Importance Guidelines for patients with atherosclerotic cardiovascular disease (ASCVD) recommend intensive statin therapy and adding nonstatin therapy if low-density lipoprotein cholesterol (LDL-C) levels are 70 mg/dL or more. Compliance with guidelines is often low.

Objective To track LDL-C treatment patterns in the US over 2 years.

Design, Setting, and Participants GOULD is a prospective observational registry study involving multiple centers. Patients with ASCVD receiving any lipid-lowering therapy (LLT) were eligible. Between December 2016 and July 2018, patients were enrolled in 1 of 3 cohorts: (1) those currently receiving proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) and 2 groups not receiving PCSK9i drugs, with (2) LDL-C levels of 100 mg/dL or more or (3) LDL-C levels of 70 to 99 mg/dL. Patients had medical record reviews and telephone interviews every 6 months. Analysis was done on data collected as of October 5, 2020.

Main Outcomes and Measures The primary outcome was the change in LLT use in 2 years. Secondary outcomes included the number of LDL-C measurements, LDL-C levels, and responses to structured physician and patient questionnaires over 2 years.

Results A total of 5006 patients were enrolled (mean [SD] age, 67.8 [9.9] years; 1985 women [39.7%]; 4312 White individuals [86.1%]). At 2 years, 885 (17.1%) had LLT intensification. In the cohorts with LDL-C levels of 100 mg/dL or more and 70 to 99 mg/dL, LLT intensification occurred in 403 (22.4%) and 383 (14.4%), respectively; statins were intensified in 115 (6.4%) and 168 (6.3%), ezetimibe added in 123 (6.8%) and 118 (4.5%), and PCSK9i added in 114 (6.3%) and 58 (2.2%), respectively. In the PCSK9i cohort, 508 of 554 (91.7%) were still taking PCSK9i at 2 years. Lipid panels were measured at least once over 2 years in 3768 patients (88.5%; PCSK9i cohort, 492 [96.1%]; LDL-C levels ≥100 mg/dL or more, 1294 [85.9%]; 70-99 mg/dL, 1982 [88.6%]). Levels of LDL-C fell from medians (interquartile ranges) of 120 (108-141) mg/dL to 95 (73-118) mg/dL in the cohort with LDL-C levels of 100 mg/dL or more, 82 (75-89) to 77 (65-90) mg/dL in the cohort with LDL-C levels of 70 to 99 mg/dL, and 67 (42-104) mg/dL to 67 (42-96) mg/dL in the PCSK9i cohort. Levels of LDL-C less than 70 mg/dL at 2 years were achieved by 308 patients (21.0%) and 758 patients (33.9%) in the cohorts with LDL-C levels of 100 mg/dL or more and 70 to 99 mg/dL, respectively, and 272 patients (52.4%) in the PCSK9i cohort. At 2 years, practice characteristics were associated with more LLT intensification (teaching vs nonteaching hospitals, 148 of 589 [25.1%] vs 600 of 3607 [16.6%]; lipid protocols or none, 359 of 1612 [22.3%] vs 389 of 2584 [15.1%]; cardiology, 452 of 2087 [21.7%] vs internal or family medicine, 204 of 1745 [11.7%] and other, 92 of 364 [25.3%]; all P < .001) and achievement of LDL-C less than 70 mg/dL (teaching vs nonteaching hospitals, 173 of 488 [35.5%] vs 823 of 2986 [27.6%]; lipid protocols vs none, 451 of 1411 [32.0%] vs 545 of 2063 [26.4%]; both P < .001; cardiology, 523 of 1686 [30.1%] vs internal or family medicine, 377 of 1472 [25.6%] and other, 96 of 316 [30.4%]; P = .003).

Conclusions and Relevance Of patients with ASCVD, most with suboptimal LDL-C levels at baseline, only 17.1% had LLT intensification after 2 years, and two-thirds remained at an LDL-C level greater than 70 mg/dL. Further intensive efforts are needed to achieve optimal LDL-C management in patients with ASCVD.

动脉粥样硬化性心血管疾病 (ASCVD) 患者的重要性指南推荐强化他汀类药物治疗，如果低密度脂蛋白胆固醇 (LDL-C) 水平为 70 mg/dL 或更高，则增加非他汀类药物治疗。对准则的遵守通常很低。

目的 追踪美国 2 年内的 LDL-C 治疗模式。

设计、设置和参与者 GOULD 是一项涉及多个中心的前瞻性观察注册研究。接受任何降脂治疗 (LLT) 的 ASCVD 患者符合条件。2016 年 12 月至 2018 年 7 月期间，患者被纳入 3 个队列中的 1 个：（1）目前接受前蛋白转化酶枯草杆菌蛋白酶 / kexin 9 型抑制剂（PCSK9i）的患者和 2 组未接受 PCSK9i 药物的患者，（2）LDL-C 水平为100 mg/dL 或更高，或 (3) LDL-C 水平为 70 至 99 mg/dL。患者每 6 个月接受一次病历审查和电话采访。对截至 2020 年 10 月 5 日收集的数据进行了分析。

主要结果和措施 主要结果是 2 年内 LLT 使用的变化。次要结果包括 LDL-C 测量的数量、LDL-C 水平以及对 2 年内结构化医生和患者问卷的反应。

结果 总共招募了 5006 名患者（平均 [SD] 年龄，67.8 [9.9] 岁；1985 名女性 [39.7%]；4312 名白人 [86.1%]）。2 年时，885 (17.1%) 例 LLT 强化。在 LDL-C 水平为 100 mg/dL 或更高和 70 至 99 mg/dL 的队列中，LLT 强化分别发生在 403 (22.4%) 和 383 (14.4%)；他汀类药物在 115 (6.4%) 和 168 (6.3%) 中被强化，依折麦布在 123 (6.8%) 和 118 (4.5%) 中被强化，PCSK9i 在 114 (6.3%) 和 58 (2.2%) 中被添加。在 PCSK9i 队列中，554 人中有 508 人 (91.7%) 在 2 年时仍在服用 PCSK9i。在 3768 名患者（88.5%；PCSK9i 队列，492 [96.1%]；LDL-C 水平≥100 mg/dL 或更高，1294 [85.9%]；70-99 mg/dL）中至少测量了一次脂质组, 1982 [88.6%])。在 LDL-C 水平为 100 mg/dL 或更高的队列中，LDL-C 水平从 120 (108-141) mg/dL 的中位数（四分位距）下降到 95 (73-118) mg/dL，82 ( 75-89) 至 77 (65-90) mg/dL 的 LDL-C 水平为 70 至 99 mg/dL，和 67 (42-104) mg/dL 至 67 (42-96) mg/dL在 PCSK9i 队列中。在 LDL-C 水平为 100 mg/dL 或更高和 70 至 99 mg 的队列中，308 名患者 (21.0%) 和 758 名患者 (33.9%) 在 2 年时达到了低于 70 mg/dL 的 LDL-C 水平/dL 和 PCSK9i 队列中的 272 名患者 (52.4%)。在 2 年时，实践特征与更多的 LLT 强化相关（教学医院与非教学医院，589 家中的 148 家 [25.1%] vs 3607 家中的 600 家 [16.6%]；脂质协议或无，1612 家中的 359 家 [22.3%] vs 2584 家中的 389 家） [15.1%]；心脏病学，2087 年中的 452 [21.7%] vs 内科或家庭医学，1745 年中的 204 [11. 7%] 和其他，364 个中的 92 个 [25.3%]；全部P  < .001) 和 LDL-C 低于 70 mg/dL（教学医院与非教学医院，488 家医院中的 173 家 [35.5%] vs 2986 家医院中的 823 家 [27.6%]；脂质治疗方案与无，1411 家中的 451 家 [32.0%] ] vs 545 of 2063 [26.4%]；两者P  <.001；心脏病学，523 of 1686 [30.1%] vs 内科或家庭医学，377 of 1472 [25.6%] 和其他，96 of 316 [30.4%]；P  = .003）。

结论和相关性 在 ASCVD 患者中，大多数基线时 LDL-C 水平欠佳，只有 17.1% 的患者在 2 年后出现 LLT 强化，三分之二的患者 LDL-C 水平仍高于 70 mg/dL。需要进一步加强努力以实现 ASCVD 患者的最佳 LDL-C 管理。