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

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 A12805-A12805, November 8, 2022. Introduction:High-bleeding risk (HBR) patients undergoing percutaneous coronary intervention (PCI) are often at high risk for thrombotic complications following coronary stenting. We sought to evaluate the frequency and predictors of myocardial infarction (MI) or stent thrombosis (ST) events in HBR patients at 1 year after PCI.Methods:We included HBR patients undergoing PCI with drug-eluting stent implantation at a tertiary-care center, between 2012 and 2019. HBR status was defined as the presence of ≥1 major or ≥2 minor Academic Research Consortium-HBR criteria. Clinical and angiographic baseline characteristics were analyzed after stratifying patients by the occurrence of MI/ST. Independent predictors of MI/ST at 1-year follow-up were assessed using Cox multivariate regression analysis.Results:Among 7,806 HBR patients undergoing PCI, 245 (3.1%) experienced MI/ST within one year of the index procedure. These patients were more frequently female (42.6% vs. 35.7%, p=0.03), had a higher prevalence of insulin-dependent diabetes mellitus (62.3% vs. 40.5%, p

Circulation, Volume 146, Issue Suppl_1, Page A12175-A12175, November 8, 2022. Endovascular venous stenting has become a more favorable intervention for occlusive, symptomatic deep vein thromboses (DVTs), especially given its decreased complication rate and shorter recovery time than its predecessor, open venous bypass. Risks, however, still exist and can include stent fragmentation and dislodgement causing cardiopulmonary complications. A 57-year-old man with bilateral lower extremity DVTs status post left external ilio-femoral stent and inferior vena cava (IVC) filter placement presented with one month of atypical chest discomfort. CT chest showed migration of his 40cm iliac stent to the IVC and right atrium. Interventional radiology visualized both a patent stent and IVC, however, attempted endovascular removal from the distal margin failed with initial retrieval of fragments only. Other fragments subsequently embolized to the pulmonary and lower lobe arteries and right ventricles. Extraction of more distal fragments was deferred due to risks of structural damage, arrhythmias, and pulmonary vasculature perforation. Fragment analysis by pathology demonstrated evidence of clot, yet cardiothoracic surgical intervention was deferred.The patient continued to experience chest pain and underwent a repeat CT chest three months later that demonstrated the stent extending from the right atrial junction to the infrahepatic IVC. Fragmented portions of the filter in the right ventricle and multiple stent fragments retained in the right upper and bilateral lower pulmonary lobes remained as prior with no evidence of pulmonary embolism (PE), pericardial effusion, or tamponade. Although rare, stent removal complications can occur with increased risk of long-term sequelae. Stent fracturing and dislodgement can result in foreign bodies showering the pulmonary vasculature and cardiac chambers, ultimately placing patients at risk for arterial perforation or dissection, pulmonary hemorrhage, intracardiac damage, tamponade, PE, and chronic thromboembolic pulmonary hypertension (CTEPH). The consideration of such risks, in addition to early involvement of interdisciplinary teams and thorough risk-benefit discussions between patients and providers are essential when undergoing stent removal and related interventions.

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 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 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

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 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 A10434-A10434, November 8, 2022. A 77-year-old man complained of intractable rest pain in his left leg, which occurred one week before hospital admission. His past medical history included diabetes mellitus and history of smoking. He was prescribed cilostazol for treatment of peripheral vascular disease. He underwent endovascular therapy (EVT) 15-years earlier with a bare nitinol stent (BNS) implantation in his left superficial femoral artery (SFA), and no restenosis was detected by annual duplex ultrasound (DUS) follow-up until this session. DUS observed restenosis with 14.8 peak systolic velocity ratio, and initial angiography (Panel A, white arrow) revealed subtotal occlusion at the stented lesion. Intravascular angioscopy (Panel C) demonstrated disrupted cavity with red thrombus attached. Optical frequency domain imaging (OFDI) (Panel D) and intravascular ultrasound (IVUS) (Panel E) demonstrated fibrous cap disruption with a clear cavity formed inside the plaque (6 to 11 o’clock in Panel D and E), as well as thin sheet calcification. The other side (11 to 6 o’clock) shows a signal rich region with high attenuation that indicates fibroatheroma. The lesion was diagnosed as very late stent thrombosis (VLST) because multimodality images revealed rupture of in-stent neoatherosclerosis with red thrombus attached. After successful vessel preparation with a high-pressure 6mm balloon, 6 mm drug-coated balloons were used. The completion angiogram revealed an acceptable result with neither residual stenosis nor flow-limiting dissection (Panel B). Neoatherosclerosis has been reported as one of the major causes of VLST in the coronary arteries; however, it has rarely been reported in the peripheral arteries. This case illustrates valuable direct visualization with multimodality imaging of a case with VLST caused by rupture of in-stent neoatherosclerosis 15-years after BNS implantation, and the value of multimodality imaging for comprehensive evaluation to diagnose the mechanism of VLST in SFA.

Circulation, Volume 146, Issue Suppl_1, Page A14141-A14141, November 8, 2022. Introduction:Endothelial dysfunction is related with in-stent restenosis (ISR) of prior drug-eluting stents (DES) implanted more than 1 year ago (late ISR). EndoPAT is a novel non-invasive test quantifying endothelial function as reactive hyperemia peripheral arterial tonometry index (RHI).Hypothesis:EndoPAT is a potential predicting test for late ISR.Methods:We conducted a case control study on 186 patients with coronary DES implanted more than 1 year ago in a single medical center. Those who had contraindications to EndoPAT test, acute myocardial infarction, coronary artery bypass graft (CABG), chronic kidney disease (CKD) stage III and above, active infection and rheumatologic disease or acute decompensated heart failure were excluded. Patients were divided into ISR and non-ISR group based on coronary angiography. EndoPAT test was done at 24 to 48 hours prior to catherization. LnRHI is an index after natural log transformation of RHI. A receiver operative characteristic (ROC) curve analysis was used to determine the sensitivity and specificity of LnRHI for predicting late ISR.Results:ISR group had significantly more patients with history of ISR or triple-vessel disease, longer stent length and fewer totally occlusive lesions than non-ISR group. LnRHI was significantly lower in ISR group than in non-ISR group (0.66 vs 0.50, p

Circulation, Volume 146, Issue Suppl_1, Page A11248-A11248, November 8, 2022. Introduction:Patients with acute coronary syndromes (ACS) are known to have a higher risk of target vessel revascularization after percutaneous coronary intervention (PCI) and worse long-term prognosis than patients with stable angina. Neoatherosclerosis is one of the significant factors at very late stent thrombosis. And the presence of in-stent neoatherosclerosis is independently associated with major adverse cardiac event. Although many studies have been reported on neoatherosclerosis, few have been reported on short-term in-stent neoatherosclerosis. Moreover, none have evaluated the impact of ACS. We investigated the impact of ACS on in-stent neoatheroscrelosis using Optical Coherence Tomography (OCT) in the present study.Methods:From March 2017 to November 2020, we investigated 102 patients (122 lesions) who had undergone PCI using drug eluting stent during that period and were followed up for OCT within one year. Subjects were categorized as ACS or non-ACS according to clinical findings at the time of target lesion intervention. We used OCT to investigate the presence of early in-stent neoatherosclerosis.Result:ACS group consisted of 21 (20.6%). In patients with ACS, women tended to be more common (38% vs 19%,P=0.0777). There were no differences in age or presence of diabetes or dyslipidemia during treatment. There were also no significant differences in LDL-C levels at the time of PCI (88 (73-114) mg/dL vs 100 (85-124) mg/dL,P=0.319) and when observed by OCT (67 (55-81) mg/dL vs 68 (57-89) mg/dL,P=0.622). The ACS group was significantly more likely to have a previous history of ACS (38% vs 12%,P=0.0104). Stent length was significantly shorter in ACS patients (24 (18-28) mm vs 32 (23-38) mm,P=0.0365). The mean dulation from PCI was 292 days. In-stent neoatherosclerosis was more frequent in the ACS group (31.8 % vs 9.9 %,P=0.014).Conclusion:This observational study using OCT indicates that stenting for ACS lesion is associated with early in-stent neoatherosclerosis.