Getting to an ImprOved Understanding of Low-Density Lipoprotein-Cholesterol and Dyslipidemia Management (GOULD): Methods and baseline data of a registry of high cardiovascular risk patients in the United States

• Published in: The American heart journal 2020-01, Vol.219, p.70-77
• Main Authors: Cannon, Christopher P., de Lemos, James A., Rosenson, Robert S., Ballantyne, Christie M., Liu, Yuyin, Yazdi, Daniel, Elliott-Davey, Mary, Mues, Katherine E., Bhatt, Deepak L., Kosiborod, Mikhail N.
• Format: Article
• Language: English
• Subjects: Aged; Arteriosclerosis; Atherosclerosis; Atherosclerosis - blood; Atherosclerosis - drug therapy; Cardiovascular disease; Cardiovascular diseases; Cholesterol; Cholesterol, LDL - blood; Clinical trials; Coronary artery; Coronary artery disease; Density; Diabetes mellitus; Diabetes mellitus (non-insulin dependent); Diabetes Mellitus, Type 2 - epidemiology; Disease control; Dyslipidemia; Dyslipidemias - blood; Dyslipidemias - drug therapy; Enrollments; Ezetimibe - therapeutic use; Female; Health risks; Heart diseases; High density lipoprotein; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use; Intolerance; Kexin; Lipids; Low density lipoprotein; Male; Metabolic disorders; Patients; Perceptions; Physicians; Proprotein Convertase 9 - antagonists & inhibitors; Proprotein convertases; Registries; Retrospective Studies; Statins; Subtilisin; Therapy; United States - epidemiology
• ISSN: 0002-8703; 1097-6744
• DOI: 10.1016/j.ahj.2019.10.014

Guidelines for managing patients with atherosclerotic cardiovascular disease (ASCVD) recommend statin therapy initially. Target levels/goals for low-density lipoprotein-cholesterol (LDL-C) were initially included, subsequently de-emphasized in 2013, and then re-introduced as thresholds, leading to confusion in clinical practice. We designed a multicenter, observational registry of patients with ASCVD, to describe and track LDL-C treatment patterns in the United States over time. Patients with ASCVD receiving any pharmacologic lipid-lowering therapy were eligible for enrollment in one of three cohorts: 1) currently receiving a proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i), or not receiving PCSK9i with 2) LDL-C 70–99 mg/dL, or 3) LDL-C ≥100 mg/dL. Patients undergo a 1-year retrospective chart review, followed by chart reviews and phone interviews every 6 months for 2 years. A total of 5006 patients were enrolled at 119 centers. Mean age was 68 years, 40% of patients were female, 86% were white, 80% had coronary artery disease, and 33% had type 2 diabetes mellitus. Among those not on a PCSK9i, high-intensity statins and ezetimibe were utilized in only 44% and 9%, respectively. Among women vs men, only 36.6% vs 48.2% received high-intensity statins (P