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Pressure-Controlled Intermittent Coronary Sinus Occlusion (PiCSO) in Acute Myocardial Infarction: The PiCSO-AMI-I

Giovanni Luigi De Maria1,2, John P Greenwood3, Azfar G Zaman4

  • 1Oxford Heart Centre, Oxford University Hospitals NHS Trust, United Kingdom (G.L.D.M., A.P.B.).

Circulation. Cardiovascular Interventions
|April 16, 2024
PubMed
Summary

Pressure-Controlled Intermittent Coronary Sinus Occlusion (PiCSO) therapy did not reduce infarct size in ST-elevation myocardial infarction patients undergoing primary percutaneous coronary intervention. The trial found no significant differences in key outcomes, though PiCSO therapy was safe up to six months.

Keywords:
ST elevation myocardial infarctioncoronary sinuspercutaneous coronary intervention

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Area of Science:

  • Cardiology
  • Interventional Cardiology
  • Biomedical Engineering

Background:

  • Primary percutaneous coronary intervention (pPCI) improves outcomes for ST-elevation myocardial infarction (STEMI) but often results in suboptimal reperfusion and significant myocardial necrosis.
  • The PiCSO-AMI-I trial investigated whether Pressure-Controlled Intermittent Coronary Sinus Occlusion (PiCSO) therapy could further minimize infarct size (IS) in STEMI patients undergoing pPCI.

Purpose of the Study:

  • To evaluate the efficacy of PiCSO therapy as an adjunct to pPCI in reducing myocardial infarct size in patients with anterior STEMI.
  • To assess secondary endpoints including microvascular obstruction and intramyocardial hemorrhage.

Main Methods:

  • A randomized trial involving 145 anterior STEMI patients with Thrombolysis in Myocardial Infarction flow 0-1 at 16 European centers.
  • Patients received either PiCSO-assisted pPCI or conventional pPCI, with the PiCSO Impulse Catheter inserted after antegrade flow restoration and before stenting.
  • The primary endpoint was the difference in IS at 5 days, assessed by cardiac magnetic resonance; secondary endpoints included IS at 6 months, microvascular obstruction, and intramyocardial hemorrhage.

Main Results:

  • No significant difference in IS at 5 days (27.2%±12.4% vs. 28.3%±11.45%; P=0.59) or 6 months (19.2%±10.1% vs. 18.8%±7.7%; P=0.83) between PiCSO and conventional pPCI groups.
  • Microvascular obstruction (67.2% vs. 64.6%; P=0.85) and intramyocardial hemorrhage (55.7% vs. 60%; P=0.72) also showed no significant differences.
  • PiCSO therapy was associated with increased procedural time and contrast use but demonstrated safety with no device-related adverse events up to 6 months.

Conclusions:

  • PiCSO therapy, as an adjunct to pPCI, did not reduce myocardial infarct size in anterior STEMI patients compared to conventional pPCI.
  • The trial was prematurely discontinued by the sponsor.
  • Despite not meeting its primary endpoint, PiCSO use up to 6 months appeared safe.