Vascepa Brings 36% Drop in Surgeries to Restore Blood Flow, Results Show

Patients who took icosapent ethyl, the purified fish oil derivative sold as Vascepa, saw a 34% reduction in the first surgical procedure to restore blood flow to the heart, and a 36% overall drop in these procedures, according to data presented today.

Deepak L. Bhatt, MD, MPH, of Brigham and Women’s Hospital Heart & Vascular Center and Harvard Medical School, presented the latest round of data from REDUCE-IT at the American Society of Preventive Cardiology 2020 this morning. According to a press release, data in Bhatt’s presentation, REDUCE-IT REVASC, showed that the early coronary revascularization signal was seen in a prespecified exploratory analysis, and statistical significance was reached by 11 months.

Bhatt is the lead investigator for REDUCE-IT. The study is funded by Amarin, which makes icosapent ethyl.

Coronary revascularization covers a group of procedures, including stenting and coronary artery bypass grafts (CABG), that restore blood flow to the heart due to diseased blood vessels. These procedures are invasive, costly, and require time in a hospital or outpatient surgical center. A 2016 study found that costs vary widely depending on the procedure; the average was $13,501 for percutaneous coronary intervention (PCI), rising to to $37,611 for CABG.

Revascularizations are performed in different circumstances; some are emergent, such as after a patient has a heart attack; others are scheduled. In recent months, hospitals have reported that stent procedures are among those that have been delayed due to the coronavirus disease 2019 pandemic.

These latest analyses concerned patients in the REDUCE-IT trial who were treated with statins for high triglycerides (135-499 mg/dL), and who also had either cardiovascular disease or diabetes and additional cardiovascular risk factors. The prespecified analysis found that taking icosapent ethyl reduced the time to an initial procedure regardless of type:

• elective procedures were reduced 32% (P < .0001)
• urgent procedures were reduced 34% (P < .0001)
• emergent procedures were reduced 38% (P = .02)

A post hoc analysis found that taking icosapent ethyl reduced PCI by 32% (P < .0001) and CABG by 39% (P = .0005), compared with placebo. The data were evaluated by an independent committee, according to the statement.

The findings are consistent with other data on icosapent ethyl over the past year. At the American Heart Association (AHA) Scientific Sessions in November 2019, results from the EVAPORATE study showed changes in measurement of a dangerous, substance called low attenuation plaque after 9 months. Together with the REDUCE-IT REVASC findings, Bhatt said, the data sets “allow for advancing insight into the connectivity between the mechanism of action and clinical outcomes of icosapent ethyl.”

Scientists have gained more knowledge of how this form of omega-3 fatty acid works since the first results of REDUCE-IT were presented at AHA in 2018. At that meeting, Bhatt shared surprising news that a capsule approved years ago to reduce triglycerides could also cut the risk of an initial cardiovascular event by 25%.

Although cardiovascular events generally tax the health system, procedures that require time in a hospital or surgical center are most costly. “Revascularization procedures significantly impact the healthcare system,” Steven Ketchum, PhD, senior vice president and president, research and development and chief scientific officer of Amarin, said in the statement. “These data reflect results consistent with FDA-approved findings that continue to support that the use of Vascepa has the potential to transform cardiovascular care in appropriate high-risk patients.”

Reference

Peterson BE, Bhatt DL, Steg G, et al. Reduction of revascularization in patients with hypertriglyceridemia with icosapent ethyl: insights from REDUCE-IT REVASC. Presented at the American Society of Preventive Cardiology Virtual Summit 2020, July 25, 2020; Abstract 106. https://www.aspcvirtualsummit.org/abstract-106