Abiomed Begins RECOVER IV RCT of Impella Device for AMI Cardiogenic Shock

November 27, 2023—Abiomed, part of Johnson & Johnson MedTech, announced the first patient has been enrolled in the company’s landmark RECOVER IV randomized controlled trial (RCT). The first patient was enrolled by interventional cardiologist Mark Bieniarz, MD at New Mexico Heart Institute in Albuquerque, New Mexico. Dr. Bieniarz is the Principal Investigator for RECOVER IV.

According to Abiomed, the on-label, two-arm RECOVER IV randomized trial will randomize 548 patients to assess whether Abiomed’s Impella support before percutaneous coronary intervention (PCI) is superior to PCI without Impella in patients with acute myocardial infarction (AMI) cardiogenic shock.

The primary endpoint of RECOVER IV is all-cause mortality at 30 days. Secondary endpoints include major adverse cardiovascular and cerebrovascular events at 30 days, days alive out of the hospital at 6 months, recovery of left ventricular (LV) function, need for durable ventricular assist device or heart transplant, and health-related quality of life as measured by responses to the Kansas City Cardiomyopathy Questionnaire at 1 year. Abiomed’s goal in conducting the RECOVER IV RCT is to achieve AMI cardiogenic shock Class I guideline recommendations for Impella use in AMI cardiogenic shock.

The company noted that RECOVER IV is using the FDA exception from informed consent (EFIC) protocol, an emergency research regulation. It has been difficult to study AMI cardiogenic shock patients because these patients are often too sick to provide consent. Emergency research regulations require study investigators to consult and disclose information about the study with representatives from the community where the research will take place. EFIC allows for patients to be enrolled before obtaining traditional consent.

“We are thrilled to be the first site to enroll a patient into the historic RECOVER IV trial,” said Dr. Bieniarz. “The EFIC process provides us a pathway to successfully enroll patients and compare outcomes in patients who receive Impella support for acute myocardial infarction cardiogenic shock and those patients who do not receive Impella support for the same condition.”

Abiomed advised that the Impella mechanical circulatory support device for the treatment of AMI cardiogenic shock has received premarket approval from the FDA. Multiples studies, including the Inova study, the National Cardiogenic Shock Initiative study, and the Japanese J-PVAD study, have demonstrated significant improvement in AMI cardiogenic shock survival rates when Impella and best practices are implemented, including the use of Impella before PCI and identifying shock early.“Fifteen years of clinical studies have helped us establish best practices and shown that Impella increases survival and heart recovery in AMI cardiogenic shock patients,” stated Abiomed’s Chief Medical Officer Chuck Simonton, MD, in the press release. “The design of RECOVER IV, which incorporates those best practices, is intended to further validate the benefits of Impella utilization in AMI cardiogenic shock patients and provide evidence to achieve a Class 1 guideline recommendation.”

More information about RECOVER IV is available on Abiomed’s Heart Recovery trials page here.