scholarly journals Early and Long-Term Outcomes of Carotid Stenting and Carotid Endarterectomy in Women

2021 ◽  
Vol 8 ◽  
Author(s):  
Edoardo Pasqui ◽  
Gianmarco de Donato ◽  
Giuseppe Alba ◽  
Brenda Brancaccio ◽  
Claudia Panzano ◽  
...  
Keyword(s):  
Overall Survival ◽  
Transient Ischemic Attack ◽  
Carotid Stenting ◽  
Long Term Outcomes ◽  
Carotid Revascularization ◽  
Kaplan Meier ◽  
Cerebral Ischemic ◽  
Ischemic Attack ◽  
Perioperative Risks

Background: The role of carotid revascularization in women remains intensely debated because of the lower benefit and higher perioperative risks concerning the male counterpart. Carotid artery endarterectomy (CEA) and stenting (CAS) represent the two most valuable stroke prevention techniques due to large vessel disease. This study investigates the early and late outcomes in female sex in a real-world everyday clinical practice.Methods: Data were retrospectively analyzed from a single-center database prospectively compiled. A total of 234 procedures, both symptomatic and asymptomatic, were identified (98 CEAs and 136 CASs). Perioperative risks of death, cerebral ischemic events, and local complications were analyzed and compared between the two groups. Long-term outcomes were evaluated in overall survival, freedom from ipsilateral stroke/transient ischemic attack, and freedom from restenosis (>50%) and reintervention.Results: Women who underwent CAS and CEA did not differ in perioperative ischemic cerebral events (2.2 vs. 0%, p = 0.26) and death (0.8 vs. 0%, p = 1). Other perioperative and 30-day outcomes were similarly distributed within the two groups. Kaplan–Meier curves between CAS and CEA groups highlighted no statistical differences at 6 years in overall survival (77.4 vs. 77.1%, p = 0.47) of ipsilateral stroke/transient ischemic attack (94.1 vs. 92.9%, p = 0.9). Conversely, significant differences were showed in 6 years freedom from restenosis (93.1 vs. 83.3%, p = 0.03) and reinterventions (97.7 vs. 87.8%, p = 0.015).Conclusion: Our results revealed that both CEA and CAS have acceptable perioperative risk in women. Long-term outcomes highlighted favorable indications for both procedures, especially for CAS, which seemed to be an excellent alternative to CEA in female patients when performed by well-trained operators.

Abstract 5: Early and Long-term Safety of Stenting and Endarterectomy in Symptomatic and Asymptomatic Patients Outside Randomized Trials

Stroke ◽  
2012 ◽  
Vol 43 (suppl_1) ◽  
Author(s):  
Paola De Rango ◽  
Massimo Lenti ◽  
Enrico Cieri ◽  
Piergiorgio Cao ◽  
Giuseppe Giordano ◽  
...  
Keyword(s):  
Randomized Trials ◽  
Carotid Stenting ◽  
Stroke Incidence ◽  
Carotid Revascularization ◽  
Kaplan Meier ◽  
Asymptomatic Patients ◽  
Current Guidelines ◽  
Periprocedural Stroke ◽  
Stroke Death

Objective. Due to the different stroke risk exposure, advisability of carotid revascularization by carotid stenting (CAS) or endarterectomy (CEA) strictly depends on patients’ symptomatic status. Periprocedural and 5-year data of 2196 consecutive procedures (1080 CAS, 1116 CEA) based on physician-guided indication for CEA vs CAS and performed after training outside randomized trials, were reviewed for safety. Methods. 684 symptomatic and 1512 asymptomatic patients were analyzed for periprocedural stroke/death and 5-year death or stroke incidence. Kaplan-Meier survival curves with type-of-procedure interaction were employed. Results. Symptomatic patients were older (71.9y vs 71.04y), less frequently females (25.3% vs 30.8%) and treated more by CEA (60.8%) than by CAS (p<0.001). Asymptomatic patients were more likely affected by cardiac disease, peripheral disease and hyperlipidemia. Periprocedural stroke/death was higher in symptomatic than in asymptomatic patients (3.5% vs 1.9%;OR 1.8, 95%CI1.07-3.2) without significant differences between CAS and CEA in both symptomatic (4.5%CAS vs 2.9%CEA) and asymptomatic (2.2% CAS vs 1.6% CEA) groups. Symptomatic patients showed higher 5-year mortality and stroke incidence: survival rate was 78.4% in symptomatic and 85.5% in asymptomatic (p<0.0001). Late stroke freedom was 93.5% in symptomatic and 97.7% in asymptomatic (p=0.001). There were no differences, according to the procedure (CAS vs CEA) for treatment, in survival (Symptomatic: 85% vs 75%; Asymptomatic: 83% vs 83%) or late stroke incidence (Symptomatic: 93% vs 93%; Asymptomatic: 97% vs 97%). Conclusions. Symptomatic patients show higher risks after carotid revascularization and 5-year outcomes are inferior to those of asymptomatic patients regardless of the surgical procedure. Periprocedural stroke/death rates, either by CAS or CEA, are within the complication threshold rates suggested in current guidelines for both symptomatic and asymptomatic patients.

scholarly journals One-Year Risk of Stroke After Transient Ischemic Attack or Minor Stroke in Hunter New England, Australia (INSIST Study)

2021 ◽  
Vol 12 ◽  
Author(s):  
Shinya Tomari ◽  
Christopher R. Levi ◽  
Elizabeth Holliday ◽  
Daniel Lasserson ◽  
Jose M. Valderas ◽  
...  
Keyword(s):  
New England ◽  
Transient Ischemic Attack ◽  
Systems Of Care ◽  
Minor Stroke ◽  
Stroke Recurrence ◽  
Carotid Revascularization ◽  
Index Event ◽  
Kaplan Meier ◽  
One Year ◽  
Ischemic Attack

Background: One-year risk of stroke in transient ischemic attack and minor stroke (TIAMS) managed in secondary care settings has been reported as 5–8%. However, evidence for the outcomes of TIAMS in community care settings is limited.Methods: The INternational comparison of Systems of care and patient outcomes In minor Stroke and TIA (INSIST) study was a prospective inception cohort community-based study of patients of 16 general practices in the Hunter–Manning region (New South Wales, Australia). Possible-TIAMS patients were recruited from 2012 to 2016 and followed-up for 12 months post-index event. Adjudication as TIAMS or TIAMS-mimics was by an expert panel. We established 7-days, 90-days, and 1-year risk of stroke, TIA, myocardial infarction (MI), coronary or carotid revascularization procedure and death; and medications use at 24 h post-index event.Results: Of 613 participants (mean age; 70 ± 12 years), 298 (49%) were adjudicated as TIAMS. TIAMS-group participants had ischemic strokes at 7-days, 90-days, and 1-year, at Kaplan-Meier (KM) rates of 1% (95% confidence interval; 0.3, 3.1), 2.1% (0.9, 4.6), and 3.2% (1.7, 6.1), respectively, compared to 0.3, 0.3, and 0.6% of TIAMS-mimic-group participants. At one year, TIAMS-group-participants had twenty-five TIA events (KM rate: 8.8%), two MI events (0.6%), four coronary revascularizations (1.5%), eleven carotid revascularizations (3.9%), and three deaths (1.1%), compared to 1.6, 0.6, 1.0, 0.3, and 0.6% of TIAMS-mimic-group participants. Of 167 TIAMS-group participants who commenced or received enhanced therapies, 95 (57%) were treated within 24 h post-index event. For TIAMS-group participants who commenced or received enhanced therapies, time from symptom onset to treatment was median 9.5 h [IQR 1.8–89.9].Conclusion: One-year risk of stroke in TIAMS participants was lower than reported in previous studies. Early implementation of antiplatelet/anticoagulant therapies may have contributed to the low stroke recurrence.

Abstract 14746: A National Level Analysis of Long-term Outcomes in Patients With Carotid Body Tumors

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Edgar Aranda-Michel ◽  
Ibrahim Sultan ◽  
James Brown ◽  
Valentino Bianco ◽  
Andreas Habertheuer ◽  
...  
Keyword(s):  
Overall Survival ◽  
Carotid Body ◽  
Survival Benefit ◽  
Multimodal Therapy ◽  
Multivariable Analysis ◽  
Carotid Body Tumor ◽  
Long Term Outcomes ◽  
Kaplan Meier ◽  
Carotid Body Tumors

Introduction: Carotid body tumors represent the most common site for extra-adrenal paragangliomas. Surgical resection is the treatment of choice as a low percentage of these tumors are malignant. Here we present long-term outcomes of a contemporary cohort of patients with a carotid body tumor. Methods: The national cancer database was quired for all cases of a carotid body tumor between 2004-2015. All baseline variables were gathered from the database. Kaplan-Meier curves were generated for the entire cohort to assess overall survival. The group was split into surgical and non-surgical cohorts. Survival was assessed via Kaplan-Meier estimates. Patients that underwent surgery were divided based on isolated surgical therapy or multimodal therapy (surgery with radiation or chemotherapy). Cox multivariable analysis was used to determine independent predictors for mortality. Results: The search returned 130 patients with a carotid body tumor. The average age of this cohort was 47 years and the majority were women (58.5%). A small proportion (9.2%) of the cohort had a metastasis at the time of diagnosis. Most patients underwent surgery (80%) followed by radiation (44.6%). The overall survival of the cohort was 81.5% at 10 years (Figure 1A) . Long-Term survival was higher in the surgical cohort (P=0.001) (Figure 1B) . Patients with multimodal therapy survived longer than those that underwent surgery alone (P=0.007) (Figure 1C). On Cox multivariable analysis (Figure 1D) , only radiation was a predictor for survival (HR 0.25, P=0.008). Having a metastasis on the time of diagnosis was a predictor for worse outcomes (HR 4.45, P=0.03). Conclusions: While surgery had a survival benefit on Kaplan-Meier analysis, when risk adjusting for other variables, radiation was the only treatment that conferred a survival benefit; an interesting finding given the historical standard of surgical management. Despite improvements in therapeutic modalities, metastasis on diagnosis carries an increased mortality, favoring aggressive treatment.

Overall survival benefit from tebentafusp in patients with best response of progressive disease.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 9509-9509
Author(s):  
Anthony M. Joshua ◽  
Jean-Francois Baurain ◽  
Sophie Piperno-Neumann ◽  
Paul Nathan ◽  
Jessica Cecile Hassel ◽  
...  
Keyword(s):  
Overall Survival ◽  
Safety Profile ◽  
Progressive Disease ◽  
Analysis Data ◽  
Cell Receptor ◽  
Kaplan Meier ◽  
Immortal Time Bias ◽  
Best Response ◽  
Overall Survival Benefit

9509 Background: Tebentafusp (tebe) is the first T cell receptor (TCR) therapeutic to demonstrate an overall survival (OS) benefit in a randomized Phase 3 (Ph3) study [ NCT03070392 ]. In Ph2, 42% of pts with best overall response (BOR) of progressive disease (PD) survived > 1 year (yr), suggesting RECIST-based radiographic assessments underestimate OS benefit of tebe. Here we analyzed OS in the Ph3 study in a cohort of pts with BOR of PD by comparing tebe to the control arm of investigator’s choice (IC). Methods: 378 pts were randomized in a 2:1 ratio to tebe vs. IC. BOR was assessed by investigators using RECIST v1.1. Treatment beyond first disease progression (TBP) was permitted for both arms. On the IC arm, only patients receiving pembrolizumab (pembro) continued with TBP and were included in the TBP-related analyses. No crossover to tebe was permitted; investigators were free to choose subsequent therapy. This analysis was conducted on the first interim analysis (data extracted Nov-2020). Kaplan-Meier estimates of OS were based on Day 100 landmark to eliminate immortal time bias and to capture majority of the PDs. Results: By Day 100, PD as BOR occurred in 52% (130/252) of tebe pts (PD-tebe) vs. 60% (76/126) of IC pts (PD-IC). Key baseline characteristics including lactate dehydrogenase, alkaline phosphatase, ECOG performance, age, and sex were similar between PD-tebe vs PD-IC. The proportion of pts with PD due to progression of target lesions (TL), non-TL, or new lesions were also similar between the two groups. More pts received TBP among PD-tebe 53% (69/130) vs PD-pembro 16% (10/61). Median duration of TBP was longer for PD-tebe (7 weeks) vs PD-Pembro (3 weeks). The safety profile of PD-tebe pts during TBP was similar to all tebe-treated pts. OS was superior for PD-tebe vs PD-IC, HR = 0.41 (95%CI 0.25-0.66), even when considering key baseline covariates. While some pts had regression of TL despite diagnosis of PD ( < 10% of pts), the OS benefit remained even when limited to pts with best change of tumor growth of TL, HR 0.46 (0.29, 0.73). 58% (75/130) PD-tebe and 52% (40/76) PD-IC pts received subsequent therapies. In a landmark OS analysis of these pts beginning on 1st day of subsequent therapy, prior tebe was associated with better OS vs. prior IC, HR 0.59 (95%CI 0.36-0.96). Conclusions: Tebe is the first TCR therapeutic to demonstrate an OS benefit in a solid tumor. Surprisingly, a strong OS benefit from tebe is observed even in pts with BOR of PD, suggesting that RECIST-based radiographic assessments do not capture the complete benefit from tebe. The safety profile of tebe during TBP was consistent with that for long-term tebe treatment. Clinical trial information: NCT03070392.

scholarly journals Simultaneous Bilateral Carotid Stenting under the Circumstance of Neuroprotection Device

2006 ◽  
Vol 12 (2) ◽  
pp. 141-148 ◽  
Author(s):  
Y.H. Lee ◽  
T.-K. Kim ◽  
S.-I. Suh ◽  
B.J. Kwon ◽  
T.H. Lee ◽  
...  
Keyword(s):  
Transient Ischemic Attack ◽  
Carotid Stenting ◽  
Neurological Impairment ◽  
Hemodynamic Instability ◽  
Minor Stroke ◽  
Procedure Time ◽  
Hyperperfusion Syndrome ◽  
Bilateral Carotid ◽  
Ischemic Attack ◽  
Second Procedure

In this study, in order to evaluate the feasibility and outcomes of simultaneous bilateral carotid artery stenting (CAS) with the use of neuroprotection in symptomatic patients, we conducted a retrospective analysis of 27 patients (19 men, eight women; median age, 69.2 years), all of whom had been scheduled to undergo bilateral CAS in a single setting. All patients presented with severe atherosclerotic bilateral carotid stenosis (>50% for symptomatic side, >80% for asymptomatic side), exhibiting symptoms of either a cerebrovascular accident or of a transient ischemic attack on at least one side. 48 arteries were treated with self-expandable stents. Neuroprotection devices were utilized for bilateral CAS in 11 patients, and in 16 unilateral CAS patients. We did not perform the second procedure in six patients, in cases in which a patient exhibited (a) hemodynamic instability, (b) a new neurological impairment, or (c) restlessness after a prolonged time for the first CAS. The second procedure was postponed in a staged manner. We achieved a mean residual stenosis of 8.1 ± 5.0 % in the treated lesions. The mean procedural time for bilateral CAS was three hours and 18 minutes. 17 patients (63%) developed transient bradycardia during the balloon dilatation of one or both of the relevant arteries. Three patients (11%) exhibited persistent bradycardia and hypotension, which required the administration of intravenous vasopressors for several days (2!7 days). None of the patients ultimately required pacemakers, or any further therapy. Two of the patients (7%) developed transient ischemic attack during the periprocedural period, but recovered completely. One patient developed a new minor stroke after the first procedure, and the second procedure was delayed in a staged manner. We observed no periprocedural deaths, major strokes, or myocardial infarctions, nor did we detect any cases of hyperperfusion syndrome within 30 days. In summary, simultaneous bilateral CAS with neuroprotection can be performed in a single setting without increased concerns with regard to hyperperfusion syndrome, hemodynamic instability, thrombo-embolism, or procedure time, when the first CAS has been safely completed with no evidence of complications in a well-managed procedure time.

scholarly journals Early and Long-Term Follow-Up for Chronic Type B and Type Non-A Non-B Aortic Dissection Using the Frozen Elephant Trunk Technique

2021 ◽  
Vol 8 ◽  
Author(s):  
Congcong Luo ◽  
Ruidong Qi ◽  
Yongliang Zhong ◽  
Suwei Chen ◽  
Hao Liu ◽  
...  
Keyword(s):  
Overall Survival ◽  
Aortic Dissection ◽  
Type B ◽  
Frozen Elephant Trunk ◽  
Long Term Outcomes ◽  
Chronic Type ◽  
Elephant Trunk ◽  
Long Term Follow Up

Background: This study aimed to evaluate the early and long-term outcomes of a single center using a frozen elephant trunk (FET) procedure for chronic type B or non-A non-B aortic dissection.Methods: From February 2009 to December 2019, 79 patients diagnosed with chronic type B or non-A non-B aortic dissection who underwent the FET procedure were included in the present study. We analyzed operation mortality and early and long-term outcomes, including complications, survival and interventions.Results: The operation mortality rate was 5.1% (4/79). Spinal cord injury occurred in 3.8% (3/79), stroke in 2.5% (2/79), and acute renal failure in 5.1% (4/79). The median follow-up time was 53 months. The overall survival rates were 96.2, 92.3, 88.0, 79.8, and 76.2% at 1/2, 1, 3, 5 and 7 years, respectively. Moreover, 79.3% of patients did not require distal aortic reintervention at 7 years. The overall survival in the subacute group was superior to that in the chronic group (P = 0.047).Conclusion: The FET technique is a safe and feasible approach for treating chronic type B and non-A non-B aortic dissection in patients who have contraindications for primary endovascular aortic repair. The technique combines the advantages of both open surgical repair and endovascular intervention, providing comparable early and long-term follow-up outcomes and freedom from reintervention.

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