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IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-08-16 DOI: 10.1016/S0002-8703(24)00191-1
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引用次数: 0
Novel markers of nocturnal hypoxemia in sleep apnea and heart failure with reduced ejection fraction (HFrEF). 睡眠呼吸暂停和射血分数降低性心力衰竭(HFrEF)夜间低氧血症的新标记物。
IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-08-16 DOI: 10.1016/j.ahj.2024.08.006
Gonzalo Labarca
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引用次数: 0
Safety and feasibility of triage and rapid discharge of patients with chest pain from emergency room: a pragmatic, randomised non-inferiority control trial of the European Society of Cardiology (ESC) 0-1 hour pathway vs. conventional 0-3 hour accelerated diagnostic protocol. 急诊室胸痛患者分流和快速出院的安全性和可行性:欧洲心脏病学会 (ESC) 0-1 小时路径与传统 0-3 小时加速诊断方案的非劣效性随机对照试验。
IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-08-14 DOI: 10.1016/j.ahj.2024.08.005
Aleem Khand, James Hatherley, Ahmed Dakshi, Guy Miller, Lisa Bailey, Christopher Goulden, Zaid Noori, Anju Rawat, Rachel Hornby, Hannah Fearon, Nirmol Meah, Sarah Davies, Katarzyna Sekulska, Awtad Hassan, Angela Lambert, Suzannah Phillips, Ray Raj, Tom Wiles, Paul Collinson

Patients presenting with chest pain represent a significant proportion of Emergency Department (ED) attendances but only a minority, typically 10%, have a final diagnosis of myocardial infarction (MI). Prompt discharge of patients without MI will alleviate ED overcrowding as well as improve patient satisfaction and reduce exposure to risk of hospital acquired infections such as Covid 19. The measurement of cardiac troponin (cTn) by a high sensitivity method is recommended by the National Institute for health and Care Excellence (NICE) for rapid categorisation of patients presenting with chest pain. Strategies proposed include measurement on admission and one hour from admission (ESC 0-1-hour pathway, the recent guideline approved pathway which has not been implemented widely), and measurement on admission and three hours from admission (0-3-hour pathway, which is conventional and widely adopted). The primary objective of this study is twofold: firstly, to assess the safety, feasibility, and impact of implementing the ESC (European Society of Cardiology) 0-1-hour pathway in clinical practice by reference to the more established ESC 0-3-hour protocol. The principal outcome measure will be the safety of the ESC 0-1-hour protocol. However, there are concerns that the time from sample draw to result availability (typically around 60 minutes) will impact on the feasibility of the ESC 0-1-hour pathway. Secondly, therefore, our goal is to evaluate whether measurement of high sensitivity troponin by a bedside analyser (point of care testing, POCT), which will produce results in 15 minutes is a feasible alternative to laboratory testing. We will compare the results produced by POCT with the laboratory results in the context of the ESC 0-1 hour and 0-3-hour pathway, as a nested controlled study in the context of a randomised controlled trial. (clinicaltrials.gov: NCT05322395).

胸痛患者在急诊科(ED)就诊人数中占很大比例,但只有少数患者(通常为 10%)最终诊断为心肌梗死(MI)。让没有心肌梗死的患者及时出院将缓解急诊科的拥挤状况,提高患者满意度,并降低医院感染的风险,如 Covid 19。美国国家健康与护理优化研究所 (NICE) 建议使用高灵敏度方法测量心肌肌钙蛋白 (cTn),以便对胸痛患者进行快速分类。建议的策略包括入院时和入院后一小时内进行测量(ESC 0-1 小时路径,这是最近获得指南批准的路径,但尚未广泛实施),以及入院时和入院后三小时内进行测量(0-3 小时路径,这是传统的路径,已被广泛采用)。本研究的主要目的有两个:首先,参照更为成熟的 ESC 0-3 小时方案,评估在临床实践中实施 ESC(欧洲心脏病学会)0-1 小时方案的安全性、可行性和影响。主要的结果衡量指标将是ESC 0-1小时方案的安全性。不过,有人担心从样本抽取到结果出来的时间(通常约为 60 分钟)会影响 ESC 0-1 小时路径的可行性。其次,我们的目标是评估床旁分析仪(护理点检测,POCT)在 15 分钟内得出结果是否是实验室检测的可行替代方案。我们将在ESC 0-1小时和0-3小时路径下,将POCT得出的结果与实验室结果进行比较,这是一项随机对照试验中的嵌套对照研究。(Clinicaltrials.gov: NCT05322395)。
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引用次数: 0
Sex differences and long-term clinical outcomes after transcatheter aortic valve replacement: A SWEDEHEART study 经导管主动脉瓣置换术后的性别差异和长期临床疗效:SWEDEHEART 研究。
IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-08-10 DOI: 10.1016/j.ahj.2024.07.018

Background

Previous studies on the impact of sex differences after transcatheter aortic valve replacement (TAVR) have shown conflicting results. The aim was to analyze the risk of long-term mortality, heart failure hospitalization, myocardial infarction, stroke, bleeding and aortic valve reintervention in females versus males after TAVR.

Methods

This nationwide, population-based cohort study included all patients who underwent TAVR in Sweden between 2008 and 2022 from the SWEDEHEART register. Additional baseline and outcome data were gathered from other national health data registers. Regression standardization was used to adjust for differences between the sexes.

Results

Of 10,475 patients, 4,886 (47%) were female and 5,589 (53%) were male. The mean age was 81 years. The cumulative incidence of mortality at 1, 5, and 10 years was 8% vs. 10%, 38% vs. 45%, and 75% vs. 82% for females and males, respectively. After regression standardization, the risk of all-cause mortality was lower for females (absolute difference at 10 years of 6.4%, 95% confidence interval [CI] 4.4%-8.4%). The mean follow up was 3.1 years (maximum 14.1 years). Females also had a lower risk of major bleeding than males (absolute survival difference at 10 years of 4.0%, 95% CI 1.9%-6.2%), but there was no difference in the risk of heart failure, myocardial infarction, stroke, or reintervention between the sexes.

Conclusions

Females had a higher survival rate and a lower bleeding risk than males after TAVR. Sex-specific factors are important to consider in the management of patients after TAVR.

背景:以往关于经导管主动脉瓣置换术(TAVR)后性别差异影响的研究结果相互矛盾。该研究旨在分析女性与男性在经导管主动脉瓣置换术后长期死亡、心衰住院、心肌梗死、中风、出血和主动脉瓣再介入的风险:这项基于人群的全国性队列研究纳入了SWEDEHEART登记册中2008年至2022年间在瑞典接受TAVR的所有患者。其他基线和结果数据来自其他国家的健康数据登记。回归标准化用于调整性别差异:在 10,475 名患者中,4,886 名(47%)为女性,5,589 名(53%)为男性。平均年龄为 81 岁。女性和男性在1年、5年和10年的累积死亡率分别为8% vs. 10%、38% vs. 45%和75% vs. 82%。回归标准化后,女性的全因死亡风险较低(10 年的绝对差异为 6.4%,95% 置信区间 [CI] 为 4.4%-8.4%)。平均随访时间为 3.1 年(最长 14.1 年)。女性发生大出血的风险也低于男性(10年的绝对存活率差异为4.0%,95% CI为1.9%-6.2%),但男女发生心力衰竭、心肌梗死、中风或再次干预的风险没有差异:结论:与男性相比,女性在TAVR术后的存活率更高,出血风险更低。结论:TAVR术后女性存活率高于男性,出血风险低于男性。
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引用次数: 0
Use of artificial intelligence‐guided echocardiography to detect cardiac dysfunction and heart valve disease in rural and remote areas: Rationale and design of the AGILE‐echo trial 使用人工智能引导超声心动图检测农村和偏远地区的心功能障碍和心脏瓣膜疾病:AGILE-Echo 试验的原理与设计。
IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-08-10 DOI: 10.1016/j.ahj.2024.08.004

Background

Transthoracic echocardiography (TTE) is essential in the diagnosis of cardiovascular diseases (CVD), including but not limited to heart failure (HF) and heart valve disease (HVD). However, its dependence on expert acquisition means that its accessibility in rural areas may be limited, leading to delayed management decisions and potential missed diagnoses. Artificial intelligence-guided (AI)-TTE offers a solution by permitting non-expert image acquisition. The impact of AI-TTE on the timing of diagnosis and early initiation of cardioprotection is undefined.

Methods

AGILE-Echo (use of Artificial intelligence-Guided echocardiography to assIst cardiovascuLar patient managEment) is a randomized-controlled trial conducted in 5 rural and remote areas around Australia. Adults with CV risk factors and exercise intolerance, or concerns regarding HVD are randomized into AI-TTE or usual care (UC). AI-TTE participants may have a cardiovascular problem excluded, identified (leading to AI-guided interventions) or unresolved (leading to conventional TTE). UC participants undergo usual management, including referral for standard TTE. The primary endpoint is a composite of HVD or HF diagnosis at 12-months. Subgroup analysis, stratified based on age range and sex, will be conducted. All statistical analyses will be conducted using R.

Results

Of the first 157 participants, 78 have been randomized into AI-TTE (median age 68 [IQR 17]) and 79 to UC (median age 65 [IQR 17], P = .034). HVD was the primary concern in 37 participants (23.6%) while 84.7% (n = 133) experienced exercise intolerance. The overall 10-year HF incidence risk was 13.4% and 20.0% (P = .089) for UC and AI-TTE arm respectively. Atrial remodeling, left ventricular remodeling and valvular regurgitation were the most common findings. Thirty-three patients (42.3%) showed no abnormalities.

Conclusions

This randomized-controlled trial of AI-TTE will provide proof-of-concept for the role of AI-TTE in identifying pre-symptomatic HF or HVD when access to TTE is limited. Additionally, this could promote the usage of AI-TTE in rural or remote areas, ultimately improving health and quality of life of community dwelling adults with risks, signs or symptoms of cardiac dysfunction.

背景:经胸超声心动图(TTE)对心血管疾病(CVD)的诊断至关重要,包括但不限于心力衰竭(HF)和心脏瓣膜病(HVD)。然而,TTE 依赖于专家的采集,这意味着在农村地区的可及性可能有限,从而导致管理决策的延误和潜在的漏诊。人工智能引导(AI)-TTE 允许非专业人员采集图像,从而提供了一种解决方案。AI-TTE 对诊断时机和早期启动心脏保护的影响尚不明确:AGILE-Echo(使用人工智能引导超声心动图协助心脏病患者管理)是一项随机对照试验,在澳大利亚的 5 个农村和偏远地区进行。具有心血管疾病风险因素、不耐运动或担心心血管疾病的成年人被随机分配到 AI-TTE 或常规护理(UC)中。AI-TTE 参与者的心血管问题可能被排除、确定(导致 AI 指导下的干预)或未解决(导致常规 TTE)。UC 参与者接受常规管理,包括转诊接受标准 TTE。主要终点是 12 个月时的 HVD 或 HF 诊断综合结果。将根据年龄范围和性别进行分组分析。所有统计分析都将使用 R 语言进行:在首批 157 名参与者中,78 人被随机分配到 AI-TTE(中位年龄 68 [IQR 17]),79 人被随机分配到 UC(中位年龄 65 [IQR 17],P=0.034)。HVD是37名参与者(23.6%)的主要问题,而84.7%(n=133)的参与者出现运动不耐受。UC臂和AI-TTE臂的总体10年HF发病风险分别为13.4%和20.0%(P=0.089)。心房重塑、左心室重塑和瓣膜反流是最常见的发现。33名患者(42.3%)未发现异常:这项 AI-TTE 随机对照试验将为 AI-TTE 在识别症状前 HF 或 HVD 方面的作用提供概念性证明。此外,这还能促进 AI-TTE 在农村或偏远地区的使用,最终改善有心脏功能障碍风险、体征或症状的社区成人的健康和生活质量。
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引用次数: 0
The pathophysiology of patent foramen ovale and its related complications 卵圆孔未闭及其相关并发症的病理生理学。
IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-08-10 DOI: 10.1016/j.ahj.2024.08.001

The foramen ovale plays a vital role in sustaining life in-utero; however, a patent foramen ovale (PFO) after birth has been associated with pathologic sequelae in the systemic circulation including stroke/transient ischemic attack (TIA), migraine, high altitude pulmonary edema, decompression illness, platypnea–orthodeoxia syndrome (POS) and worsened severity of obstructive sleep apnea. Importantly, each of these conditions is most commonly observed among specific age groups: migraine in the 20 to 40s, stroke/TIA in the 30-50s and POS in patients >50 years of age. The common and central pathophysiologic mechanism in each of these conditions is PFO-mediated shunting of blood and its contents from the right to the left atrium. PFO-associated pathologies can therefore be divided into (1) paradoxical systemic embolization and (2) right to left shunting (RLS) of blood through the PFO. Missing in the extensive literature on these clinical syndromes are mechanistic explanations for the occurrence of RLS, including timing and the volume of blood shunted, the impact of age on RLS, and the specific anatomical pathway that blood takes from the venous system to the left atrium. Visualization of the flow pattern graphically illustrates the underlying RLS and provides a greater understanding of the critical flow dynamics that determine the frequency, volume, and pathway of flow. In the present review, we describe the important role of foramen ovale in in-utero physiology, flow visualization in patients with PFO, as well as contributing factors that work in concert with PFO to result in the diverse pathophysiological sequelae.

卵圆孔在胎儿时期对维持生命起着至关重要的作用;然而,出生后出现卵圆孔未闭 (PFO) 与全身循环的病理后遗症有关,包括中风/短暂性脑缺血发作 (TIA)、偏头痛、高原肺水肿、减压病、鸭嘴兽-缺氧综合征 (POS) 以及阻塞性睡眠呼吸暂停加重。重要的是,这些疾病中的每一种都在特定年龄组中最常见:偏头痛在 20-40 岁人群中最常见,中风/TIA 在 30-50 岁人群中最常见,而 POS 则在大于 50 岁的患者中最常见。这些病症的共同核心病理生理机制都是 PFO 介导的血液及其内容物从右心房向左心房的分流。因此,PFO 相关病症可分为:(1)矛盾性全身栓塞;(2)血液通过 PFO 从右向左分流(RLS)。在有关这些临床综合征的大量文献中,缺少对 RLS 发生机理的解释,包括分流的时间和血量、年龄对 RLS 的影响以及血液从静脉系统流向左心房的特定解剖路径。血流模式的可视化图解说明了 RLS 的基本情况,并使人们对决定血流频率、血量和路径的关键血流动力学有了更深入的了解。在本综述中,我们介绍了卵圆孔在胎儿期生理中的重要作用、PFO 患者的血流可视化,以及与 PFO 协同导致各种病理生理后遗症的诱因。
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引用次数: 0
A randomized comparison of the treatment sequence of percutaneous coronary intervention and transcatheter aortic valve implantation: Rationale and design of the TAVI PCI trial 经皮冠状动脉介入治疗与经导管主动脉瓣植入术治疗顺序的随机比较:TAVI PCI 试验的原理与设计。
IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-08-08 DOI: 10.1016/j.ahj.2024.07.019

Background

About half of patients with severe aortic stenosis present with concomitant coronary artery disease. The optimal timing of percutaneous coronary intervention (PCI) and transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis and concomitant coronary artery disease remains unknown.

Study design

The TAVI PCI trial is a prospective, international, multicenter, randomized, 2-arm, open-label study planning to enroll a total of 986 patients. It is designed to investigate whether the strategy “angiography-guided complete revascularization after (within 1-45 days) TAVI” is noninferior to the strategy “angiography-guided complete revascularization before (within 1-45 days) TAVI” using the Edwards SAPIEN 3 or 3 Ultra Transcatheter Heart Valve in patients with severe aortic stenosis and concomitant coronary artery disease. Patients are randomized in a 1:1 ratio to one of the 2 treatment strategies. The primary end point is a composite of all-cause death, nonfatal myocardial infarction, ischemia-driven revascularization, rehospitalization (valve- or procedure-related including heart failure), or life-threatening/disabling or major bleeding at 1 year.

Conclusions

The TAVI PCI trial tests the hypothesis that the strategy “PCI after TAVI” is noninferior to the strategy “PCI before TAVI” in patients with severe aortic stenosis and concomitant coronary artery disease.

背景:大约一半的重度主动脉瓣狭窄患者同时伴有冠状动脉疾病。对于严重主动脉瓣狭窄并伴有冠状动脉疾病的患者,经皮冠状动脉介入治疗(PCI)和经导管主动脉瓣植入术(TAVI)的最佳时机仍然未知:TAVI PCI 试验是一项前瞻性、国际性、多中心、随机、双臂、开放标签研究,计划共招募 986 名患者。该研究旨在探讨在重度主动脉瓣狭窄并伴有冠状动脉疾病的患者中,使用 Edwards SAPIEN 3 或 3 Ultra 经导管心脏瓣膜™进行 "TAVI 后(1-45 天内)血管造影引导下的完全血运重建 "策略是否优于 "TAVI 前(1-45 天内)血管造影引导下的完全血运重建 "策略。患者按 1:1 的比例随机选择两种治疗策略中的一种。主要终点是1年内全因死亡、非致死性心肌梗死、缺血导致的血管再通、再住院(瓣膜或手术相关,包括心衰)或危及生命/致残或大出血的复合终点:TAVI PCI试验验证了一个假设,即对于严重主动脉瓣狭窄并伴有冠状动脉疾病的患者,"TAVI术后PCI "策略并不优于 "TAVI术前PCI "策略。
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引用次数: 0
Impact of sex on outcomes associated with polyvascular disease in patients after PCI 性别对 PCI 患者多血管疾病相关预后的影响。
IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-08-08 DOI: 10.1016/j.ahj.2024.08.002

Background

Atherosclerosis in more than 1 vs. 1 arterial bed is associated with increased risk for major adverse cardiovascular events (MACE). This study aimed to determine whether the risk of post percutaneous coronary intervention (PCI) MACE associated with polyvascular disease (PVD) differs by sex.

Methods

We analyzed 18,721 patients undergoing PCI at a tertiary-care center between 2012 and 2019. Polyvascular disease was defined as history of peripheral artery and/or cerebrovascular disease. The primary endpoint was MACE, a composite of all-cause death, myocardial infarction, or stroke at 1 year. Multivariate Cox regression was used to adjust for differences in baseline risk between patients with PVD vs. coronary artery disease (CAD) alone and interaction testing was used to assess risk modification by sex.

Results

Women represented 29.2% (N = 5,467) of the cohort and were more likely to have PVD than men (21.7% vs. 16.1%; P < .001). Among both sexes, patients with PVD were older with higher prevalence of comorbidities and cardiovascular risk factors. Women with PVD had the highest MACE rate (10.0%), followed by men with PVD (7.2%), women with CAD alone (5.0%), and men with CAD alone (3.6%). Adjusted analyses revealed similar relative MACE risk associated with PVD vs. CAD alone in women and men (adjusted hazard ratio [aHR] 1.54, 95% confidence interval [CI] 1.20-1.99; P < .001 and aHR 1.31, 95% CI 1.06-1.62; P = .014, respectively; p-interaction = 0.460).

Conclusion

Women and men derive similar excess risk of MACE from PVD after PCI. The heightened risk associated with PVD needs to be addressed with maximized use of secondary prevention in both sexes.

背景:一个以上动脉床与一个以上动脉床的动脉粥样硬化与主要不良心血管事件(MACE)风险增加有关。本研究旨在确定与多血管疾病(PVD)相关的经皮冠状动脉介入治疗(PCI)后MACE风险是否因性别而异:我们分析了 2012-2019 年间在一家三级医疗中心接受 PCI 治疗的 18721 名患者。多血管疾病定义为外周动脉和/或脑血管疾病史。主要终点是MACE,即1年后全因死亡、心肌梗死或中风的复合终点。多变量 Cox 回归用于调整 PVD 患者与单纯冠状动脉疾病(CAD)患者的基线风险差异,交互检验用于评估性别对风险的影响:结果:女性占队列的 29.2%(N=5,467),比男性更有可能患有 PVD(21.7% 对 16.1%;p 结论:女性和男性的超额风险相似:女性和男性在PCI术后因PVD导致MACE的超额风险相似。需要在男女患者中最大限度地使用二级预防措施来应对与 PVD 相关的更高风险。
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引用次数: 0
Pathological evaluation of predictors for delayed endothelial coverage after currently available drug-eluting stent implantation in coronary arteries: Impact of lesions with acute and chronic coronary syndromes 对冠状动脉植入现有药物洗脱支架后内皮覆盖延迟预测因素的病理学评估:急性和慢性冠状动脉综合征病变的影响。
IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-08-08 DOI: 10.1016/j.ahj.2024.08.003

Background

The optimal duration of dual antiplatelet therapy after currently available drug-eluting stent (DES) implantation to prevent stent thrombosis (ST) remains controversial. Delayed healing is frequently identified as a leading cause of ST in the early phase. However, a thorough pathological investigation into strut coverage after currently available DES implantation is lacking—a gap addressed in the current study.

Methods

From our autopsy registry of 199 stented lesions, 4,713 struts from 66 currently available DES-stented lesions with an implant duration ≤370 days were histologically evaluated. Endothelial coverage was defined as the presence of luminal endothelial cells overlying struts and an underlying smooth muscle cell layer. The stented lesions were classified into acute coronary syndrome (ACS) (n = 40) and chronic coronary syndrome (CCS) (n = 26) groups and were compared. Endothelial coverage predictors were identified through logistic analysis.

Results

Although ACS and CCS lesions presented comparable clinical characteristics, including age, sex, and cause of death, the latter exhibited a significantly higher prevalence of chronic kidney disease and hemodialysis than the former (33.3% vs. 65.2%; P = .02, 7.7% vs. 30.4%; P = .02). The poststent implant median duration was significantly shorter in ACS lesions than in CCS lesions (13 [IQR 5-26 days] vs. 40 [IQR 16-233 days]; P < .01). The endothelial coverage percentage was 3.5% at 30 days and 27.7% at 90 days after currently available DES implantation. Multivariable logistic regression analysis implicated implant duration of ≤90 days (odds ratio [OR], 0.009; 95% confidence interval [CI], 0.006-0.012; P < .01), superficial calcification (OR, 0.11; 95% CI, 0.07-0.17; P < .01), ACS culprit site (OR, 0.29; 95% CI, 0.09-0.94; P = .039), and circumferentially durable polymer-coated DES (OR, 0.32; 95% CI, 0.24-0.41; P < .01) as delayed endothelial coverage predictors.

Conclusions

Endothelial coverage was limited at 90 days after currently available DES implantation, and the ACS culprit site and circumferentially durable polymer-coated DES were identified as independent predictors of delayed endothelial coverage. Our findings suggest the importance of underlying plaque morphology and stent technology for vessel healing after such implantation.

背景:在目前可用的药物洗脱支架(DES)植入术后,预防支架血栓形成(ST)的双联抗血小板疗法的最佳持续时间仍存在争议。延迟愈合经常被认为是早期 ST 的主要原因。然而,目前还缺乏对目前可用的 DES 植入术后支架覆盖情况的彻底病理调查--本研究弥补了这一空白:方法:从我们对 199 个支架病变的尸检登记中,对 66 个目前可用的 DES 支架病变中植入时间≤370 天的 4713 个支架进行了组织学评估。内皮覆盖的定义是支架上存在管腔内皮细胞和下层平滑肌细胞层。将支架病变分为急性冠状动脉综合征(ACS)组(n = 40)和慢性冠状动脉综合征(CCS)组(n = 26),并进行比较。通过逻辑分析确定了内皮覆盖的预测因素:虽然 ACS 和 CCS 病变的临床特征(包括年龄、性别和死因)相似,但后者的慢性肾病和血液透析患病率明显高于前者(33.3% 对 65.2%;P = 0.02,7.7% 对 30.4%;P = 0.02)。ACS 病变的支架植入后中位持续时间明显短于 CCS 病变(13 [IQR 5-26 天] vs. 40 [IQR 16-233 天];P < 0.01)。植入目前可用的 DES 后,30 天和 90 天的内皮覆盖率分别为 3.5%和 27.7%。多变量逻辑回归分析显示,植入时间≤90 天[几率比 (OR),0.009;95% 置信区间 (CI),0.006-0.012;P < 0.01]、表层钙化(OR,0.11;95% CI,0.07-0.17;p < 0.01)、ACS罪魁祸首部位(OR,0.29;95% CI,0.09-0.94;p = 0.039)和圆周耐久性聚合物涂层DES(OR,0.32;95% CI,0.24-0.41;p < 0.01)为延迟内皮覆盖预测因子:结论:目前可用的DES植入90天后内皮覆盖有限,ACS罪魁祸首部位和圆周耐久性聚合物涂层DES被确定为延迟内皮覆盖的独立预测因素。我们的研究结果表明,潜在的斑块形态和支架技术对此类植入后的血管愈合非常重要。
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引用次数: 0
Rationale and design of INFINITY-SWEDEHEART: A registry-based randomized clinical trial comparing clinical outcomes of the sirolimus-eluting DynamX bioadaptor to the zotarolimus-eluting Resolute Onyx stent INFINITY-SWEDEHEART 的原理和设计:一项基于登记的随机临床试验,比较了西罗莫司洗脱的 DynamX 生物适配器和佐他罗莫司洗脱的 Resolute Onyx 支架的临床疗效。
IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-08-02 DOI: 10.1016/j.ahj.2024.07.016

Background

Modern drug-eluting stents have seen significant improvements, yet still create a rigid cage within the coronary artery. There is a 2% to 4% annual incidence of target lesion failure (TLF) beyond 1 year, and half of the patients experience angina after 5 years. The DynamX bioadaptor is a sirolimus-eluting, thin (71 µm) cobalt-chromium platform with helical strands that unlock and separate after in vivo degradation of the bioresorbable polymer coating. This allows the vessel to return to normal physiological function and motion, along with compensatory adaptive remodeling, which may reduce the need for reintervention and alleviate angina following percutaneous coronary intervention (PCI).

Methods

The INFINITY-SWEDEHEART trial is a single-blind, registry-based randomized clinical trial (R-RCT) to evaluate the safety and effectiveness of the DynamX bioadaptor compared to the Resolute Onyx stent in the treatment of patients with ischemic heart disease with de novo native coronary artery lesions. The R-RCT framework allows for recruitment, randomization, and pragmatic data collection of baseline demographics, medications, and clinical outcomes using existing national clinical registries integrated with the trial database. The primary objective is to demonstrate noninferiority in terms of freedom from TLF (cardiovascular death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) at 1 year. Powered secondary endpoints will be tested sequentially for superiority from 6 months to the end of follow-up (5 years) for the following: 1) TLF in all subjects, 2) target vessel failure in all subjects, and 3) TLF in subjects with acute coronary syndrome (ACS). Subsequent superiority testing will be performed at a time determined depending on the number of events, ensuring sufficient statistical power. Change in angina-related symptoms, function and quality of life will be assessed using the Seattle Angina Questionnaire-short version. Predefined sub-groups will be analyzed. In total, 2400 patients have been randomized at 20 sites in Sweden. Available baseline characteristic reveal relatively old age (68 years) and a large proportion of ACS patients including 25% STEMI and 37% NSTEMI patients.

Summary

The INFINITY-SWEDEHEART study is designed to evaluate the long-term safety and efficacy of the DynamX bioadaptor compared to the Resolute Onyx stent in a general PCI patient population.

背景:现代药物洗脱支架已取得重大改进,但仍会在冠状动脉内形成一个僵硬的笼。一年后靶病变失败(TLF)的年发生率为 2-4%,五年后半数患者出现心绞痛。DynamX 生物适配器是一种西罗莫司洗脱的薄型(71 微米)钴铬平台,其螺旋股可在生物可吸收聚合物涂层在体内降解后解锁和分离。这能使血管恢复正常的生理功能和运动,同时进行代偿性适应性重塑,从而减少再次介入的需要,缓解经皮冠状动脉介入治疗(PCI)后的心绞痛:INFINITY-SWEDEHEART试验是一项基于登记的单盲随机临床试验(R-RCT),旨在评估DynamX生物适配器与Resolute Onyx支架相比,在治疗新发原发性冠状动脉病变的缺血性心脏病患者中的安全性和有效性。R-RCT框架允许利用与试验数据库集成的现有国家临床登记处进行招募、随机化和基线人口统计学、药物和临床结果的务实数据收集。主要目标是证明在 1 年内免于 TLF(心血管死亡、靶血管心肌梗死或缺血导致的靶病变血管再通)的非劣效性。从 6 个月到随访结束(5 年),将依次测试下列次要终点的优越性:1)所有受试者的 TLF;2)所有受试者的靶血管失败;3)急性冠状动脉综合征(ACS)受试者的 TLF。随后的优越性测试将根据事件数量确定时间,以确保足够的统计能力。心绞痛相关症状、功能和生活质量的变化将使用西雅图心绞痛问卷-简易版进行评估。将对预先确定的亚组进行分析。在瑞典的 20 个地点,共有 2400 名患者接受了随机治疗。摘要:INFINITY-SWEDEHEART研究旨在评估DynamX生物适配器与Resolute Onyx支架在普通PCI患者群体中的长期安全性和有效性。
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American heart journal
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