Miracor Medical Begins Enrollment in PiCSO-AMI-I Randomized Study in Europe

July 25, 2019—Miracor Medical SA announced the initiation and first patient enrollment in the PiCSO-AMI-I study to evaluate the benefits of pressure-controlled intermittent coronary sinus occlusion (PiCSO) therapy compared with conventional percutaneous coronary intervention (PCI) for the treatment of anterior ST-segment elevation myocardial infarction (STEMI) patients.

PiCSO-AMI-I is a prospective, randomized, double-arm, multicenter study that is designed to prove superiority of Miracor's PiCSO, as an adjunct to PCI over a conventional strategy of PCI alone, in reducing infarct size measured by cardiovascular magnetic resonance at 5 days. The study will enroll 144 patients presenting with anterior STEMI and thrombolysis in myocardial infarction (TIMI) 0 or 1 flow at up to nine clinical sites in Western Europe.

Secondary efficacy endpoints include microvascular obstruction and cardiac function (ejection fraction, left ventricular end-systolic volume, left ventricular end-diastolic volume) at 5 days and 6 months. Secondary clinical endpoints include death, heart failure–related hospitalization, and new-onset or worsening of heart failure. The clinical endpoints will be followed up annually for 3 years.

The study’s Principal Investigator, Professor Adrian Banning, MD, enrolled the first patient in the study at Oxford Heart Center in Oxford, United Kingdom. Prof. Banning commented in the company’s press release, “We are delighted to be initiating the PiCSO-AMI-I study. This study will explore the potential for PiCSO therapy to significantly improve the care of patients with larger heart attacks. My group and I have treated over 30 patients with the PiCSO therapy, and we are excited to start this important randomized study, which builds on the existing registry data. Improving outcomes for patients with large heart attacks is an important challenge and an important unmet need currently. With this trial, we hope to help define the long-term impact and benefits of the PiCSO therapy.”

According to the company, PiCSO therapy has shown positive results in several clinical studies. Data from two recent studies (PiCSO in ACS and OxAMI-PICSO) showed that use of the PiCSO Impulse system is associated with a significant infarct size reduction. Furthermore, OxAMI-PICSO showed an early improvement of coronary microvascular function post-PiCSO treatment.

Miracor Medical’s PiCSO Impulse system is a coronary sinus intervention designed to reduce infarct size, improve cardiac function, and potentially reduce the onset of heart failure after acute myocardial infarction. The company advised that PiCSO therapy accelerates the microcirculatory recovery, resulting in significantly lower index of microcirculatory resistance at 24 to 48 hours when compared with controls leading to overall infarct size reduction. PiCSO therapy is provided during PCI in patients with acute myocardial infarct to clear the coronary microcirculation by intermittently occluding the coronary sinus outflow, resulting in improved perfusion of the infarcted area. The device is not commercially available, noted Miracor.