The Lp(a)FRONTIERS APHERESIS trial was a randomized study conducted in Germany to assess whether pelacarsen reduces the need for lipoprotein apheresis (LA) in adults with elevated lipoprotein(a) [Lp(a)] and established cardiovascular disease (CVD). The study was published in the European Heart Journal. Eligible participants had Lp(a) levels >60 mg/dL and had undergone at least 35 LA sessions in the prior year. Patients were randomized to receive pelacarsen 80 mg or placebo every four weeks for 52 weeks. Weekly LA sessions were performed if Lp(a) measured at the prior visit exceeded 60 mg/dL.

A total of 51 patients were randomized (mean age 61.7 years; baseline Lp(a) 85.4 mg/dL; mean 44.0 LA sessions in the prior year). Study completion rates were 96.2% in the pelacarsen arm and 92.0% in the placebo arm. Baseline characteristics were generally balanced between groups
Pelacarsen significantly reduced the mean rate of performed LA sessions compared with placebo (0.16 vs 0.93; odds ratio 0.006; 95% CI 0.003-0.013; P < .0001). It was associated with a higher hazard of achieving LA avoidance for ≥24 consecutive weeks (hazard ratio 88.3; P = .0014; median time 6.1 weeks) and greater total LA avoidance from week 12 to week 52 (odds ratio 163.2; P = .0005). Placebo-adjusted Lp(a) reduction at week 52 was −72% (95% CI −79% to −61%; P < .0001). Treatment-emergent adverse events were similar between groups, except for mostly mild injection-site erythema (38.5% vs 0%).

Pelacarsen substantially reduced the need for lipoprotein apheresis and lowered Lp(a) levels in patients with elevated Lp(a) and established CVD.