Clinical Research & Data, Protected PCI
Improved Outcomes with Contemporary Practices in PROTECT III
Jeffrey Moses, MD, discusses the PROTECT III study and improved outcomes in patients with severely depressed left ventricular ejection fraction (LVEF) undergoing percutaneous coronary intervention (PCI) with contemporary practices. Dr. Moses is director of complex coronary interventions at St. Francis Hospital in Roslyn, New York, and professor of cardiology and director of interventional cardiac therapeutics at Columbia University Medical Center in New York City. He gave this presentation at the 2021 Transcatheter Cardiovascular Therapeutics (TCT) conference.
Dr. Moses begins his presentation describing the need to optimize outcomes in patients undergoing high-risk PCI (HRPCI) who have comorbidities and anatomic and procedural complexity. He then provides context for discussing the PROTECT III study with an overview of the PROTECT series of studies (PROTECT I, II, III, and IV).
Dr. Moses then turns his focus to PROTECT III. He describes this prospective FDA study for Impella®-supported high-risk PCI and explains that the primary endpoint was MACCE at hospital discharge and 90 days in unmatched and matched cohorts. To help analyze the changes in practice, “and really see a snapshot of contemporary practice” compared to practices in PROTECT II from a decade ago, he describes how PROTECT III compared 504 “PROTECT II-like” patients who met PROTECT II inclusion and exclusion criteria to 216 PROTECT II patients.
Dr. Moses reviews the high quality PROTECT III study governance as well as methods, study flow, baseline characteristics, and lesion and procedural characteristics. In PROTECT III, patients had longer lesions and more severe calcification, a greater number of vessels treated, more three-vessel disease and left main disease, and atherectomy was used in a higher percentage (almost 40%) of patients.
Results included a major (78%) reduction in hypotension during support in PROTECT III compared to PROTECT II. Dr. Moses notes that an important learning is, “that the cases are much smoother with current practice in spite of extensive revascularization.” He goes on to say, “The best news, however, if you look at 90-day MACCE, in spite of these increasing complex patients, we actually reduced the MACCE.” In the “PROTECT II-like” patients in PROTECT III, 90-day MACCE was 15.1% compared to 21.9% in PROTECT II.
Dr. Moses also highlights marked reductions in myocardial infarction (MI), repeat revascularization, hypotension during support, CPR, and bleeding requiring transfusions in PROTECT III. He credits the continuous improvement in major bleeding to innovation, experience, and best practices that have evolved over time. In particular, he notes that contemporary practices for HRPCI have evolved significantly over the last decade, including access and closure techniques, anticoagulation practices, and patient identification. He looks forward to further exploration of these practices in an expanded patient population in the PROTECT IV randomized controlled trial (RCT) currently underway.