Abstract 070: A Precision Medicine Test Influenced Costs of Care Among Patients Presenting With Stable Symptoms Suggestive of Obstructive Coronary Artery Disease: Economic Endpoint Analysis From the PRESET Registry

Author(s):  
Joseph Ladapo ◽  
Matthew Budoff ◽  
David Sharp ◽  
Pejman Azarmina ◽  
Lin Huang ◽  
...  

Background: Because of diagnostic uncertainty, patients with symptoms suggestive of obstructive coronary artery disease (CAD) are referred at high rates to cardiologists and advanced cardiac testing. This evaluation process may also expose patients to appreciable costs and health risks. A previously validated, blood-based test incorporating age, sex and genomic expression into an algorithmic score (1-40) has shown clinical validity in assessing the likelihood of obstructive CAD (≥50% luminal diameter stenosis by quantitative coronary angiography) early in the cardiac workup. This test has also shown clinical utility in association with decision making around cardiac referrals and helping clinicians determine the current likelihood of obstructive CAD in symptomatic patients. Hypothesis: We hypothesized that use of the age/sex/gene expression score (ASGES) test would influence cost of care in the diagnosis and management of symptomatic patients with suspected obstructive CAD. Methods: The prospective PRESET Registry (NCT01677156) enrolled stable, non-acute adult patients presenting with symptoms suggestive of obstructive CAD to 21 US primary care practices from September 2012 to August 2014. Primary care clinicians provided pre- and post-ASGES diagnosis and evaluation plans for each patient. Demographics, clinical factors, and ASGES results (predefined as low [ASGES ≤ 15] or elevated [ASGES > 15]) were collected, as were management plans post-ASGES testing, including referrals to cardiology or further functional/anatomic testing. The economic analysis for cost of care after ASGES testing was based on the cost of cardiovascular-related tests, invasive procedures, office visits, emergency room visits, and hospital admissions during 1-year follow-up. Results: This sub-analysis cohort included 560 patients, with 50% females and median age 56 years. Patients had a median ASGES score of 18, with 246 (44%) patients with ASGES < 15. The mean cost of care for patients in the year following ASGES testing was $234 (SD ±$707) in the low ASGES versus $1,296 (SD ±$5230) in the elevated ASGES group (p=0.03 by Wilcoxon rank test). Multivariate analysis incorporating patient demographics and clinical covariates showed that low ASGES was associated with a 51% reduction in cost of follow-up care compared to elevated ASGES group (p<0.001 by log-linear regression). Conclusion: In this community-based cardiovascular registry, the ASGES influenced costs in the evaluation of patients with suspected obstructive CAD. Low score patients had approximately half the cardiovascular costs of elevated score patients in one year follow-up. Our work provides evidence supporting the economic value of using precision medicine in the delivery of cardiovascular care.

Author(s):  
Joseph Ladapo ◽  
David Sharp ◽  
Bruce Maniet ◽  
Linda Ross ◽  
John Blanchard ◽  
...  

Background: Patients with symptoms suggestive of obstructive coronary artery disease (CAD) frequently undergo unnecessary testing and procedures. Approximately $5.9 billion/year is spent on non-invasive and invasive testing in the US in the non-diabetic population without a prior revascularization or myocardial infarction, yet some patients continue to be misdiagnosed. A previously validated blood-based, gene expression diagnostic test with a 96% NPV can facilitate determination of the current likelihood of CAD in a symptomatic patient. Objective: The objective of the study is to evaluate the use of the gene expression score (GES) and its effect on clinician risk stratification of patients considered for referral to cardiology in a community-based cardiovascular registry. Methods: The prospective PRESET Registry (NCT01677156) will enroll 1,000 stable, non-acute adult patients without a history of CAD from 21 US primary care practices. Primary care clinicians provide the pre- and post-GES diagnosis and evaluation plan for each patient. Demographics, clinical factors, and GES results (predefined as low [GES ≤15] or elevated [GES >15]) are collected, as well as treatment plans, diagnostic tests performed and results, and referrals to cardiology and advanced cardiac testing. Clinician and patient quality of care measures, such as satisfaction with care, are being assessed. Results: In an interim cohort of 393 patients, 199 (50.6%) were women, the median age was 55 years with 116 (29.5%) age ≥65, and the median BMI is 29.8. The median GES was 17 (range, 1-40) and 177 patients (45.0%) had low scores. In this analysis, 19 of 177 (10.7%) patients with low scores were referred to cardiology, while 105 of 216 (48.6%) patients with elevated scores were referred (OR 7.87, p<0.0001). At 30 day follow-up, no MACE were reported in patients with low scores. Longer-term follow-up is underway. Conclusion: In this interim analysis of a community-based cardiovascular registry evaluating patterns of care among patients presenting with symptoms suggestive of obstructive CAD, a personalized medicine, gene-expression based test was adopted in clinical practice and was associated with a statistically significant and clinically relevant effect on medical decision making. In conclusion, use of the GES test showed clinical utility in efficiently and safely ruling out obstructive CAD, minimizing referral of low risk patients to cardiology.


2018 ◽  
Vol 70 ◽  
pp. S28-S29
Author(s):  
Kailash Chandra ◽  
Rajendra K. Gokhroo ◽  
Rajesh Nandal ◽  
Ashish Kumar ◽  
Tarik Mohmmad Tasleem ◽  
...  

2017 ◽  
Vol 130 (4) ◽  
pp. 482.e11-482.e17 ◽  
Author(s):  
Joseph A. Ladapo ◽  
Matt Budoff ◽  
David Sharp ◽  
Michael Zapien ◽  
Lin Huang ◽  
...  

2020 ◽  
Author(s):  
Zinuan Liu ◽  
Yipu Ding ◽  
Guanhua Dou ◽  
Xia Yang ◽  
Xi Wang ◽  
...  

Abstract Background: The prognostic value of non-obstructive CAD has always been underestimated due to its moderate stenosis. Whether the atherosclerotic extent is related to the prognosis in this group of people is uncertain, especially in the presence of diabetes. We aim to investigate the prognostic value of atherosclerotic extent in diabetic patients with non-obstructive coronary artery disease (CAD).Method: The analysis was based on a single center cohort of diabetic patients referred for coronary computed tomography angiography (CCTA) due to suspect CAD. Major adverse cardiac events (MACEs) were recorded, including cardiovascular death, non-fatal myocardial infarction, stroke and unstable angina (UA) requiring hospitalization. Four groups were defined based on coronary stenosis combined with segment involvement score (SIS), a semiquantitative index of the extent of atherosclerosis, including normal, non-obstructive SIS<3, non-obstructive SIS≥3 and obstructive. Time to event was estimated by using multivariable Cox proportional hazards models. Leidon risk score was used to replace SIS for sensitivity analysis.Results: In total, 1241 patients were included (age 60.2±10.4 years, 54.1% male), experiencing 131 MACEs (10.6%) during a median follow-up of 2.6 years. Diabetic patients with non-obstructive CAD accounts for 50.2% of included population(N=623). In multi-variate Cox model adjusting for age, gender, hyperlipidemia and presence of high-risk plaque, hazard ratio (HR) for SIS < 3 and SIS ≥ 3 in non-obstructive CAD were 1.84 (95%CI: 0.70-4.79) and 3.71 (95%CI: 1.37-10.00) respectively.The latter showed a higher risk of cardiac adverse events than the former group(HR:2.02 95%CI:1.11-3.68, p=0.021), while HR for obstructive CAD was 5.46 (95%CI: 2.18-13.69). Sensitivity analysis was performed using Leidon Risk Score instead of SIS. After adjustment, HR for Leidon ≥ 5 with non-obstructive disease was 1.92(95% CI: 1.06-3.48 p=0.032)in comparison to the non-obstructive group of Leidon < 5.Conclusion: In diabetic patients with non-obstructive CAD, atherosclerotic extent was associated with higher risk of major adverse cardiac events at long-term follow-up. Efforts should be made to determine risk stratification for the management of DM patients with non-obstructive CAD.


2020 ◽  
Author(s):  
Yue Zhang ◽  
Xiaosong Ding ◽  
Bing Hua ◽  
Qingbo Liu ◽  
Hui Chen ◽  
...  

Abstract Background: Current guidelines recommend angiotensin-converting-enzyme inhibitors (ACEI) /angiotensin receptor blockers (ARB) as a first-line therapy in diabetic hypertensive patients and for secondary prevention in patients with obstructive coronary artery disease (OCAD). However, the effects of using ACEI/ARB before the initial diagnosis of OCAD on major adverse cardiac and cerebral event (MACCE) in diabetic hypertensive patients remain unclear. This study investigated whether using ACEI/ARB before the initial diagnosis of OCAD could be associated with improved clinical outcomes in diabetic hypertensive patients. Methods: A total of 2501 patients with hypertension and diabetes, who were first diagnosed with OCAD by coronary angiography, were included in the analysis. Of the 2501 patients, 1300 did not used ACEI/ARB before the initial diagnosis of OCAD [the ACEI/ARB(-) group]; 1201 did [the ACEI/ARB(+) group]. Propensity score matching at 1:1 was performed to select 1050 patients from each group. Incidence of acute myocardial infarction (AMI), infarct size in patients with AMI, heart function, and subsequent MACCE during a median of 25.4-month follow-up were determined and compared between the 2 groups. Results: Compared with the ACEI/ARB(-) group, the ACEI/ARB(+) group had significantly lower incidence of AMI (22.5% vs. 28.4%, p=0.002), smaller infarct size in patients with AMI (pTNI: 5.7 vs. 6.8 ng/ml, p=0.044; pCKMB: 21.7 vs. 28.7 ng/ml, p=0.028), better heart function (LVEF: 60.0 vs. 58.5%, p=0.002), and lower incidences of non-fatal stroke (2.4% vs. 4.6%, p=0.015) and composite MACCE (23.1% vs. 29.7%, p=0.026). No prior ACEI/ARB therapy was significantly and independently associated with non-fatal stroke and composite MACCE. Conclusions: In diabetic hypertensive patients, treatment with ACEI/ARB before the initial diagnosis with OCAD was associated with decreased incidence of AMI, smaller infarct size, improved heart function, and lower incidences of non-fatal stroke and composite MACCE. Trial registration: retrospectively registered.


2020 ◽  
Vol 13 (Suppl_1) ◽  
Author(s):  
Muhammad Soofi ◽  
Swapnil Garg ◽  
Ronald Markert ◽  
Ajay Agarwal

Background: The mortality rate of US Veterans is greater than that of civilians, and US Veterans experience disproportionately higher burden of medical comorbidities. Disparities in coronary artery disease (CAD) incidence and its risk factors between US veterans and civilians has not previously been reported. This study seeks to identify disparities in the incidence of CAD and CAD risk factors in US veterans and the general population. Methods: A total of 1535 consecutive US Veterans presenting for left heart catheterization (LHC) were reviewed. We present risk factor burden, LHC outcome, and mortality with mean follow-up time of 112 ± 65.2 months. Results: At mean follow-up of 112 months (9.3 years), all-cause mortality was 68.3%. 12.7% had normal coronaries (NC), 14.9% had non-obstructive coronary artery disease and 72.3% had obstructive coronary artery disease (ObCAD). Mean BMI was 30.0; 87.8% had hypertension (HTN), 78.1% had hyperlipidemia (HLD), 52.2% has reduced ejection fraction (rEF), 45.5% had diabetes (DM), and 17.5% had chronic kidney disease (CKD). In order of decreasing Cox hazard, six risk factors (CKD, rEF, PVD, HTN, obesity and DM) were independent predictors of mortality. Conclusion: Mortality and incidence of ObCAD in US veterans are notably greater than in the American general population (per the CDC National Health Report) and other developed countries (per the WHO NCD Report). Compared to the general population, there is greater burden of HTN, HLD, DM and CKD in US Veterans. Among US Veterans, CKD carried a greater HR compared to HTN and DM, with no significant HR for HLD. This differs markedly from the general population studied in the REACH registry which established HTN, HLD and DM as the greatest predictors of cardiovascular mortality. The low hazard of HLD was likely secondary to its ubiquity in most patients in the cohort, regardless of CAD status. US Veterans have unique healthcare needs and our study guides which risk factors need to be managed to improve disparities in US Veteran health.


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