LAS VEGAS — Lipid apheresis is safe in the days after revascularization for acute coronary syndrome (ACS) in people without familial hypercholesterolemia (FH), with a signal for regression of atherosclerosis, the pivotal PREMIER safety trial found.
The phase I/II trial showed three major peri-procedure adverse events with extracorporeal filtration of LDL via a peripheral IV line atop atorvastatin (Lipitor) compared with no events on standard medical therapy with atorvastatin. Those three hypotensive events in two patients were treated with IV fluids.
The single apheresis session reduced coronary plaque volume at 90 days on intravascular ultrasound by 4.81% compared with an increase of 2.31% in the medical therapy control group. But this “strong trend” for the primary efficacy endpoint missed statistical significance, reported Subhash Banerjee, MD, of the VA North Texas Health Care System and UT Southwestern Medical Center in Dallas, at the Society for Cardiovascular Angiography and Interventions (SCAI) meeting.
Statistical power for the trial was based on apheresis’ effect in FH and likely left it underpowered to assess plaque regression for the studied non-FH population, Banerjee suggested at a late-breaking clinical trial session.
An outcomes trial will be important, but the treatment is already FDA approved for use in FH, he noted.
Banerjee said the idea is to “use it one time as a head start then use conventional lipid lowering therapies. … The early regression or the early lipid effect in LDL lowering might be beneficial.”
SCAI session moderator Daniel Kolansky, MD, of the Hospital of the University of Pennsylvania in Philadelphia, agreed that an early atherosclerotic approach could be useful.
“Whether by early more intensive lipid lowering, rather than just waiting for the statin to take its effect, it could have some effect” and is worth an outcomes trial, he told MedPage Today. “There is risk of recurrent MI early after ACS.”
The treatment has the advantage of being completely reimbursed (as FDA approved for use in FH) and possibly more cost effective than giving a PCSK9 inhibitor, Banerjee suggested.
Apheresis yielded a 56% reduction in LDL level (vs 17% among controls) and kept it lower at 30 and 90 days compared with controls. There was also significant mobilization of endothelial progenitor cells.
The trial included 160 patients at four VA centers randomized to standard medical therapy with atorvastatin (40 to 50 mg) alone, or with a single treatment within 72 hours of percutaneous coronary intervention for ACS with the proprietary Liposorber device. The latter uses dextran sulphate beads to filter out apolipoprotein B lipoproteins and reduce PCSK9.
Patients had to have LDL >70 mg/dL (baseline mean around 130 mg/dL) but couldn’t have triglycerides >500 mg/dL.
Poor kidney function was an exclusion criteria, due to shifting of blood volume, as was a case in which ACE inhibitor discontinuation or interruption was unacceptable, because the treatment can result in bradykinin release.
Study limitations include the almost exclusively male, veteran population and lack of genetic screening for FH.
The study was funded by the Department of Veterans Affairs.
Banerjee disclosed relevant relationships with Boston Scientific, Aralez, Medtronic, and AstraZeneca.
Kolansky disclosed relevant relationships with CathWorks.