A pilot clinical study of adjunctive therapy with selective intracoronary hypothermia in patients with ST-segment

Yong-Sheng Wang1, Jian Zhang1, Ya-Fei Li1

  • 1Department of Cardiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.

Insights

Selective intracoronary hypothermia significantly reduced infarct size in ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PPCI). This novel approach shows promise for improving outcomes in STEMI treatment.

Area of Science:

  • Cardiology
  • Interventional Cardiology
  • Medical Technology

Background:

  • Intracoronary hypothermia, validated in humans, uses trans-coronary saline infusion to reduce infarct size in ST-segment elevation myocardial infarction (STEMI) animal models.
  • Previous studies confirmed the feasibility and safety of intracoronary hypothermia in human subjects.

Purpose of the Study:

  • To evaluate the impact of selective intracoronary hypothermia on patient outcomes.
  • To assess the efficacy of intracoronary hypothermia as an adjunctive therapy during primary percutaneous coronary intervention (PPCI) for STEMI.

Main Methods:

  • Sixty STEMI patients with TIMI flow grade 0/1 were randomized.
  • Intracoronary hypothermia was induced using 4°C saline infusion in 30 patients.
  • Infarct size (IS/myocardium at risk) was assessed via cardiac MRI at 7 days post-PPCI.

Main Results:

  • Intracoronary hypothermia was safely performed, achieving a mean distal coronary artery temperature reduction of 5.8°C without increased arrhythmia or hemodynamic instability.
  • Mean IS/MaR was significantly reduced in the hypothermia group (44.85% vs. 50.69%, P=0.022), particularly in anterior STEMI (46.12% vs. 55.27%, P=0.023).
  • No significant difference in clinical events was observed between groups at 30-day follow-up.

Conclusions:

  • Selective intracoronary hypothermia demonstrated a statistically significant reduction in infarct size when used as an adjunctive therapy to PPCI.
  • These findings highlight the potential of intracoronary hypothermia and support the need for larger, powered trials to confirm efficacy.
Abstract

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