Arterial Occlusive Diseases

动脉闭塞性疾病
  • 文章类型: Journal Article
    严重的威胁肢体缺血(CLTI)是一种严重的疾病,其特征是静息疼痛和缺血性组织丢失,影响5%至10%的外周动脉疾病患者。在美国,很少有美国食品和药物管理局批准的用于膝关节以下动脉(BTK)主要治疗的设备。不幸的是,所有人都因内膜增生而遭受高再狭窄率,弹性反冲,和未经处理的解剖,因为缺乏脚手架。EspritBTK系统是一种可吸收的,药物洗脱支架装置有可能解决由于膝下动脉粥样硬化而患有CLTI的人的未满足的需求。LIFE-BTK(膝关节以下药物洗脱可吸收支架治疗的安全性和功效调查)随机对照试验(RCT)是对EspritBTK药物洗脱可吸收支架的前瞻性设计的上市前评估用于治疗这些患者。
    LIFE-BTK试验招募了261名CLTI受试者进行RCT,另外7名受试者进行了药代动力学亚研究。RCT的目的是评估EspritBTK支架与经皮腔内血管成形术相比的安全性和有效性。主要疗效终点是12个月时保肢和主要通畅的复合终点。主要的安全终点是在6个月和30天没有重大的不良肢体事件和围手术期死亡。分别。临床随访计划为5年。
    如果我们要改善这一具有挑战性的患者组的预后,必须在随机对照试验中测试新型设备,以评估其安全性和有效性,与护理标准相比。
    UNASSIGNED: Critical limb-threatening ischemia (CLTI) is a severe condition characterized by rest pain and ischemic tissue loss that affects 5% to 10% of people with peripheral artery disease. In the United States, there are few Food and Drug Administration-approved devices for the primary treatment of arteries below-the-knee (BTK). Unfortunately, all suffer from high restenosis rates due to intimal hyperplasia, elastic recoil, and untreated dissection because of a lack of scaffolding. The Esprit BTK system is a resorbable, drug-eluting scaffold device with the potential to address an unmet need in people suffering from CLTI because of infrapopliteal atherosclerosis. The LIFE-BTK (pivotaL Investigation of saFety and Efficacy of drug-eluting resorbable scaffold treatment-Below The Knee) randomized controlled trial (RCT) is a prospectively designed premarket evaluation of the Esprit BTK drug-eluting resorbable scaffold used in the treatment of those patients.
    UNASSIGNED: The LIFE-BTK trial enrolled 261 subjects with CLTI for the RCT and a further 7 subjects for a pharmacokinetic substudy. The objective of the RCT was to evaluate the safety and efficacy of the Esprit BTK scaffold compared to percutaneous transluminal angioplasty. The primary efficacy end point was a composite of limb salvage and primary patency at 12 months. The primary safety end point is freedom from major adverse limb events and peri-operative death at 6 months and 30 days, respectively. Clinical follow-up care is planned for 5 years.
    UNASSIGNED: Novel devices must be tested in RCTs to evaluate their safety and efficacy compared to the standard of care if we are to improve outcomes for this challenging group of patients.
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  • 文章类型: Journal Article
    方法:前瞻性研究。
    目的:探讨颈椎小关节脱位时椎动脉(VA)闭塞的发生率及脊髓前动脉(ASA)是否闭塞。
    方法:大学医院,中国。
    方法:在2年内,前瞻性纳入21例颈椎小关节脱位的常规患者。所有患者均接受计算机断层扫描血管造影(CTA)以评估VA的通畅性,神经根前动脉(ARAs),和受伤时的ASA。记录了临床数据,包括人口统计,症状性椎基底动脉缺血,美国脊髓损伤协会减损量表(ASIA)等级,ASA和VA放射学特征。
    结果:21例患者中有5例(24%)发生了VA单侧闭塞,其中单侧小关节脱位2例,双侧小关节脱位3例。在所有21例患者中均未发现ASA闭塞,其中5例伴有VA单侧闭塞。没有患者出现症状性椎基底动脉缺血。
    结论:VA闭塞发生在大约四分之一的颈椎关节突脱位中,很少有症状的椎基底动脉缺血。颈椎小关节脱位后ASA未闭塞,即使是单侧VA闭塞。
    METHODS: A prospective study.
    OBJECTIVE: To investigate the incidence of vertebral artery (VA) occlusion and whether anterior spinal artery (ASA) is occluded in cervical facet dislocation.
    METHODS: University hospital, China.
    METHODS: During a 2-year period, 21 conventional patients with cervical facet dislocation were prospectively enrolled. All patients received computed tomography angiography (CTA) to assess the patency of the VA, anterior radiculomedullary arteries (ARAs), and ASA at the time of injury. Clinical data were documented, including demographics, symptomatic vertebrobasilar ischemia, American Spinal Injury Association Impairment Scale (ASIA) grades, and ASA and VA radiological characteristics.
    RESULTS: VA unilateral occlusion occurred in 5 of 21 patients (24%), including 2 with unilateral facet dislocation and 3 with bilateral facet dislocation. No ASA occlusion was found in all 21 patients, including 5 with VA unilateral occlusion. No patients had symptomatic vertebrobasilar ischemia.
    CONCLUSIONS: VA occlusion occurs in approximately one-fourth of cervical facet dislocations, with infrequent symptomatic vertebrobasilar ischemia. ASA is not occluded following cervical facet dislocation, even with unilateral VA occlusion.
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  • 文章类型: Journal Article
    背景技术用于脑血管造影和神经介入治疗的经桡动脉入路(TRA)已获得普及,但是与股动脉穿刺相比,桡动脉的狭窄直径和弱搏动降低了初始穿刺成功率。这项来自单个中心的回顾性研究评估了543例经桡动脉入路(TRA)进行脑血管造影的患者中桡动脉闭塞(RAO)的发生率和相关因素。材料与方法我们纳入了2021年7月至2024年2月接受TRA的543例患者。超声用于确定桡动脉是否闭塞。记录相关临床资料以评估RAO的发生率和影响因素。结果在DSA后24小时,我们进行了超声成像。患者分为RAO组(n=32)和非RAO组(n=511)。结果显示,RAO在没有添加肝素的抗痉挛药的患者中明显更高,他们更有可能需要三次以上的桡动脉穿刺尝试,并且倾向于使用Cordis穿刺针接受11厘米的桡动脉鞘(均P<0.05)。多因素logistic回归分析显示抗痉挛药中加入肝素(OR=0.076,95%CI:0.018~0.321,P<0.001),少于3次桡动脉穿刺尝试(OR=0.245,95%CI:0.111-0.541,P<0.001),使用16厘米的桡动脉鞘(OR=0.195,95%CI:0.067-0.564,P=0.003),使用Terumo穿刺针(OR=0.325,95%CI:0.148-0.717,P=0.005)可以降低桡动脉闭塞的发生率。结论我们的中心发现,在抗痉挛药物中加入肝素可减少桡动脉穿刺尝试的次数,使用16厘米的桡动脉鞘显着降低了经桡动脉脑血管造影后早期RAO的发生率。
    BACKGROUND The transradial approach (TRA) for cerebral angiography and neurointerventional treatment has gained popularity, but the narrow diameter and weak pulsation of the radial artery lower the initial puncture success rate compared to femoral artery puncture. This retrospective study from a single center evaluated the incidence of and factors associated with radial artery occlusion (RAO) in 543 patients who underwent transradial approach (TRA) for cerebral angiography. MATERIAL AND METHODS We included 543 patients who underwent TRA from July 2021 to February 2024. Ultrasound was used to determine whether the radial artery was occluded. Relevant clinical data were recorded to assess the incidence of and factors affecting RAO. RESULTS At 24 h after DSA, we performed ultrasound imaging. The patients were divided into an RAO group (n=32) and a non-RAO group (n=511). Results showed that RAO was significantly higher in patients who did not have add heparin to the antispasmodic agents, and they were more likely to have needed more than 3 radial artery puncture attempts, and tended to have received an 11-cm radial artery sheath with the Cordis puncture needles (all P<0.05). Multiple regression logistic analysis showed that adding heparin to the antispasmodic agents (OR=0.076, 95% CI: 0.018-0.321, P<0.001), having fewer than 3 radial artery puncture attempts (OR=0.245, 95% CI: 0.111-0.541, P<0.001), using a 16-cm radial artery sheath (OR=0.195, 95% CI: 0.067-0.564, P=0.003), and using Terumo puncture needles (OR=0.325, 95% CI: 0.148-0.717, P=0.005) can reduce the incidence of radial artery occlusion. CONCLUSIONS Our center found that adding heparin to the antispasmodic agents reduced the number of radial artery punctures attempts, and using a 16-cm radial artery sheath significantly lowered the incidence of early RAO after transradial cerebral angiography.
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  • 文章类型: Journal Article
    背景:2016年9月,普纳替尼在日本被批准用于治疗对先前的酪氨酸激酶抑制剂具有抗性/不耐受的慢性粒细胞白血病患者和复发性或难治性费城染色体阳性急性淋巴细胞白血病患者。
    方法:我们进行了上市后全病例监测,以研究普纳替尼在临床实践中的安全性和有效性,关注动脉闭塞事件。
    结果:收集了724例患者自普纳替尼开始后2年的数据。据报道,动脉闭塞事件为6.49%(47/724),暴露调整后的发生率为6.8/100人年。与动脉闭塞事件相关的风险是年龄和合并症,包括高血压和糖尿病。在104周,慢性粒细胞白血病慢性期患者的累积主要分子应答率为67.2%,费城染色体阳性急性淋巴细胞白血病患者的完全细胞遗传学应答率为80.0%.此外,慢性期慢性粒细胞白血病的1年总生存率为98.5%,费城染色体阳性急性淋巴细胞白血病的1年总生存率为68.6%.
    结论:这项监测表明,普纳替尼在日本患者中具有良好的安全性和有效性,并且还表明有必要密切监测老年人和有动脉粥样硬化诱因的患者的动脉闭塞事件。
    BACKGROUND: In September 2016, ponatinib was approved in Japan for the treatment of patients with chronic myeloid leukemia with resistance/intolerance to prior tyrosine kinase inhibitors and patients with relapsed or refractory Philadelphia chromosome-positive acute lymphoblastic leukemia.
    METHODS: We conducted a post-marketing all-case surveillance to study the safety and efficacy of ponatinib in clinical practice, focusing on arterial occlusive events.
    RESULTS: Data from 724 patients were collected for 2 years from the initiation of ponatinib. The arterial occlusive events were reported in 6.49% (47/724) with an exposure-adjusted incidence rate of 6.8/100 person-years. The risks associated with arterial occlusive events were age and comorbidities including hypertension and diabetes. At 104 weeks, the cumulative major molecular response rate in patients with chronic-phase chronic myeloid leukemia was 67.2% and the complete cytogenetic response in patients with Philadelphia chromosome-positive acute lymphoblastic leukemia was 80.0%. Furthermore, the estimated 1-year overall survival rate was 98.5% for chronic-phase chronic myeloid leukemia and 68.6% for Philadelphia chromosome-positive acute lymphoblastic leukemia.
    CONCLUSIONS: This surveillance demonstrated that ponatinib has a favorable safety and efficacy profile in Japanese patients and also showed the necessity of closely monitoring arterial occlusive events in older adults and patients with predisposing factors for atherosclerosis.
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  • 文章类型: Journal Article
    横向主动脉弓阻塞是一种具有挑战性的病变,支架植入为其提供了潜在的重要替代治疗。目标是评估技术,程序,经皮支架植入术治疗主动脉弓横梗阻的中远期临床疗效。
    这是一个回顾,横型主动脉弓支架植入术的多中心研究.进行单变量和多变量分析。
    索引导管插入术包括146例患者的187个支架植入物。中位年龄为14.3岁(四分位距,9.3-19),体重是53公斤(30-69),随访53个月(12-120)。最常见的支架设计是开孔(n=90,48%)。在118例(81%)中,支架与142根弓状血管(37条颈动脉)重叠。技术和程序成功率分别为100%和88%,分别。较低的重量(P=0.018),体表面积(P=0.013),最小与降主动脉直径比值(P<0.001)与较高的基线主动脉梯度相关.残余梯度与植入物和最终扩张直径成反比(P<0.001)。主动脉损伤和支架相关并发症的综合发生率为14%。没有异常脑部扫描或中风的报告。血压袖带梯度,超声心动图弓速度,在1年随访期间,随着抗高血压药物的使用增加,高血压的发生率得到改善.据报道,在首次再干预的中位数为84(22-148)个月时,有60名(41%)患者进行了再干预。在多变量逻辑回归中,在控制每个最终扩张直径时,残余主动脉梯度>10mmHg与所有时间点再次干预的几率增加相关,体重,和最小与降主动脉直径比。
    横向主动脉弓支架植入术技术率高,程序,和中长期临床成功。主动脉梯度>10mmHg与1年和最近随访时再干预的几率增加相关。开孔式支架设计因其在顺应性方面的优势而被经常使用,弓状血管的灌注,低断裂率,以及对侧细胞进行有效血管成形术的能力。
    UNASSIGNED: Transverse aortic arch obstruction is a challenging lesion for which stent implantation provides a potentially important alternate therapy. The objectives were to evaluate the technical, procedural, and medium-to-long-term clinical outcomes of percutaneous stent implantation of transverse aortic arch obstruction.
    UNASSIGNED: This is a retrospective, multicenter study of transverse aortic arch stent implantation. Univariable and multivariable analyses were performed.
    UNASSIGNED: Index catheterization included 187 stent implants in 146 patients. The median age is 14.3 years (interquartile range, 9.3-19), weight is 53 kg (30-69), and follow-up is 53 months (12-120). The most common stent design was open cell (n=90, 48%). Stents overlapped 142 arch vessels (37 carotid arteries) in 118 (81%) cases. Technical and procedural success rates were 100% and 88%, respectively. Lower weight (P=0.018), body surface area (P=0.013), and minimum-to-descending aortic diameter ratio (P<0.001) were associated with higher baseline aortic gradient. The residual gradient was inversely associated with implant and final dilation diameters (P<0.001). The combined incidence of aortic injury and stent-related complications was 14%. There were no reports of abnormal brain scans or stroke. Blood pressure cuff gradient, echocardiographic arch velocity, and hypertension rates improved within 1-year follow-up with increased antihypertensive medication use. Reintervention was reported in 60 (41%) patients at a median of 84 (22-148) months to first reintervention. On multivariable logistic regression, residual aortic gradient >10 mm Hg was associated with increased odds of reintervention at all time points when controlling for each final dilation diameter, weight, and minimum-to-descending aortic diameter ratio.
    UNASSIGNED: Transverse aortic arch stent implantation has high rates of technical, procedural, and medium-to-long-term clinical success. Aortic gradient >10 mm Hg is associated with increased odds of reintervention at 1-year and most recent follow-ups. Open cell stent design was frequently used for its advantages in conformability, perfusion of arch vessels, low fracture rate, and the ability to perform effective angioplasty of side cells.
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  • 文章类型: Journal Article
    暂无摘要。
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  • 文章类型: Multicenter Study
    背景:本研究旨在建立并验证用于预测接受血管内血栓切除术的急性基底动脉闭塞患者90天死亡率的列线图模型。
    结果:我们的研究共纳入242例基底动脉闭塞患者进行血管内血栓切除术,其中来自3个卒中中心的172名患者被分配到训练队列中,另一个中心的70例患者被分配到验证队列.采用单因素和多因素logistic回归分析筛选预后预测因子,具有显著性的在训练队列中建立列线图模型。辨别的准确性,校准,并且在内部和外部队列中验证了列线图模型的临床有效性。六个变量,包括年龄,基线美国国立卫生研究院卒中量表评分,后循环-阿尔伯塔省卒中计划早期CT(计算机断层扫描)评分,基底动脉计算机断层造影评分,再通失败,有症状的颅内出血,被确定为基底动脉闭塞患者90天死亡率的独立预测因子,并建立列线图模型.列线图模型表现出良好的辨别力,校准,以及在内部和外部队列中的临床有用性。此外,患者被分为低,moderate-,和基于风险分层列线图模型的高危人群。
    结论:我们的研究提出了一种新的列线图模型,该模型可以有效预测血管内血栓切除术后基底动脉闭塞患者的90天死亡率,并对高死亡率患者进行分层。中度,或低风险,这可能有助于中风的预后判断和临床治疗。
    BACKGROUND: This study aimed to establish and validate a nomogram model for predicting 90-day mortality in patients with acute basilar artery occlusion receiving endovascular thrombectomy.
    RESULTS: A total of 242 patients with basilar artery occlusion undergoing endovascular thrombectomy were enrolled in our study, in which 172 patients from 3 stroke centers were assigned to the training cohort, and 70 patients from another center were assigned to the validation cohort. Univariate and multivariate logistic regression analyses were adopted to screen prognostic predictors, and those with significance were subjected to establish a nomogram model in the training cohort. The discriminative accuracy, calibration, and clinical usefulness of the nomogram model was verified in the internal and external cohorts. Six variables, including age, baseline National Institutes of Health Stroke Scale score, Posterior Circulation-Alberta Stroke Program Early CT (Computed Tomography) score, Basilar Artery on Computed Tomography Angiography score, recanalization failure, and symptomatic intracranial hemorrhage, were identified as independent predictors of 90-day mortality of patients with basilar artery occlusion and were subjected to develop a nomogram model. The nomogram model exhibited good discrimination, calibration, and clinical usefulness in both the internal and the external cohorts. Additionally, patients were divided into low-, moderate-, and high-risk groups based on the risk-stratified nomogram model.
    CONCLUSIONS: Our study proposed a novel nomogram model that could effectively predict 90-day mortality of patients with basilar artery occlusion after endovascular thrombectomy and stratify patients with high, moderate, or low risk, which has a potential to facilitate prognostic judgment and clinical management of stroke.
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  • 文章类型: Journal Article
    外周动脉闭塞性疾病(PAOD)是全身动脉粥样硬化的临床表现,常伴有脑血管疾病及各种并发症。我们研究的目的是评估2019年冠状病毒病(COVID-19)感染与随后的PAOD发展之间的关系。进行了一项回顾性队列研究,并从TriNetX分析平台确定了COVID-19感染的个体。在排除和匹配后,共招募了2206065例感染COVID-19的患者和2206065例未感染COVID-19的患者。主要结果是COVID-19感染后PAOD的发展。采用Cox比例风险回归得出组间PAOD的风险比(HR)和95%置信区间(CI)。整个随访期后,在3个月随访(HR:1.27,95%CI:1.24-1.30)和12个月随访(HR:1.33,95%CI:1.31-1.35)时,COVID-19组的PAOD发生率明显更高。在以65岁为门槛的分层分析中,COVID-19组的两个年龄组的PAOD风险均较高.同样,在性别和种族分层分析中,在两个亚组中,COVID-19组的PAOD风险较高。总之,COVID-19感染与PAOD发病率的增加密切相关。
    Peripheral arterial occlusive disease (PAOD) is a clinical manifestation of systemic atherosclerosis and is always associated with cerebrovascular disease and various complications. The aim of our study is to evaluate the relationship between the coronavirus disease 2019 (COVID-19) infection and the subsequent PAOD development. A retrospective cohort study was conducted and individuals with COVID-19 infection were identified from the TriNetX analytics platform. A total of 2 206 065 patients with COVID-19 infection and 2 206 065 patients without COVID-19 infection were recruited after exclusion and matching. The primary outcome was the development of PAOD after the COVID-19 infection. The Cox proportional hazard regression was adopted to yield the hazard ratio (HR) and 95% confidence interval (CI) of PAOD between groups. After the whole follow-up period, the incidence of PAOD was significantly higher in the COVID-19 group at both the 3-month follow-up (HR: 1.27, 95% CI: 1.24-1.30) and the 12-month follow-up (HR: 1.33, 95% CI: 1.31-1.35) The Kaplan-Meier analysis with the log-rank test demonstrated a higher cumulative probability of PAOD in the COVID-19 group compared to the non-COVID-19 group (p < 0.001). In stratified analysis using 65 years as the threshold, both age groups in the COVID-19 group exhibited a higher risk of PAOD. Similarly, in the sex and race stratified analysis, the COVID-19 group performed a higher risk of PAOD in both subgroups. In conclusion, the COVID-19 infections are strongly associated with an increment of PAOD incidence.
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    文章类型: Randomized Controlled Trial
    背景:常规径向方法(CRA),经皮冠状动脉介入治疗(PCI)的金标准方法,与桡动脉闭塞(RAO)的风险相关。桡骨远端入路(DRA)是一种有效的替代方法,并发症少。
    目的:通过DRA在突尼斯患者择期PCI中的RAO率评估穿刺成功率和安全性的有效性。
    方法:这是一项纳入择期PCI住院患者的随机对照非劣效性试验。该协议先前已发布(TunisMed2022;100(3):192-202)。主要终点是30天的穿刺成功率和RAO率。
    结果:总体而言,包括250名患者,两组具有可比性。径向脉冲的术前检查和Barbeau测试相似。大多数PCIs是冠状动脉造影(82%)。在ITT中,分别在CRA和DRA中,穿刺成功率相似(97.6%对96.8%;p≤0.500).RAO率相似(2.4%对3.2%;p≤0.500)。交叉是相似的。通过DRA进行的PCI持续时间更长,但没有更多的辐照,然而,它需要更多的对比。总体出血和血管并发症相似。
    结论:这项研究表明,在突尼斯人群中,在30天的穿刺成功率和RAO率方面,DRA与CRA相比具有非劣效性。需要多中心试验,包括紧急PCI和系统超声筛查RAO。
    BACKGROUND: The conventional radial approach (CRA), the gold standard approach for percutaneous coronary interventions (PCI), is associated with the risk of radial artery occlusion (RAO). The distal radial approach (DRA) is an effective alternative with fewer complications.
    OBJECTIVE: To evaluate the efficacy in terms of puncture success and safety by RAO rate of the DRA in elective PCI in Tunisian patients.
    METHODS: It was a randomized controlled non-inferiority trial including patients hospitalized for elective PCI. The protocol was previously published (Tunis Med 2022; 100(3): 192-202). The primary endpoints were puncture success and RAO rate at 30 days.
    RESULTS: Overall, 250 patients were included and the groups were comparable. The preprocedural examination of the radial pulse and the Barbeau test were similar. The majority of PCIs were coronary angiography (82%). In ITT, respectively in CRA versus DRA, puncture success rates were similar (97.6% versus 96.8%; p≤0.500). RAO rates were similar (2.4% versus 3.2%; p≤0.500). Crossovers were similar. PCI through DRA lasted longer but was not more irradiating, however it required more contrast. Overall bleeding and vascular complications were similar.
    CONCLUSIONS: This study demonstrated the non-inferiority of DRA compared to CRA for elective PCIs in a Tunisian population regarding puncture success and RAO rate at 30 days. Multicenter trials including urgent PCI with systematic ultrasound screening for RAO are needed.
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  • 文章类型: Multicenter Study
    背景:远端放射状入路(DRA)作为替代入路缺乏证据,尽管最近的声誉。
    目的:本研究的目的是在日常实践的基础上评估DRA的安全性和可行性。
    方法:KODRA(评估远端放射状方法的安全性和有效性的韩国前瞻性注册)试验是一项前瞻性多中心注册,于2019年9月至2021年9月在14家医院进行。主要终点是冠状动脉造影(CAG)和经皮冠状动脉介入(PCI)的成功率。次要终点包括成功的桡动脉远端穿刺,访问站点交叉,通路部位相关并发症,出血事件,和穿刺失败的预测因子。
    结果:在排除735名患者后,共招募了5,712名筛查患者中的4,977名。主要终点,通过DRA进行CAG和PCI的成功率,分别为100%和98.8%,分别,成功穿刺桡动脉远端(94.4%)。333例患者(6.7%)发生了通路交叉。1个月随访时,远端桡动脉闭塞和触诊桡动脉闭塞的发生率分别为0.8%(4,340中的36)和0.8%(4,340中的33)。在3.3%的患者中观察到DRA相关出血事件,无严重血肿.多水平逻辑回归分析确定了弱脉搏(OR:9.994;95%CI:7.252-13.774)和DRA经验<100例(OR:2.187;95%CI:1.383-3.456)是穿刺失败的预测因素。
    结论:在这个大规模的前瞻性多中心注册中,DRA显示CAG和PCI的成功率较高,穿刺成功率较高,但桡动脉远端闭塞率较低。桡动脉闭塞,出血事件,和手术相关的并发症。脉搏弱和DRA经验<100例是穿刺失败的预测因素。(评估远端放射状入路的安全性和有效性的韩国前瞻性注册[KODRA];NCT04080700)。
    BACKGROUND: Distal radial access (DRA) as an alternative access route lacks evidence, despite its recent reputation.
    OBJECTIVE: The aim of this study was to evaluate the safety and feasibility of DRA on the basis of daily practice.
    METHODS: The KODRA (Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach) trial was a prospective multicenter registry conducted at 14 hospitals between September 2019 and September 2021. The primary endpoints were the success rates of coronary angiography (CAG) and percutaneous coronary intervention (PCI). The secondary endpoints included successful distal radial artery puncture, access-site crossover, access site-related complications, bleeding events, and predictors of puncture failure.
    RESULTS: A total of 4,977 among 5,712 screened patients were recruited after the exclusion of 735 patients. The primary endpoints, the success rates of CAG and PCI via DRA, were 100% and 98.8%, respectively, among successful punctures of the distal radial artery (94.4%). Access-site crossover occurred in 333 patients (6.7%). The rates of distal radial artery occlusion and radial artery occlusion by palpation were 0.8% (36 of 4,340) and 0.8% (33 of 4,340) at 1-month follow-up. DRA-related bleeding events were observed in 3.3% of patients, without serious hematoma. Multilevel logistic regression analysis identified weak pulse (OR: 9.994; 95% CI: 7.252-13.774) and DRA experience <100 cases (OR: 2.187; 95% CI: 1.383-3.456) as predictors of puncture failure.
    CONCLUSIONS: In this large-scale prospective multicenter registry, DRA demonstrated high success rates of CAG and PCI, with a high rate of puncture success but low rates of distal radial artery occlusion, radial artery occlusion, bleeding events, and procedure-related complications. Weak pulse and DRA experience <100 cases were predictors of puncture failure. (Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach [KODRA]; NCT04080700).
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