard dose

No demonstrated result

Gastrointestinal major bleeding by 46% (harmful effect)

suggested Lifethreatening major bleeding by 31% (not demonstrated)

suggested Haemmorhagic stroke by 42% (not demonstrated)

suggested Fatal bleeding by 50% (not demonstrated)

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Primary prevention of thromboembolic events:  2 trials  - ROCKET-AF - ROCKET J

rivaroxaban vs warfarin standard dose

No demonstrated result

Gastrointestinal major bleeding by 46% (harmful effect)

suggested Lifethreatening major bleeding by 31% (not demonstrated)

suggested Haemmorhagic stroke by 42% (not demonstrated)

suggested Fatal bleeding by 50% (not demonstrated)

Secondary prevention of thromboembolic events:  1 trials  - ROCKET (2nd prevention subgroup)

rivaroxaban vs warfarin

No demonstrated result

Cardiovascular prevention

All type of patients:  2 trials  - COMPASS (rivaroxaban alone) - COMPASS (rivaroxaban + aspirin)

rivaroxaban vs aspirin

No demonstrated result
rivaroxaban + aspirin vs aspirin

No demonstrated result

suggested Cardiovascular death by 7700% (not demonstrated)

suggested stroke (fatal and non fatal) by 5700% (not demonstrated)

suggested ischemic stroke by 5000% (not demonstrated)

suggested All cause death by 8100% (not demonstrated)

suggested Fatal stroke by 7700% (not demonstrated)

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Secondary prevention:  2 trials  - COMPASS (rivaroxaban alone) - COMPASS (rivaroxaban + aspirin)

rivaroxaban vs aspirin

No demonstrated result
rivaroxaban + aspirin vs aspirin

No demonstrated result

suggested Cardiovascular death by 7700% (not demonstrated)

suggested stroke (fatal and non fatal) by 5700% (not demonstrated)

suggested ischemic stroke by 5000% (not demonstrated)

suggested All cause death by 8100% (not demonstrated)

suggested Fatal stroke by 7700% (not demonstrated)

Heart failure

All type of patients:  1 trials  - COMMANDER HF

rivaroxaban vs placebo

No demonstrated result

Post stroke

All type of patients:  1 trials  - NAVIGATE ESUS

rivaroxaban vs aspirin

No demonstrated result

Pulmonary embolism

All type of patients:  1 trials  - Einstein-PE Evaluation

rivaroxaban (without LMWH) vs LMWH/VKA

No demonstrated result

Thrombosis prevention

elective major knee surgery :  3 trials  - ODIXa-KNEE - RECORD 3 - RECORD 4

rivaroxaban vs enoxaparin (europe regimen)

No demonstrated result

suggested major VTE (fatal and non fatal DVT,PE) by 62% (not demonstrated)

suggested Deep vein thrombosis by 47% (not demonstrated)

suggested total VTE and all-cause mortality by 49% (not demonstrated)

suggested distal DVT by 47% (not demonstrated)

suggested Symptomatic venous thromboembolism (DVT, PE) by 66% (not demonstrated)

rivaroxaban vs enoxaparin (US regimen)

No demonstrated result

suggested total VTE and all-cause mortality by 31% (not demonstrated)

suggested proximal DVT by 77% (not demonstrated)

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All type of patients :  6 trials  - ODIXa-HIP 10mg - ODIXa-KNEE - RECORD 1 - RECORD 2 - RECORD 3 - RECORD 4

rivaroxaban vs enoxaparin

No demonstrated result

suggested major VTE (fatal and non fatal DVT,PE) by 88% (not demonstrated)

suggested Deep vein thrombosis by 77% (not demonstrated)

suggested total VTE and all-cause mortality by 70% (not demonstrated)

suggested proximal DVT by 97% (not demonstrated)

rivaroxaban vs enoxaparin (europe regimen)

No demonstrated result

suggested major VTE (fatal and non fatal DVT,PE) by 62% (not demonstrated)

suggested Deep vein thrombosis by 47% (not demonstrated)

suggested total VTE and all-cause mortality by 49% (not demonstrated)

suggested distal DVT by 47% (not demonstrated)

suggested Symptomatic venous thromboembolism (DVT, PE) by 66% (not demonstrated)

rivaroxaban vs enoxaparin (short duration)

No demonstrated result

suggested Deep vein thrombosis by 58% (not demonstrated)

suggested total VTE and all-cause mortality by 58% (not demonstrated)

suggested distal DVT by 64% (not demonstrated)

rivaroxaban vs enoxaparin (US regimen)

No demonstrated result

suggested total VTE and all-cause mortality by 31% (not demonstrated)

suggested proximal DVT by 77% (not demonstrated)

rivaroxaban (long duration) vs enoxaparin (short duration)

No demonstrated result

suggested major VTE (fatal and non fatal DVT,PE) by 88% (not demonstrated)

suggested Deep vein thrombosis by 80% (not demonstrated)

suggested total VTE and all-cause mortality by 79% (not demonstrated)

suggested distal DVT by 66% (not demonstrated)

suggested proximal DVT by 89% (not demonstrated)

suggested Symptomatic venous thromboembolism (DVT, PE) by 80% (not demonstrated)

Elective hip replacement:  3 trials  - ODIXa-HIP 10mg - RECORD 1 - RECORD 2

rivaroxaban vs enoxaparin

No demonstrated result

suggested major VTE (fatal and non fatal DVT,PE) by 88% (not demonstrated)

suggested Deep vein thrombosis by 77% (not demonstrated)

suggested total VTE and all-cause mortality by 70% (not demonstrated)

suggested proximal DVT by 97% (not demonstrated)

rivaroxaban vs enoxaparin (short duration)

No demonstrated result

suggested Deep vein thrombosis by 58% (not demonstrated)

suggested total VTE and all-cause mortality by 58% (not demonstrated)

suggested distal DVT by 64% (not demonstrated)

rivaroxaban (long duration) vs enoxaparin (short duration)

No demonstrated result

suggested major VTE (fatal and non fatal DVT,PE) by 88% (not demonstrated)

suggested Deep vein thrombosis by 80% (not demonstrated)

suggested total VTE and all-cause mortality by 79% (not demonstrated)

suggested distal DVT by 66% (not demonstrated)

suggested proximal DVT by 89% (not demonstrated)

suggested Symptomatic venous thromboembolism (DVT, PE) by 80% (not demonstrated)

Elective major knee surgery :  3 trials  - ODIXa-KNEE - RECORD 3 - RECORD 4

rivaroxaban vs enoxaparin (europe regimen)

No demonstrated result

suggested major VTE (fatal and non fatal DVT,PE) by 62% (not demonstrated)

suggested Deep vein thrombosis by 47% (not demonstrated)

suggested total VTE and all-cause mortality by 49% (not demonstrated)

suggested distal DVT by 47% (not demonstrated)

suggested Symptomatic venous thromboembolism (DVT, PE) by 66% (not demonstrated)

rivaroxaban vs enoxaparin (US regimen)

No demonstrated result

suggested total VTE and all-cause mortality by 31% (not demonstrated)

suggested proximal DVT by 77% (not demonstrated)

Medical patients:  1 trials  - MARINER

rivaroxaban vs placebo

No demonstrated result

suggested Symptomatic deep-vein thrombosis by 56% (not demonstrated)

suggested Venous thromboembolism or death by 27% (not demonstrated)

Orthopaedic surgery:  6 trials  - ODIXa-HIP 10mg - ODIXa-KNEE - RECORD 1 - RECORD 2 - RECORD 3 - RECORD 4

rivaroxaban vs enoxaparin

No demonstrated result

suggested major VTE (fatal and non fatal DVT,PE) by 88% (not demonstrated)

suggested Deep vein thrombosis by 77% (not demonstrated)

suggested total VTE and all-cause mortality by 70% (not demonstrated)

suggested proximal DVT by 97% (not demonstrated)

rivaroxaban vs enoxaparin (europe regimen)

No demonstrated result

suggested major VTE (fatal and non fatal DVT,PE) by 62% (not demonstrated)

suggested Deep vein thrombosis by 47% (not demonstrated)

suggested total VTE and all-cause mortality by 49% (not demonstrated)

suggested distal DVT by 47% (not demonstrated)

suggested Symptomatic venous thromboembolism (DVT, PE) by 66% (not demonstrated)

rivaroxaban vs enoxaparin (short duration)

No demonstrated result

suggested Deep vein thrombosis by 58% (not demonstrated)

suggested total VTE and all-cause mortality by 58% (not demonstrated)

suggested distal DVT by 64% (not demonstrated)

rivaroxaban vs enoxaparin (US regimen)

No demonstrated result

suggested total VTE and all-cause mortality by 31% (not demonstrated)

suggested proximal DVT by 77% (not demonstrated)

rivaroxaban (long duration) vs enoxaparin (short duration)

No demonstrated result

suggested major VTE (fatal and non fatal DVT,PE) by 88% (not demonstrated)

suggested Deep vein thrombosis by 80% (not demonstrated)

suggested total VTE and all-cause mortality by 79% (not demonstrated)

suggested distal DVT by 66% (not demonstrated)

suggested proximal DVT by 89% (not demonstrated)

suggested Symptomatic venous thromboembolism (DVT, PE) by 80% (not demonstrated)

Orthopedic surgery:  6 trials  - ODIXa-HIP 10mg - ODIXa-KNEE - RECORD 1 - RECORD 2 - RECORD 3 - RECORD 4

rivaroxaban vs enoxaparin

No demonstrated result

suggested major VTE (fatal and non fatal DVT,PE) by 88% (not demonstrated)

suggested Deep vein thrombosis by 77% (not demonstrated)

suggested total VTE and all-cause mortality by 70% (not demonstrated)

suggested proximal DVT by 97% (not demonstrated)

rivaroxaban vs enoxaparin (europe regimen)

No demonstrated result

suggested major VTE (fatal and non fatal DVT,PE) by 62% (not demonstrated)

suggested Deep vein thrombosis by 47% (not demonstrated)

suggested total VTE and all-cause mortality by 49% (not demonstrated)

suggested distal DVT by 47% (not demonstrated)

suggested Symptomatic venous thromboembolism (DVT, PE) by 66% (not demonstrated)

rivaroxaban vs enoxaparin (short duration)

No demonstrated result

suggested Deep vein thrombosis by 58% (not demonstrated)

suggested total VTE and all-cause mortality by 58% (not demonstrated)

suggested distal DVT by 64% (not demonstrated)

rivaroxaban vs enoxaparin (US regimen)

No demonstrated result

suggested total VTE and all-cause mortality by 31% (not demonstrated)

suggested proximal DVT by 77% (not demonstrated)

rivaroxaban (long duration) vs enoxaparin (short duration)

No demonstrated result

suggested major VTE (fatal and non fatal DVT,PE) by 88% (not demonstrated)

suggested Deep vein thrombosis by 80% (not demonstrated)

suggested total VTE and all-cause mortality by 79% (not demonstrated)

suggested distal DVT by 66% (not demonstrated)

suggested proximal DVT by 89% (not demonstrated)

suggested Symptomatic venous thromboembolism (DVT, PE) by 80% (not demonstrated)

Venous thrombosis

secondary prevention of VTE :  1 trials  - EINSTEIN-extension

rivaroxaban vs discontinuation

No demonstrated result

major or clinically relevant non-major bleeding by 407% (harmful effect)

suggested VTE by 81% (not demonstrated)

suggested non-fatal pulmonary embolism by 85% (not demonstrated)

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All type of patients:  4 trials  - Einstein-DVT Dose-Ranging Study - Einstein-DVT Evaluation - Einstein-PE Evaluation - EINSTEIN-extension

rivaroxaban vs discontinuation

No demonstrated result

major or clinically relevant non-major bleeding by 407% (harmful effect)

suggested VTE by 81% (not demonstrated)

suggested non-fatal pulmonary embolism by 85% (not demonstrated)

rivaroxaban (without LMWH) vs LMWH/VKA

No demonstrated result

All types of patients:  4 trials  - Einstein-DVT Dose-Ranging Study - Einstein-DVT Evaluation - Einstein-PE Evaluation - EINSTEIN-extension

rivaroxaban vs discontinuation

No demonstrated result

major or clinically relevant non-major bleeding by 407% (harmful effect)

suggested VTE by 81% (not demonstrated)

suggested non-fatal pulmonary embolism by 85% (not demonstrated)

rivaroxaban (without LMWH) vs LMWH/VKA

No demonstrated result

Patients with cancer:  4 trials  - CONKO-011 - CASTA-DIVA - SELECT D - EINSTEIN (subgroup)

rivaroxaban vs

No demonstrated result
rivaroxaban vs dalteparin

No demonstrated result

suggested recurrent VTE by 57% (not demonstrated)

suggested Bleeding by 276% (not demonstrated)

rivaroxaban vs enoxaparin

No demonstrated result

suggested Major bleeding by 58% (not demonstrated)




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