Banerjee Subhash, Luo Ping, Reda Domenic J, Latif Faisal, Hastings Jeffrey L, Armstrong Ehrin J, Bagai Jayant, Abu-Fadel Mazen, Baskar Amutharani, Kamath Preeti, Lippe Daniel, Wei Yongliang, Scrymgeour Alexandra, Gleason Theresa C, Brilakis Emmanouil S
Veterans Affairs North Texas Health Care System, Dallas (S.B., J.L.H.).
University of Texas Southwestern Medical Center, Dallas (S.B., J.L.H., A.B., P.K.).
Circ Cardiovasc Interv. 2020 Aug;13(8):e008933. doi: 10.1161/CIRCINTERVENTIONS.119.008933. Epub 2020 Aug 14.
Low-density lipoproteins (LDLs) are removed by extracorporeal filtration during LDL apheresis. It is mainly used in familial hyperlipidemia. The PREMIER trial (Plaque Regression and Progenitor Cell Mobilization With Intensive Lipid Elimination Regimen) evaluated LDL apheresis in nonfamilial hyperlipidemia acute coronary syndrome patients treated with percutaneous coronary intervention.
We randomized 160 acute coronary syndrome patients at 4 Veterans Affairs centers within 72 hours of percutaneous coronary intervention to intensive lipid-lowering therapy (ILLT) comprising single LDL apheresis and statins versus standard medical therapy (SMT) with no LDL apheresis and statin therapy alone. Trial objectives constituted primary safety and primary efficacy end points and endothelial progenitor cell colony-forming unit mobilization in peripheral blood.
Mean LDL reduction at discharge was 53% in ILLT and 17% in SMT groups (<0.0001) from baseline levels of 116.3±34.3 and 110.7±32 mg/dL (=0.2979), respectively. The incidence of the primary safety end point of major peri-percutaneous coronary intervention adverse events was similar in both groups (ILLT, 3; SMT, 0). The primary efficacy end point, percentage change in total plaque volume at 90 days by intravascular ultrasound, on average decreased by 4.81% in the ILLT group and increased by 2.31% in the SMT group (difference of means, -7.13 [95% CI, -14.59 to 0.34]; =0.0611). The raw change in total plaque volume on average decreased more in the ILLT group than in the SMT group (-6.01 versus -0.95 mm; difference of means, -5.06 [95% CI, -11.61 to 1.48]; =0.1286). Similar results were obtained after adjusting for participating sites, age, preexisting coronary artery disease, diabetes mellitus, baseline LDL levels, and baseline plaque burden. There was robust endothelial progenitor cell colony-forming unit mobilization from baseline to 90 days in the ILLT group (=0.0015) but not in SMT (=0.0844).
PREMIER is the first randomized clinical trial to demonstrate safety and a trend for early coronary plaque regression with LDL apheresis in nonfamilial hyperlipidemia acute coronary syndrome patients treated with percutaneous coronary intervention. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01004406 and NCT02347098.
在低密度脂蛋白去除术中，低密度脂蛋白（LDL）通过体外过滤被清除。它主要用于家族性高脂血症。PREMIER试验（强化脂质清除方案的斑块消退和祖细胞动员）评估了在接受经皮冠状动脉介入治疗的非家族性高脂血症急性冠状动脉综合征患者中进行低密度脂蛋白去除术的效果。
我们将4个退伍军人事务中心的160例急性冠状动脉综合征患者在经皮冠状动脉介入治疗后72小时内随机分为强化降脂治疗（ILLT）组和标准药物治疗（SMT）组。ILLT组采用单次低密度脂蛋白去除术联合他汀类药物，SMT组仅采用无低密度脂蛋白去除术的他汀类药物治疗。试验目标包括主要安全性和主要有效性终点以及外周血中内皮祖细胞集落形成单位的动员情况。
出院时，ILLT组的平均LDL较基线水平降低了53%，SMT组降低了17%（<0.0001），基线水平分别为116.3±34.3和110.7±32mg/dL（P = 0.2979）。两组主要经皮冠状动脉介入治疗不良事件这一主要安全性终点的发生率相似（ILLT组3例，SMT组0例）。主要有效性终点，即血管内超声检查显示90天时总斑块体积的百分比变化，ILLT组平均下降了4.81%，SMT组平均增加了2.31%（均值差异为-7.13 [ 95% CI，-14.59至0.34 ]；P = 0.0611）。ILLT组总斑块体积的原始变化平均比SMT组下降得更多（-6.01对-0.95mm；均值差异为-
