Risultati per: Utilizzo degli stent-retriever nell’ictus ischemico acuto

Stroke, Volume 54, Issue Suppl_1, Page A26-A26, February 1, 2023. Introduction:Plavix resistance is an independent risk factor for thromboembolic complications following carotid artery stent (CAS) placements. The VerifyNow P2Y12 assay is the best studied in gauging for Plavix responsiveness. Its performance is affected when hematocrit (HCT) value is

Stroke, Volume 54, Issue Suppl_1, Page AWMP87-AWMP87, February 1, 2023. Despite the proven benefit of stent retrievers, challenges to rapid revascularization of large vessel occlusions (LVO) persist. Current stent retrievers have limited effectiveness for removing organized thrombi. The NeVa device is a novel stent retriever designed with openings in the basket cell structure (“drop zones”) intended to capture organized thrombi within the central scaffold during retrieval. Prospective, multicenter, open label, single arm, FDA-regulated IDE study to evaluate the performance of the NeVa device for recanalizing occluded intracranial vessels including ICA, M1/M2 MCA, and vertebrobasilar arteries, within 8 hours of onset. Primary endpoint was rate of eTICI 2b-3 within 3 NeVa passes, tested for non-inferiority against a performance goal of 72% with a margin of -10%. Additional efficacy endpoints included first pass effect to eTICI 2b-3 (FPE) and 90-day mRS 0-2. Primary safety endpoint was 90-day mortality. (ClinicalTrials.gov NCT04514562) (Site-adjudicated revascularization results are reported here. Final core lab results will be presented at the conference.) From April 1, 2021 to April 28, 2022, 139 subjects were enrolled at 25 centers in the US and Europe. Mean age was 67 ± 13 years; 47% were female. Median NIHSS score was 16 (IQR: 12-20). Occlusions were 14 (10%) ICA, 85 (61%) M1, 38 (27%) M2, 1 (1%) Basilar and 1 (1%) PCA. Mean time to first pass was 19 ± 12 minutes. eTICI 2b-3 within 3 NeVa passes occurred in 87.8% (122/139; CI 81.1%,92.7%; non-inferiority p

Stroke, Volume 54, Issue Suppl_1, Page A133-A133, February 1, 2023. Introduction:Based largely on the inclusion criteria of clinical trials, the degree of cervical carotid artery stenosis is often used as an indication for stent placement in the setting of carotid atherosclerotic disease. However, the rigor and consistency with which such stenosis is measured outside of clinical trials is unclear. We compared the percent stenosis as measured by real world physician operators to that measured by independent expert reviewers.Hypothesis:We hypothesized that the documented degree of stenosis, termed operator-reported stenosis (ORS), from real world facilities performing carotid stent placement would be larger than the reviewer-measured stenosis (RMS) as assessed by clinicians experienced in treating carotid artery disease.Methods:Images were selected from patient cases used for carotid stenting facility accreditation. Data collected included demographics, National Institutes of Health Stroke Scale, modified Rankin Score, and the documented degree of stenosis (ORS). The ORS was compared to the RMS, derived from a panel of expert clinicians.Results:A total of 68 angiograms were reviewed from 39 symptomatic and 29 asymptomatic patients. The RMS values demonstrated excellent agreement with an intra-class correlation of 0.80. The median ORS was 90.0% (IQR 80.0, 90.0) versus a median RMS of 61.1% (IQR 49.8, 73.6), with a median difference of 21.8% (IQR 13.7, 34.4),p< 0.001. This discrepancy persisted within several subpopulations and was larger among asymptomatic patients and those treated at facilities granted delayed accreditation. Based on RMS values, 72% of symptomatic patients and only 10% of asymptomatic patients would meet the Centers for Medicare and Medicaid Services criteria for carotid stent placement.Conclusions:Real world operators tend to overestimate cervical carotid artery stenosis compared to external expert reviewers. Since decisions regarding carotid revascularization are often based at least partially on percent stenosis, such measuring discrepancies inevitably lead to a higher volume of procedures, which may in turn represent a degree of procedural over utilization.

Stroke, Volume 54, Issue Suppl_1, Page AWP142-AWP142, February 1, 2023. Introduction:Although there is emphasis on performing carotid artery stent placement (CAS) within two weeks after index event of transient ischemic attack (TIA) or minor stroke in patients with cervical internal carotid artery (ICA) stenosis, the risk and characteristics of recurrent cerebral ischemic events while waiting for CAS are not well defined.Method:We analyzed patients admitted to our institution over a 45-month period with symptomatic cervical ICA stenosis. All patients were initiated on daily aspirin and clopidogrel 75mg on the day of admission. We identified any new cerebral ischemic events that occurred between index event and CAS and categorized them as TIA, and minor or major ischemic strokes. We calculated the risk of new ipsilateral cerebral ischemic events between index ischemic event and CAS.Results:The mean age of 150 patients analyzed was 67 years (range: 46-94 years; 106 were men); and 94 and 56 patients had ≥ 70% and 50-69% stenosis, respectively. The mean and median time intervals between index event and CAS performance were 25 and 6 days, respectively. A total of 6 new cerebral ischemic events (5 TIAs and 1 major stroke) were observed over 3,776 patient days of observation. The risk of new ipsilateral cerebral ischemic events between index ischemic event and CAS performance was 1.6 per 1000 patient days of observation.Conclucion:We identified a low risk of new ipsilateral cerebral ischemic events in patients with ≥ 50% ICA stenosis while waiting for CAS presumably due to early initiation of dual antiplatelets.

Stroke, Volume 54, Issue 1, Page 132-134, January 1, 2023.

Stroke, Volume 54, Issue 1, Page 124-131, January 1, 2023. Background:Management of extracranial internal carotid artery steno-occlusive lesion during endovascular therapy remains debated. Stent occlusion within 24 hours of endovascular therapy is a frequent event after acute carotid artery stenting, and we currently lack large population results. We investigated the incidence, predictors, and clinical impact of stent occlusion after acute carotid artery stenting in current clinical practice.Methods:Patients treated by endovascular therapy with acute carotid artery stenting between 2015 and 2019 in 5 large-volume endovascular-capable centers were retrospectively analyzed. Patients were separated in 2 groups according to the stent patency at 24 hours after carotid artery stenting. We compared baseline characteristics, treatment modalities, and clinical outcome depending on 24-hour stent patency. Primary end point was favorable outcome, defined as a modified Rankin Scale score 0–2 at 3 months.Results:A stent occlusion was observed in 47/225 patients (20.9%). Patients with stent patency had a lower baseline National Institutes of Health Stroke Scale (median [interquartile range]: 13 [7–17] versus 18 [12–21]) and had more often stroke of atherothrombotic origin (77.0% versus 53.2%). A higher stent patency rate was found for patients treated with P2Y12antagonists at the acute phase (odds ratio [OR]‚ 2.95 [95% CI‚ 1.10–7.91];P=0.026) and treated with angioplasty (OR‚ 2.42 [95% CI‚ 1.24–4.67];P=0.008). A better intracranial angiographic reperfusion was observed in patients with 24-hour stent patency compared with patients without stent patency (OR‚ 8.38 [95% CI‚ 3.07–22.78];P

Introduction
Femoropopliteal artery in-stent restenosis (FP-ISR) represents one of the main obstacles for stent implantation in peripheral artery disease patients, especially Tosaka III FP-ISR, which is also referred to as in-stent occlusion. Diverse endovascular treatments of Tosaka III FP-ISR are available, and the results are unequivocal. However, real-world data are limited. This study aims to evaluate the efficacy, safety and health economics evaluation of various endovascular procedures in the treatment of Tosaka III FP-ISR.

Method and analysis
This study is a prospective, multicentre, real-world, observational clinical study. Patients diagnosed with Tosaka III FP-ISR and treated with endovascular procedures in nine centres from 1 April 2021 to 31 December 2022 will be recruited. The relevant clinical information, Ankle-Brachial Index and CT angiography will be collected. All the participants will undergo follow-up at 1, 6, 12, 18 and 24 months after the operation. The primary outcome is freedom from clinically driven target lesion revascularisation at 24 months. Safety and health economics issues will also be reported.

Ethics and dissemination
The FP-RESTORE clinical trial has been registered at ClinicalTrials.gov (http://clinicaltrials.gov/). This study was also approved by the Institutional Review Board and Human Research Ethics Committee of Zhongshan Hospital, Fudan University (approval number: B2021-427). Moreover, written informed consent will be obtained at the time of recruitment. The study outcomes will be disseminated by publication in a peer-reviewed journal to provide information for further clinical practice.

Trial registration number
NCT04801004.

Lo Stato ha chiesto alle imprese del settore di ripianare metà dello sforamento della spesa sanitaria per i dispositivi medici, un conto salato da oltre 2 miliardi

Circulation, Volume 146, Issue 21, Page 1577-1580, November 22, 2022.

Circulation, Ahead of Print. Background:Dual antiplatelet therapy (DAPT) with aspirin as a background therapy has become the standard care following percutaneous coronary intervention (PCI). However, some adverse non-cardiac effects limited the use of aspirin in clinical practice. Thus, evaluation of pharmacological alternatives to aspirin is attractive. Previous data indicated that indobufen could lessen the unwanted side effects of aspirin while retain the antithrombotic efficacy, but its combination with a P2Y12 inhibitor is still lack of randomized clinical trial (RCT) evidence.Methods:In this randomized, open-label, non-inferiority trial, patients with negative cardiac troponin undergoing coronary drug-eluting stent (DES) implantation were randomly assigned in a 1:1 ratio to receive either indobufen-based DAPT (indobufen 100mg twice a day plus clopidogrel 75mg/d for 12 months) or conventional DAPT (aspirin 100mg/d plus clopidogrel 75mg/d for 12 months). The primary endpoint was a 1-year composite of cardiovascular (CV) death, nonfatal myocardial infarction (MI), ischemic stroke, definite or probable stent thrombosis (ST), or Bleeding Academic Research Consortium (BARC) criteria type 2, 3 or 5 bleeding. The endpoints were adjudicated by an independent Clinical Event Committee.Results:Between January 11, 2018 and October 12, 2020, 4551 patients were randomized in 103 cardiovascular centers: 2258 patients to the indobufen-based DAPT group and 2293 to the conventional DAPT group. The primary endpoint occurred in 101 (4.47%) patients in the indobufen-based DAPT group and 140 (6.11%) patients in the conventional DAPT group (absolute difference -1.63%, pnon-inferiority 0.05). The occurrence of BARC criteria type 2, 3 or 5 bleeding events was lower in the indobufen-based DAPT group compared to the conventional DAPT group (2.97% vs 4.71%, HR 0.63, 95%CI 0.46 to 0.85, p=0.002), with main decrease in type 2 bleeding (1.68% vs 3.49%, HR 0.48, 95%CI 0.33 to 0.70, p

Studio, più vantaggi per uomini (-28%) rispetto donne (-17%)

Circulation, Volume 146, Issue Suppl_1, Page A14796-A14796, November 8, 2022. Backgrounds:Drug-eluting stent (DES) recipients require 6-12-month P2Y12 inhibitor (P2Y12i)-based dual antiplatelet treatment (DAPT) and long-term aspirin mono antiplatelet treatment (MAPT). Given the diversity of contemporary antiplatelet agents, antiplatelet treatment (APT) selection is becoming more complicated in this patient population. Herein, we evaluated 15-year APT trends among DES recipients nationwide.Methods:Nationwide prescription data of 79,654 patients who underwent percutaneous coronary intervention (PCI) using DESs from 2002 to 2018 in Korea were analyzed. APT claim data were collected longitudinally at multiple time-points post-PCI. Fifteen-year longitudinal APT pattern changes were analyzed at 3-year intervals.Results:DAPT (80.7%) was the most preferred initial APT, followed by MAPT (7.8%) at 3 months post-PCI. A substantial number of patients received prolonged DAPT post-PCI (3 years: 41.0%; 10 years: 27.7%). There was a noticeable delay in DAPT-to-MAPT conversion from the mid- to late-2000s; the conversion was similar during the 2010s, occurring most robustly at 12-18 months post-PCI. Clopidogrel had long and increasingly been used for long-term MAPT, surpassing aspirin from 2013-2015. Recent increases in newer P2Y12i (mostly ticagrelor) prescription were noted. However, P2Y12i use was still low (2013-2018: 25.8%) and peaked immediately post-PCI. The patients treated with newer P2Y12is were more likely younger men and presented with acute myocardial infarction, suggesting that physician-directed newer P2Y12i use remained limited to patients with low bleeding risks.Conclusions:Real-world APT is evolving, however guideline-practice gaps exist. Newer drugs were replacing the older ones, even challenging role of aspirin as chronic maintenance monotherapy. Further studies exploring the impact of diverse APT strategies on patient outcomes are expected to provide insights into optimal APT that can sophisticatedly balance the ischemic and bleeding risks.

Circulation, Volume 146, Issue Suppl_1, Page A11766-A11766, November 8, 2022. Background:While longer stent length of first-generation drug-eluting stents (DES) has been associated with stent-related adverse events, the association between stent length of new-generation DES and clinical outcomes remains controversial.Methods and Results:Consecutive 1403 patients including 2277 lesions who underwent intracoronary imaging-guided percutaneous coronary intervention with 2nd- and 3rd-generation DES were enrolled. Patients were divided into two groups according to total stent length (TSL), and followed up for major adverse cardiovascular events (MACE), defined as a composite of cardiac death, non-fatal myocardial infarction and target lesion revascularization (TLR) for patients. Lesions were divided into two groups according to TSL as well, and followed up for TLR and stent thrombosis. In the per patient analysis, long TSL group (TSL ≥ 32 mm, n = 703) had higher prevalence of diabetes (54.5% vs. 45.2%, P &lt 0.001), anemia (48.4% vs. 43.0%, P = 0.042), peripheral artery disease (&lt% vs. 10.6%, P = 0.003), multi-vessel disease (64.7% vs. 36.2%, P &lt 0.001) and chronic total occlusion (9.5% vs 3.4%, P 0.001) than short TSL group (TSL &lt 32 mm, n = 691). In the follow up period (mean of 1528 days), MACE and TLR were significantly higher in long TSL group than in short TSL group (P = 0.009 and P = 0.037, respectively). In the multivariate analysis after adjusting for confounding factors, the long TSL was an independent predictor of MACE and TLR (hazard ratio [HR] 1.59, P = 0.002 and HR 1.74, P = 0.047). In the per lesion analysis, Kaplan-Meier curve revealed that TLR was significantly higher in long TSL group (TSL ≥ 26 mm, n = 1160) than short TSL group (TSL < 26mm, n = 1117) (P = 0.017), while stent thrombosis was comparable between the two groups. In the multivariate analysis, TLR was an independent predictor of TLR (HR 1.62, P = 0.029).Conclusion:Longer stent length of new-generation DES was associated with MACE and TLR, but not with stent thrombosis.

Circulation, Volume 146, Issue Suppl_1, Page A9613-A9613, November 8, 2022. Introduction:Arterial dissection or rupture during percutaneous angioplasty is rare but can be lethal. We invented a balloon-expandable stent with a very thin membrane typed biodegradable graft for the treatment of arterial dissection (BioGard).Hypothesis:The efficacy and safety of BioGard were evaluated in the rabbit iliac artery rupture model. The devices would be helpful to seal the emergent blood extravasation due to arterial perforation and reduce unfavorable vascular events in long-term follow-up.Method:Twenty iliac arterial dissections by balloon over-inflation were induced under the guidance of angiography. Twelve rabbits with huge contrast extravasation to retroperitoneal space (Ellis type 3) were treated using BioGards. Serial histologic examinations and micro-computed tomography (CT) were performed at 1, 2, and 8 weeks and 3, 6, 9, and 12 months. Final angiography at 1 year was performed to evaluate any vascular complication.Results:There are no significant adverse cardiovascular events after one year of BioGard implantation. Micro-CT and follow-up angiography at one year revealed no case of significant in-stent restenosis and thrombotic occlusion in vivo. Early-stage histologic examination demonstrated that disrupted vessels were completely sealed up by BioGard with mural hematoma, inflammatory cell infiltration, and red thrombi. Mid- and long-term histologic examination revealed patent stents and neointimal coverage over the stents with biodegraded graft material and mild peri-strut area inflammatory response.Conclusions:Twelve months post-BioGard implantation in rabbit iliac artery dissections demonstrated good efficacy and safety. BioGard at a severely dissected artery would be an option for preventing lethal vascular events. Further clinical evaluation of this novel technology would be warranted.

Circulation, Volume 146, Issue Suppl_1, Page A14591-A14591, November 8, 2022. Introduction:The risk of coronary thrombosis after percutaneous coronary intervention (PCI) is high in the absence of neointima formation on coronary artery stents, evaluated by coronary angioscopy, and high whole blood platelet aggregation.Hypothesis:For high risk patients, despite dual antiplatelet therapy, coronary angioscopy should be used to check for neointima formation and/or whole platelet aggregation measured.Methods:This is a retrospective analysis of 2757 stents from 2757 patients (2024 male, mean 71±10 years) who underwent coronary angioscopy (timing determined by physicians) 3-12 months after PCI. The whole blood platelet aggregatory threshold index (PATI; WBA-Neo, ISK, Osaka, Japan) was calculated. For coronary angioscopy, we categorized neointima formation on stents: Grade 0) no neointima; 1) strut surrounded by neointima but not completely buried; 2) strut completely buried by neointima but still observable through neointima; 3) strut completely buried by neointima and not observable. PATI (μM) measured the minimum concentration of adenosine 5′-diphosphate causing non-reversible platelet aggregation and indicated platelet aggregation (range 0-8). The higher the PATI, the lower the platelet aggregation.Results:On coronary angioscopy, 689, 1341, 543, and 144 stents were Grade 0, 1, 2, and 3, respectively. The 689 stents in Grade 0 from 689 patients consisted of 207 (of 824=25%) Xience, 189 (of 579=33%) Combo, 117 (of 583=20%) Synergy, 91 (of 382=24%) Ultimaster, 26 (of 118=22%) BMX-J, 23 (of 94=24%) Orsiro, 18 (of 108=17%) Resolute, 3/10 (30%) NOBORI, and 1/6 MULTI LINK8 stents. Of 689 patients with Grade 0 stents, 14 had PATI 8.00 (low platelet aggregation). Of 14 patients with Grade 0 stents and PATI

Circulation, Volume 146, Issue Suppl_1, Page A10054-A10054, November 8, 2022. Introduction:Evaluation of in-stent-restenosis (ISR), especially of small stents, remains a challenge for computed tomography (CT) angiography.Hypothesis:To quantitatively define stent strut thickness and lumen vessel diameter at the stent site by deep learning reconstruction and compare this with conventional reconstruction strategies.Methods:We employed ultra-high-resolution CT (URCT) data to train a super resolution neural network (Precise IQ engine, or PIQE) and apply the network to current standard resolution CT (Forward projected model-based Iterative Reconstruction SoluTion, FIRST). We examined 166 stents in 85 consecutive patients who underwent CT and invasive coronary angiography (ICA) within three months of each other from 2019-2021 after percutaneous coronary intervention with coronary stent placement. The diagnostic accuracy for the presence of ISR was defined as percent diameter stenosis > 50% on ICA. All images were reconstructed with PIQE and FIRST and assessed by two blinded cardiovascular imagers.Results:Compared to FIRST, the full width at half maximum of the lumen was larger, and that of the strut was smaller in PIQE. Image quality score was significantly better in PIQE than in FIRST (4.2±1.1 vs. 2.7±1.2, P