A gap between guidelines and clinical practice for lipid management
EU-Wide Cross-Sectional Observational Study of Lipid-Modifying Therapy Use in Secondary and Primary Care: the DA VINCI study
Introduction and methods
The 2016 and 2019 EAS/ESC dyslipidemia guidelines recommend that LDL-c goals, as well as a 50% reduction in LDL-c should be achieved in patients at high or very high CV risk [1,2]. Recent surveys evaluating use of lipid-lowering therapy (LLT) and achievement of LDL-c goals described in 2016 guidelines in patients with coronary artery disease showed low attainment goal . Even lower goals for LDL-c are recommended in the 2019 guidelines for patients with very high, high and moderate risk. It is unclear what the achievement of these lower goals in the 2019 guidelines is and whether statin use alone is sufficient to achieve these lower goals.
Therefore, the DA VINCI study (EU-Wide Cross-Sectional Observational Study of Lipid-Modifying Therapy Use in Secondary and Primary Care) was performed to provide contemporary information regarding LDL-c goal attainment of patients across Europe in diverse healthcare settings.
The DA VINCI was a cross-sectional study enrolling 5888 patients receiving LLT at primary (n=3000) and secondary (n=2888) care clinics across 18 European countries between June 2017 and November 2018. Data were collected from medical records at a single (enrolment) visit. Primary outcome was the proportion of patients achieving the risk-based LDL-c goals recommended by the 2016 ESC/EAS guidelines while receiving LLT. Patients in the primary prevention setting were classified as low, moderate, high or very high risk based on 10-year CV death risk using SCORE. Patients in the secondary prevention setting were categorized as very high risk and 10-year CV risk was estimated using REACH. A post hoc analysis was conducted of the proportion of patients achieving LDL-c goals recommended in the 2019 guidelines.
- Among patients using stabilized LLT and LDL-c goal could be assessed, 94% of primary prevention patients and 94% of established ASCVD patients were on a statin. High-intensity statin use was 22% in primary prevention patients, and 42% in ASCVD patients. Moderate-intensity statins as monotherapy was the most frequent regimen across all risk categories. Ezetimibe in combination with statins was used in 9% of all patients and PCSK9 inhibitors in 1% of all patients.
- 2016 LDL-c goal attainment was reached in 54% (95%CI: 52-56) of patients. Among those at low, moderate, high and very high CV risk this was 63% (95%CI:56-70), 75% (95%CI:73-78), 63% (95%CI:59-67) and 39% (95%CI:37-41).
- In the primary prevention group, goal attainment using low-intensity statin was higher in moderate-risk patients (67%, 95%CI:55-78) than in very high-risk patients (25%, 95%CI:5-70). Few patients at very high risk attained their LDL-c goal, regardless of statin regimen. Only two patients in this group received potent statin and ezetimibe and did not achieve their goal.
- In the secondary prevention group, 39% (95%CI:37-41) achieved their LDL-c goal. Goal attainment was more likely with use of high-intensity statin (45%, 95%CI:42-49), in combination with ezetimibe (54%, 95%CI:47-61) or with PCSK9 inhibitor (67%, 95%CI: 47-82).
- Overall, less patients attained the 2019 LDL-c goals than the 2016 ones (33%, 95%CI: 32-35 vs. 54%, 95%CI; 52-56) with a lower likelihood of goal attainment with increasing risk. Goal attainment based on 2019 guideline was 18% (95%CI:17-20) of very high-risk patients.
- Among individuals at high and very high risk in the primary prevention setting, 2019 goal attainment was approximately half that of 2016 (25% vs. 63% and 11% vs. 21%, respectively).
- Among the established ASCVD group, 2019 goal attainment was approximately half that of 2016 (18% vs. 39%, respectively).
The DA VINCI study demonstrated that in patients receiving LLT 54% achieved their risk-based LDL-c goal according to the 2016 guidelines and 33% according to the 2019 guidelines. The authors conclude that ‘even with optimized statins, greater utilization of non-statin LLT is likely needed to reduce these gaps for patients at highest risk’.