Search Results for: Utilizzo degli stent-retriever nell’ictus ischemico acuto

Background
Endoscopic retrograde cholangiopancreatography (ERCP) with fully covered self-expandable metal stent (FCSEMS) placement is the preferred approach for biliary drainage in patients with suspected distal malignant biliary obstruction (MBO). However, FCSEMS placement is associated with a high risk of post-ERCP pancreatitis (PEP). Endoscopic sphincterotomy prior to FCSEMS placement may reduce PEP risk.

Objective
To compare endoscopic sphincterotomy to no sphincterotomy prior to FCSEMS placement.

Design
This multicentre, randomised, superiority trial was conducted in 17 hospitals and included patients with suspected distal MBO. Patients were randomised during ERCP to receive either endoscopic sphincterotomy (sphincterotomy group) or no sphincterotomy (control group) prior to FCSEMS placement. The primary outcome was PEP within 30 days. Secondary outcomes included procedure-related complications and 30-day mortality. An interim analysis was performed after 50% of patients (n=259) had completed follow-up.

Results
Between May 2016 and June 2023, 297 patients were included in the intention-to-treat analysis, with 156 in the sphincterotomy group and 141 in the control group. After the interim analysis, the study was terminated prematurely due to futility. PEP did not differ between groups, occurring in 26 patients (17%) in the sphincterotomy group compared with 30 patients (21%) in the control group (relative risk 0.78, 95% CI 0.49 to 1.26, p=0.37). There were no significant differences in bleeding, perforation, cholangitis, cholecystitis or 30-day mortality.

Conclusion
This trial found that endoscopic sphincterotomy was not superior to no sphincterotomy in reducing PEP in patients with distal MBO. Therefore, there was insufficient evidence to recommend routine endoscopic sphincterotomy prior to FCEMS placement.

Trial registration number
NL5130.

L’impianto di un nuovo stent evita l’intervento a cuore aperto

Stroke, Ahead of Print. BACKGROUND:The double-stent retriever (SR) technique has been described as an effective rescue technique when single-SR fails to induce recanalization. We aimed to assess the safety and efficacy of first-line double-SR in patients with stroke undergoing thrombectomy.METHODS:This was a multicenter, randomized, controlled, blinded adjudicated primary outcome study. Patients with a large vessel occlusion stroke within 24 hours after onset and undergoing thrombectomy were included. Upon confirmation of large vessel occlusion on initial angiogram, patients were randomly allocated to receive a first-line strategy: single-SR versus double-SR technique. Investigators could use their technique of choice if further passes were needed. The primary objective was to evaluate the efficacy of double-SR defined as first-pass complete recanalization (expanded Treatment in Cerebral Infarction grade 2c-3) compared with single-SR. First-pass recanalization and final successful recanalization (expanded Treatment in Cerebral Infarction grade 2b50-3) were centrally assessed by a blinded investigator. The safety outcome was the occurrence of a symptomatic intracerebral hemorrhage. The data safety monitoring board stopped the recruitment after a preplanned interim analysis because a predefined efficacy boundary was reached.RESULTS:From April 2022 to October 2023, 108 patients were included: 50 (46%) in the single-SR group and 58 (54%) in the double-SR group. First-pass recanalization was achieved in 12 of 50 patients (24%) allocated to single-SR and 27 of 58 patients (46%) allocated to double-SR (adjusted odds ratio, 2.72 [95% CI, 1.19–6.46]). Substantial reperfusion within 3 attempts was obtained in 42 patients (84%) allocated to single-SR and in 52 patients (89%) allocated to double-SR (adjusted odds ratio, 1.74 [95% CI, 0.5–5.76]). The mean number of passes was 2±1.3 with single-SR and 1.7±1 with double-SR (mean difference, −0.37 [95% CI, −0.9 to 0.06]). A symptomatic intracerebral hemorrhage occurred in 3 patients (6%) allocated to single-SR and in 6 patients (10%) allocated to double-SR (adjusted odds ratio, 1.66 [95% CI, 0.40–8.35]).CONCLUSIONS:In patients with stroke undergoing thrombectomy, first-line double-SR is safe and superior to single-SR in achieving first-pass recanalization but not final recanalization. Implications on clinical outcomes should be studied in specifically designed trials.REGISTRATION:URL:https://www.clinicaltrials.gov; Unique identifier: NCT05632458.

Circulation, Ahead of Print. BACKGROUND:Covered stent correction for a sinus venosus atrial septal defect (SVASD) was first performed in 2009. This innovative approach was initially viewed as experimental and was reserved for highly selected patients with unusual anatomic variants. In 2016, increasing numbers of procedures began to be performed, and in several centers, it is now offered as a standard of care option alongside surgical repair. However, covered stent correction for SVASD is not recognized by regulatory authorities, and in the minds of many pediatric and adult congenital cardiologists and surgeons, the condition is viewed as treatable only by cardiac surgery with cardiopulmonary bypass.METHODS:In April 2023, all centers identified from international conferences, publications, and colleague networks to be undertaking covered stent correction for SVASD were invited to participate in a retrospective audit of their procedures.RESULTS:Data were received on 381 patients from 54 units over a 12-year period with 90% of procedures being performed over the past 5 years. Balloon-expandable stents (8 types) were used in the majority; self-expanding stents (4 types) were used in 4.5%. The commonest stent was the 10-zig covered Cheatham Platinum stent in 62% of cases. In 10 procedures, the stent embolized requiring surgical retrieval and repair of the defect, resulting in technically successful implantation in 371 of 381 (97.4%). Major complications (surgical drainage of tamponade, pacemaker implantation, surgery for pulmonary vein occlusion, and late stent removal) occurred in 5 patients (1.3%). Repeat catheterization to correct residual leaks was required in 7 patients (1.8%). Thus, 359 of 381 patients (94.2%) had successful correction without major complications or additional catheter interventions.CONCLUSIONS:This article details the exponential uptake of covered stent correction for SVASD during the past 5 years. Cardiopulmonary bypass was avoided in the majority of patients, and major complications were infrequent. Prospective registries with standardized definitions, inclusion criteria, and follow-up and comparative studies with surgery are now required to help support the extension of covered stent correction as an alternative standard-of-care option for patients with an SVASD.

Background
In-stent restenosis (ISR) is the primary cause of stroke recurrence after intracranial stenting. Drug-eluting stents (DES) have recently shown great potential for reducing restenosis. This systematic review aimed to evaluate the efficacy and safety of DES compared with bare-metal stents (BMS) for intracranial atherosclerotic stenosis (ICAS).

Methods
We systematically searched the MEDLINE (Ovid), Cochrane Central Register of Controlled Trials, Embase (Ovid) and Web of Science databases for studies published from inception through 10 October 2023, comparing DES with BMS for the treatment of symptomatic severe ICAS. We included randomised controlled trials and cohort studies that compared DES and BMS in adult patients with ICAS. The primary outcomes were stroke or death within 30 days and ISR within 1 year. Secondary outcomes included procedure-related adverse events, technical success, functional evaluation findings, restenosis degree and other safety endpoints within 1 year. Subgroup analyses were conducted across different study types.

Results
A total of 510 participants fulfilling all eligibility criteria were enrolled in four studies. DES had a similar rate of any stroke or death within 1 month (3 studies, 476 participants: risk ratio (RR): 1.00; 95% CI: 0.46 to 1.11; p=1.00; I2=31%) to that of the BMS group and had a significantly lower rate of ISR within 1 year (4 studies, 429 participants: RR: 0.23; 95% CI: 0.13 to 0.41; p

Impegno per scambio di dati e studi per il recupero pazienti

Preoccupa però il mancato utilizzo del Fondo per i farmaci innovativi

Annals of Internal Medicine, Ahead of Print.

Annals of Internal Medicine, Ahead of Print.

Background
In-stent restenosis (ISR) is a crucial factor that affects the long-term efficacy of intracranial bare metal stent (BMS) implantation for intracranial atherosclerotic stenosis (ICAS). Patients with intracranial ISR are at a high risk of recurrent ischaemic events. The NOVA intracranial drug-eluting stent (DES) trial demonstrates that a DES can reduce ISR and stroke recurrence after intracranial bare stent implantation. However, the application of balloon-expanded DES necessitates specific vascular conditions. The objective of this study is to assess the safety and efficacy of self-expanding DES for treating symptomatic ICAS (sICAS).

Methods
This is a prospective, multicentre, randomised, controlled, superiority clinical trial that is conducted in 16 clinical trial centres in China. This study aims to recruit 208 patients with sICAS. Eligible subjects are randomly assigned to two groups at a ratio of 1:1. The experimental group is treated with DES (Xinwei intracranial DES system). The control group is treated with BMS (Wingspan intracranial stent system). All subjects are followed up within 7 days after surgery or before discharge; 30 days after surgery; and 6, 12 and 24 months after surgery. The primary outcome of the trial is the incidence of ISR at 6 months after surgery to verify the safety and efficacy of intracranial DESs. After 6 months of follow-up, the clinical summary report is issued for product registration application, and the follow-up of 12 months and 24 months after operation is conducted to evaluate the medium and long-term efficacy.

Ethics and dissemination
The study involving human participants is reviewed and approved by the Ethics Committee of Drugs (devices) Clinical Experiment in Henan Provincial People’s Hospital (reference number: AF/SC-08/05.0) and other research centres participating in the clinical trial (supplemental file 2). The results yield from this study will be presented at international conferences and sent to a peer-reviewed journal to be considered for publication.

Trial registration number
Registered on 2 November 2023 with Chinese clinical trial registry. Registration number is ChiCTR2300077271.

Stroke, Ahead of Print. BACKGROUND:Lack of a dedicated thrombectomy device for cerebral venous thrombosis hinders the recanalization ability of endovascular treatment (EVT). Novel NiTi-braided stent retriever (Venous-TD) is a dedicated venous sinus thrombectomy device. This study aims to demonstrate the safety and efficacy of Venous-TD.METHODS:In this pilot, prospective, randomized, single-blind, parallel-group control, single-center clinical study, patients with cerebral venous thrombosis from Beijing Xuanwu Hospital were included. Randomization was performed to EVT with either the Venous-TD or Angioguard with Sterling balloon (control group). The primary efficacy outcome was the proportion of immediate complete recanalization during EVT. Secondary outcomes included the proportion of functional independence and moderate to severe residential headache at 180 days after EVT. Safety outcomes included peri-procedural complications, all-cause mortality, and symptomatic intracranial hemorrhage after EVT.RESULTS:A total of 61 patients were enrolled and randomized. Thirty-one patients were randomized to the Venous-TD group, and 30 were randomized to the control group. The median (interquartile range) age was 28 (21–45) in the Venous-TD group and 34 (24–43) in the control group. The proportion of patients with a National Institutes of Health Stroke Scale score >8 on admission was 8 (25.8%) in the Venous-TD group and 11 (36.7%) in the control group. During EVT, Venous-TD significantly improved the proportion of complete recanalization compared with Angioguard (23 [76.7%] versus 6 [20.0%]; relative risk, 3.833 [95% CI, 1.825–8.054]). The proportions of long-term functional independence at 180 days in the Venous-TD group and the control group were not significantly different. The proportion of patients with severe residual headache at 180 days in the Venous-TD group was significantly lower than that in the control group (3 [9.7%] versus 10 [35.7%]; relative risk, 0.271 [95% CI, 0.083–0.886]). Safety outcomes showed no statistically significant difference between the 2 groups.CONCLUSIONS:This trial indicated that Venous-TD did not increase complications in EVT of cerebral venous thrombosis and can significantly increase the proportion of complete recanalization. A multicenter phase III randomized control trial assessing efficacy and safety of Venous-TD is warranted.REGISTRATION:URL:https://www.clinicaltrials.gov; Unique identifier: NCT05291585

Stroke, Volume 55, Issue 12, Page 2776-2785, December 1, 2024. BACKGROUND:Restenosis after carotid artery stenting (CAS) is associated with the risk of developing ischemic stroke. We aimed to evaluate the inhibitory effect of cilostazol addition on in-stent restenosis (ISR) in patients treated with CAS.METHODS:In a randomized, open-label, blind-end point trial, patients with symptomatic and asymptomatic carotid artery stenosis and scheduled for CAS were randomly assigned to adding cilostazol (50 or 100 mg, twice per day) on other antiplatelets from 3 days before CAS or not adding cilostazol. Concomitant use of other antiplatelets was unrestricted. ISR was diagnosed by a peak systolic velocity of at least 1.75 m/s on duplex ultrasonography. The primary outcome was incidence of ISR within 2 years after CAS. Secondary outcomes included occurrences of cardiovascular events or any death and hemorrhagic events.RESULTS:Participants were recruited from December 2010 to September 2015. Although the sample size was initially set to be 900 (450 in each group), 631 patients (mean age 69.9 years, 558 men, 325 in the cilostazol, and 306 in the noncilostazol group) were included in the primary analysis. Within 2 years’ follow-up, ISR occurred in 31 of 325 patients (cumulative incidence 10.8%) in the cilostazol group and 46 of 306 patients (19.6%) in the noncilostazol group (hazard ratio, 0.64 [95% CI, 0.41–1.0];P=0.056). In the exploratory analysis, incidence of ISR beyond 30 days after CAS was lower in the cilostazol group than in the noncilostazol group (10.3% versus 19.3%;P=0.040). Incidences of cardiovascular events or any death and hemorrhagic events were similar between the groups (6.2% versus 6.7% and 2.3% versus 1.4%, respectively).CONCLUSIONS:The addition of cilostazol to other antiplatelet agents could contribute to the reduction of ISR in the chronic stage of patients who underwent CAS, the authenticity of which depends on further studies with sufficient statistical power.REGISTRATION:URL:https://www.clinicaltrials.gov; Unique identifier: NCT01261234.