Results of REDUCE-IT PCI detail a 34% reduction in 5-point MACE and a 39% reduction in total events among patients receiving icosapent ethyl (Vascepa) in the original trial with a history of PCI.
Results from REDUCE-IT PCI presented at Transcatheter Cardiovascular Therapeutics (TCT) Connect 2020 offer further evidence of the impact icosapent ethyl (Vascepa) can have on risk of major adverse cardiovascular events (MACE).
A posthoc exploratory analysis of patients from the landmark REDUCE-IT trial, results indicate icosapent ethyl was associated with 34% and 39% reductions in composite first and total MACE, respectively, among patients who had undergone a previous percutaneous coronary intervention (PCI).
“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,” said senior investigator of REDUCE-IT PCI Deepak Bhatt, MD, MPH, executive director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital and professor of Medicine at Harvard Medical School, in a statement from Amarin. “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.”
With the original REDUCE-IT study detailing a 25% relative risk reduction with icosapent ethyl in patients with established cardiovascular disease, investigators sought to determine whether the effect of the EPA-based agent was as robust in patients with a history of PCI. Briefly, all 8179 patients included in REDUCE-IT were aged 45 years and older with a clinical history of coronary artery, cerebrovascular, carotid artery and peripheral artery disease, or 50 years and older with diabetes and additional risk factors for cardiovascular disease.
For the current analysis, investigators only included the 3408 patients, which represents 41.7% of the original population, with a history of PCI before the study. Investigators pointed out these patients were randomized a median of 2.9 years after PCI.
The primary end point of REDUCE-IT PCI was defined as a composite of time to cardiovascular death, myocardial infarction, stroke, revascularization, or hospitalization for unstable angina. The secondary end point of the study was time to cardiovascular death, myocardial infarction, or stroke.
Upon analysis, results indicated use of icosapent ethyl was associated with a 34% relative reduction in risk for the primary endpoint (HR, 0.66; 95% CI, 0.58-0.76; P <.0001) over a follow-up period lasting a median of 4.9 years. During his presentation, Benjamin Peterson, MD, MPH, pointed out this equated to an absolute risk reduction of 8.5% and a number needed to treat (NNT) of 12.
For the secondary end point, results indicated use of icosapent ethyl was associated with a 34% relative risk reduction for 3-point MACE (HR, 0.66; 95% CI, 0.58-0.76; P <.0001). Again, Peterson pointed out this equated to an absolute risk reduction of 5.4% and an NNT of 19.
Further analysis indicated icosapent ethyl was associated with a 39% red action in total events among this patient population (RR< 0.61; 95% CI, 0.52-0.72; P <.0001). Peterson noted the reduction in first events was 34% while second and third or greater events were reduced by 40% and 50%, respectively.
Peterson pointed out icosapent ethyl was well-tolerated among this patient population, but did note an increase in atrial fibrillation/flutter (3.4% vs 2.2%; P=.04) and bleeding. However, Peterson noted bleeding (12.7% vs 12.1%; P=.6) and serious bleeding (3.2% vs 2.8%; P=.42) were not significantly different between the study arms.
“These data reflect the substantial impact of icosapent ethyl on the at-risk REDUCE-IT patient population, including patients with a history of prior PCI,” reflected Peterson during his presentation.
This study, “Treatment with Icosapent Ethyl to Reduce Ischemic Events in Patients with Prior Percutaneous Coronary Intervention – Insights From REDUCE-IT PCI,” was presented at TCT Connect 2020.