Abstract
Background
Anticoagulant treatment is recommended in patients with thrombosis and antiphospholipid
syndrome (APS). Conflicting results have been reported on the role of direct oral
anticoagulants (DOACs) in these patients. We performed a meta-analysis of randomized
controlled trials (RCTs) focused on this issue.
Methods
We searched MEDLINE and EMBASE for RCTs comparing DOACs and vitamin K antagonists
(VKAs) for secondary thromboprophylaxis in patients with thrombotic APS. The primary
objective was to assess the efficacy of DOACs compared to VKAs to prevent recurrence
of thromboembolic events. Risk difference (RD) was reported as weighted RD according
to Mantel-Haenszel random-effect method.
Results
Three RCTs (426 patients) were included, all comparing rivaroxaban with VKAs. The
proportion of recurrences (either arterial or venous) was higher among rivaroxaban
patients when compared with those receiving VKAs (9.5% vs 2.8%; RD 6%, 95% CI, -0.05
– 0.18, p=0.29), although non-statistically significant. In patients with an arterial
index event, thromboembolic recurrences were more frequent in those treated with rivaroxaban
compared to those treated with VKAs (25% vs 6.2%; RD 19%, 95% CI, 0.04 – 0.33; p =0.01;
I2 49%). In triple aPL positive patients, rivaroxaban showed higher rates of thromboembolic
recurrences compared with VKAs (12% vs 3%; RD 9%, 95% CI, 0.02 – 0.15; p= 0.01; I2 13%). Non-statistically significant differences were observed in major bleeding events
or mortality.
Conclusions
The use of rivaroxaban in APS patients is associated with an increased rate of thromboembolic
recurrences compared to VKAs, at least in those with arterial index event or triple
aPL positivity.
Keywords
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Article info
Publication history
Published online: May 29, 2020
Accepted:
May 6,
2020
Received in revised form:
May 3,
2020
Received:
January 11,
2020
Identification
Copyright
© 2020 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.
