Brigham and Women's Hospital, Boston, MA; Baim Institute for Clinical Research, Boston, MA.
Sanofi, Bridgewater, NJ.
Am Heart J. 2019 Oct;216:30-41. doi: 10.1016/j.ahj.2019.06.005. Epub 2019 Jun 12.
In patients with atherosclerotic cardiovascular disease (ASCVD), guidelines recommend statins as first-line lipid-lowering therapy (LLT) with addition of nonstatin agents in those with persistently elevated low-density lipoprotein cholesterol levels.
To estimate the cardiovascular (CV) risk reduction implications of treatment intensification, we used a previously reported simulation model with enhancements. An ASCVD cohort was developed from a US claims database. A Cox model was used to estimate baseline risk of CV events: myocardial infarction, ischemic stroke, unstable angina hospitalization, elective coronary revascularization, or cardiovascular death. Patients were sampled with replacement (bootstrapping) and entered the simulation model, which applied stepwise LLT intensification logic, with a goal of achieving low-density lipoprotein cholesterol less than 70 mg/dL at each step. CV risk reduction assumptions were based on published data. Two treatment intensification scenarios were investigated: ideal and real-world (which accounted for statin intolerance, nonadherence, and payer restrictions).
In a cohort of 1,000 patients with ASCVD, approximately 813 (809-818) would require treatment intensification with LLT under an ideal treatment intensification scenario. Before treatment intensification, 183 (179-187) events would be expected to occur over 5 years. With treatment intensification, 40 (34-45) of these events could be avoided. In a real-world scenario, about 818 (813-823) patients require treatment intensification with LLT, resulting in 29 (24-34) events avoided over 5 years.
Intensification of LLT in an ASCVD population translates into a substantial number of CV events avoided. This simulation-based model could assist in assessing the potential benefits of various types of population-level LLT interventions.
在患有动脉粥样硬化性心血管疾病（ASCVD）的患者中，指南建议将他汀类药物作为一线降脂治疗（LLT），对于低密度脂蛋白胆固醇水平持续升高的患者，可加用非他汀类药物。
为了评估治疗强化的心血管（CV）风险降低意义，我们使用了先前报告的模拟模型并进行了增强。从美国索赔数据库中开发了 ASCVD 队列。使用 Cox 模型估算 CV 事件的基线风险：心肌梗死、缺血性卒中和不稳定型心绞痛住院、择期冠状动脉血运重建或心血管死亡。患者进行了替换抽样（自举）并进入模拟模型，该模型应用逐步 LLT 强化逻辑，目标是在每个步骤中使低密度脂蛋白胆固醇低于 70mg/dL。CV 风险降低假设基于已发表的数据。研究了两种治疗强化方案：理想和现实世界（考虑了他汀类药物不耐受、不依从和支付者限制）。
在 ASCVD 患者的 1000 例队列中，大约 813 例（809-818 例）需要根据理想的治疗强化方案进行 LLT 治疗强化。在治疗强化之前，预计在 5 年内会发生 183 例（179-187 例）事件。通过治疗强化，可以避免其中的 40 例（34-45 例）事件。在现实世界的情况下，大约有 818 例（813-823 例）患者需要接受 LLT 治疗强化，导致在 5 年内避免了 29 例（24-34 例）事件。
在 ASCVD 人群中强化 LLT 可显著避免 CV 事件。这种基于模拟的模型可以帮助评估各种类型的人群 LLT 干预措施的潜在获益。
