The SANTORINI registry is an observational study that aims to evaluate the management of patients with high and very high cardiovascular (CV) risk in clinical practice, collecting data at enrolment and after 12 months. Italy participated in this study with 1531 patients at very high risk and 446 at high risk. The scope of the present analysis was to investigate low-density lipoprotein cholesterol (LDL-C) goal attainment in patients who do not qualify for PCSK9 inhibitors (PCSK9i) (according to Italian reimbursement regulations) in Italian cohort, with focus on patients in secondary prevention. The current indications for PCKS9i charged to the National Health System in Italy in secondary prevention, are for patients aged ≤ 80 years with LDL-c levels ≥ 70 mg/dl in at least three detections despite therapy for at least 6 months with high intensity statin at the highest tolerated dose and ezetimibe or after a single LDL-C detection for recent myocardial infarction or multiple cardiovascular events or with demonstrated intolerance to statins and/or ezetimibe. At enrolment, a total of 509 (33.2%) of 1531 patients at very-high risk had an LDL-C level of less than 70 mg/dl. Of them, about half do not reach the LDL-C target. In particular, 34.4% takes statin monotherapy, and 50.3% of them do not reach the target. Even patients taking high-intensity statins as monotherapy reach the target in only 47.9% of cases, leaving more than half of patients with LDL-C levels between 55 and 70 mg/dl. Regarding combination therapy, statin and ezetimibe, patients taking this combination account for 26.9%, of these those taking the combination of moderate-intensity statin and ezetimibe reach the target in 56.7% of cases while those taking high-intensity statins and ezetimibe reach the target in 51.4% of cases. Our findings show that there is a proportion of patients with LDL-C below 70 mg/dl who do not qualify for PCSK9i who are not at target for LDL-C levels despite maximal therapy with statins and ezetimibe.
The SANTORINI study is an observational study that enrolled 9606 adult patients at high or very high cardiovascular (CV) risk from 14 European countries, aiming at providing information on the management of hypercholesterolemia, in light of the new European guidelines published in 2019. The scope of the present analysis was to assess the cardiovascular risk in patients and to investigate whether the 2019 ESC/EAS guidelines for the management of dyslipidaemia are being implemented in clinical practice. Italy participated in the study with 1977 patients, of which, according to the investigators, 1531 (77.4%) were classified as very high CV risk and 446 (22.6%) as high CV risk. In 72.8% of the cases, the cardiovascular risk classification according to the most recent European ESC/EAS guidelines was applied, in 22.81% it was based on clinical experience alone, and in the remaining 4.4% on national, regional or local guidelines. Following the investigator's risk classification according to guidelines, 1144 (79.5%) patients fell into the very high cardiovascular risk and 295 (20.5%) into the high cardiovascular risk. Considering all available data, the cardiovascular risk was re-evaluated according to ESC/EAS guidelines, with 1288 (89.51%) patients being allocated to the very high-risk class and 119 (8.3%) into the high-risk class; for 32 patients (2.2%) there was no evidence to support very high-risk classification. The discrepancy shown after reassessment of patients’ risk classes highlights an underestimation of patients’ cardiovascular risk in Italian clinical practice. In fact, reclassifying the risk of the enrolled population according to guidelines shows that the percent of patients who were originally classified as very high risk rose from 79.5% to 89.5%, and those at high risk decreased from 20.5% to 8.3%. It is therefore concluded that although the investigating clinician in most cases follows the guidelines for the management of dyslipidaemia, these are not correctly applied, underestimating the cardiovascular risk of patients, especially when they belong to the highest risk classes. Considering the therapeutic goals recommended by the most recent European guidelines (LDL-C <55 mg/dL or <70 mg/dL respectively in very high or high-risk patients), only 20.33% of the overall study population achieved such goals (19.92% of very high-risk patients and 21.75% of high-risk patients). Regarding the use of hypolipidemic therapies, although most patients are at very high CV risk, overall, only 33% received combination therapy, 32.6% have no documented hypolipidemic therapy and 34.4% monotherapy. Three years after the 2019 update of the dyslipidemia guidelines, underestimation of cardiovascular risk and low utilisation of hypolipidemic combination therapies, even in patients at very high cardiovascular risk, remain important barriers to guideline implementation. This means that about 80% of patients are far from the recommended therapeutic goals for their risk category and additional measures are requested to improve the goals achievement.
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