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Updated: Oct 13, 2025

The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
Network meta-analysis and trial sequential analysis for atrial fibrillation patients receiving PCI or with ACS
Shu-Mei Yang1, Chi-Jung Huang1, Chen-Huan Chen2,3,4,5
1Center for Evidence-based Medicine, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.
Insights
Novel oral anticoagulants plus a P2Y12 inhibitor reduce bleeding risk in atrial fibrillation (AF) patients post-PCI or with ACS. However, this strategy shows a numerically higher risk of stent thrombosis and myocardial infarction, suggesting triple therapy remains an option.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Antithrombotic treatment selection is complex for patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) or with acute coronary syndrome (ACS).
- Optimizing antithrombotic therapy balances efficacy and safety in this high-risk population.
Purpose of the Study:
- To compare the efficacy and safety of different antithrombotic strategies in patients with AF following PCI or ACS.
- To evaluate novel oral anticoagulants (NOACs) combined with P2Y12 inhibitors against traditional therapies.
Main Methods:
- A systematic review and network meta-analysis of randomized controlled trials were conducted.
- Five studies involving 11,532 patients were analyzed.
- Trial sequential analysis (TSA) assessed the reliability of findings regarding dual versus triple antithrombotic therapy.
Main Results:
- Novel oral anticoagulant (NOAC) + P2Y12 inhibitor demonstrated a significantly better primary safety outcome compared to vitamin K antagonist + dual antiplatelet therapy (OR: 0.53; 95% CI, 0.31-0.90).
- This NOAC combination showed the lowest probability of major bleeding and intracranial hemorrhage.
- In patients not on aspirin, TSA indicated conclusive evidence for reduced safety outcomes but inconclusive evidence for increased stent thrombosis and myocardial infarction risks.
Conclusions:
- NOAC + P2Y12 inhibitor offers the lowest bleeding risk for AF patients undergoing PCI or with ACS.
- A statistically nonsignificant, numerically higher risk of stent thrombosis and myocardial infarction was observed with this strategy.
- Triple antithrombotic therapy should remain a consideration for patients at high risk of stent thrombosis or myocardial infarction.
Background:
In patients with atrial fibrillation (AF) and acute coronary syndrome (ACS) or undergoing percutaneous coronary intervention (PCI), choosing the most appropriate antithrombotic treatment remains a dilemma. We aimed to compare the relative efficacy and safety outcomes of antithrombotic drugs in patients with AF after undergoing PCI or ACS.
Methods:
Randomized controlled trials were systematically searched on PubMed, EMBASE, and the Cochrane Library. Five studies (11,532 patients) were included in the network meta-analysis. Trial sequential analysis (TSA) was performed to assess the reliability and conclusiveness of the meta-analysis comparing the dual antithrombotic therapy strategies with the triple antithrombotic therapy strategy.
Results:
Compared with vitamin K antagonist + dual antiplatelet therapy, novel oral anticoagulant (NOAC) + P2Y12 inhibitor was associated with a significantly better trial-defined primary safety outcome (odds ratio: 0.53; 95% CI, 0.31-0.90) and the lowest probability of thrombolysis in myocardial infarction major bleeding and intracranial hemorrhage using the cumulative ranking technique. In patients omitting aspirin, TSA demonstrated conclusive evidence with significant decreases in all safety outcomes and inconclusive evidence with a nonsignificant increase in in-stent thrombosis (risk ratio: 1.32; TSA-adjusted 95% CI, 0.54-3.24) and myocardial infarction (risk ratio: 1.19; TSA-adjusted 95% CI, 0.84-1.68).
Conclusions:
In patients with AF receiving PCI or with ACS, NOAC + P2Y12 inhibitor was associated with the lowest bleeding risk but resulted in a statistically nonsignificant, numerically greater risk for stent thrombosis and myocardial infarction, suggesting that triple antithrombotic therapy should still be an option for certain patients at a high risk of stent thrombosis or myocardial infarction.
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