Abstract
BACKGROUND: Severe aortic stenosis (AS) is associated with an increased risk of adverse outcomes in patients undergoing percutaneous coronary intervention (PCI). While Impella-supported high-risk PCI (HRPCI) has demonstrated improved outcomes, its safety in patients with AS remains inadequately established. OBJECTIVES: We evaluated the effectiveness and safety of Impella support in patients with AS undergoing HRPCI. METHODS: Patients from the PROTECT III study (NCT04136392), a single-arm, FDA-audited, multicenter investigation of Impella-supported HRPCI, were assessed. AS severity was classified as none/trivial, mild, moderate, or severe. The primary outcome was 90-day major adverse cardiac and cerebrovascular events [MACCE, defined as the composite of all-cause mortality, MI, stroke/transient ischemic attack (TIA), and revascularization]. Secondary outcomes included in-hospital complications, stroke/TIA, and vascular complications requiring surgery. RESULTS: Of the 594 patients with available echocardiographic data, 490 had none/trivial AS, while 34, 24, and 46 had mild, moderate, or severe AS, respectively. Patients with AS were older, had fewer incidences of diabetes, were more likely to have left main disease, and had higher left ventricular ejection fraction. Severely calcified lesions and atherectomy were more frequent among patients with moderate or severe AS. No significant differences were observed in PCI-related complications, stroke/TIA, and 30-day or 90-day MACCE across AS severity groups. However, transfusion rates were higher in patients with AS. CONCLUSION: In patients undergoing Impella-supported HRPCI, 90-day MACCE and PCI-related complications were similar across all levels of AS severity. These findings suggest that the procedure is safe in this complex, high-risk population. CLINICAL TRIAL INFORMATION: Trial Name: The Global cVAD Study (cVAD). ClinicalTrial.gov URL: https://clinicaltrials.gov/ct2/show/NCT04136392?term=cvad&draw=2&rank=2. ClinicalTrial.gov Identifier: NCT04136392.