October 15, 2020
Findings Presented From REDUCE-IT PCI Analysis of Amarin’s Vascepa Therapy
October 15, 2020—Amarin Corporation announced the presentation of REDUCE-IT PCI on the clinical impact of the company’s Vascepa (icosapent ethyl) in patients undergoing percutaneous coronary intervention (PCI).
The REDUCE-IT PCI analysis evaluated 3,408 (41.7%) patients enrolled in REDUCE-IT who had undergone a previous PCI. These patients were randomized a median of 2.9 years after PCI. Baseline characteristics were similar among patients randomized to Vascepa versus placebo.
Benjamin E. Peterson, MD, presented the analysis at TCT Connect, the 32nd annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held online October 14-18, 2020.
According to the company, post hoc exploratory analyses of the subgroup of 3,408 patients with a previous PCI showed that for the primary composite endpoint of five-point major adverse cardiac events (MACE), time to first event was significantly reduced with Vascepa versus placebo by 34% (P < .0001) and total (first and subsequent) events were also reduced by 39% (P < .0001). For the key secondary composite endpoint of three-point MACE, time to first event was reduced by 34% (P < .0001) in the subgroup of patients with a previous PCI.
Deepak L. Bhatt, MD, is Principal Investigator of REDUCE-IT and senior author of the REDUCE-IT PCI analyses. In the company’s announcement, Dr. Bhatt commented, “The opportunity to further explore REDUCE-IT data and effects in those patients with prior PCI provides additional understanding of the potential benefit of icosapent ethyl in the clinical setting. The findings of benefit in at-risk patients with prior PCI are consistent with previously presented data on overall reductions in first and total coronary revascularization events of 34% and 36%, respectively. Moreover, the statistically significant substantial benefit in reduced coronary revascularization procedures seen as early as 11 months, provides clinicians with a potential additional intervention in a patient population for whom time is of the essence.”
Amarin advised that 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, stated the company.