Acute rule out of non-ST segment elevation acute coronary syndrome in the (pre)hospital setting by HEART score assessment and a single point of care troponin. The ARTICA randomized trial

Acute rule out of non-ST segment elevation acute coronary syndrome in the pre-hospital setting by HEART score assessment and a single point of care troponin. The ARTICA randomized trial. Nederlands: DOEL/VRAAGSTELLING: Het vergelijken van de kosteneffectiviteit en doelmatigheid van een prehospitale ambulance triage met aanvullende diagnostiek en behandeling bij de huisarts versus standaard ziekenhuisopname bij patienten met een laag risico op non-ST elevatie acuut coronair syndroom (NSTE-ACS) HYPOTHESE: Prehospitale triage met aanvullende eerstelijnsbehandeling is op 30 dagen kosteneffectiever dan standaard ziekenhuisopname bij patienten met laag risico NSTE-ACS. Op 12 maanden is deze strategie even veilig STUDIE OPZET: Prospectieve, gerandomiseerde, investigator-geïnitieerde multicenter studie STUDIEPOPULATIE: Patienten met een laag risico op NSTE-ACS zich uitend in een HEART-score (inclusief een negatieve troponine) gelijk of kleiner dan 3 met minimale klachtenduur van twee uur INTERVENTIE: Prehospitale triage gevolgd door behandeling via de huisarts GEBRUIKELIJKE ZORG /VERGELIJKING: Prehospitale triage gevolgd door directe verwijzing naar het ziekenhuis UITKOMSTMATEN: Primair economisch - significante afname van gezondheidszorgkosten op 30 dagen door het berekenen van de kosten per QALY. Secundair klinisch/safety- vaststellen van (de al eerder bewezen) veligheid op één, zes en 12 maanden op "major adverse cardiovascular events (MACE)": overlijden, hartinfarct en beroerte SAMPLE SIZE BEREKENING/DATA-ANALYSE: N=866, 433 per arm. Analyses worden uitgevoerd na 30 dagen (economisch én klinisch), 6 maanden (klinisch) en 12 maanden (klinisch). KOSTENEFFECTIVITEITSANALYSE/ BUDGET IMPACT ANALYSE: Indien prehospitale triage gevolgd door aanvullende behandeling via de huisarts superieur is aan een ziekenhuisverwijzing wordt een jaarlijkse kostenbesparing verwacht van meer dan 37 miljoen Euro. TIJDPAD: 36 maanden Engels: OBJECTIVE(S)/RESEARCH QUESTION(S): To assess the cost-effectiveness and efficacy of ambulance triage with further general practitioner (GP) management versus standard hospital admission in patients with symptoms suggestive for non-ST elevation acute coronary syndrome (NSTE-ACS), but with very low risk (HEART score equal or less than 3, a point-of-care (POC) troponin T level < 40 ng/l and two hour symptom duration. HYPOTHESIS: pre-hospital triage in patients with low risk of NSTE-ACS will reveal a large saving in health care resources in favor of the pre-hospital rule strategy with additional GP management. At 12 months the strategy will corroborate with a very low event rate (MACE rate < 1.5% STUDY DESIGN: Prospective, randomized controlled, investigator-initiated, multicentre study STUDY POPULATION(S)/DATASETS: Patients suspected of NSTE-ACS with symptom duration of at least two hours and a low risk profile (HEART score equal or less than 3; POC troponin T level <40 ng/l) INTERVENTION: pre-hospital triage with management by the GP USUAL CARE /COMPARISON: pre-hospital triage with standard referral to the hospital OUTCOME MEASURES The primary endpoint consists of a significant reduction in health care costs at 30 days by a decrease in health care resources and use of ambulance. The secondary endpoint will determine the safety at one, six months and 12 months in MACE SAMPLE SIZE CALCULATION/DATA ANALYSIS: For the primary endpoint, as there is still considerable uncertainty, we assume a small effect size (0,2) and equal standard deviation in both arms of the trial. Group sample sizes of 392 and 392 achieve 80% power to detect a difference of 507,0 between the null hypothesis that both group means are € 1512 and the alternative hypothesis that the mean of group 2 is € 1005 with known group standard deviations of 2533 and 2533 and with a significance level (alpha) of 0,05 using a two-sided two-sample t-test. To compensate for any loss of follow-up, the sample size is enlarged by 10% to a total of 866 patients. The economical endpoint will be assessed at 30 days. The secondary clinical endpoint will be assessed at one, six months and 12 months COST-EFFECTIVENESS ANALYSIS /BUDGET IMPACT: Cost and QALYs will be measured on a per patient basis over the relevant time path in which the (most important) differences in both measures between both arms manifest themselves. It is hypothesized that both arms of the study will not differ concerning the secondary outcome (proven safety in early studies) but will reveal a large saving (more than EUR 37 million) in health care resources in favor of the pre-hospital rule out strategy. TIME SCHEDULE: 36 months