scholarly journals Impact of Prior Statin Use on Reperfusion Rate and Stroke Outcomes in Patients Receiving Endovascular Treatment

2021 ◽  
Vol 10 (21) ◽  
pp. 5147
Author(s):  
Sang-Hwa Lee ◽  
Min Uk Jang ◽  
Yerim Kim ◽  
So Young Park ◽  
Chulho Kim ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Endovascular Treatment ◽  
Primary Outcome ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Dose Response Relationship ◽  
Stroke Outcomes ◽  
The Impact ◽  
Reperfusion Rate ◽  
Statin Use

Background: We evaluated the impact of prior statin use on successful reperfusion and stroke outcomes after endovascular treatment (EVT). Method: Using consecutive multicenter databases, we enrolled acute ischemic stroke patients receiving EVT between 2015 and 2021. Patients were classified into prior statin users and no prior statin users after a review of premorbid medications. The primary outcome measure was successful reperfusion defined as modified TICI grade 2b or 3 after EVT. Secondary outcome measures were early neurologic deterioration (END) and a 3-month modified Rankin Scale (mRS) score of 0 to 2. Results: Among 385 patients receiving EVT, 74 (19.2%) were prior statin users, who had a significantly higher successful reperfusion rate compared with no prior statin users (94.6% versus 78.8%, p = 0.002). Successful reperfusion and END occurrence were improved according to statin intensity with a dose–response relationship. In multivariate analysis, prior statin was associated with successful reperfusion after EVT (adjusted odds ratio (95% confidence interval) 5.31 (1.67–16.86)). In addition, prior statin was associated with a lower occurrence of END and good functional status. Conclusion: Our study showed that prior statin use before ischemic stroke might improve successful reperfusion and stroke outcomes after EVT.

scholarly journals The Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios Predict Reperfusion and Prognosis after Endovascular Treatment of Acute Ischemic Stroke

2021 ◽  
Vol 11 (8) ◽  
pp. 696
Author(s):  
Sang-Hwa Lee ◽  
Min Uk Jang ◽  
Yerim Kim ◽  
So Young Park ◽  
Chulho Kim ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Endovascular Treatment ◽  
Acute Ischemic Stroke ◽  
Characteristic Curve ◽  
Area Under The Curve ◽  
Predictive Ability ◽  
Primary Outcome Measure ◽  
Lymphocyte Ratio ◽  
Prognostic Effect ◽  
Reperfusion Rate

Background: Studies assessing the prognostic effect of inflammatory markers of blood cells on the outcomes of patients with acute ischemic stroke treated with endovascular treatment (EVT) are sparse. We evaluated whether the neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) affect reperfusion status in patients receiving EVT. Methods: Using a multicenter registry database, 282 patients treated with EVT were enrolled in this study. The primary outcome measure was unsuccessful reperfusion rate after EVT defined by thrombolysis in cerebral infarction grades 0–2a. Logistic regression analysis was performed to analyze the association between NLR/PLR and unsuccessful reperfusion rate after EVT. Results: Both NLR and PLR were higher in the unsuccessful reperfusion group than in the successful reperfusion group (p < 0.001). Multivariate analysis showed that both NLR and PLR were significantly associated with unsuccessful reperfusion (adjusted odds ratio (95% confidence interval): 1.11 (1.04–1.19), PLR: 1.004 (1.001–1.01)). The receiver operating characteristic curve showed that the predictive ability of both NLR and PLR was close to good (area under the curve (AUC) of NLR: 0.63, 95% CI (0.54–0.72), p < 0.001; AUC of PLR: 0.65, 95% CI (0.57–0.73), p < 0.001). The cutoff values of NLR and PLR were 6.2 and 103.6 for unsuccessful reperfusion, respectively. Conclusion: Higher NLR and PLR were associated with unsuccessful reperfusion after EVT. The combined application of both biomarkers could be useful for predicting outcomes after EVT.

scholarly journals National Institutes of Health Stroke Scale

Stroke ◽  
2020 ◽  
Vol 51 (1) ◽  
pp. 282-290 ◽  
Author(s):  
Vicky Chalos ◽  
Nadinda A.M. van der Ende ◽  
Hester F. Lingsma ◽  
Maxim J.H.L. Mulder ◽  
Esmee Venema ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Endovascular Treatment ◽  
Treatment Effect ◽  
Acute Treatment ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
National Institutes Of Health ◽  
Unique Identifier ◽  
Mr Clean

Background and Purpose— The modified Rankin Scale (mRS) at 3 months is the most commonly used primary outcome measure in stroke treatment trials, but it lacks specificity and requires long-term follow-up interviews, which consume time and resources. An alternative may be the National Institutes of Health Stroke Scale (NIHSS), early after stroke. Our aim was to evaluate whether the NIHSS assessed within 1 week after treatment could serve as a primary outcome measure for trials of acute treatment for ischemic stroke. Methods— We used data from 2 randomized controlled trials of endovascular treatment for ischemic stroke: the positive MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands; N=500) and the neutral IMS (Interventional Management of Stroke) III trial (N=656). We used a causal mediation model, with linear and ordinal logistic regression adjusted for confounders, to evaluate the NIHSS 24 hours and 5 to 7 days after endovascular treatment as primary outcome measures (instead of the mRS at 3 months) in both trials. Patients who had died before the NIHSS was assessed received the maximum score of 42. NIHSS+1 was then log10-transformed. Results— In both trials, there was a significant correlation between the NIHSS at 24 hours and 5 to 7 days and the mRS. In MR CLEAN, we found a significant effect of endovascular treatment on the mRS and on the NIHSS at 24 hours and 5 to 7 days. After adjustment for NIHSS at 24 hours and 5 to 7 days, the effect of endovascular treatment on the mRS decreased from common odds ratio 1.68 (95% CI, 1.22–2.32) to respectively 1.36 (95% CI, 0.97–1.91) and 1.24 (95% CI, 0.87–1.79), indicating that treatment effect on the mRS is in large part mediated by the NIHSS. In the IMS III trial there was no treatment effect on the NIHSS at 24 hours and 5 to 7 days, corresponding with the absence of a treatment effect on the mRS. Conclusions— The NIHSS within 1 week satisfies the requirements for a surrogate end point and may be used as a primary outcome measure in trials of acute treatment for ischemic stroke, particularly in phase II(b) trials. This could reduce stroke-outcome assessment to its essentials (ie, neurological deficit), and reduce trial duration and costs. Whether and under which conditions it could be used in phase III trials requires a debate in the field with all parties. Clinical Trial Registration— URL: http://www.isrctn.com . Unique identifier: ISRCTN10888758; https://www.clinicaltrials.gov . Unique identifier: NCT00359424.

Comparative study of intracranial access in thrombectomy using next generation 0.088 inch guide catheter technology

2021 ◽  
pp. neurintsurg-2021-017341
Author(s):  
Devin V Bageac ◽  
Blake S Gershon ◽  
Jan Vargas ◽  
Maxim Mokin ◽  
Zeguang Ren ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Control Group ◽  
Anterior Circulation ◽  
Guide Catheter ◽  
Catheter Failure ◽  
Catheter Technology ◽  
Intracranial Vasculature

BackgroundMost conventional 0.088 inch guide catheters cannot safely navigate intracranial vasculature. The objective of this study is to evaluate the safety of stroke thrombectomy using a novel 0.088 inch guide catheter designed for intracranial navigation.MethodsThis is a multicenter retrospective study, which included patients over 18 years old who underwent thrombectomy for anterior circulation large vessel occlusions. Technical outcomes for patients treated using the TracStar Large Distal Platform (TracStar LDP) or earlier generation TRX LDP were compared with a matched cohort of patients treated with other commonly used guide catheters. The primary outcome measure was device-related complications. Secondary outcome measures included guide catheter failure and time between groin puncture and clot engagement.ResultsEach study arm included 45 patients. The TracStar group was non-inferior to the control group with regard to device-related complications (6.8% vs 8.9%), and the average time to clot engagement was 8.89 min shorter (14.29 vs 23.18 min; p=0.0017). There were no statistically significant differences with regard to other technical outcomes, including time to recanalization (modified Thrombolysis In Cerebral Infarction (mTICI) ≥2B). The TracStar was successfully advanced into the intracranial internal carotid artery in 33 cases (73.33%); in three cases (6.67%), it was swapped for an alternate catheter. Successful reperfusion (mTICI 2B-3) was achieved in 95.56% of cases. Ninety-day follow-up data were available for 86.67% of patients, among whom 46.15% had an modified Rankin Score of 0–2%, and 10.26% were deceased.ConclusionsTracstar LDP is safe for use during stroke thrombectomy and was associated with decreased time to clot engagement. Intracranial access was regularly achieved.

scholarly journals The Impact of Time Interval between Hepatic Resection and Liver Transplantation on Clinical Outcome in Patients with Hepatocellular Carcinoma

Cancers ◽  
2021 ◽  
Vol 13 (10) ◽  
pp. 2398
Author(s):  
Matteo Serenari ◽  
Enrico Prosperi ◽  
Marc-Antoine Allard ◽  
Michele Paterno ◽  
Nicolas Golse ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Liver Transplantation ◽  
Hepatic Resection ◽  
Primary Outcome ◽  
Polynomial Regression ◽  
Secondary Outcome ◽  
Time Interval ◽  
Comprehensive Complication Index ◽  
Fractional Polynomial ◽  
The Impact

Hepatic resection (HR) for hepatocellular carcinoma (HCC) may require secondary liver transplantation (SLT). However, a previous HR is supposed to worsen post-SLT outcomes. Data of patients treated by SLT between 2000 and 2018 at two tertiary referral centers were analyzed. The primary outcome of the study was to analyze the impact of HR on post-LT complications. A Comprehensive Complication Index ≥ 29.6 was chosen as cutoff. The secondary outcome was HCC-related death by means of competing-risk regression analysis. In the study period, 140 patients were included. Patients were transplanted in a median of 23 months after HR (IQR 14–41). Among all the features analyzed regarding the prior HR, only time interval between HR and SLT (time HR-SLT) was an independent predictor of severe complications after LT (OR = 0.98, p < 0.001). According to fractional polynomial regression, the probability of severe complications increased up to 15 months after HR (43%), then slowly decreased over time (OR = 0.88, p < 0.001). There was no significant association between HCC-related death and time HR-SLT at the multivariable competing risks regression model (SHR, 1.06; 95% CI: 0.69–1.62, p = 0.796). This study showed that time HR-SLT was key in predicting complications after LT, without affecting HCC-related death.

scholarly journals Randomized controlled trial of convalescent plasma therapy against standard therapy in patients with severe COVID-19 disease

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Manaf AlQahtani ◽  
Abdulkarim Abdulrahman ◽  
Abdulrahman Almadani ◽  
Salman Yousif Alali ◽  
Alaa Mahmood Al Zamrooni ◽  
...  
Keyword(s):  
Standard Therapy ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Severe Disease ◽  
Pilot Trial ◽  
Standard Of Care ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Open Label ◽  
Plasma Therapy

AbstractConvalescent plasma (CP) therapy in COVID-19 disease may improve clinical outcome in severe disease. This pilot study was undertaken to inform feasibility and safety of further definitive studies. This was a prospective, interventional and randomized open label pilot trial in patients with severe COVID-19. Twenty COVID-19 patients received two 200 ml transfusions of convalescent patient CP over 24-h compared with 20 who received standard of care. The primary outcome was the requirement for ventilation (non-invasive or mechanical ventilation). The secondary outcomes were biochemical parameters and mortality at 28 days. The CP group were a higher risk group with higher ferritin levels (p < 0.05) though respiratory indices did not differ. The primary outcome measure was required in 6 controls and 4 patients on CP (risk ratio 0.67, 95% CI 0.22–2.0, p = 0.72); mean time on ventilation (NIV or MV) did not differ. There were no differences in secondary measures at the end of the study. Two patients died in the control and one patient in the CP arm. There were no significant differences in the primary or secondary outcome measures between CP and standard therapy, although a larger definitive study is needed for confirmation. However, the study did show that CP therapy appears to be safe in hospitalized COVID-19 patients with hypoxia.Clinical trials registration NCT04356534: 22/04/2020.

scholarly journals Sex Differences in Ischemic Stroke Outcomes in Patients With Pulmonary Hypertension

2021 ◽  
Author(s):  
Tiberiu A. Pana ◽  
Dana K. Dawson ◽  
Mohamed O. Mohamed ◽  
Fiona Murray ◽  
David L. Fischman ◽  
...  
Keyword(s):  
Pulmonary Hypertension ◽  
Sex Differences ◽  
Ischemic Stroke ◽  
Hospital Mortality ◽  
Acute Ischemic Stroke ◽  
Systemic Hypertension ◽  
Stroke Outcomes ◽  
Female Patients ◽  
Prolonged Hospitalization ◽  
The Impact

Background The association between systemic hypertension and cerebrovascular disease is well documented. However, the impact of pulmonary hypertension (PH) on acute ischemic stroke outcomes is unknown despite PH being recognized as a risk factor for acute ischemic stroke. We aimed to determine the association between PH and adverse in‐hospital outcomes after acute ischemic stroke, as well as whether there are sex differences in this association. Methods and Results Acute ischemic stroke admissions from the US National Inpatient Sample between October 2015 and December 2017 were included. The relationship between PH and outcomes (mortality, prolonged hospitalization >4 days, and routine home discharge) was analyzed using logistic regressions adjusting for demographics, comorbidities, and revascularization therapies. Interaction terms between PH and sex and age groups were also included. A total of 221 249 records representative of 1 106 045 admissions were included; 2.9% of patients had co‐morbid PH, and 35.34% of those were male. PH was not associated with in‐hospital mortality (odds ratio [OR], 0.96; 95% CI, 0.86–1.09) but was associated with increased odds of prolonged hospitalization (OR, 1.15; 95% CI, 1.09–1.22) and decreased odds of routine discharge (OR, 0.87; 95% CI, 0.81–0.94) for both sexes. Older patients with PH were significantly less likely to be discharged routinely ( P =0.028) than their younger counterparts. Compared with female patients with PH, men were 31% more likely to die in hospital ( P =0.024). Conclusions PH was not significantly associated with in‐hospital mortality but was associated with prolonged hospitalization and adverse discharge status. Male patients with PH were more likely to die in hospital than female patients.

Reducing surgical site infections following craniotomy: examination of the use of topical vancomycin

2015 ◽  
Vol 123 (6) ◽  
pp. 1600-1604 ◽  
Author(s):  
Kalil G. Abdullah ◽  
Mark A. Attiah ◽  
Andrew S. Olsen ◽  
Andrew Richardson ◽  
Timothy H. Lucas
Keyword(s):  
Primary Outcome ◽  
Surgical Site Infections ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Time Interval ◽  
Infection Rates ◽  
Skin Flora ◽  
Vancomycin Powder ◽  
Subgaleal Space ◽  
Typical Skin

OBJECT Although the use of topical vancomycin has been shown to be safe and effective for reducing postoperative infection rates in patients after spine surgery, its use in cranial wounds has not been studied systematically. The authors hypothesized that topical vancomycin, applied in powder form directly to the subgaleal space during closure, would reduce cranial wound infection rates. METHODS A cohort of 150 consecutive patients who underwent craniotomy was studied retrospectively. Seventy-five patients received 1 g of vancomycin powder applied in the subgaleal space at the time of closure. This group was compared with 75 matched-control patients who were accrued over the same time interval and did not receive vancomycin. The primary outcome measure was the presence of surgical site infection within 3 months. Secondary outcome measures included tissue pH from a subgaleal drain and vancomycin levels from the subgaleal space and serum. RESULTS Vancomycin was associated with significantly fewer surgical site infections (1 of 75) than was standard antibiotic prophylaxis alone (5 of 75; p < 0.05). Cultures were positive for typical skin flora species. As expected, local measured vancomycin concentrations peaked immediately after surgery (mean ± SD 499 ± 37 μg/ml) and gradually decreased over 12 hours. Vancomycin in the circulating serum remained undetectable. Subgaleal topical vancomycin was associated with a lower incidence of surgical site infections after craniotomy. The authors attribute this reduction in the infection rate to local vancomycin concentrations well above the minimum inhibitory concentration for antimicrobial efficacy. CONCLUSIONS Topical vancomycin is safe and effective for reducing surgical site infections after craniotomy. These data support the need for a prospective randomized examination of topical vancomycin in the setting of cranial surgery.

A phase III trial of intramuscular recombinant interferon beta as treatment for exacerbating-remitting multiple sclerosis: design and conduct of study and baseline characteristics of patients

1995 ◽  
Vol 1 (2) ◽  
pp. 118-135 ◽  
Author(s):  
LD Jacobs ◽  
DL Cookfair ◽  
RA Rudick ◽  
RM Herndon ◽  
J R Richert ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Interferon Beta ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Phase Iii ◽  
Secondary Outcome ◽  
Recombinant Interferon ◽  
Study Population ◽  
The Mean ◽  
Baseline Characteristics

The design and conduct of a randomized, double-blinded, placebo-controlled, multicenter, phase III study of recombinant interferon beta-1a (IFN-β-1a) as treatment for exacerbating-remitting MS are described, as are baseline characteristics of the study population. The purpose of the study was to determine if 6.0 × 106 IU (30 μg) of IFN-β-1a, administered by weekly intramuscular (i.m.) injections, was effective in delaying the onset of sustained disability. The primary outcome measure was time to onset of treatment failure, defined as a worsening on the Kurtzke Expanded Disability Status Scale (EDSS) of greater than or equal to 1.0 point compared with baseline, persisting for at least 6 months. An intent-to-treat design was used. The primary outcome measure was analyzed using the Mantel-Cox log-rank statistic and Kaplan-Meier survival curves. Secondary outcomes included quantitative measures of upper and lower extremity function, neuropsychological test performance, functional and quality of life assessments and several measures derived from annual brain MRI studies. Entry criteria included prestudy exacerbation rates of at least 0.67 per year and EDSS scores of 1.0–3.5. A total of 301 MS patients were randomly assigned to receive weekly i.m. injections of IFN-β-1a or placebo. The average age of the study population at entry was 37 years; 92% were Caucasian and 73% were women. The mean prestudy disease duration was 6.5 years, mean prestudy exacerbation rate was 1.2 per year and the mean EDSS score was 2.3. The randomization yielded well-balanced treatment arms. Various aspects of the study are discussed, including: (1) the decision to focus study design on sustained disability; (2) the rationale for the treatment regimen; (3) measures taken to assure the reliability of the primary outcome measure; and (4) a description of the secondary outcome measures.

Abstract 18519: Withdrawal of Antiplatelet Therapy Results in Worse Short-term Prognosis in Patients Undergoing Elective Major Noncardiac Surgery

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Jesús álvarez-García ◽  
Miquel Vives-Borrás ◽  
Joan I Llao ◽  
Andreu Ferrero-Gregori ◽  
Marc Bausili ◽  
...  
Keyword(s):  
Antiplatelet Therapy ◽  
Cardiovascular Events ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Postoperative Mortality ◽  
Primary Outcome Measure ◽  
Noncardiac Surgery ◽  
Concomitant Treatment ◽  
Short Term ◽  
The Impact

Background: The decision whether to discontinue antiplatelet therapy in patients undergoing major noncardiac surgery can be clinically challenging. There is insufficient clinical evidence to establish comprehensive guidelines and most of recommendations are based on expert consensus. Objective: To evaluate the effectof withdrawal of antiplatelet therapy on 30-day postoperative outcome in subjects undergoing elective major noncardiac surgery. Methods: A retrospective cohort study was performed in 1630 patients, 40 years and older, who underwent major noncardiac surgery. Age, gender, risk factors, previous chronic heart or lung disease, renal function, anemia and concomitant treatment were used in a binary logistic regression to determine the impact of withdrawal of antiplatelet therapy on prognosis. The primary outcome measure was a composite of 30-day postoperative mortality or cardiovascular events (cardiac arrest, myocardial infarction, stroke or pulmonary embolism). Results: Five percent of patients presented the composite primary outcome measure of 30-day postoperative mortality or cardiovascular events. Antiplatelet therapy was withdrawn in 11.4% of patients (table). Discontinuation of antiplatelet therapy was associated with a significant increase in the primary outcome measure (OR 2.27; CI95%: 1.16-4.46). Conclusions: In a contemporary cohort of patients undergoing noncardiac surgery, withdrawal of antiplatelet therapy was associated with a worse short-term prognosis. There is an urgent need for further research in this field.

Abstract 104: Disability After Minor Stroke and TIA in the POINT Trial

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Brett L Cucchiara ◽  
Jordan Elm ◽  
J Donald Easton ◽  
Shelagh Coutts ◽  
Joshua Willey ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Adverse Events ◽  
Antiplatelet Therapy ◽  
Primary Outcome ◽  
Dual Antiplatelet Therapy ◽  
Recurrent Stroke ◽  
Primary Outcome Measure ◽  
Minor Stroke ◽  
Serious Adverse Events ◽  
Index Event

Background and Purpose: To assess the effect of combination antiplatelet therapy with aspirin and clopidogrel versus aspirin alone on disability following TIA or minor stroke and to identify factors associated with disability. Methods: The POINT trial randomized patients with TIA or minor stroke (NIHSS≤3) within 12 hours of onset to dual antiplatelet therapy (DAPT) with aspirin plus clopidogrel versus aspirin alone. The primary outcome measure was a composite of stroke, MI, or vascular death. We performed a post-hoc exploratory analysis to examine the effect of treatment on overall disability (defined as mRS>1) at 90 days as well as disability ascribed by the local investigator to index or recurrent stroke. We also evaluated predictors of disability. Results: At 90 days, 188/1964 (9.6%) of patients enrolled with TIA and 471/2586 (18.2%) of those enrolled with stroke were disabled. Overall disability was similar between patients assigned DAPT versus aspirin alone (14.7% vs. 14.3%, OR 0.97, 95%CI 0.82-1.14, p=0.69). However, there were numerically fewer patients with disability in conjunction with a primary outcome event in the DAPT arm (3.0% vs. 4.0%, OR 0.73, 95%CI 0.53-1.01, p=0.06), and significantly fewer patients in the DAPT arm with disability attributed by the investigators to either the index event or recurrent stroke (5.9% vs. 7.4%, OR 0.78, 95% CI 0.62-0.99, p=0.04). Notably, disability attributed to the index event accounted for the majority of this difference (4.5% vs. 6.0%, OR 0.74 95% CI 0.57-0.96, p=0.02). In multivariate analysis of patients enrolled with TIA, disability was significantly associated with age, subsequent ischemic stroke, serious adverse events, and major bleeding. In patients enrolled with stroke, disability was associated with female sex, hypertension, diabetes, NIHSS score, recurrent ischemic stroke, subsequent myocardial infarction, and serious adverse events. Conclusions: In addition to reducing recurrent stroke in patients with acute minor stroke and TIA, dual antiplatelet therapy might reduce stroke-related disability.

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