Individualized treatment optimization is needed for the prevention of stroke in patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) who require oral anticoagulation (OAC) medications, according to a review published in Clinical Research in Cardiology.
OACs are often prescribed to patients with AF to reduce the risk for stroke. However, PCI procedures increase the risk for bleeding, and OACs are inefficient for the prevention of stent thrombosis after PCI. In 5 recent studies, the effectiveness of alternative therapies for the prevention of clinically relevant nonmajor bleeding was examined in patients with AF requiring PCI.
In the WOEST study (ClinicalTrials.gov Identifier: NCT00769938; n=573), the percentage of participants experiencing major bleeding was lower for those treated with a dual therapy of OAC with clopidogrel and a loading dose of acetylsalicylic acid (ASA; 19.4%) compared with patients treated with a triple therapy of vitamin K antagonists (VKA), clopidogrel, and ASA (44.4%).
In the PIONEER AF-PCI trial (ClinicalTrials.gov Identifier: NCT01830543; n=2124), patients on a triple therapy (VKA, a P2Y12 inhibitor, and ASA) had more bleeding (26.7%) compared with those on an alternative triple therapy (rivaroxaban, a P2Y12 inhibitor, and ASA; 18.0%) or a dual therapy (rivaroxaban and a P2Y12 inhibitor; 16.8%) during the year following PCI. Strokes increased by 0.3% in the VKA triple therapy group, by 1.4% in the rivaroxaban triple therapy group, and by 1.5% in the dual therapy group.
In the RE-DUAL PCI trial (ClinicalTrials.gov Identifier: NCT02164864; n=2725), lower bleeding within 1 year of PCI was reported for patients on a dual therapy of dabigatran and a P2Y12 inhibitor (15.4%) compared with the triple therapy of VKA, ASA, and a P2Y12 inhibitor (26.9%). However, patients on dual vs triple therapy had higher rates of stroke (1.7% vs 1.3%, respectively), myocardial infarction (4.5% vs 3.0%, respectively ), stent thrombosis (1.5% vs 0.8%, respectively ), and death (5.6% vs 4.9%, respectively).
In the AUGUSTUS trial (ClinicalTrials.gov Identifier: NCT02415400; n=4614), 10.5% of participants on apixaban with OAC had a significant bleed with 6 months of PCI compared with 14.7% of patients on VKA and OAC. All patients were randomly assigned to receive ASA or a placebo. Bleeding occurred in 16.1% of patients treated with ASA compared with 9.0% of placebo recipients. Ischemic events were not meaningfully higher in the apixaban vs placebo group.
The ENTRUST-AF PCI trial (ClinicalTrials.gov Identifier: NCT02866175; n=1506), significant bleed within 1 year of PCI occurred in 25.6% of participants on a triple therapy of VKA, a P2Y12 inhibitor, and ASA compared with 20.7% of participants on a dual therapy of edoxaban and a P2Y12 inhibitor. Ischemic and embolic events occurred within 1 year of PCI in 6.9% and 7.3% of participants assigned the triple and dual therapy, respectively.
“In general the available data from all studies suggest that bleeding can be lowered significantly by reducing the intensity of anti-thrombotic treatment,” concluded the review authors. “In patients [who have undergone PCI for] AF as an indication for OAC, [novel] OACs in the same dose as approved for stroke prevention have shown the most reliable protection regarding stroke prevention and coronary ischemia.”
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Schäfer A, Flier U, and Bauersachs J. Anti‑thrombotic strategies in patients with atrial fibrillation undergoing PCI. [Published online July 21, 2020] Clin Res Cardiol. doi:10.1007/s00392-020-01708-8