Evaluation of cardiovascular ischemic event rates in dasatinib-treated patients using standardized incidence ratios.
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ABSTRACT:
SUBMITTER: Saglio G
PROVIDER: S-EPMC5486782 | biostudies-literature | 2017 Aug
REPOSITORIES: biostudies-literature
Publications
Evaluation of cardiovascular ischemic event rates in dasatinib-treated patients using standardized incidence ratios.
Saglio Giuseppe G le Coutre Philipp P Cortes Jorge J Mayer Jiří J Rowlings Philip P Mahon François-Xavier FX Kroog Glenn G Gooden Kyna K Subar Milayna M Shah Neil P NP
Annals of hematology 20170522 8
With high survival rates for chronic myeloid leukemia (CML) patients treated with BCR-ABL1 tyrosine kinase inhibitors (TKIs), emerging consequences, such as arterial ischemic events, require consideration when evaluating treatment options. Cardiovascular ischemic event incidence in clinical trials was evaluated in 2712 dasatinib-treated patients with Philadelphia chromosome-positive (Ph+) leukemias from 11 first- and second-line trials (pooled), newly diagnosed CML patients treated with dasatini ...[more]
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Project description:BackgroundStandardized Mortality Ratios (SMRs) are case-mix adjusted mortality rates per hospital and are used to evaluate quality of care. However, acute care is increasingly organized on a regional level, with more severe patients admitted to specialized hospitals. We hypothesize that the current case-mix adjustment insufficiently captures differences in case-mix between non-specialized and specialized hospitals. We aim to improve the SMR by adding proxies of disease severity to the model and by calculating a regional SMR (RSMR) for acute cerebrovascular disease (CVD) and myocardial infarction (MI).MethodsWe used data from the Dutch National Basic Registration of Hospital Care. We selected all admissions from 2016 to 2018. SMRs and RSMRs were calculated by dividing the observed in-hospital mortality by the expected in-hospital mortality. The expected in-hospital mortality was calculated using logistic regression with adjustment for age, sex, socioeconomic status, severity of main diagnosis, urgency of admission, Charlson comorbidity index, place of residence before admission, month/year of admission, and in-hospital mortality as outcome.ResultsThe IQR of hospital SMRs of CVD was 0.85-1.10, median 0.94, with higher SMRs for specialized hospitals (median 1.12, IQR 1.00-1.28, 71%-SMR > 1) than for non-specialized hospitals (median 0.92, IQR 0.82-1.07, 32%-SMR > 1). The IQR of RSMRs was 0.92-1.09, median 1.00. The IQR of hospital SMRs of MI was 0.76-1.14, median 0.98, with higher SMRs for specialized hospitals (median 1.00, IQR 0.89-1.25, 50%-SMR > 1 versus median 0.94, IQR 0.74-1.11, 44%-SMR > 1). The IQR of RSMRs was 0.90-1.08, median 1.00. Adjustment for proxies of disease severity mostly led to lower SMRs of specialized hospitals.ConclusionSMRs of acute regionally organized diseases do not only measure differences in quality of care between hospitals, but merely measure differences in case-mix between hospitals. Although the addition of proxies of disease severity improves the model to calculate SMRs, real disease severity scores would be preferred. However, such scores are not available in administrative data. As a consequence, the usefulness of the current SMR as quality indicator is very limited. RSMRs are potentially more useful, since they fit regional organization and might be a more valid representation of quality of care.
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Project description:PurposeTo estimate the risk of recurrent cardiovascular events in a real-world population of very high-risk Korean patients with prior myocardial infarction (MI), ischemic stroke (IS), or symptomatic peripheral artery disease (sPAD), similar to the Further cardiovascular OUtcomes Research with proprotein convertase subtilisin-kexin type 9 Inhibition in subjects with Elevated Risk (FOURIER) trial population.MethodsThis retrospective study used the Asan Medical Center Heart Registry database built on electronic medical records (EMR) from 2000 to 2016. Patients with a history of clinically evident atherosclerotic cardiovascular disease (ASCVD) with multiple risk factors were followed up for 3 years. The primary endpoint was a composite of MI, stroke, hospitalization for unstable angina, coronary revascularization, and all-cause mortality.ResultsAmong 15,820 patients, the 3-year cumulative incidence of the composite primary endpoint was 15.3% and the 3-year incidence rate was 5.7 (95% CI 5.5-5.9) per 100 person-years. At individual endpoints, the rates of deaths, MI, and IS were 0.4 (0.3-0.4), 0.9 (0.8-0.9), and 0.8 (0.7-0.9), respectively. The risk of the primary endpoint did not differ significantly between recipients of different intensities of statin therapy. Low-density lipoprotein cholesterol (LDL-C) goals were only achieved in 24.4% of patients during the first year of follow-up.ConclusionBy analyzing EMR data representing routine practice in Korea, we found that patients with very high-risk ASCVD were at substantial risk of further cardiovascular events in 3 years. Given the observed risk of recurrent events with suboptimal lipid management by statin, additional treatment to control LDL-C might be necessary to reduce the burden of further cardiovascular events for very high-risk ASCVD patients.
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Project description:BackgroundMost epidemiological risk indicators strongly depend on the age composition of populations, which makes the direct comparison of raw (unstandardized) indicators misleading because of the different age structures of the spatial units of study. Age-standardized rates (ASR) are a common solution for overcoming this confusing effect. The main drawback of ASRs is that they depend on age-specific rates which, when working with small areas, are often based on very few, or no, observed cases for most age groups. A similar effect occurs with life expectancy at birth and many more epidemiological indicators, which makes standardized mortality ratios (SMR) the omnipresent risk indicator for small areas epidemiologic studies.MethodsTo deal with this issue, a multivariate smoothing model, the M-model, is proposed in order to fit the age-specific probabilities of death (PoDs) for each spatial unit, which assumes dependence between closer age groups and spatial units. This age-space dependence structure enables information to be transferred between neighboring consecutive age groups and neighboring areas, at the same time, providing more reliable age-specific PoDs estimates.ResultsThree case studies are presented to illustrate the wide range of applications that smoothed age specific PoDs have in practice . The first case study shows the application of the model to a geographical study of lung cancer mortality in women. This study illustrates the convenience of considering age-space interactions in geographical studies and to explore the different spatial risk patterns shown by the different age groups. Second, the model is also applied to the study of ischaemic heart disease mortality in women in two cities at the census tract level. Smoothed age-standardized rates are derived and compared for the census tracts of both cities, illustrating some advantages of this mortality indicator over traditional SMRs. In the latest case study, the model is applied to estimate smoothed life expectancy (LE), which is the most widely used synthetic indicator for characterizing overall mortality differences when (not so small) spatial units are considered.ConclusionOur age-space model is an appropriate and flexible proposal that provides more reliable estimates of the probabilities of death, which allow the calculation of enhanced epidemiological indicators (smoothed ASR, smoothed LE), thus providing alternatives to traditional SMR-based studies of small areas.
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Project description:BackgroundThere is a lack of comprehensive view of the association between acute exacerbation of COPD (AECOPD) and the risk of acute cardiovascular events.ObjectiveTo determine the association of AECOPD with 30-day and 1-year incidences of acute cardiovascular event.DesignSelf-controlled case series analysis using population-based datasets from three US states from 2005 through 2011.ParticipantsPatients aged ≥ 40 years with AECOPD.Main measuresThe primary outcome was a composite of an ED visit or hospitalization for acute cardiovascular events, including acute myocardial infarction, heart failure, atrial fibrillation, pulmonary embolism, and stroke. We compared the incidence of each patient's acute cardiovascular event during the first 30-day period before the index AECOPD (30-day reference period) in comparison with that during the 30-day period after the index AECOPD. Likewise, with the 1-year period before the index AECOPD as reference, we also estimated incidence rate ratios (IRRs) for each patient's outcomes during 1-year period after the index AECOPD.Key resultsOverall, there were 362,867 patients with an ED visit or hospitalization for AECOPD. Compared with the 30-day reference period, the incidence of acute cardiovascular event in the 30-day period after the AECOPD was significantly higher (IRR, 1.34; 95%CI, 1.30-1.39; P < 0.001). Likewise, compared with the 1-year reference period, the incidence during the 1-year period after the AECOPD was also higher (IRR, 1.20; 95%CI, 1.18-1.22; P < 0.001). For each of acute cardiovascular conditions, the associations remained significant (all P < 0.05).ConclusionsAECOPD was associated with increased 30-day and 1-year incidences of acute cardiovascular event.
| S-EPMC6108996 | biostudies-literature
Project description:BackgroundHomozygous familial hypercholesterolaemia (HoFH) is characterized by a markedly increased risk of premature cardiovascular (CV) events and cardiac death. Lomitapide reduces low-density lipoprotein cholesterol (LDL-C) levels; however, the probable impact on LDL-C goals and CV events is unknown.MethodsWe used data collected in the first 26 weeks of the lomitapide pivotal phase 3 study (NCT00730236) to evaluate achievement of European Atherosclerosis Society (EAS) LDL-C targets. We used publicly available data reporting major adverse CV events (MACE) rates from other cohorts of HoFH patients to compare event rates for an equivalent number of patient years of exposure (98) in the lomitapide extension trial (NCT00943306).ResultsTwenty-nine patients were included in the phase 3 study. During the first 26 weeks, 15 (51%) and eight (28%) reached LDL-C targets of 100 mg/dL and 70 mg/dL, respectively, at least once. Fourteen (74%) and 11 (58%) of the 19 patients who remained in the extension study after week 126 reached LDL-C targets of 100 mg/dL and 70 mg/dL at least once during the entire study period. Only two MACE were reported in the lomitapide trials (one cardiac death and one coronary artery bypass graft (CABG)) - equivalent to 1.7 events per 1000 patient months of treatment. MACE rates were 21.7, 9.5 and 1.8 per 1000 patient-months respectively in cohorts of HoFH patients pre- and post-mipomersen, and receiving evolocumab. On treatment LDL-C levels were 166, 331 and 286 mg/dL for lomitapide, mipomersen and evolocumab, respectively.ConclusionsApproximately three quarters and half of patients who took lomitapide for at least 2 years reached LDL-C goals of 100 mg/dL and 70 mg/dL, respectively. There were fewer major CV events per 1000 patient months of treatment in patients taking lomitapide, mipomersen or evolocumab than reported in the mipomersen cohort prior to starting mipomersen. These results support the hypothesis that novel lipid-lowering therapies may reduce CV events in HoFH patients by lowering LDL-C further.Trial registrationNCT00730236 (registered 8 Aug 2008) and NCT00943306 (registered 22 July 2009).
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Project description:AimsCardiovascular risk assessment beyond traditional risk factors in subjects with prediabetes is not well-established. Here, we evaluated the utility of N-terminal pro-B-type natriuretic peptide (NT-proBNP) in predicting incident adverse cardiovascular outcomes in prediabetic subjects.MethodsNT-proBNP was analyzed in 3,235 stable subjects with prediabetes undergoing cardiovascular risk evaluation and followed for both 3-year major adverse cardiac events (MACE; death, myocardial infarction, stroke), and 5-year all-cause mortality.ResultsUsing Cox proportional hazard models, we found that plasma NT-proBNP was associated with incident (3-year) MACE risk (Q4 vs Q1, HR 6.04 [95%CI 4.17-8.76], P < 0.001) and 5-year mortality risk (HR 8.64 [95%CI 5.78-12.9], P < 0.001). These associations remained significant after adjustments for traditional cardiovascular risk factors, multiple indices of glycemic control, cardiovascular disease (CVD), left ventricular ejection fraction (LVEF), and medication (e.g. diuretic) use (adjusted HR for 3-year MACE 2.65 [95% CI 1.16-6.05], P < 0.05; and adjusted HR for 5-year mortality 3.45 [95% CI 1.42-8.39], P < 0.01). NT-proBNP significantly improved the clinical prognostic value (C-statistic, NRI, IDI) for both 3-year MACE and 5-year death when added to models.ConclusionsNT-proBNP independently predicts increased long-term MACE and mortality risks in prediabetic subjects, and may help identify those for whom more aggressive global preventive efforts are indicated.
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Project description:BackgroundThere is substantial evidence that systemic anticancer therapies and radiotherapy can increase the long-term risk of cardiovascular disease (CVD). Optimal management decisions for cancer patients therefore need to take into account the likely risks from a proposed treatment option, as well as its likely benefits. For CVD, the magnitude of the risk depends on the incidence of the disease in the general population to which the patient belongs, including variation with age and sex, as well as on the treatment option under consideration. The aim of this paper is to provide estimates of CVD incidence rates in the general population of England for use in cardio-oncology and in other relevant clinical, research and health policy contexts.MethodsWe studied a population-based representative cohort, consisting of 2,633,472 individuals, derived by electronic linkage of records from primary care with those of admitted-patient care in England during April 1, 2010, to April 1, 2015. From 38 individual CVDs available via the linked dataset we identified five relevant categories of CVD whose risk may be increased by cancer treatments: four of heart disease and one of stroke.ResultsWe calculated incidence rates by age-group and sex for all relevant CVD categories combined, for the four relevant categories of heart disease combined, and for the five relevant CVD categories separately. We present separate incidence rates for all 38 individual CVDs available via the linked dataset. We also illustrate how our data can be used to estimate absolute CVD risks in a range of people with Hodgkin lymphoma treated with chemotherapy and radiotherapy.ConclusionsOur results provide population-based CVD incidence rates for a variety of uses, including the estimation of absolute risks of CVD from cancer treatments, thus helping patients and clinicians to make appropriate individualized cancer treatment decisions. Graphical Abstract: Cardiovascular incidence rates for use in cardio-oncology and elsewhere: A presentation of age- and sex-specific cardiovascular disease (CVD) incidence rates for use in calculation of absolute cardiovascular risks of cancer treatments, and in other clinical, research and health policy contexts. Abbreviations - CVD: cardiovascular disease; y: years.
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Project description:Assessment of the influence of cardiovascular risk factors (CVRF) on cardiovascular event (CVE) using machine learning algorithms offers some advantages over preexisting scoring systems, and better enables personalized medicine approaches to cardiovascular prevention. Using data from four different sources, we evaluated the outcomes of three machine learning algorithms for CVE prediction using different combinations of predictive variables and analysed the influence of different CVRF-related variables on CVE prediction when included in these algorithms. A cohort study based on a male cohort of workers applying populational data was conducted. The population of the study consisted of 3746 males. For descriptive analyses, mean and standard deviation were used for quantitative variables, and percentages for categorical ones. Machine learning algorithms used were XGBoost, Random Forest and Naïve Bayes (NB). They were applied to two groups of variables: i) age, physical status, Hypercholesterolemia (HC), Hypertension, and Diabetes Mellitus (DM) and ii) these variables plus treatment exposure, based on the adherence to the treatment for DM, hypertension and HC. All methods point out to the age as the most influential variable in the incidence of a CVE. When considering treatment exposure, it was more influential than any other CVRF, which changed its influence depending on the model and algorithm applied. According to the performance of the algorithms, the most accurate was Random Forest when treatment exposure was considered (F1 score 0.84), followed by XGBoost. Adherence to treatment showed to be an important variable in the risk of having a CVE. These algorithms could be applied to create models for every population, and they can be used in primary care to manage interventions personalized for every subject.
| S-EPMC10653526 | biostudies-literature
Project description:BackgroundTo manage the risk factors and to improve clinical outcomes, patients with stroke commonly receive multiple cardiovascular medications. However, there is a lack of evidence on the optimum combination of medication therapy in the primary care setting after ischemic stroke. Therefore, this study aimed to investigate the effect of multiple cardiovascular medications on long-term survival after an incident stroke event (ischemic stroke or transient ischemic attack (TIA)).MethodsThis study consisted of 52,619 patients aged 45 and above with an incident stroke event between 2007 and 2016 in The Health Improvement Network database. We estimated the risk of all-cause mortality in patients with multiple cardiovascular medications versus monotherapy using a marginal structural model.ResultsDuring an average follow-up of 3.6 years, there were 9230 deaths (7635 in multiple cardiovascular medication groups and 1595 in the monotherapy group). Compared with patients prescribed monotherapy only, the HRs of mortality were 0.82 (95% CI 0.75-0.89) for two medications, 0.65 (0.59-0.70) for three medications, 0.61 (0.56-0.67) for four medications, 0.60 (0.54-0.66) for five medications and 0.66 (0.59-0.74) for ≥ six medications. Patients with any four classes of antiplatelet agents (APAs), lipid-regulating medications (LRMs), angiotensin-converting enzyme inhibitors (ACEIs)/angiotensin receptor blockers (ARBs), beta-blockers, diuretics and calcium channel blockers (CCBs) had the lowest risk of mortality (HR 0.51, 95% CI 0.46-0.57) versus any one class. The combination containing APAs, LRMs, ACEIs/ARBs and CCBs was associated with a 61% (95% CI 53-68%) lower risk of mortality compared with APAs alone.ConclusionOur results suggested that combination therapy of four or five cardiovascular medications may be optimal to improve long-term survival after incident ischemic stroke or TIA. APAs, LRMs, ACEIs/ARBs and CCBs were the optimal constituents of combination therapy in the present study.
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