Treatment Patterns and FLT3 Mutation Testing Among Patients with Acute Myeloid Leukemia in China: A Retrospective Observational Study.

Introduction: For acute myeloid leukemia (AML), prognosis is particularly poor in patients harboring FMS-like tyrosine kinase 3 (FLT3) gene mutations, though routine screening for these mutations at diagnosis has been shown to be insufficient. The understanding of the impact of FLT3 mutations on treatment decisions is limited. Methods: In this retrospective, observational study, we investigated the key epidemiological characteristics, treatment patterns and responses among adult patients with newly diagnosed (ND) AML in China, who initiated treatment from January 1, 2015, to December 31, 2019, or progressed to relapsed/refractory (R/R) AML by December 31, 2020. Results: Of the 853 ND AML patients included, 63.4% were screened for FLT3 status, and 20.1% tested positive (FLT3MUT) at initial diagnosis. Of 289 patients who progressed to R/R AML during the study period, 24.9% were screened at the diagnosis of R/R AML, and 19.4% tested positive; 20.5% of screened patients changed FLT3 status at first diagnosis of R/R AML. Initial treatment regimens or treatment responses did not seem to differ in patients with ND AML by FLT3 mutation status. In patients with R/R AML, there was an apparent difference in second-line treatment choices by FLT3 mutation status; however, the number of FLT3-mutated patients were limited to demonstrate any meaningful distinction. FLT3-mutated R/R AML was associated with shorter relapse time. Conclusion: Study findings showed that there was a lack of routine testing for FLT3 mutations at first diagnosis of R/R AML, and initial treatment decisions did not differ by FLT3 mutation status. Given the clinical burden of FLT3MUT, likelihood of FLT3 status changes, and emerging FLT3 inhibitors, further routine FLT3 screening is needed to optimize treatment of R/R AML.

Cost-effectiveness analysis of the orbital atherectomy system: Two-year follow-up.

BACKGROUND: The presence of coronary artery calcification is associated with a significant burden of coronary artery disease along with being a predictor of increased adverse ischemic events. The Diamondback 360® Coronary Orbital Atherectomy System (OAS) is a novel device designed to facilitate treatment of calcified lesions. This study aimed to evaluate the cost-effectiveness of OAS compared to standard treatment. METHODS: A decision tree model utilizing ORBIT II clinical trial and Medicare data from the health system perspective was constructed. Target population was U.S. patients age≥65 with coronary atherosclerosis due to a calcified coronary lesion, both inpatients and outpatients, and combined over a time horizon of two years for costs and lifetime for mortality. OAS was compared to standard treatment (use of balloon angioplasty to prepare stent-placement site). Outcomes were costs of index event and target vessel revascularization in two years, life-years gained, and incremental cost-effectiveness ratios (ICERs). RESULTS: On average, OAS was projected to cost $1702 less than standard treatment for inpatients, $2360 more than standard treatment for outpatients, and $959 more than standard treatment overall; the projected mortality reduction implies 0.41 life-years gained. Compared to standard treatment, OAS was dominant in an inpatient setting, had an ICER of $5759 per QALY in the outpatient setting, and had an ICER of $2340 per QALY overall. These ICERs are below the accepted threshold for highly cost-effective interventions of $50,000 per QALY. CONCLUSIONS: Compared to standard treatment, OAS is likely to be cost-effective and was projected to be cost-saving in an inpatient setting. SUMMARY: A decision tree from the health system perspective was used to evaluate the cost-effectiveness of Diamondback 360® Coronary Orbital Atherectomy System (OAS), a novel device designed to facilitate treatment of calcified lesions. OAS was projected to cost $1702 less than standard treatment for inpatients, $2360 more than standard treatment for outpatients, and $959 more than standard treatment overall; the projected mortality reduction implies 0.41 life-years gained. Compared to standard treatment, OAS was dominant in an inpatient setting, had an ICER of $5759 per QALY in the outpatient setting, and overall had an ICER of $2340 per QALY.

The clinical and cost burden of coronary calcification in a Medicare cohort: An economic model to address under-reporting and misclassification.

BACKGROUND: Coronary artery calcification (CAC) is a well-established risk factor for the occurrence of adverse ischemic events. However, the economic impact of the presence of CAC is unknown. OBJECTIVES: Through an economic model analysis, we sought to estimate the incremental impact of CAC on medical care costs and patient mortality for de novo percutaneous coronary intervention (PCI) patients in the 2012 cohort of the Medicare elderly (≥65) population. METHODS: This aggregate burden-of-illness study is incidence-based, focusing on cost and survival outcomes for an annual Medicare cohort based on the recently introduced ICD9 code for CAC. The cost analysis uses a one-year horizon, and the survival analysis considers lost life years and their economic value. RESULTS: For calendar year 2012, an estimated 200,945 index (de novo) PCI procedures were performed in this cohort. An estimated 16,000 Medicare beneficiaries (7.9%) were projected to have had severe CAC, generating an additional cost in the first year following their PCI of $3500, on average, or $56 million in total. In terms of mortality, the model projects that an additional 397 deaths would be attributable to severe CAC in 2012, resulting in 3770 lost life years, representing an estimated loss of about $377 million, when valuing lost life years at $100,000 each. CONCLUSIONS: These model-based CAC estimates, considering both moderate and severe CAC patients, suggest an annual burden of illness approaching $1.3 billion in this PCI cohort. The potential clinical and cost consequences of CAC warrant additional clinical and economic attention not only on PCI strategies for particular patients but also on reporting and coding to achieve better evidence-based decision-making.

Cardiovascular care facts: a report from the national cardiovascular data registry: 2011.

OBJECTIVES: The aim of this report was to characterize the patients, participating centers, and measures of quality of care and outcomes for 5 NCDR (National Cardiovascular Data Registry) programs: 1) ACTION (Acute Coronary Treatment and Intervention Outcomes Network) Registry-GWTG (Get With The Guidelines) for acute coronary syndromes; 2) CathPCI Registry for coronary angiography and percutaneous coronary intervention; 3) CARE (Carotid Artery Revascularization and Endarterectomy) Registry for carotid revascularization; 4) ICD Registry for implantable cardioverter defibrillators; and the 5) PINNACLE (Practice INNovation And CLinical Excellence) Registry for outpatients with cardiovascular disease (CVD). BACKGROUND: CVD is a leading cause of death and disability in the United States. The quality of care for patients with CVD is suboptimal. National registry programs, such as NCDR, permit assessments of the quality of care and outcomes for broad populations of patients with CVD. METHODS: For the year 2011, we assessed for each of the 5 NCDR programs: 1) demographic and clinical characteristics of enrolled patients; 2) key characteristics of participating centers; 3) measures of processes of care; and 4) patient outcomes. For selected variables, we assessed trends over time. RESULTS: In 2011 ACTION Registry-GWTG enrolled 119,967 patients in 567 hospitals; CathPCI enrolled 632,557 patients in 1,337 hospitals; CARE enrolled 4,934 patients in 130 hospitals; ICD enrolled 139,991 patients in 1,435 hospitals; and PINNACLE enrolled 249,198 patients (1,436,328 individual encounters) in 74 practices (1,222 individual providers). Data on performance metrics and outcomes, in some cases risk-adjusted with validated NCDR models, are presented. CONCLUSIONS: The NCDR provides a unique opportunity to understand the characteristics of large populations of patients with CVD, the centers that provide their care, quality of care provided, and important patient outcomes.

The National Cardiovascular Data Registry (NCDR) Data Quality Brief: the NCDR Data Quality Program in 2012.

OBJECTIVES: The National Cardiovascular Data Registry (NCDR) developed the Data Quality Program to meet the objectives of ensuring the completeness, consistency, and accuracy of data submitted to the observational clinical registries. The Data Quality Program consists of 3 main components: 1) a data quality report; 2) a set of internal quality assurance protocols; and 3) a yearly data audit program. BACKGROUND: Since its inception in 1997, the NCDR has been the basis for the development of performance and quality metrics, site-level quality improvement programs, and peer-reviewed health outcomes research. METHODS: Before inclusion in the registry, data are filtered through the registry-specific algorithms that require predetermined levels of completeness and consistency for submitted data fields as part of the data quality report. Internal quality assurance protocols enforce data standards before reporting. Within each registry, 300 to 625 records are audited annually in 25 randomly identified sites (i.e., 12 to 25 records per audited site). RESULTS: In the 2010 audits, the participant average raw accuracy of data abstraction for the CathPCI Registry, ICD Registry, and ACTION Registry-GWTG were, respectively, 93.1% (range, 89.4% minimum, 97.4% maximum), 91.2% (range, 83.7% minimum, 95.7% maximum), and 89.7.% (range, 85% minimum, 95% maximum). CONCLUSIONS: The 2010 audits provided evidence that many fields in the NCDR accurately represent the data from the medical charts. The American College of Cardiology Foundation is undertaking a series of initiatives aimed at creating a quality assurance rapid learning system, which, when complete, will monitor, evaluate, and improve data quality.

Patterns of antihypertensive therapy in new users of angiotensin II-receptor blockers.

PURPOSE: The patterns of angiotensin II-receptor blocker (ARB) therapy in patients with and without a history of antihypertensive use were studied. METHODS: Data for this retrospective cohort study were obtained from Caremark's data warehouse. Patients were included in the analysis if they filled prescriptions for ARBs only, did not receive ARB therapy within the 6 months before the filling of the first ARB prescription (index date), were continuously eligible for benefits for 6 months before the index date, were eligible for prescription benefits for the 12 months following the index date, and were age 20-80 years. RESULTS: Of the 174,573 patients sampled, 53.4% were new to all antihypertensive therapies. Of the patients receiving an ARB, 67.9% received another antihypertensive during the evaluation period. Over 40% of patients new to all antihypertensive therapies had no other antihypertensive added to their ARB regimen. Of the patients with a history of antihypertensive use, 22.3% discontinued all antihypertensives before starting therapy with an ARB. Patients starting therapy with losartan and valsartan were less likely to be treated with mono-therapy and more likely to be treated with ARB-diuretic therapy than were patients starting therapy with telmisartan, irbesartan, or candesartan. CONCLUSION: Patients who started antihypertensive therapy with ARBs tended to be new to antihypertensive therapy and, in a plurality of cases, continued to receive therapy with ARBs only. More than a fifth of patients who received antihypertensive therapy in the recent past were switched from that therapy to treatment with ARBs only. Treatment patterns differed by initial ARB used and the demographic profile of the patient.

Selective serotonin reuptake inhibitor usage patterns as risk factors for hospitalization.

The authors examined how differences in SSRI utilization affect the risk of hospitalization among persons with depression. In particular, they decompose how different types of drug therapy affect hospitalization and how that effect varies with the usage pattern of the drug. Using retrospective medical and pharmacy claims from a Midwestern health maintenance organization, they employed multiple logistic regression analyses of patients newly treated for depression. Their findings were that (a) paroxetine may be a significant risk factor for early discontinuation compared with fluoxetine; and (b) sertraline initiation among stable-use patients may lower the risk of hospitalization. However, initiation on paroxetine or sertraline rather than fluoxetine may increase the risk of hospitalization among patients not exhibiting a stable usage pattern.