TripleAiM1: a nationwide registry of de novo metastatic hormone-sensitive prostate cancer with prospective quality-of-life assessment.

INTRODUCTION: The treatment landscape for de novo metastatic hormone sensitive prostate cancer (mHSPC) is rapidly evolving. With an abundance of available treatment strategies, selecting the optimal strategy for an individual patient is becoming increasingly challenging. TripleAiM1 aims to evaluate the impact of mHSPC treatments on health-related quality of life (HRQoL) and to provide real-world data insights on diagnostics, treatment strategies, patient subgroups and related healthcare expenditure for mHSPC. The aspirational target of TripleAiM1 is that in the near future, a more tailored therapy can be offered based on the individual patient's wishes and needs in accordance with the overarching principle of value-based healthcare. METHODS AND ANALYSIS: We describe the TripleAiM1 study design; a nationwide registry comprising a retrospective and prospective cohort of patients with de novo mHSPC. Starting in May 2020, eligible patients are identified, selected and recruited in 14 participating hospitals in the Netherlands. Our hypothesis is that, in a real-world setting, differences in clinically meaningful HRQoL deterioration will be observed for treatment strategies over time. HRQoL data, assessed with patient-reported outcome measures, costs and clinical data will be collected for 24 months.For the retrospective cohort, all patients diagnosed with de novo mHSPC from January 2017 onwards are eligible for inclusion. Patient and tumour characteristics, imaging modalities and treatment patterns will be analysed descriptively to provide a real-world overview.Time-to-event endpoints will be assessed using the Kaplan-Meier method and regression models will be employed to analyse baseline characteristics associated with an increased likelihood of death, progression and HRQoL deterioration. Longitudinal mixed-effects models will be employed to assess change of patient-reported outcome scores from baseline until the end of follow-up. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Medical Research Ethics Committee, Twente. Study results will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NL9719.

Long-Term Prognosis of Patients With Intramural Course of Coronary Arteries Assessed With CT Angiography.

OBJECTIVES: The aim of the present study was to evaluate, in low-to-intermediate pre-test probability patients who were referred for coronary computed tomography angiography (CTA) and did not show obstructive coronary artery disease (CAD), whether an intramural course of a coronary artery is associated with worse outcome compared with patients without an intramural course of the coronary arteries. BACKGROUND: The prognostic value of an intramural course of the coronary arteries on coronary CTA in patients without obstructive CAD is not well-known. METHODS: The study population consisted of 947 patients with a low-to-intermediate pre-test probability who were referred for coronary CTA and who did not have obstructive CAD. During follow-up, the occurrence of unstable angina pectoris that required hospitalization, nonfatal myocardial infarction, and all-cause mortality was evaluated. RESULTS: On coronary CTA, 210 patients (22%) had an intramural course of a coronary artery. The median depth of the intramural course was 1.9 mm (interquartile range: 1.4 to 2.6 mm). In 84 patients (40%), the depth of the intramural course was considered deep (>2 mm surrounded by myocardium). During a median follow-up of 4.9 years (interquartile range: 3.2 to 6.9 years), a total of 43 events occurred: hospitalization due to unstable angina pectoris in 13 patients (1.4%); 7 patients (0.7%) had a nonfatal myocardial infarction; and 23 patients died (2.4%). The 6-year cumulative event rate of unstable angina pectoris requiring hospitalization (0.0% vs. 1.1%), nonfatal myocardial infarction (0.5% vs. 0.4%), all-cause mortality (1.9% vs. 2.2%) as well as the combined endpoint of all 3 events (2.4% vs. 3.7%) was similar in patients with and without an intramural course of a coronary artery. CONCLUSIONS: In patients without obstructive CAD on coronary CTA, the presence of an intramural course of a coronary artery was not associated with worse outcome.