EU-Wide Cross-Sectional Observational Study of Lipid-Modifying Therapy Use in Secondary and Primary Care: the DA VINCI study

Abstract

Aims To provide contemporary data on the implementation of European guideline recommendations for lipid-lowering therapies (LLTs) across different settings and populations and how this impacts low-density lipoprotein cholesterol (LDL-C) goal achievement. Methods and results An 18 country, cross-sectional, observational study of patients prescribed LLT for primary or secondary prevention in primary or secondary care across Europe. Between June 2017 and November 2018, data were collected at a single visit, including LLT in the preceding 12 months and most recent LDL-C. Primary outcome was the achievement of risk-based 2016 European Society of Cardiology (ESC)/European Atherosclerosis Society (EAS) LDL-C goal while receiving stabilized LLT; 2019 goal achievement was also assessed. Overall, 5888 patients (3000 primary and 2888 secondary prevention patients) were enrolled; 54% [95% confidence interval (CI) 52–56] achieved their risk-based 2016 goal and 33% (95% CI 32–35) achieved their risk-based 2019 goal. High-intensity statin monotherapy was used in 20% and 38% of very high-risk primary and secondary prevention patients, respectively. Corresponding 2016 goal attainment was 22% and 45% (17% and 22% for 2019 goals) for very high-risk primary and secondary prevention patients, respectively. Use of moderate–high-intensity statins in combination with ezetimibe (9%), or any LLT with PCSK9 inhibitors (1%), was low; corresponding 2016 and 2019 goal attainment was 53% and 20% (ezetimibe combination), and 67% and 58% (PCSK9i combination). Conclusion Gaps between clinical guidelines and clinical practice for lipid management across Europe persist, which will be exacerbated by the 2019 guidelines. Even with optimized statins, greater utilization of non-statin LLT is likely needed to reduce these gaps for patients at highest risk.

Role of Bempedoic Acid in Clinical Practice

“…Use of additional and effective add-on treatments in patients for whom statins alone do not sufficiently lower LDL-C levels, or alternative treatments for patients who cannot take statins, may help to reduce the risk of ASCVD. Despite this, a recent cross-sectional study of almost 6000 patients in 18 countries in the European Union found that combination of a statin with another lipid-lowering agent was low, including those patients who are at high and very high risk for ASCVD [6]. To date, add-on or alternative treatments to statins include primarily ezetimibe, PCSK9 inhibitors, and/or bile acid sequestrants, mainly because they have been proven to reduce LDL-C levels and cardiovascular events in randomized, placebo-controlled trials [7][8][9].…”

Practical guidance for combination lipid-modifying therapy in high- and very-high-risk patients: A statement from a European Atherosclerosis Society Task Force

“…Despite this, there is a considerable shortfall with what is put into action. Real-world data show that poor LDL-C goal attainment is an issue across all categories of high-risk and very-high-risk patients [5,6]. Limited uptake of high-intensity statin therapy [6][7][8][9][10], and underuse of ezetimibe contribute [6,11].…”

“…Real-world data show that poor LDL-C goal attainment is an issue across all categories of high-risk and very-high-risk patients [5,6]. Limited uptake of high-intensity statin therapy [6][7][8][9][10], and underuse of ezetimibe contribute [6,11]. Suboptimal treatment adherence is a major issue, due to various reasons including adverse effects (whether perceived or real), and clinician inertia [9,12,13] This EAS Task Force recognizes that the new LDL-C goals for high and very-high-risk patients with dyslipidaemia are even more demanding than previously; indeed, in real-world practice only about one-third attain LDL-C goal [6].…”

Reinforcing adherence to lipid-lowering therapy after an acute coronary syndrome: A pragmatic randomized controlled trial

“…The EUROASPIRE IV [19] reported an achievement rate of 19.5%, which climbed to 29% in EUROASPIRE V [31]. The latest LLT dedicated study -the DA VINCI study [32]-in 18 European countries demonstrated 2016 ESC/EAS goal attainment rate of 39%, even greater than the abovementioned registries. However, the gaps between clinical guidelines and clinical practice for dyslipidemia management persist and will be further exacerbated by the stricter 2019 ESC/EAS guidelines.…”

“…Concerning LLT, the EUROASPIRE IV [19], V [31], and DA VINCI [32] studies demonstrated a signi cant down-titration of statin's intensity over the rst year after the index event resulting in less than half of the patients treated with high-intensity statins at one year. The same downward trend in high-intensity utilization was also observed in IDEAL-LDL (high-intensity statin: 84.4% at discharge vs. 72.4% at 1-year).…”