Lipoprotein apheresis for lipoprotein(a)-associated progressive atherosclerotic cardiovascular disease: 12-years follow-up

BACKGROUND AND AIMS: Progressive atherosclerotic cardiovascular disease (ASCVD) associated with high Lp(a) (>60 mg/dl) has been approved as indication for regular lipoprotein apheresis (LA) in Germany since 2008.

METHODS: This observational multicenter study enrolled 170 consecutive patients with high Lp(a) and progressive ASCVD despite effective treatment of other ASCVD risk factors as required for approval of reimbursement to analyse the long-term effect of LA on cardiovascular event rates. Additionally cardiovascular event rates were compared to an appropriate UK-Biobank cohort (UKBBC) with established ASCVD and verified impact of elevated Lp(a) on ASCVD risk.

RESULTS: Investigations were conducted on patients retrospectively over a 5-year period before the initiation of regular LA, prospectively 5 years after the commencement of LA, and again retrospectively until the completion of 12 years of LA. 154 patients (90.6 %) completed 5 years follow-up, 129 patients (75.9 %) were available in year 12. A decline in the mean annual rate of cardiovascular events per patient was observed from y-5 to y-1 (0.27 ± 0.25) versus y+1 until y+12 (0.06 ± 0.08) (p < 0.001). One year before commencing LA mean event rates per 100 patient years of the primary composite endpoint parameter of major adverse cardiac events (MACE) including nonfatal ischemic stroke (IS) were significantly higher in Pro(a)LiFe patients compared to the UKBBC. Most importantly they were significantly lower one year after commencing LA.

CONCLUSIONS: Regular LA was associated with a decreased rate of cardiovascular events in patients with high Lp(a) (>60 mg/dl) and progressive ASCVD up to 12 years. Comparison with corresponding incidence rates in the UKBBC supports the clinical efficacy of LA to bring progressive ASCVD associated with high Lp(a) to a halt. However, this comparative analysis cannot replace a true control group or determine the exact effect size.