Browsing by Author "Solomon, Nicole C"
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Item Open Access Exploring the Unmet Need in Acute Ischemic Stroke Patients Not Treated With Intravenous Alteplase: The Get With The Guidelines‐Stroke Registry(Stroke: Vascular and Interventional Neurology, 2022-01) Mac Grory, Brian; Xian, Ying; Solomon, Nicole C; Matsouaka, Roland A; Decker‐Palmer, Marquita R; Fonarow, Gregg C; Smith, Eric E; Schwamm, Lee HBackground Early administration of intravenous tissue plasminogen activator (IV alteplase) improves functional outcomes in patients with acute ischemic stroke, yet many patients are not treated with IV alteplase. There is a need to understand the reasons for nontreatment and the short‐ and long‐term outcomes in this patient population. Methods We analyzed patients ≥65 years old with a primary diagnosis of acute ischemic stroke presenting within 24 hours of time last known well (LKW) but not treated with IV alteplase from 1630 Get With The Guidelines‐Stroke hospitals in the United States between January 2016 and December 2016. We report clinical characteristics, reasons for withholding treatment, in‐hospital mortality, and 90‐day and 1‐year outcomes including costs, stratified by time from LKW to presentation (≤4.5, >4.5–6, and >6–24 hours). Results Of 39 760 patients (median age 80 [25th–75th quartiles: 73–87], 56.7% female), 19 391 (48.8%) presented within 4.5 hours of LKW. In those with documented reasons for withholding IV alteplase, the most common reasons were rapid improvement of symptoms (3985/14 782, 27.0%) and mild symptoms (3791/14 782, 25.6%). In 1100 out of 1174 (93.7%) patients presenting in the >3.0‐ to 4.5‐hour time window, the most common reason for not treating was a delay in patient arrival. The most common discharge location for those presenting ≤4.5 hours since LKW was home (8660/19 391, 44.7%). The 90‐day mortality and readmission rates were 18.9% and 23.0% in those presenting ≤4.5 hours since LKW, 19.0% and 22.2% in those presenting between 4.5 and 6 hours, and 19.1% and 23.2% in those presenting between 6 and 24 hours. Median 90‐day total in‐hospital costs remained relatively high at $9471 (Q25–Q75: $5622–$21 356) in patients presenting ≤4.5 hours since LKW. Conclusions Patients within the Get With The Guidelines‐Stroke registry not treated with IV alteplase have a high risk of readmission and mortality and have high total in‐hospital and postdischarge costs. This study may inform future efforts to address the unmet need to improve the scope of IV alteplase delivery along with other aspects of acute ischemic stroke care and, consequently, outcomes in this patient population.Item Open Access Kidney Outcomes Among Medicare Beneficiaries After Hospitalization for Heart Failure.(JAMA cardiology, 2024-05) Ostrominski, John W; Greene, Stephen J; Patel, Ravi B; Solomon, Nicole C; Chiswell, Karen; DeVore, Adam D; Butler, Javed; Heidenreich, Paul A; Huang, Joanna C; Kittleson, Michelle M; Joynt Maddox, Karen E; Linganathan, Karthik K; McDermott, James J; Owens, Anjali Tiku; Peterson, Pamela N; Solomon, Scott D; Vardeny, Orly; Yancy, Clyde W; Fonarow, Gregg C; Vaduganathan, MuthiahImportance
Kidney health has received increasing focus as part of comprehensive heart failure (HF) treatment efforts. However, the occurrence of clinically relevant kidney outcomes in contemporary populations with HF has not been well studied.Objective
To examine rates of incident dialysis and acute kidney injury (AKI) among Medicare beneficiaries after HF hospitalization.Design, setting, and participants
This retrospective cohort study evaluated adults aged 65 years or older who were hospitalized for HF across 372 sites in the Get With The Guidelines-Heart Failure registry in the US between January 1, 2014, and December 31, 2018. Patients younger than 65 years or requiring dialysis either during or prior to hospitalization were excluded. Data were analyzed from May 4, 2021, to March 8, 2024.Main outcomes and measures
The primary outcome was inpatient dialysis initiation in the year after HF hospitalization and was ascertained via linkage with Medicare claims data. Other all-cause and cause-specific hospitalizations were also evaluated. The covariate-adjusted association between discharge estimated glomerular filtration rate (eGFR) and 1-year postdischarge outcomes was examined using Cox proportional hazards regression models.Results
Overall, among 85 298 patients included in the analysis (mean [SD] age, 80 [9] years; 53% women) mean (SD) left ventricular ejection fraction was 47% (16%) and mean (SD) eGFR was 53 (29) mL/min per 1.73 m2; 54 010 (63%) had an eGFR less than 60 mL/min per 1.73 m2. By 1 year after HF hospitalization, 6% had progressed to dialysis, 7% had progressed to dialysis or end-stage kidney disease, and 7% had been readmitted for AKI. Incident dialysis increased steeply with lower discharge eGFR category: compared with patients with an eGFR of 60 mL/min per 1.73 m2 or more, individuals with an eGFR of 45 to less than 60 and of less than 30 mL/min per 1.73 m2 had higher rates of dialysis readmission (45 to <60: adjusted hazard ratio [AHR], 2.16 [95% CI, 1.86-2.51]; <30: AHR, 28.46 [95% CI, 25.25-32.08]). Lower discharge eGFR (per 10 mL/min per 1.73 m2 decrease) was independently associated with a higher rate of readmission for dialysis (AHR, 2.23; 95% CI, 2.14-2.32), dialysis or end-stage kidney disease (AHR, 2.34; 95% CI, 2.24-2.44), and AKI (AHR, 1.25; 95% CI, 1.23-1.27), with similar findings for all-cause mortality, all-cause readmission, and HF readmission. Baseline left ventricular ejection fraction did not modify the covariate-adjusted association between lower discharge eGFR and kidney outcomes.Conclusions and relevance
In this study, older adults with HF had substantial risk of kidney complications, with an estimated 6% progressing to dialysis in the year after HF hospitalization. These findings emphasize the need for health care approaches prioritizing kidney health in this high-risk population.Item Open Access Meta-Analysis Evaluating the Impact of Site of Metastasis on Overall Survival in Men With Castration-Resistant Prostate Cancer.(Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2016-05) Halabi, Susan; Kelly, William Kevin; Ma, Hua; Zhou, Haojin; Solomon, Nicole C; Fizazi, Karim; Tangen, Catherine M; Rosenthal, Mark; Petrylak, Daniel P; Hussain, Maha; Vogelzang, Nicholas J; Thompson, Ian M; Chi, Kim N; de Bono, Johann; Armstrong, Andrew J; Eisenberger, Mario A; Fandi, Abderrahim; Li, Shaoyi; Araujo, John C; Logothetis, Christopher J; Quinn, David I; Morris, Michael J; Higano, Celestia S; Tannock, Ian F; Small, Eric JPurpose
Reports have suggested that metastatic site is an important predictor of overall survival (OS) in men with metastatic castration-resistant prostate cancer (mCRPC), but these were based on a limited number of patients. We investigate the impact of site of metastases on OS of a substantial sample of men with mCRPC who received docetaxel chemotherapy in nine phase III trials.Patients and methods
Individual patient data from 8,820 men with mCRPC enrolled onto nine phase III trials were combined. Site of metastases was categorized as lymph node (LN) only, bone with or without LN (with no visceral metastases), any lung metastases (but no liver), and any liver metastases.Results
Most patients had bone with or without LN metastases (72.8%), followed by visceral disease (20.8%) and LN-only disease (6.4%). Men with liver metastases had the worst median OS (13.5 months). Although men with lung metastases had better median OS (19.4 months) compared with men with liver metastases, they had significantly worse median survival duration than men with nonvisceral bone metastases (21.3 months). Men with LN-only disease had a median OS of 31.6 months. The pooled hazard ratios for death in men with lung metastases compared with men with bone with or without LN metastases and in men with any liver metastases compared with men with lung metastases were 1.14 (95% CI, 1.04 to 1.25; P = .007) and 1.52 (95% CI, 1.35 to 1.73; P < .0001), respectively.Conclusion
Specific sites of metastases in men with mCRPC are associated with differential OS, with successive increased lethality for lung and liver metastases compared with bone and nonvisceral involvement. These data may help in treatment decisions, the design of future clinical trials, and understanding the variation in biology of different sites of metastases in men with mCRPC.Item Open Access Prostate-specific antigen changes as surrogate for overall survival in men with metastatic castration-resistant prostate cancer treated with second-line chemotherapy.(Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2013-11) Halabi, Susan; Armstrong, Andrew J; Sartor, Oliver; de Bono, Johann; Kaplan, Ellen; Lin, Chen-Yen; Solomon, Nicole C; Small, Eric JPurpose
Prostate-specific antigen (PSA) kinetics, and more specifically a ≥ 30% decline in PSA within 3 months after initiation of first-line chemotherapy with docetaxel, are associated with improvement in overall survival (OS) in men with metastatic castration-resistant prostate cancer (mCRPC). The objective of this analysis was to evaluate post-treatment PSA kinetics as surrogates for OS in patients receiving second-line chemotherapy.Patients and methods
Data from a phase III trial of patients with mCRPC randomly assigned to cabazitaxel plus prednisone (C + P) or mitoxantrone plus prednisone were used. PSA decline (≥ 30% and ≥ 50%), velocity, and rise within the first 3 months of treatment were evaluated as surrogates for OS. The Prentice criteria, proportion of treatment explained (PTE), and meta-analytic approaches were used as measures of surrogacy.Results
The observed hazard ratio (HR) for death for patients treated with C + P was 0.66 (95% CI, 0.55 to 0.79; P < .001). Furthermore, a ≥ 30% decline in PSA was a statistically significant predictor of OS (HR for death, 0.52; 95% CI, 0.43 to 0.64; P < .001). Adjusting for treatment effect, the HR for a ≥ 30% PSA decline was 0.50 (95% CI, 0.40 to 0.62; P < .001), but treatment remained statistically significant, thus failing the third Prentice criterion. The PTE for a ≥ 30% decline in PSA was 0.34 (95% CI, 0.11 to 0.56), indicating a lack of surrogacy for OS. The values of R(2) were < 1, suggesting that PSA decline was not surrogate for OS.Conclusion
Surrogacy for any PSA-based end point could not be demonstrated in this analysis. Thus, the benefits of cabazitaxel in mediating a survival benefit are not fully captured by early PSA changes.