Hohenstein Bernd, Julius Ulrich, Lansberg Peter, Jaeger Beate, Mellwig Klaus-Peter, Weiss Norbert, Graehlert Xina, Roeder Ingo, Ramlow Wolfgang
Department of Internal Medicine III, University Hospital and Faculty of Medicine Carl Gustav Carus, Technische Universität Dresden, Germany.
Department of Internal Medicine III, University Hospital and Faculty of Medicine Carl Gustav Carus, Technische Universität Dresden, Germany.
Atheroscler Suppl. 2017 Nov;30:180-186. doi: 10.1016/j.atherosclerosissup.2017.05.009. Epub 2017 Jun 1.
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.
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).
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.
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.
血脂异常是动脉粥样硬化及后续心血管疾病（CVD）的一个众所周知的危险因素。虽然低密度脂蛋白胆固醇（LDL-C）已得到充分确认，并在风险管理和治疗中予以考虑，但脂蛋白（a）[Lp(a)]是另一个已确定的心血管疾病危险因素，由于缺乏治疗选择，常常未接受筛查。对于因Lp(a)大幅升高且LDL-C水平正常而患有心血管疾病的患者，脂蛋白分离术是唯一可用的治疗选择。虽然在德国，这种情况是脂蛋白分离术（LA）的公认适应症，但仍缺乏包括对照组的前瞻性研究。
本试验的主要目的是评估脂蛋白分离术对Lp(a)升高的受试者心肌梗死、经皮冠状动脉介入治疗（PCI）、冠状动脉旁路移植术（CABG）和心血管疾病死亡的临床益处。本研究评估了德国联邦联合委员会认可的每周一次脂蛋白分离术对患有进展性心血管疾病的受试者的临床益处（治疗组）。对照组将是接受最大耐受降脂治疗但无法接受脂蛋白分离术治疗的匹配良好的受试者。
MultiSELECt是一项前瞻性、多中心、跨国、双臂匹配对列研究，旨在直接比较被批准接受脂蛋白分离术并随后每周进行一次分离治疗的Lp(a)显著升高的受试者与继续进行最大药物治疗的受试者。随访期为基线访视后2年，直至对照组至少发生60例主要终点事件。一个中央试验专家委员会将根据既定的德国指南，以盲法审查所有受试者接受脂蛋白分离术的潜在适应症。所有对照受试者将每月通过电话访视进行联系，以弥补分离术期间更频繁的访视。为了检测脂蛋白分离术治疗的受试者中事件减少至少10%，大约需要150对匹配对。
MultiSELECt试验提供了一个独特的机会，以在严格控制的条件下证明脂蛋白分离术对Lp(a)升高的患者心血管疾病的疗效。
