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In vitro Assessment of Myocardial Protection following Hypothermia-Preconditioning in a Human Cardiac Myocytes Model
Published on: October 27, 2020
A randomised trial of selective intracoronary hypothermia during primary PCI
Mohamed El Farissi1, Nico H J Pijls1, Richard Good2
1Department of Cardiology, Catharina Hospital, Eindhoven, the Netherlands.
Insights
Selective intracoronary hypothermia during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) was feasible and safe. However, this method did not significantly reduce infarct size compared to standard primary PCI.
Area of Science:
- Cardiology
- Interventional Cardiology
- Cardiovascular Research
Background:
- Experimental data suggest hypothermia reduces infarct size.
- Clinical studies on intracoronary hypothermia for STEMI patients are limited.
Purpose of the Study:
- To evaluate the efficacy of selective intracoronary hypothermia during primary PCI in reducing infarct size in STEMI patients.
- To assess the safety and feasibility of this novel therapeutic approach.
Main Methods:
- A multicenter randomized controlled trial involving 200 STEMI patients.
- Patients were randomized to either selective intracoronary hypothermia plus primary PCI or primary PCI alone.
- Hypothermia was achieved using cold saline infusion via a specialized catheter, targeting 30-33°C for 7-10 minutes before and 10 minutes after reperfusion.
Main Results:
- Selective intracoronary hypothermia was successfully implemented in 94% of the targeted patients.
- A significant drop in distal coronary temperature was observed within seconds.
- No significant difference in infarct size (23.1% vs 21.6%) or left ventricular ejection fraction (49.1% vs 50.1%) was found between the hypothermia and control groups at 3 months.
Conclusions:
- Selective intracoronary hypothermia is a feasible and safe adjunctive therapy during primary PCI for anterior wall STEMI.
- The study did not demonstrate a reduction in infarct size compared to standard primary PCI.
- Further research may be needed to optimize hypothermia protocols or patient selection.
Background:
While experimental data suggest that selective intracoronary hypothermia decreases infarct size, studies in patients with ST-elevation myocardial infarction (STEMI) are lacking.
Aims:
We investigated the efficacy of selective intracoronary hypothermia during primary percutaneous coronary intervention (PCI) to decrease infarct size in patients with STEMI.
Methods:
In this multicentre randomised controlled trial, 200 patients with large anterior wall STEMI were randomised 1:1 to selective intracoronary hypothermia during primary PCI or primary PCI alone. Using an over-the-wire balloon catheter for infusion of cold saline and a pressure-temperature wire to monitor the intracoronary temperature, the anterior myocardium distal to the occlusion was selectively cooled to 30-33°C for 7-10 minutes before reperfusion (occlusion phase), immediately followed by 10 minutes of cooling after reperfusion (reperfusion phase). The primary endpoint was infarct size as a percentage of left ventricular mass on cardiovascular magnetic resonance imaging after 3 months.
Results:
Selective intracoronary hypothermia was performed in 94/100 patients randomised to cooling. Distal coronary temperature decreased by 6°C within 43 seconds (interquartile range [IQR] 18-113). The median duration of the occlusion phase and reperfusion phase were 8.2 minutes (IQR 7.2-9.0) and 9.1 minutes (IQR 8.2-10.0), respectively. The infarct size at 3 months was 23.1±12.5% in the selective intracoronary hypothermia group and 21.6±12.2% in the primary PCI alone group (p=0.43). The left ventricular ejection fraction at 3 months in each group were 49.1±10.2% and 50.1±10.4%, respectively (p=0.53).
Conclusions:
Selective intracoronary hypothermia during primary PCI in patients with anterior wall STEMI was feasible and safe but did not decrease infarct size compared with standard primary PCI. (ClinicalTrials.gov: NCT03447834).
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