Associations between physical activity and cataract treated surgically in patients with diabetes: findings from the 45 and Up Study

2018 ◽  
Vol 103 (8) ◽  
pp. 1099-1105 ◽  
Author(s):  
Changfan Wu ◽  
Xiaotong Han ◽  
Xixi Yan ◽  
Xianwen Shang ◽  
Lei Zhang ◽  
...  
Keyword(s):  
Physical Activity ◽  
Cataract Surgery ◽  
Cox Regression ◽  
P Value ◽  
Intensity Level ◽  
Medication History ◽  
Aged Patients ◽  
Cox Regression Analysis ◽  
Patients With Diabetes

AimTo investigate the association between physical activity (PA) and incidence of cataract surgery among patients with diabetes.MethodsWe obtained data from all diabetic subjects aged 45-65 years from the baseline of the prospective 45 and Up Study from 2006 to 2009 and linked to the Medicare Benefits Schedule (MBS) and Pharmaceutical Benefits Scheme (PBS) until 2016. Diabetes was defined as self-reported on questionnaire or diabetes medication history based on PBS. Cataract surgery was determined based on the MBS, and metabolic equivalent intensity level number of PA sessions per week was used to assess PA. Cox regression was used to assess the association between baseline PA and cataract surgery during the follow-up.ResultsA total of 9113 diabetic participants in the 45 and Up Study were included in the current analysis with a mean age of 57.3±5.2 years (43.6% female). During a mean follow-up of 8.8 years, 950 participants (10.4% of baseline) received cataract surgery with a corresponding incidence of 12.4/1000 person-years. Cox regression analysis showed that people with less PA (p=0.01), older age (p<0.001), female gender (p<0.001), higher educational level (p<0.001) and longer diabetic duration (p<0.001) had significantly higher cataract surgery risk. Participants with a PA level of ≥14 sessions per week had 19% decreased risk of cataract surgery compared to those with <5 sessions per week. Stratification analysis showed that participants with more obesity (p value for interaction=0.03), not taking insulin (p value for interaction=0.01) and without cardiovascular disease (p value for interaction=0.008) could benefit significantly more from PA in reducing their cataract surgery risk.ConclusionsMore vigorous PA was independently associated with a reduced risk of cataract surgery in working-aged patients with diabetes.

Association of Different Physical Activity Domains on All-Cause Mortality in Adults Participating in Primary Care in the Brazilian National Health System: 4-Year Follow-up

2017 ◽  
Vol 14 (1) ◽  
pp. 45-51 ◽  
Author(s):  
Bruna C. Turi ◽  
Jamile S. Codogno ◽  
Romulo A. Fernandes ◽  
Xuemei Sui ◽  
Carl J. Lavie ◽  
...  
Keyword(s):  
Physical Activity ◽  
Mortality Risk ◽  
Cox Regression ◽  
National Health System ◽  
Circulatory System ◽  
Cox Regression Analysis ◽  
Circulatory System Diseases ◽  
All Cause Mortality ◽  
Males And Females

Background:Evidence has shown that physical activity (PA) is associated with low mortality risk. However, data about reduced mortality due to PA are scarce in developing countries and the dose–response relationship between PA from different domains and all-cause mortality remains unclear. Thus, the aim of this study is to investigate the association of PA from different domains on all-cause mortality among Brazilian adults.Methods:679 males and females composed the study sample. Participants were divided into quartile groups according to PA from different domains (occupational, sports, and leisure-time). Medical records were used to identify the cause of the death. Cox regression analysis was performed to determine the independent associations of PA from different domains and all-cause mortality.Results:During the follow-up period, 59 participants died. The most prevalent cause of death was circulatory system diseases (n = 20; 33.9% [21.8%–45.9%]). Higher scores of occupational (HR= 0.45 [95% CI: 0.20–0.97]), sports (HR= 0.44 [95% CI: 0.20–0.95]) and overall PA (HR= 0.40 [95% CI: 0.17–0.90]) were associated with lower mortality, even after adjustment for confounders.Conclusions:The findings in this study showed the importance of being active in different domains to reduce mortality risk.

scholarly journals Incidence and Risk Factors for Amputation in Patients With Diabetes in Japan: A Historical Cohort Study Using a Nationwide Claims Database

2020 ◽  
Author(s):  
Masanori Kaneko ◽  
Kazuya Fujihara ◽  
Taeko Osawa ◽  
Masahiko Yamamoto ◽  
Mayuko Yamada Harada ◽  
...  
Keyword(s):  
Cox Regression ◽  
Historical Cohort ◽  
Cox Regression Analysis ◽  
Claims Database ◽  
Hazard Ratios ◽  
Patients With Diabetes ◽  
Mortality Predictors ◽  
Hba1c Levels

Abstract Background: Because amputation negatively affects the quality of life of patients with diabetes and increases the risk of cardiovascular events and mortality, predictors of amputation must be identified. However, no large cohort studies have been conducted regarding the incidence of amputation in patients with diabetes in East Asia.Methods: We analyzed data from a nationwide claims database in Japan accumulated from 2008–2016, involving 17,288 patients with diabetes aged 18–72 y (2942 women, mean age 50.2 y, HbA1c 7.2%).Results: The mean follow-up time was 5.3 years, and 16 amputations occurred (0.17/1000 person-years). Multivariate Cox regression analysis showed that age and HbA1c levels were independent predictors of amputation (hazard ratios [HRs], 1.09 and 1.43; 95% confidence intervals [CIs], 1.01–1.16 and 1.12–1.82, respectively). Compared with patients aged <60 y and with HbA1c <8%, the HR for patients aged ≥60 y and with HbA1c ≥8% was 32.1 (95% CI, 7.30–141.2).Conclusions: Improved glycemic control may lower amputation risk.

scholarly journals Effects of parathyroid hormone and vitamin D supplementation on stroke among patients receiving peritoneal dialysis

2020 ◽  
Author(s):  
Xiaohan You ◽  
Ying Zhou ◽  
Jianna Zhang ◽  
Qiongxiu Zhou ◽  
Yanling Shi ◽  
...  
Keyword(s):  
Vitamin D ◽  
Regression Analysis ◽  
Peritoneal Dialysis ◽  
Parathyroid Hormone ◽  
Cox Regression ◽  
Vitamin D Supplementation ◽  
P Value ◽  
Cox Regression Analysis ◽  
Increased Risk

Abstract Background : Continuous ambulatory peritoneal dialysis (CAPD) patients have a high incidence of stroke and commonly have increased parathyroid hormone levels and vitamin D insufficiency. We seek to investigate the incidence of stroke and the role of parathyroid hormone and vitamin D supplementation in stroke risk among CAPD patients. Methods: This study employed a retrospective design. We enrolled a Chinese cohort of 980 CAPD patients who were routinely followed in our department. The demographic and clinical data were recorded at the time of initial CAPD and during follow-up. The included patients were separated into non-stroke and stroke groups. The effects of parathyroid hormone and vitamin D supplementation on stroke in CAPD patients was evaluated. The primary endpoint is defined as the first occurrence of stroke, and composite endpoint events are defined as death or switch to hemodialysis during follow-up. Results: A total of 757 eligible CAPD patients with a mean follow-up time of 54.7 (standard deviation, 33) months were included in the study. The median incidence of stroke among our CAPD patients was 18.9 (interquartile range, 15.7 - 22.1) per 1000 person-years. A significant nonlinear correlation between baseline iPTH and hazard of stroke (p-value of linear association = 0.2 and nonlinear association = 0.002) was observed in our univariate Cox regression analysis, and low baseline iPTH levels (≤150 pg/ml) were associated with an increased cumulative hazard of stroke. Multivariate Cox regression analysis indicated a significant interaction effect between age and iPTH after adjusting for other confounders. Vitamin D supplementation during follow-up was a predictive factor for stroke in our cohort. Conclusions: CAPD patients suffered a high risk of stroke, and lower iPTH levels were significantly correlated with an increased risk of stroke. Nevertheless, vitamin D supplementation may reduce the risk of stroke in these patients.

Gene-Expression for Prediction of Disease Progression Following Initial Management of Follicular Lymphoma

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 4804-4804
Author(s):  
Etienne Mahe ◽  
Ariz Akhter ◽  
Danielle H. Oh ◽  
Fahad Farooq ◽  
Meer-Taher Shabani-Rad ◽  
...  
Keyword(s):  
Follicular Lymphoma ◽  
Regression Model ◽  
Disease Progression ◽  
Cox Regression ◽  
Tumor Grade ◽  
Age At Diagnosis ◽  
P Value ◽  
Cox Regression Model ◽  
Cox Regression Analysis

Abstract Introduction Patients with advanced staged Follicular Lymphoma (FL) are initially managed with either immediate chemoimmunotherapy (CI) or "watchful waiting" (WW) depending on clinical symptoms, tumor burden, and organ compromise. Clinicians currently predict time to progression (TTP) using the Follicular Lymphoma International Prognostic Index (FLIPI) score. Well-defined & validated molecular techniques capable of additional predictive power are lacking, however. We hypothesized that gene-expression (GE) data, employing an evidence-based feature set, might assist in the upfront stratification of FL patients. Objectives 1 Identify genes whose GE has previously been identified as relevant to FL 2 Perform GE testing on an series of FL cases, classified by upfront intervention, using this custom gene feature set 3 Identify the gene(s) most strongly predictive of disease progression in each of the clinical classes (i.e. CI vs. WW) 4 Compare the performance of GE data to other prognostic parameters Methods We performed a search of MEDLINE-indexed studies reporting FL GE results. We input all available appertaining data into NVIVO (v10), in which a computer-assisted search for GE features was performed. This list, after refinement, formed the basis of a custom NanoString codeset. We used the MD Anderson Microarray Sample Size Calculator for sample size estimation and retrieved FL cases from our regional archives; those cases with sufficient tissue were organized by upfront treatment approach and available clinical data recorded (age at diagnosis, sex, stage, grade, FLIPI scores & TTP). TTP was defined as time in months either to diagnosed disease progression or, in the WW group, first CI-based treatment. After pathology review, RNA was isolated using standard protocols. GE data was analyzed using gene-specific receiver-operating characteristic analysis, ranking performed according to the area-under-the-curve (MATLAB v 8.3.0.532). Validation against TTP using Cox-regression was then performed (SPSS v22); p < 0.05 was considered significant. Results Our MEDLINE search yielded 713 publications; after refinement, our NVIVO analysis suggested 282 valid gene features. Review of local FL cases accessioned between 2004 & 2012 was performed; this period ensured uniform follow-up and CI treatment strategies for all FL patients. Patients were classified as WW (68 patients) & CI (98 patients), and then sub-classified as WW1 (WW without need for CI over the follow-up interval; 23 patients) and WW2 (WW requiring CI in the follow-up interval; 45 patients) and CI1 (CI without disease progression over the follow-up interval; 61 patients) and CI2 (CI with disease progression; 37 patients). Median follow-up time was 60 months in the WW group and 56 months in the CI group (Mann-Whitney p = 0.177). With the exception of FLIPI score in the WW class (higher on average in the WW2 sub-class), no other clinical factor differed significantly between the sub-classes. GE analyses suggested that ACTB in the WW group and MEK1 in the CI group might be most predictive of TTP. Table 1. TTP results by Cox-regression analysis for the WW group WW Variable Cox-Regression Model Co-efficient p-value Cox-Regression Model Linear Co-efficient 95% CI Age at diagnosis 0.56 0.98-1.04 Sex 0.34 0.67-3.19 Tumor Grade 0.41 0.40-9.48 Tumor Stage 0.54 0.69-2.04 FLIPI Score 0.06 0.97-3.6 ACTB Expression 0.006 1.4-7.74 Table 2. TTP results by cox-regression analysis for the CI group CI Variable Cox-Regression Model Co-efficient p-value Cox-Regression Model Linear Co-efficient 95% CI Age at diagnosis 0.34 0.99-1.04 Sex 0.96 0.48-2.16 Tumor Grade 0.92 0.43-2.13 Tumor Stage 0.17 0.874-2.11 FLIPI Score 0.4 0.47-1.35 MEK1 Expression 0.011 0.19-0.81 Conclusions To our knowledge, we have performed the first GE analysis of FL cases classified by intervention, and have identified GE features predictive of disease progression or requirement of intervention (as in the WW group). In the CI group, identification of MEK1 as a major prognostic player echoes previous work studying the MAP-kinase pathway in FL. In the WW group, however, identification of ACTB as a potential prognostic player is a novel observation requiring validation, especially since this gene is ubiquitously expressed across multiple cell types. Figure 1. WW TTP, stratified by ACTB expression Figure 1. WW TTP, stratified by ACTB expression Figure 2. CI TTP, stratified by MEK1 expression Figure 2. CI TTP, stratified by MEK1 expression Disclosures No relevant conflicts of interest to declare.

scholarly journals Long-term Prognostic Value of Homocysteine in Patients with Acute Coronary Syndrome Complicated with Hypertension: A Multicenter Retrospective Study

2021 ◽  
Author(s):  
Qiang Chen ◽  
Xunshi Ding ◽  
Caiyan Cui ◽  
Tao Ye ◽  
Lin Cai
Keyword(s):  
Acute Coronary Syndrome ◽  
Regression Analysis ◽  
Prognostic Value ◽  
Cox Regression ◽  
P Value ◽  
Cox Regression Analysis ◽  
Coronary Syndrome ◽  
Kaplan Meier

Abstract Background and aims: This study investigates the long-term prognostic value of homocysteine in patients with acute coronary syndrome complicated with hypertension. Methods:The current work is a multicenter, retrospective, observational cohort study. We consecutively enrolled 1288 ACS patients hospitalized in 11 general hospitals in Chengdu, China, from June 2015 to December 2019. The patients were divided into hypertension and non-hypertension groups, and each was further classified into hyperhomocysteinemia (H-Hcy) and normal homocysteinemia (N-Hcy) groups according to the cut-off value of homocysteine predicting long-term mortality during follow-up. In both groups, we used Kaplan-Meier and multivariate Cox regression analysis to assess the relationship between homocysteine and long-term prognosis. Results: The median follow-up time was 18 months (range: 13.83-22.37). During this period, 78 (6.05%) death cases were recorded. The hypertension was further divided into H-Hcy (n=245) and N-Hcy (n=543), with an optimal cut-off value of 16.81 µmol/L. Similarly, non-hypertension was further divided into H-Hcy (n=200) and N-Hcy (n=300), with an optimal cut-off value of 14 µmol/L. Kaplan-Meier survival curves revealed that H-Hcy had a significantly lower survival probability than N-Hcy, both in hypertension and non-hypertension (P-value<0.01). After adjusting for confounding factors, multivariate Cox regression analysis revealed that H-Hcy (HR=2.1923, 95% CI: 1.213-3.9625, P＜0.01) was an independent predictor of long-term all-cause death in ACS with hypertension, but not in non-hypertension.Conclusion: Elevated homocysteine level predicts risk of all-cause mortality in ACS with hypertension, but not in those without hypertension. it should be considered when determining risk stratification for ACS, particularly those complicating hypertension.

Abstract TP432: Predictors for Dementia Conversion in Cerebral Amyloid Angiopathy From a Stroke Unit

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Li Xiong ◽  
Raffaella Valenti ◽  
Andreas Charidimou ◽  
Gregoire Boulouis ◽  
Duangnapa Roongpiboonsopit ◽  
...  
Keyword(s):  
Cerebral Amyloid Angiopathy ◽  
Stroke Unit ◽  
Cox Regression ◽  
Superficial Siderosis ◽  
P Value ◽  
Amyloid Angiopathy ◽  
Perivascular Spaces ◽  
Cox Regression Analysis ◽  
Cerebral Amyloid

Objective: Cerebral amyloid angiopathy (CAA) is increasing recognized as a cause of cognitive impairment and dementia in older individuals. This study aimed to investigate predictors of dementia, including imaging markers, in CAA patients from a stroke unit. Methods: A total of 71 non-demented patients from a stroke unit were included according to modified Boston Criteria for probable CAA with available cognitive follow up. These CAA patients included both patients with and patients without previous intracerebral hemorrhage (ICH). At baseline, neuroimaging markers, including lobar microbleeds (CMBs), white matter hyperintensities (WMH), cortical superficial siderosis (cSS) and MRI-visible centrum semiovale perivascular spaces (CSO-PVS) were assessed. The small vessel disease (SVD) score for CAA was calculated by the scores of CMBs, WMH, cSS and CSO-PVS. The association between these neuroimaging markers and dementia conversion was analyzed. Results: The median follow up time is 1.91 years (quartiles 1.14-4.23 years). Fourteen (19.72%) CAA patients developed dementia during follow up period. Thirty-seven CAA patients (52.11%) had previous symptomatic ICH. Age, lobar CMBs≥20 and SVD score were selected from the univariate Cox-regression analysis with p value less than 0.1 (Table1). In a backward stepwise multivariabte analysis including age, previous ICH history and either SVD score or number of CMBs, age and SVD score independently predicted dementia conversion (Table 1). The individual neuroimaging markers for SVD related brain damage (CSO-PVS, cSS, lobar MBs and WMH) did not predict dementia conversion for probable CAA patients. Conclusion: Our results demonstrate that cognitive deterioration of CAA patients appears attributed to cumulative CAA related vasculopathic changes.

Interim analysis of survival outcomes in a prospective cohort evaluating a prognostic 31-gene expression profile (GEP) test for melanoma.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 9573-9573
Author(s):  
Eddy C. Hsueh ◽  
James R. DeBloom ◽  
Jonathan H. Lee ◽  
Jeffrey J. Sussman ◽  
Craig L. Slingluff ◽  
...  
Keyword(s):  
High Risk ◽  
Interim Analysis ◽  
Cox Regression ◽  
P Value ◽  
Prognostic Information ◽  
Clinical Registry ◽  
Cox Regression Analysis ◽  
Kaplan Meier ◽  
Class 1

9573 Background: DecisionDx-Melanoma has been validated as an accurate prognosticator of cutaneous melanoma (CM) metastasis risk. The GEP test classifies CM pts as Class 1 (low risk) or Class 2 (high risk). Interim survival analysis from two clinical registry studies (NCT02355574/NCT02355587) designed to prospectively evaluate outcomes in pts for whom the GEP test was performed is described. Methods: Eleven US dermatologic and surgical centers participated in the IRB-approved protocols. Physicians enrolled CM pts who were ≥16 years old and had successful GEP test results. Endpoints of recurrence-free (RFS), distant metastasis-free (DMFS) and melanoma-specific survival (MSS) were assessed using Kaplan-Meier and Cox regression analysis. As an interim analysis at year 3 of an expected 5-year study, the critical alpha level (p-value) was 0.01. Results: At the time of data extraction, 322 pts were accrued and completed at least one follow-up visit. Median age was 58 years (range 18-87), median Breslow thickness (BT) was 1.2mm, 55% were male, 20% (58/296) were ulcerated, and 15% (36/237 biopsied) had a positive sentinel lymph node (SLN). Median follow-up time was 1.5 years for pts without a recurrence. Of 25 recurrent cases, 80% (20/25) were Class 2 and 40% (10/25) were SLN-positive. Two percent of Class 1 pts had a recurrence compared to 6% (12/201 biopsied) of SLN-negative pts. Of the SLN-negative pts who recurred, 75% (9/12) were called Class 2. Combined GEP and SLN risk prediction identified 88% (21/24) of recurrences. Kaplan-Meier event rates for each class are shown in the table. In Cox multivariate analysis, BT and GEP Class 2 were significant predictors of recurrence (p<0.01 for each). Conclusions: Results of this analysis show that the GEP test provides prognostic information that complements conventional staging and significantly enhances identification of high risk CM pts, consistent with reported validation studies.The results support use of the test for guiding surveillance decisions and enrollment of CM pts in clinical trials. Clinical trial information: NCT02355574, NCT02355587. [Table: see text]

scholarly journals Accelerometer-derived sedentary time and physical activity and the incidence of depressive symptoms – The Maastricht Study

2020 ◽  
pp. 1-8
Author(s):  
Magdalena J. Konopka ◽  
Sebastian Köhler ◽  
Coen D. A. Stehouwer ◽  
Nicolaas C. Schaper ◽  
Ronald M. A. Henry ◽  
...  
Keyword(s):  
Physical Activity ◽  
Depressive Symptoms ◽  
Sex Education ◽  
Sedentary Time ◽  
Cox Regression ◽  
Future Research ◽  
Cox Regression Analysis ◽  
Increased Risk ◽  
Intensity Physical Activity

Abstract Background This study examined the associations between accelerometer-derived sedentary time (ST), lower intensity physical activity (LPA), higher intensity physical activity (HPA) and the incidence of depressive symptoms over 4 years of follow-up. Methods We included 2082 participants from The Maastricht Study (mean ± s.d. age 60.1 ± 8.0 years; 51.2% men) without depressive symptoms at baseline. ST, LPA and HPA were measured with the ActivPAL3 activity monitor. Depressive symptoms were measured annually over 4 years of follow-up with the 9-item Patient Health Questionnaire (PHQ-9). Cox regression analysis was performed to examine the associations between ST, LPA, HPA and incident depressive symptoms (PHQ-9 ⩾ 10). Analyses were adjusted for total waking time per day, age, sex, education level, type 2 diabetes mellitus, body mass index, total energy intake, smoking status and alcohol use. Results During 7812.81 person-years of follow-up, 203 (9.8%) participants developed incident depressive symptoms. No significant associations [Hazard Ratio (95% confidence interval)] were found between sex-specific tertiles of ST (lowest v. highest tertile) [1.13 (0.76–1.66], or HPA (highest v. lowest tertile) [1.14 (0.78–1.69)] and incident depressive symptoms. LPA (highest v. lowest tertile) was statistically significantly associated with incident depressive symptoms in women [1.98 (1.19–3.29)], but not in men (p-interaction <0.01). Conclusions We did not observe an association between ST or HPA and incident depressive symptoms. Lower levels of daily LPA were associated with an increased risk of incident depressive symptoms in women. Future research is needed to investigate accelerometer-derived measured physical activity and ST with incident depressive symptoms, preferably stratified by sex.

scholarly journals Effects of parathyroid hormone and vitamin D supplementation on stroke among patients receiving peritoneal dialysis

2020 ◽  
Author(s):  
Xiaohan You ◽  
Ying Zhou ◽  
Jianna Zhang ◽  
Qiongxiu Zhou ◽  
Yanling Shi ◽  
...  
Keyword(s):  
Vitamin D ◽  
Regression Analysis ◽  
Peritoneal Dialysis ◽  
Parathyroid Hormone ◽  
Cox Regression ◽  
Vitamin D Supplementation ◽  
P Value ◽  
Cox Regression Analysis ◽  
Increased Risk

Abstract Background: Continuous ambulatory peritoneal dialysis (CAPD) patients have a high incidence of stroke and commonly have increased parathyroid hormone levels and vitamin D insufficiency. We seek to investigate the incidence of stroke and the role of parathyroid hormone and vitamin D supplementation in stroke risk among CAPD patients.Methods: This study employed a retrospective design. We enrolled a Chinese cohort of 980 CAPD patients who were routinely followed in our department. The demographic and clinical data were recorded at the time of initial CAPD and during follow-up. The included patients were separated into non-stroke and stroke groups. The effects of parathyroid hormone and vitamin D supplementation on stroke in CAPD patients was evaluated. The primary endpoint is defined as the first occurrence of stroke, and composite endpoint events are defined as death or switch to hemodialysis during follow-up.Results: A total of 757 eligible CAPD patients with a mean follow-up time of 54.7 (standard deviation, 33) months were included in the study. The median incidence of stroke among our CAPD patients was 18.9 (interquartile range, 15.7 - 22.1) per 1000 person-years. A significant nonlinear correlation between baseline iPTH and hazard of stroke (p-value of linear association = 0.2 and nonlinear association = 0.002) was observed in our univariate Cox regression analysis, and low baseline iPTH levels (≤150 pg/ml) were associated with an increased cumulative hazard of stroke. Multivariate Cox regression analysis indicated a significant interaction effect between age and iPTH after adjusting for other confounders. Vitamin D supplementation during follow-up was a predictive factor for stroke in our cohort.Conclusions: CAPD patients suffered a high risk of stroke, and lower iPTH levels were significantly correlated with an increased risk of stroke. Nevertheless, vitamin D supplementation may reduce the risk of stroke in these patients.

scholarly journals Mortality after Use of Paclitaxel-Coated Balloons Correlates with Total Cumulative Dosage of Paclitaxel in Real-World Analysis

2021 ◽  
Vol 10 (16) ◽  
pp. 3747
Author(s):  
Seon-Hee Heo ◽  
Shin-Young Woo ◽  
Seung-Hyuk Choi ◽  
Taek-Kyu Park ◽  
Young-Soo Do ◽  
...  
Keyword(s):  
Real World ◽  
Cox Regression ◽  
Sudden Cardiac Arrest ◽  
P Value ◽  
Limited Information ◽  
Total Dosage ◽  
Cox Regression Analysis ◽  
Cumulative Dosage ◽  
Patient Level

This study used independent, real-world, patient-level data to examine whether the dosage or frequency of paclitaxel exposure correlated with mortality during follow up. We conducted a retrospective analysis of patients treated with a drug-coated balloon (DCB) for an atherosclerotic femoropopliteal lesion from February 2013 to December 2018, excluding patients with non-atherosclerotic lesions or restenosis after DCB treatment in another hospital. We investigated the causes of death, comorbidities (including cancer status), and the initial and total cumulative dosages and frequency of paclitaxel use. To determine whether the dosage or frequency of paclitaxel exposure affected mortality during follow up, we analyzed the risk factors for all-cause death by conducting a time-dependent Cox regression analysis that considered demographics, comorbidities, lesion and procedural characteristics, and paclitaxel exposure data (dosage and frequency). Our analysis examined 225 patients (mean age 71 ± 9 years, range 38–93 years, male 81%). During a mean follow-up duration of 35 months (range 1–89 months), 56 patients (24.9%) died from cardiac disorders (16%, including acute myocardial infarction, heart failure, or sudden cardiac arrest), malignancy (14.3%), respiratory failure with pneumonia (12.5%), septic shock (12.5%), or another cause. Univariable and multivariable Cox regression analyses identified age (hazard ratio, HR, 1.057; 95% confidence interval, CI, 1019–1096; p = 0.0032), critical limb ischemia (CLI) (HR, 4135; 95% CI, 2171–7876; p < 0.0001), and the total dosage of paclitaxel (mg) (HR, 1.040; 95% CI, 1006–1074; p = 0.0210) as predictors of mortality during follow up. The subgroup analysis found that the total dosage of paclitaxel (mg) was also a predictor of mortality during follow up in the CLI group (HR, 1.046; 95% CI, 1007–1087, p = 0.0198). The estimated cut-off value of total cumulative paclitaxel dosage for predicting mortality was 12 mg as evaluated by minimum p value approach. This patient-level analysis identified the total cumulative dosage of paclitaxel as a predictor of mortality after the use of paclitaxel-coated balloons. Our results provide limited information about the potential dose–response relationship underlying paclitaxel-associated mortality concerns.

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