Cardiology Department, Ferrarotto Hospital, University of Catania, Catania, Italy.
J Cardiovasc Med (Hagerstown). 2010 Feb;11(2):130-6. doi: 10.2459/JCM.0b013e32832e0ae1.
Prompt reperfusion with percutaneous coronary intervention (PCI) in the setting of acute coronary syndromes (ACS) improves clinical outcomes through salvage of myocardial tissue. Although use of intracoronary glycoprotein IIb/IIIa inhibition with PCI can result in improved rates of normal epicardial flow and myocardial perfusion, several unmet needs remain. The purpose of this trial is to evaluate the efficacy and safety of an intracoronary bolus of abciximab delivered using the ClearWayRX Therapeutic Perfusion Catheter followed by a dosing regimen of intravenous abciximab infusion after PCI, compared with intracoronary abciximab infusion, via the guiding catheter, followed by a dosing regimen of intravenous abciximab infusion after PCI in patients with ACS.
Patients with ACS (either unstable angina/non-ST-elevation myocardial infarction or ST-elevation myocardial infarction with open infarct-related artery) and visible thrombus referred for PCI will be randomized to receive one of the two treatment regimens: local intracoronary infusion of abciximab through the ClearWayRX System or intracoronary infusion of abciximab via the guiding catheter. Both groups will receive intravenous infusion of abciximab during the 12-h period following the procedure. Optical coherence tomography assessment will be performed prior to abciximab administration and after the intracoronary infusions to document the change in the thrombus score. In addition, postintervention assessments of coronary microcirculatory function will be evaluated by means of the corrected thrombolysis in myocardial infarction frame count flow and the 'myocardial blush grade'.
If local intracoronary infusion of abciximab through the ClearWayRX System significantly reduces thrombus burden, it will lend support to the use of this delivery system as a valuable tool in patients with ACS treated with PCI.
在急性冠脉综合征（ACS）的情况下，经皮冠状动脉介入治疗（PCI）的即刻再灌注可通过挽救心肌组织来改善临床结果。虽然 PCI 中使用冠状动脉内糖蛋白 IIb/IIIa 抑制剂可提高正常心外膜血流和心肌灌注率，但仍存在一些未满足的需求。本试验旨在评估经 ClearWayRX 治疗性灌注导管行冠状动脉内阿昔单抗推注联合 PCI 后静脉阿昔单抗输注与经指引导管行冠状动脉内阿昔单抗输注联合 PCI 后静脉阿昔单抗输注对 ACS 患者的疗效和安全性。
将 ACS（不稳定型心绞痛/非 ST 段抬高型心肌梗死或 ST 段抬高型心肌梗死伴梗死相关动脉开通）且需要 PCI 的患者随机分为接受以下两种治疗方案之一：通过 ClearWayRX 系统行局部冠状动脉内阿昔单抗输注或经指引导管行冠状动脉内阿昔单抗输注。两组患者在术后 12 小时内均接受静脉阿昔单抗输注。在给予阿昔单抗前和冠状动脉内输注后进行光学相干断层扫描评估，以记录血栓评分的变化。此外，还将通过校正的心肌梗死溶栓帧数计数血流和“心肌灌注分级”评估冠状动脉微循环功能的术后评估。
如果通过 ClearWayRX 系统行冠状动脉内局部阿昔单抗输注能显著降低血栓负荷，将支持将该输送系统作为 ACS 患者接受 PCI 治疗的有价值工具。
