LOW INCIDENCE OF SYMPTOMATIC STROKES AFTER CAROTID STENTING WITHOUT EMBOLIZATION PROTECTION DEVICES FOR EXTRACRANIAL CAROTID STENOSIS

Neurosurgery ◽  
2008 ◽  
Vol 63 (5) ◽  
pp. 867-873 ◽  
Author(s):  
Aditya S. Pandey ◽  
Christopher J. Koebbe ◽  
Kenneth Liebman ◽  
Robert H. Rosenwasser ◽  
Erol Veznedaroglu
Keyword(s):  
Carotid Stenosis ◽  
Controlled Trial ◽  
Carotid Stenting ◽  
Published Data ◽  
Cerebrovascular Accidents ◽  
Period 2 ◽  
In Series ◽  
Protection Devices ◽  
Low Incidence

Abstract OBJECTIVE Carotid angioplasty and stenting (CAS) remains the primary modality of treating individuals with carotid stenosis and significant comorbidities or anatomically difficult lesions. The use of embolization protection devices (EPD) has been mandated by the cerebrovascular community even though the ability of these devices to prevent symptomatic strokes is not supported by the current literature. Our goal was to assess the clinical and radiological outcomes of patients who underwent CAS without EPDs at our hospital from 1996 to 2006. METHODS We performed a retrospective chart analysis of all patients who underwent CAS without EPDs at the Jefferson Hospital for Neuroscience in Philadelphia, PA. The clinical and angiographic outcomes of these patients were studied retrospectively using chart reviews and operative, angiographic, and radiological reports. The mean clinical and radiological follow-up period was 18.6 months. RESULTS One hundred five patients (97.2%) had clinical follow-up at 1 month. During this period, the following complications were observed: cerebrovascular accidents in 2 patients (1.9%), myocardial infarctions in 2 patients (1.9%), femoral hematoma in 1 patient (0.9%), retroperitoneal hematomas in 3 patients (2.8%), and cervical carotid dissections in 4 patients (3.7%); 2 patients (1.9%) died. Seventy-six patients (80.9%) had a mean clinical follow-up period of 18.6 months. During this period, 2 patients (2.6%) had cerebrovascular accidents, 1 of which was fatal. The long-term morbidity and mortality rate was 2.6%. In the same follow-up period, the restenosis (>50% stenosis from baseline) rate was 9.2% (7 patients). Three (3.9%) of these patients went on to require repeat CAS. CONCLUSION Our experience reveals that CAS can be performed safely with risks similar to those reported in series in which EPDs were used. Any procedure or device that adds risk and cost to the patient should be evaluated with a randomized, controlled trial to evaluate its efficacy, especially in situations in which published data provide conflicting results. The use of EPDs should be no exception to this paradigm.

scholarly journals The Asymptomatic Carotid Surgery Trial-2 (ACST-2): an ongoing randomised controlled trial comparing carotid endarterectomy with carotid artery stenting to prevent stroke

2017 ◽  
Vol 21 (57) ◽  
pp. 1-40 ◽  
Author(s):  
Richard Bulbulia ◽  
Alison Halliday
Keyword(s):  
Carotid Artery ◽  
Carotid Stenosis ◽  
Controlled Trial ◽  
Carotid Stenting ◽  
Carotid Surgery ◽  
Asymptomatic Carotid ◽  
Randomised Controlled ◽  
Surgery Trial

Background A successful open surgical operation to remove atheromatous carotid artery narrowing that has not yet caused a stroke (asymptomatic carotid stenosis) carries some procedural risk but, if completed successfully, halves patients’ future annual stroke risk for at least 10 years. A newer, less invasive alternative is carotid stenting, which also carries some procedural risk, especially if the carotid lesion has recently given rise to a stroke (symptomatic carotid stenosis). For both surgery and stenting, improvements in technique (and in medication) have reduced risk. Early studies showed that treating carotid narrowing by stenting, particularly for symptomatic lesions, caused more procedural minor strokes than surgery, but more recent trials in symptomatic and in asymptomatic patients found that both procedures might now be equally safe and effective. However, low patient numbers, short follow-up of the long-term effects on stroke rates and wide confidence intervals mean that worldwide uncertainty persists between carotid surgery and carotid stenting, and national and international guidelines remain unclear as to which is generally better. Objectives The second Asymptomatic Carotid Surgery Trial (ACST-2) compares carotid endarterectomy (CEA) with carotid artery stenting (CAS) directly, randomising patients with asymptomatic carotid stenosis for whom a carotid procedure is considered definitely necessary; both procedures seem anatomically feasible, and there is substantial uncertainty as to which of the two would be better for such individuals. Although it will compare procedural risks, the trial’s primary aim is to compare the long-term durability of protection against strokes occurring in the years post procedure due to any remaining or recurrent carotid disease. Design Randomised controlled trial comparing CEA with CAS. Setting Hospitals in the UK and worldwide, in which carotid procedures are common. Participants Men and women with severely stenotic atherosclerotic carotid artery disease, with or without previous stroke but with no recent symptoms from the randomised artery. Interventions CEA and CAS. Outcomes (1) Periprocedural risk defined as myocardial infarction, stroke or death within 30 days after the randomised procedure and (2) long-term rates of disabling or fatal stroke during follow-up of patients. Measurement of costs and outcomes Measurement of intervention costs and stroke costs (periprocedural and during follow-up) and of quality of life [EuroQol-5 Dimensions (EQ-5D®)] for patients in the top six recruiting countries (UK, Italy, Belgium, Germany, Serbia and Sweden), who currently constitute 85% of those randomised. Progress so far By the end of March 2016, ACST-2 had included 2125 patients, nearly two-thirds of the planned recruitment of 3600; 1061 were randomly allocated to CEA and 1064 to CAS. Conclusions Further funding has been secured and recruitment continues, with completion anticipated by the end of 2019. ACST-2 will report initial results in 2021. Trial registration Current Controlled Trials ISRCTN21144362. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 57. See the NIHR Journals Library website for further project information. Funding was also received from BUPA Foundation [BUPAF/33(a)/05].

scholarly journals The Therapy with Oral Anticoagulants in Patients with Atrial Fibrillation in Outpatient and Hospital Settings (Data from RECVASA Registries)

2019 ◽  
Vol 15 (4) ◽  
pp. 538-545 ◽  
Author(s):  
M. M. Loukianov ◽  
S. Yu. Martsevich ◽  
O. M. Drapkina ◽  
S. S. Yakushin ◽  
A. N. Vorobyev ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Oral Anticoagulants ◽  
Hospital Treatment ◽  
Pronounced Difference ◽  
Period 2 ◽  
Significant Difference ◽  
History Of ◽  
Low Incidence ◽  
Outpatient Settings

Aim. To evaluate an incidence of oral anticoagulants (OAC) administration during longterm follow-up period in patients with atrial fibrillation (AF) enrolled in outpatient and hospital RECVASA registries.Material and methods. 3169 patients with AF were enrolled in outpatient registries RECVASA (Ryazan), RECVASA AF-Yaroslavl and hospital registries RECVASA AF (Moscow, Kursk, Tula), age 70.9±10.7 years, 43.1% men. The incidence of OAC administration was evaluated in hospital and outpatient settings, including longterm follow-up period (2-6 years).Results. OAC were administrated only in 42.2% of cases (1335 from 3169 patients; age 69.1±10.4 years, 43% men), including warfarin (817 patients; 26%) and non-vitamin K antagonist oral anticoagulants (NOAC) – 518 (16%). Patients with permanent and persistant types of AF had lower incidence of OAC administration (43% and 40%) than in cases of paroxysmal type (47.6%, p<0.05), despite of the higher СНА2DS2-VASc risk score (4.69±1.66 and 4.23±1.57 vs 3.81±1.69; р<0.05). Patients with and without history of stroke received OAC in 42.5% and 40% of cases that means no significant difference (p>0.05) contrary to the pronounced difference of thromboembolic risk in these groups (6.14±1.34 and 3.77±1.39; р<0.001). The incidence of OAC administration in hospitals (54.1%) was 2.3 times higher than before hospitalization (23.8%) and was 4.1 times higher than in outpatient registries (13.5%). During follow-up period after hospital treatment (2.3±0.9 years) this parameter decreased from 54.1% to 41.2%, but was still 1.8 times higher than before admission to the hospital. After 4 years follow-up in RECVASA (Ryazan) registry we revealed 4.4 times higher incidence of OAC administration compared with enrollment data (4.2% and 18.3%, р<0.0001). This data was confirmed by the information from outpatient medical cards of accidentally generated group (75 from 297 patients survived during follow-up period): 5.3% at baseline and 22.7% six years later.Conclusions. RECVASA registries in 5 regions of Russia revealed low incidence of OAC administration. The risk of thromboembolic events was higher in patients with AF and no OAC administration compared with patients who received OAC. Patients with paroxysmal type of AF received OAC more often than those with permanent type. There were no significant differences of incidence of OAC therapy in patients with and without history of stroke. Both questioning of patients with AF and analysis of medical cards in outpatient clinics revealed higher incidence of OAC administration after 4-6 years of follow-up compared with the stage of enrollment in registries.

scholarly journals The Incidence of Postoperative Seizures Following Treatment of Postinfectious Hydrocephalus in Ugandan Infants: A Post Hoc Comparison of Endoscopic Treatment vs Shunt Placement in a Randomized Controlled Trial

Neurosurgery ◽  
2019 ◽  
Vol 85 (4) ◽  
pp. E714-E721 ◽  
Author(s):  
Maria Punchak ◽  
Edith Mbabazi Kabachelor ◽  
Michael Ogwal ◽  
Esther Nalule ◽  
Joyce Nalwoga ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Bivariate Analysis ◽  
Third Ventriculostomy ◽  
Published Data ◽  
Intention To Treat ◽  
Kaplan Meier ◽  
Significant Difference ◽  
Postoperative Seizure ◽  
Post Hoc

Abstract BACKGROUND There are currently no published data directly comparing postoperative seizure incidence following endoscopic third ventriculostomy (ETV), with/without choroid plexus cauterization (CPC), to that for ventriculoperitoneal shunt (VPS) placement. OBJECTIVE To compare postoperative epilepsy incidence for ETV/CPC and VPS in Ugandan infants treated for postinfectious hydrocephalus (PIH). METHODS We performed an exploratory post hoc analysis of a randomized trial comparing VPS and ETV/CPC in 100 infants (&lt;6 mo old) presenting with PIH. Minimum follow-up was 2 yr. Variables associated with and the incidence of postoperative epilepsy were compared (intention-to-treat) using a bivariate analysis. Time to first seizure was compared using the Kaplan–Meier method, and the relative risk for the 2 treatments was determined using Mantel-Haenszel hazard ratios. RESULTS Seizure incidence was not related to age (P = .075), weight (P = .768), sex (P = .151), head circumference (P = .281), time from illness to hydrocephalus onset (P = .973), or hydrocephalus onset to treatment (P = .074). Irritability (P = .027) and vision deficit (P = .04) were preoperative symptoms associated with postoperative seizures. Ten (10%) patients died, and 20 (20%) developed seizures over the follow-up period. Overall seizure incidence was 9.4 per 100 person-years (9.4 and 9.5 for ETV/CPC and VPS, respectively; P = .483), with no significant difference in seizure risk between groups (hazard ratio, 1.02; 95% CI: 0.42, 2.45; P = .966). Mean time to seizure onset was 8.5 mo for ETV/CPC and 11.2 mo for VPS (P = .464). As-treated, per-protocol, and attributable-intervention analyses yielded similar results. CONCLUSION Postoperative seizure incidence following treatment of PIH was 20% within 2 yr, regardless of treatment modality.

scholarly journals O05 1-YEAR RESULTS OF AN INTERNATIONAL RANDOMIZED CONTROLLED TRIAL (ESTOIH STUDY) COMPARING THE “SHORT STITCH” VERSUS “LONG STITCH” TECHNIQUE USING AN ULTRA-LONG ABSORBABLE ELASTIC SUTURE MATERIAL

2021 ◽  
Vol 108 (Supplement_8) ◽  
Author(s):  
René Fortelny ◽  
Markus Albertsmeier ◽  
Anna Hofmann ◽  
Stefan Riedl ◽  
Jan Ludolf Kewer ◽  
...  
Keyword(s):  
Incisional Hernia ◽  
Controlled Trial ◽  
Cox Proportional Hazards Model ◽  
Published Data ◽  
Burst Abdomen ◽  
Midline Laparotomy ◽  
Short Stitch ◽  
To Receive ◽  
Incisional Hernia Rate

Abstract Aim The aim of this multicenter, randomized, double blinded study was to compare the short stitch technique for elective, primary, median laparotomy closure with the long stitch closure using the ultra-long absorbable, elastic monofilament suture made of poly 4-hydroxybutyrate (MonoMax®). Material and Methods Eligible patients were randomly allocated to receive either the short or the long stitch suture technique in a 1:1 ratio in 9 centers in Austria and Germany after elective midline laparotomy. Results 425 patients were randomized to receive either the short stitch (n = 215) or long stitch technique (n = 210). In a cox proportional hazards model, the risk for burst abdomen was reduced by 7-fold (HR 0.183 (0.0427 - 0.7435), p = 0.0179) for the short stitch group. Complications such as seroma, hematoma and other wound healing disorders occurred without significant differences between groups. After one year, the incisional hernia rate was 3.65% in the short stitch group compared to 8.80% in the long stitch group (p = 0.055). The combination of burst abdomen and incisional hernia rate had a significantly lower rate of 5.38% for the short stitch technique compared to 13.17% for the long stitch technique (p = 0.0142). Conclusions Both in the short-term results, the short-stitch technique showed substantial advantages in burst abdomen rate, as well as in the 1-year follow-up regarding the incidence of incisional hernias. The low incidence of incisional hernia in the short stitch technique with MonoMax® is promising in comparison to previously published data and should be confirmed in the 3-year follow-up.

scholarly journals Treatment of carotid stenosis: surgery and stent in comparison

2021 ◽  
Vol 23 (Supplement_E) ◽  
pp. E91-E94
Author(s):  
Rocco Giudice ◽  
Claudio Spataro
Keyword(s):  
Endovascular Treatment ◽  
Carotid Stenosis ◽  
Carotid Stenting ◽  
Perioperative Outcomes ◽  
Controlled Clinical Trials ◽  
Safe Alternative ◽  
Symptomatic Carotid ◽  
Asymptomatic Patients ◽  
Symptomatic Carotid Stenosis

Abstract Carotid stenosis in the extracranial tract determines 10–15% of all ischaemic strokes. The aim of treatment, therefore, is to prevent major neurological events. Carotid endarterectomy surgery has proved effective in this regard, with various randomized studies that have demonstrated its validity in both symptomatic and asymptomatic patients. As an alternative, since the late 1990s, the endovascular treatment of carotid stenosis by stenting has gradually established itself. Numerous controlled clinical trials have compared surgery and carotid stenting in terms of perioperative outcomes (death, stroke, and myocardial infarction within 30 days of the procedure) and stroke prevention ipsilateral to the lesion treated during follow-up, evaluating both symptomatic and asymptomatic patients. From the systematic review of the data, it is legitimate to state that stenting may represent a safe alternative to conventional surgery in patients with symptomatic carotid stenosis under the age of 70, while endarterectomy is clearly safer and more effective than endovascular treatment for symptomatic older patients. On the other hand, as regards asymptomatic patients, the available evidence is limited and further data are needed to compare the two methods and to compare them with the best current medical therapy in order to draw conclusions.

The Anturane Reinfarction Italian Study (Aris)

1981 ◽  
Author(s):  
E Polli ◽  
M Cortellaro
Keyword(s):  
Controlled Trial ◽  
Critical Event ◽  
Event Analysis ◽  
Thromboembolic Events ◽  
Double Blind ◽  
Period 2 ◽  
Time Period ◽  
Physical Examinations ◽  
Fixed Times

ARIS, which closed on Dec. 31, 1980, was a multicenter (26 centers coordinated by Medical Clinic I, Milan University), randomized, double-blind, placebo-controlled trial designed to assess the efficacy of sulfinpyrazone (S) (200 mg × 2 twice a day, dose reached gradually during the 1st week) in reducing cardiac mortality, non-fatal reinfarction and other major thromboembolic events (endpoints selected to evidence S’s antithrombotic effect) in patients (≤ 70 yr) with a documented myocardial infarction (MI). Enrollment was at 15-25 days after MI during hospitalization and follow-up was 1-3 yr. The population required (700 patients;α = 0.05, 1 -β = 0.90) was based on the assumption that the rate of endpoints would be about 20% in the mean observation period (2 yr) and that S would reduce this to 10%, considering also dropouts. All events were classified according to predetermined criteria. Interim history, physical examinations, laboratory tests and EOT were performed at various fixed times. Trial enrollment closed on Dec. 31, 1979 with a total of 727 patients. Statistical analysis will be performed according to life tables methods. Response time (period of time until a critical event) analysis will be done by Gehan’s and log-rank procedures and by a regression-life table technique (Cox).At Dec. 15, 1980, before the final blind revision, the following data are available: 41 total deaths; 37 deaths for cardiac causes; 42 non-fatal reinfarctions; 9 other thromboembolic events. This trial included a study of the trend of some hemostatic parameters.

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