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LDL apheresis may benefit certain patients with ACS after PCI
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LAS VEGAS — LDL apheresis was safe and was linked to a trend toward early coronary atheroma regression in patients with ACS and high LDL who underwent PCI, according to data from the PREMIER study presented at the Society for Cardiovascular Angiography and Interventions Scientific Sessions.
According to the study background, LDL apheresis is primarily used in patients with familial hypercholesterolemia. Cardiology Today’s Intervention Editorial Board Member Subhash Banerjee, MD, FSCAI, professor of medicine at UT Southwestern Medical Center and chief of the division of cardiology at the VA North Texas in Dallas, and colleagues conducted a randomized investigational device exemption study to evaluate LDL apheresis in 160 patients (99% men; mean LDL, 113 mg/dL) from four Veterans Affairs centers with ACS who had undergone an uncomplicated PCI. For the pilot study of the first 31 patients, minimum LDL was 100 mg/dL, but for the rest of the cohort, minimum LDL was 70 mg/dL, Banerjee said.
“LDL apheresis has a long history of dramatically reducing LDL,” Banerjee told Cardiology Today’s Intervention. “We wanted to test it in ACS patients who do not have familial hyperlipidemia but who have a very high risk of recurrent events, and in whom LDL lowering through statins is effective, but not always achievable because of side effects and other compliance issues. This could be a good way of getting a head start while continuing statin therapy, albeit at a lower dose if needed. This is the first study of LDL apheresis in nonfamilial hyperlipidemia with an LDL level that is ubiquitous around us.”
All patients were on background statin therapy and were randomly assigned to a one-time procedure whereby LDL was removed by extracorporeal filtration during LDL apheresis (Liposorber, Kaneka), or no procedure. Although there was no sham procedure, the clinical follow-up was completely blinded, Banerjee said in an interview.
The primary efficacy endpoint was percent change in atheroma volume at 90 days as determined by IVUS.
At discharge, mean LDL reduction was 53% in the LDL apheresis group and 17% in the control group (P < .0001), according to the researchers.
The groups did not differ in serious adverse events (P = .7505).
At 90 days, in the as-observed analysis percent change in atheroma volume dropped by 5.46% (95% CI, –10.11 to –0.81) in the LDL apheresis group and rose by 2.59% in the control group (95% CI, –4.46 to 9.64; P for interaction = .06), Banerjee said, noting the intention-to-treat and as-treated analyses produced similar results.
Endothelial progenitor cell-colony forming units increased at a similar rate in both groups between baseline and 90 days (LDL apheresis group, 12.4 to 20; control group, 12.3 to 16.4; P = .1), according to the researchers.
“‘LDL apheresis is great’ is not a conclusion I can reach today,” Banerjee said in an interview. “We can say that if effective LDL lowering is achieved early after ACS, we could see a very strong trend for plaque regression. I view the implications as more than just for one therapy, rather, for effective LDL lowering post-ACS.”
More studies are needed in larger populations, including in women, he said. – by Erik Swain
Reference:
Banerjee S, et al. Featured Clinical Research I. Presented at: Society for Cardiovascular Angiography and Interventions Scientific Sessions; May 19-22, 2019; Las Vegas.
Disclosure: The study was funded by the Department of Veterans Affairs. Banerjee reports no relevant financial disclosures.