scholarly journals QFR Predicts the Incidence of Long-Term Adverse Events in Patients with Suspected CAD: Feasibility and Reproducibility of the Method

2020 ◽  
Vol 9 (1) ◽  
pp. 220
Author(s):  
Andrea Buono ◽  
Annika Mühlenhaus ◽  
Tabitha Schäfer ◽  
Ann-Kristin Trieb ◽  
Julian Schmeißer ◽  
...  
Keyword(s):  
Coronary Vessels ◽  
Sensitivity Analyses ◽  
Significant Stenosis ◽  
Cerebrovascular Events ◽  
Long Term Follow Up ◽  
Angiographic Evidence ◽  
Quantitative Flow Ratio ◽  
Post Hoc

AIMS: We evaluate feasibility and reproducibility of post hoc quantitative flow ratio (QFR) measurements and their prognostic predictive power during long-term follow-up. METHODS AND RESULTS: Between 2010 and 2012, 167 patients without angiographic evidence of significant stenoses were enrolled in a prospective registry. Of these patients, 96% presented 7 years follow-up data. QFR was measured post hoc by three certified investigators. QFR analysis was feasible in 71% of left anterior descending (LAD), 72% of left circumflex (LCX), and 61% of right (RCA) coronaries for a total of 350 measurements repeated in triplicate. Coefficients of variation were 2.1% for RCA and LCX, and 2.8% for the LAD (quartile coefficients of dispersion respectively 1.5, 1.4, and 1.3). QFR ≤0.80 was recorded in 25 patients (27 vessels, in 74% of the cases LAD). A total of 86 major adverse cardiovascular and cerebrovascular events were observed in 76 patients. QFR ≤0.80 in at least one of the three vessels was the strongest predictor of events (HR 3.14, 95%CI 1.78–5.54, p = 0.0001). This association was maintained in several sensitivity analyses. CONCLUSIONS: QFR reproducibility is acceptable, even when analysis is performed post hoc. A pathological QFR is not rare in patients without angiographic evidence of significant stenosis and is a predictor of incident events during long-term follow-up. Condensed Abstract: In a post hoc analysis of 167 patients without evidence of angiographic significant stenosis, the presence of QFR value ≤0.80 in at least one of the three coronary vessels showed to be the strongest predictor of major adverse cardiovascular and cerebrovascular events during long-term follow-up. QFR reproducibility have been shown to be acceptable among experienced operators.

scholarly journals Disability improvement as a clinically relevant outcome in clinical trials of relapsing forms of multiple sclerosis

2021 ◽  
pp. 135245852110002
Author(s):  
Bruce AC Cree ◽  
Jeffrey A Cohen ◽  
Anthony T Reder ◽  
Davorka Tomic ◽  
Diego Silva ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trials ◽  
Therapeutic Benefit ◽  
Disease Modifying Therapies ◽  
Long Term Follow Up ◽  
Post Hoc ◽  
Switch Group ◽  
Relevant Outcome

Background: Disease-modifying therapies (DMTs) can reduce the risk of disability worsening in patients with relapsing forms of multiple sclerosis (RMS). High-efficacy DMTs can lead to confirmed or sustained disability improvement (CDI and SDI). Objective and Methods: Post hoc analyses of data from the TRANSFORMS, FREEDOMS, and FREEDOMS II trials and their extensions assessed the effects of fingolimod (0.5–1.25 mg/day) on stabilizing or improving disability over ⩽8 years in participants with RMS. CDI and SDI rates were compared between participants initially randomized to fingolimod, interferon (IFNβ-1a), or placebo. Results: At 8 years’ follow-up in TRANSFORMS, 35.1% (95% confidence interval [CI], 28.2%–43.1%) of assessed participants in the IFNβ-1a–fingolimod switch group and 41.9% (36.6%–47.6%) on continuous fingolimod experienced CDI; disability did not worsen in approximately 70%. Similar results were seen in the combined FREEDOMS population. Proportionally fewer TRANSFORMS participants achieved SDI in the IFNβ-1a–fingolimod switch group than on continuous fingolimod (5.4% [3.0%–9.5%] vs 14.2% [10.8%–18.4%], p = 0.01). Conclusion: CDI and SDI are outcomes of interest for clinical trials and for long-term follow-up of participants with RMS. Monitoring CDI and SDI in addition to disability worsening may facilitate understanding of the therapeutic benefit of RMS treatments.

scholarly journals Carotid artery stenting has similar outcomes in men and women

2021 ◽  
Vol 20 ◽  
Author(s):  
Marina Ansuategui ◽  
Gabriela Ibarra ◽  
Carmen Romero ◽  
Alejandra Comanges ◽  
Jose A. Gonzalez-Fajardo
Keyword(s):  
Myocardial Infarction ◽  
Cardiovascular Risk ◽  
Carotid Artery ◽  
Carotid Artery Stenting ◽  
Therapeutic Option ◽  
Stent Patency ◽  
Cerebrovascular Events ◽  
Long Term Follow Up

Abstract Background The aim of carotid interventions is to prevent cerebrovascular events. Endovascular treatment (carotid-artery-stenting/CAS) has become established as an alternative to open surgery in some cases. Historically, female sex has been considered as a perioperative risk factor, however, there are few studies regarding this hypothesis when it comes to CAS. Objectives To analyze the CAS results in our center adjusted by sex. Methods A retrospective cohort study was designed, including patients with carotid atheromatosis operated at a single center from January 2016 to June 2019. Our objective was to compare cardiovascular risk, including myocardial infarction, stroke, and mortality, by sex. Follow-up rates of stent patency, restenosis, stroke, myocardial infarction, and death were reported. Results 71 interventions were performed in 50 men (70.42%) and 21 women (29.57%). Mean age was 70.50 ± 10.72 years for men and 73.62 ± 11.78 years for women. Cardiovascular risk factors did not differ significantly between sexes. Mean follow-up was 11.28 ± 11.28 months. There were no significant differences in neurological events during follow-up. No adverse cardiological events were detected at any time. Regarding the mortality rate, during medium-term follow up there were 2 neurological related deaths with no significant differences between sexes (p=0.8432). Neither sex had higher rated of restenosis during long term follow-up (5.63% vs. 1.41%, p = 0.9693) or reoperation (1.41% vs. 1.41%, p = 0.4971). All procedures remained patent (<50% restenosis). Conclusions Despite the limitations of our study, CAS is a therapeutic option that is as effective and safe in women as in men. No sex differences were observed.

Durability of complete response (CR) with atezolizumab (atezo) in locally advanced/metastatic urothelial carcinoma (mUC).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 4527-4527
Author(s):  
Yohann Loriot ◽  
Arjun Vasant Balar ◽  
Robert Dreicer ◽  
Jean H. Hoffman-Censits ◽  
Jose Luis Perez-Gracia ◽  
...  
Keyword(s):  
Locally Advanced ◽  
Complete Response ◽  
First Response ◽  
Long Term Follow Up ◽  
Metastatic Urothelial Carcinoma ◽  
Post Hoc ◽  
Clinical Trial Information ◽  
Disposition Time

4527 Background: Atezo (anti–PD-L1) has been shown to elicit CRs in a number of mUC patients (pts) in clinical trials. We sought to describe the kinetics, durability and outcomes associated with these CRs in Ph I (PCD) and II (IMvigor210) atezo studies, each with long-term follow-up. Methods: In PCD (pre-treated mUC) and IMvigor210 (Cohort 1, cisplatin-ineligible untreated mUC; Cohort 2, platinum-treated mUC), pts received atezo per protocol (Petrylak JAMA Oncol 2018; Balar Lancet 2017; Rosenberg Lancet 2016). This post hoc analysis descriptively assessed pt disposition, time to and duration of RECIST 1.1 response and overall survival in pts with CR. Results: CR rates were 13%, 8% and 7% in PCD, IMvigor210 Cohort 1 and Cohort 2, respectively. First response was PR in most pts with CR. Median CR duration was > 3 y in PCD, not estimable (NE) in IMvigor210 Cohort 1 and > 2 y in Cohort 2 (Table). At data cutoff, all but 2, 0 and 1 pts were alive, respectively; across studies, ≥ 40% of pts with CR were on treatment. CR pts had a first response (PR/CR) by a median of 3.5 cycles. Further pt characteristics and survival outcomes will be reported. Conclusions: Across Ph I/II atezo mUC studies, CRs appeared durable (median duration > 2 y) despite small pt numbers. Most pts with CR were alive, with responses ongoing after long-term follow-up (median follow-up > 30 mo). Clinical trial information: NCT01375842, NCT02951767, NCT02108652. [Table: see text]

Effectiveness of exercise-based interventions in reducing depressive symptoms in people without clinical depression: systematic review and meta-analysis of randomised controlled trials

2021 ◽  
pp. 1-10
Author(s):  
Juan Ángel Bellón ◽  
Sonia Conejo-Cerón ◽  
Almudena Sánchez-Calderón ◽  
Beatriz Rodríguez-Martín ◽  
Darío Bellón ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Sample Size ◽  
Randomised Controlled Trials ◽  
Clinical Depression ◽  
Sensitivity Analyses ◽  
Controlled Trials ◽  
Long Term Follow Up ◽  
Randomised Controlled

Background In most trials and systematic reviews that evaluate exercise-based interventions in reducing depressive symptoms, it is difficult to separate treatment from prevention. Aims To evaluate the effectiveness of exercise-based interventions in reducing depressive symptoms in people without clinical depression. Method We searched PubMed, PsycINFO, Embase, WOS, SPORTDiscus, CENTRAL, OpenGrey and other sources up to 25 May 2020. We selected randomised controlled trials (RCTs) that compared exclusively exercise-based interventions with control groups, enrolling participants without clinical depression, as measured using validated instruments, and whose outcome was reduction of depressive symptoms and/or incidence of new cases of people with depression. Pooled standardised mean differences (SMDs) were calculated using random-effect models (registration at PROSPERO: CRD42017055726). Results A total of 14 RCTs (18 comparisons) evaluated 1737 adults without clinical depression from eight countries and four continents. The pooled SMD was −0.34 (95% CI −0.51 to −0.17; P < 0.001) and sensitivity analyses confirmed the robustness of this result. We found no statistical evidence of publication bias and heterogeneity was moderate (I2 = 54%; 95% CI 22–73%). Only two RCTs had an overall low risk of bias and three had long-term follow-up. Multivariate meta-regression found that a larger sample size, country (Asia) and selective prevention (i.e. people exposed to risk factors for depression) were associated with lower effectiveness, although only sample size remained significant when adjustment for multiple tests was considered. According to the Grading of Recommendations Assessment, Development and Evaluation tool, the quality of evidence was low. Conclusions Exercise-based interventions have a small effect on the reduction of depressive symptoms in people without clinical depression. It could be an alternative to or complement psychological programmes, although further higher-quality trials with larger samples and long-term follow-up are needed.

scholarly journals 274 Cerebrovascular events in takotsubo syndrome: short- and long-term outcome. Results from a multicentre-prospective registry

2021 ◽  
Vol 23 (Supplement_G) ◽  
Author(s):  
Alessandra Leopizzi ◽  
Francesco Santoro ◽  
Adriana Mallardi ◽  
Enrica Vitale ◽  
Natale Daniele Brunetti
Keyword(s):  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Hospital Death ◽  
Takotsubo Syndrome ◽  
Ventricular Ejection Fraction ◽  
Long Term Outcome ◽  
Cerebrovascular Events ◽  
Long Term Follow Up

Abstract Aims Several studies have shown that Takotsubo syndrome (TTS) secondary to neurological disorders is associated with higher rate of in-hospital complications. Imaging brain studies found that atrophy or damage of some regions and their altered connectivity with other brain regions are typical features of TTS patients. The aim of the study is to evaluate rates of in hospital and long-term Follow-up events in TTS patients with history or acute cerebrovascular events (CVE). Methods and results 395 consecutive patients were enrolled in a multicentre prospective registry. History, clinical data, echocardiographic parameters and in-hospital and long-term follow-up events of all patients were evaluated. Prevalence of cerebrovascular events among TTS patients was 9.4% (num = 37). Compared to the control group, these patients were older (80 ± 7 vs. 71 ± 12, P = 0.01) and predominantly men (24% vs. 9%, P = 0.01). No differences in term of cardiovascular risk factors and left ventricular ejection fraction at admission and discharge were found among the two groups. The prevalence of physical stressor was higher in the CVE group (67% vs. 44% P = 0.01). The incidence of in-hospital adverse events was higher in the CVE than in the control one (70% vs. 29%), mainly driven by higher rate of Cardiogenic shock (19 vs. 8% P = 0.01) and in-hospital death (19 vs. 4%, P = 0.01). At long-term follow-up, patients in CVE group hat higher mortality rate (38% vs. 20% P = 0.01)). Patients presenting with acute CVE, 10 out of 37 patients (27%) when compared with chronic CVE had higher in-hospital mortality (40% vs. 11% P = 0.01). Conclusions TTS patients with history or acute cerebrovascular events had higher rate of in-hospital events and death at long-term follow-up. Acute cerebrovascular events in the setting of TTS are featured with worst prognosis.

Long term follow-up of quality of life and functional ability in patients with ICU acquired Weakness – A post hoc analysis

2019 ◽  
Vol 53 ◽  
pp. 223-230 ◽  
Author(s):  
Georgios Sidiras ◽  
Irini Patsaki ◽  
Eleftherios Karatzanos ◽  
Maria Dakoutrou ◽  
Alexandros Kouvarakos ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Functional Ability ◽  
Post Hoc Analysis ◽  
Long Term Follow Up ◽  
Post Hoc ◽  
Icu Acquired Weakness

scholarly journals P.006 Efficacy of adjunctive brivaracetam in adult patients with secondarily generalized tonic-clonic seizures at baseline: pooled results from long-term follow-up trials

2019 ◽  
Vol 46 (s1) ◽  
pp. S15
Author(s):  
BD Moseley ◽  
A Diaz ◽  
S Elmoufti ◽  
J Whitesides
Keyword(s):  
Controlled Trials ◽  
Open Label ◽  
Efficacy Data ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Long Term Follow Up ◽  
Clonic Seizures ◽  
Post Hoc

Background: Previous post-hoc analysis of three 12-week, double-blind, placebo-controlled trials showed adjunctive brivaracetam (BRV) reduced focal and secondarily generalized tonic-clonic seizures (SGTCS; Type IC) in patients with baseline SGTCS. This analysis explored long-term efficacy of adjunctive BRV in these patients. Methods: Patients (≥16 years) with focal seizures with SGTCS at Baseline were identified from 12-week double-blind, placebo-controlled trials (NCT00490035/NCT00464269/NCT01261325) and subsequent open-label, long-term follow-up (LTFU) trials (NCT00175916/NCT00150800/NCT01339559). Outcomes were assessed at protocol-specified time-points (up to 60 months). We report post-hoc efficacy data for patients receiving BRV (50–200 mg/day). Results: At double-blind Baseline, 409 patients had SGTCS (mean epilepsy duration: 22.2 years); 28.4%, 38.9%, and 32.8% had 0–1, 2–4, and ≥5 previous AEDs. Baseline median seizure frequency/28 days was 8.1 (focal) and 3.0 (SGTCS only). 325/409 patients (79.5%) entered LTFU. In the 12-month (n=150), 24-month (n=89), 36-month (n=73), 48-month (n=68) and 60-month (n=57) exposure cohorts, median percent reduction from Baseline in SGTCS frequency/28 days was 81.1%, 84.0%, 89.2%, 91.0%, and 90.6%, respectively. ≥50% responder rates for SGTCS were 75.3%, 78.7%, 80.8%, 79.4%, and 78.9%. No safety concerns were identified. Conclusions: Adjunctive BRV (50–200 mg/day) reduced SGTCS frequency during LTFU (up to 60 months) in patients with SGTCS at Baseline.

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