Safety and Efficacy of Different Antithrombotic Regimens in Patients with Atrial Fibrillation after Percutaneous Coronary Intervention

Analyzed Data

Out of a total of 1448 papers found in the PubMed, EMBASE, EBSCO, and Cochrane databases, 4 studies were included in the meta-analysis (WOEST, PIONEER AF-PCI, RE-DUAL PCI, and AUGUSTUS) comparing different antithrombotic regimens. The inclusion criteria were as follows:

• randomized controlled trial with at least 2 arms
• study population of patients with ACS or post-PCI for stable ischemic heart disease or ACS
• combination of anticoagulant and antiplatelet therapy
• monitoring of major bleeding and major adverse cardiovascular events (MACE = cardiovascular death, myocardial infarction, CVS, or stent thrombosis)
• monitoring duration of at least 6 months

The selected studies were conducted in Europe or North America, published between 2013 and 2019, involving a total of 10,026 patients (smallest study with 563, largest 4614 subjects; 20−29% women; average age 70−72 years) monitored for 6−14 months, with ACS prevalence between 28 and 61%. Common comorbidities included hypertension, dyslipidemia, and diabetes mellitus. Most patients had a CHA₂DS₂-VASc score of ≥ 3 for assessing the risk of thromboembolic complications in atrial fibrillation.

Four antithrombotic regimens were compared:

1. vitamin K antagonists (VKA) + dual antiplatelet therapy (DAPT = aspirin + P2Y₁₂ receptor antagonist, primarily clopidogrel)
2. VKA + P2Y₁₂ receptor antagonist
3. novel oral anticoagulants (NOACs: apixaban, dabigatran, and rivaroxaban) + DAPT
4. NOAC + P2Y₁₂ receptor antagonist

In all four studies, the safety and efficacy of the VKA + DAPT combination were monitored, setting this regimen as the reference.

Results

For major bleeding according to TIMI criteria (Thrombolysis in Myocardial Infarction), the odds ratio (OR) compared to the VKA + DAPT regimen was 0.58 (95% confidence interval [CI] 0.31−1.08) for the VKA + P2Y₁₂ antagonist regimen, OR 0.49 (95% CI 0.30−0.82) for NOAC + P2Y₁₂ antagonist, and OR 0.70 (95% CI 0.38−1.23) for NOAC + DAPT.

Compared to the VKA + DAPT regimen, the odds ratio for major adverse cardiovascular events (MACE) was 0.96 (95% CI 0.60−1.46) for the VKA + P2Y₁₂ antagonist regimen, OR 1.02 (95% CI 0.71−1.47) for NOAC + P2Y₁₂ inhibitor, and OR 0.94 (95% CI 0.60−1.45) for NOAC + DAPT.

Conclusion

The antithrombotic regimen NOAC + P2Y₁₂ antagonist is associated with a significantly lower risk of bleeding compared to the VKA + DAPT regimen, with no significant difference in efficacy. Therefore, the combination of NOAC + P2Y₁₂ antagonist should be the preferred antithrombotic regimen in high-risk patients with AF post-percutaneous coronary intervention. On the other hand, the VKA + DAPT regimen should be avoided due to a higher risk of bleeding complications.

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Source: Lopes R. D., Hong H., Harskamp E. E. et al. Safety and efficacy of antithrombotic strategies in patients with atrial fibrillation undergoing percutaneous coronary intervention. JAMA Cardiol 2019; 4 (8): 747−755, doi: 10.1001/jamacardio.2019.1880.