Background
Proper antithrombotic management of patients with AF and ACS is challenging. The current ESC guidelines in
2014 recommend ‘triple therapy’ with OAC plus aspirin and clopidogrel for 1 or 6 months titrated to double therapy
for 6 or 11 months. The effectiveness and safety of double therapy with rivaroxaban plus clopidogrel for 12 months
are uncertain in such scenario.
Methods
Single-center non randomized prospective trial enrolled 100 participants with AF who had UA/NSTEMI treated either
medically or underwent PCI. Fifty patients received rivaroxaban 20mg once daily plus clopidogrel (75mg) for
12 months (group:1). Another 50 patients received triple then double therapy of dose-adjusted vitamin K antagonist
plus (clopidogrel and aspirin) according to ESC guidelines up to 12 months (group:2). The primary outcome
was the combination of minor and major non CABG TIMI bleeding up to 12 months. The secondary outcomes were
major adverse cardiovascular events (cardiac mortality, non fatal MI, stent thrombosis or stroke).
Results
Rates of both minor and major bleeding were lower in Group:1 (Rivaroxaban plus clopidogrel) but with no significant
differences (OR=0.73 [95% CI=0.73to1.4]; NNT=12.5; P=0.58). RRR of bleeding rates in the rivaroxaban group
was (25 to 27%). The composite rates of MACCE showed no significant differences in both groups (36% vs 30%,
OR=1.14 [95% CI=0.6to2.0]; P=0.652). In subgroup analysis, patients in group:1 who treated with PCI had lower
rates of non fatal MI and definite stent thrombosis in comparison to group:2 (RRR=16%; P=0.63).
Conclusion
Rivaroxaban (20 mg OD) plus clopidogrel (75 mg) for 12 months was safe and effective in participants with AF and
UA who treated medically or PCI. We recommend this regimen over standard triple therapy with a dose-adjusted
vitamin K antagonist. This regimen provide better adherence and advantage that patients do not need to switch
from triple to dual therapy. |
