Amarin Corporation plc (NASDAQ:AMRN) today announced the presentation of REDUCE-IT® CABG at American Heart Association’s (AHA) Virtual Scientific Sessions 2020, being held virtually from November 13 – November 17, 2020, adding to the growing body of knowledge on the clinical impact of VASCEPA® (icosapent ethyl). These new analyses supported by Amarin were presented by Subodh Verma, M.D., Ph.D., FRCSC, Professor and Cardiac Surgeon at University of Toronto.
“The REDUCE-IT CABG analysis results are another piece of the puzzle when looking at the potential use of icosapent ethyl in the procedural setting,” commented Dr. Deepak L. Bhatt, M.D., M.P.H., Executive Director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital and Professor of Medicine at Harvard Medical School, principal investigator of REDUCE-IT. “The findings of benefit in at-risk patients with prior CABG are consistent with previously presented data on overall reductions in first and total coronary revascularization events, as well as in patients with prior percutaneous coronary interventions, and further strengthen the case for consideration of icosapent ethyl as an additional intervention for use by physicians to care for this patient population.”
The REDUCE-IT CABG analysis examined 1,837 (22.5%) of the patients enrolled in REDUCE-IT, representing all patients who had undergone a prior coronary artery bypass grafting (CABG) procedure, a common form of surgical intervention to help treat coronary heart disease. Baseline characteristics were similar among patients randomized to VASCEPA versus placebo. Post hoc exploratory analyses of this subgroup showed that, for the composite endpoint of 5-point MACE, which was the prespecified primary endpoint for the full REDUCE-IT study cohort, time to first event was significantly reduced with VASCEPA versus placebo by 24% (p=0.004) and total (first and subsequent) events were also reduced by 36% (p=0.0002). For the REDUCE-IT study’s key secondary composite endpoint of 3-point MACE, time to first event was reduced by 31% (p=0.001) in the subgroup of patients with a prior CABG.
Coronary revascularization procedures, such as CABG, are invasive, carry multiple risks, and can have significant direct and indirect costs. Patients with elevated triglycerides despite statin therapy have increased risk for ischemic events, including coronary revascularizations. These procedures, whether pre-scheduled or performed in an emergency, inevitably result in additional time spent in a healthcare setting. The latest statistical update from the American Heart Association (AHA) shows that, in 2014, an estimated 371,000 inpatient CABG procedures were performed in the United States with a mean inpatient hospital charge for CABG of $168,541.1
“Revascularization procedures overall significantly impact the healthcare system, with CABG procedures adding to the burden and driving substantial costs,” said Steven Ketchum, Ph.D., senior vice president and president, research & development and chief scientific officer, Amarin. “The subgroup data presented at AHA Virtual Scientific Sessions 2020 suggests another way in which VASCEPA can possibly alleviate the significant burden that at-risk patients and the healthcare system face with CABG procedures and how VASCEPA therapy can potentially reduce the risk of dangerous subsequent events.”
REDUCE-IT was not specifically powered to examine individual cardiovascular endpoints or patient subgroups, therefore p-values presented for these revascularization analyses are nominal and exploratory with no adjustment for multiple comparisons. In addition, coronary revascularization as an endpoint can sometimes be considered subjective; however, these endpoints were adjudicated by an independent, blinded clinical endpoint committee. Results from the total coronary revascularization events analyses are consistent across the various recurrent event statistical models and are also consistent with the first coronary revascularization events results. Together, the REDUCE-IT first and total coronary revascularization events results support the robustness and consistency of the clinical benefit of VASCEPA therapy in reducing coronary revascularization.
These REDUCE-IT CABG results follow multiple scientific presentations of analysis results from other important patient subgroups in the REDUCE-IT study, including REDUCE-IT REVASC2 and REDUCE-IT PCI. References to these other subgroup analyses are available on Amarin’s website at www.amarincorp.com.
Additional information on AHA Virtual Scientific Sessions 2020 can be found here.