WHY THIS STUDY?

Modern primary PCI (PPCI) STEMI treatment is effective in restoring epicardial flow. However microvascular obstruction (MVO) is present in nearly 60% of cases where PPCI fails to achieve effective myocardial reperfusion. As a result, 1 in 5 anterior STEMI patients return with heart failure (HF) and mortality rates remain close to 10% at 1 year. Although these outcomes are closely related to infarct size (IS), recent research shows that MVO has greater prognostic value for adverse outcomes. The gold standard for MVO detection is cardiac MRI (CMRI), which is not routinely utilized and is not performed early in the management of STEMI. No direct measurement of MVO in the catheterization laboratory is routinely implemented in patients with anterior STEMI. The MOCA I first in human study evaluates the safety and feasibility of a novel real-time catheter-based system to detect MVO immediately after PPCI, with the capability to timely deliver therapeutic intracoronary agents. If successful, this study and system could enable novel diagnostic and therapeutic opportunities.

HOW WAS IT EXECUTED?

MOCA I is enrolling anterior STEMI patients undergoing PPCI within 6 hours from symptom onset. After PPCI, the Controlled Flow Infusion (CoFI) balloon catheter is positioned over a pressure guidewire within the stent. The diagnostic procedure is performed by occluding the infarct vessel during controlled, distal infusion of Ringer?s Lactate, while simultaneously measuring back pressure over 1 minute via a new console and software. Data post-processing is performed to determine a novel pressure parameter (PCoFI) for diagnosis of MVO. All patients undergo CMRI 3-5 days after PPCI for detection of the myocardium affected by a deficit of perfusion despite culprit vessel recanalization.

WHAT WERE THE ESSENTIAL RESULTS?

The CoFI device and procedure were shown safe with no device related death, flow limiting dissection or thrombotic events at 30 days as adjudicated by an independent clinical events committee with a diagnostic procedural success rate of 94%. Among the total population with complete data sets (27 patients), in 17 patients (63%) MVO was detected at CMRI. Patients with MVO in CMRI had increased PCoFI compared with patients without MVO (142.6 ± 18.1mmHg vs 114.2 ± 8.8 mmHg, p<0.001). An ROC analysis was performed to identify the optimal PCoFI value for identification of MVO, with a sensitivity = 94.1%, specificity = 90.0%, accuracy 92.6%, and AUC = 0.94, for a threshold of 121.5 mmHg (p<0.001). Infarct size and area at risk were numerically increased in patients with PCoFI ? 121.5 mmHg than in those with PCoFI < 121.5 mmHg (15.9% ± 7.7% vs 9.0% ± 12.4% for IS and 41% ± 7.6% vs 31.6% ± 18.0% for area at risk respectively, both p=0.08). The trial is ongoing and additional data will be provided at a later stage.

WHY IT IS IMPORTANT?

Accurate MVO diagnosis will substantially improve stratification of patients for adjunctive therapies immediately following PCI, when salvage of myocardium might still be possible, as well as administration of targeted medical therapy. Previous studies have shown that early MVO and microvascular dysfunction diagnosis can improve outcomes, and this study may lead to significant advances in the field for patients at highest risk. Existing and emerging MVO therapies - both interventional and pharmacologic - can have dramatically better efficacy if patients are targeted with early diagnosis. 

PLEASE LIST THE DEVICE(S)/TECHNOLOGY(IES) INVOLVED IN THIS TRIAL

CorFlow Therapeutics AG Controlled Flow Infusion Rapid Exchange Catheter Controlled Flow Infusion Minimal Viable Clinical Console