What the trial was testing
The PRECISE enrolled 2,103 patients with coronary artery disease. The study was sponsored by HeartFlow, Inc. and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
Researchers followed patients through treatment and into recovery, tracking the outcomes that mattered most for the disease being studied.
What the results showed
64% of low-risk patients never needed testing, and none had a heart attack or died.
JAMA cardiology · 2023 · NCT03702244
These findings — that far fewer patients had bad outcomes when testing was deferred for low-risk people — were published in the JAMA cardiology and represent the headline result of the study.
Researchers tracked outcomes across 2,103 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with coronary artery disease, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
This approach is not yet standard practice. If you have chest pain but your doctor thinks your risk is very low, this study suggests it may be safe to wait on testing. Talk to your cardiologist about whether the PROMISE minimal risk score applies to you and whether deferring tests makes sense for your situation.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open coronary artery disease trials
The FOCUS-ADHF Registry
Acute heart failure (AHF) represents a significant clinical and economic burden due to its impact on patients' quality of life, poor prognosis, and high healthcare costs. Despite advancements in treatment, the optimal therapeutic management of these patients, particularly those with severely reduced ejection fraction and dilated left ventricles, remains uncertain. The last European Society of Cardiology (ESC) guidelines gave a weak recommendation for using intravenous (IV) vasodilators in patients with adequate systolic blood pressure. This is derived from heterogeneous randomized controlled trials (RCTs) enrolling all-comers heart failure patients. Those studies did not specifically target conditions that from a pathophysiological perspective might derive potential positive response from vasodilators like left ventricle dilatation, significant mitral regurgitation and/or increased filling pressure. Patients with such characteristics show higher myocardial wall tension and are particularly vulnerable to afterload increases, positioning them as optimal candidates for vasodilator therapy during acute decompensation. Little evidence is available from real world cohort study on the benefit of vasodilators in this group of patients. Many of these studies used pre-defined protocol and invasive hemodynamic monitoring. On the contrary the use of echocardiographic evaluation to phenotype, infer hemodynamic parameters and assess treatment effect has become the most common adopted technique in real life. The present prospective registry aims to investigate acute treatment management and outcomes in a focused population of patients admitted for an acute decompensation of heart failure (ADHF) with severely reduced ejection fraction and dilated left ventricle or significant functional mitral regurgitation. Inclusion Criteria: * Patients within 24h since admission for an ADHF defined as 1. signs and symptoms of volume overload with necessity of iv diuretic treatment. 2. and NT-proBNP (N-terminal pro-B-type natriuretic peptide) \>1500 pg/mL or a B-type natriuretic peptide level of \>500 ng/mL. • Admission echocardiography with evidence of a dilated left ventricle and/or at least moderate functional mitral regurgitation (FMR), reduced ejection fraction (\<40%), increased LV (II/III degree diastolic dysfunction) and pulmonary pressure (sPAP ≥ 40 mmHg or MPAP ≥ 20 mmHg). Exclusion Criteria: \- Cardiogenic shock at admission warranting immediate MCS / inotropic support, severe renal or hepatic impairment, recent myocardial infarction, and other terminal illnesses. * Use of vasopressors/inotropes or mechanical support at admission. Methods Patients will receive treatments according to their physician's discretion based on ESC guidelines. Serial evaluations of heart function will be conducted using echocardiography and lung ultrasound (LUS) at multiple time points as well as hemodynamic data, laboratory and HF medications' prescription and dosages Primary endpoint * 3 months incidence of need of Heart Replacement Therapies (LVAD or heart transplantation) and/or heart failure re-hospitalization and/or all-cause death. Secondary endpoints • In hospital and 3 months All-cause death • All cause and HF related hospitalizations within 3 months • Heart replacement therapies (LVAD or heart transplantation) within 3 months. • In hospital Worsening Heart Failure (WHF) • Need of renal replacement therapy (RRT) within 3 months • In-hospital length of stay (days), NT-proBNP variations, GDMT and diuretics prescription and dosages up to three months; Objectives: <!-- --> 1. To describe the acute therapeutic management and discharge prescriptions for heart failure medications, including doses, in a selected population with ADHF. 2. To evaluate clinical outcomes and NT-proBNP variation in relation to initial intravenous medications, particularly comparing the use versus non-use of vasodilators. 3. To identify the incidence and timing of a significant therapeutic response through serial evaluations of LUS and echo-derived parameters, and to examine their association with the initial intravenous medications prescribed. 4. To investigate the association between the criteria for therapeutic response and clinical outcomes in both short- and medium-term follow-up, with a focus on the relationship to the initially administered therapy.
Predictive Value of Glycemic Parameters Measured With the FSL Pro iQ During ACS
Disorders of glycemic regulation are common in patients hospitalized for acute coronary syndrome (ACS). Abnormal glycaemia is observed in 50% of cases, in 30-40% diabetes, and in 25-35% fasting hyperglycaemia or glucose intolerance. Hyperglycemia is a major prognostic factor in ACS, with admission hyperglycemia having independent prognostic value for both short- and long-term major cardiovascular events (MACE), regardless of the presence of diabetes. Metabolically, several situations can be distinguished: * Hyperglycaemia occurs in known non-diabetic ACS subjects. It can be indicative of (i) Type 2 Diabetes or (ii) stress hyperglycaemia (diagnostic threshold for blood sugar varies according to learned societies, with HbA1c \< 6.5%). * Hyperglycaemia occurs in known diabetic ACS subjects Most studies use admission blood sugar as a predictor. However, it has recently been shown that glycemic variability indexes would be better predictors of MACE. Using continuous glucose measurement for 48 h, it has been shown that significant glycemic variability is a more powerful predictor of MACE at 1 year than admission glycemia The measurement of glycemic variability is mainly possible thanks to the development of CGM (continuous glucose measurement). To our knowledge, no study has been interested in evaluating the predictive value of the various glycemic parameters measured by CGM. Published studies have used continuous glucose measurements for very short periods (24 or 72 hours maximum), which limits these measurements. The freestyle libre Pro iQ (FSLPro iQ) is a professional sensor for continuous, non-invasive interstitial glucose measurement allowing the recording of glycemic parameters for 2 weeks. Our hypothesis is that glycaemic parameters, alone or in combination with each other or with other patient risk factors, measured with the Freestyle libre Pro iQ have a significant prognostic value in terms of cardiovascular clinical events at 12 months in a population of patients with ACS managed as standard and followed up.