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Is symptom-guided therapy after primary PCI in STEMI patients with multivessel disease cost saving, associated with improved quality of life and increased patient satisfaction compared to complete revascularization at 1 year follow up: The PERSIST trial

Projectomschrijving

Het doel van deze studie is om na te gaan of symptoom-gestuurde behandeling, na een direkte PCI in STEMI patiënten met meervaatslijden, is geassocieerd met kostenbesparing, betere kwaliteit van leven en meer patiënttevredenheid in vergelijking met complete revascularisatie. Wij hopen met de uitkomsten van de PERSIST studie aan te kunnen tonen dat een symptoom-gedreven behandeling significant goedkoper is, betere kwaliteit van leven en meer patiënttevredenheid geeft zonder een negatief effect op de klinische uitkomsten (non-inferieur effect op klinische eind komsten)

Deze studie is voortijdig gestopt. De onderzoeksvragen zijn niet (volledig) beantwoord.

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OBJECTIVE/RESEARCH QUESTION In the recent European guideline on STEMI, routine revascularization of all other lesions is recommended during the initial hospitalisation. Implementation of the guidelines may result in a serious increase in costs. STEMI patients are treated by primary PCI. Fifty percent of patients have lesions in other coronary vessels than the infarct-related coronary artery (multivessel disease). Until recently, treatment of these other lesions was guided by recurrence of symptoms and/or after ischemia testing (symptom-guided). Both strategies are considered to be in equipoise regarding hard clinical endpoints. The objective is to evaluate whether symptom-guided therapy after primary PCI in STEMI patients with multi-vessel disease is associated with reduced costs, improved quality of life and a higher patient satisfaction compared to complete revascularization. STUDY HYPOTHESES At 12 months of follow-up, patients undergoing symptom-guided therapy will have significantly fewer PCI’s compared to complete revascularization (undergoing a second PCI procedure to treat the other lesions before hospital discharge). We hypothesize that symptom-guided approach will reduce total costs, will positively affect quality of life and patients satisfaction. STUDY DESIGN This is a prospective, multicenter randomized study in STEMI patients whom have had a primary PCI and have multivessel disease. Patients will be randomized between symptom-guided therapy versus complete revascularization. STUDY POPULATION/DATASETS All adult patients with an acute myocardial infarction who undergo primary PCI and have multivessel disease are eligible for randomization. Patients with a significant left main stem stenosis are excluded. INTERVENTION The intervention consist symptom-guided treatment wherein patients will be treated by medical therapy and only in case of recurrent symptoms and/or documented ischemia subsequent revascularization will be performed. USUAL CARE/COMPARISON In the complete revascularization arm all other non-infarct related lesions will be treated in a second procedure before hospital discharge. OUTCOME MEASURES The outcomes measured are the clinical outcomes, costs, disease-specific, domain-specific and generic (enabling to derive health utilities) quality of life, and patient satisfaction. The clinical outcomes are death, myocardial infarction, urgent revascularization up to 1 year follow-up. The quality of life of the patient regarding the treatment strategy will be evaluated using the Quality of Life after Myocardial Infarction (QLMI) questionnaire and Hospital Anxiety and Depression Scale (HADS), and the EQ-5D-5L. Baseline characteristics and clinical outcomes of STEMI patients collected per centers will be obtained from ‘Meetbaar Beter’. SAMPLE SIZE CALCULATION/DATA ANALYSIS Although cost-differences and patient experience is the main focus of the study, the sample size allows for confirmation of the equipoise of both strategies in everyday clinical practice in the Netherlands. Therefore, the sample size is chosen to test whether the symptom-guided treatment is non-inferior to complete revascularization, as determined by the composite of death, myocardial infarction and urgent revascularization at 1 year. Follow up starts at the time of randomization, where planned revascularization in the complete revascularization group is not part of the endpoint. The number of patients will allow enough power to test the other study questions. To satisfy the non-inferiority hypothesis, the upper limit of the (two-sided) 95% confidence interval for the rate difference (equivalent to non-inferiority testing at a one-sided alpha level of 2.5%) had to fall below a prespecified margin of 8.0 percentage points. Under the assumption of a 8.0% event rate for the primary end point at 1 year, we estimated that we would need to enroll 362 patients for the study to have at least 80% power. Analyses will be performed with SPSS (Chicago, IL, USA). COST-EFFECTIVENESS ANALYSIS/ BUDGET IMPACT ANALYSIS An economic evaluation from a societal and health care perspective will be performed as a cost-effectiveness and cost-utility analysis. The primary outcome will be the costs per unit of the disease-specific quality of life, respectively the costs per quality adjusted life year (QALY). The time horizon will be 12 months. Additionally, the yearly financial impact on governmental, medical specialists', and paramedical health care budgets will be estimated by linking claimable reimbursements during the first year after presentation to the yearly incidence of new STEMI patients with non-culprit lesions. Budget impacts for a four-year calendar period following the year of reporting of study results will be assessed under likely, alternative diffusion scenarios of symptom-guided revascularization, if proven cost-effective. TIME SCHEDULE Start inclusion: Q3 2018 End inclusion: Q3 2019 End of FU: Q3 2020 Presentation of report: Q3 2020 Publication date: Q4 2020

Kenmerken

Projectnummer:
843004123
Looptijd: 100%
Looptijd: 100 %
2018
2019
Onderdeel van programma:
Gerelateerde subsidieronde:
Projectleider en penvoerder:
Dr. M.A.M. Beijk
Verantwoordelijke organisatie:
Amsterdam UMC - locatie AMC