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

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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.

Ipertensione, fibrillazione atriale e fumo

Circulation, Volume 150, Issue Suppl_1, Page A4145821-A4145821, November 12, 2024. Introduction and Background:Arterial dissection during endovascular therapy rarely occurs but can be lethal. A significant blood volume extravasation during coronary artery interventions is related to the very high mortality (20-30%). In this hyperacute emergent clinical situation, covered stents have been considered as a primary measure to prevent further serious arterial events. A fabric-based covered graft stents yield poor clinical outcomes. To overcome these challenges, the balloon-expandable stent with biodegradable film-type graft for treating arterial dissection was invented.Research Questions and Objectives:A novel balloon-expandable stent with biodegradable film graft for overcoming these issues would be valid for efficacy and safety in a rabbit iliac artery dissection model.Method and Approach:Eighteen iliac artery dissections were induced by balloon over-inflation on angiography (Ellis type 2 or 3) and treated using the test device (3.0 x 24 mm). Subsequently, twelve animals underwent histologic examinations and micro-computed tomography (CT) at 0, 2, 4, and 8 weeks and 3, 6, 9, and 12 months and angiography at one-year.Results and Data:There were no adverse cardiovascular events during the one-year. Early-stage histologic examination revealed complete sealing of disrupted vessels by the device, exhibiting mural hematoma, peri-stent red thrombi, and dense infiltration of inflammatory cells. Mid- and long-term histologic examination showed patent stents with neointimal hyperplasia over the stents (% area stenosis: 11.8 at 2weeks, 26.1 at 1month, 29.7 at 3months, 49.2 at 9months, and 51.0 at 1year), along with mild peri-strut inflammatory response (Grade: 1-2 at mid-term and 0-1 at long-term). The graft film became scarcely visible after six months. Both CT and angiography revealed no instances of thrombotic occlusion or in-stent restenosis (% diameter stenosis: 5.7 at 2weeks, 12.3 at 1month, 14.2 at 3months, 25.1 at 9months, and 26.6 at 1 year).Conclusion:The novel balloon-expandable stent with a biodegradable film graft demonstrates feasibility in managing severe artery dissection and preventing lethal vascular events in animal model. Future human studies are warranted to validate these findings and elucidate the clinical outcomes of the study.

Circulation, Volume 150, Issue Suppl_1, Page A4140163-A4140163, November 12, 2024. Background:There is limited data on use of the mini-crush technique in two-stent bifurcation percutaneous coronary intervention (PCI).Methods:This retrospective, observational, cohort study was performed across 6 centers in the United States, Russia, and Turkey between 2013-2024, as part of the Prospective Global Registry of Percutaneous Coronary Intervention in Bifurcation Lesions (PROGRESS-BIFURCATION, NCT05100992). We evaluated procedural characteristics of patients who underwent bifurcation stenting using the mini-crush technique and compared it with those who were treated with double kissing (DK) crush.Results:Of 1,138 PCIs involving 1,499 lesions, 46 (4.04%) were performed using the mini-crush technique and 147 lesions (12.91%) using the DK crush technique. Baseline characteristics of the patients were similar in both groups. There was no difference between mini-crush versus DK-crush in technical success (100.0% versus 98.6%; p=0.99), procedural success (95.1% versus 97.1%, p=0.62), procedural complications (10.9% versus 14.7%, p=0.51), or in-hospital major adverse cardiovascular events (MACE) (6.5% versus 5.7%, p=0.73). In contrast, mini-crush technique was associated with shorter procedure time (79.00 vs 116.50 minutes; p

Circulation, Volume 150, Issue Suppl_1, Page A4142793-A4142793, November 12, 2024. Background:Despite advances in Second-generation drug-eluting stents (DES), 5-10% of patients still experience in-stent restenosis (ISR) after percutaneous coronary intervention (PCI), which generates significant financial burden and elevates the risk of acute coronary syndrome (ACS) and rehospitalization. Thus, early identification of patients at high risk for ISR is crucial for guiding clinical stratification and early intervention.Aims:To develop and validate a multimodal artificial intelligence (AI) model based on coronary angiography images for predicting ISR risk in patients post-DES implantation.Methods:To establish an accurate predictive model, our approach begins with the pre-training on 100,000 angiographic images to enhance the model’s capability in recognizing image features. Subsequently, we employ the DenseNet architecture as the primary deep learning model, incorporating angiographic images from 2,000 cases of DES-treated de novo lesions—1,000 from patients who did not experience ISR within two years and 1,000 from those who did. A multivariate logistic regression analysis, including radiomic features, clinical baselines, and functional information, constructs the predictive model. Additionally, a separate prospective cohort of 300 cases was assembled for validation to simulate real-world application and to verify the model’s reliability and accuracy.Results:Our study successfully developed an AI prediction model for ISR, utilizing a large cohort of coronary angiography images, which effectively predicts ISR with high accuracy. Leveraging the DenseNet architecture and finely tuned machine learning algorithms, the model achieved a sensitivity and specificity of 90% in the validation cohort. The ROC curve from the test phase demonstrated an AUC above 0.90, underscoring the model’s exceptional diagnostic capabilities. Furthermore, the implementation of this model in a prospective cohort confirmed its reliability and practical utility in real-world clinical settings.Conclusions:This study introduces the first multimodal AI model using angiographic imaging to predict ISR. By demonstrating high diagnostic accuracy and reliability in real-world settings, this model serves as an essential tool for early ISR detection and intervention, ultimately helping to reduce the incidence of major adverse cardiac events (MACEs) and mortality.

Circulation, Volume 150, Issue Suppl_1, Page A4143264-A4143264, November 12, 2024. Background:R-on-T phenomenon occurs when an electrical stimulus is delivered at a critical point during ventricular repolarization. This can initiate ventricular arrhythmias like polymorphic ventricular tachycardia (PMVT). We describe a case of ventricular pacemaker spikes delivered on the T wave causing PMVT.Case:A 53-year-old female with CAD s/p stent, postpartum cardiomyopathy s/p Bi-V CRT-D (Boston Scientific G124), and paroxysmal atrial fibrillation presented for elective endoscopy and colonoscopy to evaluate her dysphagia and abdominal pain. Her CRT-D was reprogrammed from DDD pacing with lower rate limit (LRL) 50 bpm to an asynchronous Bi-V DOO mode at 50 bpm (‘electrocautery mode’) for the procedure (tachy therapy disabled). Her LV-RV offset was 40 msec. Prior to receiving sedation or medications, she was found unresponsive. Telemetry showed Spike-on-T phenomenon which initiated PMVT. She was externally defibrillated with 200J and received magnesium and an IV amiodarone bolus. She returned to sinus rhythm, but one minute later had another Spike-on-T event initiating PMVT. She was successfully defibrillated with 360J. Post-shock EKG showed an asynchronous Bi-V paced rhythm at 50 bpm.Decision Making:The patient was admitted to the CCU for post-resuscitation care. Her electrolytes and cardiac enzymes were unremarkable. Her CRT-D was reprogrammed to DDD 80-140 bpm. Transthoracic echocardiogram showed normal biventricular systolic function. Cardiac catheterization did not show obstructive CAD. After reprogramming of her device, she had no further events. After initial treatment with IV amiodarone load, she was discharged home on oral magnesium gluconate.Discussion:The only intervention prior to her procedure was device reprogramming (DDD 50 bpm to DOO 50 bpm). Telemetry showed pacer spikes initiating PMVT. Given the LV-RV offset of 40 msec, she would have received these two tightly coupled pacemaker spikes in an asynchronous mode, in this unfortunate instance during her T wave. While her bowel preparation may have led to electrolytes abnormalities, post-resuscitation electrolytes were normal. Fortunately, she received prompt therapy and was reprogrammed with increased LRL.Conclusion:We described a case of Spike-on-T PMVT prior to colonoscopy without obvious provocation other than asynchronous pacemaker spikes. Reprogramming devices in DOO mode with increased LRL may prevent PVCs and asynchronous pacemaker spikes from triggering PMVT.

Circulation, Volume 150, Issue Suppl_1, Page A4141481-A4141481, November 12, 2024. Background:Upfront two-stent techniques are often used in bifurcation percutaneous coronary interventions (PCI), but there is controversy about optimal strategy selection.Methods:We examined the clinical, angiographic characteristics, and long-term outcomes of 206 bifurcation PCIs using the double kissing (DK) crush or the culotte techniques in 192 patients between 2014-2023 from the Prospective Global Registry for the Study of Bifurcation Lesion Interventions (NCT05100992). For the long-term outcomes adjusted hazard ratios (aHR) and 95% confidence intervals (CI) were calculated using the mixed effects Cox proportional hazards model.Results:DK crush was more commonly used (70.4%). Patients in the culotte group had similar baseline characteristics with the DK crush group. Lesions treated with culotte were more likely to be in the left anterior descending (54.1% vs. 35.9%, p

Circulation, Volume 150, Issue Suppl_1, Page A4120583-A4120583, November 12, 2024. Background:First generation drug eluting stents (DES) with thick polymers may contribute to local vascular inflammation and late stent thrombosis. Thinner-strut DES (ultrathin), particularly those with biodegradable polymers, aim to reduce this risk by minimizing flow disturbance and vascular injury. However, the long-term safety and efficacy of ultrathin biodegradable polymer sirolimus eluting stents (BP-SES) compared to durable polymer everolimus eluting stents (DP-EES) are still uncertain. Thus, we performed a meta analysis to compare outcomes of these two stents.Methods:Inclusion criteria comprised randomized controlled trials comparing ultrathin BP SES and thin DP EES in patients undergoing percutaneous coronary interventions with long term follow-up of at least 3 years. We excluded cohort studies, case reports, editorials, conference abstracts, and animal studies. Primary outcomes were target lesion failure (TLF), cardiac death (CD), target-vessel myocardial infarction (TV-MI), and clinically indicated target lesion revascularization (CI-TLR). We systematically searched PubMed, Cochrane CENTRAL, and Scopus. Cochrane’s ROB 2.0 tool assessed trial quality, and RevMan software (5.4) performed the meta-analysis.Results:Our analysis included ten RCTs, totaling 16,216 patients, with 9,108 in the BP SES group and 7,108 in the DP EES group. TLF occurred in 905 patients (9.94%) in the BP-SES group and 821 patients (11.55%) in the DP-EES group, with no statistically significant differences between the groups (RR = 0.92, 95% CI = 0.85 to 1.01, p = 0.08). Additionally, there were no significant differences in cardiac death (RR = 1.00, 95% CI = 0.84 to 1.19, p = 1.00), TV-MI (RR = 0.91, 95% CI = 0.78 to 1.05, p = 0.19), and CI-TLR (RR = 0.88, 95% CI = 0.78 to 1.01, p = 0.06) between the two groups.Conclusion:The use of BP-SES did not result in higher rates of TLF, CD, TV-MI, or CI-TLR compared to DP-DES. These findings suggest that both BP-SES and DP-DES are viable options for PCI procedures, with comparable long-term safety profiles. However, some trials used strut thicknesses exceeding 70µm in cases requiring wider diameters, similar to the strut thickness in the DP-EES group. This makes it challenging to assess whether, in addition to biodegradable polymers, lower strut thickness contributes to reducing target lesion-related events. Further research may be needed to explore other relevant outcomes and to confirm these findings in diverse patient populations.

Circulation, Volume 150, Issue Suppl_1, Page A4140100-A4140100, November 12, 2024. Background:There is limited data on the long-term outcomes of percutaneous coronary intervention (PCI) in patients with left main coronary artery (LM) bifurcation lesions.Methods:This retrospective, observational, cohort study was performed across 6 centers in the United States, Russia, and Turkey between 2013-2024, as part of the Prospective Global Registry of Percutaneous Coronary Intervention in Bifurcation Lesions (PROGRESS-BIFURCATION, NCT05100992). We examined procedural characteristics and follow-up outcomes of patients with versus without LM bifurcation lesions undergoing PCI. Multivariable adjusted hazard ratios (aHR) with 95% CI were calculated using Cox regression.Results:Of 1,089 patients who underwent bifurcation PCI, 289 (26.5%) underwent LM PCI. Patients in the LM group were older (70.1±11.9 vs 65.4±11.5 years; p