Miracor Medical launches the 2nd randomized study, targeting expanded indications. 300 patients were treated with PiCSO®
The principal investigator of the study is Professor Adrian BanningOxford Heart Center, Oxford, United Kingdom. “We are pleased to initiate the PiCSO-AMI-V study. He will explore the potential of PiCSO therapy to improve outcomes for patients with heart attacks affecting the lower side of the heart. The study builds on data from the First-In-Man study that we published in 20213. We know that improving outcomes for patients with major heart attacks remains a significant unmet need, particularly because these patients often progress to heart failure.“says Professor Banning.
PICSO-AMI-V is a prospective, randomized, multicenter feasibility study that will enroll 75 lower STEMI patients with TIMI 0 and 1 flow, in up to 10 clinical sites in Europe. In the study, patients will be randomized 2:1 to a group receiving PiCSO as an adjunct to their primary PCI procedure versus a conventional strategy of primary PCI alone. The adverse device event (ADE) rate 30 days after the indexing procedure will be assessed as the primary endpoint. In addition, cardiac function and clinical safety endpoints – including death, heart failure-related hospitalization, new or worsening heart failure – will be assessed. Patients will be followed for 1 year.
PiCSO therapy has demonstrated positive results in several clinical studies. Data from two recent studies (“PiCSO in ACS” and “OxAMI-PICSO”) have shown that use of the PiCSO Impulse System is associated with a significant reduction in infarct size in prior STEMI patients 1.2. In addition, OxAMI-PICSO3 showed early improvement in coronary microvascular function after PiCSO treatment in anterior and inferior STEMI patients. PiCSO therapy accelerates microcirculatory recovery, resulting in a significant reduction in MRI (microcirculatory resistance index) and RRR (resistive reserve ratio) after the procedure compared to controls.
“We are excited to begin this second randomized clinical trial in Europe, and to advance our strategy to expand indications beyond our initial anterior STEMI indication. The PiCSO-AMI-V Inferior STEMI study will complement the ongoing PiCSO-AMI-I (Anterior STEMI) study, which has enrolled over 100 prior STEMI patients and is expected to complete enrollment in the second half of this year. We also recently processed the 300and patient with PiCSO therapy, illustrating acceleration of use and therapy experience,” said Olivier DelporteCEO of Miracor Medical.
PiCSO therapy is used during the primary PCI procedure in acute myocardial infarction (AMI). Through its unique differentiated mechanism of action, the PiCSO Impulse System clears coronary microcirculation by intermittently obstructing coronary sinus outflow. Use of the PiCSO Impulse System has been associated with a reduction in infarct size after STEMI, leading to reduced heart failure hospitalizations and reduced mortality4. Heart failure develops in 18-28% of patients 90 days after their STEMI 5.
The PiCSO-AMI-V Inferior STEMI study is partially funded by a recoverable cash advance granted by the Walloon Region to Miracor Medical.
About Miracor Medical
Miracor Medical (www.miracormedical.com), located in Awans, Belgiumprovides innovative solutions for the treatment of serious heart disease, aimed at improving short- and long-term clinical outcomes and reducing associated costs.
Miracor Medical is developing the PiCSO Impulse System, the first and only coronary sinus intervention designed to reduce infarct size, improve heart function and potentially reduce the onset of heart failure after acute myocardial infarction.
NOTE: The PiCSO® Impulse System is commercially available for prior STEMI patients in the EU, UK and EFTA. It is not commercially available for lower STEMI patients.
1 DeMaria, et al. (2018). Microcirculatory resistance-guided therapy index with pressure-controlled intermittent coronary sinus occlusion improves coronary microvascular function and reduces infarct size in patients with ST-segment elevation myocardial infarction: the Oxford study Acute Myocardial Infarction – Pressure-pressed Intermittent Coronary Sinus Occlusion (OxAMI-PICSO study). EuroIntervention 2018;14(3):e352-e359
2 Edred, et al. (2020). Effect of pressure-controlled intermittent coronary sinus occlusion (PiCSO) on infarct size in the prior STEMI study: PiCSO in the ACS study. Int J Cardiol Heart Vasc, 28, 100526. https://doi.org/10.1016/j.ijcha.2020.100526
3Scarsini, et.all. (2021), Acute myocardial infarction from Oxford, S., Kharbanda, R., Ferreira, VM, Channon, KM, De Maria, GL and Banning, AP (2021). Intermittent pressure-controlled coronary sinus occlusion improves microvascular vasodilator capacity and reduces myocardial damage in patients with STEMI. Catheter Cardiovasc Interv, Epub ahead of print (doi:10.1002/ccd.29793). https://doi.org/10.1002/ccd.29793
4 Peter, et al. (2016). Relationship between infarct size and outcome after primary PCI: patient-level analysis from 10 randomized trials. J Am Coll Cardiol. 2016 Apr 12, 67(14), 1674-1683.
5 Cahill, et al. (2017). Heart failure after myocardial infarction in the era of primary percutaneous coronary intervention: mechanisms, incidence and identification of patients at risk. World J Cardiol. 2017 May 26;9(5), 407-415.
SOURCE Miracor Medical SA
For more information: Olivier Delporte, CEO, Miracor Medical SA, [email protected]