Results from the multi-center, randomized PREMIER clinical trial show a new treatment option dramatically lowers rates of low-density lipoprotein (LDL) for heart attack patients following an interventional cardiology procedure called percutaneous coronary intervention (PCI).
The minimally invasive, one-time treatment decreases LDL levels by 50 to 80% in two to three hours. The study was funded by the Department of Veterans Affairs (VA) and present as late breaking clinical research; so at the Society for Cardiovascular Angiography and Interventions (SCAI) 2019 Scientific Sessions.
Experience a heart attack
According to the American Heart Association, one in four men and one in three women; so will die within the following year of having a heart attack; so most often by cardiac arrest or another heart attack. High levels of LDL, know as the “bad cholesterol”, causes plaque build up in arteries; so increasing one’s risk for heart attack, stroke and other adverse cardiac events.
Yet, of the more than 71 million adults in the U.S. with high LDL; so less than half seek treatment (CDC); so making them more likely to experience a heart attack and need PCI. The clinical trial include patients from across four VA centers in the U.S. The study randomize 160 acute coronary syndrome (ACS) patients within 72 hours after PCI. LDL was remove by extracorporeal filtration; so during LDL-apheresis, using a machine that filters out only LDL from the blood.
The study comprise single LDL-apheresis vs. no LDL apheresis on background statin therapy. Trial objectives include primary safety and efficacy endpoints. Findings show LDL was dramatically lower by an average 53% in patients by a single LDL-apheresis treatment lasting an approximately three hours. Both treatment groups were comparable at baseline. The mean LDL reduction at discharge was lower by a mere 17% in no LDL-apheresis group.
Reduce burden of bad cholesterol
The primary efficacy endpoint, percent change in atheroma or plaque volume at 90 days by intravascular ultrasound decrease by 4.81% (95% CI, -8.91 to -.71) in LDL-apheresis group and increase by 2.31% (95% CI, -3.98 to 8.61) in no LDL-apheresis group. These results were not statistically significant (p=0.06).
With the incidence of heart attacks on the rise; so the ability to rapidly reduce the burden of bad cholesterol is critical. The LDL-apheresis technology may provide patients an incredibly effective and efficient treatment option to reduce risk of a second heart attack and improve coronary health,” said lead author Subhash Banerjee, MD, FSCAI, VA North Texas Health Care System & UT Southwestern Medical Center in Dallas, TX.
They saw that LDL levels remain low for up to six weeks, giving patients critical time to jump start their recovery after a heart attack. We have now create the opportunity to interrupt the course of this disease and advance outcomes for heart attack patients across the country. To further verify their findings, the next step the authors claim is to examine the outcome of LDL-apheresis treatment on a broader range of patients, with greater representation of women