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Bleeding and ischemic outcomes in patients treated with dual or triple antithrombotic therapy - systematic review and meta-analysis.

AIM
The combination of oral anticoagulation with a P2Y12 inhibitor and aspirin in patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) is associated with a high bleeding risk. Dual antithrombotic therapy (DAT) with omission of aspirin is a promising option to reduce bleedings, but carries a yet unknown risk of ischemic events. We therefore sought to systematically review and analyse randomized controlled trials investigating DAT versus triple antithrombotic therapy (TAT) in patients with AF following PCI and/or acute coronary syndrome (ACS).


METHODS AND RESULTS
We included 4 trials with overall 9317 patients (5039 DAT, 4278 TAT) in our analysis. DAT was associated with a significant reduction in thrombolysis in myocardial infarction (TIMI) major bleeding (HR 0.52 [95% CI 0.42 - 0.65]; p = 0.0001), while the composite trial-defined ischemic endpoint did not differ significantly between DAT and TAT (HR 0.98 [95% CI 0.79 - 1.22]; p = 0.88). There was also no difference regarding the occurrence of myocardial infarction (MI; HR 1.16 [95% CI 0.92 - 1.46]; p = 0.21) or stent thrombosis (HR 1.25 [95% CI 0.69 - 2.26]; p = 0.46). Absolute numbers for MI were 131/4278 (3.1%) with TAT and 182/5039 (3.6%) with DAT, and for stent thrombosis 32/4278 (0.75%) and 52/5039 (1%), respectively. A post-hoc power calculation based on the size and event rate of this meta-analysis revealed 80% power to detect a 37% and 100% increase in MI and stent thrombosis, respectively.


CONCLUSION
DAT significantly reduces bleedings compared to TAT and seems to have a similar effect in preventing ischemic endpoints in AF patients post PCI or ACS. Future investigations are needed to determine its applicability specifically in patients with high risk of ischemic outcomes.