Pentasaccharides for the prevention of venous thromboembolism

Kezhou Dong; Yanzhi Song; Xiaodong Li; Jie Ding; Zhiyong Gao; Daopei Lu; Yimin Zhu

doi:10.1002/14651858.CD005134.pub3

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Figure 1

Study flow diagram.

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Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Figure 4

Funnel plot of comparison: 1 fondaparinux versus placebo, outcome: 1.1 total VTE.

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Figure 5

Funnel plot of comparison: 5 fondaparinux versus LMWH, outcome: 5.1 total VTE.

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Analysis 1.1

Comparison 1 Fondaparinux versus placebo, Outcome 1 total VTE.

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Analysis 1.2

Comparison 1 Fondaparinux versus placebo, Outcome 2 symptomatic VTE.

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Analysis 1.3

Comparison 1 Fondaparinux versus placebo, Outcome 3 total DVT.

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Analysis 1.4

Comparison 1 Fondaparinux versus placebo, Outcome 4 proximal DVT.

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Analysis 1.5

Comparison 1 Fondaparinux versus placebo, Outcome 5 total PE.

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Analysis 1.6

Comparison 1 Fondaparinux versus placebo, Outcome 6 fatal PE.

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Analysis 1.7

Comparison 1 Fondaparinux versus placebo, Outcome 7 non‐fatal PE.

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Analysis 1.8

Comparison 1 Fondaparinux versus placebo, Outcome 8 major bleeding.

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Analysis 1.9

Comparison 1 Fondaparinux versus placebo, Outcome 9 fatal bleeding.

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Analysis 1.10

Comparison 1 Fondaparinux versus placebo, Outcome 10 MI.

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Analysis 1.11

Comparison 1 Fondaparinux versus placebo, Outcome 11 all causes of death.

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Analysis 1.12

Comparison 1 Fondaparinux versus placebo, Outcome 12 other serious adverse effects.

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Analysis 2.1

Comparison 2 Fondaparinux versus placebo sensitivity analysis inserting Yokote 2011, Outcome 1 total VTE.

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Analysis 2.2

Comparison 2 Fondaparinux versus placebo sensitivity analysis inserting Yokote 2011, Outcome 2 symptomatic VTE.

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Analysis 2.3

Comparison 2 Fondaparinux versus placebo sensitivity analysis inserting Yokote 2011, Outcome 3 total DVT.

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Analysis 2.4

Comparison 2 Fondaparinux versus placebo sensitivity analysis inserting Yokote 2011, Outcome 4 proximal DVT.

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Analysis 2.5

Comparison 2 Fondaparinux versus placebo sensitivity analysis inserting Yokote 2011, Outcome 5 total PE.

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Analysis 2.6

Comparison 2 Fondaparinux versus placebo sensitivity analysis inserting Yokote 2011, Outcome 6 fatal PE.

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Analysis 2.7

Comparison 2 Fondaparinux versus placebo sensitivity analysis inserting Yokote 2011, Outcome 7 non‐fatal PE.

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Analysis 2.8

Comparison 2 Fondaparinux versus placebo sensitivity analysis inserting Yokote 2011, Outcome 8 major bleeding.

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Analysis 2.9

Comparison 2 Fondaparinux versus placebo sensitivity analysis inserting Yokote 2011, Outcome 9 fatal bleeding.

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Analysis 2.10

Comparison 2 Fondaparinux versus placebo sensitivity analysis inserting Yokote 2011, Outcome 10 all causes of death.

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Analysis 3.1

Comparison 3 Fondaparinux versus placebo sensitivity analysis excluding CALISTO, Outcome 1 total VTE.

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Analysis 3.2

Comparison 3 Fondaparinux versus placebo sensitivity analysis excluding CALISTO, Outcome 2 symptomatic VTE.

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Analysis 3.3

Comparison 3 Fondaparinux versus placebo sensitivity analysis excluding CALISTO, Outcome 3 total DVT.

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Analysis 3.4

Comparison 3 Fondaparinux versus placebo sensitivity analysis excluding CALISTO, Outcome 4 proximal DVT.

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Analysis 3.5

Comparison 3 Fondaparinux versus placebo sensitivity analysis excluding CALISTO, Outcome 5 total PE.

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Analysis 3.6

Comparison 3 Fondaparinux versus placebo sensitivity analysis excluding CALISTO, Outcome 6 fatal PE.

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Analysis 3.7

Comparison 3 Fondaparinux versus placebo sensitivity analysis excluding CALISTO, Outcome 7 non‐fatal PE.

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Analysis 3.8

Comparison 3 Fondaparinux versus placebo sensitivity analysis excluding CALISTO, Outcome 8 major bleeding.

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Analysis 3.9

Comparison 3 Fondaparinux versus placebo sensitivity analysis excluding CALISTO, Outcome 9 fatal bleeding.

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Analysis 3.10

Comparison 3 Fondaparinux versus placebo sensitivity analysis excluding CALISTO, Outcome 10 MI.

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Analysis 3.11

Comparison 3 Fondaparinux versus placebo sensitivity analysis excluding CALISTO, Outcome 11 all causes of death.

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Analysis 3.12

Comparison 3 Fondaparinux versus placebo sensitivity analysis excluding CALISTO, Outcome 12 other serious adverse effects.

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Analysis 4.1

Comparison 4 Fondaparinux versus placebo subgroup analysis, Outcome 1 total VTE.

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Analysis 4.2

Comparison 4 Fondaparinux versus placebo subgroup analysis, Outcome 2 symptomatic VTE.

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Analysis 4.3

Comparison 4 Fondaparinux versus placebo subgroup analysis, Outcome 3 total DVT.

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Analysis 4.4

Comparison 4 Fondaparinux versus placebo subgroup analysis, Outcome 4 proximal DVT.

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Analysis 4.5

Comparison 4 Fondaparinux versus placebo subgroup analysis, Outcome 5 total PE.

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Analysis 4.6

Comparison 4 Fondaparinux versus placebo subgroup analysis, Outcome 6 fatal PE.

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Analysis 4.7

Comparison 4 Fondaparinux versus placebo subgroup analysis, Outcome 7 non‐fatal PE.

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Analysis 4.8

Comparison 4 Fondaparinux versus placebo subgroup analysis, Outcome 8 major bleeding.

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Analysis 4.9

Comparison 4 Fondaparinux versus placebo subgroup analysis, Outcome 9 fatal bleeding.

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Analysis 4.10

Comparison 4 Fondaparinux versus placebo subgroup analysis, Outcome 10 MI.

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Analysis 4.11

Comparison 4 Fondaparinux versus placebo subgroup analysis, Outcome 11 all causes of death.

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Analysis 4.12

Comparison 4 Fondaparinux versus placebo subgroup analysis, Outcome 12 other serious adverse effects.

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Analysis 5.1

Comparison 5 Fondaparinux versus LMWH, Outcome 1 total VTE.

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Analysis 5.2

Comparison 5 Fondaparinux versus LMWH, Outcome 2 symptomatic VTE.

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Analysis 5.3

Comparison 5 Fondaparinux versus LMWH, Outcome 3 total DVT.

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Analysis 5.4

Comparison 5 Fondaparinux versus LMWH, Outcome 4 proximal DVT.

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Analysis 5.5

Comparison 5 Fondaparinux versus LMWH, Outcome 5 total PE.

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Analysis 5.6

Comparison 5 Fondaparinux versus LMWH, Outcome 6 fatal PE.

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Analysis 5.7

Comparison 5 Fondaparinux versus LMWH, Outcome 7 non‐fatal PE.

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Analysis 5.8

Comparison 5 Fondaparinux versus LMWH, Outcome 8 major bleeding.

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Analysis 5.9

Comparison 5 Fondaparinux versus LMWH, Outcome 9 fatal bleeding.

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Analysis 5.10

Comparison 5 Fondaparinux versus LMWH, Outcome 10 MI.

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Analysis 5.11

Comparison 5 Fondaparinux versus LMWH, Outcome 11 all causes of death.

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Analysis 5.12

Comparison 5 Fondaparinux versus LMWH, Outcome 12 death associated with VTE or bleeding.

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Analysis 5.13

Comparison 5 Fondaparinux versus LMWH, Outcome 13 other serious adverse effects.

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Analysis 6.1

Comparison 6 Fondaparinux versus LMWH sensitivity analysis, Outcome 1 total VTE.

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Analysis 6.2

Comparison 6 Fondaparinux versus LMWH sensitivity analysis, Outcome 2 symptomatic VTE.

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Analysis 6.3

Comparison 6 Fondaparinux versus LMWH sensitivity analysis, Outcome 3 total DVT.

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Analysis 6.4

Comparison 6 Fondaparinux versus LMWH sensitivity analysis, Outcome 4 proximal DVT.

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Analysis 6.5

Comparison 6 Fondaparinux versus LMWH sensitivity analysis, Outcome 5 total PE.

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Analysis 6.6

Comparison 6 Fondaparinux versus LMWH sensitivity analysis, Outcome 6 fatal PE.

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Analysis 6.7

Comparison 6 Fondaparinux versus LMWH sensitivity analysis, Outcome 7 non‐fatal PE.

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Analysis 6.8

Comparison 6 Fondaparinux versus LMWH sensitivity analysis, Outcome 8 major bleeding.

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Analysis 6.9

Comparison 6 Fondaparinux versus LMWH sensitivity analysis, Outcome 9 fatal bleeding.

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Analysis 6.10

Comparison 6 Fondaparinux versus LMWH sensitivity analysis, Outcome 10 all causes of death.

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Analysis 6.11

Comparison 6 Fondaparinux versus LMWH sensitivity analysis, Outcome 11 other serious adverse effects.

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Analysis 7.1

Comparison 7 Fondaparinux versus LMWH sensitivity analysis without EFFORT, Outcome 1 total VTE.

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Analysis 7.2

Comparison 7 Fondaparinux versus LMWH sensitivity analysis without EFFORT, Outcome 2 symptomatic VTE.

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Analysis 7.3

Comparison 7 Fondaparinux versus LMWH sensitivity analysis without EFFORT, Outcome 3 total DVT.

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Analysis 7.4

Comparison 7 Fondaparinux versus LMWH sensitivity analysis without EFFORT, Outcome 4 proximal DVT.

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Analysis 7.5

Comparison 7 Fondaparinux versus LMWH sensitivity analysis without EFFORT, Outcome 5 total PE.

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Analysis 7.6

Comparison 7 Fondaparinux versus LMWH sensitivity analysis without EFFORT, Outcome 6 fatal PE.

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Analysis 7.7

Comparison 7 Fondaparinux versus LMWH sensitivity analysis without EFFORT, Outcome 7 non‐fatal PE.

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Analysis 7.8

Comparison 7 Fondaparinux versus LMWH sensitivity analysis without EFFORT, Outcome 8 major bleeding.

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Analysis 7.9

Comparison 7 Fondaparinux versus LMWH sensitivity analysis without EFFORT, Outcome 9 fatal bleeding.

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Analysis 7.10

Comparison 7 Fondaparinux versus LMWH sensitivity analysis without EFFORT, Outcome 10 MI.

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Analysis 7.11

Comparison 7 Fondaparinux versus LMWH sensitivity analysis without EFFORT, Outcome 11 all causes of death.

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Analysis 7.12

Comparison 7 Fondaparinux versus LMWH sensitivity analysis without EFFORT, Outcome 12 death associated with VTE or bleeding.

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Analysis 7.13

Comparison 7 Fondaparinux versus LMWH sensitivity analysis without EFFORT, Outcome 13 other serious adverse effects.

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Analysis 8.1

Comparison 8 Fondaparinux versus LMWH subgroup analysis, Outcome 1 total VTE.

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Analysis 8.2

Comparison 8 Fondaparinux versus LMWH subgroup analysis, Outcome 2 symptomatic VTE.

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Analysis 8.3

Comparison 8 Fondaparinux versus LMWH subgroup analysis, Outcome 3 total DVT.

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Analysis 8.4

Comparison 8 Fondaparinux versus LMWH subgroup analysis, Outcome 4 proximal DVT.

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Analysis 8.5

Comparison 8 Fondaparinux versus LMWH subgroup analysis, Outcome 5 total PE.

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Analysis 8.6

Comparison 8 Fondaparinux versus LMWH subgroup analysis, Outcome 6 fatal PE.

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Analysis 8.7

Comparison 8 Fondaparinux versus LMWH subgroup analysis, Outcome 7 non‐fatal PE.

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Analysis 8.8

Comparison 8 Fondaparinux versus LMWH subgroup analysis, Outcome 8 major bleeding.

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Analysis 8.9

Comparison 8 Fondaparinux versus LMWH subgroup analysis, Outcome 9 fatal bleeding.

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Analysis 8.10

Comparison 8 Fondaparinux versus LMWH subgroup analysis, Outcome 10 MI.

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Analysis 8.11

Comparison 8 Fondaparinux versus LMWH subgroup analysis, Outcome 11 all causes of death.

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Analysis 8.12

Comparison 8 Fondaparinux versus LMWH subgroup analysis, Outcome 12 other serious adverse effects.

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Analysis 9.1

Comparison 9 Fondaparinux versus variable dose warfarin, Outcome 1 total VTE.

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Analysis 9.2

Comparison 9 Fondaparinux versus variable dose warfarin, Outcome 2 symptomatic VTE.

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Analysis 9.3

Comparison 9 Fondaparinux versus variable dose warfarin, Outcome 3 total DVT.

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Analysis 9.4

Comparison 9 Fondaparinux versus variable dose warfarin, Outcome 4 proximal DVT.

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Analysis 9.5

Comparison 9 Fondaparinux versus variable dose warfarin, Outcome 5 total PE.

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Analysis 9.6

Comparison 9 Fondaparinux versus variable dose warfarin, Outcome 6 major bleeding.

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Analysis 9.7

Comparison 9 Fondaparinux versus variable dose warfarin, Outcome 7 all causes of death.

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Analysis 10.1

Comparison 10 Fondaparinux versus 1 mg warfarin, Outcome 1 total VTE.

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Analysis 10.2

Comparison 10 Fondaparinux versus 1 mg warfarin, Outcome 2 symptomatic VTE.

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Analysis 10.3

Comparison 10 Fondaparinux versus 1 mg warfarin, Outcome 3 total DVT.

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Analysis 10.4

Comparison 10 Fondaparinux versus 1 mg warfarin, Outcome 4 proximal DVT.

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Analysis 10.5

Comparison 10 Fondaparinux versus 1 mg warfarin, Outcome 5 total PE.

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Analysis 10.6

Comparison 10 Fondaparinux versus 1 mg warfarin, Outcome 6 major bleeding.

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Analysis 10.7

Comparison 10 Fondaparinux versus 1 mg warfarin, Outcome 7 all causes of death.

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Analysis 11.1

Comparison 11 Fondaparinux versus edoxaban, Outcome 1 total VTE.

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Analysis 11.2

Comparison 11 Fondaparinux versus edoxaban, Outcome 2 major bleeding.

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Analysis 11.3

Comparison 11 Fondaparinux versus edoxaban, Outcome 3 all causes of death.

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Analysis 12.1

Comparison 12 Fondaparinux versus mechanical thromboprophylaxis, Outcome 1 total VTE.

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Analysis 12.2

Comparison 12 Fondaparinux versus mechanical thromboprophylaxis, Outcome 2 symptomatic VTE.

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Analysis 12.3

Comparison 12 Fondaparinux versus mechanical thromboprophylaxis, Outcome 3 total DVT.

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Analysis 12.4

Comparison 12 Fondaparinux versus mechanical thromboprophylaxis, Outcome 4 proximal DVT.

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Analysis 12.5

Comparison 12 Fondaparinux versus mechanical thromboprophylaxis, Outcome 5 total PE.

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Analysis 12.6

Comparison 12 Fondaparinux versus mechanical thromboprophylaxis, Outcome 6 major bleeding.

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Analysis 12.7

Comparison 12 Fondaparinux versus mechanical thromboprophylaxis, Outcome 7 all causes of death.

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Analysis 12.8

Comparison 12 Fondaparinux versus mechanical thromboprophylaxis, Outcome 8 other serious adverse effects.

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Summary of findings for the main comparison. Fondaparinux versus placebo for the prevention of venous thromboembolism

Fondaparinux versus placebo for the prevention of venous thromboembolism
Patient or population: people requiring prevention of venous thromboembolism Settings: hospital and outpatient Intervention: fondaparinux versus placebo
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	Number of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Placebo	Fondaparinux
Total VTE Follow‐up: 7‐45 days	Study population		RR 0.24 (0.15 to 0.38)	5717 (8 studies)	⊕⊕⊕⊝ moderate^1,2
	91 per 1000	22 per 1000 (14 to 34)
	Moderate
	181 per 1000	43 per 1000 (27 to 69)
Symptomatic VTE Follow‐up: 7‐45 days	Study population		RR 0.15 (0.06 to 0.36)	6503 (8 studies)	⊕⊕⊕⊕ high^2,3
	12 per 1000	2 per 1000 (1 to 4)
	Moderate
	7 per 1000	1 per 1000 (0 to 3)
Total DVT Follow‐up: 7‐45 days	Study population		RR 0.25 (0.15 to 0.4)	5715 (8 studies)	⊕⊕⊕⊝ moderate^1,2
	87 per 1000	22 per 1000 (13 to 35)
	Moderate
	173 per 1000	43 per 1000 (26 to 69)
Proximal DVT Follow‐up: 7‐45 days	Study population		RR 0.12 (0.04 to 0.39)	2746 (7 studies)	⊕⊕⊕⊝ moderate^1,2,3
	60 per 1000	7 per 1000 (2 to 23)
	Moderate
	54 per 1000	6 per 1000 (2 to 21)
Total PE Follow‐up: 7‐45 days	Study population		RR 0.16 (0.04 to 0.62)	6412 (8 studies)	⊕⊕⊕⊕ high^2,3
	5 per 1000	1 per 1000 (0 to 3)
	Moderate
	1 per 1000	0 per 1000 (0 to 1)
Major bleeding Follow‐up: 7‐45 days	Study population		RR 2.56 (1.48 to 4.44)	6659 (8 studies)	⊕⊕⊕⊝ moderate^2,4
	5 per 1000	12 per 1000 (7 to 21)
	Moderate
	3 per 1000	8 per 1000 (4 to 13)
All causes of death Follow‐up: 7‐45 days	Study population		RR 0.76 (0.48 to 1.22)	6674 (8 studies)	⊕⊕⊕⊝ moderate^2,5
	12 per 1000	9 per 1000 (6 to 15)
	Moderate
	0 per 1000	0 per 1000 (0 to 0)
The basis for the assumed risk* (e.g. median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; DVT: deep vein thrombosis; PE: pulmonary embolism; RR: risk ratio; VTE: venous thromboembolism.
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹ Data were pooled with a random‐effects model owing to heterogeneity ‐ downgraded by one level. ² All studies were published in English; most studies were organised by a pharmaceutical company and could indicate potential publication bias, but we did not deem this sufficient to downgrade the quality of the evidence. ³ Small number of events but no imprecision of effect estimate, therefore not downgraded. ⁴ Small number of events causing wide CI ‐ downgraded by one level. ⁵ Small number of events; many studies do not contribute to effect estimate ‐ downgraded by one level for imprecision.

Summary of findings for the main comparison. Fondaparinux versus placebo for the prevention of venous thromboembolism

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Summary of findings 2. Fondaparinux versus LMWH for the prevention of venous thromboembolism

Fondaparinux versus LMWH for the prevention of venous thromboembolism
Patient or population: people requiring prevention of venous thromboembolism Settings: hospital Intervention: fondaparinux versus LMWH
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	Number of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	LMWH	Fondaparinux
Total VTE Follow‐up: 7‐45 days	Study population		RR 0.55 (0.42 to 0.73)	9339 (11 studies)	⊕⊕⊕⊝ moderate^1,2
	108 per 1000	60 per 1000 (46 to 79)
	Moderate
	83 per 1000	46 per 1000 (35 to 61)
Symptomatic VTE Follow‐up: 7‐45 days	Study population		RR 1.03 (0.65 to 1.63)	12240 (9 studies)	⊕⊕⊕⊝ moderate^2,3
	6 per 1000	6 per 1000 (4 to 9)
	Moderate
	3 per 1000	3 per 1000 (2 to 5)
Total DVT Follow‐up: 7‐45 days	Study population		RR 0.54 (0.4 to 0.71)	9356 (10 studies)	⊕⊕⊕⊝ moderate^1,2
	106 per 1000	57 per 1000 (42 to 75)
	Moderate
	86 per 1000	46 per 1000 (34 to 61)
Proximal DVT Follow‐up: 7‐45 days	Study population		RR 0.58 (0.33 to 1.02)	8361 (9 studies)	⊕⊕⊝⊝ low^1,2,3
	23 per 1000	13 per 1000 (7 to 23)
	Moderate
	25 per 1000	14 per 1000 (8 to 25)
Total PE Follow‐up: 7‐45 days	Study population		RR 1.24 (0.65 to 2.34)	12350 (10 studies)	⊕⊕⊕⊝ moderate^2,3
	3 per 1000	3 per 1000 (2 to 6)
	Moderate
	1 per 1000	1 per 1000 (1 to 2)
Major bleeding Follow‐up: 7‐45 days	Study population		RR 1.38 (1.09 to 1.75)	12501 (11 studies)	⊕⊕⊕⊕ high²
	18 per 1000	25 per 1000 (19 to 31)
	Moderate
	23 per 1000	32 per 1000 (25 to 40)
All causes of death Follow‐up: 7‐45 days	Study population		RR 0.88 (0.63 to 1.22)	12400 (11 studies)	⊕⊕⊕⊝ moderate^2,4
	12 per 1000	10 per 1000 (7 to 15)
	Moderate
	3 per 1000	3 per 1000 (2 to 4)
The basis for the assumed risk* (e.g. median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; DVT: deep vein thrombosis; PE: pulmonary embolism; RR: risk ratio; VTE: venous thromboembolism.
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹ Data were pooled with the random‐effects model because of heterogeneity ‐ downgraded by one level. ² All studies were written in English; most studies were funded by a pharmaceutical company, which could indicate potential publication bias but we did not deem this sufficient to downgrade the quality of the evidence. ³ Few events leading to wide confidence interval ‐ downgraded by one level. ⁴ Small number of events; many studies do not contribute to effect estimate ‐ downgraded by one level for imprecision.

Summary of findings 2. Fondaparinux versus LMWH for the prevention of venous thromboembolism

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Summary of findings 3. Fondaparinux versus variable dose warfarin for the prevention of venous thromboembolism

Fondaparinux versus variable dose warfarin for the prevention of venous thromboembolism
Patient or population: patients requiring prevention of venous thromboembolism Settings: hospital Intervention: fondaparinux versus variable dose warfarin
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	Number of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Variable dose warfarin	Fondaparinux
Total VTE Follow‐up: mean 28 days	See comment	See comment	Not estimable	236 (1 study)	⊕⊝⊝⊝ very low¹	No VTE events recorded
Symptomatic VTE Follow‐up: mean 28 days	See comment	See comment	Not estimable	236 (1 study)	⊕⊝⊝⊝ very low¹	No VTE events recorded
Total DVT Follow‐up: mean 28 days	See comment	See comment	Not estimable	236 (1 study)	⊕⊝⊝⊝ very low¹	No DVT events recorded
Proximal DVT Follow‐up: mean 28 days	See comment	See comment	Not estimable	236 (1 study)	⊕⊝⊝⊝ very low¹	No proximal DVT events recorded
Total PE Follow‐up: mean 28 days	See comment	See comment	Not estimable	236 (1 study)	⊕⊝⊝⊝ very low¹	No PE events recorded
Major bleeding Follow‐up: mean 28 days	Study population		RR 7 (0.37 to 134.05)	236 (1 study)	⊕⊝⊝⊝ very low¹
Major bleeding Follow‐up: mean 28 days	No cases of bleeding (0/118) were reported in the variable warfarin group. Three cases (3/118) of bleeding were reported in the fondaparinux group.		RR 7 (0.37 to 134.05)	236 (1 study)	⊕⊝⊝⊝ very low¹
All causes of death Follow‐up: mean 28 days	See comment	See comment	Not estimable	236 (1 study)	⊕⊝⊝⊝ very low¹	No deaths recorded
The basis for the assumed risk* (e.g. median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; DVT: deep vein thrombosis; PE: pulmonary embolism; RR: risk ratio; VTE: venous thromboembolism.
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹ One study was included in this comparison; the study sample was small, and the events were rare ‐ downgraded by three levels.

Summary of findings 3. Fondaparinux versus variable dose warfarin for the prevention of venous thromboembolism

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Summary of findings 4. Fondaparinux versus 1 mg warfarin for the prevention of venous thromboembolism

Fondaparinux versus 1 mg warfarin for the prevention of venous thromboembolism
Patient or population: people requiring prevention of venous thromboembolism Settings: hospital Intervention: fondaparinux versus 1mg warfarin
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	Number of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	1 mg warfarin	Fondaparinux
Total VTE Follow‐up: mean 28 days	Study population		RR 0.2 (0.01 to 4.12)	236 (1 study)	⊕⊝⊝⊝ very low¹
	17 per 1000	3 per 1000 (0 to 70)
	Moderate
	17 per 1000	3 per 1000 (0 to 70)
Symptomatic VTE Follow‐up: mean 28 days	See comment	See comment	Not estimable	236 (1 study)	⊕⊝⊝⊝ very low¹	No systematic VTE events recorded
Total DVT Follow‐up: mean 28 days	Study population		RR 0.2 (0.01 to 4.12)	236 (1 study)	⊕⊝⊝⊝ very low¹
	17 per 1000	3 per 1000 (0 to 70)
	Moderate
	17 per 1000	3 per 1000 (0 to 70)
Proximal DVT Follow‐up: mean 28 days	See comment	See comment	Not estimable	236 (1 study)	⊕⊝⊝⊝ very low¹	No proximal DVT events recorded
Total PE Follow‐up: mean 28 days	See comment	See comment	Not estimable	236 (1 study)	⊕⊝⊝⊝ very low¹	No PE events recorded
Major bleeding Follow‐up: mean 28 days	Study population		RR 3 (0.32 to 28.43)	236 (1 study)	⊕⊝⊝⊝ very low¹
	8 per 1000	25 per 1000 (3 to 241)
	Moderate
	9 per 1000	27 per 1000 (3 to 256)
All causes of death Follow‐up: mean 28 days	See comment	See comment	Not estimable	236 (1 study)	⊕⊝⊝⊝ very low¹	No deaths recorded
The basis for the assumed risk* (e.g. median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; DVT: deep vein thrombosis; PE: pulmonary embolism; RR: risk ratio; VTE: venous thromboembolism.
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹ One study was included in this comparison; the study sample was small, and the events were rare ‐ downgraded by three levels.

Summary of findings 4. Fondaparinux versus 1 mg warfarin for the prevention of venous thromboembolism

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Summary of findings 5. Fondaparinux versus edoxaban for the prevention of venous thromboembolism

Fondaparinux versus edoxaban for the prevention of venous thromboembolism
Patient or population: people requiring prevention of venous thromboembolism Settings: hospital Intervention: fondaparinux versus edoxaban
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	Number of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Edoxaban	Fondaparinux
Total VTE Follow‐up: 25 to 35 days after treatment completion	See comment	See comment	Not estimable	38 (1 study)	⊕⊝⊝⊝ very low¹	No VTE events recorded
Symptomatic VTE Follow‐up: 25 to 35 days after treatment completion	See comment	See comment	Not estimable	38 (1 study)	⊕⊝⊝⊝ very low¹	No VTE events recorded
Total DVT Follow‐up: 25 to 35 days after treatment completion	See comment	See comment	Not estimable	38 (1 study)	⊕⊝⊝⊝ very low¹	No DVT events recorded
Proximal DVT Follow‐up: 25 to 35 days after treatment completion	See comment	See comment		38 (1 study)		Proximal DVT not an outcome of this study
Total PE Follow‐up: 25 to 35 days after treatment completion	See comment	See comment	Not estimable	38 (1 study)	⊕⊝⊝⊝ very low¹	No PE events recorded
Major bleeding Follow‐up: 25 to 35 days after treatment completion	See comment	See comment	Not estimable	38 (1 study)	⊕⊝⊝⊝ very low¹	No major bleeding events recorded
All causes of death Follow‐up: 25 to 35 days after treatment completion	See comment	See comment	Not estimable	38 (1 study)	⊕⊝⊝⊝ very low¹	No deaths recorded
The basis for the assumed risk* (e.g. median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; DVT: deep vein thrombosis; PE: pulmonary embolism; RR: risk ratio; VTE: venous thromboembolism.
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹ One study was included in this comparison; the study sample was small, and no events were recorded ‐ downgraded by three levels.

Summary of findings 5. Fondaparinux versus edoxaban for the prevention of venous thromboembolism

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Summary of findings 6. Fondaparinux versus mechanical thromboprophylaxis for the prevention of venous thromboembolism

Fondaparinux versus mechanical thromboprophylaxis for the prevention of venous thromboembolism
Patient or population: people requiring prevention of venous thromboembolism Settings: hospital and outpatient Intervention: fondaparinux versus mechanical thromboprophylaxis
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	Number of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Mechanical thromboprophylaxis	Fondaparinux
Total VTE Follow‐up: 4 to 8 days	Study population		RR 0.61 (0.22 to 1.67)	99 (1 study)	⊕⊕⊝⊝ low¹
	176 per 1000	108 per 1000 (39 to 295)
	Moderate
	177 per 1000	108 per 1000 (39 to 296)
Symptomatic VTE Follow‐up: 4 to 8 days	See comment	See comment	Not estimable	120 (1 study)	⊕⊕⊝⊝ low¹	No cases of symptomatic VTE recorded
Total DVT Follow‐up: 4 to 8 days	Study population		RR 0.63 (0.23 to 1.72)	100 (1 study)	⊕⊕⊝⊝ low¹
	171 per 1000	108 per 1000 (39 to 295)
	Moderate
	171 per 1000	108 per 1000 (39 to 294)
Proximal DVT Follow‐up: 4 to 8 days	See comment	See comment	Not estimable	105 (1 study)	⊕⊕⊝⊝ low¹	No cases of proximal DVT recorded
Total PE Follow‐up: 4 to 8 days	See comment	See comment	Not estimable	120 (1 study)	⊕⊕⊝⊝ low¹	No cases of PE recorded
Major bleeding Follow‐up: 4 to 8 days	See comment	See comment	Not estimable	120 (1 study)	⊕⊕⊝⊝ low¹	No cases of major bleeding recorded
All causes of death Follow‐up: 4 to 8 days	See comment	See comment	Not estimable	120 (1 study)	⊕⊕⊝⊝ low¹	No deaths recorded
The basis for the assumed risk* (e.g. median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; DVT: deep vein thrombosis; PE: pulmonary embolism; RR: risk ratio; VTE: venous thromboembolism.
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹ One study included in this comparison, small study sample, funded by pharmaceutical company, very short follow‐up ‐ downgraded by two levels.

Summary of findings 6. Fondaparinux versus mechanical thromboprophylaxis for the prevention of venous thromboembolism

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Comparison 1. Fondaparinux versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 total VTE Show forest plot	8	5717	Risk Ratio (M‐H, Random, 95% CI)	0.24 [0.15, 0.38]

2 symptomatic VTE Show forest plot	8	6503	Risk Ratio (M‐H, Fixed, 95% CI)	0.15 [0.06, 0.36]

3 total DVT Show forest plot	8	5715	Risk Ratio (M‐H, Random, 95% CI)	0.25 [0.15, 0.40]

4 proximal DVT Show forest plot	7	2746	Risk Ratio (M‐H, Random, 95% CI)	0.12 [0.04, 0.39]

5 total PE Show forest plot	8	6412	Risk Ratio (M‐H, Fixed, 95% CI)	0.16 [0.04, 0.62]

6 fatal PE Show forest plot	8	6412	Risk Ratio (M‐H, Fixed, 95% CI)	0.14 [0.02, 1.17]

7 non‐fatal PE Show forest plot	8	6412	Risk Ratio (M‐H, Fixed, 95% CI)	0.22 [0.05, 1.03]

8 major bleeding Show forest plot	8	6659	Risk Ratio (M‐H, Fixed, 95% CI)	2.56 [1.48, 4.44]

9 fatal bleeding Show forest plot	6	5993	Risk Ratio (M‐H, Fixed, 95% CI)	4.87 [0.58, 40.81]

10 MI Show forest plot	5	5777	Risk Ratio (M‐H, Fixed, 95% CI)	0.25 [0.03, 2.19]

11 all causes of death Show forest plot	8	6674	Risk Ratio (M‐H, Fixed, 95% CI)	0.76 [0.48, 1.22]

12 other serious adverse effects Show forest plot	7	6581	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.77, 1.24]

Comparison 1. Fondaparinux versus placebo

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Comparison 2. Fondaparinux versus placebo sensitivity analysis inserting Yokote 2011

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 total VTE Show forest plot	9	5884	Risk Ratio (M‐H, Random, 95% CI)	0.27 [0.17, 0.43]

2 symptomatic VTE Show forest plot	9	6670	Risk Ratio (M‐H, Fixed, 95% CI)	0.19 [0.09, 0.42]

3 total DVT Show forest plot	9	5882	Risk Ratio (M‐H, Random, 95% CI)	0.28 [0.17, 0.45]

4 proximal DVT Show forest plot	8	2913	Risk Ratio (M‐H, Random, 95% CI)	0.16 [0.05, 0.51]

5 total PE Show forest plot	9	6579	Risk Ratio (M‐H, Fixed, 95% CI)	0.16 [0.04, 0.62]

6 fatal PE Show forest plot	9	6579	Risk Ratio (M‐H, Fixed, 95% CI)	0.14 [0.02, 1.17]

7 non‐fatal PE Show forest plot	9	6579	Risk Ratio (M‐H, Fixed, 95% CI)	0.22 [0.05, 1.03]

8 major bleeding Show forest plot	9	6829	Risk Ratio (M‐H, Fixed, 95% CI)	2.56 [1.48, 4.44]

9 fatal bleeding Show forest plot	7	6163	Risk Ratio (M‐H, Fixed, 95% CI)	4.87 [0.58, 40.81]

10 all causes of death Show forest plot	8	6766	Risk Ratio (M‐H, Fixed, 95% CI)	0.76 [0.48, 1.22]

Comparison 2. Fondaparinux versus placebo sensitivity analysis inserting Yokote 2011

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Comparison 3. Fondaparinux versus placebo sensitivity analysis excluding CALISTO

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 total VTE Show forest plot	7	2715	Risk Ratio (M‐H, Random, 95% CI)	0.25 [0.15, 0.40]

2 symptomatic VTE Show forest plot	7	3501	Risk Ratio (M‐H, Fixed, 95% CI)	0.16 [0.05, 0.54]

3 total DVT Show forest plot	7	2713	Risk Ratio (M‐H, Random, 95% CI)	0.25 [0.15, 0.43]

4 proximal DVT Show forest plot	7	2746	Risk Ratio (M‐H, Random, 95% CI)	0.12 [0.04, 0.39]

5 total PE Show forest plot	7	3412	Risk Ratio (M‐H, Fixed, 95% CI)	0.20 [0.04, 0.92]

6 fatal PE Show forest plot	7	3410	Risk Ratio (M‐H, Fixed, 95% CI)	0.14 [0.02, 1.17]

7 non‐fatal PE Show forest plot	7	3410	Risk Ratio (M‐H, Fixed, 95% CI)	0.43 [0.06, 2.93]

8 major bleeding Show forest plot	7	3672	Risk Ratio (M‐H, Fixed, 95% CI)	2.66 [1.52, 4.67]

9 fatal bleeding Show forest plot	5	3006	Risk Ratio (M‐H, Fixed, 95% CI)	4.87 [0.58, 40.81]

10 MI Show forest plot	4	2790	Risk Ratio (M‐H, Fixed, 95% CI)	0.19 [0.01, 4.05]

11 all causes of death Show forest plot	7	3672	Risk Ratio (M‐H, Fixed, 95% CI)	0.73 [0.45, 1.18]

12 other serious adverse effects Show forest plot	6	3594	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.80, 1.32]

Comparison 3. Fondaparinux versus placebo sensitivity analysis excluding CALISTO

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Comparison 4. Fondaparinux versus placebo subgroup analysis

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 total VTE Show forest plot	8	5717	Risk Ratio (M‐H, Random, 95% CI)	0.24 [0.15, 0.38]

1.1 surgery patients	6	2071	Risk Ratio (M‐H, Random, 95% CI)	0.21 [0.13, 0.35]
1.2 superficial thrombophlebitis	1	3002	Risk Ratio (M‐H, Random, 95% CI)	0.15 [0.04, 0.50]
1.3 medically ill patients	1	644	Risk Ratio (M‐H, Random, 95% CI)	0.53 [0.31, 0.92]
2 symptomatic VTE Show forest plot	8	6503	Risk Ratio (M‐H, Fixed, 95% CI)	0.15 [0.06, 0.36]

2.1 surgery patients	6	2857	Risk Ratio (M‐H, Fixed, 95% CI)	0.19 [0.05, 0.73]
2.2 superficial thrombophlebitis	1	3002	Risk Ratio (M‐H, Fixed, 95% CI)	0.15 [0.04, 0.50]
2.3 medically ill patients	1	644	Risk Ratio (M‐H, Fixed, 95% CI)	0.09 [0.01, 1.65]
3 total DVT Show forest plot	8	5715	Risk Ratio (M‐H, Random, 95% CI)	0.25 [0.15, 0.40]

3.1 surgery patients	6	2069	Risk Ratio (M‐H, Random, 95% CI)	0.21 [0.13, 0.35]
3.2 superficial thrombophlebitis	1	3002	Risk Ratio (M‐H, Random, 95% CI)	0.17 [0.05, 0.56]
3.3 medically ill patients	1	644	Risk Ratio (M‐H, Random, 95% CI)	0.62 [0.35, 1.10]
4 proximal DVT Show forest plot	7	2745	Risk Ratio (M‐H, Fixed, 95% CI)	0.12 [0.07, 0.22]

4.1 surgery patients	6	2101	Risk Ratio (M‐H, Fixed, 95% CI)	0.07 [0.03, 0.15]
4.2 medically ill patients	1	644	Risk Ratio (M‐H, Fixed, 95% CI)	0.72 [0.23, 2.24]
5 total PE Show forest plot	8	6412	Risk Ratio (M‐H, Fixed, 95% CI)	0.16 [0.04, 0.62]

5.1 surgery patients	6	2766	Risk Ratio (M‐H, Fixed, 95% CI)	0.34 [0.05, 2.14]
5.2 superficial thrombophlebitis	1	3002	Risk Ratio (M‐H, Fixed, 95% CI)	0.09 [0.01, 1.64]
5.3 medically ill patients	1	644	Risk Ratio (M‐H, Fixed, 95% CI)	0.09 [0.01, 1.65]
6 fatal PE Show forest plot	8	6412	Risk Ratio (M‐H, Fixed, 95% CI)	0.14 [0.02, 1.17]

6.1 surgery patients	6	2766	Risk Ratio (M‐H, Fixed, 95% CI)	0.34 [0.01, 8.25]
6.2 superficial thrombophlebitis	1	3002	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
6.3 medically ill patients	1	644	Risk Ratio (M‐H, Fixed, 95% CI)	0.09 [0.01, 1.65]
7 non‐fatal PE Show forest plot	8	6412	Risk Ratio (M‐H, Fixed, 95% CI)	0.22 [0.05, 1.03]

7.1 surgery patients	6	2766	Risk Ratio (M‐H, Fixed, 95% CI)	0.43 [0.06, 2.93]
7.2 superficial thrombophlebitis	1	3002	Risk Ratio (M‐H, Fixed, 95% CI)	0.09 [0.01, 1.64]
7.3 medically ill patients	1	644	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
8 major bleeding Show forest plot	8	6659	Risk Ratio (M‐H, Fixed, 95% CI)	2.56 [1.48, 4.44]

8.1 surgery patients	6	2833	Risk Ratio (M‐H, Fixed, 95% CI)	2.78 [1.56, 4.95]
8.2 superficial thrombophlebitis	1	2987	Risk Ratio (M‐H, Fixed, 95% CI)	0.99 [0.06, 15.86]
8.3 medically ill patients	1	839	Risk Ratio (M‐H, Fixed, 95% CI)	0.97 [0.06, 15.52]
9 fatal bleeding Show forest plot	6	5993	Risk Ratio (M‐H, Fixed, 95% CI)	4.87 [0.58, 40.81]

9.1 surgery patients	4	2167	Risk Ratio (M‐H, Fixed, 95% CI)	4.87 [0.58, 40.81]
9.2 superficial thrombophlebitis	1	2987	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
9.3 medically ill patients	1	839	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
10 MI Show forest plot	5	5777	Risk Ratio (M‐H, Fixed, 95% CI)	0.25 [0.03, 2.19]

10.1 surgery patients	3	1951	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
10.2 superficial thrombophlebitis	1	2987	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.01, 8.12]
10.3 medically ill patients	1	839	Risk Ratio (M‐H, Fixed, 95% CI)	0.19 [0.01, 4.05]
11 all causes of death Show forest plot	8	6674	Risk Ratio (M‐H, Fixed, 95% CI)	0.76 [0.48, 1.22]

11.1 surgery patients	6	2833	Risk Ratio (M‐H, Fixed, 95% CI)	1.09 [0.52, 2.31]
11.2 superficial thrombophlebitis	1	3002	Risk Ratio (M‐H, Fixed, 95% CI)	2.00 [0.18, 22.00]
11.3 medically ill patients	1	839	Risk Ratio (M‐H, Fixed, 95% CI)	0.55 [0.29, 1.03]
12 other serious adverse effects Show forest plot	7	6581	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.77, 1.24]

12.1 surgery patients	5	2755	Risk Ratio (M‐H, Fixed, 95% CI)	1.05 [0.80, 1.38]
12.2 superficial thrombophlebitis	1	2987	Risk Ratio (M‐H, Fixed, 95% CI)	0.62 [0.28, 1.36]
12.3 medically ill patients	1	839	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.51, 1.69]

Comparison 4. Fondaparinux versus placebo subgroup analysis

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Comparison 5. Fondaparinux versus LMWH

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 total VTE Show forest plot	11	9339	Risk Ratio (M‐H, Random, 95% CI)	0.55 [0.42, 0.73]

2 symptomatic VTE Show forest plot	9	12240	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.65, 1.63]

3 total DVT Show forest plot	10	9356	Risk Ratio (M‐H, Random, 95% CI)	0.54 [0.40, 0.71]

4 proximal DVT Show forest plot	9	8361	Risk Ratio (M‐H, Random, 95% CI)	0.58 [0.33, 1.02]

5 total PE Show forest plot	10	12350	Risk Ratio (M‐H, Fixed, 95% CI)	1.24 [0.65, 2.34]

6 fatal PE Show forest plot	9	11107	Risk Ratio (M‐H, Fixed, 95% CI)	0.72 [0.25, 2.05]

7 non‐fatal PE Show forest plot	9	11107	Risk Ratio (M‐H, Fixed, 95% CI)	1.40 [0.63, 3.11]

8 major bleeding Show forest plot	11	12501	Risk Ratio (M‐H, Fixed, 95% CI)	1.38 [1.09, 1.75]

9 fatal bleeding Show forest plot	6	10293	Risk Ratio (M‐H, Fixed, 95% CI)	0.71 [0.14, 3.62]

10 MI Show forest plot	6	10720	Risk Ratio (M‐H, Fixed, 95% CI)	1.28 [0.69, 2.37]

11 all causes of death Show forest plot	11	12400	Risk Ratio (M‐H, Fixed, 95% CI)	0.88 [0.63, 1.22]

12 death associated with VTE or bleeding Show forest plot	5	4774	Risk Ratio (M‐H, Fixed, 95% CI)	0.89 [0.38, 2.07]

13 other serious adverse effects Show forest plot	10	12465	Risk Ratio (M‐H, Fixed, 95% CI)	1.06 [0.94, 1.19]

Comparison 5. Fondaparinux versus LMWH

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Comparison 6. Fondaparinux versus LMWH sensitivity analysis

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 total VTE Show forest plot	13	9709	Risk Ratio (M‐H, Random, 95% CI)	0.57 [0.43, 0.74]

2 symptomatic VTE Show forest plot	11	12569	Risk Ratio (M‐H, Fixed, 95% CI)	1.08 [0.69, 1.70]

3 total DVT Show forest plot	12	9726	Risk Ratio (M‐H, Random, 95% CI)	0.55 [0.42, 0.72]

4 proximal DVT Show forest plot	10	8528	Risk Ratio (M‐H, Random, 95% CI)	0.61 [0.35, 1.06]

5 total PE Show forest plot	12	12720	Risk Ratio (M‐H, Fixed, 95% CI)	1.24 [0.65, 2.34]

6 fatal PE Show forest plot	11	11477	Risk Ratio (M‐H, Fixed, 95% CI)	0.72 [0.25, 2.05]

7 non‐fatal PE Show forest plot	11	11486	Risk Ratio (M‐H, Fixed, 95% CI)	1.40 [0.63, 3.11]

8 major bleeding Show forest plot	13	12874	Risk Ratio (M‐H, Fixed, 95% CI)	1.34 [1.06, 1.68]

9 fatal bleeding Show forest plot	8	10499	Risk Ratio (M‐H, Fixed, 95% CI)	0.71 [0.14, 3.62]

10 all causes of death Show forest plot	12	12603	Risk Ratio (M‐H, Fixed, 95% CI)	0.88 [0.63, 1.22]

11 other serious adverse effects Show forest plot	11	12707	Risk Ratio (M‐H, Fixed, 95% CI)	1.06 [0.95, 1.20]

Comparison 6. Fondaparinux versus LMWH sensitivity analysis

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Comparison 7. Fondaparinux versus LMWH sensitivity analysis without EFFORT

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 total VTE Show forest plot	10	9141	Risk Ratio (M‐H, Random, 95% CI)	0.55 [0.41, 0.73]

2 symptomatic VTE Show forest plot	8	12042	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.65, 1.63]

3 total DVT Show forest plot	9	9158	Risk Ratio (M‐H, Random, 95% CI)	0.53 [0.40, 0.71]

4 proximal DVT Show forest plot	8	8163	Risk Ratio (M‐H, Random, 95% CI)	0.56 [0.31, 1.03]

5 total PE Show forest plot	9	12152	Risk Ratio (M‐H, Fixed, 95% CI)	1.24 [0.65, 2.34]

6 fatal PE Show forest plot	8	10909	Risk Ratio (M‐H, Fixed, 95% CI)	0.72 [0.25, 2.05]

7 non‐fatal PE Show forest plot	8	10909	Risk Ratio (M‐H, Fixed, 95% CI)	1.40 [0.63, 3.11]

8 major bleeding Show forest plot	10	12303	Risk Ratio (M‐H, Fixed, 95% CI)	1.38 [1.09, 1.75]

9 fatal bleeding Show forest plot	5	10095	Risk Ratio (M‐H, Fixed, 95% CI)	0.71 [0.14, 3.62]

10 MI Show forest plot	6	10720	Risk Ratio (M‐H, Fixed, 95% CI)	1.28 [0.69, 2.37]

11 all causes of death Show forest plot	10	12202	Risk Ratio (M‐H, Fixed, 95% CI)	0.88 [0.63, 1.22]

12 death associated with VTE or bleeding Show forest plot	5	4774	Risk Ratio (M‐H, Fixed, 95% CI)	0.89 [0.38, 2.07]

13 other serious adverse effects Show forest plot	9	12267	Risk Ratio (M‐H, Fixed, 95% CI)	1.06 [0.95, 1.20]

Comparison 7. Fondaparinux versus LMWH sensitivity analysis without EFFORT

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Comparison 8. Fondaparinux versus LMWH subgroup analysis

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 total VTE Show forest plot	11	9339	Risk Ratio (M‐H, Random, 95% CI)	0.55 [0.42, 0.73]

1.1 orthopaedic patients	8	7057	Risk Ratio (M‐H, Random, 95% CI)	0.52 [0.38, 0.70]
1.2 abdominal surgery	1	2048	Risk Ratio (M‐H, Random, 95% CI)	0.75 [0.52, 1.09]
1.3 ICU patients	1	36	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
1.4 bariatric surgery patients	1	198	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.14, 6.82]
2 symptomatic VTE Show forest plot	9	12240	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.65, 1.63]

2.1 orthopaedic patients	6	9079	Risk Ratio (M‐H, Fixed, 95% CI)	1.00 [0.61, 1.65]
2.2 abdominal surgery	1	2927	Risk Ratio (M‐H, Fixed, 95% CI)	1.20 [0.37, 3.92]
2.3 ICU patients	1	36	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
2.4 bariatric surgery patients	1	198	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3 total DVT Show forest plot	10	9356	Risk Ratio (M‐H, Random, 95% CI)	0.54 [0.40, 0.71]

3.1 orthopaedic patients	7	7080	Risk Ratio (M‐H, Random, 95% CI)	0.50 [0.37, 0.69]
3.2 abdominal surgery	1	2042	Risk Ratio (M‐H, Random, 95% CI)	0.72 [0.49, 1.06]
3.3 ICU patients	1	36	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3.4 bariatric surgery patients	1	198	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.14, 6.82]
4 proximal DVT Show forest plot	9	8361	Risk Ratio (M‐H, Random, 95% CI)	0.58 [0.33, 1.02]

4.1 orthopaedic patients	6	5974	Risk Ratio (M‐H, Random, 95% CI)	0.52 [0.26, 1.02]
4.2 abdominal surgery	1	2153	Risk Ratio (M‐H, Random, 95% CI)	1.00 [0.29, 3.45]
4.3 ICU patients	1	36	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
4.4 bariatric surgery patients	1	198	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.14, 6.82]
5 total PE Show forest plot	10	12350	Risk Ratio (M‐H, Fixed, 95% CI)	1.24 [0.65, 2.34]

5.1 orthopaedic patients	7	9189	Risk Ratio (M‐H, Fixed, 95% CI)	1.14 [0.56, 2.34]
5.2 abdominal surgery	1	2927	Risk Ratio (M‐H, Fixed, 95% CI)	1.66 [0.40, 6.95]
5.3 ICU patients	1	36	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
5.4 bariatric surgery patients	1	198	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
6 fatal PE Show forest plot	9	11107	Risk Ratio (M‐H, Fixed, 95% CI)	0.72 [0.25, 2.05]

6.1 orthopaedic patients	6	7946	Risk Ratio (M‐H, Fixed, 95% CI)	0.56 [0.14, 2.29]
6.2 abdominal surgery	1	2927	Risk Ratio (M‐H, Fixed, 95% CI)	1.00 [0.20, 4.94]
6.3 ICU patients	1	36	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
6.4 bariatric surgery patients	1	198	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
7 non‐fatal PE Show forest plot	9	11107	Risk Ratio (M‐H, Fixed, 95% CI)	1.40 [0.63, 3.11]

7.1 orthopaedic patients	6	7946	Risk Ratio (M‐H, Fixed, 95% CI)	1.22 [0.53, 2.83]
7.2 abdominal surgery	1	2927	Risk Ratio (M‐H, Fixed, 95% CI)	4.99 [0.24, 103.84]
7.3 ICU patients	1	36	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
7.4 bariatric surgery	1	198	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
8 major bleeding Show forest plot	11	12501	Risk Ratio (M‐H, Fixed, 95% CI)	1.38 [1.09, 1.75]

8.1 orthopaedic patients	8	9409	Risk Ratio (M‐H, Fixed, 95% CI)	1.38 [1.03, 1.84]
8.2 abdominal surgery	1	2858	Risk Ratio (M‐H, Fixed, 95% CI)	1.43 [0.93, 2.21]
8.3 ICU patients	1	36	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.01, 7.68]
8.4 bariatric surgery patients	1	198	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
9 fatal bleeding Show forest plot	7	10329	Risk Ratio (M‐H, Fixed, 95% CI)	0.71 [0.14, 3.62]

9.1 orthopaedic patients	4	7237	Risk Ratio (M‐H, Fixed, 95% CI)	0.34 [0.01, 8.28]
9.2 abdominal surgery	1	2858	Risk Ratio (M‐H, Fixed, 95% CI)	0.99 [0.14, 7.05]
9.3 ICU patients	1	36	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
9.4 bariatric surgery patients	1	198	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
10 MI Show forest plot	6	10720	Risk Ratio (M‐H, Fixed, 95% CI)	1.28 [0.69, 2.37]

10.1 orthopaedic patients	5	7862	Risk Ratio (M‐H, Fixed, 95% CI)	1.21 [0.61, 2.39]
10.2 abdominal surgery	1	2858	Risk Ratio (M‐H, Fixed, 95% CI)	1.66 [0.40, 6.92]
11 all causes of death Show forest plot	11	12400	Risk Ratio (M‐H, Fixed, 95% CI)	0.88 [0.63, 1.22]

11.1 orthopaedic patients	8	9308	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.64, 1.35]
11.2 abdominal surgery	1	2858	Risk Ratio (M‐H, Fixed, 95% CI)	0.75 [0.38, 1.45]
11.3 ICU patients	1	36	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
11.4 bariatric surgery patients	1	198	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
12 other serious adverse effects Show forest plot	10	12470	Risk Ratio (M‐H, Fixed, 95% CI)	1.06 [0.95, 1.19]

12.1 orthopaedic patients	8	9414	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.89, 1.19]
12.2 abdominal surgery	1	2858	Risk Ratio (M‐H, Fixed, 95% CI)	1.14 [0.92, 1.41]
12.3 bariatric surgery patients	1	198	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.33, 2.93]

Comparison 8. Fondaparinux versus LMWH subgroup analysis

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Comparison 9. Fondaparinux versus variable dose warfarin

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 total VTE Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2 symptomatic VTE Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

3 total DVT Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

4 proximal DVT Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

5 total PE Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

6 major bleeding Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

7 all causes of death Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

Comparison 9. Fondaparinux versus variable dose warfarin

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Comparison 10. Fondaparinux versus 1 mg warfarin

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 total VTE Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2 symptomatic VTE Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

3 total DVT Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

4 proximal DVT Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

5 total PE Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

6 major bleeding Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

7 all causes of death Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

Comparison 10. Fondaparinux versus 1 mg warfarin

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Comparison 11. Fondaparinux versus edoxaban

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 total VTE Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2 major bleeding Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

3 all causes of death Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

Comparison 11. Fondaparinux versus edoxaban

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Comparison 12. Fondaparinux versus mechanical thromboprophylaxis

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 total VTE Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2 symptomatic VTE Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

3 total DVT Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

4 proximal DVT Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

5 total PE Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

6 major bleeding Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

7 all causes of death Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

8 other serious adverse effects Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

Comparison 12. Fondaparinux versus mechanical thromboprophylaxis

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