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Rationale and design of MultiSELECt: A European Multicenter Study on the Effect of Lipoprotein(a) Elimination by
Bernd Hohenstein1, Ulrich Julius1, Peter Lansberg2
1Department of Internal Medicine III, University Hospital and Faculty of Medicine Carl Gustav Carus, Technische Universität Dresden, Germany.
Insights
Lipoprotein apheresis (LA) effectively reduces cardiovascular events in patients with high lipoprotein(a) and progressive cardiovascular disease. This study compares LA treatment against maximal medical therapy in a controlled trial.
Area of Science:
- Cardiology
- Lipidology
- Clinical Trials
Background:
- Dyslipidemia, particularly elevated low-density lipoprotein cholesterol (LDL-C), is a major risk factor for atherosclerosis and cardiovascular disease (CVD).
- Lipoprotein(a) [Lp(a)] is another established CVD risk factor, but screening is often overlooked due to limited treatment options.
- For patients with CVD and significantly elevated Lp(a) despite normal LDL-C, lipoprotein apheresis (LA) is the sole available treatment.
Purpose of the Study:
- To evaluate the clinical benefit of weekly LA in subjects with elevated Lp(a) and progressive cardiovascular disease.
- To compare the efficacy of LA treatment against maximal tolerated lipid-lowering therapy in a matched-pair cohort study.
- To assess the impact of LA on myocardial infarction, PCI, CABG, and cardiovascular death.
Main Methods:
- The MultiSELECt trial is a prospective, multicenter, multinational, two-arm matched-pair cohort study.
- It compares weekly LA treatment versus maximal medical therapy in patients with significantly elevated Lp(a).
- The study includes a 2-year follow-up, blinded review for LA indication, and monthly telephone visits for the control group.
Main Results:
- Approximately 150 matched pairs are needed to detect a 10% event reduction in the LA group.
- The study aims to gather at least 60 primary endpoint events in the control group.
- The trial is designed to provide robust data on LA's effectiveness in a specific patient population.
Conclusions:
- The MultiSELECt trial offers a unique opportunity to demonstrate the efficacy of LA in managing CVD in patients with elevated Lp(a).
- The study will provide evidence under strongly controlled conditions for this specific indication.
- Results will inform clinical practice regarding lipoprotein apheresis for high Lp(a) patients.
Background:
Dyslipidemia is a well-known risk factor for atherosclerosis and subsequent cardiovascular disease (CVD). While low density lipoprotein cholesterol (LDL-C) is well-established and taken into consideration for risk management and therapy, lipoprotein(a) is another established CVD risk factor frequently not undergoing screening due to a lack of medical treatment options. For patients suffering from CVD due to massive elevation of Lp(a) in presence of normal LDL-C levels, lipoprotein apheresis is the only available treatment option. While this constellation is an accepted indication for lipoprotein apheresis (LA) in Germany, prospective studies including a control group are still lacking.
Objective:
Primary objective of this trial is to evaluate the clinical benefit of lipoprotein apheresis on myocardial infarction, PCI, CABG and death from cardiovascular disease in subjects with elevated Lp(a). This study evaluates the clinical benefit of weekly LA in subjects with progressive cardiovascular disease, as accepted by the German Federal Joint Committee (treatment group). Comparator will be well-matched subjects under maximum tolerated lipid lowering therapy without access to LA treatment (control group).
Methods:
MultiSELECt, is a prospective, multicenter, multinational, two-arm matched-pair cohort study designed to directly compare subjects with significantly elevated Lp(a) approved for LA subsequently undergoing weekly apheresis treatment versus a continuation of maximal medical therapy. The follow-up period will be 2 years after the baseline visit and until at least 60 events of the primary end-point occurred in the control group. A central trial expert committee will review all subjects with respect to their potential indication for LA according to established German guidelines in a blinded fashion. All control subjects will be contacted monthly via telephone visits to compensate for the more frequent visits during apheresis. Approximately 150 matched pairs will be necessary to detect an event reduction of at least 10% in subjects under LA treatment.
Conclusion:
The MultiSELECt trial provides the unique opportunity to demonstrate the efficiency of LA on CVD in patients with elevated Lp(a) under strongly controlled conditions.
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