Advances in Clinical Cardiology 2020: A Summary of Key Clinical Trials

Kearney, Aileen; Linden, Katie; Savage, Patrick; Menown, Ian

doi:10.1007/s12325-021-01711-z

Cited by 7 publications

(3 citation statements)

References 100 publications

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“…Furthermore, the single-arm design precludes a direct comparison to other DES. Nevertheless, these first 36-month outcomes of this innovative device are relevant and the trial was listed in the Advances in Clinical Cardiology Summary of Key Clinical Trials [ 25 ]. Several trials are currently ongoing to assess the device in larger patient populations with more complex lesions, and to compare it against contemporary DES in randomized settings.…”

Section: Discussionmentioning

confidence: 99%

Final 36-Month Outcomes from the Multicenter DynamX Study Evaluating a Novel Thin-Strut Novolimus-Eluting Coronary Bioadaptor System and Supporting Preclinical Data

Verheye¹,

Vrolix²,

Montorfano³

et al. 2023

Rev. Cardiovasc. Med.

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Background: The DynamX Novolimus-Eluting Coronary Bioadaptor System ( Bioadaptor) has uncaging elements that disengage after the resorption of the polymer coating, aiming to restore vessel function in the treated segment and to avoid long-term adverse outcomes associated with the permanent caging of the coronary artery seen with conventional stenting. Methods: This prospective, multicenter, single-arm first-in-human study enrolled 50 patients in Belgium and Italy who were treated with the DynamX Bioadaptor. Eligible patients had de novo lesions in coronary arteries measuring between 2.5 and 3.5 mm in diameter and 24 mm in length. Clinical follow-up was performed up to 36 months. This analysis includes the intention-to-treat population and is based on data available. The preclinical studies include optical coherence tomography (OCT) analyses of 5 DynamX Bioadaptors implanted in 3 mini Yucatan pigs (at 3, 12 and 24 months), and assessment of smooth muscle cell gene expression profile in 8 pigs of which each was implanted with the DynamX Bioadaptor and the Xience drug-eluting stent. To assess the gene expression profile by quantitative real-time polymerase chain reaction, animals were sacrificed at 3, 6, 9 and 12 months. Results: Target lesion failure at 36 months was 8.7% (4/46), consisting of one clinically-driven target lesion revascularization and 3 cardiac deaths (all site-reported to be unrelated to the device or procedure). There were no additional target vessel revascularization and no definite or probable scaffold thrombosis. Preclinical data confirmed late lumen enlargement (from 7.02 1.31 at baseline to 8.46 1.31 at 24 months) and identified an increased expression of contractile genes around 9 months compared to a conventional drug-eluting stent. Conclusions: The DynamX Bioadaptor demonstrated very good 36-month clinical outcomes, highlighted by the absence of target-vessel myocardial infarction and definite or probable device thrombosis, and only one target lesion revascularization up to 36 months. These data are supported by preclinical studies that showed late lumen enlargement by OCT and an increased expression of contractile genes around 9 months compared to conventional drug-eluting stents, indicating faster vessel healing. Larger clinical studies are necessary to compare outcomes against contemporary drug-eluting stents. Clinical Trial Registration: : NCT03429894.

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Section: Discussionmentioning

confidence: 99%

Final 36-Month Outcomes from the Multicenter DynamX Study Evaluating a Novel Thin-Strut Novolimus-Eluting Coronary Bioadaptor System and Supporting Preclinical Data

Verheye¹,

Vrolix²,

Montorfano³

et al. 2023

Rev. Cardiovasc. Med.

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“…Thus, vascular inflammation is considered to have a central role in the pathophysiology of atherosclerosis and colchicine , due to its anti-inflammatory properties, has been shown to be beneficial in secondary prevention (AKODAD et al, 2020;KEARNEY et al, 2021).…”

Section: Colchicine In the Vascular Inflammatory Processmentioning

confidence: 99%

Colchicine in atherosclerotic coronary artery disease: new challenges for an old drug

Girardi¹,

Couto²

2022

JHS

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The aim of this review was to summarize current data that support the efficacy and safety of colchicine therapy in atherosclerotic cardiovascular disease. Vascular inflammation plays a central role in coronary atherosclerosis, and the antiinflammatory action of colchicine in low doses (0.5 mg per day) has a recognized effect on reducing ischemic events. We conducted a bibliographic review that included free access publications from the PubMed platform, using the descriptors "colchicine" and "coronary disease". There were included metaanalysis studies, randomized controlled trials, reviews and systematic reviews between 2018 and 2022. Colchicine has important actions in the interruption of cellular inflammatory activities, as it binds to free tubulin dimers, preventing elongation of the microtubule, and interferes with intracellular protein trafficking, secretion, and ionic organization of homeostasis. It also impairs neutrophils recruitment, inhibits nuclear factor-kappa B (NF-κ B) signaling and affects inflammatory receptor protein 3 (NLPR3) activation, leading to the suppression of interleukins 1 β , 18 and 6 release. Gastrointestinal intolerance limits its use in 10% of patients approximately. Attention is needed for drug interactions with CYP3A4 and p-glycoprotein inhibitors/competitors. Its use in acute and chronic coronary syndromes and in coronary angioplasty procedures have been studied in several trials, showing promising results. However, an increase in cases of non-cardiovascular death in patients treated with colchicine was observed in a metaanalysis study, in comparison with placebo or standard therapy. Thus, it is imperative to identify those who will adapt or be harmed by colchicine treatment. In conclusion, coronary arteriopathy is the leading cause of mortality in the world, it justifies the research of lowcost agents that can minimize the impact of this pathology.

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“…Currently, the diabetic population is becoming younger, and the International Diabetes Federation has reported that the total number of people with diabetes is expected to reach 642 million by 2040 [ 1 , 2 ]. Hyperglycemia, the underlying cause, not only aggravates the debilitating illness, but is one of the significant risk factors for increasing cardiovascular, renal or retinal complications [ 3 , 4 , 5 ]. Diabetic patients are likely to develop cardiovascular complications, which contributes to the high morbidity and mortality associated with the disease.…”

Section: Introductionmentioning

confidence: 99%

Puerarin-V Improve Mitochondrial Respiration and Cardiac Function in a Rat Model of Diabetic Cardiomyopathy via Inhibiting Pyroptosis Pathway through P2X7 Receptors

Sun

Dawuti

Gong

et al. 2022

IJMS

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There is a new form of puerarin, puerarin-V, that has recently been developed, and it is unclear whether puerarin-V has a cardioprotective effect on diabetic cardiomyopathy (DCM). Here, we determined whether puerarin-V had any beneficial influence on the pathophysiology of DCM and explored its possible mechanisms. By injecting 30 mg/kg of STZ intraperitoneally, diabetes was induced in rats. After a week of stability, the rats were injected subcutaneously with ISO (5 mg/kg). We randomly assigned the rats to eight groups: (1) control; (2) model; (3) metformin; (4–6) puerarin-V at different doses; (7) puerarin (API); (8) puerarin injection. DCM rats were found to have severe cardiac insufficiency (arrythmia, decreased LVdP/dt, and increased E/A ratio). In addition, cardiac injury biomarkers (cTn-T, NT-proBNP, AST, LDH, and CK-MB), inflammatory cytokines (IL-1β, IL-18, IL-6, and TNF-α), and oxidative damage markers (MDA, SOD and GSH) were markedly increased. Treatment with puerarin-V positively adjusts these parameters mentioned above by improving cardiac function and mitochondrial respiration, suppressing myocardial inflammation, and maintaining the structural integrity of the cardiac muscle. Moreover, treatment with puerarin-V inhibits the P2X7 receptor-mediated pyroptosis pathway that was upregulated in diabetic hearts. Given these results, the current study lends credence to the idea that puerarin-V can reduce myocardial damage in DCM rats. Furthermore, it was found that the effect of puerarin-V in diabetic cardiomyopathy is better than the API, the puerarin injection, and metformin. Collectively, our research provides a new therapeutic option for the treatment of DCM in clinic.

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Advances in Clinical Cardiology 2020: A Summary of Key Clinical Trials

Cited by 7 publications

References 100 publications

Final 36-Month Outcomes from the Multicenter DynamX Study Evaluating a Novel Thin-Strut Novolimus-Eluting Coronary Bioadaptor System and Supporting Preclinical Data

Final 36-Month Outcomes from the Multicenter DynamX Study Evaluating a Novel Thin-Strut Novolimus-Eluting Coronary Bioadaptor System and Supporting Preclinical Data

Colchicine in atherosclerotic coronary artery disease: new challenges for an old drug

Puerarin-V Improve Mitochondrial Respiration and Cardiac Function in a Rat Model of Diabetic Cardiomyopathy via Inhibiting Pyroptosis Pathway through P2X7 Receptors

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