Bhatt: Vascepa Cuts Need for Surgeries to Restore Blood Flow

Vascepa, the fish oil pill from Amarin, cut by a third the need for surgery to restore blood flow to the heart, a leading Harvard researcher said today.

Deepak L. Bhatt, M.D., M.P.H., of Brigham and Women’s Hospital Heart & Vascular Center and Harvard Medical School, said a new round of data from the REDUCE-IT trial shows patients taking Vascepa (icosapent ethyl, Amarin) cut the risk of their first surgery by 34% and all surgeries by 36%.

Bhatt’s results, shared at the American Society of Preventive Cardiology 2020, were released in a statement from Amarin, which funded the study. The full presentation will be available online later Saturday. Amarin’s statement said results from this prespecified exploratory analysis showed it had reached significance by 11 months.

In todays’ statement, Bhatt said the results are illuminating when combined with those presented at AHA in November 2019, which showed that a measurable difference in harmful plaques could be seen at just nine months between patients taking Vascepa and those taking placebo. The two data sets, Bhatt said, “allow for advancing insight into the connectivity between the mechanism of action and clinical outcomes of icosapent ethyl.”

Patients avoided coronary revascularization, which includes stenting, coronary artery bypass grafts, known as CABG, and other procedures that restore blood flow to the heart due to diseased blood vessels. None of the surgeries are cheap, and all are invasive, with varying levels of risk and time in a hospital or surgical center. Costs vary: a study found the average was $13,501 for percutaneous coronary intervention (PCI) or $37,611 for CABG.

Vascepa was first approved in 2012 to treat patients with high triglycerides, and in November 2018, Bhatt stunned those attending the American Heart Association meeting with the first results from REDUCE-IT. Results showed that this purified form of omega-3 fatty acid could cut the risk of an initial cardiovascular event by 25%. The drug has since received a cardiovascularindication from FDA as an add-on therapy to statins.

The analysis found that Vascepa reduced the time to an initial procedure no matter the circumstances: elective procedures were reduced 32%, urgent procedures were reduced 34%, and emergent procedures were reduced 38%. A separate analysis found that PCI procedures fell 32% and CABG dropped 39% with Vascepa, compared to placebo.

“Revascularization procedures significantly impact the healthcare system,” Steven Ketchum, Ph.D., senior vice president and president, research and development and chief scientific officer of Amarin. “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.”