Design and Rationale of the Safe Surveillance of PCI Under Mechanical Circulatory Support With the Saranas Early Bird Bleed Monitoring System (SAFE-MCS) Study

Philippe Généreux; Amir Kaki; Mostafa Naguib; Brittany Fuller; Hursh Naik; Michael Kim; Amirali Masoumi; Thomas Waggoner; Zaffer Syed; Julia Walsh; Dimitri Karmpaliotis; Mir Babar Basir

doi:10.1016/j.jscai.2023.101049

Design and Rationale of the Safe Surveillance of PCI Under Mechanical Circulatory Support With the Saranas Early Bird Bleed Monitoring System (SAFE-MCS) Study

J Soc Cardiovasc Angiogr Interv. 2023 Jul 5;2(5):101049. doi: 10.1016/j.jscai.2023.101049. eCollection 2023 Sep-Oct.

Authors

Affiliations

¹ Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, New Jersey.
² Ascension St. John Hospital, Detroit, Michigan.
³ Henry Ford Health System, Detroit, Michigan.
⁴ St. Joseph's Medical Center, Phoenix, Arizona.
⁵ Lenox Hill Hospital, Northwell Health, New York, New York.
⁶ USHV Heart & Vascular, Tucson Medical Center, Tucson, Arizona.
⁷ Saranas, Inc, Houston, Texas.

Abstract

Background: High-risk percutaneous coronary intervention (PCI) with mechanical circulatory support (MCS) has been associated with varying rates of bleeding due to variable bleeding definitions, incomplete data relative to site-specific bleeding, and inclusion of variable patient populations.

Study design and objectives: SAFE-MCS (NCT05077657) is a multicenter, single-arm, open-label study designed to evaluate the safety of complex high-risk PCI using Impella and surveillance with the Saranas Early Bird Bleed Monitoring System (EBBMS). The study aims to enroll 184 evaluable subjects at up to 15 US centers. The primary clinical end point is the incidence of access-site related BARC type III or V bleeding. Secondary clinical end points include the incidence of each of the Saranas EBBMS level 1, 2, and 3 indicators and the incidence of all BARC type III or V bleeding. Enrollment is anticipated to complete in September 2023 with no longitudinal follow-up.

Conclusions: SAFE-MCS is the first study to exclusively assess bleeding complications in patients undergoing PCI with Impella with independent adjudication via a clinical end point committee and will gather meaningful real-world data using contemporary practice.

Keywords: bleeding; high-risk PCI; mechanical circulatory support.