Drug-coated balloon

药物涂层球囊
  • 文章类型: Journal Article
    背景:药物涂层球囊(DCB)是支架内再狭窄和小血管的既定治疗选择,从头,冠状动脉疾病(CAD)。虽然这种工具在日常实践中的使用越来越多,有关从头治疗表现的数据,大型血管CAD(LV-CAD)仍然缺乏。进行了系统评价和荟萃分析,以评估DCB与药物洗脱支架(DES)在这种情况下的疗效和安全性。
    方法:进行了全面的文献检索,包括Medline,Embase,和截至2024年1月24日的Cochrane电子数据库,用于比较DCB与DES治疗大血管(≥2.5mm)新生病变的疗效和安全性的研究,报告至少一个感兴趣的临床结果(PROSPEROID:CRD42023470417)。分析的结果是心血管死亡(CVD),心肌梗死(MI),靶病变血运重建(TLR),全因死亡(ACD),和随访时的晚期管腔丢失(LLL)。使用随机效应模型作为风险比(RR)和平均差(MD)以及相对95%置信区间(CI)估计效应大小。
    结果:根据我们的纳入标准,共有13项研究(6项随机对照试验和7项观察性研究)纳入了2888例初发LV-CAD患者(DCBn=1334;DESn=1533)。DCB和DES在CVD方面没有观察到差异(RR0.49;95%CI[0.23-1.03];p=0.06),MI(RR0.48;95%CI[0.16-1.45];p=0.89),TLR(RR0.73;95%CI[0.40-1.34];p=0.32),ACD(RR0.78;95%CI[0.57-1.07];p=0.12),和LLL(MD-0.14;95%CI[-0.30至0.02];p=0.10)。DES证明平均急性增益高于DCB[1.94(1.73,2.14)vs1.31(1.02,1.60);p=0.0006]。
    结论:我们的荟萃分析显示,DCBPCI可能为选定的患者的管理提供有希望的选择,从头LV-CAD与DES相比。然而,需要更集中的RCT来进一步证明"无金属"策略在CAD子集中的益处.
    BACKGROUND: Drug-coated balloon (DCB) is an established treatment option for in-stent restenosis and small vessel, de novo, coronary artery disease (CAD). Although the use of this tool is increasing in everyday practice, data regarding performance in the treatment of de novo, large vessel CAD (LV-CAD) is still lacking. A systematic review and meta-analysis were conducted to evaluate the efficacy and safety of DCB versus drug-eluting stent (DES) in this setting.
    METHODS: A comprehensive literature search was performed including Medline, Embase, and Cochrane electronic databases up to January 24, 2024, for studies which compared the efficacy and safety of DCB versus DES in the treatment of de novo lesions in large vessels (≥ 2.5 mm), reporting at least one clinical outcome of interest (PROSPERO ID: CRD42023470417). The analyzed outcomes were cardiovascular death (CVD), myocardial infarction (MI), target lesion revascularization (TLR), all-cause death (ACD), and late lumen loss (LLL) at follow-up. The effect size was estimated using a random effects model as risk ratio (RR) and mean difference (MD) and relative 95% confidence interval (CI).
    RESULTS: A total of 13 studies (6 randomized controlled trials and 7 observational studies) involving 2888 patients (DCB n = 1334; DES n = 1533) with de novo LV-CAD were included in this meta-analysis following our inclusion criteria. No differences were observed between DCB and DES in terms of CVD (RR 0.49; 95% CI [0.23-1.03]; p = 0.06), MI (RR 0.48; 95% CI [0.16-1.45]; p = 0.89), TLR (RR 0.73; 95% CI [0.40-1.34]; p = 0.32), ACD (RR 0.78; 95% CI [0.57-1.07]; p = 0.12), and LLL (MD - 0.14; 95% CI [- 0.30 to 0.02]; p = 0.10) at follow-up. DES proved a higher mean acute gain versus DCB [1.94 (1.73, 2.14) vs 1.31 (1.02, 1.60); p = 0.0006].
    CONCLUSIONS: Our meta-analysis showed that DCB PCI might provide a promising option for the management of selected, de novo LV-CAD compared to DES. However, more focused RCTs are needed to further prove the benefits of a \"metal-free\" strategy in this subset of CAD.
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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: Comparative Study
    综述目的:本综述旨在解释小血管冠状动脉疾病(SVCAD)和经皮冠状动脉介入治疗(PCI)后新生病变的治疗方式的最新进展。专注于药物涂层支架(DES)和药物涂层球囊(DCB)。其目标是解决这些病变管理中缺乏标准的问题,并评估DCB作为长期优于DES的优先治疗策略的潜力。最新发现:技术进步改进了药物洗脱支架(DES)和药物涂层球囊(DCB),为管理SVCAD提供了更有前途的途径。根据新数据,DCB,最初认识到它们在支架置入后三到五年内预防再狭窄的功效,在某些临床情况下,与DES相比,可能会提供更好的结果。这篇综述表明,DCB在治疗SVCAD方面具有良好的治疗效果。它们可以被视为DES的替代品。尽管最初的数据令人信服,没有进一步的大规模,长期临床试验。这些发现的含义表明SVCAD管理的未来发生了变化,需要进行更多的研究来证实DCB在SVCAD中使用的长期益处。如果正在进行的和未来的研究证实了目前的证据,DCB可能会成为SVCAD的护理标准,显著影响临床实践和未来研究。
    PURPOSE OF REVIEW: This review aims to explain the current advancements in the treatment modalities for small vessel coronary artery disease (SVCAD) and de novo lesions post-percutaneous coronary intervention (PCI), focusing on drug-coated stents (DES) and drug-coated balloons (DCB). Its goal is to address the lack of standards in the management of these lesions and to assess the potential of DCB as a preferential treatment strategy over DES in the long term. RECENT FINDINGS: Technological advancements have improved drug-eluting stents (DES) and drug-coated balloons (DCB) which offer a more promising avenue for managing SVCAD. According to new data, DCBs, initially recognized for their efficacy in preventing restenosis within three to five years of stent placement, may offer superior outcomes compared to DES in certain clinical scenarios. This review shows that DCBs have a favorable therapeutic profile in the treatment of SVCAD, and they could be considered as an alternative to DES. Although the initial data is compelling, definitive conclusions cannot be met without further large-scale, long-term clinical trials. The implication of these findings suggests a shift in the future of SVCAD management and requires additional research to substantiate the long-term benefits of DCB use in SVCAD. Should ongoing and future studies corroborate the current evidence, DCB could emerge as the standard of care for SVCAD, significantly influencing clinical practices and future research.
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  • 文章类型: Journal Article
    自从冠状动脉支架出现以来,经皮冠状动脉介入治疗(PCI)后最常见的两种长期并发症是支架内再狭窄(ISR)和支架内血栓形成(ST).尽管目前的黄金标准第二代药物洗脱支架(DES)几乎取消了ST的发生率,并且ISR的发生率有所下降,DES的晚期ISR仍然是介入心脏病学领域值得关注的问题.药物涂层球囊(DCB)是一种非支架技术,它依赖于从充气球囊进行靶向均匀药物递送以恢复管腔血管的概念,治疗动脉粥样硬化,并克服了PCI的一些局限性,包括ISR和延长的双联抗血小板治疗,通过不留下任何东西来预防ST.大多数关于冠状动脉DCB的临床证据主要来自小的,使用紫杉醇DCB治疗ISR和冠状动脉间隙从头病变的随机数据和注册表。自2014年以来,在美国以外,DCB已被批准用于治疗ISR,欧洲心脏病学会推荐的一级课程。美国食品和药物管理局最近批准DCB用于治疗美国冠状动脉疾病患者的ISR。此外,最近的随机临床数据也显示DCB的安全性和有效性,用于治疗从头小血管疾病和高出血风险患者,虽然它们对其他临床情况包括急性冠脉综合征的作用,大血管疾病,分叉病变,长弥漫性远端病变目前正在研究中。在这里,我们回顾了DCBs在冠状动脉病变治疗中的循证作用,并提出了未来的观点.
    Since the advent of coronary stents, two of the most common long-term complications after percutaneous coronary intervention (PCI) are in-stent restenosis (ISR) and stent thrombosis (ST). Although the rates of ST have been nearly abolished and ISR rates have declined with the current gold-standard second-generation drug-eluting stents (DES), late ISR of DES remains a valid concern in the field of interventional cardiology. The drug-coated balloon (DCB) is a non-stent technology that relies on the concept of targeted homogeneous drug delivery from an inflated balloon to restore luminal vascularity, treat atherosclerosis, and overcome some limitations of PCI, including ISR and prolonged dual antiplatelet therapy to prevent ST by leaving nothing behind. Most clinical evidence on coronary DCBs predominantly comes from small, randomized data and registries using paclitaxel DCBs for ISR and de novo lesions in the coronary space. Since 2014, outside the United States, DCBs have been approved for the treatment of ISR, with a class I recommendation by the European Society of Cardiology. The Food and Drug Administration very recently approved the Agent DCB to treat ISR in patients with coronary artery disease in the US. Additionally, recent randomized clinical data also showed DCB\'s safety and efficacy for the treatment of de novo small-vessel disease and high-bleeding-risk patients, while their role for other clinical situations including acute coronary syndrome, large-vessel disease, bifurcation lesions, and long-diffuse distal lesions is currently under investigation. Herein, we review the evidence-based role of DCBs in the treatment of coronary lesions and offer future perspectives.
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  • 文章类型: Journal Article
    暂无摘要。
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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
    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
    药物涂层球囊(DCB)是一种避免支架相关并发症的新颖方法,已被证明可有效治疗支架内再狭窄(ISR)和小血管。然而,其在大血管新生病变治疗中的作用较少。
    评估药物涂层球囊与支架治疗大冠状动脉新生病变的疗效和安全性。
    我们搜索了文献,直到2023年4月。我们根据主要不良心血管事件(MACEs)判断DCB的安全性,心脏死亡,全因死亡率,非致死性心肌梗死,靶病变血运重建(TLR),和出血事件;以及根据晚期管腔丢失(LLL)的疗效,最小管腔直径(MLD)。我们根据支架类型和是否需要紧急PCI进行了亚组分析。
    共包括10项RCT。总的来说,DCB组的LLL(平均差异(MD)=-0.19,95%置信区间(CI):-0.32至-0.06,P=0.003)低于支架组。无论支架类型和疾病类型如何,这种效应在亚组分析中都是一致的。在安全指标方面,DCB和支架之间无显著差异。亚组分析发现,安全性指标显示DCB和药物洗脱支架(DES)之间没有显着差异。但DCB中的TLR低于裸金属支架(BMS)。此外,在ST段抬高型心肌梗死(STEMI)中,安全指标和LLL在DCB和DES之间没有显着差异,但是DCB中的MLD较小。而在排除STEMI的患者中,与整个支架相比,DCB中的MACE和TLR较低。
    DCB可能是治疗大冠状动脉新生病变的一种有希望的替代方法,疗效满意,风险低。优于BMS,而不低于DES,具有降低晚期管腔损失的趋势。
    UNASSIGNED: Drug-coated balloon (DCB) is a novel approach to avoiding stent-related complications and has proven effective for the treatment of in-stent restenosis (ISR) and small vessels. However, its role in the treatment of de novo lesions in large vessels is less settled.
    UNASSIGNED: To estimate the efficacy and safety of drug-coated balloon versus stent in the treatment of de novo lesions in large coronary arteries.
    UNASSIGNED: We searched the literature until April 2023. We judged the safety of DCB based on major adverse cardiovascular events (MACEs), cardiac death, all-cause mortality, non-fatal myocardial infarction, target lesion revascularization (TLR), and bleeding event; and efficacy according to late lumen loss (LLL), minimum lumen diameter (MLD). We conducted subgroup analyses according to stent type and whether urgent PCI was required.
    UNASSIGNED: A total of 10 RCTs were included. Overall, LLL (mean difference (MD) = -0.19, 95 % confidence interval (CI): -0.32 to -0.06, P = 0.003) was lower in the DCB group than in the Stent arm. This effect was consistent in subgroup analysis regardless of stent type and disease type. In terms of safety indicators, there were no significant differences between DCB and stent. The subgroup analyses found that safety indicators showed no significant differences between DCB and drug-eluting stent (DES), but TLR was lower in the DCB than in the bare metal stent (BMS). Moreover, in ST-elevation myocardial infarction (STEMI), safety indicators and LLL showed no significant differences between DCB and DES, but MLD in the DCB was smaller. While in patients with excluded STEMI, MACE and TLR was lower in the DCB compared with the overall stent.
    UNASSIGNED: DCB could be a promising alternative for treating de novo lesions in large coronary arteries with satisfactory efficacy and low risk, superior to BMS and not inferior to DES, with a trend toward lower late lumen loss.
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  • 文章类型: Journal Article
    目的:尽管许多涉及小血管新生冠状动脉疾病的研究显示了药物涂层球囊(DCB)的临床益处,DCB在大血管病变中的作用尚不清楚.
    方法:我们在主要电子数据库中搜索了比较DCB和支架治疗大血管新生冠状动脉疾病的随机对照试验(RCT)。主要终点是主要心血管不良事件(MACE),复合心血管死亡(CD),心肌梗死(MI),或靶病变血运重建(TLR)。
    结果:本研究包括7项RCTs和770名参与者。DCB与MACE中明显的风险降低相关[风险比(RR):0.48;95%置信区间[CI]:0.24至0.97;P=0.04],TLR(RR:0.53;95%CI:0.25至1.14;P=0.10),和晚期管腔损失[标准平均差(SMD):-0.57;95%CI:-1.09至-0.05;P=0.03]与支架相比。MI无显著差异(RR:0.58;95%CI:0.21~1.54;P=0.27),CD(RR:0.33;95%CI:0.06至1.78;P=0.19),和最小管腔直径(SMD:-0.34;95%CI:-0.72至0.05;P=0.08)。在亚组分析中,慢性冠脉综合征患者MACE风险持续降低(RR:0.25;95%CI:0.07~0.89;P=0.03),和患者接受DCB与裸金属支架(RR:0.19;95%CI:0.05~0.73;P=0.01)。此外,DCB组与药物洗脱支架组MACE比较差异无统计学意义(RR:0.69;95%CI:0.30~1.60;P=0.38)。
    结论:DCB可能是大血管新生冠状动脉疾病患者的有效治疗选择。
    OBJECTIVE: Although a number of studies involving small-vessel de novo coronary disease showed clinical benefits of drug-coated balloons (DCB), the role of DCB in large vessel lesions is still unclear.
    METHODS: We searched main electronic databases for randomized controlled trials (RCTs) comparing DCB with stents for large vessel de novo coronary artery disease. The primary endpoint was major cardiovascular adverse events (MACE), composite cardiovascular death (CD), myocardial infarction (MI), or target lesion revascularization (TLR).
    RESULTS: This study included 7 RCTs with 770 participants. DCB were associated with a marked risk reduction in MACE [Risk Ratio (RR): 0.48; 95% confidence interval [CI]: 0.24 to 0.97; P = 0.04], TLR (RR: 0.53; 95% CI: 0.25 to 1.14; P = 0.10), and late lumen loss [standard mean difference (SMD): -0.57; 95% CI: -1.09 to -0.05; P = 0.03] as compared with stents. There is no significant difference in MI (RR: 0.58; 95% CI: 0.21 to 1.54; P = 0.27), CD (RR: 0.33; 95% CI: 0.06 to 1.78; P = 0.19), and minimal lumen diameter (SMD: -0.34; 95% CI: -0.72 to 0.05; P = 0.08) between groups. In subgroup analyses, the risk reduction of MACE persisted in patients with chronic coronary syndrome (RR: 0.25; 95% CI: 0.07 to 0.89; P = 0.03), and patients receiving DCB vs. bare metal stent (RR: 0.19; 95% CI: 0.05 to 0.73; P = 0.01). In addition, there was no significant difference between the DCB group and the drug eluting stent group for MACE (RR: 0.69; 95% CI: 0.30 to 1.60; P = 0.38).
    CONCLUSIONS: DCB may be an effective therapeutic option in patients with large vessel de novo coronary artery disease.
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  • 文章类型: Journal Article
    Takayasu动脉炎(TAK)是一种罕见的慢性肉芽肿性动脉炎,主要影响主动脉及其主要分支。在10-25%的TAK患者中可以观察到冠状动脉(CA)受累。我们报告了一名21岁的年轻女性,她先前被诊断出患有TAK和严重的左主干冠状动脉(LMCA)狭窄,并且由于支架内再狭窄(ISR)在我们医院接受了多次经皮冠状动脉介入治疗(PCI)。这一次,在LMCA对ISR进行了准分子激光冠状动脉粥样斑块切除术(ELCA)和药物涂层球囊扩张术(DCB).手术后血流顺畅,出院后没有症状.不幸的是,5个月后,在LMCA支架和左前降支(LAD)冠状动脉中仍可见严重的内膜增生。进行了冠状动脉旁路移植手术(CABG),从那以后她就没有症状了.ELCA加DCB是我们最早报导的新办法之一。然而,确保长期控制炎症对恢复血流同样重要。建议将血运重建和抗炎/免疫抑制相结合,以改善TAK患者CA受累的预后。
    Takayasu\'s arteritis (TAK) is a rare chronic granulomatous arteritis that mainly affects the aorta and its major branches. Coronary artery (CA) involvement can be observed in 10-25% of TAK patients. We report a 21-year-old young female who was previously diagnosed with TAK and severe left main coronary artery (LMCA) stenosis and underwent numerous percutaneous coronary interventions (PCIs) in our hospital due to in-stent restenosis (ISR). This time, an excimer laser coronary atherectomy (ELCA) and drug-coated balloon (DCB) dilation was taken at the LMCA for the ISR. The blood flow was smooth after the operation, and she was symptom-free after discharge. Unfortunately, 5 months later, severe intimal hyperplasia was still seen in the stent of LMCA and left anterior descending (LAD) coronary artery. A coronary artery bypass graft surgery (CABG) was performed, and she has been symptom-free ever since. ELCA plus DCB is one of the novel ways we first reported. However, ensuring long-term inflammation control is equally important to restore blood flow. The combination of revascularization and anti-inflammation/immunosuppression is recommended to improve the outcomes of TAK patients with CA involvements.
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