A new analysis from the REDUCE-IT trial has shown that the high-strength eicosapentaenoic acid product icosapent ethyl (Vascepa, Amarin) reduced the number of revascularization procedures by approximately one third in statin-treated patients whose triglyceride levels were elevated and who were at increased cardiovascular risk.
The new data were presented at the virtual Society for Cardiovascular Angiography and Interventions (SCAI) 2020 meeting.
REDUCE-IT, a multicenter, double-blind, placebo-controlled trial, randomly assigned statin-treated patients whose triglyceride levels were elevated (135 – 499 mg/dL), whose low-density lipoprotein (LDL) levels were controlled (41 – 100 mg/dL), and who had established cardiovascular disease or diabetes plus risk factors to receive either icosapent ethyl 4 g daily or placebo.
The primary composite and other cardiovascular endpoints were substantially reduced. Prespecified analyses examined all coronary revascularizations, recurrent revascularizations, and revascularization subtypes.
“Compared with placebo, icosapent ethyl 4 g/day significantly reduced first and total revascularization events by 34% and 36%, respectively,” REDUCE-IT investigator Benjamin Peterson, MD, Brigham and Women’s Hospital, Boston, Massachusetts, concluded during the SCAI presentation.
This reduction was consistent with respect to urgent, emergent, and elective revascularization procedures overall, as well as percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) individually, he reported.
“Prior therapies aimed at patients with elevated triglycerides have not demonstrated a consistent benefit in reducing coronary revascularization, and to the best of our knowledge, this is the first non-LDL cholesterol intervention in a major randomized trial in which statin-treated patients underwent fewer CABG surgeries,” Peterson stated.
“These data highlight the substantial impact of icosapent ethyl on the underlying atherothrombotic burden in the at-risk REDUCE-IT population,” he added.
Detailed results showed that the percentage of patients who underwent first revascularizations was 9.2% with icosapent ethyl vs 13.3% with placebo (hazard ratio [HR], 0.66; P < .0001; number needed to treat, 25).
Similar reductions were observed in total (first and subsequent) revascularizations (risk ratio, 0.64; P < .0001) and across urgent, emergent, and elective revascularizations. Icosapent ethyl significantly reduced the need for PCI (HR, 0.68; P < .0001) and CABG (HR, 0.61; P = .0005).
The moderator of a SCAI press conference, Kirk Garratt, MD, Center for Heart and Vascular Health, Christiana Care Health System, Wilmington, Delaware, said: “This is an impressive impact. I couldn’t count the number of zeros in the P value.”
Commenting on the study, Timothy Henry, MD, Christ Hospital, Cincinnati, Ohio, said REDUCE-IT was an important trial. “It showed a very impressive effect on revascularizations along with all the other benefits.” But he suggested that the uptake in usage of icosapent ethyl in the United States has been slow, and he asked what could be done to enhance this.
REDUCE-IT senior investigator Deepak Bhatt, MD, replied that the product was only approved for the REDUCE-IT indication in December, and he suggested that initial uptake may have been affected by the current COVID-19 pandemic.
“This new REDUCE-IT indication ― patients with established cardiovascular disease or diabetes plus risk factors who have moderately elevated triglycerides and controlled LDL ― includes a lot of patients, between 15% and 50% of all cardiovascular patients,” he said.
“We wanted to present this revascularization data at the SCAI meeting, as it is super-important that interventional cardiologists know about this. Interventionalists have now taken ownership of LDL and make sure patients are on statins, and we hope they will now do the same thing for triglycerides,” Bhatt commented.
Henry agreed. “It should be a simple thing to take all secondary prevention patients with eligible triglycerides and be aggressive with this new therapy.”
Bhatt noted that a cost-effectiveness analysis of the REDUCE-IT trial that was presented at last year’s American Heart Association meeting “has shown the drug to be highly cost-effective and actually cost saving at the current list price.”
Asked what the mechanism of benefit is, Bhatt said: “”There has been good basic science showing that EPA [eicosapentaenoic acid] stabilizes cell membranes and reduces plaque vulnerability and progression.”
REDUCE-IT was sponsored by Amarin. Brigham and Women’s Hospital receives research funding from Amarin for Bhatt’s role as chair of the trial.
Society for Cardiovascular Angiography and Interventions (SCAI) 2020 Virtual Scientific Sessions: Abstract 11665. Presented May 14, 2020.