Guided Optimisation of Long-term Disease rEduction in secoNdary Prevention of CVD (GOLDEN). A Prospective Observational Study of Long-term Outcomes.
Guided Optimisation of Long-term Disease rEduction in secoNdary Prevention of CVD (GOLDEN). A Prospective Observational Study of Long-term Outcomes.
The goal of this observational study is to evaluate the implementation of a 'first-time-right' pharmacological treatment strategy in patients hospitalized with coronary artery disease.
The main question it aims to answer is:
Does early (immediately post-event) initiation of a full set of guideline-based, individualized, preventive medication lead to reductions in cardiovascular events compared to current practice (incremental titration strategies)?
Researchers will compare the 'first-time-right' strategy group to the current practice group to see if there are improvements in major adverse cardiac and cerebrovascular events (MACE) at 36 months.
Participants will:
Rationale:
Individuals with clinically established coronary artery disease are at high risk of recurrent events and death. To reduce this risk, incremental titration of preventive medication to reach pre-defined risk factor targets is recommended by international guidelines.
However, using this approach, disappointing reductions in risk are generally attained, mainly resulting from inadequate use of preventive medication. The European 2021 Prevention guidelines recommend compressing preventive strategies into a maximum of two steps: first, attainment of 'minimal' risk-factor targets, followed by rapid individualized residual risk management (1). While the conventional interpretation of preventive guidelines has led to medication titration over months or even years, - with suboptimal results, the new guideline-based approach de facto constitutes a front-loaded, 'first- time-right' strategy, where as early as during hospitalization, a complete medication plan is formulated and implemented. However, the practical implementation and effects on clinical outcomes of such a strategy have not been investigated. The investigators therefore aim to investigate the effects of implementing a 'first-time-right' guideline-based pharmacological treatment strategy, compared to current incremental, individual-titration strategies, in patients hospitalized with coronary artery disease. As both treatment strategies constitute a different application of current international guidelines, no experimental treatments are included. The investigators will therefore conduct an observational study to investigate the effects of both strategies. The investigators hypothesize that application of the first-time-right pharmacological strategy, i.e. early (immediately post-event) initiation of a full set of guideline-based, individualized, preventive medications will lead to greater risk factor control, and to reductions in cardiovascular events, compared to current practice (i.e. incremental titration strategies).
Goals:
Primary Objective: To evaluate the impact of a 'first-time-right' pharmacological risk factor management strategy, according to the European 2021 Prevention guidelines, compared with current practice (i.e. incremental titration) on major adverse cardiac- and cerebrovascular events (MACE, 4-point: CVD death, myocardial infarction, (ischemic or hemorrhagic) stroke, and ischemia-driven revascularization) at 36 months. Secondary objectives: CVD death, myocardial infarction, stroke, and ischemia-driven revascularization (plus in 2 and 3-point MACE combinations), acute limb ischemia, carotid revascularization, unplanned cardiovascular hospital readmission, improvement in cardiovascular risk factors (drug- targeted and lifestyle-related risk factors), self-reported medication use and adherence scores, quality of life.
Study design:
GOLDEN is a prospective, observational study designed to evaluate the implementation of the guideline-based 'first-time-right' strategy in at least 30 cardiology departments in the Netherlands (Figure 1, Appendix). Study supervision, including data management and statistical analyses of the study, will be performed and coordinated at the Amsterdam UMC, assisted by the Dutch Network forCardiovascular Research (WCN), Utrecht, The Netherlands.
The study will be embedded in the collaboration of the partners of the Dutch Cardiovascular Alliance, supporting the goal of reducing the cardiovascular disease burden in The Netherlands by collaboration in research and implementation. Amsterdam UMC has the role of sponsor and is responsible for the scientific and operational leadership. When all relevant national partners support the implementation goal of First Time Right, participating centers will be recruited within the academic centers (through NetherLands Heart Institute, NLHI) and non-academic centers (through the Dutch Network for Cardiovascular Research, WCN), Utrecht, The Netherlands. Patient data will be captured and stored in an electronic database (Castor) and will only be available for the investigator (sponsor). WCN (Werkgroep Cardiologische centra Nederland) is a research network of cardiovascular investigators (www.WCN.life). The network consists of nearly 60 cardiovascular research departments across the Netherlands. The WCN office provides central support to both the sponsor and the participating sites through central feasibility, site ID, contracting, recruitment and quality support. The research professionals are employed by each individual site. Data on patient inclusion and data quality will be shared with WCN for quality assurance purposes. No individual patient data will be shared with WCN.
Our observational study comprises two groups:1) The 'current practice' group, constituting current secondary prevention practices treated patients (i.e. incremental, individual titration at treating physician's discretion) 2) The 'first-time-right' group, when the 'first- time-right' guideline-based strategy is implemented. The study program is outlined in Figure 2 (Appendix). All centers will start including in the 'current practice' arm. After inclusion of 50% of the sample size, a blanking period of 8 weeks will be observed, where no inclusions will take place in any center. This time period will be used to train all participating centers in the 'first-time-right' strategy.
Subsequently, all centers will proceed to include in the 'first-time- right' cohort. The 'current practice' treated patients' group will provide data on current practices in the preventive treatment after hospitalization for acute coronary syndrome or coronary revascularization.
Inclusion Criteria:
Exclusion Criteria:
m.vandenbogaart@amsterdamumc.nl003120 5660703
m.snaterse@amsterdamumc.nl