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激活凝血时间指导接受经皮冠状动脉介入治疗和使用 IIb/IIIa 抑制剂的非 ST 段抬高型急性冠状动脉综合征患者的肝素剂量:对缺血和出血结局的影响:来自 TAO 试验的见解。

Activated Clotting Time to Guide Heparin Dosing in Non-ST-Segment-Elevation Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention and Treated With IIb/IIIa Inhibitors: Impact on Ischemic and Bleeding Outcomes: Insights From the TAO Trial.

机构信息

From the Department of Cardiology, CREATIF, Hôpital Lariboisière, AP-HP, Université Paris Diderot-Sorbonne Paris Cité, Inserm U-942, France (J.-G.D., P.H.).

FACT (French Alliance for Cardiovascular Trials), an F-CRIN network, DHU FIRE, Hôpital Bichat, AP-HP, Université Paris Diderot-Sorbonne Paris Cité, Inserm U-1148, France (G.D., Y.E., P.G.S.).

出版信息

Circ Cardiovasc Interv. 2018 Jun;11(6):e006084. doi: 10.1161/CIRCINTERVENTIONS.118.006084.

Abstract

BACKGROUND

Monitoring anticoagulation with activated clotting time (ACT) has been proposed to reduce ischemic or bleeding events. However, the value of using ACT to improve outcomes is uncertain. This study sought to determine the relationship between ACT and outcomes during percutaneous coronary intervention in patients with non-ST-segment-elevation acute coronary syndrome (NSTE-ACS) treated by unfractionated heparin with GPIs (glycoprotein IIb/IIIa inhibitors).

METHODS AND RESULTS

From the randomized TAO trial (Treatment of Acute Coronary Syndromes With Otamixaban), we analyzed the value of ACT to predict ischemic and bleeding outcomes in the 3275 patients receiving unfractionated heparin plus eptifibatide. Ischemic and safety outcomes were analyzed according to ACT to determine the best threshold. Median peak ACT was 225 s. There was no correlation (=-0.02; =0.24) between the unfractionated heparin dose received and the ACT value before percutaneous coronary intervention. There was no evidence of a nonlinear association between ACT and either ischemic or bleeding events (=0.66; =0.07). No threshold was found to predict ischemic complications. Conversely, increased bleeding was observed with ACT >230 s with an optimal threshold of ACTs ≥250 s (4.53% versus 6.17%; odds ratio, 1.46; 95% confidence interval, 1.04-2.06; =0.028). This optimal threshold varied according to access site: ≥250 s (6.86% versus 10.18%; odds ratio, 1.57; 95% confidence interval, 1.00-2.45; =0.047) by femoral approach and ≥290 s (2.86% versus 5.43%; odds ratio, 2.24; 95% confidence interval, 1.05-4.44; =0.027) by radial approach.

CONCLUSIONS

In the TAO trial, peak procedural ACT ≥250 s was associated with increased bleeding risk in non-ST-segment-elevation acute coronary syndrome patients treated with unfractionated heparin plus GPIs. This threshold was increased to 290 s when performing radial approach.

CLINICAL TRIAL REGISTRATION

URL: https://www.clinicaltrials.gov. Unique identifier: NCT01076764.

摘要

背景

监测激活凝血时间(ACT)以减少缺血或出血事件已被提议。然而,使用 ACT 改善结果的价值尚不确定。本研究旨在确定非 ST 段抬高急性冠状动脉综合征(NSTE-ACS)患者经未分级肝素联合糖蛋白 IIb/IIIa 抑制剂(GPI)行经皮冠状动脉介入治疗时 ACT 与结果之间的关系。

方法和结果

来自随机 TAO 试验(Otamixaban 治疗急性冠状动脉综合征),我们分析了在接受未分级肝素加依替巴肽的 3275 例患者中,ACT 预测缺血和出血结果的价值。根据 ACT 分析缺血和安全性结果,以确定最佳阈值。中位峰值 ACT 为 225 s。接受的未分级肝素剂量与经皮冠状动脉介入治疗前的 ACT 值之间没有相关性(=-0.02;=0.24)。ACT 与缺血或出血事件之间没有证据表明存在非线性关联(=0.66;=0.07)。没有发现预测缺血并发症的阈值。相反,ACT >230 s 时观察到出血增加,最佳 ACT 阈值为≥250 s(4.53%比 6.17%;比值比,1.46;95%置信区间,1.04-2.06;=0.028)。这个最佳阈值根据入路而变化:股动脉入路时≥250 s(6.86%比 10.18%;比值比,1.57;95%置信区间,1.00-2.45;=0.047),桡动脉入路时≥290 s(2.86%比 5.43%;比值比,2.24;95%置信区间,1.05-4.44;=0.027)。

结论

在 TAO 试验中,未分级肝素加 GPI 治疗的非 ST 段抬高急性冠状动脉综合征患者,峰值操作 ACT ≥250 s 与出血风险增加相关。当行桡动脉入路时,该阈值增加至 290 s。

临床试验注册

网址:https://www.clinicaltrials.gov。唯一标识符:NCT01076764。

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