Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, Italy (E.D.M., F.D.S., R.O., M.F., F.P., S.S.).
Department of Neurology, ASST Cremona Hospital, Italy (B.C., V.P., L.V., A.G.).
Stroke. 2023 May;54(5):1172-1181. doi: 10.1161/STROKEAHA.122.041660. Epub 2023 Mar 23.
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.
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.
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.
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.
URL: https://www.
gov; Unique identifier: NCT05476081.
随机对照试验（RCT）证明，短期（21-90 天）双联抗血小板治疗（DAPT）可降低非心源性小卒中和高危短暂性脑缺血发作（TIA）后早期缺血性复发的风险，而不会显著增加出血风险。我们旨在了解真实世界中 DAPT 的使用情况是否与 RCT 存在差异，以及差异的程度如何。
READAPT（非心源性小卒中和高危 TIA 患者短期双联抗血小板治疗的真实世界研究）是一项前瞻性队列研究，纳入了来自意大利 51 个中心的非心源性小卒中和高危 TIA 后接受 DAPT 治疗的 >18 岁患者。该研究的随访时间为症状发作后 90 天。在本工作中，我们报告了截至 2022 年 7 月 31 日招募的患者的基线数据描述性统计数据，以及将被排除在 RCT 之外的患者比例。我们通过 χ²检验比较了分类数据。
我们评估了 1070 名患者，中位年龄为 72（四分位距，62-79）岁，大多数为白种人（1045 名；97.7%），男性为 711 名（66.4%）。在 726 名（67.9%）缺血性卒中和 344 名（32.1%）TIA 患者中，226 名（31.1%）因 NIHSS 评分>3 而不符合 RCT 纳入标准，50 名（6.9%）因 NIHSS 评分>5 而不符合 RCT 纳入标准。在 344 名（32.1%）TIA 患者中，69 名（19.7%）因年龄、血压、临床特征、TIA 持续时间、糖尿病评分<4 和 252 名（74.7%）因年龄、血压、临床特征、TIA 持续时间、糖尿病评分<6 和无症状动脉狭窄而不符合 RCT 标准。此外，144 名（13.5%）患者因血管重建手术而被排除。345 名（32.2%）患者因 DAPT 开始延迟（>24 小时）而不符合 RCT 程序；776 名（72.5%）和 676 名（63.2%）患者未服用阿司匹林和氯吡格雷负荷剂量。总体而言，84 名（7.8%）患者符合 RCT 纳入/排除标准。
真实世界中 DAPT 的使用范围比 RCT 更广。大多数患者因缺血性卒中严重程度、TIA 风险较低、DAPT 起始延迟或缺乏抗血小板负荷剂量而不符合 RCT 标准。
网址：https://www.
gov；唯一标识符：NCT05476081。
