急性冠状动脉综合征患者行全剂量或低剂量比伐芦定术后输注。

Post-Procedural Bivalirudin Infusion at Full or Low Regimen in Patients With Acute Coronary Syndrome.

机构信息

Department of Cardiology, Bern University Hospital, Bern, Switzerland; Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy.

Advice Pharma Group, Milan, Italy.

出版信息

J Am Coll Cardiol. 2019 Feb 26;73(7):758-774. doi: 10.1016/j.jacc.2018.12.023.

DOI:10.1016/j.jacc.2018.12.023

PMID:30784669

Abstract

BACKGROUND

The value of prolonged bivalirudin infusion after percutaneous coronary intervention (PCI) in acute coronary syndrome (ACS) patients with or without ST-segment elevation remains unclear.

OBJECTIVES

The purpose of this study was to assess efficacy and safety of a full or low post-PCI bivalirudin regimen in ACS patients with or without ST-segment elevation.

METHODS

The MATRIX program assigned bivalirudin to patients without or with a post-PCI infusion at either a full (1.75 mg/kg/h for ≤4 h) or reduced (0.25 mg/kg/h for ≤6 h) regimen at the operator's discretion. The primary endpoint was the 30-day composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events (composite of all-cause death, myocardial infarction, or stroke, or major bleeding).

RESULTS

Among 3,610 patients assigned to bivalirudin, 1,799 were randomized to receive and 1,811 not to receive a post-PCI bivalirudin infusion. Post-PCI full bivalirudin was administered in 612 (ST-segment elevation myocardial infarction [STEMI], n = 399; non-ST-segment elevation acute coronary syndromes [NSTE-ACS], n = 213), whereas the low-dose regimen was administered in 1,068 (STEMI, n = 519; NSTE-ACS, n = 549) patients. The primary outcome did not differ in STEMI or NSTE-ACS patients who received or did not receive post-PCI bivalirudin. However, full compared with low bivalirudin regimen remained associated with a significant reduction of the primary endpoint after multivariable (rate ratio: 0.21; 95% CI: 0.12 to 0.35; p < 0.001) or propensity score (rate ratio: 0.16; 95% CI: 0.09 to 0.26; p < 0.001) adjustment. Full post-PCI bivalirudin was associated with improved outcomes consistently across ACS types compared with the no post-PCI infusion or heparin groups.

CONCLUSIONS

In ACS patients with or without ST-segment elevation, the primary endpoint did not differ with or without post-PCI bivalirudin infusion but a post-PCI full dose was associated with improved outcomes when compared with no or low-dose post-PCI infusion or heparin (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX [MATRIX]; NCT01433627).

摘要

背景

急性冠状动脉综合征（ACS）患者经皮冠状动脉介入治疗（PCI）后延长比伐卢定输注的价值，无论是否存在 ST 段抬高，均不明确。

目的

本研究旨在评估 ACS 患者（无论是否存在 ST 段抬高）接受全剂量或低剂量 PCI 后比伐卢定治疗方案的疗效和安全性。

方法

MATRIX 研究方案根据医生的判断，将比伐卢定分配给无或有 PCI 后输注的患者，输注方案分别为全剂量（1.75 mg/kg/h 输注≤4 h）或低剂量（0.25 mg/kg/h 输注≤6 h）。主要终点为 30 天内紧急靶血管血运重建、明确的支架血栓形成或净临床不良事件（包括全因死亡、心肌梗死或卒中，或大出血）的复合终点。

结果

在 3610 例接受比伐卢定治疗的患者中，1799 例随机接受 PCI 后比伐卢定输注，1811 例未接受。612 例（ST 段抬高型心肌梗死 [STEMI]，n=399；非 ST 段抬高型急性冠状动脉综合征 [NSTE-ACS]，n=213）患者接受了 PCI 后的全剂量比伐卢定治疗，1068 例（STEMI，n=519；NSTE-ACS，n=549）患者接受了低剂量方案。接受或不接受 PCI 后比伐卢定输注的 STEMI 或 NSTE-ACS 患者的主要结局无差异。然而，多变量（率比：0.21；95%置信区间：0.12 至 0.35；p<0.001）或倾向评分（率比：0.16；95%置信区间：0.09 至 0.26；p<0.001）调整后，全剂量比伐卢定方案与低剂量比伐卢定方案相比，仍与主要终点显著降低相关。与无 PCI 后输注或肝素组相比，全剂量 PCI 后比伐卢定输注在各种 ACS 类型中均能改善结局。

结论

在 STEMI 或 NSTE-ACS 患者中，无论是否存在 ST 段抬高，PCI 后是否输注比伐卢定与主要终点无关，但与无或低剂量 PCI 后输注或肝素相比，全剂量 PCI 后输注比伐卢定与改善结局相关（经桡动脉入路最小化不良出血事件和系统应用 angioX[MATRIX]；NCT01433627）。