PiCSO-AMI-I Study Results Presented at TCT

October 25, 2023—The first multicenter, prospective randomized trial of pressure-controlled intermittent coronary sinus occlusion (PiCSO) therapy used in conjunction with percutaneous coronary intervention (PCI) found that it did not reduce myocardial infarct size in patients with anterior ST-segment elevation myocardial infarction (STEMI).

The findings were presented at TCT 2023, the 35th annual Transcatheter Cardiovascular Therapeutics scientific symposium held October 23-26 in San Francisco, California.

According to the TCT press release, primary PCI has improved clinical outcomes in patients with STEMI; however, as many as 50% of patients still have suboptimal myocardial reperfusion and experience extensive myocardial necrosis, which adversely affects long-term clinical outcomes. Novel pharmacological and device-based therapies have been developed in the past two decades to limit infarct size in STEMI patients, many of which have been unsuccessful.

The PiCSO-AMI-I trial evaluated whether PiCSO therapy can further reduce myocardial infarct size in STEMI patients undergoing primary PCI. Miracor Medical SA, which funded the PiCSO-AMI-I study, announced the initiation and first patient enrollment in the study in July 2019.

As summarized by TCT, between July 2019 and August 2022, the study enrolled 145 patients with anterior STEMI presenting within 12 hours of symptom onset and angiography demonstrated thrombolysis in myocardial infarction (TIMI) flow 0-1 of the left anterior descending coronary artery. Patients were randomized 1:1 to PiCSO-assisted primary PCI (n = 72) or conventional primary PCI (n = 73) at 16 centers in Europe.

Miracor’s PiCSO Impulse catheter was inserted via femoral venous access after antegrade flow restoration of the culprit vessel before inserting a stent.

The primary endpoint was the difference in infarct size (expressed as a percentage of left ventricular mass) at 5 days by cardiac magnetic resonance imaging. Secondary endpoints were the extent of microvascular obstruction (MVO) and intramyocardial hemorrhage (IMH) at 5 days and infarct size at 6 months.

The study found no differences in infarct size at 5 days (27.2% ± 12.4 vs 28.3%±11.45; P = .59) or 6 months (19.2% ± 10.1 vs 18.8% ± 7.7; P = .83). In addition, there were no differences between PiCSO-treated and control patients related to the occurrence of MVO (67.2% vs 64.6%; P = .85) or IMH (55.7% vs 60%; P = .72). PiCSO use was safe with no device-related adverse events, noted the TCT press release.

“Randomized trials like PiCSO-AMI-I play a crucial role in advancing our understanding of how to minimize infarct size,” commented Giovanni Luigi De Maria, MD, in the TCT press release. “These results contribute to the ongoing body of research, offering valuable insight and stressing the importance of refining patient selection to better define the phenotype of STEMI patients who can benefit from additional therapies on top of primary PCI.”

Dr. De Maria is consultant interventional cardiologist with the Oxford Heart Centre—John Radcliffe Hospital and clinical lead with the AMIIC Catheterization Laboratory at the University of Oxford in Oxford, United Kingdom.