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Is There an Alternative Oral Anticoagulation to Vitamin-K-Antagonists for Patients with Mechanical Aortic Valve Replacement? - A Literature Review. 机械主动脉瓣置换术患者是否有替代维生素 K 拮抗剂的口服抗凝药?- 文献综述。
IF 3 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-09-01 Epub Date: 2024-05-16 DOI: 10.1007/s40119-024-00371-8
Stephen Gerfer, Thorsten Wahlers, Elmar Kuhn

Current guidelines exclusively recommend vitamin-K-antagonists (VKA) as anticoagulation for patients after mechanical aortic valve replacement due to the increased postoperative risk of valve thrombosis and thrombo-embolism. Strict and regular assessments are mandatory during VKA therapy to ensure a potent anticoagulatory effect within the desired range. From the patients' perspective, VKA are associated with relevant interactions and side effects reducing the quality of life and contributing to a high number of patients not achieving the optimal therapeutic target. Direct oral anticoagulants (DOAC) have replaced VKA therapy in the past for several indications, e.g., atrial fibrillation. However, it is still unclear if DOACs could replace VKA therapy in patients after mechanical aortic valve replacement. While the PROACT-Xa study did not show a sufficient anticoagulatory effect of apixaban plus aspirin compared to VKA therapy in patients after mechanical aortic valve replacement, the direct thrombin inhibitor dabigatran and the oral factor Xa inhibitors apixaban and rivaroxaban showed promising results in comparable patient cohorts in smaller studies and case reports. Factor Xa inhibitors were able to prevent thrombosis and thrombo-embolic events in patients after mechanical aortic valve replacement. Therefore, factor Xa inhibitors or factor XI inhibitors could provide a potent alternative to VKA for patients after a mechanical aortic valve replacement.

由于术后瓣膜血栓形成和血栓栓塞的风险增加,目前的指南只推荐使用维生素-K-拮抗剂(VKA)作为机械主动脉瓣置换术后患者的抗凝药物。在 VKA 治疗期间,必须进行严格和定期的评估,以确保在理想范围内发挥有效的抗凝作用。从患者的角度来看,VKA 与相关的相互作用和副作用有关,会降低患者的生活质量,并导致大量患者无法达到最佳治疗目标。过去,直接口服抗凝剂(DOAC)已在心房颤动等多个适应症中取代了 VKA 疗法。然而,对于机械主动脉瓣置换术后的患者,DOAC 能否取代 VKA 治疗仍不清楚。虽然 PROACT-Xa 研究并未显示阿哌沙班加阿司匹林与 VKA 相比对机械主动脉瓣置换术后患者有足够的抗凝效果,但直接凝血酶抑制剂达比加群、口服 Xa 因子抑制剂阿哌沙班和利伐沙班在较小规模的研究和病例报告中对可比患者群显示出了良好的效果。Xa 因子抑制剂能够预防机械主动脉瓣置换术后患者的血栓形成和血栓栓塞事件。因此,Xa 因子抑制剂或 XI 因子抑制剂可作为机械主动脉瓣置换术后患者 VKA 的有效替代药物。
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引用次数: 0
Recent Advances in Targeted Management of Inflammation In Atherosclerosis: A Narrative Review. 动脉粥样硬化炎症靶向治疗的最新进展:叙述性综述。
IF 3 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-09-01 Epub Date: 2024-07-20 DOI: 10.1007/s40119-024-00376-3
Rafael Zubirán, Edward B Neufeld, Amaury Dasseux, Alan T Remaley, Alexander V Sorokin

Atherosclerotic cardiovascular disease (ASCVD) remains a leading cause of morbidity and mortality despite effective low-density lipoprotein cholesterol-targeted therapies. This review explores the crucial role of inflammation in the residual risk of ASCVD, emphasizing its impact on atherosclerosis progression and plaque stability. Evidence suggests that high-sensitivity C-reactive protein (hsCRP), and potentially other inflammatory biomarkers, can be used to identify the inflammatory residual ASCVD risk phenotype and may serve as future targets for the development of more efficacious therapeutic approaches. We review the biological basis for the association of inflammation with ASCVD, propose new therapeutic strategies for the use of inflammation-targeted treatments, and discuss current challenges in the implementation of this new treatment paradigm for ASCVD.

尽管采用了有效的低密度脂蛋白胆固醇靶向疗法,动脉粥样硬化性心血管疾病(ASCVD)仍然是发病率和死亡率的主要原因。本综述探讨了炎症在 ASCVD 剩余风险中的关键作用,强调了炎症对动脉粥样硬化进展和斑块稳定性的影响。有证据表明,高敏C反应蛋白(hsCRP)和其他潜在的炎症生物标志物可用于识别炎症性残余ASCVD风险表型,并可作为未来开发更有效治疗方法的靶点。我们回顾了炎症与 ASCVD 关联的生物学基础,提出了使用炎症靶向疗法的新治疗策略,并讨论了目前在实施这种新的 ASCVD 治疗模式时所面临的挑战。
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引用次数: 0
Prevalence of Tendon Rupture and Tendinopathies Among Patients with Atherosclerotic Cardiovascular Disease Derived From United States Administrative Claims Data. 从美国行政索赔数据中得出的动脉粥样硬化性心血管疾病患者肌腱断裂和肌腱病的患病率。
IF 3 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-09-01 Epub Date: 2024-07-14 DOI: 10.1007/s40119-024-00374-5
Kristin K Gillard, LeAnne Bloedon, John C Grady-Benson, Alison Edwards, Sean Fahy, William J Sasiela, Michael J Louie, Paul D Thompson

Introduction: The prevalence of tendon rupture and tendinopathies (TRT) has not been determined in a large population of patients with atherosclerotic cardiovascular disease (ASCVD). We investigated TRT prevalence among patients with ASCVD and in the general population, using data from the Symphony Health Integrated Dataverse, a large US medical and pharmacy claims database.

Methods: This retrospective, observational study included patients aged ≥ 19 years from the claims database during the identification period (January 2019 to December 2020) and 12 months of continuous enrollment. The primary outcome was evidence of TRT in the 12 months following the index date (first ASCVD diagnosis in the ASCVD cohort; first claim in the claims database in the overall population). Diagnostic codes (ICD-10 and/or CPT) were used to define ASCVD and TRT diagnosis.

Results: The ASCVD cohort and overall population included 5,589,273 and 61,715,843 patients, respectively. In the ASCVD cohort, use of medications with a potential or known association with TRT was identified in 67.9% (statins), 17.7% (corticosteroids), and 16.7% (fluoroquinolones) of patients. Bempedoic acid use was reported in 1556 (< 0.1%) patients. TRT prevalence during 12-month follow-up was 3.4% (ASCVD cohort) and 1.9% (overall population). Among patients with ASCVD, 83.5% experienced TRT in only one region of the body. Factors most associated with TRT in the ASCVD cohort were increasing age, most notably in those aged 45-‍64 years (odds ratio [OR] 2.19; 95% confidence interval [CI] 2.07-2.32), obesity (OR 1.51; 95% CI 1.50-1.53), and rheumatoid arthritis (OR 1.47; 95% CI 1.45-1.79). Use of statins or bempedoic acid was not associated with increased TRT risk.

Conclusion: Patients with ASCVD may have greater risk of TRT than the general population, which may be driven by an increased prevalence of comorbidities and use of medications with a potential or known association with TRT.

简介:尚未确定大量动脉粥样硬化性心血管疾病(ASCVD)患者中肌腱断裂和肌腱病(TRT)的发病率。我们利用美国大型医疗和药费报销数据库 Symphony Health Integrated Dataverse 中的数据,调查了 ASCVD 患者和普通人群中的 TRT 患病率:这项回顾性观察研究纳入了索赔数据库中年龄≥ 19 岁的患者,这些患者在识别期(2019 年 1 月至 2020 年 12 月)和连续注册的 12 个月内都在该数据库中。主要结果是指数日期(ASCVD 队列中的首次 ASCVD 诊断;总体人群中理赔数据库中的首次理赔)后 12 个月内的 TRT 证据。诊断代码(ICD-10和/或CPT)用于定义ASCVD和TRT诊断:ASCVD队列和总体人群分别包括5,589,273和61,715,843名患者。在ASCVD队列中,67.9%的患者(他汀类药物)、17.7%的患者(皮质类固醇)和16.7%的患者(氟喹诺酮类药物)使用了可能或已知与TRT有关的药物。据报道,1556 例患者使用了本贝多克酸(结论:ASCVD 患者可能更有可能使用本贝多克酸):ASCVD患者发生TRT的风险可能高于普通人群,其原因可能是合并症的发生率增加,以及使用与TRT有潜在或已知关联的药物。
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引用次数: 0
Narrative Review: Surgical and Hybrid Management of Atrial Fibrillation. 叙述性评论:心房颤动的手术和混合治疗。
IF 3 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-09-01 Epub Date: 2024-08-12 DOI: 10.1007/s40119-024-00377-2
Richard G Trohman

Although significant strides have been made in non-pharmacologic management of atrial fibrillation (AF), these treatments remain a work in progress. While catheter ablation is often effective for management of paroxysmal AF, it is less successful in patients with persistent or longstanding persistent AF. This review was undertaken to clarify the risks, benefits, and alternatives to catheter ablation for non-pharmacologic AF management. In order to clarify the roles of surgical and hybrid ablation, this narrative review was undertaken by searching MEDLINE to identify peer-reviewed clinical trials, randomized controlled trials, meta-analyses, review articles, and other clinically relevant studies. The search was limited to English-language reports published between 1960 and 2023. Atrial fibrillation was searched using the terms surgical ablation, catheter ablation, hybrid ablation, stroke prevention, left atrial occlusion, and atrial excision. Google and Google Scholar, as well as bibliographies of identified articles, were also reviewed for additional references. The Cox-maze surgical approach is still the most efficacious non-pharmacological treatment for AF. Hybrid ablation, combining cardiac surgical and catheter ablation techniques, has become an attractive option for persistent or longstanding persistent AF.

尽管心房颤动(房颤)的非药物治疗取得了长足进步,但这些治疗方法仍在不断改进中。虽然导管消融治疗阵发性房颤通常很有效,但对于持续性房颤或长期持续性房颤患者来说,成功率较低。本综述旨在阐明非药物房颤治疗中导管消融的风险、益处和替代方法。为了明确手术消融和混合消融的作用,本叙述性综述通过检索 MEDLINE 来确定同行评议的临床试验、随机对照试验、荟萃分析、综述文章和其他临床相关研究。检索仅限于 1960 年至 2023 年间发表的英文报告。使用手术消融、导管消融、混合消融、中风预防、左心房闭塞和心房切除等术语对心房颤动进行了检索。此外,还查阅了谷歌和谷歌学术以及已确定文章的参考文献,以获取更多参考文献。考克斯迷宫手术方法仍是治疗房颤最有效的非药物疗法。混合消融结合了心脏外科手术和导管消融技术,已成为治疗持续性或长期持续性房颤的一种有吸引力的选择。
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引用次数: 0
Safety and Effectiveness of Four-Factor Prothrombin Complex Concentrate in Special Populations with INR Below 2: A Post-Marketing Surveillance Study. 四因子凝血酶原复合物浓缩物在 INR 值低于 2 的特殊人群中的安全性和有效性:一项上市后监测研究。
IF 3 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-09-01 Epub Date: 2024-08-03 DOI: 10.1007/s40119-024-00380-7
Masahiro Yasaka, Fumihiko Shimizu, Yuki Niwa, Ayako Kiyonaga, Naoki Terasaka

Introduction: We previously conducted a prospective, observational post-marketing surveillance study to assess the safety and effectiveness of four-factor prothrombin complex concentrate (4F-PCC) for rapid vitamin K antagonist (VKA) reversal in Japanese patients.

Methods: This subgroup analysis compared the safety, especially thromboembolic events (TEEs), and effectiveness of 4F-PCC by stratifying patients into two subgroups according to baseline international normalized ratio (INR) levels with < 2.0 and ≥ 2.0.

Results: Of 1271 eligible patients, 215 (17.9%) had INR < 2.0 and 987 (82.1%) had INR ≥ 2.0. Overall baseline characteristics were similar between groups; age (74.0 years vs 74.0 years), body mass index (22.1 kg/m2 vs 21.9 kg/m2), ratio of inpatients (90.2% vs 88.7%), manifested atrial fibrillation (46.0% vs 48.8%). Median INRs at baseline were 1.72 (minimum 0.92, maximum 1.99) in the INR < 2.0 group and 2.95 (2.00, 27.11) in the INR ≥ 2.0 group. The most common reason for 4F-PCC administration was intracranial hemorrhage (67.0% vs 59.5%), and lesser gastrointestinal bleeding (0.9% vs 7.5%). After 4F-PCC administration (average doses 24.5 IU/kg [INR < 2.0 group] and 29.2 IU/kg [INR ≥ 2.0 group]), INRs were significantly reduced to 1.21 (- 28%) and 1.31 (- 68%), respectively, and resulted in hemostasis in a similarly rapid manner. The incidences of adverse drug reactions were 3.7% in each group. TEEs occurred in 4 (1.9%) patients in the INR < 2.0 group and 11 (1.1%) patients in the INR ≥ 2.0 group and were predominantly composed of stroke, while similar rates (67.0% vs 62.9%) of bleeding events post-anticoagulant resumption were observed between groups.

Conclusion: This study supports the favorable tolerability and efficacy of 4F-PCC regardless of baseline INR (< 2.0 or ≥ 2.0), with a prompt reduction of INR and substantial hemostatic effectiveness in the real-world setting for patients requiring urgent VKA reversal, although no indicated 4F-PCC dose for VKA reversal exists for INR < 2.0 to date.

简介:我们曾进行过一项前瞻性、观察性的上市后监测研究,以评估四因子凝血酶原复合物浓缩物(4F-PCC)在日本患者中用于快速逆转维生素 K 拮抗剂(VKA)的安全性和有效性:该亚组分析比较了 4F-PCC 的安全性(尤其是血栓栓塞事件 (TEE))和有效性,根据基线国际标准化比值 (INR) 水平将患者分为两个亚组:在 1271 名符合条件的患者中,215 人(17.9%)的 INR 为 2 vs 21.9 kg/m2,住院患者比例为 90.2% vs 88.7%,表现为心房颤动(46.0% vs 48.8%)。INR基线中位数为1.72(最低0.92,最高1.99):这项研究支持 4F-PCC 具有良好的耐受性和疗效,无论基线 INR (
{"title":"Safety and Effectiveness of Four-Factor Prothrombin Complex Concentrate in Special Populations with INR Below 2: A Post-Marketing Surveillance Study.","authors":"Masahiro Yasaka, Fumihiko Shimizu, Yuki Niwa, Ayako Kiyonaga, Naoki Terasaka","doi":"10.1007/s40119-024-00380-7","DOIUrl":"10.1007/s40119-024-00380-7","url":null,"abstract":"<p><strong>Introduction: </strong>We previously conducted a prospective, observational post-marketing surveillance study to assess the safety and effectiveness of four-factor prothrombin complex concentrate (4F-PCC) for rapid vitamin K antagonist (VKA) reversal in Japanese patients.</p><p><strong>Methods: </strong>This subgroup analysis compared the safety, especially thromboembolic events (TEEs), and effectiveness of 4F-PCC by stratifying patients into two subgroups according to baseline international normalized ratio (INR) levels with < 2.0 and ≥ 2.0.</p><p><strong>Results: </strong>Of 1271 eligible patients, 215 (17.9%) had INR < 2.0 and 987 (82.1%) had INR ≥ 2.0. Overall baseline characteristics were similar between groups; age (74.0 years vs 74.0 years), body mass index (22.1 kg/m<sup>2</sup> vs 21.9 kg/m<sup>2</sup>), ratio of inpatients (90.2% vs 88.7%), manifested atrial fibrillation (46.0% vs 48.8%). Median INRs at baseline were 1.72 (minimum 0.92, maximum 1.99) in the INR < 2.0 group and 2.95 (2.00, 27.11) in the INR ≥ 2.0 group. The most common reason for 4F-PCC administration was intracranial hemorrhage (67.0% vs 59.5%), and lesser gastrointestinal bleeding (0.9% vs 7.5%). After 4F-PCC administration (average doses 24.5 IU/kg [INR < 2.0 group] and 29.2 IU/kg [INR ≥ 2.0 group]), INRs were significantly reduced to 1.21 (- 28%) and 1.31 (- 68%), respectively, and resulted in hemostasis in a similarly rapid manner. The incidences of adverse drug reactions were 3.7% in each group. TEEs occurred in 4 (1.9%) patients in the INR < 2.0 group and 11 (1.1%) patients in the INR ≥ 2.0 group and were predominantly composed of stroke, while similar rates (67.0% vs 62.9%) of bleeding events post-anticoagulant resumption were observed between groups.</p><p><strong>Conclusion: </strong>This study supports the favorable tolerability and efficacy of 4F-PCC regardless of baseline INR (< 2.0 or ≥ 2.0), with a prompt reduction of INR and substantial hemostatic effectiveness in the real-world setting for patients requiring urgent VKA reversal, although no indicated 4F-PCC dose for VKA reversal exists for INR < 2.0 to date.</p>","PeriodicalId":9561,"journal":{"name":"Cardiology and Therapy","volume":" ","pages":"603-614"},"PeriodicalIF":3.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11333383/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141888512","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
All-Cause Mortality of Atrial Fibrillation and Heart Failure in the Same Patient: Does the Order Matter? 同一患者心房颤动和心力衰竭的全因死亡率:顺序重要吗?
IF 3 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-09-01 Epub Date: 2024-08-13 DOI: 10.1007/s40119-024-00378-1
Tímea Papp, György Rokszin, Zoltán Kiss, Dávid Becker, Béla Merkely, Zoltán Járai, András Jánosi, Zoltán Csanádi

Introduction: Atrial fibrillation (AF) and heart failure (HF) often coexist due to the common elements of the pathomechanism they share. The potential significance of the order these entities present in the same patient is ill-defined. Herein, we report our results from a nationwide database on the occurrence of various sequences AF and HF may present, the time delays between the two conditions and all-cause mortality associated with different scenarios.

Methods: Patients diagnosed with both AF and HF between 2015 and 2021 were enrolled from the Hungarian National Health Insurance Fund (NHIF) database. The order the two entities followed each other, and the time delay in between were registered. Median survival rates were calculated in AF → HF; HF → AF and simultaneous scenarios.

Results: A total of 109,075 patients were enrolled: 29,937 with AF → HF, 38,171 with HF → AF, and 40,967 diagnosed simultaneously. Time delays between AF → HF and HF → AF were 6 and 10 months, respectively. The median survival was 46 months in the AF → HF, 38 months in the HF → AF, and 21 months in the simultaneous group. Patients with HF → AF, and with simultaneous presentations had 5% and 16% greater mortality risk as compared to the AF → HF sequence, with hazard ratios (95% confidence intervals) of 0.95 (0.93-0.97) and 0.84 (0.82-0.85), respectively (P < 0.0001).

Conclusions: HF occurred significantly earlier after the diagnosis of AF than vice versa. Patients diagnosed simultaneously had the worst, while the AF → HF sequence had the best prognosis. These data should have implications for the intensification of monitoring and therapy in different scenarios.

导言:由于心房颤动(AF)和心力衰竭(HF)的共同病理机制,它们常常同时存在。这两种疾病在同一患者身上出现的先后顺序的潜在意义尚不明确。在此,我们从一个全国性数据库中报告了房颤和心房颤动可能出现的各种顺序、两种病症之间的时间延迟以及与不同情况相关的全因死亡率:方法:从匈牙利国家医疗保险基金(NHIF)数据库中选取了 2015 年至 2021 年期间诊断为房颤和高血压的患者。登记了两种疾病发生的先后顺序以及之间的时间差。计算了房颤→高频、高频→房颤和同时发生情况下的中位生存率:共有 109,075 名患者登记:29,937 名患者为房颤→高频,38,171 名患者为高频→房颤,40,967 名患者为同时诊断。房颤→高频和高频→房颤之间的时间差分别为 6 个月和 10 个月。房颤→高频组的中位生存期为46个月,高频→房颤组为38个月,同时确诊组为21个月。与房颤→高频序列相比,高频→房颤和同时出现房颤的患者的死亡风险分别高出5%和16%,危险比(95%置信区间)分别为0.95(0.93-0.97)和0.84(0.82-0.85)(P 结论:房颤→高频和同时出现房颤的患者的死亡风险分别高出5%和16%,危险比(95%置信区间)分别为0.95(0.93-0.97)和0.84(0.82-0.85):心房颤动诊断后发生心房颤动的时间明显早于心房颤动诊断后发生心房颤动的时间。同时确诊的患者预后最差,而房颤→高频序列的患者预后最好。这些数据将对在不同情况下加强监测和治疗产生影响。
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引用次数: 0
Patient and Physician Perspectives on the Benefits and Risks of Antiplatelet Therapy for Acute Coronary Syndrome. 患者和医生对急性冠状动脉综合征抗血小板疗法的益处和风险的看法。
IF 3 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-09-01 Epub Date: 2024-06-21 DOI: 10.1007/s40119-024-00372-7
Marc Cohen, Colin Jones

This article is co-authored by a patient with acute coronary syndrome (ACS) who is receiving long-term antiplatelet therapy in the USA and a cardiologist who routinely treats patients with ACS. The patient describes his experience from diagnosis to the present day and discusses his concerns regarding treatment and management of the condition, including the balance between the benefits and risks of antiplatelet therapy. The patient also describes his work as an advocate for cardiac health. The physician perspective on treating and managing patients with ACS is provided by a cardiologist based in the USA who is and was not involved in this patient's care. The physician reviews the benefits and risks of antiplatelet therapies for the treatment of patients with ACS and discusses his own clinical experience of managing these patients, including how issues such as treatment adherence, as well as the potential inertia to prescribing certain medications that may be seen among physicians, could be overcome.

本文由一位在美国接受长期抗血小板治疗的急性冠状动脉综合征(ACS)患者和一位常规治疗 ACS 患者的心脏病专家共同撰写。该患者描述了他从诊断到现在的经历,并讨论了他对治疗和病情管理的担忧,包括抗血小板治疗的益处和风险之间的平衡。患者还介绍了他作为心脏健康倡导者所做的工作。美国的一位心脏病专家从医生的角度阐述了对 ACS 患者的治疗和管理,他现在和过去都没有参与该患者的治疗。该医生回顾了抗血小板疗法治疗 ACS 患者的益处和风险,并讨论了他自己管理这些患者的临床经验,包括如何克服治疗依从性等问题,以及医生在开具某些药物处方时可能出现的惰性。
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引用次数: 0
Pharmacodynamic Comparison of Two Aspirin Formulations in the Caribbean: The ARC Study. 加勒比地区两种阿司匹林配方的药效学比较:ARC 研究。
IF 3 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-09-01 Epub Date: 2024-07-15 DOI: 10.1007/s40119-024-00373-6
Naveen Seecheran, Penelope McCallum, Kathryn Grimaldos, Priya Ramcharan, Jessica Kawall, Arun Katwaroo, Valmiki Seecheran, Cathy-Lee Jagdeo, Salma Rafeeq, Rajeev Seecheran, Abel Leyva Quert, Nafeesah Ali, Lakshmipathi Peram, Shari Khan, Fareed Ali, Shastri Motilal, Neal Bhagwandass, Stanley Giddings, Anil Ramlackhansingh, Sherry Sandy

Introduction: This prospective, single-arm, crossover pharmacodynamic study assessed the effect of Bayer® low-dose enteric-coated aspirin 81 mg tablets (LD EC-ASA) (Bayer AG, Leverkusen, North Rhine-Westphalia, Germany) compared to Vazalore® low-dose phospholipid-aspirin liquid-filled 81 mg capsules (LD PL-ASA) (PLx Pharma Inc., Sparta, NJ, USA) on platelet reactivity with respect to aspirin reaction units (ARU).

Methods: Forty-seven healthy volunteers were recruited. Platelet function was evaluated with the VerifyNow™ ARU assay (Werfen, Bedford, MA, USA) and assessed post-initiation of Bayer® LD EC-ASA daily for 14 days, with a washout period of 28 days, followed by Vazalore® LD PL-ASA daily for 14 days, again followed by ARU testing.

Results: Participants on LD EC-ASA had a mean ARU score of 426, with 19.1% of participants having an ARU > 550; patients on LD PL-ASA derived a mean ARU score of 435, with 14.9% achieving an ARU > 550. There were no significant differences in aspirin resistance (ARU > 550) according to the formulation (Bayer® LD EC-ASA vs. Vazalore® LD PL-ASA) used. Aspirin resistance was independent of ethnicity regardless of the formulation used. In addition, there were no significant associations between body surface area (BSA) and Bayer® LD EC-ASA ARU value (p value 0.788) or Vazalore® LD PL-ASA ARU value (p value 0.477). No patients experienced any serious adverse events or treatment-emergent adverse events.

Conclusions: There were no significant differences in aspirin resistance between Bayer® LD EC-ASA and Vazalore® LD PL-ASA. This dedicated pharmacodynamic study could potentially be informative and applicable for Trinidadian patients on dual antiplatelet therapy (DAPT). Further studies are required to confirm these exploratory findings.

Trial registration: ClinicalTrials.gov identifier, NCT06228820, prospectively registered 1/18/2024.

研究简介这项前瞻性、单臂、交叉药效学研究评估了拜耳®低剂量阿司匹林81毫克肠溶片(LD EC-ASA)(拜耳股份公司,德国北威州勒沃库森)与Vazalore®低剂量磷脂阿司匹林81毫克液体填充胶囊(LD PL-ASA)(PLx Pharma Inc:方法:招募了 47 名健康志愿者。使用 VerifyNow™ ARU 分析仪(Werfen,美国马萨诸塞州贝德福德)评估血小板功能,并在开始每天服用拜耳® LD EC-ASA 14 天后进行评估,28 天为冲洗期,然后每天服用 Vazalore® LD PL-ASA 14 天,之后再次进行 ARU 测试:服用低剂量EC-ASA的患者平均ARU评分为426分,其中19.1%的患者ARU大于550分;服用低剂量PL-ASA的患者平均ARU评分为435分,其中14.9%的患者ARU大于550分。不同配方(拜耳® LD EC-ASA 与 Vazalore® LD PL-ASA)的阿司匹林耐药性(ARU > 550)没有明显差异。无论使用哪种配方,阿司匹林耐药性都与种族无关。此外,体表面积(BSA)与拜耳® LD EC-ASA ARU 值(p 值 0.788)或 Vazalore® LD PL-ASA ARU 值(p 值 0.477)之间无明显关联。没有患者出现任何严重不良事件或治疗突发不良事件:拜耳® LD EC-ASA和Vazalore® LD PL-ASA在阿司匹林耐药性方面没有明显差异。这项专门的药效学研究可能具有参考价值,适用于接受双重抗血小板疗法(DAPT)的特立尼达患者。还需要进一步的研究来证实这些探索性发现:试验注册:ClinicalTrials.gov标识符,NCT06228820,2024年1月18日前瞻性注册。
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引用次数: 0
Emergent Coronary Thrombectomy for Acute Myocardial Infarction Immediately Following Craniotomy with Tumor Resection. 开颅肿瘤切除术后立即进行冠状动脉血栓清除术治疗急性心肌梗死
IF 3 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-06-01 Epub Date: 2024-03-27 DOI: 10.1007/s40119-024-00356-7
Curtis R Ginder, Giselle A Suero-Abreu, Saad S Ghumman, Brian A Bergmark, Omar Arnaout, Robert P Giugliano

The management of perioperative acute myocardial infarction (AMI) following oncologic neurosurgery requires balancing competing risks of myocardial ischemia and postoperative bleeding. There are limited human data to establish the safest timing of antiplatelet or anticoagulation therapy following neurosurgical procedures. For patients with malignancy experiencing AMI in the acute postoperative period, staged percutaneous coronary intervention (PCI) with upfront coronary aspiration thrombectomy followed by delayed completion PCI may offer an opportunity for myocardial salvage while minimizing postoperative bleeding risks. CYP2C19 genotyping and platelet aggregation studies can help confirm adequate platelet inhibition once antiplatelet therapy is resumed.

肿瘤神经外科手术后围术期急性心肌梗死(AMI)的处理需要平衡心肌缺血和术后出血的风险。目前只有有限的人类数据可以确定神经外科手术后抗血小板或抗凝治疗的最安全时机。对于在术后急性期发生急性心肌梗死的恶性肿瘤患者,分阶段进行经皮冠状动脉介入治疗(PCI),先进行冠状动脉抽吸血栓切除术,然后再延迟完成PCI,这样既能挽救心肌,又能最大限度地降低术后出血风险。一旦恢复抗血小板治疗,CYP2C19 基因分型和血小板聚集研究可帮助确认充分的血小板抑制。
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引用次数: 0
Effects of Ivabradine on Myocardial Perfusion in Chronic Angina: A Prospective, Preliminary, Open-Label, Single-Arm Study. 伊伐布雷定对慢性心绞痛心肌灌注的影响:一项前瞻性、初步、开放标签、单臂研究
IF 3 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-06-01 Epub Date: 2024-03-22 DOI: 10.1007/s40119-024-00363-8
Olímpio R França Neto, Miguel M Fernandes-Silva, Rodrigo J Cerci, Carlos A Cunha-Pereira, Margaret Masukawa, João V Vitola

Introduction: Ivabradine reduces heart rate (HR), episodes of angina, and nitrate consumption, and increases exercise capacity in patients with chronic angina (CA). In this exploratory study, myocardial perfusion scintigraphy (MPS) was used to evaluate changes in the percentage of myocardial ischemia after ivabradine therapy in patients with CA.

Methods: This prospective, open-label, single-arm study included patients with CA receiving maximum tolerated doses of beta blockers, who had a resting HR ≥ 70 bpm and had experienced ischemia according to MPS during an exercise test at baseline. Participants received ivabradine 5 mg twice daily (titrated according to HR) concomitant with beta blockers. A second MPS was performed after 3 months, without interruption of treatment with beta blockers or ivabradine. The primary outcome was change in the percentage of myocardial ischemia from baseline to 3 months. Time to ischemia during the exercise test, the proportion of patients presenting angina during the exercise test, and health status, assessed using the seven-item Seattle Angina Questionnaire-7 (SAQ-7), were also evaluated.

Results: Twenty patients (3 females) with a mean (± standard deviation [SD]) age of 62.2 ± 6.5 years were included in the study, of whom 55% had diabetes, 70% had previous myocardial revascularization, and 45% had previous myocardial infarction. The percentage of patients with myocardial ischemia significantly decreased from baseline to 3 months after initiation of treatment with ivabradine (- 2.9%; 95% confidence interval [CI] - 0.3 to - 5.5; p = 0.031). Mean time to appearance of ischemia increased from 403 ± 176 s at baseline to 466 ± 136 s at 3 months after initiation of ivabradine (Δ62 s; 95% CI 18-106 s; p = 0.008), and the proportion of patients experiencing angina during the exercise test decreased from 40% at baseline to 5% also at 3 months (p = 0.016). Mean resting HR decreased from 76 ± 7 bpm at baseline to 55 ± 8 bpm at 3 months (p < 0.001). The mean SAQ-7 summary score improved from 69 ± 21 at baseline to 83 ± 12 at 3 months (p = 0.001). No serious adverse effects were reported.

Conclusion: Ivabradine added to beta blockers was associated with a reduction in detectable myocardial ischemia by MPS in patients with CA. Infographic available for this article.

Trial registration: The trial has been retrospectively registered with the Brazilian Registry of Clinical Trials (REBEC) under the following number RBR-5fysqrh (date of registration: 30 November 2023).

简介伊伐布雷定可降低慢性心绞痛(CA)患者的心率(HR)、心绞痛发作次数和硝酸盐消耗量,并提高运动能力。在这项探索性研究中,心肌灌注闪烁成像(MPS)用于评估伊伐布雷定治疗后慢性心绞痛患者心肌缺血比例的变化:这项前瞻性、开放标签、单臂研究纳入了接受最大耐受剂量β受体阻滞剂治疗的CA患者,这些患者的静息心率≥70 bpm,并在基线运动测试中出现了MPS显示的心肌缺血。参试者在服用β受体阻滞剂的同时服用伊伐布雷定,每次 5 毫克,每天两次(根据心率滴定)。3 个月后,在不中断β受体阻滞剂或伊伐布雷定治疗的情况下进行第二次MPS。主要结果是从基线到 3 个月期间心肌缺血百分比的变化。此外,还评估了运动测试中出现心肌缺血的时间、运动测试中出现心绞痛的患者比例,以及使用西雅图心绞痛问卷-7(SAQ-7)七项评估的健康状况:研究共纳入 20 名患者(3 名女性),平均年龄(± 标准差 [SD])为 62.2±6.5 岁,其中 55% 患有糖尿病,70% 曾接受过心肌血运重建,45% 曾患心肌梗死。从基线到开始使用伊伐布雷定治疗 3 个月后,心肌缺血患者的比例显著下降(- 2.9%;95% 置信区间 [CI] - 0.3 至 - 5.5;P = 0.031)。出现缺血的平均时间从基线时的 403 ± 176 秒增加到开始使用伊伐布雷定 3 个月后的 466 ± 136 秒(Δ62 秒;95% 置信区间 18-106 秒;p = 0.008),在运动测试中出现心绞痛的患者比例从基线时的 40% 减少到 3 个月时的 5% (p = 0.016)。平均静息心率从基线时的 76 ± 7 bpm 降至 3 个月时的 55 ± 8 bpm(P = 0.008):伊伐布雷定与β受体阻滞剂联用可减少CA患者通过MPS检测到的心肌缺血。本文附有信息图表:该试验已在巴西临床试验注册中心(REBEC)进行了回顾性注册,注册号为 RBR-5fysqrh(注册日期:2023 年 11 月 30 日)。
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引用次数: 0
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