Background: In patients with atrial fibrillation (AF) who undergo percutaneous coronary intervention (PCI), dual antithrombotic therapy (DAT) with a direct oral anticoagulant (DOAC) and a P2Y12 inhibitor has largely replaced triple therapy as the initial antithrombotic strategy to reduce the risk of bleeding. However, the ideal duration of DAT is unknown, and guidelines provide a wide range of acceptable treatment intervals (1–6 months), resulting in significant variability in clinical practice.
Objectives: To evaluate and compare 1-month versus 3-month DOAC-based DAT regimens in patients with AF who undergo PCI for major adverse cardiovascular events (MACE) and safety outcomes.
Methods: This systematic review and meta-analysis were performed in accordance with PRISMA guidelines. PubMed, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), and ClinicalTrials.gov databases were systematically searched from database inception through January 2025 for randomized controlled trials (RCTs) and high-quality observational cohort studies. The primary outcome measures were major bleeding (ISTH or BARC definitions 3-5) and MACE (cardiovascular death, myocardial infarction, or ischemic stroke). Study data were pooled using random-effects models to produce risk ratios (RR) with 95% confidence intervals (CI). The quality of evidence was graded using the GRADE approach.
Results: A total of nine studies (4 RCTs and 5 observational cohort studies) that contained a total of 10,842 patients were included in this meta-analysis. Compared with a 3-month DAT regimen, a 1-month regimen was associated with a significantly lower incidence of major bleeding (RR 0.64, 95% CI 0.52–0.78; I²=32%) without an increase in MACE (RR 1.03, 95% CI 0.88–1.21; I²=25%) or all-cause mortality (RR 0.98, 95% CI 0.81–1.19). Stent thrombosis was rare and exhibited similar rates between the 2 treatment strategies (RR 1.15, 95% CI 0.75–1.76). The net clinical benefit of a 1-month DAT regimen versus a 3-month DAT regimen was highest in patients who exhibited a high risk of bleeding (HAS-BLED ≥3) and did not differ significantly in RCT-restricted sensitivity analyses.
Conclusions: In patients with atrial fibrillation who undergo percutaneous coronary intervention, a 1-month DOAC-based DAT regimen is associated with a reduction in major bleeding events without an increase in ischemic events. These findings indicate that a strategy of routine transition to oral anticoagulation monotherapy (vs DAT) should be implemented for the majority of patients being treated with this approach; however, treatments should be individualized (i.e., allow for the prolongation of DAT treatment duration in patients exhibiting a high risk of myocardial ischemia). Prospective clinical trials are needed to clarify the individual factors that may influence the choice of treatment duration.
To be updated shortly..
Copyright 2024 Mathews International LLC All Rights Reserved