Outcomes Among Patients with Coronary Bifurcation Lesions Undergoing Impella-Supported High-Risk Percutaneous Coronary Intervention.
Academic Article
Overview
abstract
BACKGROUND: Coronary bifurcation lesions (CBL) are associated with lower procedural success, worse post-procedural outcomes, and greater unplanned repeat revascularization. We sought to better understand the impact of Impella support in patients undergoing percutaneous coronary intervention (PCI) of CBLs. METHODS: We used data from the cVAD PROTECT III study (NCT04136392), an FDA-audited, single-arm study of patients undergoing high-risk PCI with Impella support, to examine the outcomes of patients undergoing PCI of CBLs. Patients with a Medina classification of 1.1.1, 1.0.1, or 0.1.1 were considered to have a true CBL, and were compared to patients with non-true CBLs and/or no CBLs. The primary outcome was the rate of CEC-adjudicated major adverse cardiac and cerebrovascular events (MACCE: composite of all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeat revascularization) at 90 days. Cox proportional hazards regression models were adjusted for age, sex, left main disease, and triple vessel disease. RESULTS: Of 1044 patients, 523 had at least one true CBL treated. Baseline characteristics were comparable between groups except for age which was higher in patients with CBLs. Patients with CBLs had a significantly higher pre-PCI SYNTAX scores and number of treated lesions, more left main disease and triple vessel disease, and longer procedure duration. There was no difference in post-PCI SYNTAX score, PCI-related complications, or failure to achieve angiographic success. After adjustment for potential confounders, patients with CBLs had similar rates of 90-day MACCE. CONCLUSIONS: While patients with CBLs undergoing Impella-supported high-risk PCI had higher complexity, there were similar rates of PCI-related complications and 90-day MACCE. TRIAL REGISTRATION: Trial Name: The Global cVAD Study (cVAD), ClinicalTrial.gov Identifier: NCT04136392, URL:https://clinicaltrials.gov/ct2/show/NCT04136392?term=cvad&draw=2&rank=2.
