Abstract TP201: Diabetes and the Risk of Death and Stroke Recurrence Following Ischemic Stroke

Background and Purpose: Diabetes mellitus (DM) is a well-established risk factor for ischemic stroke (IS), but the literature is inconsistent on the effect of DM on outcomes after IS. We sought to determine if DM increases the risk of mortality and recurrence after IS, and if these associations are greater in Mexican Americans (MA) than non-Hispanic whites (NHW). Methods: IS cases, all-cause mortality, and recurrent strokes were identified from the Brain Attack Surveillance in Corpus Christi (BASIC) project (2006-2012). Sociodemographics and clinical data were obtained from medical records and interviews. Cumulative mortality and stroke recurrence risk were estimated at 30 days and 1 year using Kaplan-Meier analysis and Cox proportional hazards models. Effect modification by ethnicity was examined. Results: There were 1,301 IS cases, 46% with a history of DM, median age 70 (IQR: 58-81), and 61% MA. Patients with DM were younger and more likely to be MA compared to patients without DM. Risk of 30-day and 1-year mortality was 8.4% and 20.5% for those with DM and 9.5% and 20.8% for those without DM, respectively. Risk of 30-day and 1-year stroke recurrence was 1.2% and 7.5% for those with DM and 1.5% and 5.8% for those without DM, respectively. Unadjusted, DM was not a significant predictor of mortality or recurrence (see table). After adjustment, DM predicted mortality (30-day HR=1.58, 95% CI: 0.98-2.53; 1-year HR=1.48, 95% CI: 1.10-2.00) but not stroke recurrence (1-year HR=1.28, 95% CI: 0.78-2.08). Effect modification by ethnicity was not significant (p>0.2 for all models). Conclusions: Given that patients with DM were significantly younger than patients without DM, the crude association between DM and mortality revealed no difference. However, after accounting for age and other factors, patients with DM were 50% more likely to die at 1 year after IS compared to patients without DM.

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Stroke, Timing of Atrial Fibrillation Diagnosis, and Risk of Death

Neurology ◽

10.1212/wnl.0000000000011633 ◽

2021 ◽

Vol 96 (12) ◽

pp. e1655-e1662

Author(s):

Anjali Bhatla ◽

Yuliya Borovskiy ◽

Ronit Katz ◽

Matthew C. Hyman ◽

Parin J. Patel ◽

...

Keyword(s):

Atrial Fibrillation ◽

Ischemic Stroke ◽

Proportional Hazards ◽

Cox Proportional Hazards ◽

Inception Cohort ◽

Stroke Event ◽

Risk Of Death ◽

Cox Proportional Hazards Models ◽

Multivariable Adjustment

ObjectiveTo evaluate the prognosis of patients with ischemic stroke according to the timing of an atrial fibrillation (AF) diagnosis, we created an inception cohort of incident stroke events and compared the risk of death between patients with stroke with (1) sinus rhythm, (2) known AF (KAF), and (3) AF diagnosed after stroke (AFDAS).MethodsWe used the Penn AF Free study to create an inception cohort of patients with incident stroke. Mortality events were identified after linkage with the National Death Index through June 30, 2017. We also evaluated initiation of anticoagulants and antiplatelets across the study duration. Cox proportional hazards models evaluated associations between stroke subtypes and death.ResultsWe identified 1,489 individuals who developed an incident ischemic stroke event: 985 did not develop AF at any point during the study period, 215 had KAF before stroke, 160 had AF detected ≤6 months after stroke, and 129 had AF detected >6 months after stroke. After a median follow-up of 4.9 years (interquartile range 1.9–6.8), 686 deaths occurred. The annualized mortality rate was 8.8% in the stroke, no AF group; 12.2% in the KAF group; 15.8% in the AFDAS ≤6 months group; and 12.7% in the AFDAS >6 months group. Patients in the AFDAS ≤6 months group had the highest independent risk of all-cause mortality even after multivariable adjustment for demographics, clinical risk factors, and the use of antithrombotic therapies (hazard ratio 1.62 [1.22–2.14]). Compared to the stroke, no AF group, those with KAF had a higher mortality risk that was rendered nonsignificant after adjustment.ConclusionsThe AFDAS group had the highest risk of death, which was not explained by comorbidities or use of antithrombotic therapies.

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Hemoglobin, Albumin, Lymphocyte, and Platelet Score is Associated With Adverse Clinical Outcomes of Acute Ischemic Stroke: A Prospective Cohort Study

10.21203/rs.3.rs-38304/v1 ◽

2020 ◽

Author(s):

Mengke Tian ◽

Youfeng Li ◽

Xiao Wang ◽

Xuan Tian ◽

Lu-lu Pei ◽

...

Keyword(s):

Ischemic Stroke ◽

Acute Ischemic Stroke ◽

Clinical Outcomes ◽

Proportional Hazards ◽

Cox Proportional Hazards ◽

Stroke Recurrence ◽

Vascular Events ◽

Risk Of Death ◽

Clinical Events ◽

Secondary Outcomes

Abstract Background The combined index of hemoglobin, albumin, lymphocyte and platelet (HALP) is considered as a novel score to reflect systemic inflammation and nutritional status. This study aimed to investigate the association between HALP score and adverse clinical events in patients with acute ischemic stroke (AIS). Methods This study prospectively included patients with AIS within 24 hours of admission to the First Affiliated Hospital of Zhengzhou University. The primary outcomes were all-cause death within 90 days and 1 year. The secondary outcomes included stroke recurrence and combined vascular events. The association between HALP score and adverse clinical outcomes was analyzed using Cox proportional hazards. Results A total of 1337 patients were included. Patients in the highest tertile of HALP score had a lower risk of death within 90 days and 1 year (Hazard ratio: 0.20 and 0.30; 95% confidence intervals: 0.06–0.66 and 0.13–0.69, P for trend < 0.01 for all) compared with the lowest tertile after adjusting relevant confounding factors. Similar results were found for secondary outcomes. Subgroup analyses further confirmed these association. Adding HALP score to the conventional risk factors improved prediction of death in patients with AIS within 90 days and 1 year (net reclassification index, 38.63% and 38.68%; integrated discrimination improvement, 2.43% and 2.57%; P < 0.02 for all). Conclusions High HALP score levels were associated with decreased risk of adverse clinical outcomes within 90 days and 1 year after stroke onset, suggesting that HALP score may serve as a powerful indicator for AIS.

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Abstract P005: Comparative Effectiveness of Rivaroxaban versus Warfarin for the Treatment of Patients with Non-valvular Atrial Fibrillation

Circulation ◽

10.1161/circ.133.suppl_1.p005 ◽

2016 ◽

Vol 133 (suppl_1) ◽

Author(s):

Faye L Norby ◽

Lindsay G Bengtson ◽

Lin Y Chen ◽

Richard F MacLehose ◽

Pamela L Lutsey ◽

...

Keyword(s):

Atrial Fibrillation ◽

Ischemic Stroke ◽

Real World ◽

Proportional Hazards ◽

Large Population ◽

Population Based ◽

Cox Proportional Hazards ◽

Gi Bleeding ◽

Cox Proportional Hazards Models ◽

The Us

Background: Rivaroxaban is a novel oral anticoagulant approved in the US in 2011 for prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF). Information on risks and benefits among rivaroxaban users in real-world populations is limited. Methods: We used data from the US MarketScan Commercial and Medicare Supplemental databases between 2010 and 2013. We selected patients with a history of NVAF and initiating rivaroxaban or warfarin. Rivaroxaban users were matched with up to 5 warfarin users by age, sex, database enrollment date and drug initiation date. Ischemic stroke, intracranial bleeding (ICB), myocardial infarction (MI), and gastrointestinal (GI) bleeding outcomes were defined by ICD-9-CM codes in an inpatient claim after drug initiation date. Cox proportional hazards models were used to assess the association between rivaroxaban vs. warfarin use and outcomes adjusting for age, sex, and CHA2DS2-VASc score. Separate models were used to compare a) new rivaroxaban users with new warfarin users, and b) switchers from warfarin to rivaroxaban to continuous warfarin users. Results: Our analysis included 34,998 rivaroxaban users matched to 102,480 warfarin users with NVAF (39% female, mean age 71), in which 487 ischemic strokes, 179 ICB, 647 MI, and 1353 GI bleeds were identified during a mean follow-up of 9 months. Associations of rivaroxaban vs warfarin were similar in new users and switchers; therefore we pooled both analyses. Rivaroxaban users had lower rates of ICB (hazard ratio (HR) (95% confidence interval (CI)) = 0.72 (0.46, 1.12))) and ischemic stroke (HR (95% CI) = 0.88 (0.68, 1.13)), but higher rates of GI bleeding (HR (95% CI) = 1.15 (1.01, 1.33)) when compared to warfarin users (table). Conclusion: In this large population-based study of NVAF patients, rivaroxaban users had a non-significant lower risk of ICB and ischemic stroke than warfarin users, but a higher risk of GI bleeding. These real-world findings are comparable to results reported in published clinical trials.

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One-Year Risk of Recurrent Stroke and Death Associated with Vertebrobasilar Artery Stenosis and Occlusion in a Cohort of 10,515 Patients

Cerebrovascular Diseases ◽

10.1159/000495418 ◽

2019 ◽

Vol 47 (1-2) ◽

pp. 40-47 ◽

Cited By ~ 3

Author(s):

Adnan I. Qureshi ◽

Mushtaq H. Qureshi ◽

Li-Ming Lien ◽

Jiunn-Tay Lee ◽

Jiann-Shing Jeng ◽

...

Keyword(s):

Ischemic Stroke ◽

Proportional Hazards ◽

Proportional Hazards Model ◽

Recurrent Stroke ◽

Cox Proportional Hazards ◽

Cox Proportional Hazards Model ◽

Large Artery ◽

Stroke Registry ◽

Risk Of Death ◽

Vertebrobasilar Artery

Background: The natural history of vertebrobasilar artery (VBA) stenosis or occlusion remains understudied. Methods: Patients with diagnosis of ischemic stroke or transient ischemic attack (TIA) who were noted to have VBA stenosis based on computed tomography or magnetic resonance imaging or catheter-based angiogram were selected from Taiwan Stroke Registry. Cox proportional hazards model was used to determine the hazards ratio (HR) of recurrent stroke and death within 1 year of index event in various groups based on severity of VBA stenosis (none to mild: 0–49%; moderate to severe: 50–99%: occlusion: 100%) after adjusting for differences in demographic and clinical characteristics between groups at baseline evaluation. Results: None to mild or moderate to severe VBA stenosis was diagnosed in 6972 (66%) and 3,137 (29.8%) among 10,515 patients, respectively, and occlusion was identified in 406 (3.8%) patients. Comparing with patients who showed none to mild stenosis of VBA, there was a significantly higher risk of recurrent stroke (HR 1.21, 95% CI 1.01–1.45) among patients with moderate to severe VBA stenosis. There was a nonsignificantly higher risk of recurrent stroke (HR 1.49, 95% CI 0.99–2.22) and significantly higher risk of death (HR 2.21, 95% CI 1.72–2.83), among patients with VBA occlusion after adjustment of potential confounders. Conclusions: VBA stenosis or occlusion was relatively prevalent among patients with TIA or ischemic stroke and associated with higher risk of recurrent stroke and death in patients with ischemic stroke or TIA who had large artery atherosclerosis.

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Antiandrogen withdrawal (AAWD) in patients (pts) with prostate cancer (PCa): Retrospective analysis of data from the South Australian Prostate Cancer Clinical Outcome Collaborative (SA-PCCOC).

Journal of Clinical Oncology ◽

10.1200/jco.2015.33.7_suppl.240 ◽

2015 ◽

Vol 33 (7_suppl) ◽

pp. 240-240

Author(s):

Sina Vatandoust ◽

Ganessan Kichenadasse ◽

Michael E O'Callaghan ◽

Tina Kopsaftis ◽

Scott Walsh ◽

...

Keyword(s):

Prostate Cancer ◽

Overall Survival ◽

Proportional Hazards ◽

South Australia ◽

Progression Free Survival ◽

Cox Proportional Hazards ◽

Risk Of Death ◽

Cox Proportional Hazards Models ◽

Australian State ◽

Chi Squared

240 Background: In 15-30% of pts with metastatic PCa who progress on Maximal Androgen Blockade (MAB), withdrawal of the antiandrogen agent (AAWD) and continuing the LHRH agonist alone, leads to PSA decreases of ≥50% and prolonged progression free survival. Here we describe patient and disease characteristics, treatment history and outcomes of pts who have been managed with AAWD. Methods: Data were obtained from SA-PCCOC (a longitudinal, observational registry of biopsy-proven PCa cases, throughout the Australian state of South Australia since 1998). Proportions were compared using a Chi squared test. A multivariable model used competing risks (Fine and Gray) and Cox proportional Hazards models to assess overall survival and Prostate cancer specific mortality (PCSM). Survival was calculated from the date of rising PSA for patients on LHRH and AA. Results: 140 pts were found to have MAB. Of these, 31(22.1%) had AAWD. In the AAWD group, median age was 81y (51-95). Age at diagnosis, Gleason score at biopsy and diagnostic PSA were not significantly different amongst the two groups. Treatment PSA was significantly lower in the AAWD group (20.55 (range 0.6-9,995) vs 50.50 (range 0.95-4378) p= 0.02). There was a significant association of AAWD with PCSM (sHR 0.35, 95% CI 0.16-0.76; p = 0.008). Also significant in the model was prior time on hormones (sHR [per month increase] 0.96 95% CI 0.95-0.98, p<0.001). There was also a significant association of AAWD with overall survival (HR 0.22, 95% CI 0.10-0.46; p <0.001). Again, prior time on hormones was also significant (HR [per month increase] 0.96 95% CI 0.95-0.98, p<0.001). Multivariate analysis was performed on data from 80 pts (60 pts omitted due to missing data). Conclusions: Pts in whom AAWD was used were older and had lower treatment PSA. In this small cohort, AAWD was associated with both reduced PCSM and overall risk of death. The time spent on MAB also appeared to be significant. This retrospective observational study may be subject to confounding, however the observation warrants further investigation in larger cohorts and in a prospective setting.

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The role of ALBI and IGF-CTP score in refining prognostication of HCC.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.e16659 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. e16659-e16659

Author(s):

Sunyoung S. Lee ◽

Yehia I. Mohamed ◽

Aliya Qayyum ◽

Manal Hassan ◽

Lianchun Xiao ◽

...

Keyword(s):

Overall Survival ◽

Proportional Hazards ◽

Cox Proportional Hazards ◽

Survival Prediction ◽

Score System ◽

Risk Of Death ◽

U Statistics ◽

Cox Proportional Hazards Models ◽

Ctp Score

e16659 Background: Child-Turcotte-Pugh (CTP) score is widely used in the assessment of prognosis of HCC and CTP-A is the standard criterion for active therapy and clinical trials entry. Recently, ALBI and insulin-like growth factor-1 (IGF)-CTP scores have been reported to improve survival prediction over CTP score. However, comparative studies to compare both scores and to integrate IGF into Albi score are lacking. Methods: After institutional board approval, data and samples were prospectively collected. 299 HCC patients who had data to generate both IGF-CPG and Albi index were used. The ALBI index, and IGF score were calculated, Cox proportional hazards models were fitted to evaluation the association between overall survival (OS) and CTP, IGF-CTP, Albi and IGF, albumin, bilirubin. Harrell’s Concordance index (C-index) was calculated to evaluate the ability of the three score system to predict overall survival. And the U-statistics was used to compare the performance of prediction of OS between the score system. Results: OS association with CTP, IGF-CTP and Albi was performed (Table). IGF-CTP B was associated with a higher risk of death than A (HR = 1.6087, 95% CI: 1.2039, 2.1497, p = 0.0013), ALBI grade 2 was also associated with a higher risk of death than 1 (HR = 2.2817, 95% CI: 1.7255, 3.0172, p < 0.0001). IGF-1(analyzed as categorical variable) was independently associated with OS after adjusting for the effects of ALBI grade. Which showed IGF-1 ≤26 was significantly associated with poor OS, P = 0.001. Conclusions: Although ALBI grade and IGF-CTP score in this analysis had similar prognostic values in most cases, their benefits might be heterogenous in some specific conditions. We looked into corporation of IGF-1 into ALBI grade, IGF score with cutoff ≤26 which clearly refined OS prediction and better OS stratification of ALBI-grade.

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Missing data in breast cancer: Relationship with survival in national databases.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.e19114 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. e19114-e19114

Author(s):

Jennifer Kay Plichta ◽

Christel N. Rushing ◽

Holly C. Lewis ◽

Dan G. Blazer ◽

Terry Hyslop ◽

...

Keyword(s):

Breast Cancer ◽

Missing Data ◽

Proportional Hazards ◽

Cancer Registries ◽

Cox Proportional Hazards ◽

Future Research ◽

Risk Of Death ◽

Cox Proportional Hazards Models ◽

N Stage ◽

National Databases

e19114 Background: National cancer registries are valuable tools used to analyze patterns of care and clinical oncology outcomes; yet, patients with missing data may impact the accuracy and generalizability of these data. We sought to evaluate the association between missing data and overall survival (OS). Methods: Using the NCDB and SEER, we compared data missingness among patients diagnosed with invasive breast cancer from 2010-2014. Key variables included: demographic variables (age, race, ethnicity, insurance, education, income), tumor variables (grade, ER, PR, HER2, TNM stage), and treatment variables (surgery in both databases; chemotherapy and radiation in NCDB). OS was compared between those with and without missing data via Cox proportional hazards models. Results: Overall, 775,996 patients in the NCDB and 263,016 in SEER were identified; missingness of at least 1 key variable was 29% and 13%, respectively. Of those, the majority were missing a tumor variable (NCDB 80%; SEER 88%), while demographic and treatment variables were missing less often. When compared to patients with complete data, missingness was associated with a greater risk of death; NCDB 17% vs. 14% (HR 1.23, 99% CI 1.21-1.25) and SEER 27% vs 14% (HR 2.11, 99% CI 2.05-2.18). Rate of death was similar whether the patient was missing 1 or ≥2 variables. When stratified by the type of missing variable, differences in OS between those with and without missing data in the NCDB were small. In SEER, reductions in OS were largest for those missing tumor variables (HR 2.26, 99% CI 2.19-2.33) or surgery data (HR 3.84, 99% CI 3.32-4.45). Among the tumor variables specifically, few clinically meaningful differences in OS were noted in the NCDB, while the most significant differences in SEER were noted in T and N stage (table). Conclusions: Missingness of select variables is associated with a worse OS and is not uncommon within large national cancer registries. Therefore, researchers must use caution when choosing inclusion/exclusion criteria for outcomes studies. Future research is needed to elucidate which patients are most often missing data and why OS differences are observed. [Table: see text]

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Relationship Between Change in Serum Uric Acid and Ischemic Stroke in Chinese Hypertensive Patients

Frontiers in Cardiovascular Medicine ◽

10.3389/fcvm.2021.717128 ◽

2021 ◽

Vol 8 ◽

Author(s):

Qiu-hong Tan ◽

Lin Liu ◽

Yu-qing Huang ◽

Yu-ling Yu ◽

Jia-yi Huang ◽

...

Keyword(s):

Uric Acid ◽

Ischemic Stroke ◽

Serum Uric Acid ◽

Proportional Hazards ◽

Cox Proportional Hazards ◽

Elevated Risk ◽

Rank Test ◽

Hypertensive Patients ◽

Cox Proportional Hazards Models ◽

The Relationship

Background: Limited studies focused on the association between serum uric acid (SUA) change with ischemic stroke, and their results remain controversial. The present study aimed to investigate the relationship between change in SUA with ischemic stroke among hypertensive patients.Method: This was a retrospective cohort study. We recruited adult hypertensive patients who had two consecutive measurements of SUA levels from 2013 to 2014 and reported no history of stroke. Change in SUA was assessed as SUA concentration measured in 2014 minus SUA concentration in 2013. Multivariable Cox proportional hazards models were used to estimate adjusted hazard ratios (HRs) and 95% confidence intervals (CIs). The Kaplan–Meier analysis and log-rank test were performed to quantify the difference in cumulative event rate. Additionally, subgroup analysis and interaction tests were conducted to investigate heterogeneity.Results: A total of 4,628 hypertensive patients were included, and 93 cases of ischemic stroke occurred during the mean follow-up time of 3.14 years. Participants were categorized into three groups according to their SUA change tertiles [low (SUA decrease substantially): <-32.6 μmol/L; middle (SUA stable): ≥-32.6 μmol/L, <40.2 μmol/L; high (SUA increase substantially): ≥40.2 μmol/L]. In the fully adjusted model, setting the SUA stable group as reference, participants in the SUA increase substantially group had a significantly elevated risk of ischemic stroke [HR (95% CI), 1.76 (1.01, 3.06), P = 0.0451], but for the SUA decrease substantially group, the hazard effect was insignificant [HR (95% CI), 1.31 (0.75, 2.28), P = 0.3353]. Age played an interactive role in the relationship between SUA change and ischemic stroke. Younger participants (age < 65 years) tended to have a higher risk of ischemic stroke when SUA increase substantially.Conclusion: SUA increase substantially was significantly correlated with an elevated risk of ischemic stroke among patients with hypertension.

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Characteristics and outcomes of an international cohort of 400,000 hospitalised patients with Covid-19

10.1101/2021.09.11.21263419 ◽

2021 ◽

Author(s):

◽

Christiana Kartsonaki

Keyword(s):

Clinical Outcomes ◽

Proportional Hazards ◽

Invasive Mechanical Ventilation ◽

Case Fatality ◽

Cox Proportional Hazards ◽

Risk Of Death ◽

Cox Proportional Hazards Models ◽

Hospitalised Patients ◽

Male Sex ◽

Viable Model

Background: Policymakers need robust data to respond to the COVID-19 pandemic. We describe demographic features, treatments and clinical outcomes in the International Severe Acute Respiratory and emerging Infection Consortium (ISARIC) COVID-19 cohort, the world's largest international, standardised cohort of hospitalised patients. Methods: The dataset analysed includes COVID-19 patients hospitalised between January 2020 and May 2021. We investigated how symptoms on admission, comorbidities, risk factors, and treatments varied by age, sex, and other characteristics. We used Cox proportional hazards models to investigate associations between demographics, symptoms, comorbidities, and other factors with risk of death, admission to intensive care unit (ICU), and invasive mechanical ventilation (IMV). Findings: 439,922 patients with laboratory-confirmed (91.7%) or clinically-diagnosed (8.3%) SARS-CoV-2 infection from 49 countries were enrolled. Age (adjusted hazard ratio [HR] per 10 years 1.49 [95% CI 1.49-1.50]) and male sex (1.26 [1.24-1.28]) were associated with a higher risk of death. Rates of admission to ICU and use of IMV increased with age up to age 60, then dropped. Symptoms, comorbidities, and treatments varied by age and had varied associations with clinical outcomes. Tuberculosis was associated with an 86% higher risk of death, and HIV with an 87% higher risk of death. Case fatality ratio varied by country partly due to differences in the clinical characteristics of recruited patients. Interpretation: The size of our international database and the standardized data collection method makes this study a reliable and comprehensive international description of COVID-19 clinical features. This is a viable model to be applied to future epidemics.

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Early hemoglobin decline and survival prognosis in epoetin alfa studies

Journal of Clinical Oncology ◽

10.1200/jco.2009.27.15_suppl.9625 ◽

2009 ◽

Vol 27 (15_suppl) ◽

pp. 9625-9625

Author(s):

J. A. Berlin ◽

P. J. Bowers ◽

S. Rao ◽

S. Sun ◽

K. Liu ◽

...

Keyword(s):

Proportional Hazards ◽

Cox Proportional Hazards ◽

Time Dependent ◽

Epoetin Alfa ◽

Survival Prognosis ◽

Proportional Hazards Models ◽

Risk Of Death ◽

Cox Proportional Hazards Models ◽

Level Data ◽

Increased Risk

9625 Background: When cancer patients (pts) with chemotherapy-induced anemia (CIA) respond to erythropoietic-stimulating agents (ESA), hemoglobin (Hb) typically increases within 4–8 weeks. This exploratory analysis examined whether mortality differs depending on Hb response after 4 or 8 weeks of epoetin alfa (EPO) treatment or depending on transfusion. Methods: Pt-level data were analyzed from 31 randomized studies (7,215 pts) of epoetin alfa vs non-EPO (15 studies) or placebo (16 studies) in pts with CIA. A landmark analysis was used; Hb change was set at a specific time (4 and 8 weeks) and subsequent survival was examined separately for EPO and placebo. Pts were categorized as “Hb increased” (>0.5 g/dL), “Hb decreased” (>0.5 g/dL), or “Hb stable” (within ±0.5 g/dL) compared to baseline. Hb stable was compared to other Hb change categories with Cox proportional hazards models, stratified by study and adjusted for potential confounders. Results: The hazard ratio (HR) for Hb decreased versus Hb stable at 4 weeks was 1.44 for EPO (95% CI: 1.04, 1.99), indicating worse survival for pts with a decline in Hb. This association was weaker for placebo (HR: 1.12; 95% CI: 0.74, 1.67). Increased risk with declining Hb in EPO-treated pts was most pronounced in studies that maintained Hb ≥12 g/dL or treated pts for >12–16 weeks (1,876 pts). Patterns were similar using the 8-week landmark. In both EPO-treated and placebo pts, transfusion increased the rate of on-study death ∼3.5 fold (treating transfusion as a time-dependent variable). Conclusions: These exploratory findings suggest that both decreased Hb after 4 or 8 weeks of EPO treatment and transfusion are associated with increased risk of death. In spite of adjustment for other prognostic factors, it is likely that this association reflects poorer underlying prognosis of pts whose Hb fails to respond. ESAs should be discontinued in the absence of a Hb response. [Table: see text]

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