Background and Aims

With 900’000 coronary angiographies (CA) per year, Germany has the highest annual per capita volume in Europe. Two thirds of these are performed in patients without acute myocardial infarction. Encouraged by a longstanding discussion, ENLIGHT-KHK (DRKS00015638) is the first prospective observational trial to evaluate guideline adherence of CA in patients with suspected obstructive stable coronary artery disease (SCAD) in Germany. The economic part of ENLIGHT-KHK aimed to evaluate the clinical and economic consequences of guideline-non-adherent use of CA in patients with SCAD from the perspective of the German Statutory Health Insurance (SHI).

Methods

901 patients were recruited by 9 different centres in North Rhine-Westphalia and Hamburg (01/2019-08/2021). Guideline-adherence was evaluated according to the German National Disease Management Guideline (GNDMG) 2019 on SCAD. To compare the clinical outcomes (i.e. MACE-events) and costs of the real guideline adherence in the observed clinical practice for use of CA with an assumed complete guideline-adherent process, a decision-analytic model was constructed. This model compared the degree of guideline-adherence (GNDMG 2019) in current clinical practice of using CA with a hypothetical complete guideline-adherence. Parameters obtained from the ENLIGHT-KHK trial included non-invasive testing, CA, revascularization, potential MACE-events (up to 30 days after CA) and medical costs (CA and non-invasive testing). The clinical data was based on health records, a standardized questionnaire and claims data from the SHI, while costs were based on claims data only. The outcomes of interest were presented as differences in costs and MACE-events per patient between the observed and an assumed complete guideline adherence. The robustness of results was analysed by sensitivity analyses.

Results

Preliminary analyses (773/901 (86% of patients enrolled)) indicated that complete guideline-adherence for using CA would be economical superior to the guideline adherence observed in the current clinical practice. Complete guideline-adherent process for using CA had a slightly lower rate of MACE-events (-0,0002) and was less expensive than that observed in clinical practice  (€ 1524 versus € 2377 per patient). Various sensitivity analyses confirmed the results.

Conclusion

The economic analysis in ENLIGHT-KHK indicates that improving guideline-adherence for CA would result in savings for the SHI. These findings can contribute to the design of incentive-based contract- and reimbursement models that may stimulate and strengthen a guideline-oriented and resource-efficient care in German healthcare setting.