Results Presented and Published From OxAMI-PiCSO Study
June 4, 2018—Miracor Medical SA recently announced that the clinical results from the physician-sponsored Oxford Acute Myocardial Infarction–Pressure-Controlled Intermittent Coronary Sinus Occlusion (OxAMI-PiCSO) study were presented by Giovanni Luigi De Maria, MD, at the EuroPCR conference held May 22–25 in Paris, France. The study was simultaneously published online by Dr. De Maria et al in EuroIntervention. Dr. De Maria is with the Heart Center at Oxford University Hospitals in Oxford, United Kingdom, where the study was conducted.
OxAMI-PiCSO evaluated Miracor's PiCSO Impulse system, which is a coronary sinus intervention device designed to reduce infarct size, improve cardiac function, and potentially reduce the onset of heart failure in patients with ST-segment elevated myocardial infarction (STEMI).
PiCSO therapy is provided during the stenting procedure of patients experiencing acute myocardial infarction (AMI) and intermittently increases pressure in the coronary venous system, which is intended to improve microcirculatory flow and improve perfusion of the infarcted area, resulting in smaller residual infarct size after AMI compared to non-PiCSO treated patients. The PiCSO Impulse system is not commercially available, advised Miracor.
According to the company, the results support the use of the PiCSO system, which led to a significantly smaller residual infarct size after AMI. The company noted that decreased infarct size after AMI has been shown to directly correlate with reduced mortality and hospitalizations for heart failure.
Additional results from the PiCSO in acute coronary syndrome study were presented at EuroPCR by Mohaned Egred, MD, of Freeman Hospital in Newcastle upon Tyne, United Kingdom. The data show that PiCSO-treated patients have a statistically smaller infarct size compared with a group of propensity score–matched control patients.
Professor Adrian Banning, MD, who is Chief Investigator of the ongoing OxAMI-PiCSO study, commented in the company's press release, “These positive results show promise that the PiCSO system can be used safely and effectively as an adjunctive therapy during primary [percutaneous coronary intervention]." Prof. Banning added, "Results demonstrating PiCSO’s ability to reduce myocardial injury for STEMI patients is noticed at 24-hours postprocedure with the index of microvascular resistance technique. This therapy has the potential to change my practice for STEMI patients.”