Cochrane · systematic review · CD012169
Antiplatelet and anticoagulant agents for secondary prevention of stroke and other thromboembolic events in people with antiphospholipid syndrome
Bala, MM, Celinska-Lowenhoff, M, Szot, W, et al. · Cochrane Database of Systematic Reviews · 2020 · Cochrane Library
SoF tableOnly the outcomes this review put in its Summary of Findings table are listed (the Cochrane Handbook caps them at about seven per comparison). Its other analyses are not shown here.
Questions
24
current version
GRADE rated
22
No studies
2
Included studies
NR
No studies 2 · 8.3%Ungraded 0 · 0%Very low 6 · 25%Low 11 · 45.8%Moderate 5 · 20.8%High 0 · 0%
Ungraded means an effect was reported without a GRADE rating; it is not a gap. No studies means the review found nothing to answer the question. The six categories are a display order, not a score.
Questions and results
Current version onlyNOAC (rivaroxaban) versus standard‐dose VKA
Population: people with antiphospholipid syndrome and a history of stroke and or thromboembolic events
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Any thromboembolic event NOAC (rivaroxaban) vs standard‐dose VKA | RR 4.08 [0.48, 34.79] | 3 studies · 425 participants | Moderate Downgraded: imprecision |
Major bleeding NOAC (rivaroxaban) vs standard‐dose VKA | RR 1.1 [0.45, 2.68] | 3 studies · 425 participants | Moderate Downgraded: imprecision |
All‐cause mortalitya NOAC (rivaroxaban) vs standard‐dose VKA | RR 1.45 [0.44, 4.78] | 3 studies · 425 participants | Moderate Downgraded: imprecision |
Strokea NOAC (rivaroxaban) vs standard‐dose VKA | RR 14.13 [1.87, 106.81] | 3 studies · 425 participants | Moderate Downgraded: imprecision |
Mean quality of life ‐ health utility NOAC (rivaroxaban) vs standard‐dose VKA | no estimate extracted | 1 study · 111 participants | Low Downgraded: risk of bias, imprecision |
Mean quality of life ‐ health state NOAC (rivaroxaban) vs standard‐dose VKA | no estimate extracted | 1 study · 112 participants | Low Downgraded: risk of bias, imprecision |
Clinically relevant non‐major bleeding NOAC (rivaroxaban) vs standard‐dose VKA | RR 1.7 [0.69, 4.19] | 2 studies · 302 participants | Moderate |
High‐dose VKA versus standard‐dose VKA
Population: people with antiphospholipid syndrome and a history of stroke or thromboembolic events
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Any thromboembolic event High‐dose VKA vs standard‐dose VKA | RR 2.22 [0.79, 6.23] | 2 studies · 223 participants | Low Downgraded: risk of bias, imprecision |
Major bleeding High‐dose VKA vs standard‐dose VKA | RR 0.74 [0.24, 2.25] | 2 studies · 223 participants | Low Downgraded: risk of bias, imprecision |
All‐cause mortalitya High‐dose VKA vs standard‐dose VKA | RR 1.53 [0.27, 8.79] | 2 studies · 223 participants | Low Downgraded: risk of bias, imprecision |
Strokea High‐dose VKA vs standard‐dose VKA | RR 1.37 [0.26, 7.12] | 2 studies · 223 participants | Low Downgraded: risk of bias, imprecision |
Any bleedingb High‐dose VKA vs standard‐dose VKA | RR 1.56 [0.93, 2.62] | 2 studies · 223 participants | Low Downgraded: risk of bias, imprecision |
Adverse events High‐dose VKA vs standard‐dose VKA | no estimate extracted | NR | No studies |
Standard‐dose VKA plus single antiplatelet agent versus standard‐dose VKA
Population: people with antiphospholipid syndrome and a history of stroke or thromboembolic events
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Any thromboembolic event Standard‐dose VKA plus single antiplatelet agent vs standard‐dose VKA | RR 2.14 [1.04, 4.43] | 1 study · 82 participants | Low Downgraded: risk of bias, imprecision |
Major bleeding Standard‐dose VKA plus single antiplatelet agent vs standard‐dose VKA | RR 7.42 [0.91, 60.7] | 1 study · 82 participants | Low Downgraded: risk of bias, imprecision |
All‐cause mortalitya Standard‐dose VKA plus single antiplatelet agent vs standard‐dose VKA | RR 0.49 [0.02, 11.68] | 1 study · 82 participants | Very low Downgraded: risk of bias, imprecision |
Strokea Standard‐dose VKA plus single antiplatelet agent vs standard‐dose VKA | RR 4.45 [0.48, 41] | 1 study · 82 participants | Low Downgraded: risk of bias, imprecision |
Minor bleedingb Standard‐dose VKA plus single antiplatelet agent vs standard‐dose VKA | RR 1.29 [0.86, 1.94] | 1 study · 82 participants | Low Downgraded: risk of bias, imprecision |
Adverse events Standard‐dose VKA plus single antiplatelet agent vs standard‐dose VKA | no estimate extracted | NR | No studies |
Standard‐dose VKA plus single antiplatelet agent versus single antiplatelet agent
Population: people with antiphospholipid syndrome, with previous stroke
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Major bleeding (minor cerebral hemorrhage) Standard‐dose VKA plus single antiplatelet agent vs single antiplatelet agent | RR 0.4 [0.02, 8.78] | 1 study · 20 participants | Very low Downgraded: risk of bias, imprecision |
Stroke Standard‐dose VKA plus single antiplatelet agent vs single antiplatelet agent | RR 0.14 [0.01, 2.6] | 1 study · 40 participants | Very low Downgraded: risk of bias, imprecision |
Any bleeding that does not meet criteria for major bleeding ‐ Gastrointestinal bleeding (no definition) Standard‐dose VKA plus single antiplatelet agent vs single antiplatelet agent | RR 3.6 [0.16, 79.01] | 1 study · 20 participants | Very low Downgraded: risk of bias, imprecision |
Standard‐dose VKA plus single antiplatelet agent versus dual antiplatelet agent
Population: people with antiphospholipid syndrome, with previous stroke
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Stroke Standard‐dose VKA plus single antiplatelet agent vs dual antiplatelet agent | RR 5 [0.26, 98] | 1 study · 40 participants | Very low Downgraded: risk of bias, imprecision |
Dual antiplatelet agent versus single antiplatelet agent
Population: people with antiphospholipid syndrome, with previous stroke
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Stroke Dual antiplatelet agent vs single antiplatelet agent | RR 0.14 [0.01, 2.6] | 1 study · 40 participants | Very low Downgraded: risk of bias, imprecision |
Anticoagulant drugs: VKA high dose versus standard VKA therapy
Population: people with antiphospholipid syndrome and a history of stroke or thromboembolic events
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Any thromboembolic event Anticoagulant drugs: VKA high dose vs standard VKA therapy | RR 2.22 [0.79, 6.23] | 2 studies · 223 participants | Low Downgraded: risk of bias, imprecision |
Major bleeding Anticoagulant drugs: VKA high dose vs standard VKA therapy | RR 0.74 [0.24, 2.25] | 2 studies · 223 participants | Low Downgraded: risk of bias, imprecision |
Death (any cause)c Anticoagulant drugs: VKA high dose vs standard VKA therapy | RR 1.53 [0.27, 8.79] | 2 studies · 223 participants | Low Downgraded: risk of bias, imprecision |
Strokec Anticoagulant drugs: VKA high dose vs standard VKA therapy | RR 1.37 [0.26, 7.12] | 2 studies · 223 participants | Low Downgraded: risk of bias, imprecision |
Any bleedingd Anticoagulant drugs: VKA high dose vs standard VKA therapy | RR 1.56 [0.93, 2.62] | 2 studies · 223 participants | Low Downgraded: risk of bias, imprecision |
Adverse events Anticoagulant drugs: VKA high dose vs standard VKA therapy | no estimate extracted | NR | No studies |
Novel oral anticoagulant (NOAC) versus standard VKA therapy
Population: people with antiphospholipid syndrome and a history of stroke or thromboembolic events
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Any thromboembolic Novel oral anticoagulant (NOAC) vs standard VKA therapy | no estimate extracted | 1 study · 115 participants | Low |
Major bleeding Novel oral anticoagulant (NOAC) vs standard VKA therapy | no estimate extracted | 1 study · 115 participants | Low |
Death (any cause)b Novel oral anticoagulant (NOAC) vs standard VKA therapy | RR 0.34 [0.01, 8.15] | 1 study · 115 participants | Low Downgraded: imprecision |
Strokeb Novel oral anticoagulant (NOAC) vs standard VKA therapy | no estimate extracted | 1 study · 115 participants | Low |
Quality of life ‐ Health stated (100 mm VAS) Novel oral anticoagulant (NOAC) vs standard VKA therapy | no estimate extracted | 1 study · 112 participants | Low Downgraded: risk of bias, imprecision |
Clinically relevant non‐major bleeding Novel oral anticoagulant (NOAC) vs standard VKA therapy | RR 1.45 [0.25, 8.33] | 1 study · 112 participants | Moderate Downgraded: imprecision |
Adverse events Novel oral anticoagulant (NOAC) vs standard VKA therapy | no estimate extracted | NR | No studies |
VKA plus antiplatelet agents (VKA + AP)versus single antiplatelet agent
Population: people with antiphospholipid syndrome, with previous stroke
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Stroke | RR 0.14 [0.01, 2.6] | 1 study · 40 participants | Very low Downgraded: risk of bias |
Major bleeding (minor cerebral hemorrhage) | RR 0.4 [0.02, 8.78] | 1 study · 20 participants | Very low Downgraded: risk of bias |
Any bleeding that does not meet criteria for major bleeding ‐ GI bleeding (no definition) | no estimate extracted | NR | No studies |