Niet-valvulair atriumfibrilleren
Methoden
Uitgangsvraag
Cruciale uitkomstmaten
-
Beroerte en systemische embolie
-
Ischemische beroerte
-
Sterfte (aan alle oorzaken)
-
Ernstige bloeding
-
Gastro-intestinale bloeding
-
Intracraniële bloeding
-
Myocardinfarct
Literatuursearch
Resultaten
Beschrijving onderzoeken
Type onderzoeken |
|
Type patiënten |
|
Type interventies |
|
Type vergelijkingen |
|
Type uitkomstmaten | Primair:
|
Kwaliteit van bewijs
Effectiviteit
Uitkomstmaat | Geneesmiddel | Kwaliteit van bewijs uit RCT’s | RR (95%-BI) uit RCT’s | RR (95%-BI) uit cohortonderzoeken |
---|---|---|---|---|
Beroerte en systemische embolie(21 RCT’s, 11 cohortonderzoeken) | Dabigatran (150 mg) | ????Matig (door indirect bewijs) | 0,66 (0,48-0,89) | 0,86 (0,64-1,14) |
Rivaroxaban | ????Matig (door indirect bewijs) | 0,74 (0,55-1,00) | 0,87 (0,54-1,41) | |
Apixaban | ????Matig (door indirect bewijs) | 0,83 (0,65-1,07) | n.v.t. | |
Edoxaban | ????Laag (door indirect bewijs en onnauwkeurigheid) | 0,85 (0,65-1,12) | n.v.t. | |
Ischemische beroerte(16 RCT’s, 6 cohortonderzoeken) | Dabigatran (150 mg) | ????Matig (door indirect bewijs) | 0,76 (0,59-0,98) | 0,73 (0,47-1,14) |
Rivaroxaban | ????Laag (door indirect bewijs en onnauwkeurigheid) | 0,90 (0,72-1,11) | 1,03 (0,45-2,38) | |
Apixaban | ????Laag (door indirect bewijs en onnauwkeurigheid) | 0,95 (0,78-1,16) | n.v.t. | |
Edoxaban | ????Laag (door indirect bewijs en onnauwkeurigheid) | 1,00(0,83-1,20) | n.v.t. | |
Sterfte aan alle oorzaken(20 RCT’s, 5 cohortonderzoeken) | Dabigatran (150 mg) | ????Matig (door indirect bewijs) | 0,88 (0,77-1,01) | 0,74 (0,37-1,50) |
Rivaroxaban | ????Matig (door indirect bewijs) | 0,87 (0,73-1,05) | n.v.t. | |
Apixaban | ????Matig (door indirect bewijs) | 0,89 (0,80-0,98) | n.v.t. | |
Edoxaban | ????Matig (door indirect bewijs) | 0,92(0,83-1,01) | n.v.t. |
Uitkomstmaat | Geneesmiddel | RR (95%-BI), leeftijd 65 tot 75 jaar | RR (95%-BI), leeftijd 75 tot 85 jaar |
---|---|---|---|
Beroerte en systemische embolie(21 RCT’s, 11 cohortonderzoeken) | Dabigatran (150 mg) | 0,63 (0,33-1,20) | 0,74 (0,55-0,98) |
Rivaroxaban | 0,83 (0,35-1,97) | 0,80 (0,64-1,00) | |
Apixaban | 0,72 (0,38-1,36) | 0,69 (0,53-0,90) | |
Edoxaban | 0,92 (0,50-1,68) | 0,83 (0,66-1,03) | |
Ischemische beroerte(16 RCT’s, 6 cohortonderzoeken) | Dabigatran (150 mg) | 0,76 (0,24-2,47) | 0,85 (0,69-1,05) |
Rivaroxaban | 0,81 (0,26-2,47) | 0,86 (0,66-1,12) | |
Apixaban | n.v.t. | n.v.t. | |
Edoxaban | n.v.t. | n.v.t. | |
Sterfte aan alle oorzaken(20 RCT’s, 5 cohortonderzoeken) | Dabigatran (150 mg) | n.v.t. | 0,89 (0,78-1,02) |
Rivaroxaban | n.v.t. | n.v.t. | |
Apixaban | n.v.t. | 0,89 (0,76-1,04) | |
Edoxaban | n.v.t. | n.v.t. |
Veiligheid
Uitkomstmaat | Geneesmiddel | Kwaliteit van bewijs uit RCT’s | RR (95%-BI) uit RCT’s | RR (95%-BI) uit cohortonderzoeken |
---|---|---|---|---|
Ernstige bloeding(21 RCT’s, 8 cohortonderzoeken) | Dabigatran (150 mg) | ????Matig (door indirect bewijs) | 0,93(0,81-1,06) | 0,95 (0,63-1,43) |
Rivaroxaban | ????Laag (door indirect bewijs en onnauwkeurigheid) | 1,04(0,91-1,20) | 0,93 (0,45-1,95) | |
Apixaban | ????Matig (door indirect bewijs) | 0,70(0,61-0,81) | n.v.t. | |
Edoxaban | ????Matig (door indirect bewijs) | 0,80(0,70-0,91) | n.v.t. | |
Gastro-intestinale bloeding(10 RCT’s, 17 cohortonderzoeken) | Dabigatran (150 mg) | ????Laag (door indirect bewijs en onnauwkeurigheid) | 1,48(0,41-5,33) | 1,07 (0,85-1,36) |
Rivaroxaban | ????Laag (door indirect bewijs en onnauwkeurigheid) | 1,01(0,36-2,85) | 0,76 (0,54-1,08) | |
Apixaban | ????Laag (door indirect bewijs en onnauwkeurigheid) | 0,72(0,21-2,43) | n.v.t. | |
Edoxaban | ????Laag (door indirect bewijs en onnauwkeurigheid) | 1,23(0,34-4,41) | n.v.t. | |
Intracraniële bloeding(12 RCT’s, 14 cohortonderzoeken) | Dabigatran (150 mg) | ????Matig (door indirect bewijs) | 0,42(0,29-0,61) | 0,37 (0,30-0,47) |
Rivaroxaban | ????Matig (door indirect bewijs) | 0,69(0,50-0,96) | 0,82 (0,49-1,38) | |
Apixaban | ????Matig (door indirect bewijs) | 0,41(0,30-0,57) | n.v.t. | |
Edoxaban | ????Matig (door indirect bewijs) | 0,46(0,34-0,62) | n.v.t. | |
Myocardinfarct(15 RCT’s, 3 cohortonderzoeken) | Dabigatran (150 mg) | ????Laag (door indirect bewijs en onnauwkeurigheid) | 1,40(0,90-2,17) | 0,65 (0,46-0,92) |
Rivaroxaban | ????Laag (door indirect bewijs en onnauwkeurigheid) | 0,85(0,57-1,28) | 0,43 (0,04-4,92) | |
Apixaban | ????Laag (door indirect bewijs en onnauwkeurigheid) | 0,95(0,65-1,38) | n.v.t. | |
Edoxaban | ????Laag (door indirect bewijs en onnauwkeurigheid) | 0,93(0,64-1,37) | n.v.t. |
Uitkomstmaat | Geneesmiddel | RR (95%-BI), leeftijd 65 tot 75 jaar | RR (95%-BI),leeftijd 75 tot 85 jaar |
---|---|---|---|
Ernstige bloeding(21 RCT’s, 8 cohortonderzoeken) | Dabigatran (150 mg) | 0,73 (0,48-1,09) | 1,17 (0,99-1,39) |
Rivaroxaban | 0,83 (0,48-1,44) | 1,12 (0,93-1,36) | |
Apixaban | 0,71 (0,44-1,12) | 0,67 (0,55-0,82) | |
Edoxaban | 0,75 (0,47-1,21) | 0,84 (0,69-1,01) | |
Gastro-intestinale bloeding(10 RCT’s, 17 cohortonderzoeken) | Dabigatran (150 mg) | 0,88 (0,58-1,35) | 1,51 (1,16-1,96) |
Rivaroxaban | 1,16 (0,65-2,07) | 1,16 (0,81-1,66) | |
Apixaban | n.v.t. | n.v.t. | |
Edoxaban | n.v.t. | n.v.t. | |
Intracraniële bloeding(12 RCT’s, 14 cohortonderzoeken) | Dabigatran (150 mg) | 0,35 (0,21-0,59) | 0,39 (0,29-0,51) |
Rivaroxaban | 0,52 (0,26-1,05) | 0,79 (0,51-1,23) | |
Apixaban | 0,35 (0,16-0,74) | 0,33 (0,20-0,56) | |
Edoxaban | 0,34 (0,16-0,73) | 0,41 (0,27-0,62) | |
Myocardinfarct(15 RCT’s, 3 cohortonderzoeken) | Dabigatran (150 mg) | n.v.t. | n.v.t. |
Rivaroxaban | n.v.t. | n.v.t. | |
Apixaban | n.v.t. | n.v.t. | |
Edoxaban | n.v.t. | n.v.t. |
Conclusie
Diepe veneuze trombose
Methoden
Uitgangsvraag
Cruciale uitkomstmaten
-
Recidief veneuze trombo-embolie
-
Sterfte (aan alle oorzaken)
-
Ernstige bloeding
Literatuursearch
Resultaten
Beschrijving onderzoeken
Type onderzoeken | RCT’s |
Type patiënten | Patiënten met een bevestigde DVT |
Type interventies | Orale DOACUitgesloten: behandeling korter dan drie maanden |
Type vergelijkingen |
|
Type uitkomstmaten | Primair:
|
Kwaliteit van bewijs
Effectiviteit
Uitkomstmaat | Geneesmiddel | Kwaliteit van bewijs uit RCT’s | RR (95%-BI) uit RCT’s | RR (95%-BI) uit cohortonderzoek |
---|---|---|---|---|
Recidief veneuze trombo-embolie | Directe trombineremmers(3 RCT’s) | ????Laag (door indirect bewijs en onnauwkeurigheid) | 1,09 (0,80-1,49) | n.v.t. |
Factor Xa-remmers(8 RCT’s, 1 cohortonderzoek) | ????Matig (door indirect bewijs) | 0,89 (0,73-1,07) | 0,91 (0,54-1,54) | |
Sterfte aan alle oorzaken | Directe trombineremmers(3 RCT’s) | ????Laag (door indirect bewijs en onnauwkeurigheid) | 0,84 (0,62-1,15) | n.v.t. |
Factor Xa-remmers(5 RCT’s, 1 cohortonderzoek) | ????Laag (door indirect bewijs en onnauwkeurigheid) | 0,84 (0,64-1,11) | 0,51 (0,24-1,07) |
Veiligheid
Uitkomstmaat | Geneesmiddel | Kwaliteit van bewijs uit RCT’s | RR (95%-BI) uit RCT’s | RR (95%-BI) uit cohortonderzoek |
---|---|---|---|---|
Ernstige bloeding | Directe trombineremmers(3 RCT’s) | ????Matig (door indirect bewijs) | 0,68 (0,47-0,98) | n.v.t. |
Factor Xa-remmers(8 RCT’s, 1 cohortonderzoek) | ????Matig (door indirect bewijs) | 0,57 (0,43-0,76) | 0,77(0,40-1,50) |
Conclusie
Bijlage 2: GRADE evidenceprofielen
Effectiviteit van DOAC’s ten opzichte van warfarine bij AF (RCT resultaten, 65-plussers)
Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | DOACs | Warfarin | Relative(95%-CI) | Absolute | ||
Stroke and systemic embolism - dabigatran follow-up 184090 patient-years) | ||||||||||||
21 | randomised trials | no serious risk of bias1 | no serious inconsistency | serious2 | no serious imprecision3 | none4 | – | – | RR 0.66 (0.48 to 0.89) | – | ????MODERATE | CRITICAL |
Stroke and systemic embolism - rivaroxaban (follow-up 184090 patient-years) | ||||||||||||
21 | randomised trials | no serious risk of bias1 | no serious inconsistency | serious2 | no serious imprecision3 | none4 | – | – | RR 0.74(0.55 to 1) | – | ????MODERATE | CRITICAL |
Stroke and systemic embolism - apixaban (follow-up 184090 patient-years) | ||||||||||||
21 | randomised trials | no serious risk of bias1 | no serious inconsistency | serious2 | no serious imprecision3 | none4 | – | – | RR 0.83(0.65 to 1.07) | – | ????MODERATE | CRITICAL |
Stroke and systemic embolism - edoxaban (follow-up 184090 patient-years) | ||||||||||||
21 | randomised trials | no serious risk of bias1 | no serious inconsistency | serious2 | serious5 | none4 | – | – | RR 0.85(0.65 to 1.12) | – | ????LOW | CRITICAL |
Ischemic stroke - dabigatran (follow-up 179915 patient-years) | ||||||||||||
16 | randomised trials | no serious risk of bias1 | no serious inconsistency | serious2 | no serious imprecision3 | none4 | – | – | RR 0.76(0.59 to 0.98) | – | ????MODERATE | CRITICAL |
Ischemic stroke - rivaroxaban (follow-up 179915 patient-years) | ||||||||||||
16 | randomised trials | no serious risk of bias1 | no serious inconsistency | serious2 | serious5 | none4 | – | – | RR 0.90(0.72 to 1.11) | – | ????LOW | CRITICAL |
Ischemic stroke - apixaban (follow-up 179915 patient-years) | ||||||||||||
16 | randomised trials | no serious risk of bias1 | no serious inconsistency | serious2 | serious5 | none4 | – | – | RR 0.95(0.78 to 1.16) | – | ????LOW | CRITICAL |
Ischemic stroke - edoxaban (follow-up 179915 patient-years) | ||||||||||||
16 | randomised trials | no serious risk of bias1 | no serious inconsistency | serious2 | serious5 | none4 | – | – | RR 1(0.83 to 1.2) | – | ????LOW | CRITICAL |
All-cause mortality - dabigatran (follow-up 185023 patient-years) | ||||||||||||
20 | randomised trials | no serious risk of bias1 | no serious inconsistency | serious2 | no serious imprecision3 | none | – | – | RR 0.88(0.77 to 1.01) | – | ????MODERATE | CRITICAL |
All-cause mortality - rivaroxaban (follow-up 185023 patient-years) | ||||||||||||
20 | randomised trials | no serious risk of bias1 | no serious inconsistency | serious2 | no serious imprecision3 | none | – | – | RR 0.87(0.73 to 1.05) | – | ????MODERATE | CRITICAL |
All-cause mortality - apixaban (follow-up 185023 patient-years) | ||||||||||||
20 | randomised trials | no serious risk of bias1 | no serious inconsistency | serious2 | no serious imprecision3 | none | – | – | RR 0.89(0.8 to 0.98) | – | ????MODERATE | CRITICAL |
All-cause mortality - edoxaban (follow-up 185023 patient-years) | ||||||||||||
20 | randomised trials | no serious risk of bias1 | no serious inconsistency | serious2 | no serious imprecision3 | none | – | – | RR 0.92 (0.83 to 1.01) | – | ????MODERATE | CRITICAL |
Effectiviteit van DOAC’s ten opzichte van warfarine bij AF (resultaten uit observationele onderzoeken, 65-plussers)
Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | DOACs | Warfarin | Relative(95%-CI) | Absolute | ||
Stroke and systemic embolism - dabigatran(follow-up 255341 patient-years) | ||||||||||||
11 | observational studies | no serious risk of bias1 | no serious inconsistency | no serious indirectness2 | serious3 | none | – | – | RR 0.86(0.64 to 1.14) | – | ????VERY LOW | CRITICAL |
Stroke and systemic embolism - rivaroxaban (follow-up 255341 patient-years) | ||||||||||||
11 | observational studies | no serious risk of bias1 | no serious inconsistency | no serious indirectness2 | serious3 | none | – | – | RR 0.87(0.54 to 1.41) | – | ????VERY LOW | CRITICAL |
Stroke and systemic embolism - apixaban - not reported | ||||||||||||
0 | – | – | – | – | – | none | – | – | – | – | CRITICAL | |
Stroke and systemic embolism - edoxaban - not reported | ||||||||||||
0 | – | – | – | – | – | none | – | – | – | – | CRITICAL | |
Ischemic stroke - dabigatran (follow-up 363322 patient-years) | ||||||||||||
6 | observational studies | no serious risk of bias1 | no serious inconsistency | no serious indirectness2 | serious3 | none | – | – | RR 0.73(0.47 to 1.14) | – | ????VERY LOW | CRITICAL |
Ischemic stroke - rivaroxaban (follow-up 363322 patient-years) | ||||||||||||
6 | observational studies | no serious risk of bias1 | no serious inconsistency | no serious indirectness2 | serious3 | none | – | – | RR 1.03(0.45 to 2.38) | – | ????VERY LOW | CRITICAL |
Ischemic stroke - apixaban - not reported | ||||||||||||
0 | – | – | – | – | – | none | – | – | – | – | CRITICAL | |
Ischemic stroke - edoxaban - not reported | ||||||||||||
0 | – | – | – | – | – | none | – | – | – | – | CRITICAL | |
All-cause mortality - dabigatran (follow-up 195118 patient-years) | ||||||||||||
5 | observational studies | no serious risk of bias1 | no serious inconsistency | no serious indirectness2 | serious3 | none | – | – | RR 0.74(0.37 to 1.50) | – | ????VERY LOW | CRITICAL |
All-cause mortality - rivaroxaban - not reported | ||||||||||||
0 | – | – | – | – | – | none | – | – | – | – | CRITICAL | |
All-cause mortality - apixaban - not reported | ||||||||||||
0 | – | – | – | – | – | none | – | – | – | – | CRITICAL | |
All-cause mortality - edoxaban - not reported | ||||||||||||
0 | – | – | – | – | – | none | – | – | – | – | CRITICAL |
Veiligheid van DOAC’s t.o.v. warfarine bij AF (RCT resultaten, 65-plussers)
Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | DOACs | Warfarin | Relative(95%-CI) | Absolute | ||
Major bleeding - dabigatran (follow-up 169569 patient-years) | ||||||||||||
21 | randomised trials | no serious risk of bias1 | no serious inconsistency | serious2,3 | no serious imprecision4 | none5 | – | – | RR 0.93(0.81 to 1.06) | – | ????MODERATE | CRITICAL |
Major bleeding - rivaroxaban (follow-up 169569 patient-years) | ||||||||||||
21 | randomised trials | no serious risk of bias1 | no serious inconsistency | serious2,3 | serious6 | none5 | – | – | RR 1.04(0.91 to 1.2) | – | ????LOW | CRITICAL |
Major bleeding - apixaban (follow-up 169569 patient-years) | ||||||||||||
21 | randomised trials | no serious risk of bias1 | no serious inconsistency | serious2,3 | no serious imprecision4 | none5 | – | – | RR 0.70(0.61 to 0.81) | – | ????MODERATE | CRITICAL |
Major bleeding - edoxaban (follow-up 169569 patient-years) | ||||||||||||
21 | randomised trials | no serious risk of bias1 | no serious inconsistency | serious2,3 | no serious imprecision4 | none5 | – | – | RR 0.80(0.70 to 0.91) | – | ????MODERATE | CRITICAL |
Gastrointestinal bleeding - dabigatran (follow-up 154149 patient-years) | ||||||||||||
10 | randomised trials | no serious risk of bias1 | no serious inconsistency | serious2,3 | serious6 | none5 | – | – | RR 1.48(0.41 to 5.33) | – | ????LOW | CRITICAL |
Gastrointestinal bleeding - rivaroxaban (follow-up 154149 patient-years) | ||||||||||||
10 | randomised trials | no serious risk of bias1 | no serious inconsistency | serious2,3 | serious6 | none5 | – | – | RR 1.01(0.36 to 2.85) | – | ????LOW | CRITICAL |
Gastrointestinal bleeding - apixaban (follow-up 154149 patient-years) | ||||||||||||
10 | randomised trials | no serious risk of bias1 | no serious inconsistency | serious2,3 | serious6 | none5 | – | – | RR 0.72(0.21 to 2.43) | – | ????LOW | CRITICAL |
Gastrointestinal bleeding - edoxaban (follow-up 154149 patient-years) | ||||||||||||
10 | randomised trials | no serious risk of bias1 | no serious inconsistency | serious2,3 | serious6 | none5 | – | – | RR 1.23(0.34 to 4.41) | – | ????LOW | CRITICAL |
Intracranial bleeding - dabigatran (follow-up 160812 patient-years) | ||||||||||||
12 | randomised trials | no serious risk of bias1 | no serious inconsistency | serious2,3 | no serious imprecision4 | none5 | – | – | RR 0.42(0.29 to 0.61) | – | ????MODERATE | CRITICAL |
Intracranial bleeding - rivaroxaban (follow-up 160812 patient-years) | ||||||||||||
12 | randomised trials | no serious risk of bias1 | no serious inconsistency | serious2,3 | no serious imprecision4 | none5 | – | – | RR 0.69(0.5 to 0.96) | – | ????MODERATE | CRITICAL |
Intracranial bleeding - apixaban (follow-up 160812 patient-years) | ||||||||||||
12 | randomised trials | no serious risk of bias1 | no serious inconsistency | serious2,3 | no serious imprecision4 | none5 | – | – | RR 0.41 (0.3 to 0.57) | – | ????MODERATE | CRITICAL |
Intracranial bleeding - edoxaban (follow-up 160812 patient-years) | ||||||||||||
12 | randomised trials | no serious risk of bias1 | no serious inconsistency | serious2,3 | no serious imprecision4 | none5 | – | – | RR 0.46(0.34 to 0.62) | – | ????MODERATE | CRITICAL |
Myocardial infarction - dabigatran (follow-up 181221 patient-years) | ||||||||||||
15 | randomised trials | no serious risk of bias1 | no serious inconsistency | serious2 | serious6 | none5 | – | – | RR 1.40(0.9 to 2.17) | – | ????LOW | CRITICAL |
Myocardial infarction - rivaroxaban (follow-up 181221 patient-years) | ||||||||||||
15 | randomised trials | no serious risk of bias1 | no serious inconsistency | serious2 | serious6 | none5 | – | – | RR 0.85(0.57 to 1.28) | – | ????LOW | CRITICAL |
Myocardial infarction - apixaban (follow-up 181221 patient-years) | ||||||||||||
15 | randomised trials | no serious risk of bias1 | no serious inconsistency | serious2 | serious6 | none5 | – | – | RR 0.95(0.65 to 1.38) | – | ????LOW | CRITICAL |
Myocardial infarction - apixaban (follow-up 181221 patient-years) | ||||||||||||
15 | randomised trials | no serious risk of bias1 | no serious inconsistency | serious2 | serious6 | none5 | – | – | RR 0.93(0.64 to 1.37) | – | ????LOW | CRITICAL |
Veiligheid van DOAC’s ten opzichte van warfarine bij AF (resultaten uit observationele onderzoeken, 65-plussers)
Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | DOACs | Warfarin | Relative(95%-CI) | Absolute | ||
Major bleeding - dabigatran (follow-up 83375 patient-years) | ||||||||||||
8 | observational studies | no serious risk of bias1 | no serious inconsistency | no serious indirectness2 | serious3 | none | – | – | RR 0.95(0.63 to 1.43) | – | ????VERY LOW | CRITICAL |
Major bleeding - rivaroxaban (follow-up 83375 patient-years) | ||||||||||||
8 | observational studies | no serious risk of bias1 | no serious inconsistency | no serious indirectness2 | serious3 | none | – | – | RR 0.93(0.45 to 1.95) | – | ????VERY LOW | CRITICAL |
Major bleeding - apixaban - not reported | ||||||||||||
0 | – | – | – | – | – | none | – | – | – | – | CRITICAL | |
Major bleeding - edoxaban - not reported | ||||||||||||
0 | – | – | – | – | – | none | – | – | – | – | CRITICAL | |
Gastrointestinal bleeding - dabigatran (follow-up 517194 patient-years) | ||||||||||||
17 | observational studies | no serious risk of bias1 | no serious inconsistency | no serious indirectness2 | serious3 | none | – | – | RR 1.07(0.85 to 1.36) | – | ????VERY LOW | CRITICAL |
Gastrointestinal bleeding - rivaroxaban (follow-up 517194 patient-years) | ||||||||||||
17 | observational studies | no serious risk of bias1 | no serious inconsistency | no serious indirectness2 | no serious imprecision4 | none | – | – | RR 0.76(0.54 to 1.08) | – | ????LOW | CRITICAL |
Gastrointestinal bleeding - apixaban - not reported | ||||||||||||
0 | – | – | – | – | – | none | – | – | – | – | CRITICAL | |
Gastrointestinal bleeding - edoxaban - not reported | ||||||||||||
0 | – | – | – | – | – | none | – | – | – | – | CRITICAL | |
Intracranial bleeding - dabigatran (follow-up 555037 patient-years) | ||||||||||||
14 | observational studies | no serious risk of bias1 | no serious inconsistency | no serious indirectness2 | no serious imprecision4 | none | – | – | RR 0.37(0.30 to 0.47) | – | ????LOW | CRITICAL |
Intracranial bleeding - rivaroxaban (follow-up 555037 patient-years) | ||||||||||||
14 | observational studies | no serious risk of bias1 | no serious inconsistency | no serious indirectness2 | serious3 | none | – | – | RR 0.82(0.49 to 1.38) | – | ????VERY LOW | CRITICAL |
Intracranial bleeding - apixaban - not reported | ||||||||||||
0 | – | – | – | – | – | none | – | – | – | – | CRITICAL | |
Intracranial bleeding - edoxaban - not reported | ||||||||||||
0 | – | – | – | – | – | none | – | – | – | – | CRITICAL | |
Myocardial infarction - dabigatran (follow-up 60251 patient-years) | ||||||||||||
3 | observational studies | no serious risk of bias1 | no serious inconsistency | no serious indirectness2 | no serious imprecision4 | none | – | – | RR 0.65(0.46 to 0.92) | – | ????LOW | CRITICAL |
Myocardial infarction - rivaroxaban (follow-up 60251 patient-years) | ||||||||||||
3 | observational studies | no serious risk of bias1 | no serious inconsistency | no serious indirectness2 | serious3 | none | – | – | RR 0.43(0.04 to 4.92) | – | ????VERY LOW | CRITICAL |
Myocardial infarction - apixaban - not reported | ||||||||||||
0 | – | – | – | – | – | none | – | – | – | – | CRITICAL | |
Myocardial infarction - edoxaban - not reported | ||||||||||||
0 | – | – | – | – | – | none | – | – | – | – | CRITICAL |
Effectiviteit en veiligheid van directe trombineremmers ten opzichte van (LMWH +) cumarinederivaten bij diepe veneuze trombose (RCT-resultaten)
Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Direct thrombin inhibitor | Other anticoagulant | Relative(95%-CI) | Absolute (95%-CI) | ||
Recurrent VTE (follow-up 3-6 months) | ||||||||||||
3 | randomised trials | no serious risk of bias | no serious inconsistency | serious1 | serious2 | none3 | 86/3793 (2.3%) | 79/3803 (2.1%) | RR 1.09 (0.8 to 1.49) | 2 more per 1000 (from 4 fewer to 10 more) | ???? LOW | CRITICAL |
Recurrent DVT (follow-up 3-6 months) | ||||||||||||
3 | randomised trials | no serious risk of bias | no serious inconsistency | serious1 | serious2 | none3 | 56/3793 (1.5%) | 52/3803 (1.4%) | RR 1.08(0.74 to 1.58) | 1 more per 1000 (from 4 fewer to 8 more) | ????LOW | IMPORTANT |
Fatal pulmonary embolism (follow-up 3-6 months) | ||||||||||||
3 | randomised trials | no serious risk of bias | no serious inconsistency | serious1 | very serious2,4 | none3 | 4/3793 (0.11%) | 4/3803 (0.11%) | RR 1(0.27 to 3.7) | 0 fewer per 1000 (from 1 fewer to 3 more) | ????VERY LOW | IMPORTANT |
Non-fatal pulmonary embolism (follow-up 3-6 months) | ||||||||||||
3 | randomised trials | no serious risk of bias | no serious inconsistency | serious1 | serious2 | none3 | 29/3793 (0.76%) | 26/3803 (0.68%) | RR 1.12(0.66 to 1.9) | 1 more per 1000 (from 2 fewer to 6 more) | ????LOW | IMPORTANT |
All-cause mortality (follow-up 3-6 months) | ||||||||||||
3 | randomised trials | no serious risk of bias | no serious inconsistency | serious1,5 | serious2 | none3 | 74/3792 (2%) | 88/3804 (2.3%) | RR 0.84(0.62 to 1.15) | 4 fewer per 1000 (from 9 fewer to 3 more) | ????LOW | CRITICAL |
Major bleeding (follow-up 3-6 months) | ||||||||||||
3 | randomised trials | no serious risk of bias | no serious inconsistency | serious1,5 | no serious imprecision6 | none3 | 49/3793 (1.3%) | 72/3803 (1.9%) | RR 0.68(0.47 to 0.98) | 6 fewer per 1000 (from 0 fewer to 10 fewer) | ????MODERATE | CRITICAL |
Effectiviteit en veiligheid van factor Xa-remmers ten opzichte van LMWH/cumarinederivaten bij diepe veneuze trombose (RCT-resultaten)
Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Factor Xa inhibitor | Other anticoagulant | Relative(95%-CI) | Absolute | ||
Recurrent VTE (follow-up 3-6 months) | ||||||||||||
8 | randomised trials | no serious risk of bias1 | no serious inconsistency | serious2 | no serious imprecision3 | none4 | 223/8604 (2.6%) | 226/7752 (2.9%) | RR 0.89(0.73 to 1.07) | 3 fewer per 1000 (from 8 fewer to 2 more) | ????MODERATE | CRITICAL |
Recurrent DVT (follow-up 3-6 months) | ||||||||||||
7 | randomised trials | no serious risk of bias1 | no serious inconsistency | serious2 | no serious imprecision3 | none4 | 102/8548 (1.2%) | 119/7724 (1.5%) | RR 0.75(0.57 to 0.98) | 4 fewer per 1000 (from 0 fewer to 7 fewer) | ????MODERATE | IMPORTANT |
Fatal pulmonary embolism (follow-up 3-6 months) | ||||||||||||
6 | randomised trials | no serious risk of bias1 | no serious inconsistency | serious2 | serious5 | none4 | 33/7945 (0.42%) | 23/7137 (0.32%) | RR 1.2(0.71 to 2.03) | 1 more per 1000 (from 1 fewer to 3 more) | ????LOW | IMPORTANT |
Non-fatal pulmonary embolism (follow-up 3-6 months) | ||||||||||||
6 | randomised trials | no serious risk of bias1 | no serious inconsistency | serious2 | serious5 | none4 | 79/7945 (0.99%) | 79/7137 (1.1%) | RR 0.94(0.68 to 1.28) | 1 fewer per 1000 (from 4 fewer to 3 more) | ????LOW | IMPORTANT |
All-cause mortality (follow-up 3-6 months) | ||||||||||||
5 | randomised trials | no serious risk of bias6 | no serious inconsistency | serious2,7 | serious5 | none4 | 111/5662 (2%) | 107/4775 (2.2%) | RR 0.84(0.64 to 1.11) | 4 fewer per 1000 (from 8 fewer to 2 more) | ????LOW | CRITICAL |
Major bleeding (follow-up 3-6 months) | ||||||||||||
8 | randomised trials | no serious risk of bias1 | no serious inconsistency | serious2,7 | no serious imprecision3 | none4 | 81/8789 (0.92%) | 123/7856 (1.6%) | RR 0.57(0.43 to 0.76) | 7 fewer per 1000 (from 4 fewer to 9 fewer) | ????MODERATE | CRITICAL |
Effectiviteit en veiligheid van rivaroxaban t.o.v. standaard antistolling (resultaten XALIA-cohort)
Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Relative(95%-CI) | Absolute | ||||
Recurrent VTE | ||||||||||||
1 | observational studies | no serious risk of bias | no serious inconsistency | no serious indirectness | serious1 | none2 | 36/2505 (1.4%) | 47/2010 (2.3%) | RR 0.91(0.54 to 1.54) | 2 fewer per 1000 (from 11 fewer to 13 more) | ????VERY LOW | CRITICAL |
Recurrent DVT | ||||||||||||
1 | observational studies | serious3 | no serious inconsistency | no serious indirectness | serious4 | none2 | 13/2619 (0.5%) | 30/2149 (1.4%) | -5 | 14 fewer per 10006 | ????VERY LOW | IMPORTANT |
Fatal pulmonaryembolism | ||||||||||||
1 | observational studies | serious3 | no serious inconsistency | no serious indirectness | serious4 | none2 | 1/2619 (0.04%) | 1/2149 (0.05%) | -5 | 0 fewer per 10006 | ????VERY LOW | IMPORTANT |
Non-fatal pulmonaryembolism | ||||||||||||
1 | observational studies | serious3 | no serious inconsistency | no serious indirectness | serious4 | none2 | 17/2619 (0.65%) | 17/2149 (0.79%) | -5 | 8 fewer per 10006 | ????VERY LOW | IMPORTANT |
All-cause mortality | ||||||||||||
1 | observational studies | no serious risk of bias | no serious inconsistency | no serious indirectness | no serious imprecision7 | none2 | 11/2505 (0.44%) | 69/2010 (3.4%) | RR 0.51(0.24 to 1.07) | 17 fewer per 1000 (from 26 fewer to 2 more) | ????LOW | CRITICAL |
Cancer-related mortality | ||||||||||||
1 | observational studies | serious3 | no serious inconsistency | no serious indirectness | serious4 | none2 | 6/2619 (0.23%) | 61/2149 (2.8%) | -5 | 28 fewer per 10006 | ????VERY LOW | IMPORTANT |
Major bleeding | ||||||||||||
1 | observational studies | no serious risk of bias | no serious inconsistency | no serious indirectness | serious1 | none2 | 19/2505 (0.76%) | 43/2010 (2.1%) | RR 0.77(0.4 to 1.5) | 5 fewer per 1000 (from 13 fewer to 11 more) | ????VERY LOW | CRITICAL |
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