scholarly journals Endpoint Event Indicator

2020 ◽  
Author(s):  
Keyword(s):  
Endpoint Event

scholarly journals Mortality in patients with atrial fibrillation with or without heart failure following hospital discharge

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Kartas ◽  
A Samaras ◽  
D Vasdeki ◽  
G Dividis ◽  
G Fotos ◽  
...  
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Primary Endpoint ◽  
Cox Regression ◽  
Cross Sectional ◽  
Tertiary Center ◽  
All Cause Mortality ◽  
Endpoint Event ◽  
Secondary Endpoints ◽  
Sectional Analysis

Abstract Background The association of heart failure (HF) with the prognosis of atrial fibrillation (AF) remains unclear. OBJECTIVES To assess all-cause mortality in patients following hospitalization with comorbid AF in relation to the presence of HF. Methods We performed a cross-sectional analysis of data from 977 patients discharged from the cardiology ward of a single tertiary center between 2015 and 2018 and followed for a median of 2 years. The association between HF and the primary endpoint of death from any cause was assessed using multivariable Cox regression. Results HF was documented in 505 (51.7%) of AF cases at discharge, including HFrEF (17.9%), HFmrEF (16.5%) and HFpEF (25.2%). A primary endpoint event occurred in 212 patients (42%) in the AF-HF group and in 86 patients (18.2%) in the AF-no HF group (adjusted hazard ratio [aHR] 2.27; 95% confidence interval [CI], 1.65 to 3.13; P<0.001). HF was associated with a higher risk of the composite secondary endpoint of death from any cause, AF or HF-specific hospitalization (aHR 1.69; 95% CI 1.32 to 2.16 p<0.001). The associations of HF with the primary and secondary endpoints were significant and similar for AF-HFrEF, AF-HFmrEF, AF-HFpEF. Conclusions HF was present in half of the patients discharged from the hospital with comorbid AF. The presence of HF on top of AF was independently associated with a significantly higher risk of all-cause mortality than did absence of HF, irrespective of HF subtype. Funding Acknowledgement Type of funding source: None

Encephaloduroarteriosynangiosis (EDAS) revascularization for symptomatic intracranial atherosclerotic steno-occlusive (ERSIAS) Phase-II objective performance criterion trial

2020 ◽  
pp. 174749302096725
Author(s):  
Nestor R Gonzalez ◽  
Hao Jiang ◽  
Patrick Lyden ◽  
Shlee Song ◽  
Konrad Schlick ◽  
...  
Keyword(s):  
Phase Ii ◽  
Primary Endpoint ◽  
Medical Management ◽  
Performance Criterion ◽  
Atherosclerotic Disease ◽  
Intracranial Atherosclerotic Disease ◽  
Objective Performance ◽  
Endpoint Event ◽  
One Year ◽  
Event Rates

Background Intracranial atherosclerotic disease (ICAD) is one of the most challenging stroke etiologies, with frequent recurrences despite optimized medical management. Encephaloduroarteriosynangiosis (EDAS) is an indirect revascularization method that produces extra-cranial collaterals to intracranial vessels. We present the results of a phase-II trial of EDAS in intracranial atherosclerotic disease patients. Aims To evaluate the feasibility, safety, and preliminary efficacy of EDAS in intracranial atherosclerotic disease patients. Methods ERSIAS was a prospective objective-performance-criterion trial of EDAS plus intensive medical management (IMM) in intracranial atherosclerotic disease (ICAD) patients failing medical treatment. Primary endpoint was any stroke/death within 30-days post-surgery or stroke in the territory of the qualifying artery beyond 30 days. The primary analysis compared event rates through one year with an objective-performance-criterion based on a 10% reduction from the 20% rate in the intensive medical management arm of the stenting versus aggressive medical management for preventing recurrent stroke in intracranial stenosis trial (SAMMPRIS) in patients with poor collaterals. Event rates through two years were compared with propensity-score-matched (PSM) medically treated patients from SAMMPRIS and the carotid occlusion surgery study (COSS). Results During a median follow-up of 24.5 months, 5 (9.6%) of 52 patients had a primary endpoint event. The primary endpoint rate at one year met the threshold for nonfutility and advancement to phase III (<10%). In the sensitivity analysis, primary endpoint event rate at two years was lower than in PSM controls, 9.6% versus 21.2% (p < 0.07). Overall, 86% of EDAS-plus-intensive medical management patients were functionally independent at last follow-up and 89% demonstrated neovascularization. There were two (3.8%) surgical complications and no intracranial hemorrhages. Conclusion ERSIAS phase II provides evidence of safety and strong signals of efficacy of EDAS-plus-intensive medical management, supporting advancement to a seamless phase-IIb/III trial. Clinical Trial Registration URL: https://www.clinicaltrials.gov.NCT01819597 .

P1-050: ADJUDICATING MILD COGNITIVE IMPAIRMENT DUE TO ALZHEIMER'S DISEASE AS A NOVEL ENDPOINT EVENT IN THE TOMMORROW STUDY: A DELAY-OF-ONSET PHASE 3 CLINICAL TRIAL

2006 ◽  
Vol 14 (7S_Part_5) ◽  
pp. P286-P286
Author(s):  
Carl Chiang ◽  
Robert Alexander ◽  
Kathleen A. Welsh-Bohmer ◽  
Brenda L. Plassman ◽  
Heather Romero ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trial ◽  
Cognitive Impairment ◽  
Mild Cognitive Impairment ◽  
Phase 3 ◽  
Endpoint Event ◽  
Onset Phase

scholarly journals Prognostic Factors in Patients With Osteosarcoma With the Surveillance, Epidemiology, and End Results Database

2020 ◽  
Vol 19 ◽  
pp. 153303382094770
Author(s):  
Peng Fu ◽  
Yu Shi ◽  
Gang Chen ◽  
Yaohua Fan ◽  
Yanhong Gu ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Survival Data ◽  
Risk Model ◽  
Cox Regression ◽  
Survival Rates ◽  
Rare Type ◽  
Hazards Model ◽  
Kaplan Meier ◽  
Endpoint Event ◽  
Prognostic Risk Factors

Background: Osteosarcoma is a rare type of bone tumor, and this study aimed to assess the clinicopathologic features and prognoses of osteosarcoma patients. Methods: Clinicopathologic and survival data of 1025 patients between 2010 and 2016, 230 between 2008 and 2009 were downloaded and analyzed from the SEER database. Patients’ survival was analyzed using the Kaplan-Meier analysis; prognostic factors were assessed using the Cox regression hazards model. The 1-, 3-, and 5-year survival rates were estimated with nomogram. Competitive risk models were used to identify prognostic risk factors related to endpoint events of osteosarcoma patients. Results: Overall, 722 samples were obtained from the extremities, 134 from the axial bones, and 119 from the cranial and mandible in SEER (2010-2016 cohort). After the preliminary diagnosis, the median survival time of patients with osteosarcoma was 39 months, and the 1-, 3-, and 5-year survival rates were 87.3%, 67.2%, and 58.0%, respectively (P < 0.001). The competitive risk model revealed no competitive risks of the endpoint event. Conclusion: Our study found out the prognostic factors in patients with Osteosarcoma by Cox regression hazards model, after that, nomogram was established to predict the 1-, 3-, and 5-year survival rates, which may help oncologists to understand the highly malignant tumor.

Balloon Angioplasty in Chronic Critical Limb Ischemia: Factors Affecting Clinical and Angiographic Outcome

2002 ◽  
Vol 9 (4) ◽  
pp. 403-410 ◽  
Author(s):  
Hannes Balmer ◽  
Felix Mahler ◽  
Dai-Do Do ◽  
Jürgen Triller ◽  
Iris Baumgartner
Keyword(s):  
Balloon Angioplasty ◽  
Critical Limb Ischemia ◽  
Duplex Ultrasound ◽  
Limb Ischemia ◽  
Target Lesion ◽  
Major Amputation ◽  
Factors Affecting ◽  
Chronic Critical Limb Ischemia ◽  
Endpoint Event ◽  
Artery Disease

Purpose: To assess factors that affect clinical and angiographic outcome in chronic critical limb ischemia (CLI) 12 months after primary, technically successful balloon angioplasty (BA) in infrainguinal arteries. Methods: Sixty consecutive patients (37 women; mean age 75 ± 10 years, range 53–99) with technically successful BA in 66 limbs were followed for 12 months or until death, for major amputation, or repeat target lesion revascularization (TLR). Assessment at baseline and 1 day and 12 months after BA or at an endpoint event, if feasible, was performed with angiography or duplex ultrasound (above-knee revascularization only). Mortality, limb prognosis, and restenosis rate were correlated with cardiovascular risk factors, hemodynamic measures, and angiographic features. Results: Mortality was 25% at 1 year; compared to survivors, nonsurvivors more often had coronary artery disease (93% versus 44% for survivors, p<0.001), bilateral CLI (60% versus 29%, p=0.033), and higher fibrinogen levels (5.1 g/L versus 4.3 g/L, p=0.049). CLI resolved in more than half (35, 53%) of the limbs without repeat TLR. The major amputation rate was 6%. Limb prognosis correlated with ankle pressures after BA. Restenosis rates were 65% at the femoropopliteal and 56% at the infrapopliteal level (NS); these correlated with the length of the treated arterial segment (8.7 cm with restenosis versus 4.0 cm without, p<0.001). Conclusions: High mortality in CLI was associated with an extensive, clinically manifest arteriosclerotic process and high fibrinogen levels. Limb prognosis and restenosis after BA were primarily influenced by local hemodynamic and technical factors. Despite considerable restenosis, more than 90% of survivors avoided major amputations.

scholarly journals Treatment Adherence and Secondary Prevention of Ischemic Stroke Among Discharged Patients Using Mobile Phone- and WeChat-Based Improvement Services: Cohort Study

10.2196/16496 ◽  
2020 ◽  
Vol 8 (4) ◽  
pp. e16496 ◽  
Author(s):  
Yuanjin Zhang ◽  
Dongsheng Fan ◽  
Hong Ji ◽  
Shudong Qiao ◽  
Xia Li
Keyword(s):  
Ischemic Stroke ◽  
Secondary Prevention ◽  
Event Rate ◽  
Influencing Factor ◽  
Community Based ◽  
Traditional Group ◽  
Self Monitoring ◽  
Endpoint Event ◽  
Discharged Patients

Background Real-world studies have indicated that adherence is important for guaranteeing medication effectiveness. Few studies have tested the feasibility and efficacy of WeChat-based improvement services, via mobile phone, in secondary prevention-specific follow-up among discharged stroke patients. Objective We evaluated a quadruple-domain, WeChat-based service for ischemic stroke secondary prevention designed to improve treatment adherence of discharged patients. This service focuses on sending reminders for drug use, blood pressure recording, and glucose recording; it also records medication use. We compared the endpoint event rate between WeChat self-monitoring and traditional monitoring. Methods A cohort study was used to determine the feasibility of a physician-assisted, WeChat-based improvement service and follow-up self-monitoring platform for the secondary prevention of ischemic stroke. The platform was developed by the Peking University Third Hospital based on the information-motivation-behavioral skills model. The overall adherence rate was calculated as the proportion of medication doses verified via uploading. The ischemic endpoint event rate and medication noncompliance rate were compared between traditional prevention monitoring and WeChat self-monitoring. Factors influencing adherence were summarized. Results The 1-year follow-up event rate of the WeChat self-monitoring group was 11.9% (12/101), which was less than that of the traditional group (21/157, 13.4%). Compared with the traditional group, the risk ratio of the WeChat group was 0.983 (95% CI 0.895-1.080); this difference was not noted to be significant. The 1-year medication noncompliance ratio tended to be lower in the WeChat monitoring group (3/101, 3.0%) than in the traditional group (11/157, 7.0%; χ2=1.9, df=1, P=.16). Of the platform registry participants, 89.7% (210/234: 167 hospital-based and 43 community-based participants) adhered to inputting information into WeChat for 8-96 weeks. The average adherence time was 16.54 (SD 0.80, range 2-24) months. The average decrease in adherence was 4 participants (1.1%) per month. Being a member of a community-based population was an influencing factor for good adherence at the 2-year follow-up (OR 2.373, 95% CI 1.019-5.527, P=.045), whereas transient ischemic attack was an influencing factor for poor adherence at the 2-year follow-up (OR 0.122, 95% CI 0.016-0.940, P=.04). Conclusions Use of WeChat self-monitoring showed a trend of increasing medication compliance and decreasing ischemic endpoint event rate compared with traditional monitoring. However, there were ceiling effects in the outcomes, and a relatively small sample size was used. Male participants displayed better adherence to WeChat self-monitoring. The community-based population displayed good adherence when using WeChat self-monitoring. Trial Registration ClinicalTrials.gov NCT02618265; https://clinicaltrials.gov/ct2/show/NCT02618265

scholarly journals Association Between Heart Rate and Major Adverse Cardiovascular Events Among 9,991 Hypertentive Patients: A Multicenter Retrospective Follow-Up Study

2021 ◽  
Vol 8 ◽  
Author(s):  
Ningling Sun ◽  
Yuanyuan Chen ◽  
Yang Xi ◽  
Hongyi Wang ◽  
Luyan Wang
Keyword(s):  
Heart Rate ◽  
Cardiovascular Events ◽  
Antihypertensive Drugs ◽  
Diastolic Pressure ◽  
Systolic Pressure ◽  
Major Adverse Cardiovascular Events ◽  
Hypertensive Patients ◽  
Hazard Ratios ◽  
Endpoint Event

Objective: To assess the effect of heart rate at baseline on major adverse cardiovascular events (MACEs) among hypertensive patients in China.Methods: A multicenter retrospective study was conducted with a 24 month follow-up period. A total of 10,031 hypertensive patients treated with standard antihypertensive drugs were grouped according to their heart rate before treatment: &lt;65 beats per min (bpm), 65–69 bpm, 70–74 bpm, 75–79 bpm, and ≥80 bpm. The occurrence of any of MACEs was as the endpoint event during the 24 month follow-up period. The effect of heart rate at baseline on MACEs was analyzed using univate and multivariable Cox proportional regression analyses, with hazard ratios (HRs) and 95% confidence intervals (CIs). The restricted cubic spline (RCS) model was used to fit the Cox proportional harzard model with 5 knots at the 5th, 25th, 50th, 75th, and 95th percentiles of heart rate.Results: Totally 9,991 patients were finally enrolled with the mean systolic pressure (SBP)/diastolic pressure (DBP) of 130.59 ± 7.13/77.66 ± 5.99 mmHg at 24 month follow-up. The incidence of MACEs was 4.80% (n = 480). After adjustment for age, gender, baseline blood pressure, alcohol drinking, smoking, hyperlipidemia, diabetes, coronary heart disease, cerebrovascular disease and antihypertensive drug use, patients with heart rate &lt;65 bpm (HR = 1.450, 95% CI: 1.098–1.915) and ≥80 bpm (HR = 1.391, 95% CI: 1.056–11.832) showed 0.45 fold and 0.391 fold increases of MACE risks, compared with patients with heart rate of 70–74 bpm. Furthermore, MACE risks were increased by 86.0% and 65.4% in men, and 59.3% and 69.0% in elderly patients aged ≥65 years at heart rate &lt;65 bpm or ≥80 bpm, respectively. We also found a non-liner U-shaped correlation between heart rate and the occurrence of MACEs.Conclusions: Heart rate might be an independent risk factor for MACEs in hypertensive patients. An appropriate range of heart rate control may offer guidance to hypertension treatment.

scholarly journals Predictive Efficacy of Serum Lipoprotein(A) Combined with TSH in Patients with Acute Coronary Syndrome After Coronary Angiography

2021 ◽  
Author(s):  
Kaihang Xu ◽  
Le Wang ◽  
Chuyi Han ◽  
Yingyi Zhang ◽  
Rui Zhang ◽  
...  
Keyword(s):  
Risk Factor ◽  
Coronary Angiography ◽  
Cardiovascular Events ◽  
Independent Risk Factor ◽  
Latex Agglutination ◽  
Thyroid Stimulating Hormone ◽  
Major Adverse Cardiovascular Events ◽  
Lipoprotein A ◽  
Coronary Syndrome ◽  
Endpoint Event

Abstract Backgroud： Elevated lipoprotein(a) [Lp(a)] and thyroid stimulating hormone (TSH) are both associated with coronary artery disease (CAD), but it was controversial in ACS patients. Moreover, patients with elevated plasma TSH tend to have higher levels of lipoprotein. We supposed that patients with elevated LP (a) and TSH may have a adverse prognosis after coronary angiography.Methods: We consecutively recruited 1756 patients who underwent coronary angiography, of which 1473 patients with ACS were eventually enrolled. Major adverse cardiovascular events (MACEs) contained a complex of non-fatal stroke, non-fatal myocardial infarction, ischemic cardiovascular events, and cardiovascular death. According to the occurrence of end events within 27.4 months, the patients were split into two groups: non-endpoint event group (n = 1288) and endpoint event group (n = 185). The date between the two groups were compared. Serum LP (a) was measured by latex agglutination immunoassay (Roche Diagnostics GmbH, Mannheim, Germany).Results: During a median follow-up of 27.4 months, 185 (12.56%) MACEs occurred. Compared with the non-endpoints group，patients in the end-points group had higher level of preoperative LP (a), LDL and TSH (all P<0.05). Multivariate Cox proportional hazard model showed that LP (a) was an independent risk factor for adverse prognosis after coronary angiography in ACS patients, LP (a) > 53.8nmol/L (highest tertile ) predicted 1.704-fold risk for adverse prognosis of ACS (95%CI 1.194~2.433；P＜0.05); Interestingly, patients with elevated LP (a) and TSH concomitantly conferred the highest risk for adverse prognosis OR=3.090 95%CI 1.657~5.765；P＜0.001).Conclusion: LP (a) was an independent risk factor for adverse prognosis after coronary angiography in ACS patients, and the predictive efficacy was enhanced by TSH.

scholarly journals The Value of Left Internal Mammary Artery Velocity in Predicting the Prognosis of Patients After CABG

2021 ◽  
Author(s):  
Feng-Wei Guo ◽  
Hong Chen ◽  
Ya-Ling Dong ◽  
Jia-nan Shang ◽  
Li-tao Ruan ◽  
...  
Keyword(s):  
Cardiac Death ◽  
Doppler Ultrasonography ◽  
Internal Mammary Artery ◽  
Cardiovascular Surgery ◽  
Left Internal Mammary Artery ◽  
Bypass Grafting ◽  
Endpoint Event ◽  
Internal Mammary ◽  
Surgery Department ◽  
Transthoracic Ultrasound

Abstract Objectives: The purpose of this study was to explore the value of the LIMAV measured by ultrasound before CABG in predicting the prognosis of patients after LIMA bypass grafting. Methods: 104 patients who underwent CABG with LIMA as the bridge vessel in the cardiovascular surgery department of our hospital between May 2018 and June 2019 were selected. All patients underwent transthoracic Doppler ultrasonography to measure LIMAV preoperatively. Intraoperatively, MGF and PI of the LIMA bridge were measured using TTFM. The primary endpoint event in this study was cardiac death within 18 months after surgery. Results: The Cox survival analysis showed that the MGF , the LIMAV and LVEF were risk factors for death after CABG . The cut-offs of MGF ,LIMAV and LVEF for the prediction of death after CABG were ≤14 ml/min [AUC: 0.830; Sensitivity:100%; Specificity: 65.6%], ≤60cm/s (AUC: 0.759; Sensitivity:65.5%; Specificity:85.3%) and ≤44%（AUC:0.724; Sensitivity:50%; Specificity: 88.5% ）respectively. Compared with the use of MGF, MGF+LIMAV, combination of the MGF+LIMAV+LVEF （AUC:0.929; Sensitivity:100%; Specificity: 81.1%）resulted in a stronger predictive value（MGF vs MGF+LIMAV+LVEF: p=0.02）. Conclusion: LIMAV measured by transthoracic ultrasound pre-operation combined with intraoperative MGF and LVEF may have a greater value in predicting patients' risk of cardiac death after CABG.

scholarly journals Independent endpoint event review for the elimination of reporting bias in an open label phase III pharmaceutical trial

Trials ◽  
2015 ◽  
Vol 16 (S2) ◽  
Author(s):  
Peter Hall ◽  
Anna Waterhouse ◽  
Isabelle Smith ◽  
Julia Brown ◽  
Walter Gregory ◽  
...  
Keyword(s):  
Phase Iii ◽  
Reporting Bias ◽  
Open Label ◽  
Open Label Phase ◽  
Endpoint Event
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