SCAI Announces Publication of SAFE-MCS Study’s Design and Rationale

July 5, 2023—The Society for Cardiovascular Angiography and Interventions (SCAI) announced the publication of the design and rationale of the SAFE-MCS study by Philippe Généreux, MD, et al online in the JSCAI.

Dr. Généreux and Babar Basir, DO, are Coprincipal Investigators of the study. Dr. Généreux is from Gagnon Cardiovascular Institute at Morristown Medical Center, New Jersey. Dr. Basir is Director of Acute Mechanical Circulatory Support at Henry Ford Health System in Detroit, Michigan.

According to SCAI, the multicenter, single-arm, open-label SAFE-MCS study will exclusively assess bleeding complications in patients undergoing high-risk percutaneous coronary interventions (PCI) using the Impella heart pump (Abiomed, part of Johnson & Johnson MedTech) with mechanical circulatory support (MCS) and surveillance using the Early Bird bleed monitoring system (Saranas, Inc.). The study will gather meaningful real-world data based on contemporary practice.

The SAFE-MCS study is funded by Saranas. Independent adjudication will be conducted by a clinical events adjudication committee from the Cardiovascular Research Foundation. Medical Metrics is the independent imaging core laboratory.

Saranas’ Early Bird system includes a bleed detection array with integrated electrodes in a fully functional vascular access sheath. It is designed to measure changes in bioimpedance to detect and monitor bleeding from vessel injury.

SCAI advised that the SAFE-MCS study will enroll a total of 184 evaluable patients at up to 15 centers in the United States. Evaluable patients are defined as all participants who had the Early Bird system placed ipsilateral to MCS and had post-procedure monitoring with Early Bird for a minimum of 2 hours.

The study’s primary clinical endpoint is the incidence of access site-related Bleeding Academic Research Consortium (BARC) type III or V bleeding. Secondary clinical endpoints include the incidence of each Saranas Early Bird system level 1, 2, and 3 indicators, and the incidence of all BARC type III or V bleeding.

In addition to the main clinical study, data from SAFE-MCS will be used to perform an economic analysis of the potential economic benefit of the Saranas Early Bird system.

“SAFE-MCS is the first study dedicated to evaluating bleeding events post-Impella use and will bring meaningful important insight on the rates of bleeding events during those procedures,” commented Dr. Généreux in the SCAI press release. “While most of the studies on MCS devices focus on efficacy outcomes, SAFE-MCS focuses on safety and risk mitigation, and outcomes which are very important for patients, caregivers, and the healthcare system in general.”

Dr. Généreux also noted that although this study focuses on stable patients undergoing high-risk PCI, the role of early bleeding detection is even more important in an emergency such as cardiogenic shock, ST-elevated myocardial infarction, and during extracorporeal membrane oxygenation initiation.

Dr. Basir added, “Timely identification of bleeding events is crucial in preventing adverse events that can have serious consequences for patients. The data from SAFE-MCS will provide meaningful guidance on how real-time monitoring can improve clinical outcomes through a proactive approach to managing bleeding risk.”

SCAI stated that the SAFE-MCS study is anticipated to complete enrollment by the end of 2023. In March 2023, Saranas announced that the SAFE-MCS trial reached the midpoint for enrollment. The company announced the initiation of the trial in December 2021.