scholarly journals HydroCoils Are Associated with Lower Angiographic Recurrence Rates Than Are Bare Platinum Coils in Treatment of “Difficult-to-Treat” Aneurysms: A Post Hoc Subgroup Analysis of the HELPS Trial

2015 ◽  
Vol 36 (9) ◽  
pp. 1689-1694 ◽  
Author(s):  
W. Brinjikji ◽  
P.M. White ◽  
H. Nahser ◽  
J. Wardlaw ◽  
R. Sellar ◽  
...  
Keyword(s):  
Subgroup Analysis ◽  
Recurrence Rates ◽  
Bare Platinum Coils ◽  
Post Hoc ◽  
Platinum Coils

Abstract 112: Hydrocoils Reduce Recurrence Rates in Recently Ruptured Medium Sized Intracranial Aneurysms: A Subgroup Analysis of the HELPS Trial

Stroke ◽  
2015 ◽  
Vol 46 (suppl_1) ◽  
Author(s):  
Waleed Brinjikji ◽  
Phil M White ◽  
Harry J Cloft ◽  
David F Kallmes
Keyword(s):  
Recurrence Rate ◽  
Subgroup Analysis ◽  
Controlled Trial ◽  
Multivariate Logistic Regression Analysis ◽  
Control Group ◽  
Recurrence Rates ◽  
Aneurysm Neck ◽  
Ruptured Aneurysms ◽  
Bare Platinum Coils ◽  
Platinum Coils

Background and Purpose: The Hydrocoil Endovascular aneurysm occlusion and Packing Study (HELPS) was a randomized controlled trial comparing Hydrocoil to bare platinum coils . We performed a subgroup analysis of angiographic and clinical outcomes of medium sized aneurysms in the HELPS trial. Methods: We selected all patients with medium sized aneurysms (5mm-9.9mm) in the HELPS trial. The following outcomes were compared between the HydroCoil and control groups: 1) any recurrence, 2) major recurrence, 3) retreatment and 4) good neurological outcome defined as mRS≤2. Outcomes of recently ruptured and non-recently ruptured aneurysms were compared separately. Comparisons between groups were performed using Fisher’s exact test. A multivariate logistic regression analysis adjusting for aneurysm neck size, shape, use of adjunctive device and rupture status was performed. Results: A total of 288 patients with medium sized aneurysms were randomized (144 in each group). At 15-18 months post-treatment, major recurrence rate was significantly lower in the HydroCoil group than the control group (18.6% versus 30.8%, P=0.03, respectively). For recently ruptured aneurysm patients, major recurrence rate was significantly lower for HydroCoil than controls (20.3% versus 47.5%, P=0.003), while rates were similar between coil types for unruptured aneurysms (16.7% versus 14.8%, P=0.80). On multivariate analysis for patients with recently ruptured aneurysms, HydroCoil was associated with lower odds of any recurrence as compared to bare platinum (OR=0.37, 95%CI=0.18-0.76, P=0.006) and major recurrence (OR=0.27, 95%CI=0.12-0.58, P=0.0007). There was a trend towards lower retreatment rates in the recently ruptured group treated with HydroCoil (OR=0.00, 95%CI=0.00-2.01, P=0.12). Conclusion: For recently ruptured, medium sized aneurysms, as compared to bare platinum coils HydroCoils were associated with lower rates of major recurrence that were both statistically significant and clinically relevant. These findings suggest that HydroCoils should be the preferred treatment for this subset of patients.

Abstract W P75: New Generation Hydrogel Endovascular Aneurysm Treatment Trial

Stroke ◽  
2015 ◽  
Vol 46 (suppl_1) ◽  
Author(s):  
Samer G Zammar ◽  
Youssef J Hamade ◽  
Jennifer Ward ◽  
Byron K Yip ◽  
Nicole Reinholdt ◽  
...  
Keyword(s):  
Endovascular Treatment ◽  
Packing Density ◽  
Intracranial Aneurysms ◽  
Recurrence Rates ◽  
2Nd Generation ◽  
Aneurysm Treatment ◽  
Unruptured Intracranial Aneurysms ◽  
Bare Platinum Coils ◽  
New Generation ◽  
Platinum Coils

Background: Endovascular treatment of intracranial aneurysms has seen significant advances. One major limitation of the endovascular approach is durability of treatment and aneurysm recanalization. To address this issue, one approach was the development of hydrogel-coated coils. Hydrogel expands upon exposure to blood and thus enhances coil packing density. Higher initial coil packing density may potentially result in lower rates of recurrence. Hypothesis: The 2nd Generation HydroCoil Embolic System allows for a higher packing density, higher initial occlusion, lower recanalization, and lower retreatment rates compared to bare platinum coils. Objective: To compare clinical and angiographic outcomes (initial complete occlusion, recanalization, retreatment, and adverse event rates) in patients receiving the 2nd Generation HydroCoil Embolic System versus patients receiving bare platinum coils. Methods: This is a randomized, controlled, multicenter, post-market clinical trial. Subjects between 18 and 75 years of age with ruptured or unruptured intracranial aneurysms (3-14 mm in size) who are amenable to endovascular treatment are randomly assigned 1:1 to one of two treatment arms: 1) the HydroCoil Embolic System (HES), or 2) bare platinum coils. No bioactive coils, 1st generation HydroCoils or liquid embolics are allowed in the study. In the HES arm, up to 10% of total coil length using bare platinum is allowed if deemed necessary by the investigator. Any type of bare platinum coil may be utilized in the bare platinum arm. Assist-devices can be used at the discretion of the investigator. The duration of the open enrollment phase will be 24 months or until the required number of subjects are enrolled (n = 600). Each subject will have a post-procedure follow-up of at least 18 months. Subjects will be recruited from up to 50 national and international centers. Each Investigational Site will be expected to enroll at least 20 Subjects. Results: A total of 368 patients have been enrolled to date in the study. The study is still ongoing. Conclusions: A limitation of endovascular aneurysm treatment is recurrence. This trial aims to answer the question of whether the new generation hydrogel coil reduces recurrence rates when compared to bare platinum coils.

scholarly journals The effect of angiotensin-converting enzyme inhibitors on clinical outcomes in patients with ischemic cardiomyopathy and midrange ejection fraction: a post hoc subgroup analysis from the PEACE trial

2018 ◽  
Vol 12 (12) ◽  
pp. 351-359 ◽  
Author(s):  
Talal Alzahrani ◽  
John Tiu ◽  
Gurusher Panjrath ◽  
Allen Solomon
Keyword(s):  
Ejection Fraction ◽  
Angiotensin Converting Enzyme ◽  
Clinical Outcomes ◽  
Ace Inhibitors ◽  
Subgroup Analysis ◽  
Ischemic Cardiomyopathy ◽  
Angiotensin Converting Enzyme Inhibition ◽  
Converting Enzyme ◽  
All Cause Mortality ◽  
Post Hoc

Background: There have been significant advances in the treatment of patients with cardiomyopathy with reduced ejection fraction (EF < 40%). However, there is a dearth of information in the treatment of patients with cardiomyopathy and midrange EF (40–50%). Current guidelines state to treat these patients similarly to patients with cardiomyopathy and preserved EF. Data from the Prevention of Events with Angiotensin-Converting Enzyme Inhibition (PEACE) trial were used to elucidate whether angiotensin-converting enzyme (ACE) inhibitors improve clinical outcomes in patients with ischemic cardiomyopathy and midrange EF. Methods: A post hoc subgroup analysis of the PEACE trial was conducted to evaluate the effect of ACE inhibitors in a subgroup of patients with ischemic cardiomyopathy and midrange EF (40–50%). A Chi-square test and a Student‘s t-test were used to examine and compare the binary and continuous variables of baseline characteristics and outcomes between experimental and comparison groups. Results: We studied a subgroup of patients from the PEACE trial with ischemic cardiomyopathy and midrange EF ( n = 2512 of 8290 total patients). Patients were assigned to either the interventional group ( n = 1247) or the placebo group ( n = 1265). There were no significant differences in baseline demographic and health characteristics between the two groups. During a total of 7 years (mean 4.7 years) of follow up, the risk of composite outcomes [all-cause mortality, nonfatal myocardial infarction, and stroke; relative risk (RR) 0.79, 95% confidence interval (CI) 0.63–0.98; p = 0.03] and all-cause mortality (RR 0.85, 95% CI 0.73–0.99; p = 0.03) was reduced in patients treated with trandolapril. Conclusion: This study revealed the benefit of ACE inhibitors among patients with ischemic cardiomyopathy and midrange EF.

scholarly journals Oxaliplatin-Based Chemotherapy in Patients with Metastatic Colorectal Cancer Aged at Least 75 Years: A Post-Hoc Subgroup Analysis of Three Phase II Trials

Cancers ◽  
2019 ◽  
Vol 11 (4) ◽  
pp. 578 ◽  
Author(s):  
Gerardo Rosati ◽  
Stefano Cordio ◽  
Giorgio Reggiardo ◽  
Giuseppe Aprile ◽  
Alfredo Butera ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Elderly Patients ◽  
Metastatic Colorectal Cancer ◽  
Phase Ii ◽  
Subgroup Analysis ◽  
Performance Status ◽  
Phase Ii Trials ◽  
Younger Patients ◽  
Three Phase ◽  
Post Hoc

Patients older than 75 years of age are usually excluded from metastatic colorectal cancer studies based on a combination chemotherapy containing oxaliplatin. Our group conducted three phase II trials in elderly patients in recent years. A post-hoc subgroup analysis of 67 patients aged at least 75 years was included in this study. Oxaliplatin was combined with capecitabine in two trials and with uracil-tegafur (UFT) plus folinic acid in the third trial. In one study, bevacizumab was also added to chemotherapy. The median age of patients was 77 years, and all had a good performance status (0 to 1). The observed overall response rate was 45%, comparable to younger patients (51%, p = 0.49). The estimated median progression-free survival (PFS) time and overall survival (OS) time were 8.7 and 19.3 months, respectively. These results did not significantly differ from those in younger patients (8.0 months for PFS (p = 0.58) and 19.7 months for OS (p = 0.94), respectively). The most common grade 3–4 adverse events included diarrhea (13%), fatigue (13%), peripheral neuropathy (10%), and neutropenia (7%). Moreover, the toxicity was never statistically different from that in younger patients. The efficacy of oxaliplatin-based combination was maintained in fit elderly patients ≥75 years.

scholarly journals But Did You Use HydroCoil? Perianeurysmal Edema and Hydrocephalus with Bare Platinum Coils

2008 ◽  
Vol 29 (2) ◽  
pp. 299-300 ◽  
Author(s):  
J.B. White ◽  
H.J. Cloft ◽  
D.F. Kallmes
Keyword(s):  
Bare Platinum Coils ◽  
Platinum Coils
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