Drug-coated balloon

药物涂层球囊
  • 文章类型: Case Reports
    背景:颅内动脉狭窄是导致短暂的脑血流量减少的重要因素,称为短暂性脑缺血发作,或全面的中风。虽然动脉粥样硬化通常与颅内动脉狭窄有关,在年轻患者中,它通常具有非动脉粥样硬化性质。
    方法:这里,我们介绍了一个年轻的中风患者,大脑中动脉(MCA)狭窄,表现为非动脉粥样硬化病变,尽管接受了标准药物治疗,但仍经历了缺血性中风。患者接受了数字减影血管造影(DSA)以评估大脑中的整个血管网络,显示右侧MCAM1段明显变窄(约80%)。随后,患者接受药物涂层球囊血管成形术治疗右侧MCAM1段狭窄。随访DSA证实该节段狭窄的消退。尽管其余分支显示出令人满意的血流,血管壁显示不规则。6个月后进行的DSA检查显示右侧MCA无明显狭窄,有一个光滑的血管壁。
    结论:使用药物涂层球囊血管成形术在年轻患者的血管壁修复和重塑中显示出良好的结果。因此,它可能被认为是类似病例的一种有希望的治疗选择.
    BACKGROUND: Intracranial arterial narrowing is a significant factor leading to brief episodes of reduced blood flow to the brain, known as transient ischemic attacks, or full-blown strokes. While atherosclerosis is commonly associated with intracranial arterial narrowing, it is frequently of a non-atherosclerotic nature in younger patients.
    METHODS: Here, we present the case of a young stroke patient with narrowing of the middle cerebral artery (MCA), characterized as non-atherosclerotic lesions, who experienced an ischemic stroke despite receiving standard drug therapy. The patient underwent digital subtraction angiography (DSA) to assess the entire network of blood vessels in the brain, revealing significant narrowing (approximately 80%) in the M1 segment of the right MCA. Subsequently, the patient underwent Drug-Coated Balloon Angioplasty to treat the stenosis in the right MCA\'s M1 segment. Follow-up DSA confirmed the resolution of stenosis in this segment. Although the remaining branches showed satisfactory blood flow, the vessel wall exhibited irregularities. A review of DSA conducted six months later showed no evident stenosis in the right MCA, with a smooth vessel wall.
    CONCLUSIONS: The use of drug-coated balloon angioplasty demonstrated favorable outcomes in repairing and reshaping the blood vessel wall in young patients. Therefore, it may be considered a promising treatment option for similar cases.
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  • 文章类型: Systematic Review
    背景:随着慢性全冠状动脉闭塞(CTO)再通技术和概念的进步,再通成功率一直在稳步提高。然而,目前的数据太有限,无法得出关于CTO经皮冠状动脉介入治疗(PCI)中药物涂层球囊(DCBs)的疗效和安全性的可靠结论.在这里,我们进行了一项荟萃分析,以证实DCB在CTOPCI中的疗效.
    方法:我们系统地搜索了PubMed,WebofScience和Embase从成立到2023年7月25日。主要结局是主要的心血管事件(MACE),包括心脏死亡,非致死性心肌梗死(MI),靶病变血运重建(TLR),和目标血管血运重建(TVR)。随访血管造影终点为晚期管腔增大(LLE),再闭塞和再狭窄。
    结果:5项研究共511名患者纳入荟萃分析。在整个研究中,患者主要为男性(72.9-85.7%),年龄超过50岁.MACE的总估计率为13.0%(95%CI10.1%-15.9%,I2=0%,p=0.428)。心源性死亡和MI的总估计率为2.2%(95%CI0.7%-3.7%,I2=0%,p=0.873)和1.2%(95%CI-0.2-2.6%,I2=13.7%,p=0.314),分别。最后,TLR和TVR的合并发生率为10.1%(95%CI5.7%-14.5%,I2=51.7%,p=0.082)和7.1%(95%CI3.0%-11.2%,I2=57.6%,p=0.070),分别。最后,LLE的汇总估计率,再闭塞和再狭窄为59.4%(95%CI53.5-65.3%,I2=0%,p=0.742),3.3%(95%CI1.1-5.4%,I2=0%,p=0.865)和17.5%(95%CI12.9-22.0%,I2=0%,p=0.623),分别。
    结论:因此,DCB有潜力在合适的患者中用作CTO的治疗。
    BACKGROUND: With advancements in chronic total coronary occlusion (CTO) recanalization techniques and concepts, the success rate of recanalization has been steadily increasing. However, the current data are too limited to draw any reliable conclusions about the efficacy and safety of drug-coated balloons (DCBs) in CTO percutaneous coronary intervention (PCI). Herein, we conducted a meta-analysis to confirm the efficacy of DCB in CTO PCI.
    METHODS: We systematically searched PubMed, Web of Science and Embase from inception to July 25, 2023. The primary outcome was major advent cardiovascular events (MACE), including cardiac death, nonfatal myocardial infarction (MI), target lesion revascularization (TLR), and target vessel revascularization (TVR). The follow-up angiographic endpoints were late lumen enlargement (LLE), reocclusion and restenosis.
    RESULTS: Five studies with a total of 511 patients were included in the meta-analysis. Across studies, patients were predominantly male (72.9-85.7%) and over fifty years old. The summary estimate rate of MACE was 13.0% (95% CI 10.1%-15.9%, I2 = 0%, p = 0.428). The summary estimate rates of cardiac death and MI were 2.2% (95% CI 0.7%-3.7%, I2 = 0%, p = 0.873) and 1.2% (95% CI -0.2-2.6%, I2 = 13.7%, p = 0.314), respectively. Finally, the pooled incidences of TLR and TVR were 10.1% (95% CI 5.7%-14.5%, I2 = 51.7%, p = 0.082) and 7.1% (95% CI 3.0%-11.2%, I2 = 57.6%, p = 0.070), respectively. Finally, the summary estimate rates of LLE, reocclusion and restenosis were 59.4% (95% CI 53.5-65.3%, I2 = 0%, p = 0.742), 3.3% (95% CI 1.1-5.4%, I2 = 0%, p = 0.865) and 17.5% (95% CI 12.9-22.0%, I2 = 0%, p = 0.623), respectively.
    CONCLUSIONS: Accordingly, DCB has the potential to be used as a treatment for CTO in suitable patients.
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  • 文章类型: Journal Article
    背景:经皮冠状动脉介入治疗(PCI),这代表支架植入,无论获得满意的结果与球囊血管成形术,已取代传统的普通旧球囊血管成形术和临时支架。带有药物涂层球囊(DCB),对于新发冠状动脉小血管疾病,初次DCB血管成形术和临时支架置入术显示出非劣效性。然而,在无血管直径限制的新生病变中,这种策略对临床终点的主要支架置入术的长期疗效和安全性仍不确定.
    方法:REC-CAGEFREEI是研究者发起的,多中心,随机化,开放标签试验旨在招募来自中国43个介入心脏病学中心的2270例急性或慢性冠状动脉综合征患者,以评估初级紫杉醇涂层球囊血管成形术对初级支架置入治疗从头治疗的非劣效性,非复杂病变无血管直径限制。符合所有纳入和排除标准并已成功实现病变预扩张的患者将以1:1的比例随机分配到两臂。在初次DCB血管成形术组中,协议指导的DCB血管成形术和不满意的血管成形术后的救助支架置入是强制性的。第二代西罗莫司洗脱支架将在主要DCB血管成形术组中用作救助支架,在主要支架置入组中用作治疗装置。主要终点是随机化后24个月内面向设备的复合终点(DoCE)的发生率,包括心脏死亡,靶血管心肌梗死,临床和生理指示的靶病变血运重建。
    结论:正在进行的REC-CAGEFREEI试验是第一个具有临床终点的随机试验,用于评估原发性DCB血管成形术治疗从头,非复杂病变无血管直径限制。如果显示出非劣效性,采用原发性DCB血管成形术的PCI可能是原发性支架置入术的替代治疗选择。
    背景:在clinicaltrial.gov(NCT04561739)注册。
    BACKGROUND: Percutaneous coronary intervention (PCI) with primary stenting, which stands for stent implantation regardless of obtaining satisfactory results with balloon angioplasty, has superseded conventional plain old balloon angioplasty with provisional stenting. With drug-coated balloon (DCB), primary DCB angioplasty with provisional stenting has shown non-inferiority to primary stenting for de novo coronary small vessel disease. However, the long-term efficacy and safety of such a strategy to the primary stenting on clinical endpoints in de novo lesions without vessel diameter restrictions remain uncertain.
    METHODS: The REC-CAGEFREE I is an investigator-initiated, multicenter, randomized, open-label trial aimed to enroll 2270 patients with acute or chronic coronary syndrome from 43 interventional cardiology centers in China to evaluate the non-inferiority of primary paclitaxel-coated balloons angioplasty to primary stenting for the treatment of de novo, non-complex lesions without vessel diameter restrictions. Patients who fulfill all the inclusion and exclusion criteria and have achieved a successful lesion pre-dilatation will be randomly assigned to the two arms in a 1:1 ratio. Protocol-guided DCB angioplasty and bailout stenting after unsatisfactory angioplasty are mandatory in the primary DCB angioplasty group. The second-generation sirolimus-eluting stent will be used as a bailout stent in the primary DCB angioplasty group and the treatment device in the primary stenting group. The primary endpoint is the incidence of Device-oriented Composite Endpoint (DoCE) within 24 months after randomization, including cardiac death, target vessel myocardial infarction, and clinically and physiologically indicated target lesion revascularization.
    CONCLUSIONS: The ongoing REC-CAGEFREE I trial is the first randomized trial with a clinical endpoint to assess the efficacy and safety of primary DCB angioplasty for the treatment of de novo, non-complex lesions without vessel diameter restrictions. If non-inferiority is shown, PCI with primary DCB angioplasty could be an alternative treatment option to primary stenting.
    BACKGROUND: Registered on clinicaltrial.gov (NCT04561739).
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  • 文章类型: Journal Article
    背景:药物涂层球囊(DCB)血管成形术对于特定的新冠状动脉病变似乎是安全有效的选择。然而,血管内超声(IVUS)引导下的DCB血管成形术在新生病变中的有益效果仍不确定.
    目的:本研究旨在评估在新冠状动脉病变的DCB血管成形术中,IVUS引导相对于血管造影引导的益处。
    方法:共260例出血风险较高的患者发生了新冠状动脉病变(参考血管直径2.0-4.0mm,并且病变长度≤15mm)被随机分配到IVUS引导或血管成形术引导的DCB血管成形术组。主要终点是手术后7个月的段内晚期管腔丢失(LLL)。次要终点是6个月时的目标血管衰竭。
    结果:共有2例血管造影引导组患者和7例IVUS引导组患者接受了救助支架植入术(P=0.172)。7个月LLL的主要终点是血管造影指导下的0.03±0.52mm,与IVUS指导下的-0.10±0.34mm(平均差0.14mm;95%CI:0.02-0.26;P=0.025)。与血管造影引导相比,IVUS引导还与较大的7个月最小管腔直径(2.06±0.62mmvs1.75±0.63mm;P<0.001)和较小的直径狭窄(28.15%±13.88%vs35.83%±17.69%;P=0.001)相关。在6个月时发生了5次目标血管故障,血管造影引导组4例(3.1%),IVUS引导组1例(0.8%)(P=0.370)。
    结论:这项研究表明,与血管造影指导相比,IVUS指导的DCB血管成形术与新冠状动脉病变患者的LLL降低相关。(血管内超声与血管造影引导的药物涂层球囊[ULTIMATE-III];NCT04255043)。
    BACKGROUND: Drug-coated balloon (DCB) angioplasty seems a safe and effective option for specific de novo coronary lesions. However, the beneficial effect of intravascular ultrasound (IVUS)-guided DCB angioplasty in de novo lesions remains uncertain.
    OBJECTIVE: This study aimed to assess the benefits of IVUS guidance over angiography guidance during DCB angioplasty in de novo coronary lesions.
    METHODS: A total of 260 patients with high bleeding risk who had a de novo coronary lesion (reference vessel diameter 2.0-4.0 mm, and lesion length ≤15 mm) were randomly assigned to either an IVUS-guided or an angioplasty-guided DCB angioplasty group. The primary endpoint was in-segment late lumen loss (LLL) at 7 months after procedure. The secondary endpoint was target vessel failure at 6 months.
    RESULTS: A total of 2 patients in the angiography-guided group and 7 patients in the IVUS-guided group underwent bailout stent implantation (P = 0.172). The primary endpoint of 7-month LLL was 0.03 ± 0.52 mm with angiography guidance vs -0.10 ± 0.34 mm with IVUS guidance (mean difference 0.14 mm; 95% CI: 0.02-0.26; P = 0.025). IVUS guidance was also associated with a larger 7-month minimal lumen diameter (2.06 ± 0.62 mm vs 1.75 ± 0.63 mm; P < 0.001) and a smaller diameter stenosis (28.15% ± 13.88% vs 35.83% ± 17.69%; P = 0.001) compared with angiography guidance. Five target vessel failures occurred at 6 months, with 4 (3.1%) in the angiography-guided group and 1 (0.8%) in the IVUS-guided group (P = 0.370).
    CONCLUSIONS: This study demonstrated that IVUS-guided DCB angioplasty is associated with a lower LLL in patients with a de novo coronary lesion compared with angiography guidance. (Intravascular Ultrasound Versus Angiography Guided Drug-Coated Balloon [ULTIMATE-III]; NCT04255043).
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  • 文章类型: Journal Article
    背景:AccuFFRangio是一种基于冠状动脉造影和计算流体动力学的快速计算血流储备分数(FFR)的新颖方法。药物涂层球囊(DCB)或普通旧球囊血管成形术(POBA)后,AccuFFRangio与临床结果之间的关联仍有待研究。
    方法:本研究纳入2016年12月至2020年10月连续接受球囊血管成形术的患者。AccuFFRangio是根据血管成形术后立即获得的术后血管造影进行回顾性计算的。主要终点是主要不良心脏事件(MACE),定义为全因死亡的复合物,血管相关性心肌梗死,并重复目标血管血运重建。
    结果:本研究共对169例患者进行了回顾性分析。术后AccuFFRangio(风险比[HR]每0.1增加0.33,95%置信区间[CI]0.22-0.48,p<0.001)是2年随访时MACE的独立预测因子。术后AccuFFRangio≤0.87被确定为预测MACE的最佳临界值,曲线下面积(AUC)为0.872(95%CI0.813-0.919,p<0.001)。
    结论:球囊血管成形术后立即测量的AccuFFRangio是不良临床结局的有希望的预测指标。
    BACKGROUND: AccuFFRangio is a novel method for fast computation of fractional flow reserve (FFR) based on coronary angiography and computational fluid dynamics. The association between the AccuFFRangio and clinical outcomes after drug-coated balloon (DCB) or plain old balloon angioplasty (POBA) remains to be investigated.
    METHODS: This study included consecutive patients who underwent balloon angioplasty from December 2016 to October 2020. AccuFFRangio was calculated retrospectively based on the post-procedural angiography obtained immediately after angioplasty. The primary endpoint was major adverse cardiac events (MACE), defined as a composite of all-cause death, vessel-related myocardial infarction, and repeat target vessel revascularization.
    RESULTS: A total of 169 patients were retrospectively analyzed in this study. Post-procedural AccuFFRangio (hazard ratio [HR] per 0.1 increase 0.33, 95% confidence interval [CI] 0.22-0.48, p < 0.001) was an independent predictor for MACE at 2-year follow-up. Post-procedural AccuFFRangio ≤ 0.87 was determined as the optimal cutoff value to predict MACE with an area under the curve (AUC) of 0.872 (95% CI 0.813-0.919, p < 0.001).
    CONCLUSIONS: AccuFFRangio measured immediately after balloon angioplasty is a promising predictor of unfavorable clinical outcomes.
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  • 文章类型: Journal Article
    目的:随着血管内治疗的发展,一些研究表明,斑块切除术(AT)治疗膝下动脉血运重建具有潜在的治疗价值.本研究旨在进行一项荟萃分析,以研究AT联合经皮腔内血管成形术(PTA)或药物涂层球囊(DCB)与PTA或DCB相比,治疗膝下动脉疾病的疗效。
    方法:这是一项系统综述和荟萃分析。Pubmed,WebofScience,和CochraneLibrary系统检索了截至2022年11月发表的文章,报道了使用动脉粥样硬化切除装置治疗膝下动脉患者的情况.纳入随机对照试验和回顾性研究,和临床特征结局被提取并合并.然后,我们分析了AT(AT+PTA或DCB)组和非AT(DCB或PTA)组对膝下动脉患者的疗效.
    结果:我们确定了6项研究,1269名患者纳入了该荟萃分析。6个月时,斑块切除术组与非斑块切除术组患者的初次通畅风险比(RR)为1.03(95%置信区间(CI)0.86-1.23,p=0.74),12个月时为1.05(95%CI=0.84-1.30,p=.66),在AT联合DCB和单独DCB之间的亚组分析中,原发性通畅的RR为1.56(95%CI=1.02-2.39,p=.04)。6个月时无靶病变血运重建(TLR)的RR为1.04(95%CI=0.93-1.17,p=.45),12个月时为1.20(95%CI=0.83-1.75,p=0.33)。6个月死亡率的RR为0.57(95%CI=0.29-1.11,p=.10),12个月时为0.79(95%CI0.50-1.25,p=0.31)。12个月时保肢的RR为0.99(95%CI=0.92-1.07,p=0.87)。12个月时(踝臂指数)ABI的标准化平均差(SMD)为0.16(95%CI=0.06-0.26,p=0.001)。
    结论:根据本系统综述和荟萃分析,在膝下段球囊血管成形术中加入斑块切除术并没有显著优势.仅在对小亚组的粥样斑块切除术+DCB与单独DCB的分析中,当添加粥样斑块切除术时,六个月的主要通畅率明显更高。没有发现与12个月的原发性通畅有关的进一步显着差异,TLR,肢体抢救,以及群体间的死亡率。
    OBJECTIVE: With the development of endovascular therapies, some studies have indicated a therapeutic potential for infrapopliteal arterial revascularization with atherectomy (AT). This study was designed to perform a meta-analysis to investigate the efficacy of AT combined with percutaneous transluminal angioplasty (PTA) or drug-coated balloon (DCB) compared with PTA or DCB for infrapopliteal arterial diseases.
    METHODS: This is a systematic review and meta-analysis. The Pubmed, Web of Science, and Cochrane Library were systematically searched for articles published up to November 2022, reporting using atherectomy devices for infrapopliteal arterial patients. Randomized controlled trials and retrospective studies were included, and clinical characteristic outcomes were extracted and pooled. Then, we analyzed the efficacies of the AT (AT + PTA or DCB) group and the non-AT (DCB or PTA) group for infrapopliteal arterial patients.
    RESULTS: We identified 6 studies with 1269 patients included in this meta-analysis. The risk ratios (RRs) of primary patency for patients treated with atherectomy group compared to non-atherectomy group at 6 months was 1.03 (95% confidence intervals (CIs) 0.86-1.23, p = .74), at 12 months was 1.05 (95% CIs 0.84-1.30, p = .66), in the subgroup analysis between AT combined with DCB and DCB alone, the RRs of primary patency was 1.56 (95% CIs 1.02-2.39, p = .04). The RRs of freedom from target lesion revascularization (TLR) at 6 months was 1.04 (95% CIs 0.93-1.17, p = .45), at 12 months was 1.20 (95% CIs 0.83-1.75, p = .33). The RRs of mortality at 6 months was 0.57 (95% CIs 0.29-1.11, p = .10), and at 12 months was 0.79 (95% CI 0.50-1.25, p = .31). The RRs of limb salvage at 12 months was 0.99 (95% CIs 0.92-1.07, p = .87). The standardized mean difference (SMD) of (Ankle-brachial index) ABI at 12 months was 0.16 (95% CIs 0.06-0.26, p = .001).
    CONCLUSIONS: According to this systematic review and meta-analysis, no significant advantages were found with the addition of atherectomy to balloon angioplasty in the below-the-knee segment. Only in the analysis of a small subgroup of atherectomy + DCB versus DCB alone was the primary patency rate at six months significantly higher when adding atherectomy. No further significant differences were found related to 12 months of primary patency, TLR, limb salvage, and mortality among groups.
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  • 文章类型: Journal Article
    BACKGROUND: To accurately assess the treatment effect of paclitaxel drug-coated balloon (DCB) angioplasty is essential for intracranial atherosclerotic disease (ICAD) patients. This study aimed to investigate the clinical feasibility of high-resolution vessel wall MRI (HR-VWI) in assessing ICAD with DCB angioplasty.
    METHODS: Forty-five patients with intracranial atherosclerotic stenosis ≥ 70% confirmed by digital subtraction angiography (DSA) underwent HR-VWI before and after DCB angioplasty. Postoperative follow-up was performed after 6 months (±1 month). The differences of pre- and postoperative HR-VWI characteristics, including vessel and lumen area at maximal lumen narrowing (MLN), plaque area and length, degree of stenosis, plaque burden (PB), remodeling index, and plaque enhancement amplitude (PEA) were compared. The relationship between stenotic rate obtained using HR-VWI and DSA was evaluated. Each HR-VWI characteristic and clinical factor before DCB angioplasty was separately evaluated for the association with postoperative restenosis.
    RESULTS: After six months, lumen area of MLN, plaque length and area, degree of stenosis, PB, and PEA showed a significantly difference relative to the value before DCB angioplasty (all P < 0.05). Spearman correlation coefficients of 0.865 and 0.932 were revealed between DSA and HR-VWI regarding the stenotic rate analysis pre- and post-operation (both P < 0.05). ROC analysis showed PEA, plaque length, and PB before DCB angioplasty separately provided robust prediction of postoperative restenosis (area under the curve = 0.909, 0.814 and 0.743; all P < 0.05). Multivariable analysis revealed that PEA was an independent predictor of prognosis.
    CONCLUSIONS: The HR-VWI can accurately assess the treatment effect of DCB and robustly predict prognosis.
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  • 文章类型: Meta-Analysis
    目的:通过对随机对照试验的网络荟萃分析,评估长期随访中新出现的股pop病变的最佳血管内治疗方法。
    方法:于2023年9月17日检索了医学数据库。选择17项试验和7种治疗方法。结果是初级通畅,靶病变血运重建(TLR),严重截肢和3年和/或5年全因死亡率。
    结果:关于3年的主要通畅性,药物洗脱支架(DES)是最好的,优于球囊血管成形术(BA;优势比[OR],4.96;95%置信区间[CI],2.68-9.18),裸露金属支架(BMS;或,2.81;95%CI,1.45-5.46),冷冻成形术(或,6.75;95%CI,2.76-16.50),覆膜支架(CS;或,3.25;95%CI,1.19-8.87)和药物涂层球囊(DCB;或,2.04;95%CI,1.14-3.63)。关于5年的初级通畅,DES是最好的,比BMS更好(或,2.34;95%CI,1.10-4.99)。关于3年TLR,DES是最好的,也比BA好(或者,0.24;95%CI,0.13-0.44)。关于5年TLR,DES是最好的,也比BA好(或者,0.20;95%CI,0.09-0.42)和近距离放射治疗球囊血管成形术(OR,0.21;95%CI,0.06-0.74)。关于3年和5年的严重截肢手术,DCB是最好的。关于3年死亡率,DES是最好的,也比CS好(或者,0.09;95%CI,0.01-0.67)。
    结论:DES是3年原发性通畅的最佳治疗方法,TLR和死亡率,DCB是关于大截肢最好的。DES是5年TLR的最佳治疗方法,DCB在主要通畅性和主要截肢方面是最好的。DES和DCB在治疗股pop病变时应优先考虑。
    OBJECTIVE: To evaluate the best endovascular treatment for de novo femoropopliteal lesions at long-term follow-up through network meta-analysis of randomized controlled trials.
    METHODS: Medical databases were searched on September 17, 2023. 17 trials and 7 treatments were selected. Outcomes were primary patency, target lesion revascularization (TLR), major amputation and all-cause mortality at 3 and/or 5 years.
    RESULTS: Regarding 3-year primary patency, drug-eluting stents (DES) was the best and better than balloon angioplasty (BA; odds ratio [OR], 4.96; 95% confidence interval [CI], 2.68-9.18), bare metal stents (BMS; OR, 2.81; 95% CI, 1.45-5.46), cryoplasty (OR, 6.75; 95% CI, 2.76-16.50), covered stents (CS; OR, 3.25; 95% CI, 1.19-8.87) and drug-coated balloons (DCB; OR, 2.04; 95% CI, 1.14-3.63). Regarding 5-year primary patency, DES was the best and better than BMS (OR, 2.34; 95% CI, 1.10-4.99). Regarding 3-year TLR, DES was the best and better than BA (OR, 0.24; 95% CI, 0.13-0.44). Regarding 5-year TLR, DES was the best and better than BA (OR, 0.20; 95% CI, 0.09-0.42) and balloon angioplasty with brachytherapy (OR, 0.21; 95% CI, 0.06-0.74). Regarding 3- and 5-year major amputation, DCB was the best. Regarding 3-year mortality, DES was the best and better than CS (OR, 0.09; 95% CI, 0.01-0.67).
    CONCLUSIONS: DES was the best treatment regarding 3-year primary patency, TLR and mortality, and DCB was the best regarding major amputation. DES was the best treatment regarding 5-year TLR, and DCB was the best regarding primary patency and major amputation. DES and DCB should be given priority in treating femoropopliteal lesions.
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  • 文章类型: Journal Article
    支架内再狭窄(ISR)已成为动脉粥样硬化性心血管疾病介入治疗的重要障碍。冠状动脉ISR患者的最佳经皮冠状动脉介入治疗(PCI)策略仍存在争议。该网络荟萃分析(NMA)旨在比较和评估不同PCI策略和商业设备治疗冠状动脉ISR患者的有效性。
    在本研究中,我们系统地搜索了PubMed,Embase,WebofScience,和Cochrane图书馆从数据库开始到2022年10月20日,以确定随机对照试验。我们纳入了比较各种PCI策略治疗任何类型冠状动脉ISR的研究。这项研究在PROSPERO注册,CRD42022364308。
    我们纳入了44项符合条件的试验,包括8479名患者,39项试验比较了10项PCI的治疗效果,和5项试验比较了不同类型的药物洗脱支架(DES)或药物涂层球囊(DCB)装置之间的疗效。在PCI中,依维莫司洗脱支架是考虑靶病变血运重建(TLR)的最佳策略,直径狭窄百分比(%DS),和二元再狭窄(BR),考虑到晚期管腔损失(LLL),西罗莫司涂层球囊是最佳策略。在商业设备的比较中,准分子激光冠状动脉成形术加SeQuentPlease紫杉醇涂层球囊的组合策略显示出良好的治疗前景。
    DCB和DES仍然是冠状动脉ISR的首选治疗策略,考虑到主要临床结果(TLR)和血管造影结果(LLL,BR,%DS)。包括DCB或DES在内的个性化组合干预有望成为冠状动脉ISR的新型潜在治疗模式。
    UNASSIGNED: In-stent restenosis (ISR) has become a significant obstacle to interventional therapy for atherosclerotic cardiovascular disease. The optimal percutaneous coronary intervention (PCI) strategy for patients with coronary ISR remains controversial. This network meta-analysis (NMA) was aimed to compare and estimate the effectiveness of different PCI strategies and commercial devices for the treatment of patients with coronary ISR.
    UNASSIGNED: In present study, we systematically searched PubMed, Embase, Web of Science, and Cochrane Library from database inception to October 20, 2022, to identify randomized controlled trials. We included studies comparing various PCI strategies for the treatment of any type of coronary ISR. The study was registered with PROSPERO, CRD 42022364308.
    UNASSIGNED: We included 44 eligible trials including 8479 patients, 39 trials comparing the treatment effects of 10 PCIs, and 5 trials comparing the efficacy between different types of drug-eluting stent (DES) or drug-coated balloon (DCB) devices. Among the PCIs, everolimus-eluting stent was the optimal strategy considering target lesion revascularization (TLR), percent diameter stenosis (%DS), and binary restenosis (BR), and sirolimus-coated balloon was the optimal strategy considering late lumen loss (LLL). In the comparison of commercial devices, the combination strategy excimer laser coronary angioplasty plus SeQuent Please paclitaxel-coated balloon showed promising therapeutic prospects.
    UNASSIGNED: DCB and DES remain the preferred treatment strategies for coronary ISR, considering both the primary clinical outcome (TLR) and the angiographic outcomes (LLL, BR, %DS). Personalized combination interventions including DCB or DES hold promise as a novel potential treatment pattern for coronary ISR.
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  • 文章类型: Journal Article
    背景:在动脉动脉粥样硬化病变的治疗是具有挑战性的。本研究旨在探讨准分子激光消融(ELA)联合药物涂层球囊(DCB)治疗这些病变的疗效和安全性。
    方法:回顾性分析2019年6月至2021年12月,行髂动脉联合DCB的患者资料。人口统计,病变特征,分析围手术期并发症和随访信息。主要终点是原发性通畅。次要终点包括无截肢生存率(MAFS),技术上的成功,救助支架,临床驱动的靶病变再干预(CD-TLR),踝臂指数(ABI)和卢瑟福类的改善。
    结果:共纳入61例患者。平均年龄为73.4±11.7岁。20例(32.8%)患者有狭窄病变,而41例(67.2%)患者有慢性完全闭塞(CTO)。这些病变的平均长度为7.3±2.8cm。手术技术成功率为95.1%。3例(4.9%)患者进行了支架治疗。术中远端栓塞3例(4.9%),而3例(4.9%)患者发生流量限制夹层。平均ABI从基线时的0.45±0.13显著改善至ELA后的0.90±0.12,6个月时为0.88±0.11,12个月时为0.85±0.12。在随访期间。中位随访时间为28.2±6.1个月。5例(8.2%)患者进行了再干预。2年原发性通畅率为83.5%。
    结论:ELA联合DCB是治疗the动脉粥样硬化病变的一种安全有效的策略,支架置入率低,原发性通畅性高。
    BACKGROUND: The treatment of atherosclerotic lesions in the popliteal artery is challenging. This study aims to investigate the efficacy and safety of excimer laser ablation (ELA) combined with drug-coated balloon (DCB) for these lesions.
    METHODS: From June 2019 to December 2021, data of patients who underwent ELA combined with DCB in the popliteal artery were retrospectively reviewed. Demographics, lesion characteristics, periprocedural complications, and follow-up information were analyzed. The primary endpoint was primary patency. Secondary endpoints included major amputation-free survival rate, technical success, bailout stenting, clinically-driven target lesion reintervention, improvement of ankle-brachial index (ABI), and Rutherford class.
    RESULTS: A total of 61 patients were enrolled. The mean age was 73.4 ± 11.7 years. 20 (32.8%) patients had stenotic lesions, while 41 (67.2%) patients had chronic total occlusions. The mean length of these lesions was 7.3 ± 2.8 cm. Procedure technical success rate was 95.1%. Bailout stent was performed in 3 (4.9%) patients. Intraprocedural distal embolization occurred in 3 (4.9%) patients, while flow limiting dissections occurred in 3 (4.9%) patients. The mean ABI was significantly improved from 0.45 ± 0.13 at baseline to 0.90 ± 0.12 after ELA, 0.88 ± 0.11 at 6 months and 0.85 ± 0.12 at 12 months during the follow-up period. The median follow-up time was 28.2 ± 6.1 months. Reintervention was performed in 5 (8.2%) patients. The 2-year primary patency was 83.5%.
    CONCLUSIONS: ELA combined with DCB is a safe and effective strategy in the treatment of popliteal artery atherosclerotic lesions with low rates of bail-out stenting and high primary patency.
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