Atherectomy

动脉粥样硬化切除术
  • 文章类型: Journal Article
    动脉钙化和阻力狭窄在进行经皮冠状动脉介入治疗(PCI)时存在很大困难。因为它们增加了不良结局的风险,导致更差的临床结局.尽管存在专用技术和设备,包括各种球囊和动脉粥样斑块切除系统,它们通常不能确保足够的斑块修饰和理想的血管准备以实现最佳支架部署。血管内碎石术(IVL),最初为泌尿外科手术开发的技术,最近被用于通过声波无缝转移到附近组织来安全和选择性地破坏外周动脉和冠状动脉中的钙化沉积,增强血管顺应性,对软组织的影响最小。在冠状动脉中,IVL的使用在支架放置前的“血管准备”过程中起作用,这对于恢复严重冠状动脉疾病(CAD)患者的血流至关重要,被认为是一种微创技术,减少心脏直视手术的需要以及相关的风险和并发症。研究表明,IVL可以提高严重钙化冠状动脉疾病患者的手术成功率和良好的长期预后。随着IVL的出现,冠状动脉严重钙化和狭窄病变的破坏在支架植入前可以进行。尽管有很好的治疗钙化病变的数据,IVL在临床实践中明显未得到充分利用,需要长期的临床数据和广泛的研究来进一步验证其安全性和有效性.在这篇文章中,我们回顾了在冠状动脉中使用IVL作为解决血管内动脉粥样硬化斑块的方法的文献。特别关注对标准初始PCI有抗性的严重钙化斑块,同时与替代方法相比评估其安全性。
    Calcified and resistant narrowing of arteries poses significant difficulty in performing percutaneous coronary interventions (PCIs), as they increase the risk of subpar outcomes leading to worse clinical outcomes. Despite the existence of dedicated technologies and devices, including various balloons and atherectomy systems, they often do not ensure sufficient plaque modification and ideal vessel preparation for optimal stent deployment. Intravascular lithotripsy (IVL), a technology originally developed for urological procedures, has recently been used to safely and selectively disrupt calcified depositions in both peripheral and coronary arteries by sonic waves that seamlessly transfer to nearby tissue, enhancing vessel compliance with minimal impact on soft tissues. In the coronary arteries, the use of IVL plays a role in the process of \"vessel preparation\" before the placement of stents, which is crucial for restoring blood flow in patients with severe coronary artery disease (CAD), and is considered a minimally invasive technique, reducing the need for open heart surgeries and associated risks and complications. Studies have shown that IVL can lead to improved procedural success rates and favorable long-term outcomes for patients with severely calcified coronary artery disease. With the advent of IVL, the disruption of severe calcification of coronary artery and stenotic lesions before stent implantations can be performed. Despite promising data for treating calcified lesions, IVL is significantly underutilized in clinical practice, long-term clinical data and extensive research are needed to validate its further safety and efficacy. In this article, we reviewed the literature discussing the use of IVL in the coronary arteries as an approach for addressing intravascular atherosclerotic plaques, particularly focusing on heavily calcified plaques that are resistant to standard initial PCI, while also evaluating its safety in comparison to alternative methods.
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  • 文章类型: Journal Article
    动脉粥样硬化切除术在治疗股pop疾病中的作用正在迅速发展。然而,经皮球囊成形术(BA)(普通球囊和药物涂层BA)的辅助斑块切除术的临床疗效和安全性仍存在争议。我们试图进行一项荟萃分析,比较斑块切除术加球囊血管成形术(ABA)与单用BA治疗股pop疾病。
    我们搜索了PubMed,Cochrane临床试验中央注册中心,EMBASE,和ClinicalTrials.gov(从开始到2022年1月10日),用于比较ABA和BA治疗股pop疾病的研究。我们使用随机效应模型计算95%CI的风险比(RR)。靶病变血运重建(TLR),初级通畅,救助支架是主要结果。
    纳入了9项研究,共699名患者(4项随机研究和5项回顾性研究)。与单独的BA相比,ABA组显示出由非随机研究(RR0.59;95%CI,0.40-0.85;P=0.005)和救助支架(RR,0.32;95%CI,0.21-0.48;P<0.0001)。进行分析时,TLR没有显着差异,仅包括随机试验。两组之间的主要通畅性没有显着差异(RR,1.04;95%CI,0.95-1.14;P=.37)。
    来自随机试验的数据表明,与单独的BA相比,斑块切除和BA联合显示TLR或原发通畅性无差异.在观察性研究中,ABA组TLR和救助支架降低,但原发通畅性无差异。需要进一步的研究来研究与单用BA相比,动脉粥样硬化切除联合BA在股pop病变中的临床效果。
    UNASSIGNED: The role of atherectomy in treating femoropopliteal disease has been evolving rapidly. However, the clinical efficacy and safety of adjunctive atherectomy to percutaneous balloon angioplasty (BA) (plain balloon and drug-coated BA) remains controversial. We sought to perform a meta-analysis comparing atherectomy plus balloon angioplasty (ABA) versus BA alone in treating femoropopliteal disease.
    UNASSIGNED: We searched PubMed, Cochrane Central Register of Clinical Trials, EMBASE, and ClinicalTrials.gov (from inception through January 10, 2022) for studies comparing ABA versus BA for femoropopliteal disease. We used a random-effects model to calculate risk ratio (RR) with 95% CIs. Target lesion revascularization (TLR), primary patency, and bailout stenting were the primary outcomes.
    UNASSIGNED: Nine studies with 699 patients were included (4 randomized and 5 retrospective studies). Compared to BA alone, the ABA group showed a significant decrease in TLR driven by nonrandomized studies (RR 0.59; 95% CI, 0.40-0.85; P = .005) and bailout stenting (RR, 0.32; 95% CI, 0.21-0.48; P < .0001). There was no significant difference in TLR when the analysis was performed including only randomized trials. There was no significant difference in the primary patency between the 2 groups (RR, 1.04; 95% CI, 0.95-1.14; P = .37).
    UNASSIGNED: Data from randomized trials suggest that compared with BA alone, the combination of atherectomy and BA showed no difference in TLR or primary patency. In observational studies, TLR and bailout stenting were reduced in ABA group but there was no difference in primary patency. Further studies are needed to investigate the clinical outcomes of atherectomy combined with BA in femoropopliteal lesions compared with BA alone.
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  • 文章类型: Journal Article
    钙化冠状动脉病变是经皮冠状动脉介入治疗(PCI)的挑战。冠状动脉血管内碎石术(IVL)是一项新的钙修饰技术,于2021年2月批准用于商业用途,但在美国临床实践中对其吸收知之甚少。
    我们描述了使用钙改性策略的趋势,不同医院的使用差异,以及PCI中钙修饰和IVL使用的预测因子。我们纳入了2018年4月1日至2022年12月31日期间接受PCI的国家心血管数据注册CathPCI注册患者。我们检查了钙修饰和IVL使用的趋势和医院变化。我们使用多变量分层逻辑回归来确定2022年医院钙修饰和IVL使用的预测因素。
    在4.75年的时间里,共有1676家医院的2,733,494个PCI,11.4%进行钙改性。冠状动脉IVL的使用从2020年第四季度的PCIs的0%迅速增加到2022年第四季度的PCIs的7.8%,同时在此期间所有钙修饰策略的使用总体增加(11.1%-16.0%),冠状动脉粥样斑块切除术的使用略有相应减少(5.4%-4.4%)。2022年,各医院的IVL使用差异很大(中位数,3.86%;IQR,0%-8.19%),IVL是48%医院中最常见的钙修饰策略。治疗医院是钙修饰的最强预测因子(中位比值比[OR],2.49;95%CI,2.40-2.57)和IVL使用(中位数OR,2.89;95%CI,2.74-3.04)。
    IVL迅速改变了PCI钙修饰的使用前景,尽管各医院之间仍然存在很大差异。
    UNASSIGNED: Calcified coronary lesions are a challenge for percutaneous coronary interventions (PCIs). Coronary intravascular lithotripsy (IVL) is a novel calcium modification technology approved for commercial use in February 2021, but little is known about its uptake in US clinical practice.
    UNASSIGNED: We described trends in use of calcium modification strategies, variation in use across hospitals, and predictors of calcium modification and IVL use in PCI. We included National Cardiovascular Data Registry CathPCI Registry patients who underwent PCI between April 1, 2018, and December 31, 2022. We examined trends and hospital variation in calcium modification and IVL use. We used multivariate hierarchical logistic regression to identify predictors of calcium modification and IVL use at hospitals in 2022.
    UNASSIGNED: Of 2,733,494 PCIs across 1676 hospitals over 4.75 years, 11.4% were performed with calcium modification. Coronary IVL use increased rapidly from 0% of PCIs in Q4 2020 to 7.8% of PCIs in Q4 2022, which was accompanied by an overall increase in use of all calcium modification strategies (11.1%-16.0%) during this period with a slight corresponding decrease in coronary atherectomy use (5.4%-4.4%). In 2022, there was wide variation in IVL use across hospitals (median, 3.86%; IQR, 0%-8.19%), with IVL being the most common calcium modification strategy in 48% of hospitals. The treating hospital was the strongest predictor of calcium modification (median odds ratio [OR], 2.49; 95% CI, 2.40-2.57) and IVL use (median OR, 2.89; 95% CI, 2.74-3.04).
    UNASSIGNED: IVL has rapidly changed the landscape of calcium modification use for PCI, although there remains wide variation across hospitals.
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  • 文章类型: Journal Article
    与外科动脉内膜切除术相比,经血管内治疗的股动脉(CFA)疾病通常严重钙化,通畅率低。最近的数据表明,辅助使用血管内碎石术有希望的短期结果;然而,缺乏有关其中期有效性的数据。我们比较了临床驱动的靶病变血管重建术(CD-TLR)在接受药物涂层球囊血管成形术并辅助血管内碎石术(IVL-DCB)与辅助斑块切除术(Ath-DCB)治疗CFA疾病的患者之间的差异。
    在单中心回顾性队列研究中,纳入2015年1月至2020年3月期间接受IVL-DCB和Ath-DCB治疗有症状CFA疾病的患者.主要结局为累积CD-TLR,血管造影再狭窄≥50%,在18个月的随访期间通过Kaplan-Meier分析进行估计,并通过对数秩检验进行比较。
    总共68个CFA病变(Ath-DCB,35;IVL-DCB,33)包括在内。患者的平均年龄(标准差)为72(8)岁,主要为男性(63.3%)和白人(92%)。Ath-DCB组的平均基线血管造影狭窄为78%(11),IVL-DCB组为70%(10)(P=0.002)。两组的技术成功率均为100%。在需要放置支架的IVL-DCB中发生了一次流量限制夹层,而Ath-DCB组进行了2次救助支架。Ath-DCB组的CD-TLR累积Kaplan-Meier自由度为91.2%(95%CI,81.6%-100%),IVL-DCB组为79.4%(95%CI,64.6%-94.2%)(Log-rankP=.167)。
    在18个月的随访中,IVL-DCB治疗钙化CFA疾病的安全性和有效性与Ath-DCB相当。需要进一步的研究来验证这些发现。
    UNASSIGNED: Common femoral artery (CFA) disease is often heavily calcified and prone to low patency rates with endovascular treatment compared with surgical endarterectomy. Recent data suggest promising short-term outcomes with the adjunct use of intravascular lithotripsy; however, data on its midterm effectiveness are lacking. We compared clinically driven target lesion revascularization (CD-TLR) between patients receiving drug-coated balloon angioplasty with adjunct intravascular lithotripsy (IVL-DCB) vs adjunct atherectomy (Ath-DCB) for treatment of CFA disease.
    UNASSIGNED: In a single-center retrospective cohort study, patients receiving IVL-DCB vs Ath-DCB for symptomatic CFA disease from January 2015 to March 2020 were included. The primary outcome was cumulative CD-TLR with angiographic restenosis ≥50%, estimated by Kaplan-Meier analysis during 18-month follow-up and compared by log-rank test.
    UNASSIGNED: Total of 68 CFA lesions (Ath-DCB, 35; IVL-DCB, 33) were included. Patients had a mean age (standard deviation) of 72 (8) years and were predominantly male (63.3%) and White (92%). Mean baseline angiographic stenosis was 78% (11) in the Ath-DCB group and 70% (10) in the IVL-DCB group (P = .002). Technical success was 100% in both groups. One flow-limiting dissection occurred in IVL-DCB requiring stent placement, whereas 2 bailout stentings were performed in the Ath-DCB group. Cumulative Kaplan-Meier freedom from CD-TLR was 91.2% (95% CI, 81.6%-100%) in the Ath-DCB group vs 79.4% (95% CI, 64.6%-94.2%) in the IVL-DCB group (Log-rank P = .167).
    UNASSIGNED: The safety and effectiveness of IVL-DCB were comparable to those of Ath-DCB in the treatment of calcified CFA disease during the 18-month follow-up. Further studies are required to verify these findings.
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  • 文章类型: Editorial
    冠状动脉钙化病变是常见的,冠状动脉粥样斑块切除术通常用于经皮冠状动脉介入治疗(PCI)期间的病变修饰。在动脉粥样硬化切除术期间腺苷的释放可导致缓慢性心律失常,氨茶碱通常用于预防这种反应。我们确定了138例患者,以评估冠状动脉粥样斑块切除术前静脉(IV)氨茶碱给药的安全性和有效性。共治疗了159个钙化病灶,旋切装置是眼眶旋切术,旋磨,在52%中,42%,分别为6%和6%。服用氨茶碱后,4.3%的患者需要术中插入经静脉起搏器(TVP),18.1%的患者需要静脉注射阿托品。98.6%的患者获得了技术成功,无氨茶碱不良反应报告。所有患者均存活至出院。总之,冠状动脉粥样斑块切除术前给予氨茶碱是安全有效的.没有看到氨茶碱的不良反应,救助TVP安置率较低。
    Coronary calcified lesions are commonly encountered and coronary atherectomy is commonly used for lesion modification during percutaneous coronary interventions (PCI). The release of adenosine during atherectomy can result in bradyarrhythmias and aminophylline is commonly used to prevent this reaction. We identified 138 patients to evaluate the safety and efficacy of intravenous (IV) aminophylline administration prior to coronary atherectomy. A total of 159 calcified lesions were treated, and the atherectomy device was orbital atherectomy, rotational atherectomy, and both in 52 %, 42 %, and 6 %; respectively. After administration of aminophylline, 4.3 % of patients required intraprocedural insertion of a transvenous pacer (TVP), and 18.1 % of patients required administration of IV atropine. Technical success was achieved in 98.6 % of patients, and no adverse reactions to aminophylline were reported. All patients survived to discharge. In conclusion, aminophylline administration prior to coronary atherectomy was safe and effective. No adverse effects of aminophylline were seen, and the rate of bailout TVP placement was low.
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  • 文章类型: Case Reports
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  • 文章类型: Journal Article
    慢性完全闭塞(CTO)经皮冠状动脉介入治疗(PCI)占美国稳定型心绞痛所有PCI的4%,与非-CTOPCIs相比,其成功率较低,院内事件发生率较高。我们旨在检查CTOPCI与非CTOPCI的长期结局,包括高风险非CTOPCI的预设亚组(动脉粥样硬化切除术/隐静脉移植/无保护左主干)。
    在与Medicare(2009年7月至2016年12月)相关的国家心血管数据注册CathPCI注册的551,722名患者中,我们评估了CTOPCI(N=29,407)与非CTOPCI(N=522,315)的院内事件和长期主要不良心血管事件.然后,我们评估了CTOPCI和高风险非CTOPCI之间的相似结果(N=53,662)。我们排除了ST段抬高型心肌梗死和非ST段抬高型心肌梗死的患者。
    接受CTOPCI的患者更可能是年轻和男性。与非CTOPCI(7.0%vs4.2%;P<.001)和高风险非CTOPCI(7.0%vs6.5%;P=.008)相比,CTOPCI发生院内事件的风险更高。此外,与非CTOPCI相比,CTOPCI与长期重复血运重建的风险略高相关(调整后的风险比[aHR],1.09;95%CI,1.05-1.13)。然而,与高风险的非CTOPCI相比,CTOPCI与长期主要不良心血管事件的风险略低相关(aHR,0.87;95%CI,0.84-0.90)和再入院(AHR,0.87;95%CI,0.84-0.90)。
    在这项研究中,与高风险的非CTOPCI相比,CTOPCI与院内和院外事件的风险更高相关,但长期事件的风险略低。这些发现揭示了各种PCI程序的复杂性,这些程序可以告知临床医生和患者预期的结果。
    UNASSIGNED: Chronic total occlusion (CTO) percutaneous coronary interventions (PCIs) represent 4% of all PCIs for stable angina in the United States and have been associated with lower success and higher in-hospital event rates compared with non-CTO PCIs. We aimed to examine long-term outcomes of CTO PCI compared with non-CTO PCI, including prespecified subgroups of high-risk non-CTO PCI (atherectomy/saphenous vein graft/unprotected left main).
    UNASSIGNED: Among 551,722 patients in the National Cardiovascular Data Registry CathPCI Registry linked to Medicare (July 2009-December 2016), we evaluated in-hospital events and long-term major adverse cardiovascular events of CTO PCIs (N = 29,407) compared with non-CTO PCIs (N = 522,315). We then evaluated similar outcomes between CTO PCIs and high-risk non-CTO PCIs (N = 53,662). We excluded patients with ST-elevation myocardial infarction and non-ST-elevation myocardial infarction.
    UNASSIGNED: Patients undergoing CTO PCI were more likely to be younger and male. CTO PCI was associated with a higher risk of in-hospital events compared with non-CTO PCI (7.0% vs 4.2%; P < .001) and high-risk non-CTO PCI (7.0% vs 6.5%; P = .008). In addition, CTO PCI was associated with a slightly higher risk of long-term repeat revascularization compared with non-CTO PCI (adjusted hazard ratio [aHR], 1.09; 95% CI, 1.05-1.13). However, compared with high-risk non-CTO PCIs, CTO PCIs were associated with a slightly lower risk of long-term major adverse cardiovascular events (aHR, 0.87; 95% CI, 0.84-0.90) and readmission (aHR, 0.87; 95% CI, 0.84-0.90).
    UNASSIGNED: In this study, CTO PCI was associated with higher risk of both in-hospital and out-of-hospital events but a slightly lower risk of long-term events compared with high-risk non-CTO PCIs. These findings shed light on the complexity of various PCI procedures that can inform clinicians and patients of expected outcomes.
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  • 文章类型: Case Reports
    一名83岁的右下肢跛行妇女被转诊到我们医院。由于血管造影显示严重狭窄,并有严重钙化的病变,从右股浅动脉(SFA)的开口延伸到近端,使用Jetstream™动脉粥样硬化系统进行血管内治疗(EVT)(波士顿科学,马尔伯勒,MA,美国)和紫杉醇涂层球囊(PCB)进行。使用Jetstream™旋切术导管SC1.85进行旋切术,随后使用Jetstream™旋切术导管XC2.1/3.0进行额外的旋切术。随后,血管造影和血管内超声(IVUS)图像显示,由于钙化斑块的减少,管腔面积扩大,但即使是一些没有钙化斑块的健康介质也已被清除。接下来,进行了PCB扩张,最后的血管造影显示足够的扩张。然而,EVT后9个月症状复发。血管造影显示血管增大,提示右SFA口部分有假性动脉瘤,并在增大血管远端严重狭窄。IVUS图像显示假性动脉瘤和严重狭窄,这是由于假性动脉瘤远端钙化结节所致。这种情况表明假性动脉瘤是使用Jetstream™粥样斑块切除术系统和PCB治疗SFA病变的EVT的潜在并发症。
    Jetstream™旋切术系统(波士顿科学,马尔伯勒,MA,USA)已开发用于通过去除钙化斑块和改善血管顺应性来改善下肢动脉疾病中严重钙化病变的股pop动脉病变的预后。一些临床报告显示,使用粥样斑块切除装置进行血管内治疗后,通畅率持久,并发症发生率低。然而,假性动脉瘤是使用Jetstream™动脉粥样硬化切除术系统进行血管内治疗的潜在并发症。
    An 83-year-old woman with claudication in the right lower extremity was referred to our hospital. Since angiography showed severe stenosis with a severely calcified lesion extending from the ostial to proximal part of the right superficial femoral artery (SFA), endovascular therapy (EVT) with the Jetstream™ atherectomy system (Boston Scientific, Marlborough, MA, USA) and paclitaxel-coated balloon (PCB) was performed. Atherectomy was performed using the Jetstream™ atherectomy catheter SC 1.85, followed by an additional atherectomy using the Jetstream™ atherectomy catheter XC 2.1/3.0. Subsequently, angiography and intravascular ultrasound (IVUS) images showed the enlargement of lumen area due to the reduction of calcified plaque, but even some of the healthy media on the side free of calcified plaque had been removed. Next, a PCB dilation was performed, and the final angiography showed adequate dilation. However, the symptoms recurred 9 months after EVT. Angiography revealed an enlarged vessel suggestive of pseudoaneurysm at the ostial part of the right SFA and severe stenosis distal to the enlarged vessel. IVUS images showed a pseudoaneurysm and severe stenosis due to calcified nodules distal to the pseudoaneurysm. This case suggests that pseudoaneurysm is a potential complication of EVT with the Jetstream™ atherectomy system and PCB for SFA lesions.
    UNASSIGNED: The Jetstream™ atherectomy system (Boston Scientific, Marlborough, MA, USA) has developed to improve outcomes for femoropopliteal artery lesions with severely calcified lesions in lower extremity arterial disease by removing calcified plaque and improving vascular compliance. Several clinical reports demonstrated durable patency rates and low complication rates after endovascular therapy using the atherectomy device. However, pseudoaneurysm is a potential complication of endovascular therapy with the Jetstream™ atherectomy system.
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  • 文章类型: Case Reports
    尽管血管内粥样斑块切除术广泛用于消除周围动脉疾病中的钙化粥样斑块,它与并发症有关。伴有假性动脉瘤形成的延迟破裂很少见。我们报告了一名73岁的男子,该男子在旋转粥样斑块切除术后出现了24mm×20mm×27mm的pop动脉(PA)假性动脉瘤。最初,患者出现间歇性跛行。术前计算机断层扫描血管造影(CTA)显示PA中严重钙化的动脉粥样硬化。使用Jetstream™装置(波士顿科学公司)进行旋转粥样斑块切除术。术后,踝臂指数和症状改善。然而,粥样斑块切除术后6天,患者主诉小腿疼痛和肿胀。随访CTA显示pop窝假性动脉瘤和血肿。通过后入路进行开放转换,去除严重钙化的斑块和补片血管成形术。旋磨术后延迟PA破裂和假性动脉瘤形成很少见;然而,他们需要迅速的管理。
    Although intravascular atherectomy is widely used for debulking calcified atheromas in peripheral arterial disease, it is associated with complications. Delayed rupture with pseudoaneurysm formation is rare. We report the case of a 73-year-old man who developed a 24 mm×20 mm×27 mm popliteal artery (PA) pseudoaneurysm after rotational atherectomy. Initially, the patient presented with intermittent claudication. Preoperative computed tomographic angiography (CTA) showed a severely calcified atheroma in the PA. Rotational atherectomy was performed using the Jetstream™ device (Boston Scientific). Postoperatively, the ankle-brachial index and symptoms improved. However, 6 days after the atherectomy, the patient complained of calf pain and swelling. Follow-up CTA revealed a pseudoaneurysm and hematoma in the popliteal fossa. Open conversion with removal of the heavily calcified plaque and patch angioplasty were performed via the posterior approach. Delayed PA rupture and pseudoaneurysm formation after rotational atherectomy are rare; however, they require prompt management.
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  • 文章类型: Clinical Trial Protocol
    背景:血管内治疗已成为大多数动脉区域的一线治疗。然而,开放血管手术(动脉内膜切除术)仍然是股总动脉(CFA)病变的首选治疗方法。这项研究的目的是研究定向斑块切除术加药物涂层球囊(DCB)与动脉内膜切除术治疗新生动脉硬化性CFA病变的急性和中期结果。
    方法:这种前瞻性,随机化,多中心非劣效性研究将纳入306名患有CFA(卢瑟福1-5类)从头狭窄(包括分叉)的参与者。符合两个治疗组条件的患者可以包括在这个1:1随机试验中。主要疗效终点是在12个月时靶病变的通畅性,定义为再狭窄<50%,而不需要临床驱动的靶病变血运重建(cdTLR)。主要安全终点是包括死亡在内的联合终点,心肌梗塞,目标肢体的主要或次要截肢,和围手术期并发症在30天。次要终点包括6个月和24个月时靶病变的原发通畅,二级通畅,cdTLR6、12和24个月,踝臂指数改变,卢瑟福-贝克尔在6、12和24个月上课。肢体抢救,用步行障碍问卷衡量的生活质量变化,以及包括死亡在内的主要不良事件,心肌梗塞,目标肢体的轻微或严重截肢将在6、12、24和36个月时确定。
    结论:CFA病变的血管内治疗仍存在争议。迄今为止,很少有研究将现代血管内治疗方法与所谓的金标准外科动脉内膜切除术进行比较。根据最近的积极结果,本研究旨在确认与外科治疗相比,“不留任何痕迹”的血管内途径联合定向斑块切除术和DCB的非劣效性.
    背景:ClinicalTrials.govNCT02517827。
    BACKGROUND: Endovascular therapy has become established as a first-line therapy in most arterial regions. However, open vascular surgery (endarterectomy) remains the treatment of choice for common femoral artery (CFA) lesions. The aim of this study is to investigate the acute and mid-term results of directional atherectomy plus drug-coated balloon (DCB) in comparison to endarterectomy in treatment of de novo arteriosclerotic CFA lesions.
    METHODS: This prospective, randomized, multicenter non-inferiority study will enroll 306 participants with symptomatic (Rutherford category 1 to 5) de novo stenosis of the CFA including the bifurcation. Patients eligible for both treatment groups could be included in this 1:1 randomized trial. Primary efficacy endpoint is patency of the target lesion at 12 months defined as restenosis < 50% without the need of clinically driven target lesion revascularization (cdTLR). Primary safety endpoint is a combined endpoint including death, myocardial infarction, major or minor amputation of the target limb, and peri-procedural complications at 30 days. Secondary endpoints include primary patency of the target lesion at 6 and 24 months, secondary patency, cdTLR 6, 12, and 24 months, change in ankle-brachial index, and Rutherford-Becker class at 6, 12, and 24 months. Limb salvage, change in quality of life measured by Walking Impairment Questionnaire, and major adverse events including death, myocardial infarction, and minor or major amputation of the target limb will be determined at 6, 12, 24, and 36 months.
    CONCLUSIONS: Endovascular treatment of CFA lesions is still a matter of debate. Few studies compared modern endovascular therapy methods against the so-called gold standard surgical endarterectomy so far. Based on recent positive results, this study aims to confirm non-inferiority of a \"leaving nothing behind\" endovascular approach combining directional atherectomy and DCB compared to surgical therapy.
    BACKGROUND: ClinicalTrials.gov NCT02517827.
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