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Real-World Dual Antiplatelet Therapy Use Exceeds Randomized Trials Boundaries With Possible Safety Issues in Patients
Eleonora De Matteis1, Federico De Santis2, Matteo Foschi2
1Department of Brain Sciences, Imperial College London, London, UK.
Insights
Real-world dual antiplatelet therapy (DAPT) in patients with large artery atherosclerosis (LAA) stroke showed similar effectiveness but higher bleeding risks compared to randomized trials. Extended DAPT duration and specific patient factors increased bleeding events.
Area of Science:
- Cardiology
- Neurology
- Clinical Trials
Background:
- Randomized controlled trials (RCTs) suggest dual antiplatelet therapy (DAPT) is highly effective for secondary prevention in large artery atherosclerosis (LAA).
- Real-world data is crucial to assess if DAPT effectiveness and safety differ in routine clinical practice.
Purpose of the Study:
- To evaluate the effectiveness and safety of short-term DAPT in patients with ischemic stroke or transient ischemic attack (TIA) in a real-world setting.
- To compare outcomes between patients with and without LAA and explore factors influencing DAPT effectiveness and safety.
Main Methods:
- Observational, multicenter study (READAPT) of patients with minor ischemic stroke or TIA on short-term DAPT.
- Primary outcomes assessed at 90 days: ischemic recurrence, severe bleeding, vascular death, and severe-to-moderate bleeding.
- Cox regression analysis explored associations between LAA and outcomes, with subgroup analyses based on clinical and imaging characteristics.
Main Results:
- 452 out of 1920 analyzed patients had LAA; 21.2% had NIHSS > 5, and 48.2% received DAPT > 30 days, exceeding RCT parameters.
- Patients with LAA exhibited higher bleeding rates (3.5% vs. 2.1%) primarily due to hemorrhagic infarctions and moderate bleeding.
- Despite increased bleeding, primary effectiveness outcomes were similar between LAA and non-LAA groups (4.9% vs. 3.5%).
Conclusions:
- Real-world DAPT application in LAA patients deviates from RCT protocols, potentially compromising treatment safety.
- Prolonged DAPT (>21 days), multiple MRI lesions, older age (≥65), and loading doses were associated with increased bleeding risk in LAA patients.
Background And Aim:
According to randomized controlled trials (RCTs), dual antiplatelet therapy (DAPT) is more effective for secondary prevention of ischemic events attributable to large artery atherosclerosis (LAA) than other mechanisms. We investigated whether real-world application may impact DAPT effectiveness and safety in the REAl-life study on short-term Dual Antiplatelet treatment in Patients with ischemic stroke or Transient ischemic attack (READAPT, NCT05476081).
Methods:
READAPT was an observational multicenter study including patients with minor ischemic stroke or TIA treated with short-term DAPT. At 90 days, we assessed primary effectiveness (ischemic recurrence, severe bleeding, or vascular death) and safety (severe to moderate bleeding) outcomes. We explored associations between LAA and outcomes using Cox regression. Within patients with and without LAA, outcomes were compared between subgroups based on age, NIHSS score (for ischemic stroke patients), ABCD2 score (for TIA patients), presence and number of MRI acute lesions, and DAPT regimen characteristics.
Results:
Among 1920 analyzed patients (of 2278 enrolled), 452 had LAA. Unlike RCTs, 21.2% of patients with LAA had NIHSS > 5, and 48.2% received DAPT > 30 days. Patients with LAA had higher bleeding rates (3.5% vs. 2.1%, p = 0.004), primarily hemorrhagic infarctions and moderate bleeding, than those without LAA. However, primary effectiveness outcomes were similar (4.9% vs. 3.5%, p = 0.201) between the groups. In patients with LAA, prolonged DAPT (> 21 days), multiple MRI lesions, age ≥ 65, and loading doses increased bleeding risk.
Conclusions:
The real-world DAPT use in patients with LAA exceeds RCTs boundaries with possible drawbacks on treatment safety.
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