Abstract：
OBJECTIVE: The criteria for the use of proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) more restrictive than those approved were established in Catalonia by the Health System (CatSalut) to improve their efficiency, with different LDL-C values from which to start treatment according to risk factors. The aim of the study is to analyse adherence to these criteria and results.
METHODS: A retrospective study of patients treated with PCSK9i at Vall d\'Hebron University Hospital between 2016 and 2021 was performed using data from the Registry of Patients and Treatments and medical records. The degree of agreement with the CatSalut criteria, LDL-C-responders (decrease ≥30%), cardiovascular events and discontinuations were analysed.
RESULTS: A total of 193 patients treated with PCSK9i were followed for a median of 27 months (IQR 23). The median age was 61 (IQR 15); 62.7% were men. Seventy percent of the patients had non-familial hypercholesterolemia. Treatment was for secondary prevention of cardiovascular disease in 82.4% of cases. The median LDL-C decreased from 139 (IQR 52) to 59 (IQR 45) mg/dL. The percentage of LDL-C reduction was 61.0% (IQR 30). In 72.5% of patients, all CatSalut criteria for starting treatment were met. The rate of responders was 85.4%. During follow-up, 19 patients (9.8%) had a cardiovascular event, and 15 (7.7%) discontinued treatment, in two cases due to toxicity.
CONCLUSIONS: PCSK9i were used according to CatSalut criteria in three out of four cases. In this high-risk population, incidence of cardiovascular events was similar to that in clinical trials.
METHODS: A retrospective study of patients treated with PCSK9i at Vall d\'Hebron University Hospital between 2016 and 2021 was performed using data from the Registry of Patients and Treatments and medical records. The degree of agreement with the CatSalut criteria, LDL-C-responders (decrease ≥30%), cardiovascular events and discontinuations were analysed.
RESULTS: A total of 193 patients treated with PCSK9i were followed for a median of 27 months (IQR 23). The median age was 61 (IQR 15); 62.7% were men. Seventy percent of the patients had non-familial hypercholesterolemia. Treatment was for secondary prevention of cardiovascular disease in 82.4% of cases. The median LDL-C decreased from 139 (IQR 52) to 59 (IQR 45) mg/dL. The percentage of LDL-C reduction was 61.0% (IQR 30). In 72.5% of patients, all CatSalut criteria for starting treatment were met. The rate of responders was 85.4%. During follow-up, 19 patients (9.8%) had a cardiovascular event, and 15 (7.7%) discontinued treatment, in two cases due to toxicity.
CONCLUSIONS: PCSK9i were used according to CatSalut criteria in three out of four cases. In this high-risk population, incidence of cardiovascular events was similar to that in clinical trials.
摘要：
目的：卫生系统（CatSalut）在加泰罗尼亚建立了比批准的更严格的前蛋白转化酶枯草杆菌蛋白酶/kexin9型抑制剂（PCSK9i）使用标准，以提高其效率，根据危险因素开始治疗的LDL-C值不同。该研究的目的是分析对这些标准和结果的遵守情况。
方法：对2016年至2021年在Valld\'Hebron大学医院接受PCSK9i治疗的患者进行了回顾性研究，使用来自患者注册和治疗以及医疗记录的数据。与CatSalut标准的一致程度，LDL-C反应者（减少≥30%），分析了心血管事件和停药情况.
结果：共有193名接受PCSK9i治疗的患者随访，中位时间为27个月（IQR23）。中位年龄为61岁（IQR15）；62.7％为男性。70%的患者患有非家族性高胆固醇血症。82.4%的病例用于心血管疾病的二级预防。LDL-C中位数从139(IQR52)降至59(IQR45)mg/dL。LDL-C降低的百分比为61.0%(IQR30)。在72.5%的患者中，符合开始治疗的所有CatSalut标准.应答者的比率为85.4%。随访期间,19例患者（9.8%）发生心血管事件，和15人(7.7%)停止治疗,在两种情况下由于毒性。
结论：PCSK9i根据CatSalut标准在4例中的3例中使用。在这个高危人群中，心血管事件的发生率与临床试验相似.
方法：对2016年至2021年在Valld\'Hebron大学医院接受PCSK9i治疗的患者进行了回顾性研究，使用来自患者注册和治疗以及医疗记录的数据。与CatSalut标准的一致程度，LDL-C反应者（减少≥30%），分析了心血管事件和停药情况.
结果：共有193名接受PCSK9i治疗的患者随访，中位时间为27个月（IQR23）。中位年龄为61岁（IQR15）；62.7％为男性。70%的患者患有非家族性高胆固醇血症。82.4%的病例用于心血管疾病的二级预防。LDL-C中位数从139(IQR52)降至59(IQR45)mg/dL。LDL-C降低的百分比为61.0%(IQR30)。在72.5%的患者中，符合开始治疗的所有CatSalut标准.应答者的比率为85.4%。随访期间,19例患者（9.8%）发生心血管事件，和15人(7.7%)停止治疗,在两种情况下由于毒性。
结论：PCSK9i根据CatSalut标准在4例中的3例中使用。在这个高危人群中，心血管事件的发生率与临床试验相似.
