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BACKGROUND: Drug-coated balloons (DCB) and drug-eluting stents (DES) represent the currently recommended treatments for in-stent restenosis (ISR). Optical coherence tomography (OCT) allows detailed neointimal characterisation which can guide treatment strategies. AIMS: The aims of this study were first, to assess the relation between neointimal pattern and clinical outcomes following in-stent restenosis (ISR) treatment, and second, to explore a potential interaction between neointimal pattern and treatment modality relative to clinical outcomes. METHODS: Patients undergoing OCT-guided treatment (DCB or DES) of ISR in three European centres were included. Based on the median of distribution of non-homogeneous neointima quadrants, patients were categorised into low and high inhomogeneity groups. RESULTS: A total of 197 patients (low inhomogeneity=100 and high inhomogeneity=97) were included. There were no significant differences in terms of major adverse cardiac events (MACE) (p=0.939) or target lesion revascularisation (TLR) (p=0.732) between the two groups. The exploratory analysis showed a significant interaction between neointimal pattern and treatment modality regarding MACE (pint=0.006) and TLR (pint=0.022). DES showed a significant advantage over DCB in the high (MACE: HR 0.26 [0.10-0.65], p=0.004; TLR: HR 0.28 [0.11-0.69], p=0.006), but not in the low inhomogeneity group (MACE: p=0.917; TLR: p=0.797). CONCLUSIONS: In patients with ISR treated with DCB or DES, there were no significant differences in terms of MACE or TLR between the low and high inhomogeneity groups. A significant interaction was observed between treatment modality and neointimal pattern with an advantage of DES over DCB in the high and no difference in the low inhomogeneity group. This warrants confirmation from prospective dedicated studies.

Objectives The aim of this study was to compare outcomes after transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 Ultra (Ultra) and SAPIEN 3 (S3) transcatheter heart valves (T...

Pancreatic islets possess an autonomous mechanism of blood flow regulation, independent of that of the exocrine pancreas. To study islet vascular regulation without confounding effects of the exocrine blood vessels, we have developed a technique enabling us to isolate single pancreatic islets and then to perfuse them using their endogenous vasculature for distribution of the medium. This made it possible to directly study the vascular reactivity of islet arterioles to different substances. We confirmed that control of islet blood flow is mainly located at the precapillary level. As expected, administration of angiotensin II and l-nitro-arginine methyl ester contracted islet arterioles, whereas nitric oxide and adenosine dilated them. d-glucose, the main insulin secretagogue, had a selective dilating effect on smooth muscle in islet arterioles but not in glomerular afferent arterioles. The response to glucose was amplified in islet arterioles from diabetic animals, indicating enhanced islet blood perfusion in diabetes. This newly developed technique for perfusing isolated pancreatic islets will provide new insights into islet perfusion control and its possible contributions to the pathogenesis of type 2 diabetes.

BACKGROUND: Clinical and angiographic outcomes following recanalisation of coronary chronic total occlusions (CTO) through contemporary dissection and re-entry techniques (DART) as opposed to intraplaque techniques remain controversial. AIMS: The aim of this study was to compare clinical and angiographic outcomes following subintimal and intraplaque CTO recanalisation. METHODS: A total of 454 consecutive patients undergoing successful CTO recanalisation (473 vessels) were included. Intraplaque techniques were used in 403 (85.2%) and DART in 70 (14.8%) vessels. Surveillance angiography was scheduled at 6-9 months and clinical follow-up was performed up to 12 months. RESULTS: There were no significant differences in terms of the cumulative incidence of MACE (p=0.908) or binary restenosis (p=0.320) between the two groups. There was no independent correlation between recanalisation technique and MACE occurrence or in-segment binary restenosis. Target lesion revascularisation (TLR) was performed in 60 (17.5%) and 12 (18.1%) (p=0.719) lesions, respectively. The occurrence of occlusive restenosis was low (7 [2.3%] vs 1 [1.6%]; p=0.824) and comparable between groups. CONCLUSIONS: Contemporary DART are associated with similar midterm clinical and angiographic outcomes compared to intraplaque recanalisation. The rate of occlusive restenosis was low and comparable in both groups. Regardless of recanalisation technique, the overall incidences of binary restenosis and TLR following CTO recanalisation remain higher than those reported for non-CTO PCI.

Background The clinical impact of early aspirin discontinuation compared with dual antiplatelet therapy (DAPT) in patients undergoing percutaneous coronary intervention with stenting remains poorly studied. We investigated the clinical outcomes of patients assigned to either early aspirin discontinuation or DAPT after percutaneous coronary intervention with stenting. Methods and Results We performed a meta‐analysis of aggregate data from randomized clinical trials enrolling participants receiving a percutaneous coronary intervention with stenting and assigned to either early aspirin discontinuation or DAPT. Scientific databases were searched from inception through March 30, 2020. Trial‐level hazard ratios (HRs) and 95% CIs were pooled using a random effects model with inverse variance weighting. The primary outcome was all‐cause death. Secondary outcomes were myocardial infarction, stent thrombosis, stroke, and major bleeding. Overall, 36 206 participants were allocated to either early aspirin discontinuation (experimental therapy, n=18 088) or DAPT (control therapy, n=18 118) in 7 trials. Median follow‐up was 12 months. All‐cause death occurred in 2.5% of patients assigned to experimental and 2.9% of patients assigned control therapy (hazard ratio [HR], 0.91, 95% CI, 0.75–1.11; P =0.37). Overall, patients treated with experimental versus control therapy showed no significant difference in terms of myocardial infarction (HR, 1.02 [0.85–1.22], P =0.81), stent thrombosis (HR, 1.02 [0.87–1.20], P =0.83), or stroke (HR, 1.01 [0.68–1.49], P =0.96). However, the risk for major bleeding (HR, 0.58 [0.43–0.77], P Conclusions In patients treated with percutaneous coronary intervention and stenting, assigned to a strategy of early aspirin discontinuation versus DAPT, the risk of death and ischemic events is not significantly different but the risk of bleeding is lower.

Aims To investigate the clinical outcomes associated with an antithrombotic therapy with or without clopidogrel after transcatheter aortic valve replacement (TAVR). Methods and results This is a study-level meta-analysis including all randomized trials investigating antithrombotic regimens after TAVR. The protocol was registered with PROSPERO (CRD42020191036). We searched electronic scientific databases for eligible studies. The primary outcome was all-cause death. Main secondary outcome was major bleeding. Other outcomes were life-threatening (or disabling) bleeding, myocardial infarction (MI) and stroke. Six eligible trials randomly allocated 3056 TAVR patients to aspirin or oral anticoagulation (OAC) with clopidogrel (n = 1525) versus aspirin and/or OAC without clopidogrel (n = 1531). In the overall estimates, an antithrombotic therapy with clopidogrel versus without displayed a comparable risk of all-cause death [Risk Ratio—RR = 0.83, 95% Confidence intervals—CI (0.57–1.20); P = 0.25] and major bleeding [RR = 1.33, 95% CI (0.61–2.92); P = 0.39]. However, the combination of aspirin or OAC with clopidogrel doubled the risk of major bleeding as compared to aspirin or OAC without clopidogrel [RR = 2.08, 95% CI (1.27–3.42); P = 0.015, P for interaction = 0.021]. Treatment strategies did not differ with respect to the risk of life-threatening bleeding, MI and stroke. Conclusions In patients receiving TAVR, a therapeutic strategy of aspirin or OAC with clopidogrel significantly increases the risk of major bleeding without impact on mortality and ischemic outcomes compared to aspirin or OAC without clopidogrel. The performance of different antithrombotic regimens in terms of long-term clinical outcomes and bioprosthesis valve function requires further investigation. Graphic abstract Forest plots from pairwise and network meta-analyses associated with an antithrombotic therapy with or without clopidogrel Risk ratio for all outcomes of interest calculated with the pairwise meta-analysis (left side) and for main outcomes calculated with the network meta-analysis (right side) in patients allocated to an antithrombotic therapy with clopidogrel or without. The diamonds indicate the point estimate and the left and the right ends of the lines the [95% CI]. CI: Confidence intervals; OAC; oral anticoagulation.

In patients with acute myocardial infarction (MI) receiving percutaneous coronary intervention (PCI), the role of systemic therapeutic hypothermia remains controversial. We sought to investigate the role of systemic therapeutic hypothermia versus standard of care in patients with acute MI treated with PCI. This is a study-level meta-analysis of randomized trials. The primary outcome was all-cause death. The main secondary outcome was infarct size. Other secondary outcomes were recurrent MI, ischemia-driven target vessel revascularization (TVR), major adverse cardiovascular events, and bleeding. A total of 1012 patients with acute MI receiving a PCI in nine trials (503 randomly assigned to hypothermia and 509 to control) were available for the quantitative synthesis. The weighted median follow-up was 30 days. As compared to controls, patients assigned to hypothermia had similar risk of all-cause death (risk ratio, [95% confidence intervals], 1.25 [0.80; 1.95], p = 0.32), with a trend toward higher risk of ischemia-driven TVR (3.55 [0.80; 15.87], p = 0.09) mostly due to acute or subacute stent thrombosis. Although in the overall cohort, infarct size was comparable between groups (standardized mean difference [95% Confidence intervals], 0.06 [− 0.92; 1.04], p = 0.92), patients effectively achieving the protocol-defined target temperature in the hypothermia group had smaller infarct size as compared to controls (p for interaction = 0.016). Treatment strategies did not differ with respect to the other outcomes. As compared to standard of care, systemic therapeutic hypothermia in acute MI patients treated with PCI provided similar mortality with a signal toward more frequent repeat revascularization. Among patients assigned to hypothermia, those effectively achieving the protocol-defined target temperature displayed smaller infarct size. PROSPERO, CRD42019138754.

Aims The ultrathin-strut biodegradable polymer sirolimus-eluting stent (SES) is a new-generation drug-eluting stent (DES) developed to improve the percutaneous treatment of patients with coronary artery disease. Here, we sought to investigate whether the performance of the ultrathin-strut biodegradable polymer SES is superior to that of the benchmark thin-strut fluoropolymer-based everolimus-eluting stent (EES). Methods and results We undertook a study-level meta-analysis of trials in which patients receiving percutaneous coronary intervention (PCI) were randomly assigned to either SES or EES. Primary efficacy and safety outcomes were target lesion revascularisation (TLR) and definite/probable stent thrombosis (ST), respectively. Secondary outcomes were myocardial infarction (MI), death, target lesion failure (TLF) and target vessel failure (TVF). A total of 4,853 patients received a PCI with either SES (n=2,816) or EES (n=2,037) in six trials. After a weighted median follow-up of 12 months, patients treated with SES had a risk of TLR (odds ratio [95% confidence interval]: 1.24 [0.83-1.85], p=0.30), definite/probable ST (0.84 [0.53-1.33], p=0.45) and MI related to the target vessel (0.77 [0.55-1.07], p=0.12) comparable to that of patients treated with EES. We found no significant difference with regard to other secondary outcomes. Conclusions At one-year follow-up, the ultrathin-strut biodegradable polymer sirolimus-eluting stent displays a performance comparable to that of the fluoropolymer-based everolimus-eluting stent.

An 80-year-old woman on oral anticoagulation therapy, with previous mitral valve reconstruction, subsequent coronary artery bypass grafting with aortic and mitral valve (29-mm Mosaic, Medtronic, Dublin, Ireland) replacement, and 10 years later, transcatheter mitral valve replacement (TMVR) with a 26

Neointimal infiltration with foamy macrophages is recognized as an early and important sign of de-novo atherosclerosis after stent implantation (neoatherosclerosis). Recent histopathological studies have proven that automated quantification of signal attenuation using intravascular optical coherence tomography (OCT) imaging allows for sensitive identification of macrophages in native atherosclerotic disease. Whether this is true for neointimal foam cells in the setting of neoatherosclerosis remains unknown. Autopsy samples of stented coronary arteries (n = 13 cases) were evaluated by histology and OCT. After co-registration with histology, the attenuation rate of emitted laser light was measured in regions with and without neointimal foamy macrophages relative to its peak intensity at the blood-tissue interface. Attenuation index was subsequently determined as slope of a regression curve fitted to individual data points. Receiver operating curve (ROC) analysis was used to establish an optimal cut-off for detecting foamy macrophages in homogenous and non-homogenous neointima, respectively. Finally, the tissue attenuation index was applied to confirm or exclude the presence of neointimal foamy macrophages in symptomatic patients presenting with in-stent restenosis and undergoing intravascular OCT imaging (n = 29 cases). Tissue attenuation index derived from post-mortem samples differed significantly between histologically confirmed regions with and without neointimal foamy macrophages (− 1.23 ± 1.42 vs. − 0.52 ± 1.79, p

Neoatherosclerosis is defined as foamy macrophage infiltration into the peri-strut or neointimal area after stent implantation, potentially leading to late stent failure through progressive atherosclerotic changes including calcification, fibroatheroma, thin-cap fibroatheroma, and rupture with stent thrombosis (ST) in advanced stages. Human autopsy as well as intravascular imaging studies have led to the understanding of neoatherosclerosis formation as a similar but significantly accelerated pathophysiology as compared to native atherosclerosis. This acceleration is mainly based on disrupted endothelial integrity with insufficient barrier function and augmented transmigration of lipids following vascular injury after coronary intervention and especially after implantation of drug-eluting stents. In this review, we summarize translational insights into disease pathophysiology and discuss therapeutic approaches to tackle this novel disease entity. We introduce a novel animal model of neoatherosclerosis alongside accompanyingLa neoateroesclerosis se define como infiltración de macrófagos espumosos en la zona periprotésica o de la neoíntima tras una implantación de stent, lo cual posiblemente derive en un fracaso tardío del stent mediante cambios ateroescleróticos progresivos, incluidos la calcificación, fibroateromas, fibroateromas de cápsula fina (FACF) y trombosis del stent (TS). Gracias a los estudios de autopsia humana y de imagen intravascular se ha podido comprender la formación de la neoateroesclerosis de una manera fisiopatológica similar a la ateroesclerosis nativa pero significativamente acelerada. Esta aceleración se basa principalmente en la alteración de la integridad endotelial con una función de barrera insuficiente y una mayor transmigración de lípidos a consecuencia de una lesión vascular tras una intervención coronaria y, especialmente, tras la implantación de stents farmacoactivos. En este artículo ofrecemos un resumen de las perspectivas translacionales sobre la fisiopatología de la enfermedad y analizamos los enfoques terapéuticos para abordar esta nueva enfermedad. Presentamos un modelo animal de neoateroesclerosis innovador junto con experimentos新动脉粥样硬化被定义为支架植入后泡沫巨噬细胞浸润到支柱周围或新内膜区域, 可能引起进行性动脉粥样硬化改变（包括钙化、纤维状动脉瘤、薄型纤维状动脉粥样硬化 (TCFA)）和晚期阶段的支架血栓破裂 (ST) 破裂而导致晚期支架衰竭。人体解剖以及血管内影像学研究使人们对新动脉粥样硬化的形成更为了解, 新动脉粥样硬化的形成与自然动脉粥样硬化相似, 但病理生理过程显著加快。这种加快主要是由于在冠状动脉介入治疗后, 尤其是在植入药物洗脱支架后, 发生血管损伤, 内皮功能完整性受损, 伴屏障功能不足及脂质转运增加。在这篇综述中, 我们总结了对疾病病理生理学的转化见解, 并讨论了解决这种新型疾病的治疗方法。我们引入了新的动脉粥样硬化动物模型并伴随了体外实验, 该实验显示内皮完整性受损导致 LDL-胆固醇 (LDL) 的通透性增加, 从而导致人单核细胞发生泡沫细胞转化。此外, 我们讨论了新颖的血管内影像替代物, 以期改善早期新动脉粥样硬化的可靠诊断。最后, 使用可吸收镁支架 (BRS) 和全身他汀类药物治疗以预防支架内新动脉粥样硬化的治疗方法证明了改善动脉愈合和血管内皮化的潜力, 从而使新动脉粥样硬化动物模型中新动脉粥样硬化的形成明显减轻。.

Resumen Introduccion y objetivos Esta por clarificar el valor pronostico de la troponina T de alta sensibilidad tras una intervencion coronaria percutanea en pacientes con enfermedad coronaria estable. Esta cuestion clinicamente relevante se ha investigado en 3.463 pacientes consecutivos a los que se practico una intervencion coronaria percutanea. Metodos En este estudio se incluyo a pacientes con enfermedad coronaria estable y un valor basal de troponina T de alta sensibilidad menor que el limite superior de referencia del percentil 99 (0,014 μg/l). Se determino la troponina T de alta sensibilidad antes de la intervencion y luego al cabo de 6, 12 y 24 h. El objetivo principal fue la mortalidad por cualquier causa. Resultados Se clasifico a los pacientes en un grupo con un valor maximo de troponina T tras la intervencion ≤ percentil 99 (n = 742), un grupo con un valor maximo de troponina T tras la intervencion entre > percentil 99 y 5 veces el percentil 99 (n = 1.928) y un grupo con un valor maximo de troponina T tras la intervencion > 5 veces el percentil 99 (n = 793). La edad avanzada, el indice de masa corporal mas bajo, el valor de troponina basal, las lesiones complejas, las lesiones en bifurcacion y la longitud del stent se asociaron de manera independiente a concentraciones de troponina T aumentadas despues de la intervencion. La mediana de seguimiento fue de 15,5 meses. Hubo 56 muertes: 5 pacientes (1,7%) con valor maximo de troponina T tras la intervencion ≤ percentil 99, 35 (4,5%) con valor maximo de troponina T tras la intervencion entre > percentil 99 y 5 veces el percentil 99, y 16 (4,3%) del grupo con valor maximo de troponina T tras la intervencion > 5 veces el percentil 99 (hazard ratio = 1,50; intervalo de confianza del 95%, 1,01-2,25; p = 0,047). Tras el ajuste, el valor maximo de troponina T tras el procedimiento no mostro asociacion independiente con la mortalidad tras la intervencion coronaria percutanea (p = 0,094). Conclusiones En los pacientes con enfermedad coronaria estable y sin elevacion basal de la troponina T de alta sensibilidad, la elevacion de esta despues de una intervencion coronaria percutanea no se asocio a mayor mortalidad tras el procedimiento.

Patients experiencing out-of-hospital cardiac arrest (OHCA) without ST-segment elevation are a heterogenic group with a variety of underlying causes. Up to one-third of patients display a significant coronary lesion compatible with myocardial infarction as OHCA trigger. There are no randomized data on patient selection and timing of invasive coronary angiography after admission. METHODS AND RESULTS: The TOMAHAWK trial randomly assigns 558 patients with return of spontaneous circulation after OHCA with no obvious extracardiac origin of cardiac arrest and no ST-segment elevation/left bundle-branch block on postresuscitation electrocardiogram to either immediate coronary angiography or initial intensive care assessment with delayed/selective angiography in a 1:1 ratio. The primary end point is 30-day all-cause mortality. Secondary analyses will be performed with respect to initial rhythm, electrocardiographic patterns, myocardial infarction as underlying cause, neurological outcome, as well as clinical and laboratory markers. Clinical follow-up will be performed at 6 and 12 months. Safety end points include bleeding and stroke. CONCLUSION: The TOMAHAWK trial will address the unresolved issue of timing and general indication of angiography after OHCA without ST-segment elevation.

We aimed to assess the association between arterial hypertension and bleeding in patients undergoing percutaneous coronary intervention (PCI).The impact of arterial hypertension on bleeding risk of patients with coronary artery disease undergoing PCI is unknown.This study included 14,180 patients who underwent PCI. Bleeding was defined using the Bleeding Academic Research Consortium (BARC) criteria. Arterial hypertension was defined as treatment with antihypertensive drugs or a systolic blood pressure>140 mm Hg and/or diastolic blood pressure value>90 mm Hg documented on at least 2 occasions. The primary outcome was bleeding rate within 30 days of PCI.Overall, 11,066 patients (78.0%) had arterial hypertension. Bleeding events occurred in 1,232 patients with arterial hypertension and 278 patients without arterial hypertension (11.1% vs 8.9%; odds ratio [OR] = 1.28, 95% confidence interval [CI] 1.11-1.46, P< 0.001). Access-site bleeding occurred in 730 patients with arterial hypertension and 175 patients without arterial hypertension (6.6% vs 5.6%: OR = 1.19 [1.01-1.41], P = 0.049). Non-access-site bleeding occurred in 502 patients with and 103 patients without arterial hypertension (4.5% vs 3.3%; OR = 1.39 [1.12-1.72], P = 0.003). After adjustment, arterial hypertension was significantly associated with any bleeding (adjusted OR = 1.41 [1.19-1.67], P< 0.001), access-site bleeding (adjusted OR = 1.36 [1.10-1.68], P = 0.005) and non-access-site bleeding (adjusted OR = 1.42 [1.09-1.83], P = 0.008). A history of arterial hypertension increased the risk of non-access-site bleeding (P = 0.002), whereas systolic blood pressure at the time of PCI increased the risk of access site bleeding (P = 0.018).Arterial hypertension is associated with increased risk of bleeding during PCI procedures. © 2015 Wiley Periodicals, Inc.

Multislice computed tomography (MSCT) has emerged as the mainstay in patients planned for transcatheter aortic valve implantation (TAVI). Incidental findings (IF) in MSCT are common. However, the exact incidence, clinical relevance and further consequences of IF are unclear and it is controversial whether IF adversely affect patients’ outcome. We analyzed MSCT data of 1050 patients screened for TAVI between January 2011 and December 2014. Median follow-up of patients was 20 months. In total, 3194 IF were identified, which were classified into clinically non-relevant IF (2872, 90%) and clinically relevant IF (322, 10%). In 25% of patients (258/1050) at least one clinically relevant IF was present. Age (80 ± 7 vs. 80 ± 7 years; p = 0.198) and EuroSCORE II (3.6% [2.1–5.7] vs. 3.6% [2.1–5.9]; p = 0.874) was similar between patients with and without a clinically relevant IF. TAVI was performed less frequently in patients with a clinically relevant IF (76% vs. 85%; p