A REAl-life study on short-term Dual Antiplatelet treatment in Patients with ischemic stroke or Transient ischemic attack (READAPT)
Abstract Background and purpose Clinical trials proved the efficacy of short-term dual antiplatelet therapy (DAPT) in secondary prevention of minor ischemic stroke or high-risk transient ischemic attack (TIA). In clinical practice, the use of short-term DAPT is broader than in clinical trials and procedures of clinical trials (i.e. loading dose, timely treatment start) are not always followed. We aimed at evaluating effectiveness and safety of short-term DAPT in real-world.Methods READAPT (A REAl-life study on short-term Dual Antiplatelet treatment in Patients with ischemic stroke or Transient ischemic attack) (<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" xlink:href="NCT05476081">NCT05476081</jats:ext-link>) was an observational multicenter real-world study with a 90-day follow-up. The enrollment closed on 28thFebruary 2023. We included patients aged 18+ receiving DAPT after minor ischemic stroke or high-risk TIA but no stringent exclusion criteria were applied regarding stroke severity and ABCD2score. Primary effectiveness outcome was stroke (ischemic or hemorrhagic) or death due to vascular causes, primary safety outcome was moderate-to-severe bleeding. Key secondary outcomes were the type of ischemic and hemorrhagic events, disability, cause of death, and compliance to treatment.Results We included 1920 patients; the majority started DAPT after an ischemic stroke (69.9%) rather than a TIA. Primary effectiveness outcome occurred in 3.9% and primary safety outcome in 0.6% of cases. In total, 3.3% cerebrovascular ischemic recurrences occurred, 0.2% intracerebral hemorrhages, and 2.7% bleedings; 0.2% of patients died due to vascular causes. We compared different subgroups of patients and we found significant differences among patients with NIHSS score ≤5 and those without acute lesions at neuroimaging who had higher primary effectiveness outcomes than their counterparts. Additionally, DAPT start after 24 hours from symptom onset was associated with a lower likelihood of bleeding.Conclusions Short-term DAPT after ischemic stroke or TIA is effective and safe in real-world where a broader population receives the treatment and procedures may differ from clinical trials..
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Preprint| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
bioRxiv.org - (2024) vom: 13. Jan. Zur Gesamtaufnahme - year:2024 |
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| Sprache: |
Englisch |
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| Links: |
Volltext [kostenfrei] |
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| doi: |
10.1101/2024.01.08.24301025 |
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| PPN (Katalog-ID): |
XBI042140943 |
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| 100 | 1 | |a De Matteis, Eleonora |e verfasserin |0 (orcid)0000-0003-3468-3412 |4 aut | |
| 245 | 1 | 0 | |a A REAl-life study on short-term Dual Antiplatelet treatment in Patients with ischemic stroke or Transient ischemic attack (READAPT) |
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| 520 | |a Abstract Background and purpose Clinical trials proved the efficacy of short-term dual antiplatelet therapy (DAPT) in secondary prevention of minor ischemic stroke or high-risk transient ischemic attack (TIA). In clinical practice, the use of short-term DAPT is broader than in clinical trials and procedures of clinical trials (i.e. loading dose, timely treatment start) are not always followed. We aimed at evaluating effectiveness and safety of short-term DAPT in real-world.Methods READAPT (A REAl-life study on short-term Dual Antiplatelet treatment in Patients with ischemic stroke or Transient ischemic attack) (<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" xlink:href="NCT05476081">NCT05476081</jats:ext-link>) was an observational multicenter real-world study with a 90-day follow-up. The enrollment closed on 28thFebruary 2023. We included patients aged 18+ receiving DAPT after minor ischemic stroke or high-risk TIA but no stringent exclusion criteria were applied regarding stroke severity and ABCD2score. Primary effectiveness outcome was stroke (ischemic or hemorrhagic) or death due to vascular causes, primary safety outcome was moderate-to-severe bleeding. Key secondary outcomes were the type of ischemic and hemorrhagic events, disability, cause of death, and compliance to treatment.Results We included 1920 patients; the majority started DAPT after an ischemic stroke (69.9%) rather than a TIA. Primary effectiveness outcome occurred in 3.9% and primary safety outcome in 0.6% of cases. In total, 3.3% cerebrovascular ischemic recurrences occurred, 0.2% intracerebral hemorrhages, and 2.7% bleedings; 0.2% of patients died due to vascular causes. We compared different subgroups of patients and we found significant differences among patients with NIHSS score ≤5 and those without acute lesions at neuroimaging who had higher primary effectiveness outcomes than their counterparts. Additionally, DAPT start after 24 hours from symptom onset was associated with a lower likelihood of bleeding.Conclusions Short-term DAPT after ischemic stroke or TIA is effective and safe in real-world where a broader population receives the treatment and procedures may differ from clinical trials. | ||
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