Divergence Between Clinical Trial Evidence and Actual Practice in Use of Dual Antiplatelet Therapy After Transient Ischemic Attack and Minor Stroke

Abstract

BACKGROUND: Randomized controlled trials (RCTs) proved that short-term (21–90 days) dual antiplatelet therapy (DAPT) reduces the risk of early ischemic recurrences after a noncardioembolic minor stroke or high-risk transient ischemic attack (TIA) without substantially increasing the hemorrhagic risk. We aimed at understanding whether and how real-world use of DAPT differs from RCTs. METHODS: READAPT (Real-Life Study on Short-Term Dual Antiplatelet Treatment in Patients With Ischemic Stroke or TIA) is a prospective cohort study including >18-year-old patients treated with DAPT after a noncardioembolic minor ischemic stroke or high-risk TIA from 51 Italian centers. The study comprises a 90-day follow-up from symptom onset. In the present work, we reported descriptive statistics of baseline data of patients recruited up to July 31, 2022, and proportions of patients who would have been excluded from RCTs. We compared categorical data through the χ² test. RESULTS: We evaluated 1070 patients, who had 72 (interquartile range, 62–79) years median age, were mostly Caucasian (1045; 97.7%), and were men (711; 66.4%). Among the 726 (67.9%) patients with ischemic stroke, 226 (31.1%) did not meet the RCT inclusion criteria because of National Institutes of Health Stroke Scale score >3 and 50 (6.9%) because of National Institutes of Health Stroke Scale score >5. Among the 344 (32.1%) patients with TIA, 69 (19.7%) did not meet the RCT criteria because of age, blood pressure, clinical features, duration of TIA, presence of diabetes score <4 and 252 (74.7%) because of age, blood pressure, clinical features, duration of TIA, presence of diabetes score <6 and no symptomatic arterial stenosis. Additionally, 144 (13.5%) patients would have been excluded because of revascularization procedures. Three hundred forty-five patients (32.2%) did not follow the RCT procedures because of late (>24 hours) DAPT initiation; 776 (72.5%) and 676 (63.2%) patients did not take loading doses of aspirin and clopidogrel, respectively. Overall, 84 (7.8%) patients met the RCT inclusion/exclusion criteria. CONCLUSIONS: The real-world use of DAPT is broader than RCTs. Most patients did not meet the RCT criteria because of the severity of ischemic stroke, lower risk of TIA, late DAPT start, or lack of antiplatelet loading dose. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT05476081.

A REAl-life study on short-term Dual Antiplatelet treatment in Patients with ischemic stroke or Transient ischemic attack (READAPT)

“…Study methodology has been previously reported 13 and is briefly summarized in the following S3) have enrolled all consecutive patients treated with DAPT. The enrolment closed on 28 th February 2023.…”

“…Study methodology has been previously reported 13 and is briefly summarized in the following sections. READAPT (NCT05476081) is an observational prospective multicenter real-world study, which included a baseline observation (i.e.…”

“…Data were entered in an electronic anonymized database created with the Research Electronic Data Capture (REDCap) software 22,23 hosted at University of L’Aquila. The study staff of the leading center remotely monitored progress and ensured integrity of data collection and completeness of follow-up through regular data quality checks as previously reported 13 . The investigators of the leading center – University of L’Aquila – had full access to all the data and take responsibility for its integrity and data analysis.…”

“…Despite real-world cohort studies showed that DAPT use has increased since the publication of the RCTs 10 , around half of the eligible patients do not receive the treatment yet 11,12 and there are disparities in treatment prescription – female gender, ethnicity, and cause of the index event are among the factors associated with lack of DAPT prescription 10 . Conversely, physicians occasionally prescribe DAPT to patients with non-minor stroke 11,13 or who do not follow RCTs procedure 13 . A previous analysis of A REAl-life study on short-term Dual Antiplatelet treatment in patients with ischemic stroke or Transient ischemic attack (READAPT) study showed that only 8% of patients treated with DAPT in Italian stroke centers would have met RCTs inclusion criteria and followed their procedures 13 .…”

“…Conversely, physicians occasionally prescribe DAPT to patients with non-minor stroke 11,13 or who do not follow RCTs procedure 13 . A previous analysis of A REAl-life study on short-term Dual Antiplatelet treatment in patients with ischemic stroke or Transient ischemic attack (READAPT) study showed that only 8% of patients treated with DAPT in Italian stroke centers would have met RCTs inclusion criteria and followed their procedures 13 . Benefit/risk profile of DAPT in these patients had not been assessed yet.…”