Abstract

BACKGROUND:

Assessment of platelet inhibition for aspirin therapy is important to manage patients who are at potential risk of developing thrombotic and hemorrhagic complications.

OBJECTIVE:

This study aimed to evaluate a new platelet assay (Anysis-Aspirin), compare it with VerifyNow-Aspirin in patients with cardiac diseases, and analyze the aspirin resistance rates between the two devices.

METHODS:

Citrated blood samples were collected from patients with cardiac diseases referred for the aspirin response test. In the Anysis assay, a test result was provided with a blood flow migration distance (MD) until blood flow stoppage, which was comparable to aspirin reaction units (ARUs) obtained using VerifyNow. The measurements were simultaneously conducted using the two devices and compared.

RESULTS:

The MD without and with aspirin use was 160±33 and 254±23 mm, respectively (p < 0.0001). Compared with VerifyNow (reference), the sensitivity and specificity of Anysis-200 were 96.3 and 90.3%, respectively (area under the curve, 0.968). Furthermore, the aspirin resistance rate in aspirin-administered patients was 20.9%using VerifyNow and 16.5%for Anysis-200. The Cohen’s kappa coefficient between the two devices was 0.81, indicating an almost perfect agreement between the two devices.

CONCLUSIONS:

Anysis-Aspirin, a novel aspirin assay for assessing platelet inhibition, showed excellent agreement with VerifyNow-Aspirin with high accuracy and precision. The Anysis-aspirin assay would be used as a point-of-care test to assess aspirin non-responsiveness and abnormal platelet reactivity.

中文翻译：

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Anysis和verifynow之间阿司匹林测定的性能比较：评估心脏病患者的治疗性血小板抑制

摘要

背景：

阿司匹林治疗中血小板抑制的评估对于管理有发生血栓和出血并发症潜在风险的患者很重要。

客观的：

本研究旨在评估一种新的血小板检测（Anysis-Aspirin），将其与 VerifyNow-Aspirin 进行比较，并分析两种设备之间的阿司匹林耐药率。

方法：

从患有心脏病的患者身上收集柠檬酸盐样本，用于阿司匹林反应测试。在 Anysis 测定中，测试结果提供了直到血流停止的血流迁移距离 (MD)，这与使用 VerifyNow 获得的阿司匹林反应单位 (ARU) 相当。使用两种设备同时进行测量并进行比较。

结果：

未使用和使用阿司匹林的 MD 分别为 160±33 和 254±23 mm ( p  < 0.0001)。与VerifyNow（参考）相比，Anysis-200的敏感性和特异性分别为96.3%和90.3%（曲线下面积，0.968）。此外，使用 VerifyNow 和 Anysis-200，服用阿司匹林的患者的阿司匹林耐药率为 20.9% 和 16.5%。两个设备之间的 Cohen's kappa 系数为 0.81，表明两个设备之间几乎完全吻合。

结论：

Anysis-Aspirin 是一种用于评估血小板抑制的新型阿司匹林检测方法，它与 VerifyNow-Aspirin 具有很高的准确性和精确度。Anysis-阿司匹林测定将用作即时检验，以评估阿司匹林无反应性和异常血小板反应性。