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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.).
Insights
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.
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.
Background:
Primary percutaneous coronary intervention (pPCI) has improved clinical outcomes in patients with ST-segment-elevation myocardial infarction. However, as many as 50% of patients still have suboptimal myocardial reperfusion and experience extensive myocardial necrosis. The PiCSO-AMI-I trial (Pressure-Controlled Intermittent Coronary Sinus Occlusion-Acute Myocardial Infarction-I) evaluated whether PiCSO therapy can further reduce myocardial infarct size (IS) in patients undergoing pPCI.
Methods:
Patients with anterior ST-segment-elevation myocardial infarction and Thrombolysis in Myocardial Infarction flow 0-1 were randomized at 16 European centers to PiCSO-assisted pPCI or conventional pPCI. The PiCSO Impulse Catheter (8Fr balloon-tipped catheter) was inserted via femoral venous access after antegrade flow restoration of the culprit vessel and before proceeding with stenting. The primary end point was the difference in IS (expressed as a percentage of left ventricular mass) at 5 days by cardiac magnetic resonance. Secondary end points were the extent of microvascular obstruction and intramyocardial hemorrhage at 5 days and IS at 6 months.
Results:
Among 145 randomized patients, 72 received PiCSO-assisted pPCI and 73 conventional pPCI. No differences were observed in IS at 5 days (27.2%±12.4% versus 28.3%±11.45%; P=0.59) and 6 months (19.2%±10.1% versus 18.8%±7.7%; P=0.83), nor were differences between PiCSO-treated and control patients noted in terms of the occurrence of microvascular obstruction (67.2% versus 64.6%; P=0.85) or intramyocardial hemorrhage (55.7% versus 60%; P=0.72). The study was prematurely discontinued by the sponsor with no further clinical follow-up beyond 6 months. However, up to 6 months of PiCSO use appeared safe with no device-related adverse events.
Conclusions:
In this prematurely discontinued randomized trial, PiCSO therapy as an adjunct to pPCI did not reduce IS when compared with conventional pPCI in patients with anterior ST-segment-elevation myocardial infarction. PiCSO use was associated with increased procedural time and contrast but no increase in adverse events up to 6 months.
Registration:
URL: https://www.clinicaltrials.gov; Unique identifier: NCT03625869.
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