Felice Gragnano (Inselspital, Bern University Hospital, Bern, Switzerland) outlined at PCR e-Course 2020 the initial results with the CoFlo system (CorFlow Therapeutics). He explained that the system was “safe, easy to use”, follows percutaneous coronary intervention (PCI) workflow and “may allow the detection and, therefore, directly address microvascular obstruction after primary PCI”.
According to Gragnano, microvascular obstruction is a “major prognostic determinant” after ST-segment elevation myocardial infarction (STEMI) and its prompt diagnosis and treatment “could potentially improve outcomes”. “However, the diagnosis of microvascular obstruction in the cath lab remains difficult, limited by the lack of validated diagnostic algorithms,” he said.
Therefore, the aim of the multicentre MOCA I trial is to provide first-in-human safety and efficacy data for the CorFlow controlled flow infusion (CoFl) system in diagnosing microvascular obstruction in STEMI patients undergoing primary PCI. The system, Gragnano observed, consists of a console and a catheter. A CorFlow Therapeutics press release adds that it measures dynamic microvascular resistance to “differentiate between patients with and without microvascular obstruction after stent implantation in patients with acute myocardial infarction”.
Gragnano told the online audience of PCR eCourse that the study team had been planning to present the first 20 cases with the system. However, because of the COVID-19 pandemic, the MOCA I trial was temporarily halted and, therefore, they could only present the first 10 cases. He added that the safety objective as to assess the rate of device- or procedure-related adverse events at 30 days and the efficacy objective was to look at the correlation between dynamic microvascular resistance (as measured with the CoFl system) and microvascular obstruction (as measured with cardiac magnetic resonance imaging [MRI]) at three days’ post PCI.
There were no device- or procedure-related events in either the phase 1 cohort (non-ST acute coronary events) or phase 2 cohort (STEMI), and the rate of diagnostic success was 100%. Furthermore, there was good correlation between the CoFl measurements and cardiac MRI measurements of microvascular resistance.
“The use of CoFl system may allow the detection and, therefore, directly address microvascular obstruction after primary PCI,” Gragnano concluded. The CorFlow Therapeutics press release notes: “In patients with substantial microvascular impairment, the CoFI system also allows for controlled delivery of intra-coronary therapeutic agents and monitoring the treatment effect before the patients leave the cathlab.”
Study investigator Marco Valgimigli (Cardiocentro Ticino, Lugano and Department of Cardiology, Bern University Hospital, Bern, Switzerland) told Cardiovascular News: “The data that were presented by Dr Gragnano are preliminary and not conclusive regarding the safety and efficacy of CorFlow technology. We first need to conclusively ascertain whether this technology allows quantifying microvascular obstruction, which remains unclear for the moment based on the limited number of patients investigated. Second, we would need to assess whether levering on this technology, dedicated drug-based intervention could mitigate the occurrence of microvascular obstruction. Finally, we would need to assess whether Corflow technology can inform on the efficacy of any drug-based intervention directly in the cath lab.”