Trends and consequences of lipoprotein(a) testing: Cross-sectional and longitudinal health insurance claims database analyses.

BACKGROUND AND AIMS: Lipoprotein(a) (Lp(a)) is associated with an increased risk of atherosclerotic cardiovascular disease (ASCVD). Our goal was to characterize patients undergoing Lp(a) testing and to assess the impact of Lp(a) testing on treatment changes and subsequent ASCVD events. METHODS: A cross-sectional and a longitudinal claims data analysis were performed on 4 million patient records in Germany. Patients were followed up for a maximum of 4 years. RESULTS: In 2015 and 2018, 0.25% and 0.34% of patients were tested, respectively. Testing was more frequent in younger women in the overall population, and in men in the ASCVD population. Patients tested for Lp(a) had more comorbidities and higher ASCVD risk compared to matched control patients. ASCVD hospitalizations were more frequent prior to the first Lp(a) test (5.55 vs 1.42 per 100/person-years). The mortality rate of the Lp(a)-tested cohort and the control group was similar. Mortality was lower in patients with prior ASCVD and Lp(a) testing compared to matched controls with prior ASCVD and no Lp(a) test (2.30 vs 3.64 per 100/person-years, p <0.001). Patients with Lp(a) test received more laboratory examinations and cardiovascular medications and had more visits with specialized physicians. CONCLUSIONS: Lp(a) testing is rarely performed even in patients with very high cardiovascular risk. Patients tested for Lp(a) have more comorbidities and a higher ASCVD risk. Lp(a) testing is associated with more intensive preventive treatment and with positive effects on clinical outcomes and survival. The data support the value of Lp(a) measurements to characterize ASCVD risk and to improve ASCVD prevention.

Rationale and study design of OUTSTEP-HF: a randomised controlled study to assess the effect of sacubitril/valsartan and enalapril on physical activity measured by accelerometry in patients with heart failure with reduced ejection fraction.

AIM: In PARADIGM-HF, sacubitril/valsartan demonstrated superiority to enalapril in reducing mortality and morbidity in patients with heart failure (HF) with reduced ejection fraction (HFrEF). Several patient-centred outcomes like improved physical activity and quality of life have been emphasised as important treatment goals in HF management. OUTSTEP-HF has been designed to evaluate the effect of sacubitril/valsartan compared with enalapril on non-sedentary daytime physical activity in patients with HFrEF. METHODS: OUTSTEP-HF is a randomised, actively controlled, double-blind, double-dummy study that plans to enrol 600 ambulatory patients with symptomatic HFrEF in 19 European countries. Patients will be randomised 1:1 to receive sacubitril/valsartan 97/103 mg bid or enalapril 10 mg bid. The primary objective of the study is to assess changes from baseline (Week 0) to Week 12 in exercise capacity measured by the 6-min walk test and in daily non-sedentary daytime activity. Physical activity and objective sleep parameters will be measured by accelerometry using a wrist-worn device, worn continuously from screening (Week -2) until the end of study (Week 12). As a co-primary outcome, changes from baseline in sub-maximal exercise capacity will be assessed by the 6-min walk test. Patient- and physician-reported questionnaires will be used to assess quality of life, changes in signs and symptoms of HF and sleep parameters. CONCLUSION: OUTSTEP-HF will be the largest randomised trial in HF to date to use non-invasive accelerometry to assess whether treatment with sacubitril/valsartan improves patients' daily physical activity and exercise capacity compared with enalapril.