Objectives

The aim of this study was to determine the safety of selective intracoronary hypothermia during primary percutaneous coronary intervention (PPCI) in patients with anterior ST-segment elevation myocardial infarction (STEMI).

Background

Selective intracoronary hypothermia is a novel treatment designed to reduce myocardial reperfusion injury and is currently being investigated in the ongoing randomized controlled EURO-ICE (European Intracoronary Cooling Evaluation in Patients With ST-Elevation Myocardial Infarction) trial (NCT03447834). Data on the safety of such a procedure during PPCI are still limited.

Methods

The first 50 patients with anterior STEMI treated with selective intracoronary hypothermia during PPCI were included in this analysis and compared for safety with the first 50 patients randomized to the control group undergoing standard PPCI. In-hospital mortality, occurrence of rhythm or conduction disturbances, stent thrombosis, onset of heart failure during the procedure, and subsequent hospital admission were assessed.

Results

In-hospital mortality was 0%. One patient in both groups developed cardiogenic shock. Atrial fibrillation occurred in 0 and 3 patients (P = 0.24), and ventricular fibrillation occurred in 5 and 3 patients (P = 0.72) in the intracoronary hypothermia group and control group, respectively. Stent thrombosis occurred in 2 patients in the intracoronary hypothermia group; 1 instance was intraprocedural, and the other occurred following interruption of dual-antiplatelet therapy consequent to an intracranial hemorrhage 6 days after enrollment. No stent thrombosis was observed in the control group (P = 0.50).

Conclusions

Selective intracoronary hypothermia during PPCI in patients with anterior STEMI can be implemented within the routine of PPCI and seems to be safe. The final safety results will be reported at the end of the trial.

中文翻译：

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前部 STEMI 患者初次经皮冠状动脉介入治疗期间选择性冠状动脉内低温的安全性

目标

本研究的目的是确定前 ST 段抬高型心肌梗死 (STEMI) 患者初次经皮冠状动脉介入治疗 (PPCI) 期间选择性冠状动脉内低温的安全性。

背景

选择性冠状动脉内低温疗法是一种旨在减少心肌再灌注损伤的新型治疗方法，目前正在开展的随机对照 EURO-ICE（欧洲 ST 段抬高心肌梗死患者的冠状动脉内冷却评估）试验 (NCT03447834) 中进行研究。PPCI 期间此类程序的安全性数据仍然有限。

方法

在 PPCI 期间接受选择性冠状动脉内低温治疗的前 50 名前部 STEMI 患者被纳入该分析，并与前 50 名随机分配到接受标准 PPCI 的对照组的患者进行安全性比较。评估了住院死亡率、节律或传导障碍的发生、支架血栓形成、手术过程中心力衰竭的发作以及随后的入院情况。

结果

住院死亡率为0%。两组中的一名患者出现心源性休克。 冠状动脉低温组和对照组分别发生房颤0例和3例（P  =0.24），发生室颤5例和3例（P =0.72）。冠脉低温组2例患者发生支架血栓；1 例发生在术中，另一例发生在入组后 6 天因颅内出血而中断双联抗血小板治疗后。对照组未见支架内血栓形成（P  =0.50）。

结论

前部 STEMI 患者 PPCI 期间的选择性冠状动脉内低温可在 PPCI 常规中实施，并且似乎是安全的。最终的安全性结果将在试验结束时报告。