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De-risking primary prevention: role of imaging. 降低初级预防风险:影像学的作用。
IF 2.3 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2021-01-01 DOI: 10.1177/17539447211051248
Ahmed M Shafter, Kashif Shaikh, Amit Johanis, Matthew J Budoff

Atherosclerotic cardiovascular disease (ASCVD) is a common disease among the general population, and includes four major areas: (1) coronary heart disease (CHD), manifested by stable angina, unstable angina, myocardial infarction (MI), heart failure, and coronary death; (2) cerebrovascular disease, manifested by transient ischemia attack and stroke; (3) peripheral vascular disease, manifested by claudication and critical limb ischemia; and (4) aortic atherosclerosis and aortic aneurysm (thoracic and abdominal). CHD remains the leading cause of death for both men and women in the United States. So, it is imperative to identify people at risk of CHD and provide appropriate medical treatment or intervention to prevent serious complications and outcomes including sudden cardiac death. Coronary artery calcification (CAC) is a marker of subclinical coronary artery disease. Therefore, coronary artery calcium score is an important screening method for Coronary artery disease (CAD). In this article, we performed a comprehensive review of current literatures and studies assessing the prognostic value of CAC for future cardiovascular disease (CVD) events. We searched PubMed, MEDLINE, Google Scholar, and Cochrane library. We also reviewed the 2018 American College of Cardiology (ACC)/American Heart Association (AHA) guideline on the assessment of CVD risk. A CAC score of zero corresponds to very low CVD event rates (∼1% per year) and hence a potent negative risk marker. This has been referred to as the 'power of zero' and affords the lowest risk of any method of risk calculation. It is now indicated in the 2018 ACC/AHA Cholesterol guidelines to be used to avoid statins for 5-10 years after a score of zero, and then re-assess the patient.

动脉粥样硬化性心血管疾病(ASCVD)是普通人群的常见病,主要包括四大领域:(1)冠心病(CHD),表现为稳定型心绞痛、不稳定型心绞痛、心肌梗死(MI)、心力衰竭和冠状动脉死亡;(2)脑血管疾病,表现为短暂性缺血发作和脑卒中;(3)周围血管疾病,表现为跛行和危急肢体缺血;(4)主动脉粥样硬化和主动脉瘤(胸腹)。冠心病仍然是美国男性和女性死亡的主要原因。因此,识别有冠心病风险的人群,并提供适当的医疗或干预,以防止严重的并发症和包括心源性猝死在内的后果,是至关重要的。冠状动脉钙化(CAC)是亚临床冠状动脉疾病的标志。因此,冠状动脉钙评分是冠状动脉疾病(CAD)的重要筛查方法。在本文中,我们对评估CAC对未来心血管疾病(CVD)事件的预后价值的现有文献和研究进行了全面的回顾。我们检索了PubMed, MEDLINE, Google Scholar和Cochrane图书馆。我们还回顾了2018年美国心脏病学会(ACC)/美国心脏协会(AHA)关于心血管疾病风险评估的指南。CAC评分为零对应于非常低的心血管事件发生率(每年约1%),因此是一个强有力的负风险标记。这被称为“零的力量”,提供了任何风险计算方法中最低的风险。现在,在2018年ACC/AHA胆固醇指南中指出,在得分为零后的5-10年内避免使用他汀类药物,然后重新评估患者。
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引用次数: 2
Vasopressin antagonism in heart failure: a review of the hemodynamic studies and major clinical trials. 抗利尿激素在心力衰竭中的拮抗作用:血流动力学研究和主要临床试验的综述。
IF 2.3 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2021-01-01 DOI: 10.1177/1753944720977741
Jonathan Urbach, Steven R Goldsmith
For decades, plasma arginine vasopressin (AVP) levels have been known to be elevated in patients with congestive heart failure (HF). Excessive AVP signaling at either or both the V1a and V2 receptors could contribute to the pathophysiology of HF by several mechanisms. V1a activation could cause vasoconstriction and/or direct myocardial hypertrophy as intracellular signaling pathways are closely related to those for angiotensin II. V2 activation could cause fluid retention and hyponatremia. A hemodynamic study with the pure V2 antagonist tolvaptan (TV) showed minimal hemodynamic effects. Compared with furosemide in another study, the renal and neurohormonal effects of TV were favorable. Several clinical trials with TV as adjunctive therapy in acute HF have shown beneficial effects on fluid balance and dyspnea, with no worsening of renal function or neurohormonal stimulation. Two smaller studies, one in acute and one in chronic HF, have shown comparable clinical and more favorable renal and neurohormonal effects of TV compared with loop diuretics. However, long-term treatment with TV did not alter outcomes in acute HF. No data are available other than single-dose studies of an intravenous pure V1a antagonist, which showed a vasodilating effect if plasma AVP levels were elevated. One hemodynamic study and one short-duration clinical trial with the balanced intravenous V1a/V2 antagonist conivaptan (CV) showed hemodynamic and clinical effects largely similar to those with TV in similar studies. A new orally effective balanced V1/V2 antagonist (pecavaptan) is currently undergoing phase II study as both adjunctive and alternative therapy during and after hospitalization for acute HF. The purpose of this review is to summarize what we have learned from the clinical experience with TV and CV, and to suggest implications of these findings for future work with newer agents.
几十年来,血浆精氨酸加压素(AVP)水平在充血性心力衰竭(HF)患者中升高。AVP信号在V1a和V2受体中的任何一个或两个都过量,可能通过多种机制促进HF的病理生理。V1a的激活可引起血管收缩和/或直接心肌肥大,因为细胞内信号通路与血管紧张素II的信号通路密切相关。V2激活会导致液体潴留和低钠血症。一项使用纯V2拮抗剂托伐普坦(TV)的血流动力学研究显示其血流动力学影响很小。与另一项研究中的速尿相比,TV对肾脏和神经激素的影响是有利的。一些临床试验表明,TV作为急性心衰的辅助治疗对体液平衡和呼吸困难有有益的作用,没有肾功能恶化或神经激素刺激。两项较小的研究,一项针对急性心衰,另一项针对慢性心衰,显示了与利尿剂相比,TV的临床效果和更有利的肾脏和神经激素作用。然而,长期电视治疗并没有改变急性心衰的结果。除了静脉注射纯V1a拮抗剂的单剂量研究外,没有其他数据,该研究显示,如果血浆AVP水平升高,则有血管舒张作用。一项血液动力学研究和一项短期临床试验显示,静脉注射平衡V1a/V2拮抗剂康尼伐坦(CV)的血液动力学和临床效果与类似研究中使用TV的血液动力学和临床效果基本相似。一种新的口服有效的平衡V1/V2拮抗剂(pecavaptan)作为急性心衰住院期间和住院后的辅助和替代治疗,目前正在进行II期研究。本综述的目的是总结我们从TV和CV的临床经验中学到的东西,并提出这些发现对未来使用新药物的意义。
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引用次数: 14
Modulating inflammation to reduce atherosclerotic cardiovascular events: should colchicine be part of the therapeutic regimen? 调节炎症以减少动脉粥样硬化性心血管事件:秋水仙碱应该成为治疗方案的一部分吗?
IF 2.3 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2021-01-01 DOI: 10.1177/17539447211042714
Ishwarlal Jialal, Naval Vikram
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引用次数: 0
The role of directional atherectomy in critical-limb ischemia. 定向动脉粥样硬化切除术在危急肢体缺血中的作用。
IF 2.3 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2021-01-01 DOI: 10.1177/17539447211046953
Prakash Krishnan, Arthur Tarricone, Simon Chen, Samin Sharma

Background: Our aim was to review the current literature of the use of directional atherectomy (DA) in the treatment of lower extremity critical-limb ischemia.

Methods: A search for relevant literature was performed in PubMed and PubMed Central on 16 April 2020, sorted by best match. Three searches across two databases were performed. Articles were included that contained clinical and procedural data of DA interventions in lower extremity critical-limb ischemia patients. All studies that were systematic reviews were excluded.

Results: Eleven papers were included in this review. Papers were examined under several parameters: primary patency and secondary patency, limb salvage/amputation, technical/procedural success, complications/periprocedural events, and mean lesion length. Primary and secondary patency rates ranged from 56.3% to 95.0% and 76.4% to 100%, respectively. Limb salvage rates ranged from 69% to 100%. Lesion lengths were highly varied, representing a broad population, ranging from 30 ± 33 mm to 142.4 ± 107.9 mm.

Conclusions: DA may be a useful tool in the treatment of lower extremity critical-limb ischemia.

背景:我们的目的是回顾目前有关定向动脉粥样硬化切除术(DA)治疗下肢危急肢体缺血的文献。方法:于2020年4月16日在PubMed和PubMed Central检索相关文献,按最佳匹配排序。在两个数据库中执行三次搜索。纳入了包含DA干预在下肢危急肢体缺血患者中的临床和手术资料的文章。所有系统评价的研究都被排除在外。结果:共纳入11篇论文。论文根据几个参数进行审查:原发性通畅和继发性通畅,肢体保留/截肢,技术/手术成功,并发症/手术期间事件,平均病变长度。原发性和继发性通畅率分别为56.3% ~ 95.0%和76.4% ~ 100%。残肢保留率从69%到100%不等。病变长度变化很大,代表了广泛的人群,范围从30±33 mm到142.4±107.9 mm。结论:DA可能是治疗下肢危急肢体缺血的有效工具。
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引用次数: 0
Trace elements in patients with aortic valve sclerosis. 主动脉瓣硬化患者的微量元素。
IF 2.3 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2021-01-01 DOI: 10.1177/1753944720985985
Hataw Al-Taesh, Abuzer Çelekli, Murat Sucu, Seyithan Taysi

Background: Aortic valve sclerosis (AVSc) is defined as the thickening and calcification of aortic valve cusps, in the absence of obstruction of ventricular outflow. AVSc is linked with a clear imbalance in some trace elements.

Aims: The objective of this study was to investigate the relationship between AVSc and serum levels of iron (Fe), zinc (Zn), selenium (Se), and copper (Cu). Additionally, this research aimed to explore the clinical significance of human serum zinc, selenium, copper, and iron concentrations as a potential new biomarker for AVSc patients and to clarify the pathophysiological role in individuals at risk of developing AVSc.

Patients and methods: The study included 40 subjects with AVSc (25% male and 75% female) who were compared with a healthy control group with the same gender ratio. AVSc was based on comprehensive echocardiographic assessments. Blood samples were taken and Zn and Cu concentrations were determined through the use of atomic absorption spectroscopy. Se was measured using an inductively coupled plasma mass spectrometry device and Fe was measured using a Beckman Coulter instrument.

Results: There was a significant difference in the prevalence of diabetes, blood pressure levels, and body mass index between the patients and the healthy subjects (p < 0.05). The differences between the serum Fe, Se, and Cu levels of the AVSc patients and the healthy subjects (p > 0.05) were recorded. The serum Zn of AVSc patients when compared was significantly lower compared with that of the control group (p < 0.01).

Conclusion: Patients with AVSc had an imbalance in some of the trace elements in their blood. The patient group's valves had higher serum Cu levels and lower serum Se, Zn, and Fe concentrations compared with the healthy group's valves. In the valve patients as compared, AVSc had a high prevalence of obesity, hypertension, and diabetes.

背景:主动脉瓣硬化(AVSc)被定义为主动脉瓣尖增厚和钙化,没有心室流出受阻。AVSc与某些微量元素明显失衡有关。目的:探讨AVSc与血清铁(Fe)、锌(Zn)、硒(Se)、铜(Cu)水平的关系。此外,本研究旨在探讨人类血清锌、硒、铜和铁浓度作为AVSc患者潜在的新生物标志物的临床意义,并阐明其在AVSc高危个体中的病理生理作用。患者和方法:本研究纳入40例AVSc患者(男性25%,女性75%),并与相同性别比例的健康对照组进行比较。AVSc是基于全面的超声心动图评估。取血样,用原子吸收光谱法测定锌、铜浓度。硒用电感耦合等离子体质谱仪测量,铁用贝克曼库尔特仪测量。结果:两组患者糖尿病患病率、血压水平、体质指数与健康对照组比较,差异均有统计学意义(p > 0.05)。与对照组相比,AVSc患者血清锌含量明显降低(p)。结论:AVSc患者血液中部分微量元素存在失衡。与健康组相比,患者组瓣膜的血清Cu水平较高,血清Se、Zn和Fe浓度较低。相比之下,AVSc患者中肥胖、高血压和糖尿病的患病率较高。
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引用次数: 4
The dawn of the four-drug era? SGLT2 inhibition in heart failure with reduced ejection fraction. 四药时代的来临?SGLT2抑制剂治疗射血分数降低型心力衰竭。
IF 2.6 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2021-01-01 DOI: 10.1177/17539447211002678
Michael V Genuardi, Paul J Mather

Sodium-glucose cotransporter type 2 (SGLT2) inhibitors are a relatively new class of antihyperglycemic drug with salutary effects on glucose control, body weight, and blood pressure. Emerging evidence now indicates that these drugs may have a beneficial effect on outcomes in heart failure with reduced ejection fraction (HFrEF). Post-approval cardiovascular outcomes data for three of these agents (canagliflozin, empagliflozin, and dapagliflozin) showed an unexpected improvement in cardiovascular endpoints, including heart failure hospitalization and mortality, among patients with type 2 diabetes mellitus (T2DM) and established cardiovascular disease or risk factors. These studies were followed by a placebo controlled trial of dapagliflozin in patients with HFrEF both with and without T2DM, showing a reduction in all-cause mortality comparable to current guideline-directed HFrEF medical therapies such as angiotensin-converting enzyme inhibitors and beta-blockers. In this review, we discuss the current landscape of evidence, safety and adverse effects, and proposed mechanisms of action for use of these agents for patients with HFrEF. The United States (US) and European guidelines are reviewed, as are the current US federally approved indications for each SGLT2 inhibitor. Use of these agents in clinical practice may be limited by an uncertain insurance environment, especially in patients without T2DM. Finally, we discuss practical considerations for the cardiovascular clinician, including within-class differences of the SGLT2 inhibitors currently available on the US market (217/300).

钠-葡萄糖共转运体 2 型(SGLT2)抑制剂是一类相对较新的降糖药物,对血糖控制、体重和血压有良好作用。现在有新的证据表明,这类药物可能对射血分数降低型心力衰竭(HFrEF)的预后产生有益的影响。其中三种药物(canagliflozin、empagliflozin 和 dapagliflozin)获得批准后的心血管疗效数据显示,在患有 2 型糖尿病(T2DM)并伴有心血管疾病或风险因素的患者中,心血管终点(包括心衰住院率和死亡率)得到了意想不到的改善。在这些研究之后,达帕格列净又在有 T2DM 和无 T2DM 的 HFrEF 患者中进行了安慰剂对照试验,结果显示其降低的全因死亡率与目前指导性的 HFrEF 医疗疗法(如血管紧张素转换酶抑制剂和β-受体阻滞剂)相当。在这篇综述中,我们将讨论当前的证据情况、安全性和不良反应,以及将这些药物用于 HFrEF 患者的拟议作用机制。我们回顾了美国和欧洲的指南,以及目前美国联邦政府批准的每种 SGLT2 抑制剂的适应症。在临床实践中,这些药物的使用可能会受到不确定的保险环境的限制,尤其是在没有 T2DM 的患者中。最后,我们讨论了心血管临床医生的实际考虑因素,包括目前在美国市场上销售的 SGLT2 抑制剂(217/300)的类内差异。
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引用次数: 0
Mechanisms and management of prothrombotic state in COVID-19 disease. COVID-19疾病血栓形成前状态的机制和处理。
IF 2.3 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2021-01-01 DOI: 10.1177/17539447211053470
Trishna Acherjee, Aparna Behara, Muhammad Saad, Timothy J Vittorio

The novel severe acute respiratory syndrome viral disease outbreak due to SARS-CoV-2 is a rapidly evolving disease and represents one of the greatest medical challenges in recent times. It is believed that SARS-CoV-2 has migrated from bats to an intermediate host and then to humans. This article aims at the mechanism and management of prothrombotic state in COVID-19 positive patients. We tried to present how the SARS-CoV-2 virus can induce thromboembolic events and the incidence of these thromboembolic events. We also tried to depict anticoagulation management in these patients as well as postdischarge plan and follow-up. Invasion of type 2 pneumocytes by the SARS-CoV-2 virus is critical in the course of illness because it results in activation of immune cells leading to elevation of cytokines. The subsequent activation of T cells and macrophages infiltrates the infected myocardial cells causing direct myocardiocyte toxicity and development of arrhythmia. Hypoxia or hypotension during the clinical course causes a mismatch between myocyte oxygen supply and workload demand resulting in cardiac distress. SARS-CoV-2 affects endothelial cells and pericytes that lead to severe micro and macrovascular dysfunction, and together with oxygen supply-demand mismatch, immune hyperresponsivity can potentially cause destabilization and plaque rupture causing acute coronary syndromes. Other mechanisms of injury include myocarditis, pericarditis, stress cardiomyopathy, vasculitis, and DIC (Disseminated intravascular coagulation)/microthrombi. SARS-CoV-2 enters the cells by the Spike protein S whose surface unit, S1, binds to the ACE2 receptor on the host cell. The type II transmembrane serine proteases TMPRSS2 and histone acetyltransferases (HAT) are host cell proteases that are recruited by the virus to cleave ACE2 surface protein S which facilitates the viral entry. Therefore, TMPRSS2 and HAT could be targeted for potential drugs against SARS-CoV-2. SARS-CoV-2 uses an RNA-dependent RNA polymerase for proliferation, which is targeted by remdesivir that is currently approved for emergency use by Food and Drug Administration (FDA). We need to adopt a multifaceted approach when combating SARS-CoV-2 because it presents several challenges including medical, psychological, socioeconomic, and ethical. COVID-19 is the biggest calamity during the 21st century, we need to have a keen understanding of its pathophysiology and clinical implications for the development of preventive measures and therapeutic modalities.

由SARS-CoV-2引起的新型严重急性呼吸系统综合征病毒性疾病暴发是一种快速发展的疾病,是近年来最大的医学挑战之一。据信,SARS-CoV-2已经从蝙蝠迁移到中间宿主,然后转移到人类。本文旨在探讨COVID-19阳性患者血栓形成前状态的机制及处理。我们试图介绍SARS-CoV-2病毒如何诱导血栓栓塞事件以及这些血栓栓塞事件的发生率。我们也试图描述这些患者的抗凝治疗以及出院后的计划和随访。SARS-CoV-2病毒入侵2型肺细胞在疾病过程中至关重要,因为它会激活免疫细胞,导致细胞因子升高。随后激活的T细胞和巨噬细胞浸润被感染的心肌细胞,直接引起心肌细胞毒性和心律失常的发生。临床过程中的缺氧或低血压会导致心肌细胞供氧和负荷需求之间的不匹配,从而导致心脏窘迫。SARS-CoV-2影响内皮细胞和周细胞,导致严重的微血管和大血管功能障碍,再加上氧供需不匹配,免疫高反应性可能导致不稳定和斑块破裂,从而导致急性冠状动脉综合征。其他损伤机制包括心肌炎、心包炎、应激性心肌病、血管炎和DIC(弥散性血管内凝血)/微血栓。SARS-CoV-2通过刺突蛋白S进入细胞,刺突蛋白S的表面单位S1与宿主细胞上的ACE2受体结合。II型跨膜丝氨酸蛋白酶TMPRSS2和组蛋白乙酰转移酶(HAT)是宿主细胞蛋白酶,它们被病毒招募来切割ACE2表面蛋白S,从而促进病毒进入。因此,TMPRSS2和HAT可以作为潜在药物靶向治疗SARS-CoV-2。SARS-CoV-2使用依赖RNA的RNA聚合酶进行增殖,这是目前美国食品和药物管理局(FDA)批准紧急使用的瑞德西韦的目标。在抗击新冠肺炎时,我们需要采取多方面的方法,因为它带来了医学、心理、社会经济和道德等方面的挑战。COVID-19是21世纪最大的灾难,我们需要深刻认识其病理生理学和临床意义,以制定预防措施和治疗方法。
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引用次数: 14
Safety of day-case endovascular interventions for peripheral arterial disease in a rural, underserved area. 在农村,服务不足地区外周动脉疾病的一天病例血管内介入治疗的安全性。
IF 2.3 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2020-01-01 DOI: 10.1177/1753944720948651
Athar Ansari, Moiz Ali Shah, Manaim Amir Shah, Zahra Ansari

Background: We aimed to investigate the safety of endovascular procedures undertaken in a single outpatient center located in a rural, underserved area. Endovascular procedures for Peripheral Arterial Disease (PAD) have become increasingly common in outpatient settings; their safety is yet to be determined in a rural, underserved area with no stand-by vascular surgeon on site.

Methods: We undertook a retrospective case review of endovascular procedures for the investigation and management of lower extremity PAD between December 2012 and August 2015. Patients were classified by Rutherford score, degree of stenosis and length of lesions. Complications were major (requiring hospitalization) or minor, including perforation, distal embolization, hematoma, and allergic reactions, which could be treated immediately in the catheterization laboratory with no sequelae. Patients were monitored in the facility and followed up using clinical, biochemical and radiological parameters at 24 h and 1 month.

Results: A total of 692 patients underwent endovascular procedures for the investigation and/or treatment of PAD, of which 608 were interventional. Of these patients, 10.20% experienced procedural complications, of which 0.66% were classified as major, including wire retention and retroperitoneal hemorrhage. In total, 99.34% were discharged safely on the same day as the procedure. No adverse events were reported at follow up.

Conclusion: Endovascular procedures for PAD can be performed safely in a rural outpatient setting with low complication rates. Most complications are minor and do not require hospitalization. Outpatient procedures for PAD are safe and may widen access to specialist procedures in areas of socio-economic deprivation.

背景:我们的目的是调查在位于农村,服务不足地区的单一门诊中心进行的血管内手术的安全性。外周动脉疾病(PAD)的血管内手术在门诊越来越普遍;他们的安全还有待确定,在农村,服务不足的地区,没有备用血管外科医生在现场。方法:回顾性分析2012年12月至2015年8月血管内手术治疗下肢PAD的病例。根据卢瑟福评分、狭窄程度和病变长度对患者进行分类。并发症有大的(需要住院治疗),也有小的,包括穿孔、远端栓塞、血肿、过敏反应等,均可在置管实验室立即处理,无后遗症。对患者进行监测,并于24小时和1个月进行临床、生化和放射学参数随访。结果:共有692例患者接受了血管内手术来调查和/或治疗PAD,其中608例为介入性手术。10.20%的患者出现了手术并发症,其中0.66%为严重并发症,包括钢丝潴留和腹膜后出血。在手术当天,99.34%的患者安全出院。随访无不良事件报告。结论:血管内手术治疗PAD可以在农村门诊安全进行,并发症发生率低。大多数并发症是轻微的,不需要住院治疗。PAD的门诊程序是安全的,并且可以扩大社会经济贫困地区的专科程序。
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引用次数: 4
Differences in RAAS/vitamin D linked to genetics and socioeconomic factors could explain the higher mortality rate in African Americans with COVID-19. 与遗传和社会经济因素有关的 RAAS/维生素 D 的差异可能是 COVID-19 非裔美国人死亡率较高的原因。
IF 2.6 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2020-01-01 DOI: 10.1177/1753944720977715
Virna Margarita Martín Giménez, León Ferder, Felipe Inserra, Joxel García, Walter Manucha

COVID-19 is said to be a pandemic that does not distinguish between skin color or ethnic origin. However, data in many parts of the world, especially in the United States, begin to show that there is a sector of society suffering a more significant impact from this pandemic. The Black population is more vulnerable than the White population to infection and death by COVID-19, with hypertension and diabetes mellitus as probable predisposing factors. Over time, multiple disparities have been observed between the health of Black and White populations, associated mainly with socioeconomic inequalities. However, some mechanisms and pathophysiological susceptibilities begin to be elucidated that are related directly to the higher prevalence of multiple diseases in the Black population, including infection and death by COVID-19. Plasma vitamin D levels and evolutionary adaptations of the renin-angiotensin-aldosterone system (RAAS) in Black people differ considerably from those of other races. The role of these factors in the development and progression of hypertension and multiple lung diseases, among them SARS-CoV-2 infection, is well established. In this sense, the present review attempts to elucidate the link between vitamin D and RAAS ethnic disparities and susceptibility to infection and death by COVID-19 in Black people, and suggests possible mechanisms for this susceptibility.

据说 COVID-19 是一种不分肤色和种族的流行病。然而,世界许多地区,尤其是美国的数据开始显示,社会上有一部分人受到这种流行病的影响更为严重。黑人比白人更容易感染 COVID-19 并导致死亡,高血压和糖尿病可能是诱发因素。随着时间的推移,人们发现黑人和白人的健康状况存在多种差异,这主要与社会经济不平等有关。然而,一些机制和病理生理学易感性开始被阐明,它们与黑人多种疾病的高发病率直接相关,包括 COVID-19 感染和死亡。黑人的血浆维生素 D 水平和肾素-血管紧张素-醛固酮系统(RAAS)的进化适应性与其他种族有很大不同。这些因素在高血压和多种肺部疾病(其中包括 SARS-CoV-2 感染)的发生和发展中的作用已得到公认。因此,本综述试图阐明维生素 D 和 RAAS 的种族差异与黑人易受 COVID-19 感染和死亡之间的联系,并提出这种易感性的可能机制。
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引用次数: 0
Endpoint selection for noninferiority percutaneous coronary intervention trials: a methodological description. 非劣效性经皮冠状动脉介入试验的终点选择:方法学描述。
IF 2.3 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2020-01-01 DOI: 10.1177/1753944720911329
Matthias Waliszewski, Mark Rosenberg, Harald Rittger, Viktor Breul, Florian Krackhardt

Background: The objective of this review is to provide a practical update on endpoint selection for noninferiority (NI) studies in percutaneous coronary intervention studies.

Methods: A PubMed search was conducted for predefined terms to explore the use of NI designs and intrapatient comparisons to determine their current importance. Sample size calculations for the most frequently used endpoints with NI hypotheses were done to increase statistical awareness.

Results: Reported NI trials, with the most frequently chosen clinical endpoint of major adverse cardiac events (MACE), had NI margins ranging from 1.66% to 5.00%, resulting in patient populations of 400-1500 per treatment group. Clinical study endpoints comprising of MACE complemented with rates of bleeding complications and stent thrombosis (ST) are suggested to conduct a statistically and clinically meaningful NI trial. Study designs with surrogate endpoints amenable to intrapatient randomizations, are a very attractive option to reduce the number of necessary patients by about half. Comparative clinical endpoint studies with MACE and ST/bleeding rates to study a shortened dual antiplatelet therapy (DAPT) in coronary stent trials are feasible, whereas ST as the sole primary endpoint is not useful.

Conclusions: Expanded composite clinical endpoints (MACE complemented by ST and bleeding rates and intrapatient randomization for selected surrogate endpoints) may be suitable tools to meet future needs in device approval, recertification and reimbursement.

背景:本综述的目的是为经皮冠状动脉介入研究中非劣效性(NI)研究的终点选择提供一个实用的更新。方法:在PubMed上搜索预定义的术语,探索NI设计的使用和患者内比较,以确定它们当前的重要性。用NI假设对最常用的终点进行样本量计算,以提高统计意识。结果:报告的NI试验中,最常选择的临床终点是主要不良心脏事件(MACE),其NI边缘范围为1.66%至5.00%,导致每个治疗组的患者人数为400-1500人。临床研究终点包括MACE、出血并发症和支架血栓(ST)发生率,建议进行具有统计学和临床意义的NI试验。采用可适应患者内部随机化的替代终点的研究设计是一个非常有吸引力的选择,可以减少大约一半的必要患者数量。比较临床终点研究MACE和ST/出血率来研究冠状动脉支架试验中缩短双重抗血小板治疗(DAPT)是可行的,而ST作为唯一的主要终点是没有用的。结论:扩展的复合临床终点(MACE辅以ST和出血率以及选定替代终点的患者内随机化)可能是满足未来器械审批、再认证和报销需求的合适工具。
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引用次数: 2
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Therapeutic Advances in Cardiovascular Disease
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