Sex differences in implantable cardiac defibrillator therapy according to arrhythmia detection times

Heart ◽  
2019 ◽  
Vol 106 (7) ◽  
pp. 520-526 ◽  
Author(s):  
Maurizio Gasparini ◽  
Axel Kloppe ◽  
Maurizio Lunati ◽  
Niraj Varma ◽  
Jose B Martinez-Ferrer ◽  
...  
Keyword(s):  
Sex Differences ◽  
Ventricular Arrhythmias ◽  
Regression Models ◽  
Cox Regression ◽  
Implantable Cardiac Defibrillator ◽  
Clinical Trial Registration ◽  
Arrhythmia Detection ◽  
Post Hoc Analysis ◽  
Kaplan Meier ◽  
Post Hoc

ObjectiveIn implantable cardiac defibrillators (ICDs), long-detection times safely reduce unnecessary and inappropriate therapies. We aimed to evaluate ICD treatment of ventricular arrhythmias in women, compared with men, also taking into account ICD detection.MethodsThe Advance III trial randomised patients implanted with an ICD for primary or secondary prevention in two arms—long and nominal ventricular arrhythmias detection times before therapy delivering (number of intervals needed to detect (NID) 30/40 and 18/24, respectively). The main endpoint of this post hoc analysis was the incidence of ICD therapies evaluated through Kaplan-Meier method and univariate Cox regression models.ResultsOverall, 1902 patients (304 women, 65±11 years) were randomised. Women showed a lower risk of ICD therapy (HR 0.63, 95% CI 0.43 to 0.93, p=0.022); this difference was observed only in the long-detection arm (HR 0.37, p=0.013) and not in the short detection arm (HR 0.82, p=0.414). No significant sex differences were observed concerning inappropriate therapies and mortality rate. Long-detection settings significantly reduced overall ICD therapies and appropriate ICD therapies, both in women (overall HR 0.31, p=0.007; appropriate HR 0.33, p=0.033) and in men (overall HR 0.69, p=0.006; appropriate HR 0.73, p=0.048).ConclusionsIn patients with ICDs, the strategy of setting a long-detection time to treat ventricular arrhythmias (NID 30/40) reduces overall delivered therapies, both in women and men, when compared with nominal setting (NID 18/24). The reduction was significantly higher in women. Overall, women were less likely to experience ICD therapies than men; this result was only observed in the long-detection arm.Clinical trial registrationNCT00617175.

scholarly journals Similar glycaemic control and risk of hypoglycaemia with patient- versus physician-managed titration of insulin glargine 300 U/mL across subgroups of patients with T2DM: a post hoc analysis of ITAS

2021 ◽  
Author(s):  
Andrea Giaccari ◽  
R. C. Bonadonna ◽  
R. Buzzetti ◽  
G. Perseghin ◽  
D. Cucinotta ◽  
...  
Keyword(s):  
Glycaemic Control ◽  
Insulin Glargine ◽  
Patient Characteristics ◽  
Efficacy And Safety ◽  
Clinical Trial Registration ◽  
Post Hoc Analysis ◽  
Almost All ◽  
Antihyperglycaemic Drugs ◽  
Post Hoc ◽  
Patient Subgroups

Abstract Aims The Italian Titration Approach Study (ITAS) demonstrated comparable HbA1c reductions and similarly low hypoglycaemia risk at 6 months in poorly controlled, insulin-naïve adults with T2DM who initiated self- or physician-titrated insulin glargine 300 U/mL (Gla-300) in the absence of sulphonylurea/glinide. The association of patient characteristics with glycaemic and hypoglycaemic outcomes was assessed. Methods This post hoc analysis investigated whether baseline patient characteristics and previous antihyperglycaemic drugs were associated with HbA1c change and hypoglycaemia risk in patient- versus physician-managed Gla-300 titration. Results HbA1c change, incidence of hypoglycaemia (any type) and nocturnal rates were comparable between patient- and physician-managed arms in all subgroups. Hypoglycaemia rates across subgroups (0.03 to 3.52 events per patient-year) were generally as low as observed in the full ITAS population. Small increases in rates of 00:00–pre-breakfast and anytime hypoglycaemia were observed in the ≤ 10-year diabetes duration subgroup in the patient- versus physician-managed arm (heterogeneity of effect; p < 0.05). Conclusions Comparably fair glycaemic control and similarly low hypoglycaemia risk were achieved in almost all patient subgroups with patient- versus physician-led Gla-300 titration. These results reinforce efficacy and safety of Gla-300 self-titration across a range of phenotypes of insulin-naïve people with T2DM. Clinical trial registration EudraCT 2015-001167-39

scholarly journals Outcomes After Drug-Coated Balloon Treatment of Femoropopliteal Lesions in Patients With Critical Limb Ischemia: A Post Hoc Analysis From the IN.PACT Global Study

2019 ◽  
Vol 26 (3) ◽  
pp. 305-315 ◽  
Author(s):  
Michel M. P. J. Reijnen ◽  
Iris van Wijck ◽  
Thomas Zeller ◽  
Antonio Micari ◽  
Pierfrancesco Veroux ◽  
...  
Keyword(s):  
Critical Limb Ischemia ◽  
Limb Ischemia ◽  
Target Lesion ◽  
Major Amputation ◽  
Limb Amputation ◽  
Post Hoc Analysis ◽  
Kaplan Meier ◽  
Global Study ◽  
Post Hoc ◽  
Drug Coated Balloon

Purpose: To report a post hoc analysis performed to evaluate 1-year safety and efficacy of the IN.PACT Admiral drug-coated balloon (DCB) for the treatment of femoropopliteal lesions in subjects with critical limb ischemia (CLI) enrolled in the IN.PACT Global study ( ClinicalTrials.gov identifier NCT01609296). Materials and Methods: Of 1535 subjects enrolled in the study, 156 participants (mean age 71.8±10.4; 87 men) with CLI (Rutherford categories 4,5) were treated with DCB angioplasty in 194 femoropopliteal lesions. This cohort was compared to the 1246 subjects (mean age 68.2±10.0 years; 864 men) with intermittent claudication (IC) treated for 1573 lesions. The CLI cohort had longer lesions (13.9±10.6 vs 11.9±9.4 cm, p=0.009) and a higher calcification rate (76.8% vs 67.7%, p=0.011). Major adverse events [MAE; composite of all-cause mortality, clinically-driven target lesion revascularization (CD-TLR), major (above-ankle) target limb amputation, and thrombosis at the target lesion site], lesion and vessel revascularization rates, and EuroQol-5D were assessed through 1 year. The Kaplan-Meier method was used to estimate survival, CD-TLR, and amputation events; estimates are presented with the 95% confidence intervals (CI). Results: Estimates of 12-month freedom from major target limb amputation were 98.6% (95% CI 96.7% to 100.0%) in subjects with CLI and 99.9% (95% CI 99.8% to 100.0%) in subjects with IC (p=0.002). Freedom from CD-TLR through 12 months was 86.3% (95% CI 80.6% to 91.9%) in CLI subjects and 93.4% (95% CI 91.9% to 94.8%) in IC subjects (p<0.001). The MAE rate through 12 months was higher in CLI subjects (22.5% vs 10.7%, p<0.001), and CLI patients had poorer overall survival (93.0%, 95% CI 88.9% to 97.2%) than IC subjects (97.0%, 95% CI 96.0% to 97.9%, p=0.011). Health status significantly improved in all domains at 6 and 12 months in both groups. Conclusion: Treatment of femoropopliteal disease with DCB in CLI patients is safe through 12-month follow-up, with a low major amputation rate of 1.4%. The rates of MAE and CD-TLR were higher in CLI subjects and reinterventions were required sooner. Additional research is needed to evaluate long-term outcomes of DCB treatment for femoropopliteal lesions in CLI patients.

scholarly journals Comparison of Efficacy Between Triamcinolone Acetonide and Triamcinolone Hexacetonide for Intraarticular Therapy in Juvenile Idiopathic Arthritis: A Retrospective Analysis

2021 ◽  
Author(s):  
Deirdre De Ranieri ◽  
Angela Chun ◽  
Lutfiyya Muhammad
Keyword(s):  
Regression Models ◽  
Cox Regression ◽  
Mixed Effects ◽  
Rank Test ◽  
Triamcinolone Hexacetonide ◽  
Drug Of Choice ◽  
Log Rank Test ◽  
Kaplan Meier ◽  
Time To Relapse ◽  
Corticosteroid Injections

Abstract Background There are many FDA-approved corticosteroid preparations available for intra-articular injection, however triamcinolone hexacetonide is not one of them. It was the intraarticular drug of choice among pediatric rheumatologists up until approximately a decade ago, when production of this medication ceased. It can be obtained in the United States and Canada via importation from Europe, but it is not FDA-approved at this time. We wish to compare the duration of remission of intraarticular triamcinolone hexacetonide (TH) with that of triamcinolone acetonide (TA) in children with Juvenile Idiopathic Arthritis (JIA) and demonstrate its safety in this population. Methods This retrospective chart review included 39 patients with JIA who received intraarticular corticosteroid injections (IACIs) from September 2018 to September 2019. These patients were reviewed and their life-time injections with either TH (41 joints) or TA (124 joints) was noted through May 30, 2021. Patients with concomitant systemic therapy initiation were excluded. The primary outcome was time to relapse. Relapse was defined by the presence of arthritis on physical examination by an attending rheumatologist. Kaplan-Meier curves and a log-rank test were constructed to compare the probability of time to relapse between IACI injections. Additionally, mixed effects cox regression models were constructed to account for multiple injections per participant. Results Kaplan-Meier estimator of median relapse time in months was higher for TH. Based on the log-rank test, TA joints had a higher probability of experiencing a relapse during the study time (p-value < 0.001). The hazard of time to relapse was reduced when comparing TH to TA in both unadjusted and adjusted mixed effects cox regression models (unadjusted hazard ratio (95% confidence interval): 0.184 (0.089, 0.381); adjusted hazard ratio (95% confidence interval): 0.189 (0.092, 0.386)). Conclusions TH has longer duration of action than TA and is associated with less systemic side effects. It should be considered the drug of choice for intraarticular corticosteroid injections in children with JIA.

scholarly journals A comparison of the prognostic significance of changes in NT-proBNP levels in HFrEF and HFpEF.

2021 ◽  
Author(s):  
Nishant Sahni ◽  
Umesh Sharma ◽  
Rashi Arora
Keyword(s):  
Regression Models ◽  
Cox Regression ◽  
Survival Rates ◽  
Prognostic Significance ◽  
Rank Test ◽  
Log Rank Test ◽  
Kaplan Meier ◽  
Regional Health Care ◽  
Comorbidity Scores ◽  
Blood Pressures

Background: Rising NT-proBNP are associated with reduced survival patients with HFrEF. However, it remains to be conclusively and formally demonstrated that the temporal trend in NT-proBNP level carries prognostic significance in HFpEF. Objective: To determine whether there is an association between rising NT-proBNP levels and 6-month survival in patients with HFpEF and HFrEF. Methods: We examined a cohort of 5203 patients to 5 hospitals in a regional health care system — who had at least one admission to the hospital with diagnoses of heart failure over a 3-year period. Kaplan-Meier survival curves were constructed for patients with downtrending (>25% net decrease), stable or uptrending (>25% net increase) NT-proBNP levels in HF, HFpEF and HFrEF patients. The log-rank test was used to test for differences in 6-month survival amongst the groups. Multivariate extended Cox regression models were constructed for 6-month survival with NT-proBNP as a time-varying covariate. Age, albumin, sex, race, serum creatinine, systolic and diastolic blood pressures and Charlson comorbidity scores at baseline were used as covariates in the model. Separate analyses were done for HFpEF and HFrEF patients. Results: HFpEF and HFrEF patients with up-trending levels had significantly lower 6-month survival rates than patients with downtrending or stable NT-proBNP levels. A doubling of the NT-proBNP level in patients was significantly associated with reduced 6-month survival in patients with in both subgroups of HF, HFpEF and HFrEF (HFpEF-HR: 1.53(1.49-2.57), HFrEF HR: 1.45(1.43-1.48) after adjusting for covariates.

scholarly journals The Neutrophil-to-lymphocyte Ratio at the Time of Admission: A New Prognostic Indicator for Hospital Mortality of Trauma Patients

2021 ◽  
Author(s):  
Hamed Fouladseresht ◽  
Shahram Bolandparvaz ◽  
Hamid Reza Abbasi ◽  
Hossein Abdolrahimzadeh Fard ◽  
Shahram Paydar
Keyword(s):  
Survival Analysis ◽  
Hospital Mortality ◽  
Regression Models ◽  
Cox Regression ◽  
Prognostic Indicator ◽  
Neutrophil To Lymphocyte Ratio ◽  
Trauma Patients ◽  
Lymphocyte Ratio ◽  
Kaplan Meier ◽  
Time Of Admission

The elevated neutrophil-to-lymphocyte ratio (NLR) is associated with poor clinical outcomes, especially in pro-inflammatory states such as surgical injuries and severe hemorrhages. Therefore, it was hypothesized whether NLR value at the time of admission could be a prognostic indicator of hospital mortality in trauma patients. This retrospective cohort study was conducted on 865 trauma patients referred to Rajaee Hospital between April 2016 and July 2019. The NLR value was calculated at the time of admission, and receiver operating characteristics (ROC) curve analysis was used to determine the cut-off point value of admission NLR related to hospital mortality of trauma patients. Furthermore, Kaplan-Meier survival analysis and Cox regression models have been applied to determine the effectiveness and prognostic potential of the admission NLR in the hospital mortality of trauma patients. The median age of the trauma patients was 32 years with an interquartile range (IQR) of 23 to 48 years, and most of them were male (83.9%). Also, trauma patients had a median injury severity score (ISS) of 9 (IQR=4-16) and a median Glasgow coma scale (GCS) of 14 (IQR=9-15). The cut-off value for admission NLR was 5.27 (area under the curve: 0.642, 95%CI: 0.559-0.726, p=0.001). In Kaplan-Meier survival analysis, the admission NLR>5.27 was an indicator of hospital mortality in trauma patients (p=0.001). Multivariate Cox regression models demonstrated that trauma patients with an admission NLR>5.27 had a 2.33-fold risk of hospital mortality (hazard ratio=2.33, 95%CI: 1.02-5.38, p=0.041). Furthermore, the admission NLR>5.27 was associated with a higher risk of hospital mortality in trauma patients with age≥65 years, systolic blood pressure≤90 mmHg, blood potassium>4.5 mmol/L, blood sodium>144 mEq/L, blood potential hydrogen (pH)≤7.28, GCS≤8, ISS>24 and blood base excess≤-6.1 mEq/L. The NLR value greater than 5.27 at the time of admission was associated with poorer outcomes, and it can be considered an independent prognostic indicator of hospital mortality in trauma patients.

scholarly journals P.005 Long-term retention on adjunctive brivaracetam in adults with focal seizures and previous carbamazepine, lamotrigine, levetiracetam, or topiramate use: Post-hoc analysis

2019 ◽  
Vol 46 (s1) ◽  
pp. S14-S15
Author(s):  
K Foris ◽  
M Martin ◽  
S Dimova ◽  
S Elmoufti ◽  
C Laloyaux ◽  
...  
Keyword(s):  
Retention Rates ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Post Hoc Analysis ◽  
Focal Seizures ◽  
Term Retention ◽  
Kaplan Meier ◽  
Long Term Retention ◽  
Post Hoc

Background: Previous post-hoc analysis of three 12-week, double-blind, placebo-controlled trials of adjunctive brivaracetam (BRV) in patients with focal seizures demonstrated similar efficacy over placebo regardless of previous carbamazepine (CBZ), lamotrigine (LTG), levetiracetam (LEV), or topiramate (TPM) failure. This analysis explored long-term retention of adjunctive BRV in patients with previous CBZ/LTG/LEV/TPM. Methods: Post-hoc analysis of double-blind, placebo-controlled trial (N01358 [NCT01261325]) and open-label extension (N01379 [NCT01339559]; cut-off 15-March-2017) of adjunctive BRV in patients (≥16 years) with focal seizures. Outcomes were assessed in patients randomized to BRV (100 or 200 mg/day) who had previous CBZ/LTG/LEV/TPM (stopped ≥90 days before BRV initiation). Results: 503 patients were analyzed. Baseline characteristics were generally similar in subgroups with previous CBZ/LTG/LEV/TPM (n=209/162/256/182). Overall, Kaplan-Meier-estimated BRV retention at 1-, 3-, and 5-years was 71.0%, 50.9%, and 32.4%. Across previous antiepileptic drug (AED) subgroups, Kaplan-Meier-estimated BRV retention (1-year: 64.8%–73.2%; 3-year: 41.9%–49.9%; 5-year: 31.5%–35.7%), BRV discontinuations (58.4%–63.0%), and most common reasons for discontinuation (lack of efficacy: 23.0%–25.3%; adverse event: 16.7%–22.2%) were generally similar. Conclusions: Post-hoc analysis demonstrated similar long-term retention rates and discontinuation reasons with adjunctive BRV in adults previously treated with CBZ/LTG/LEV/TPM. Adjunctive BRV provides long-term effectiveness in patients who failed common AED treatments, including LEV.UCB Pharma-sponsored

scholarly journals Khorana score and thromboembolic risk in stage II–III colorectal cancer patients: a post hoc analysis from the adjuvant TOSCA trial

2020 ◽  
Vol 12 ◽  
pp. 175883591989985
Author(s):  
Sandro Barni ◽  
Gerardo Rosati ◽  
Sara Lonardi ◽  
Nicoletta Pella ◽  
Maria Banzi ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Adjuvant Chemotherapy ◽  
Cox Regression ◽  
Risk Groups ◽  
Phase Iii ◽  
Independent Predictive Factor ◽  
Thromboembolic Risk ◽  
Post Hoc Analysis ◽  
Venous Thromboembolic Events ◽  
Post Hoc

Background: The risk of venous thromboembolic events (VTE) during adjuvant chemotherapy for colorectal cancer (CRC) is unknown. We aim to evaluate if the Khorana score (KS) can predict this risk, and if it represents a prognostic factor for overall survival (OS) through a post hoc analysis of the phase III TOSCA trial of different durations (3- versus 6-months) of adjuvant chemotherapy. Methods: A logistic regression model was used to test the associations between the risk of VTE and the KS. The results are expressed as odds ratios (OR) with 95% confidence intervals (95% CI). To assess the effect of the KS on OS, multivariable analyses using Cox regression models were performed. The results are expressed as hazard ratios (HR) with 95% CI. Results: Among 1380 CRC patients with available data, the VTE risk ( n = 72 events: 5.2%) was similar in the two duration arms (5.5% versus 4.9%), with 0.2% of patients belonging to the high-risk KS group. Rates of VTE were similar in the low- and intermediate-risk groups (4.8% versus 6.4%). KS did not represent an independent predictive factor for VTE occurrence. Chemotherapy duration was not associated with VTE risk. In addition, KS was not prognostic for OS in multivariate analysis (HR: 0.92, 95% CI, 0.63–1.36; p = 0.6835). Conclusions: The use of the KS did not predict VTEs in a low–moderate thromboembolic risk population as CRC. These data did not support the use of KS to predict VTE during adjuvant chemotherapy, and suggest that other risk assessment models should be researched.

Sex Differences in Vasovagal Syncope: A Post Hoc Analysis of the Prevention of Syncope Trials (POST) I and II

2020 ◽  
Vol 36 (1) ◽  
pp. 79-83 ◽  
Author(s):  
Adam P. Deveau ◽  
Robert Sheldon ◽  
Connor Maxey ◽  
Deborah Ritchie ◽  
Steve Doucette ◽  
...  
Keyword(s):  
Sex Differences ◽  
Vasovagal Syncope ◽  
Post Hoc Analysis ◽  
Post Hoc

scholarly journals Empagliflozin for Patients With Presumed Resistant Hypertension: A Post Hoc Analysis of the EMPA-REG OUTCOME Trial

2020 ◽  
Author(s):  
João Pedro Ferreira ◽  
David Fitchett ◽  
Anne Pernille Ofstad ◽  
Bettina Johanna Kraus ◽  
Christoph Wanner ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Resistant Hypertension ◽  
Repeated Measures ◽  
Cox Regression ◽  
Antihypertensive Drugs ◽  
Target Organ Damage ◽  
Organ Damage ◽  
Cardiac Events ◽  
Post Hoc Analysis ◽  
Post Hoc

Abstract BACKGROUND Type 2 diabetes (T2D) and resistant hypertension often coexist, greatly increasing risk of target-organ damage and death. We explored the effects of empagliflozin in patients with and without presumed resistant hypertension (prHT) in a post hoc analysis of EMPA-REG OUTCOME (NCT01131676). METHODS Overall, 7,020 patients received empagliflozin 10, 25 mg, or placebo with median follow-up of 3.1 years. We defined baseline prHT as ≥3 classes of antihypertensive drugs including a diuretic and uncontrolled blood pressure (BP; systolic blood pressure (SBP) ≥140 and/or diastolic blood pressure ≥90 mm Hg) or ≥4 classes of antihypertensive, including a diuretic, and controlled BP. We explored the effect of empagliflozin on cardiovascular (CV) death, heart failure (HF) hospitalization, 3-point major adverse cardiac events, all-cause death, and incident/worsening nephropathy by Cox regression and BP over time by a mixed-repeated-measures-model analysis. RESULTS 1,579 (22.5%) patients had prHT. The mean difference in change in SBP from baseline to week 12 vs. placebo was −4.5 (95% confidence interval, −5.9 to −3.1) mm Hg (P &lt; 0.001) in prHT and −3.7 (−4.5, −2.9) mm Hg (P &lt; 0.001) in patients without prHT. SBP was more frequently controlled (&lt;130/80 mm Hg) with empagliflozin than with placebo. Patients with prHT had 1.5- to 2-fold greater risk of HF hospitalization, incident/worsening nephropathy, and CV death compared with those without prHT. Empagliflozin improved all outcomes in patients with and without prHT (interaction P &gt; 0.1 for all outcomes). CONCLUSIONS Empagliflozin induced a clinically relevant reduction in SBP and consistently improved all outcomes regardless of prHT status. Due to these dual effects, empagliflozin should be considered for patients with hypertension and T2D.

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