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Impact of Lipidic Plaque on In-Stent and Stent Edge-Related Events After PCI in Myocardial Infarction: A PROSPECT II Substudy. 心肌梗死 PCI 后脂质斑块对支架内和支架边缘相关事件的影响:PROSPECT II 子研究。
IF 6.1 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-10-01 Epub Date: 2024-09-25 DOI: 10.1161/CIRCINTERVENTIONS.124.014215
Lars Kjøller-Hansen, Akiko Maehara, Henning Kelbæk, Mitsuaki Matsumura, Michael Maeng, Thomas Engstrøm, Ole Fröbert, Jonas Persson, Rune Wiseth, Alf Inge Larsen, Lisette Okkels Jensen, Jan Erik Nordrehaug, Elmir Omerovic, Claes Held, Stefan James, Gary S Mintz, Ziad A Ali, Gregg W Stone, David Erlinge

Background: Lipid content in untreated nonobstructive coronary artery lesions is associated with adverse clinical outcomes, and residual in-stent or stent edge lipid may worsen outcomes after percutaneous coronary intervention (PCI).

Methods: Near-infrared spectroscopy-intravascular ultrasound was performed before and after PCI in patients with myocardial infarction. We evaluated the impact of lipid assessed by near-infrared spectroscopy (maximal lipid core burden index over 4 mm [maxLCBI4mm]) along with intravascular ultrasound information including residual plaque burden on in-stent or edge-related major adverse cardiac events (MACE) in de novo PCI-treated culprit coronary artery lesions. The primary end point was culprit lesion-related MACE (CL-MACE), defined as cardiac death, myocardial infarction, or unstable or progressive angina either requiring revascularization or with rapid lesion progression and classified as in-stent or stent edge-related.

Results: During a median follow-up of 3.8 years, 25 CL-MACE (11 stent edge-related, 13 in-stent, and 1 in-lesion without a stent) occurred in 1041 PCI-treated lesions in 768 patients. Pre-PCI or post-PCI measures of lipid content were not related to in-stent CL-MACE. However, stent edge-related CL-MACE was increased if both the post-PCI stent edge maxLCBI4mm was greater than the upper quartile (108.7) and the stent edge plaque burden was >50% (adjusted odds ratio, 4.11 [95% CI, 1.12-15.2]; P=0.03).

Conclusions: In PROSPECT II (Providing Regional Observations to Study Predictors of Events in the Coronary Tree), CL stent implantation leaving behind greater stent edge-related lipid and uncovered plaque burden was associated with an increased risk of stent edge-related CL-MACE during follow-up. In contrast, CL lipid content was not related to in-stent CL-MACE.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02171065.

背景:未经治疗的非阻塞性冠状动脉病变中的脂质含量与不良临床预后有关,支架内或支架边缘残留的脂质可能会恶化经皮冠状动脉介入治疗(PCI)后的预后:方法:在心肌梗死患者PCI前后进行了近红外光谱-血管内超声检查。我们评估了近红外光谱仪评估的脂质(4 毫米以上最大脂质核心负荷指数[maxLCBI4mm])以及血管内超声信息(包括残留斑块负荷)对新PCI治疗的冠状动脉死角病变中支架内或边缘相关的主要心脏不良事件(MACE)的影响。主要终点是冠状动脉病变相关的MACE(CL-MACE),定义为心源性死亡、心肌梗死、不稳定或进展性心绞痛,要么需要血管重建,要么病变进展迅速,并分为支架内或支架边缘相关:在中位随访 3.8 年期间,768 名患者的 1041 个 PCI 治疗病变中发生了 25 例 CL-MACE(11 例支架边缘相关,13 例支架内,1 例无支架病变)。PCI前或PCI后的脂质含量测量与支架内CL-MACE无关。然而,如果PCI后支架边缘最大LCBI4mm大于上四分位数(108.7),且支架边缘斑块负担大于50%,则支架边缘相关的CL-MACE会增加(调整后的几率比为4.11 [95% CI, 1.12-15.2];P=0.03):在 PROSPECT II(提供区域观察以研究冠状动脉事件的预测因素)中,CL 支架植入后留下更多支架边缘相关脂质和未覆盖斑块负担与随访期间支架边缘相关 CL-MACE 风险增加有关。相比之下,CL脂质含量与支架内CL-MACE无关:URL:https://www.clinicaltrials.gov;唯一标识符:NCT02171065。
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引用次数: 0
Association Between Neurological Status and Outcomes in Cardiac Arrest Patients Undergoing PCI in Contemporary Practice: Insights From BMC2. 当代实践中接受 PCI 治疗的心脏骤停患者的神经状态与预后之间的关系:BMC2.
IF 6.1 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-10-01 Epub Date: 2024-10-15 DOI: 10.1161/CIRCINTERVENTIONS.124.014189
David E Hamilton, Daniel S Kobe, Milan Seth, Manoj Sharma, Thomas LaLonde, Ibrahim Shah, Hitinder S Gurm, Devraj Sukul

Background: Coronary artery disease remains the largest contributor to cardiac arrests worldwide; yet, long-term outcomes are often driven by neurological status after resuscitation. We examined the association between pre-percutaneous coronary intervention (PCI) level of consciousness (LOC) and outcomes among patients with cardiac arrest who underwent PCI.

Methods: The study cohort included patients undergoing PCI after cardiac arrest between April 2018 and March 2022 at 48 hospitals in the state of Michigan. Pre-PCI LOC was categorized as mentally alert, partially responsive, unresponsive, and unable to assess. In-hospital outcomes included mortality, bleeding, and acute kidney injury.

Results: Among 3021 patients who underwent PCI after cardiac arrest, 1394 (49%) were mentally alert, 132 (5%) were partially responsive, 698 (24%) were unresponsive, and 631 (22%) were unable to assess. The mentally alert cohort had lower mortality (4.59%) compared with the partially responsive (17.42%), unresponsive (50.14%), and unable to assess cohorts (38.03%; P<0.001). After adjusting for baseline differences, compared with mentally alert patients, the odds of mortality were markedly elevated in patients who were partially responsive (adjusted odds ratio, 4.63 [95% CI, 2.67-8.04]; P<0.001), unable to assess (adjusted odds ratio, 13.95 [95% CI, 9.97-19.51]; P<0.001), and unresponsive (adjusted odds ratio, 24.36 [17.34-34.23]; P<0.001). After adjustment, patients with impaired LOC also had higher risks of acute kidney injury and bleeding compared with mentally alert patients.

Conclusions: Pre-PCI LOC is a strong predictor of in-hospital outcomes after PCI among cardiac arrest patients. A patient's pre-PCI LOC should be considered an important factor when weighing treatment options, designing clinical trials, and counseling patients and their families regarding prognosis after PCI.

背景:冠状动脉疾病仍然是全球心脏骤停的最大诱因;然而,长期预后往往取决于复苏后的神经状况。我们研究了经皮冠状动脉介入治疗(PCI)前意识水平(LOC)与接受 PCI 治疗的心脏骤停患者预后之间的关系:研究队列包括 2018 年 4 月至 2022 年 3 月期间在密歇根州 48 家医院接受 PCI 手术的心脏骤停患者。PCI前LOC分为精神清醒、部分反应、无反应和无法评估。院内结果包括死亡率、出血和急性肾损伤:在3021名心脏骤停后接受PCI治疗的患者中,1394人(49%)精神正常,132人(5%)部分有反应,698人(24%)无反应,631人(22%)无法评估。与部分反应(17.42%)、无反应(50.14%)和无法评估(38.03%;PPPPC结论)相比,精神警觉组的死亡率较低(4.59%):PCI前LOC是预测心脏骤停患者PCI术后院内预后的重要指标。在权衡治疗方案、设计临床试验以及就 PCI 后的预后向患者及其家属提供咨询时,患者的 PCI 前 LOC 应被视为一个重要因素。
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引用次数: 0
Enhancing Guidewire Efficacy for Transradial Access: The EAGER Randomized Controlled Trial. 增强经桡动脉入路的导丝功效:EAGER 随机对照试验。
IF 6.1 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-10-01 Epub Date: 2024-08-31 DOI: 10.1161/CIRCINTERVENTIONS.124.014529
Adam C Bland, William Meere, Philopatir Mikhail, Eunice Chuah, Eleanor Redwood, David Ferreira, Nicklas Howden, Adam Perkovic, Samantha L Saunders, Amy Kelty, Tony Kull, Andrew Hill, Roberto Spina, Kiran Sarathy, Austin May, Michael Parkinson, Mark Ishak, Nicholas Collins, Andrew Boyle, Maged William, Prajith Jeyaprakash, Tom J Ford

Background: The 1.5 mm Baby J hydrophilic narrow J-tipped wire is a development of the standard 0.035" 3-mm J-tipped peripheral guidewire, designed to improve efficiency of transradial coronary procedures by safely navigating small caliber radial arteries to the aorta. There is currently a lack of evidence comparing the procedural success and safety of different peripheral guidewires used in transradial cardiac procedures. We compared the efficacy and safety of a narrow J-tipped hydrophilic 0.035" wire (intervention, Radifocus Baby J guidewire; TERUMO Co, Tokyo, Japan) versus a standard fixed-core 0.035" J wire (control).

Methods: Investigator-initiated, blinded, Australian, multicenter randomized trial in patients undergoing clinically indicated coronary angiography or percutaneous coronary intervention. Patients were randomized 1:1 to use either the control guidewire or the intervention guidewire. The primary end point (technical success) was defined as gaining aortic root access with the randomized guidewire.

Results: In all, 330 patients were randomized between October 2022 and June 2023 (median age was 69 years, 36% were female, and body mass index was 29 kg/m2). The primary end point was achieved more frequently in the intervention group (96% versus 84%; absolute risk reduction 12% [95% CI, 5.7-18.3]; P<0.001). Women assigned to the control wire experienced a higher failure rate compared with men (31% versus 8% in men; P<0.001). Fluoroscopy time was significantly lower in the Baby J group (median, 344 versus 491 seconds; P=0.024). The main mechanisms of failure using the control wire were radial artery spasm (15/26; 57%) and subclavian tortuosity (5/26; 19.2%). There were no differences in overall procedure times, major adverse cardiovascular events, or vascular complications between guidewires.

Conclusions: A narrow 1.5 mm J-tipped hydrophilic guidewire resulted in greater technical success and reduced fluoroscopy time compared with the standard 3-mm J-tipped nonhydrophilic guidewire. The guidewire is safe and demonstrated key incremental benefits for the transradial approach, particularly in women.

Registration: URL: https://www.anzctr.org.au/; Unique identifier: ACTRN12622001557729.

背景:1.5 毫米 "Baby J "亲水窄 J 端导引钢丝是对标准 0.035" 3 毫米 J 端外周导引钢丝的改进,旨在通过将小口径桡动脉安全引向主动脉来提高经桡动脉冠状动脉手术的效率。目前缺乏证据比较经桡动脉心脏手术中使用的不同外周导丝的手术成功率和安全性。我们比较了窄 J 端亲水 0.035 英寸导丝(干预 - Radifocus™ 'Baby J'导丝,TERUMO 公司,日本东京)与标准固定芯(FC)0.035 英寸 J 导丝(对照)的有效性和安全性。方法:由研究者发起、盲法、澳大利亚多中心随机试验,对象为接受临床冠状动脉造影术和/或 PCI 的患者。通过密封信封法以 1:1 随机分配使用对照组或介入导丝。主要终点(技术成功)定义为使用随机导丝获得主动脉根部通路。结果330 名患者在 2022 年 10 月至 2023 年 6 月期间接受了随机治疗(中位年龄 69 岁,36% 为女性,体重指数 29 kg/m²)。干预组达到主要终点的比例更高[96% 对 84%;平均差异 12% (95% CI 5.7-18.3); p结论:与标准的 3 毫米 J 端非亲水导丝相比,1.5 毫米 J 端窄亲水导丝的技术成功率更高,透视时间更短。这种导丝非常安全,并显示出经桡动脉入路的关键增量优势,尤其是对女性而言。
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引用次数: 0
Prognostic Value of Murray Law-Based QFR (μQFR)-Guided Virtual PCI in Patients With Physiological Ischemia. 基于 Murray Law 的 QFR (μQFR) 引导的虚拟 PCI 对生理性缺血患者的预后价值。
IF 6.1 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-10-01 Epub Date: 2024-09-25 DOI: 10.1161/CIRCINTERVENTIONS.124.014362
Lianglong Chen, Yuanming Yan, Jiaxin Zhong, Ping Chen, Wei Chen, Chaoxiang Xu, Long Chen, Shengxian Tu, Yukun Luo

Background: Quantitative flow ratio (QFR)-based virtual percutaneous coronary intervention (PCI) is associated with improved post-PCI physiological results. Murray law-based QFR (μQFR) is a new method for physiological assessment that has higher feasibility and efficiency. The purpose of this study was to investigate the performance of μQFR-guided virtual PCI in improving post-PCI outcomes.

Methods: The QUITE RIGHT study (Quantitative Flow Ratio Virtual Stenting and Angiography Guided Percutaneous Coronary Intervention) is a prospective, multicenter, blinded, randomized, controlled superiority study. Eligible patients were randomized 1:1 to either the μQFR-guided virtual PCI group or the angiography-guided PCI group. The primary end point was the proportion of the target vessels with a post-PCI μQFR ≥0.90, accepted as an optimal post-PCI physiological outcome.

Results: A total of 622 patients with 666 vessels were enrolled. The optimal physiological outcome was reached more often in the μQFR-guided virtual PCI group (absolute difference, 9.1% [95% CI, 4.53-13.76]; P<0.001). The μQFR-guided virtual PCI group had a better QFR value, a lower contrast agent dose and x-ray dose, and a more appropriate stent length than the angiography-guided group.

Conclusions: The QUITE RIGHT study showed that the μQFR-guided virtual PCI strategy is superior to angiography-guided PCI in terms of physiological outcomes. The μQFR-guided virtual PCI strategy is associated with lower contrast and x-ray doses and a more appropriate stent length.

Registration: URL: https://www.chictr.org.cn/; Unique identifier: ChiCTR2100045452.

背景:基于定量血流比(QFR)的虚拟经皮冠状动脉介入治疗(PCI)可改善PCI后的生理结果。基于 Murray 法的 QFR(μQFR)是一种新的生理评估方法,具有更高的可行性和效率。本研究旨在探讨μQFR引导的虚拟PCI在改善PCI术后结果方面的性能:QUITE RIGHT 研究(定量血流比虚拟支架和血管造影引导的经皮冠状动脉介入治疗)是一项前瞻性、多中心、盲法、随机对照的优越性研究。符合条件的患者按 1:1 随机分配到μQFR 引导的虚拟 PCI 组或血管造影引导的 PCI 组。主要终点是PCI后μQFR≥0.90的靶血管比例,这是PCI后的最佳生理结果:结果:共有 622 名患者、666 根血管参与了这项研究。μQFR引导的虚拟PCI组更容易达到最佳生理结果(绝对差异为9.1% [95% CI, 4.53-13.76];PC结论:QUITE RIGHT 研究表明,就生理结果而言,μQFR 引导的虚拟 PCI 策略优于血管造影引导的 PCI。μQFR引导的虚拟PCI策略与较低的造影剂和X射线剂量以及更合适的支架长度有关:URL: https://www.chictr.org.cn/; Unique identifier:ChiCTR2100045452。
{"title":"Prognostic Value of Murray Law-Based QFR (μQFR)-Guided Virtual PCI in Patients With Physiological Ischemia.","authors":"Lianglong Chen, Yuanming Yan, Jiaxin Zhong, Ping Chen, Wei Chen, Chaoxiang Xu, Long Chen, Shengxian Tu, Yukun Luo","doi":"10.1161/CIRCINTERVENTIONS.124.014362","DOIUrl":"10.1161/CIRCINTERVENTIONS.124.014362","url":null,"abstract":"<p><strong>Background: </strong>Quantitative flow ratio (QFR)-based virtual percutaneous coronary intervention (PCI) is associated with improved post-PCI physiological results. Murray law-based QFR (μQFR) is a new method for physiological assessment that has higher feasibility and efficiency. The purpose of this study was to investigate the performance of μQFR-guided virtual PCI in improving post-PCI outcomes.</p><p><strong>Methods: </strong>The QUITE RIGHT study (Quantitative Flow Ratio Virtual Stenting and Angiography Guided Percutaneous Coronary Intervention) is a prospective, multicenter, blinded, randomized, controlled superiority study. Eligible patients were randomized 1:1 to either the μQFR-guided virtual PCI group or the angiography-guided PCI group. The primary end point was the proportion of the target vessels with a post-PCI μQFR ≥0.90, accepted as an optimal post-PCI physiological outcome.</p><p><strong>Results: </strong>A total of 622 patients with 666 vessels were enrolled. The optimal physiological outcome was reached more often in the μQFR-guided virtual PCI group (absolute difference, 9.1% [95% CI, 4.53-13.76]; <i>P</i><0.001). The μQFR-guided virtual PCI group had a better QFR value, a lower contrast agent dose and x-ray dose, and a more appropriate stent length than the angiography-guided group.</p><p><strong>Conclusions: </strong>The QUITE RIGHT study showed that the μQFR-guided virtual PCI strategy is superior to angiography-guided PCI in terms of physiological outcomes. The μQFR-guided virtual PCI strategy is associated with lower contrast and x-ray doses and a more appropriate stent length.</p><p><strong>Registration: </strong>URL: https://www.chictr.org.cn/; Unique identifier: ChiCTR2100045452.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e014362"},"PeriodicalIF":6.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142342764","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
14-Day DAPT After Coronary Stenting for Patients on Oral Anticoagulants: How Short Is Too Short? 口服抗凝药患者冠状动脉支架术后的 14 天 DAPT:多短才算短?
IF 6.1 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-10-01 Epub Date: 2024-10-15 DOI: 10.1161/CIRCINTERVENTIONS.124.014691
John A Bittl
{"title":"14-Day DAPT After Coronary Stenting for Patients on Oral Anticoagulants: How Short Is Too Short?","authors":"John A Bittl","doi":"10.1161/CIRCINTERVENTIONS.124.014691","DOIUrl":"https://doi.org/10.1161/CIRCINTERVENTIONS.124.014691","url":null,"abstract":"","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":"17 10","pages":"e014691"},"PeriodicalIF":6.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142459497","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Eagerness in Navigating Upper Arm Vasculature During Transradial Access: The Path to Excellence. 经桡动脉入路时引导上臂血管的热忱:通往卓越之路。
IF 6.1 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-10-01 Epub Date: 2024-10-15 DOI: 10.1161/CIRCINTERVENTIONS.124.014692
Adel Aminian, Grigorios G Tsigkas, Gregory A Sgueglia
{"title":"Eagerness in Navigating Upper Arm Vasculature During Transradial Access: The Path to Excellence.","authors":"Adel Aminian, Grigorios G Tsigkas, Gregory A Sgueglia","doi":"10.1161/CIRCINTERVENTIONS.124.014692","DOIUrl":"https://doi.org/10.1161/CIRCINTERVENTIONS.124.014692","url":null,"abstract":"","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":"17 10","pages":"e014692"},"PeriodicalIF":6.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142459499","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Letter by Henry and Widmer Regarding Article, "Visual Estimates of Coronary Slow Flow Are Not Associated With Invasive Wire-Based Diagnoses of Coronary Microvascular Dysfunction". Henry 和 Widmer 关于 "冠状动脉慢速血流的目测值与基于侵入性导线的冠状动脉微血管功能障碍诊断无关 "一文的来信。
IF 6.1 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-10-01 Epub Date: 2024-09-26 DOI: 10.1161/CIRCINTERVENTIONS.124.014588
Timothy D Henry, R Jay Widmer
{"title":"Letter by Henry and Widmer Regarding Article, \"Visual Estimates of Coronary Slow Flow Are Not Associated With Invasive Wire-Based Diagnoses of Coronary Microvascular Dysfunction\".","authors":"Timothy D Henry, R Jay Widmer","doi":"10.1161/CIRCINTERVENTIONS.124.014588","DOIUrl":"10.1161/CIRCINTERVENTIONS.124.014588","url":null,"abstract":"","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e014588"},"PeriodicalIF":6.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142342763","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Randomized Trial of COBRA PzF Stenting to Reduce the Duration of Triple Therapy: The COBRA-REDUCE Trial. COBRA PzF 支架植入术缩短三联疗法时间的随机试验:COBRA-REDUCE试验。
IF 6.1 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-10-01 Epub Date: 2024-10-15 DOI: 10.1161/CIRCINTERVENTIONS.123.013735
Robert A Byrne, Róisín Colleran, J J Coughlan, Rajiv Jauhar, Luc Maillard, Axel De Labriolle, Michael Maeng, Charles Croft, Michael Brunner, David Leistner, Bernhard Zrenner, Marc Kollum, Karl-Ludwig Laugwitz, Erion Xhepa, Katharina Mayer, Shqipdona Lahu, Michael Joner, Ajay Kirtane, Roxana Mehran, Mark Barakat, Philip Urban, Donald E Cutlip, Adnan Kastrati

Background: Patients with an indication for oral anticoagulation who undergo percutaneous coronary intervention require a combination of oral anticoagulation and antiplatelet therapy. The use of a coronary stent with a thromboresistant and pro-healing coating may allow an abbreviated duration of dual antiplatelet therapy (DAPT) without an increase in the risk of thromboembolic events.

Methods: Patients with an indication for oral anticoagulation undergoing percutaneous coronary intervention were randomized to treatment with the COBRA polyzene F (PzF) stent followed by 14 days of DAPT or a Food and Drug Administration-approved new-generation drug-eluting stent followed by 3 or 6 months of DAPT. The bleeding coprimary end point was Bleeding Academic Research Consortium type ≥2 beyond 14 days (or after hospital discharge) until 6 months. The thromboembolic coprimary end point was the composite of all-cause death, myocardial infarction, definite or probable stent thrombosis, or ischemic stroke at 6 months. The trial hypothesis was that the COBRA PzF stent strategy would be superior with respect to bleeding events and noninferior with respect to thromboembolic events.

Results: A total of 996 patients underwent randomization. The bleeding end point occurred in 37 of 475 patients (7.8%) in the COBRA PzF group and 47 of 482 patients (9.8%) in the control group (difference, -2.0 [95% CI, -5.6 to 1.6]; P=0.14). The thromboembolic end point occurred in 37 of 492 patients (7.5%) in the COBRA PzF group and 24 of 490 patients (4.9%) in the control group (difference, 2.6%; prespecified noninferiority margin 5%, upper limit of 1-sided 95% CI of the difference, 5.2%; Pnoninferiority=0.07).

Conclusions: In patients with an indication for oral anticoagulation undergoing percutaneous coronary intervention, treatment with the COBRA PzF stent plus 14 days of DAPT was not superior with respect to bleeding events and was not noninferior with respect to thromboembolic events at 6 months compared with treatment with standard Food and Drug Administration-approved drug-eluting stent plus 3 to 6 months of DAPT.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02594501.

背景:有口服抗凝适应症并接受经皮冠状动脉介入治疗的患者需要同时接受口服抗凝和抗血小板治疗。使用具有抗血栓和促进愈合涂层的冠状动脉支架可以缩短双重抗血小板疗法(DAPT)的持续时间,同时不会增加血栓栓塞事件的风险:接受经皮冠状动脉介入治疗的有口服抗凝适应症的患者被随机分配到使用COBRA polyzene F (PzF)支架,然后进行14天的DAPT治疗,或使用食品药品管理局批准的新一代药物洗脱支架,然后进行3个月或6个月的DAPT治疗。出血的主要终点是 14 天后(或出院后)至 6 个月的出血学术研究联合会类型≥2。血栓栓塞共同主要终点为 6 个月时全因死亡、心肌梗死、明确或可能的支架血栓或缺血性卒中的复合终点。试验假设是,COBRA PzF 支架策略在出血事件方面更具优势,在血栓栓塞事件方面不具劣势:共有996名患者接受了随机分组。COBRA PzF 组 475 例患者中有 37 例(7.8%)出现出血终点,对照组 482 例患者中有 47 例(9.8%)出现出血终点(差异为-2.0 [95% CI,-5.6 至 1.6];P=0.14)。COBRA PzF治疗组492例患者中有37例(7.5%)出现血栓栓塞终点,对照组490例患者中有24例(4.9%)出现血栓栓塞终点(差异为2.6%;预设非劣效边际为5%,差异的单侧95% CI上限为5.2%;P=0.07):结论:对于有口服抗凝适应症的经皮冠状动脉介入治疗患者,使用COBRA PzF支架加14天DAPT治疗与使用美国食品药品管理局批准的标准药物洗脱支架加3至6个月DAPT治疗相比,在出血事件方面没有优越性,在6个月血栓栓塞事件方面也没有非劣效性:URL:https://www.clinicaltrials.gov;唯一标识符:NCT02594501。
{"title":"Randomized Trial of COBRA PzF Stenting to Reduce the Duration of Triple Therapy: The COBRA-REDUCE Trial.","authors":"Robert A Byrne, Róisín Colleran, J J Coughlan, Rajiv Jauhar, Luc Maillard, Axel De Labriolle, Michael Maeng, Charles Croft, Michael Brunner, David Leistner, Bernhard Zrenner, Marc Kollum, Karl-Ludwig Laugwitz, Erion Xhepa, Katharina Mayer, Shqipdona Lahu, Michael Joner, Ajay Kirtane, Roxana Mehran, Mark Barakat, Philip Urban, Donald E Cutlip, Adnan Kastrati","doi":"10.1161/CIRCINTERVENTIONS.123.013735","DOIUrl":"10.1161/CIRCINTERVENTIONS.123.013735","url":null,"abstract":"<p><strong>Background: </strong>Patients with an indication for oral anticoagulation who undergo percutaneous coronary intervention require a combination of oral anticoagulation and antiplatelet therapy. The use of a coronary stent with a thromboresistant and pro-healing coating may allow an abbreviated duration of dual antiplatelet therapy (DAPT) without an increase in the risk of thromboembolic events.</p><p><strong>Methods: </strong>Patients with an indication for oral anticoagulation undergoing percutaneous coronary intervention were randomized to treatment with the COBRA polyzene F (PzF) stent followed by 14 days of DAPT or a Food and Drug Administration-approved new-generation drug-eluting stent followed by 3 or 6 months of DAPT. The bleeding coprimary end point was Bleeding Academic Research Consortium type ≥2 beyond 14 days (or after hospital discharge) until 6 months. The thromboembolic coprimary end point was the composite of all-cause death, myocardial infarction, definite or probable stent thrombosis, or ischemic stroke at 6 months. The trial hypothesis was that the COBRA PzF stent strategy would be superior with respect to bleeding events and noninferior with respect to thromboembolic events.</p><p><strong>Results: </strong>A total of 996 patients underwent randomization. The bleeding end point occurred in 37 of 475 patients (7.8%) in the COBRA PzF group and 47 of 482 patients (9.8%) in the control group (difference, -2.0 [95% CI, -5.6 to 1.6]; <i>P</i>=0.14). The thromboembolic end point occurred in 37 of 492 patients (7.5%) in the COBRA PzF group and 24 of 490 patients (4.9%) in the control group (difference, 2.6%; prespecified noninferiority margin 5%, upper limit of 1-sided 95% CI of the difference, 5.2%; <i>P</i><sub>noninferiority</sub>=0.07).</p><p><strong>Conclusions: </strong>In patients with an indication for oral anticoagulation undergoing percutaneous coronary intervention, treatment with the COBRA PzF stent plus 14 days of DAPT was not superior with respect to bleeding events and was not noninferior with respect to thromboembolic events at 6 months compared with treatment with standard Food and Drug Administration-approved drug-eluting stent plus 3 to 6 months of DAPT.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT02594501.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":"17 10","pages":"e013735"},"PeriodicalIF":6.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142459500","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Response by Smilowitz et al to Letter Regarding Article, "Visual Estimates of Coronary Slow Flow Are Not Associated With Invasive Wire-Based Diagnoses of Coronary Microvascular Dysfunction". Smilowitz 等人对有关 "冠状动脉慢速血流的目测值与基于侵入性导线的冠状动脉微血管功能障碍诊断无关 "一文的信件的回复。
IF 6.1 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-10-01 Epub Date: 2024-09-26 DOI: 10.1161/CIRCINTERVENTIONS.124.014612
Nathaniel R Smilowitz, Kenneth L Harkin, Harmony R Reynolds
{"title":"Response by Smilowitz et al to Letter Regarding Article, \"Visual Estimates of Coronary Slow Flow Are Not Associated With Invasive Wire-Based Diagnoses of Coronary Microvascular Dysfunction\".","authors":"Nathaniel R Smilowitz, Kenneth L Harkin, Harmony R Reynolds","doi":"10.1161/CIRCINTERVENTIONS.124.014612","DOIUrl":"10.1161/CIRCINTERVENTIONS.124.014612","url":null,"abstract":"","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e014612"},"PeriodicalIF":6.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11671109/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142342765","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
CCTA-Guided Invasive Coronary Angiography in Patients With CABG: A Multicenter, Randomized Study. CABG 患者的 CCTA 引导有创冠状动脉造影:一项多中心随机研究。
IF 5.6 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-09-17 DOI: 10.1161/circinterventions.124.014045
Grigorios Tsigkas,Fotios Toulgaridis,Anastasios Apostolos,Andreas Kalogeropoulos,Grigoris V Karamasis,Georgios Vasilagkos,Loukas Pappas,Konstantinos Toutouzas,Konstantinos Tsioufis,Panagiotis Korkonikitas,Ioannis Tsiafoutis,Michalis Hamilos,Antonios Ziakas,Ioannis Kanakakis,Athanasios Moulias,Petros Zampakis,Periklis Davlouros
BACKGROUNDCoronary computed tomography angiography (CCTA) in patients with post-coronary artery bypass graft (CABG) has a high diagnostic accuracy for visualization of grafts. Invasive coronary angiography (ICA) in patients with CABG is associated with increased procedural time, contrast agent administration, radiation exposure, and complications, compared with non-CABG patients. The aim of this multicenter, randomized controlled trial was to compare the strategy of CCTA-guided ICA versus classic ICA in patients with prior CABG.METHODSPatients with prior CABG were randomly assigned (1:1 ratio) to have a CCTA before ICA (CCTA-ICA, group A) or not (ICA-only, group B). The primary end point of the study was the total volume (milliliters) of the contrast agent administered.RESULTSA total of 251 patients were randomized, and 225 were included in analysis; 110 in group A and 115 in group B. The total contrast volume was higher in group A (184.5 [143-255] versus 154 [102-240] mL; P=0.001). The contrast volume administered during the invasive procedure was lower in group A (101.5 [60-151] versus 154 [102-240]; P<0.001). Total fluoroscopy time was decreased in group A (480 [259-873] versus 594 [360-1080] seconds; P=0.027), but total effective dose was increased (24.1 [17.7-32] versus 10.8 [5.6-18] mSv; P<0.001). The rate of contrast-induced nephropathy, periprocedural complications, and major adverse cardiac events during 3 to 5 and 30 days did not differ significantly between the 2 groups.CONCLUSIONSA CCTA-directed ICA strategy for patients with CABG is associated with expedition of the invasive procedure, and less fluoroscopy time, at the cost of higher total contrast volume and effective radiation dose, compared with the classic ICA approach.REGISTRATIONURL: https://www.clinicaltrials.gov; Unique identifier: NCT04631809.
背景:冠状动脉旁路移植术(CABG)术后患者的冠状动脉计算机断层扫描血管造影(CCTA)在显示移植物方面具有很高的诊断准确性。与非 CABG 患者相比,对 CABG 患者进行侵入性冠状动脉造影术(ICA)会增加手术时间、造影剂用量、辐射暴露和并发症。这项多中心随机对照试验的目的是比较 CCTA 引导下的 ICA 与传统 ICA 在既往接受过 CABG 患者中的应用策略。方法将既往接受过 CABG 的患者随机分配(1:1 比例),在 ICA 前进行 CCTA(CCTA-ICA,A 组)或不进行 CCTA(仅 ICA,B 组)。研究的主要终点是造影剂的总用量(毫升)。结果共有 251 名患者被随机分配,其中 225 人被纳入分析;A 组 110 人,B 组 115 人。A 组的造影剂总用量更高(184.5 [143-255] mL 对 154 [102-240] mL;P=0.001)。A 组在有创手术中使用的造影剂量更少(101.5 [60-151] 对 154 [102-240] ;P<0.001)。A 组的透视总时间缩短(480 [259-873] 秒对 594 [360-1080] 秒;P=0.027),但总有效剂量增加(24.1 [17.7-32] mSv 对 10.8 [5.6-18] mSv;P<0.001)。结论与传统的 ICA 方法相比,CCTA 引导的 CABG 患者 ICA 策略可加快有创手术的进程,减少透视时间,但总造影剂量和有效辐射剂量会增加:NCT04631809。
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引用次数: 0
期刊
Circulation: Cardiovascular Interventions
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