Abstract TP9: Solitaire FR Thrombectomy For Acute Stroke: Real-world Experience After FDA Approval

Stroke ◽  
2013 ◽  
Vol 44 (suppl_1) ◽  
Author(s):  
Maxim Mokin ◽  
Travis Dumont ◽  
Erol Veznedaroglu ◽  
Mandy Binning ◽  
Richard Fessler ◽  
...  
Keyword(s):  
United States ◽  
Functional Outcome ◽  
Real World ◽  
Intravenous Thrombolysis ◽  
The United States ◽  
Aspiration Thrombectomy ◽  
Fda Approval ◽  
Excellent Functional Outcome ◽  
Solitaire Fr

Background and Purpose: Based on promising results of the Solitaire FR With the Intention for Thrombectomy (SWIFT) trial, Solitaire FR stent retriever device recently received the Food and Drug Administration (FDA) approval for recanalization of cerebral vessels in patients with acute ischemic stroke. Real world experience with this device since its FDA approval in the United States has not been previously described. Methods: We conducted retrospective analysis of consecutive acute ischemic strokes cases from March 2012 to July 2012 in 10 centers within the United States, where Solitaire FR was used as a single device or in conjunction with other intra-arterial endovascular approaches. Results: A total of 107 patients were identified (mean age, 64 years; male gender, 51%; mean admission NIHSS score 17). Mean time from symptom onset to angiogram (groin puncture) was 4 hrs 47 min. Intravenous thrombolysis with tissue plasminogen activator (tPA) was administered in 37% of cases. Other endovascular techniques utilized in conjunction with Solitaire FR included intra-arterial thrombolysis with tPA (12% of patients), aspiration thrombectomy with Penumbra system (29%) and stenting (17%). Complete recanalization (TIMI 2-3) was achieved in 88% of patients. The rate of sICH within the first 24 hours was 15%. In-hospital mortality was 24%. 30-day clinical follow up data was available on 82 (77%) patients. Of those, 28 patients (34%) had favorable functional outcome (defined as modified Ranking Scale,mRS≤2) and 22 patients (27%) had excellent functional outcome (mRS≤1) at 30 days. Three or more passes with the Solitaire device was associated with a higher incidence of mortality compared with patients requiring 1 or 2 passes only (43% and 18% respectively, p = 0.011). No statistically significant correlation between clot location or length and outcome was evident. Use of other devices with the Solitaire FR was correlated with worsened outcome (p=0.037). Conclusions: This is the first study describing real-world experience with Solitaire FR device outside the SWIFT trial in the United States. Out study shows that variety of other endovascular approaches are used in conjunction with Solitaire FR.

scholarly journals Solitaire Flow Restoration Thrombectomy for Acute Ischemic Stroke

Neurosurgery ◽  
2013 ◽  
Vol 73 (1) ◽  
pp. 19-26 ◽  
Author(s):  
Maxim Mokin ◽  
Travis M. Dumont ◽  
Erol Veznedaroglu ◽  
Mandy J. Binning ◽  
Kenneth M. Liebman ◽  
...  
Keyword(s):  
United States ◽  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Strong Predictor ◽  
Intravenous Thrombolysis ◽  
The United States ◽  
Nihss Score ◽  
Fda Approval ◽  
Flow Restoration ◽  
Solitaire Fr

Abstract BACKGROUND: The promising results of the Solitaire Flow Restoration (FR) With the Intention for Thrombectomy (SWIFT) trial recently led to Food and Drug Administration (FDA) approval of the Solitaire FR stent retriever device for recanalization of cerebral vessels in patients with acute ischemic stroke. OBJECTIVE: To report the early postmarket experience with this device since its FDA approval in the United States, which has not been previously described. METHODS: We conducted a retrospective analysis of consecutive acute ischemic strokes cases treated between March 2012 and July 2012 at 10 United States centers where the Solitaire FR was used as a single device or in conjunction with other intraarterial endovascular approaches. RESULTS: A total of 101 patients were identified (mean age, 64.7 years; mean admission National Institutes of Health Stroke Scale [NIHSS] score, 17.6). Intravenous thrombolysis was administered in 39% of cases; other endovascular techniques were utilized in conjunction with the Solitaire FR in 52%. Successful recanalization (Thrombolysis in Myocardial Infarction 2/3) was achieved in 88%. The rate of symptomatic intracranial hemorrhage within the first 24 hours was 15%. In-hospital mortality was 26%. At 30 days, 38% of patients had favorable functional outcome (modified Rankin scale score ⩽2). Severity of NIHSS score on admission was a strong predictor of poor outcome. CONCLUSION: Our study shows that a variety of other endovascular approaches are used in conjunction with Solitaire FR in actual practice in the United States. Early postmarket results suggest that Solitaire FR is an effective tool for endovascular treatment of acute ischemic stroke.

12-month uptake of PD-L1 testing and atezolizumab (atezo) + nab-paclitaxel (nab-pac) treatment in metastatic triple-negative breast cancer (mTNBC) following accelerated FDA-approval in the United States.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e13103-e13103
Author(s):  
Leisha A. Emens ◽  
Christopher Craggs ◽  
Marcio Debiasi ◽  
Matthew Kent ◽  
Patricia Luhn ◽  
...  
Keyword(s):  
Real World ◽  
Systemic Therapy ◽  
Locally Advanced ◽  
The United States ◽  
Considerable Proportion ◽  
Real World Data ◽  
Fda Approval ◽  
Third Line ◽  
Line Of Therapy

e13103 Background: In March 2019, atezo + nab-pac received accelerated FDA-approval for the treatment (tx) of patients (pts) with unresectable locally advanced or metastatic TNBC who express PD-L1 in immune cells (IC), based on the results from the randomized IMpassion130 clinical trial. A companion diagnostic, the Ventana SP142 PD-L1 assay, was concurrently approved. This real-world data analysis describes the uptake of both PD-L1 testing and therapy with atezo + nab-pac from the time of approval. Methods: This is a retrospective study using the Flatiron Health electronic health record (EHR) derived de-identified database, representing > 2.4 million US cancer pts from > 280 cancer clinics. Pts diagnosed with mTNBC starting any line of systemic therapy between March 9, 2019 and December 31, 2019 (to be updated in April 2020 for 12-months follow-up) were included. Two cohorts were examined: pts receiving either atezo-based tx, or tx without atezo. Demographics were described in the pt group overall and by line of therapy (LOT). Steroid tx at baseline was classified as any order/administration of a steroid within the first three administrations of a systemic therapy in a given LOT. Any record of a PD-L1 test was reported. Results: 228 pts diagnosed with mTNBC were included; 65 pts (28%) received any atezo combination, the majority in combination with nab-pac: 57% (n = 37) in first-line (1L), 25% (n = 16) in second-line (2L), and 18% (n = 12) in third-line or later (3L+). Median age at metastatic diagnosis (mDx) for atezo-treated pts was: 1L, 65 y (IQR: 49, 72); 2L, 56 y (IQR: 48, 64); 3L+, 52 y (IQR: 42, 60). Median age at mDx for non-atezo-treated patients was: 1L, 63 y (IQR: 53, 74); 2L, 59 y (IQR: 51, 65); 3L+, 61 y (IQR: 53, 71). Of 228 pts, 158 (69%) had any PD-L1 test recorded. Among atezo-treated pts, 62 (95%) had a documented PD-L1 test; of those 40 (62%) were tested using the SP142 assay. Overall, 205 tests were recorded: SP142, n = 96 (46.8%); unknown/not documented, n = 44 (21.5%); 22C3, n = 36 (17.6%); lab-developed test, n = 26 (12.7%); SP263, n = 2 (1.0%); and 28-8, n = 1, (0.5%). 37 (57%) atezo-treated pts received a steroid at baseline. Conclusions: Atezo tx and testing with SP142 is being implemented following accelerated FDA-approval. A considerable proportion of pts received steroids at baseline and had nab-pac as chemotherapy backbone in clinical practice. Clinical outcomes of atezo-treated pts in the real-world setting remain to be further explored pending longer pt follow-up times.

Abstract WMP89: Outcomes No Different in Real World Including Direct vs Drip-and-Ship Patients: Power of Reperfusion From Mechanical Thrombectomy

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Darshan G Shah ◽  
Aravi Loganathan ◽  
Dan Truong ◽  
Fiona Chan ◽  
Bruce Campbell ◽  
...  
Keyword(s):  
Functional Outcome ◽  
Real World ◽  
Functional Outcomes ◽  
Mechanical Thrombectomy ◽  
Vessel Occlusion ◽  
Excellent Functional Outcome ◽  
The Mean ◽  
Comprehensive Stroke Center ◽  
Stroke Center

Background: Mechanical thrombectomy (MT) became standard care in 2015 after positive trials in patients presenting with acute ischemic stroke and large vessel occlusion (LVO) 0-6h and in 2018 for selected patients up to 24h from symptom onset. Objective: To evaluate whether patients receiving MT at our center would have comparable outcomes in patients presenting to our comprehensive stroke center (direct) vs transfer patients (drip-and-ship) Methods: This is a retrospective observational study utilising prospectively collected stroke database for patients receiving MT for LVO in anterior and posterior circulation in South Brisbane network of 7 hospitals (6 drip-and-ship centers and 1 MT-capable center), Australia which serves 1.6 million. Day 90 modified Rankin scale (mRS) was used to assess functional outcomes via outpatient follow up at direct or referral center. The association of drip and ship versus mothership treatment with day 90 mRS was tested in ordinal logistic regression adjusted for age, baseline NIHSS and IV thrombolysis. Results: Of 191 patients who underwent Mechanical Thrombectomy from 2015 to June 2018 at our center, 22 patients were excluded from analysis as either their baseline mRS was >1 (13) or follow up data was missing (9). The mean age was 64.4 years. Median (inter-quartile range, IQR) NIHSS was 16 (9-21) on admission and 7 (2-18) on day 1. Thrombolysis in Cerebral Infarction (TICI) ≥2b was achieved in 88.9%. At 90 days, 50.9% achieved excellent functional outcome (mRS 0-1), 61.4% achieved good functional outcome (mRS 0-2) and 69% achieved favorable outcome (mRS 0-3). Median mRS was 1 (IQR 0-5) in 96 patients presenting directly to the endovascular center and 1 (IQR 1-4) in 73 drip-and-ship patients (common odds ratio 1.07 (95%CI 0.62-1.83), p=0.82) Conclusion: Our 7-center network experience confirms real world reproducibility of trial results, interestingly with no difference in functional outcomes for direct vs drip-and-ship patients.

scholarly journals P324 Predictors of corticosteroid-free remission after initiation of ustekinumab for ulcerative colitis: a real-world, multicenter cohort study in the United States

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S348-S349
Author(s):  
R Dalal ◽  
S Esckilsen ◽  
E Barnes ◽  
E McClure ◽  
H Goodrick ◽  
...  
Keyword(s):  
United States ◽  
Ulcerative Colitis ◽  
Logistic Regression ◽  
Cohort Study ◽  
Real World ◽  
The United States ◽  
Multicenter Cohort Study ◽  
Mayo Score ◽  
Multicenter Cohort

Abstract Background Clinical trial data has demonstrated the efficacy of ustekinumab (UST) for the treatment of ulcerative colitis (UC), however real-world clinical outcomes data are limited. We therefore performed a real-world multicenter cohort study to identify predictors of corticosteroid-free clinical remission after initiation of ustekinumab for UC. Methods This is a retrospective cohort study of adult UC patients initiating UST between 1/1/2016 and 11/1/2020 at three large IBD referral centers in the United States. Patients with prior colectomy and those receiving UST for primarily non-UC indications were excluded. Electronic health records were reviewed to obtain clinical data. Independent variables present at UST induction included demographics, disease duration, extraintestinal manifestations, current/prior IBD medications, substance use (cigarettes, cannabis, or opioids), last endoscopic extent/severity, last serum albumin and C-reactive protein (within 3 months prior to induction), and daily bowel frequency. The primary outcome was corticosteroid-free remission (i.e. simple clinical colitis activity index [SCCAI] or 9-point Mayo score of <3) 12-16 weeks after induction. Secondary outcomes included clinical response (reduction of SCCAI or Mayo score by >2 points from baseline) 12-16 weeks after induction and UST failure (i.e. UST discontinuation or colectomy due to uncontrolled disease) within 52 weeks after induction. Multivariable logistic regression was used to identify factors associated with remission. Results We identified 108 UC patients who initiated UST. Median age at induction was 39 years (IQR 30-56 years), 91.7% (99/108) of patients had prior anti-TNF exposure, and 60.2% (65/108) had prior anti-TNF and anti-integrin exposure (Table 1). Of 101 patients with available clinical follow-up data, 39.6% achieved remission and 51.5% had clinical response 12-16 weeks after induction. UST failure occurred in 41.1% (23/56 with sufficient follow-up) within 52 weeks. Adverse events were reported in 3.0% (3/101; rash, urinary tract infection, and C. difficile infection). After multivariable logistic regression, prior anti-TNF and anti-integrin exposure (OR 0.31, 95% CI 0.11-0.86), Mayo endoscopic severity >1 (OR 0.30, 95% CI 0.10-0.88), and bowel frequency (OR 0.84, 95% CI 0.72-0.98) were inversely associated with remission (Table 2). Conclusion In this multicenter cohort, nearly 40% of UC patients achieved corticosteroid-free remission 12-16 weeks after UST induction. Prior exposure to both anti-TNF and anti-integrin therapies, endoscopic severity, and daily bowel frequency were associated with failure to achieve remission. Prospective studies are needed to optimize management strategies for UC patients with failure of two biologic classes.

scholarly journals Natural History and Evolution of Anti-Interferon-γ Autoantibody-Associated Immunodeficiency Syndrome in Thailand and the United States

2019 ◽  
Vol 71 (1) ◽  
pp. 53-62 ◽  
Author(s):  
Gloria H Hong ◽  
Ana M Ortega-Villa ◽  
Sally Hunsberger ◽  
Ploenchan Chetchotisakd ◽  
Siriluck Anunnatsiri ◽  
...  
Keyword(s):  
United States ◽  
Natural History ◽  
The United States ◽  
Interferon Γ ◽  
Mycobacterium Abscessus ◽  
Annual Data ◽  
Persistent Infections ◽  
Ifn Γ ◽  
Immunodeficiency Syndrome

Abstract Background The natural history of anti-interferon-γ (IFN-γ) autoantibody-associated immunodeficiency syndrome is not well understood. Methods Data of 74 patients with anti-IFN-γ autoantibodies at Srinagarind Hospital, Thailand, were collected annually (median follow-up duration, 7.5 years). Annual data for 19 patients and initial data for 4 patients with anti-IFN-γ autoantibodies at the US National Institutes of Health were collected (median follow-up duration, 4.5 years). Anti-IFN-γ autoantibody levels were measured in plasma samples. Results Ninety-one percent of US patients were of Southeast Asian descent; there was a stronger female predominance (91%) in US than Thai (64%) patients. Mycobacterium abscessus (34%) and Mycobacterium avium complex (83%) were the most common nontuberculous mycobacteria in Thailand and the United States, respectively. Skin infections were more common in Thailand (P = .001), whereas bone (P < .0001), lung (P = .002), and central nervous system (P = .03) infections were more common in the United States. Twenty-four percent of Thai patients died, most from infections. None of the 19 US patients with follow-up data died. Anti-IFN-γ autoantibody levels decreased over time in Thailand (P < .001) and the United States (P = .017), with either cyclophosphamide (P = .01) or rituximab therapy (P = .001). Conclusions Patients with anti-IFN-γ autoantibodies in Thailand and the United States had distinct demographic and clinical features. While titers generally decreased with time, anti-IFN-γ autoantibody disease had a chronic clinical course with persistent infections and death. Close long-term surveillance for new infections is recommended.

scholarly journals SAT0172 UTILIZATION OF HYDROXYCHLOROQUINE AND CORTICOSTEROIDS AMONG LUPUS PATIENTS WITH INCIDENT END-STAGE RENAL DISEASE (ESRD) ONSET: A LONGITUDINAL STUDY USING USRDS REGISTRY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1027.2-1027
Author(s):  
A. R. Broder ◽  
W. Mowrey ◽  
A. Valle ◽  
B. Goilav ◽  
K. Yoshida ◽  
...  
Keyword(s):  
United States ◽  
Lupus Nephritis ◽  
Renal Disease ◽  
International Classification Of Diseases ◽  
The United States ◽  
Diagnostic Code ◽  
Prescribing Practices ◽  
Part D ◽  
Stage Renal Disease

Background:The development of ESRD due to lupus nephritis is one of the most common and serious complications of SLE. Mortality among SLE ESRD patients is 4-fold higher compared to lupus nephritis patients with preserved renal function1Mortality in SLE ESRD is also twice as high compared with non-SLE ESRD, even though SLE patients develop ESRD at a significantly younger age. In the absence of ESRD specific guidelines, medication utilization in SLE ESRD is unknown.Objectives:The objective of this study was to investigate the real-world current US-wide patterns of medication prescribing among lupus nephritis patients with new onset ESRD enrolled in the United States Renal Disease Systems (USRDS) registry. We specifically focused on HCQ and corticosteroids (CS) as the most used medications to treat SLE.Methods:Inclusion: USRDS patients 18 years and above with SLE as a primary cause of ESRD (International Classification of Diseases, 9thRevision (ICD9) diagnostic code 710.0, previously validated2). who developed ESRD between January 1st, 2006 and July 31, 2011 (to ensure at least 6 months of follow-up in the USRDS). Patients had to be enrolled in Medicare Part D (to capture pharmacy claims). The last follow-up date was defined as either the last date of continuous part D coverage or the end of the study period, Dec 31, 2013.Results:Of the 2579 patients included, 1708 (66%) were HCQ- at baseline, and 871 (34%) were HCQ+ at baseline. HCQ+ patients at baseline had a slightly lower duration of follow-up compared to HCQ- patients at baseline, median (IQR) of 2.32 (1.33, 3.97) years and 2.55 (1.44, 4.25) years, respectively, p= 0.02. During follow-up period, only 778 (30%) continued HCQ either intermittently or continuously to the last follow-up date, 1306 (51%) were never prescribed HCQ after baseline, and 495 (19%) discontinued HCQ before the last follow-up date. Of the 1801 patients who were either never prescribed or discontinued HCQ early after ESRD onset, 713 (40%) were prescribed CS to the end of the follow-up period: 55% were receiving a low dose <10mg/daily, and 43 were receiving moderate dose (10-20mg daily)Conclusion:HCQ may be underprescribed and CS may be overprescribed in SLE ESRD. Changing the current prescribing practices may improve outcomes in SLE ESRDReferences:[1]Yap DY et al., NDT 2012.[2]Broder A et al., AC&R 2016.Acknowledgments :The data reported here have been supplied by the United States Renal Data System (USRDS). The interpretation and reporting of these data are the responsibility of the author(s) and in no way should be seen as an official policy or interpretation of the U.S. government.Funding: :NIH/NIAMS K23 AR068441 (A Broder), NIH/NIAMS R01 AR 057327 and K24 AR 066109 (KH Costenbader)Disclosure of Interests: :Anna R. Broder: None declared, Wenzhu Mowrey: None declared, Anna Valle: None declared, Beatrice Goilav: None declared, Kazuki Yoshida: None declared, Karen Costenbader Grant/research support from: Merck, Consultant of: Astra-Zeneca

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