药物涂层球囊在冠状动脉小血管病变中的应用

相比于大血管,小血管病变植入支架后更容易发生晚期管腔丢失。为了克服药物洗脱支架的不足,药物涂层球囊(DCB)应运而生。本文通过比较DCB与DCB+裸金属支架、DCB与药物洗脱支架、单纯DCB在冠状动脉小血管病变中的相关临床研究进行综述。     

药物涂层球囊治疗冠状动脉药物洗脱支架内再狭窄临床分析

目的分析药物涂层球囊(DCB)在治疗冠状动脉药物涂层支架内再狭窄病变中的疗效。方法回顾性分析20例冠状动脉药物洗脱支架内再狭窄患者接受药物涂层球囊治疗的临床资料及随访结果。结果 20例患者共21处再狭窄病变接受DCB治疗,术中即刻成功率95.23%,1处病变在应用DCB治疗后并发夹层并出现TIMI 2级血流,然后植入药物洗脱支架(DES)治疗。所有病例术后随访至今无心绞痛再发,未发生主要心血管不良事件。其中12例患者在术后6~9个月接受冠状动脉造影复查,复查时靶病变最小管腔直径与术后即刻直径比较,按病变血管统计,差异无统计学意义(P0.05);合计统计比较差异有统计学意义(P0.05)。结论 DCB治疗DES支架内再狭窄即刻及短期疗效肯定,可以作为支架内再狭窄的一种新的治疗手段。     

药物涂层球囊在冠状动脉慢性完全闭塞病变介入治疗中的应用

药物涂层球囊(DCB)已成为冠状动脉介入治疗的有效手段之一,目前在支架内再狭窄、小血管病变、分叉病变中得到了广泛的应用。但在慢性完全闭塞(CTO)病变中应用的相关研究较少,现结合DCB的作用机制和DCB在CTO病变中应用的相关报道,阐述DCB在CTO病变中可能发挥的作用。     

药物包被球囊在治疗冠状动脉真性分叉病变中的应用

目的:探讨药物包被球囊(DCB)治疗冠状动脉真性分叉病变的疗效及安全性。方法:回顾性纳入于我院接受介入治疗的真性分叉病变患者，根据手术策略将其分为药物洗脱支架组(DES组，158例)和DCB组(98例)。主要观察终点为2年靶病变血运重建，次要观察终点为主要不良心血管事件(包括心源性死亡、靶血管血运重建、靶血管心肌梗死和支架内血栓)。结果:DCB组靶病变血运重建和主要不良心血管事件发生率均显著低于DES组(3.1%vs.11.4%,log-rank P=0.019;5.1%vs.13.9%,log-rank P=0.029)。两组均无支架内血栓和靶血管心肌梗死发生。结论:DCB治疗冠状动脉真性分叉病变疗效明确，安全可行。     

药物涂层球囊在冠状动脉小血管病变中的应用

药物涂层球囊（DCB）被广泛应用于支架内再狭窄,作为“介入无置入”理念的最成熟代表,应用范围逐渐扩展。该文主要介绍DCB在小血管病变中的应用进展。     

药物涂层球囊与药物洗脱支架治疗冠状动脉小血管病变的Meta分析

目的 比较药物涂层球囊(DCB)和药物洗脱支架(DES)在冠状动脉(冠脉)小血管病变中的疗效和安全性.方法 通过计算机检索PubMed、The Cochrane Library和Web of Science数据库,检索截止至2019年5月1日正式发表的文献.纳入比较冠脉小血管病变患者使用药物涂层球囊与药物洗脱支架治疗差...     

药物涂层球囊在冠状动脉原位病变中的应用现状

药物涂层球囊的出现使得冠状动脉介入治疗进入新阶段,其在支架内再狭窄中已经取得了成功的应用.近年来,越来越多的证据表明其可用于小血管病变中.然而,药物涂层球囊在其他原位病变如分叉、弥漫性、慢性完全闭塞等病变中的应用仍存在局限.但随着"介入无植入"理念的深入,药物涂层球囊由于自身的特性将会呈现出更多的优势.本文就药物涂层球...     

药物洗脱球囊的临床应用

药物洗脱支架能抑制血管管壁平滑肌细胞增生,较普通球囊和金属裸支架显著降低介入术后再狭窄率,但此类支架同样抑制血管内皮修复,引起内皮化延迟或不完全,容易诱发晚期支架内血栓形成.药物洗脱球囊的应用使血管内皮化保留完整,降低了小血管病变、再狭窄病变和分叉病变经皮冠状动脉介入治疗术后支架内再狭窄、晚期支架内血栓形成和主要不良心脏事件等的发生率.     

药物洗脱球囊在原位血管病变中的应用研究进展

综述药物洗脱球囊(DCB)治疗原位血管病变的临床报道。DCB作为一种新兴的冠状动脉介入技术,目前已广泛应用于临床,并且取得不错的疗效。用于支架内再狭窄的治疗已被多个国际权威指南推荐为I,A类证据,但是对于原位血管病变的治疗,DCB的应用地位还需要大量的临床数据支持。     

药物涂层球囊治疗冠状动脉小血管狭窄伴轻度钙化病变的疗效观察

目的 探索药物涂层球囊（DCB）治疗冠状动脉（冠脉）小血管狭窄伴轻度钙化病变的效果。方法 选取中国人民解放军总医院第七医学中心心内科自2019年1月至2022年1月期间收治的80例经冠脉造影（CAG）证实为冠脉小血管狭窄伴轻度钙化的病变,并接受了DCB或药物洗脱支架（DES）治疗的患者作为研究对象。将所有入选病例按治疗方法分为观察组（DCB治疗37例）和对照组（DES治疗43例）。将两组患者术后即刻、12个月的治疗效果、不良心血管事件发生率、出血事件进行对比。结果观察组、对照组术后即刻、术后12个月的治疗效果,靶血管最小管腔直径（MLD）、晚期管腔丢失（LLL）、再血管化（TLR）以及不良心血管事件比较,均无统计学差异（P>0.05）;观察组出血事件发生率明显低于对照组（2.7%vs. 17.5%,P<0.05）。结论 DCB与DES治疗冠脉小血管狭窄伴钙化病变,具有相似的近期及远期效果,由于更低的出血性事件,DCB可能作为支架植入的替代方案,具有更广阔的应用前景。     

Drug-Coated Balloon for De Novo Coronary Artery Disease: JACC State-of-the-Art Review

Percutaneous coronary intervention with a drug-eluting stent is the most common mode of revascularization for coronary artery disease. However, restenosis rates remain high. Non-stent-based local drug delivery by a drug-coated balloon (DCB) has been investigated, as it leaves no metallic mesh. A DCB consists of a semicompliant balloon coated with antiproliferative agents encapsulated in a polymer matrix, which is released into the wall after inflation and contact with the intima. DCB have demonstrated effectiveness in treating in-stent restenosis. Clinical studies using DCB in de novo coronary artery disease have shown mixed results, with a major benefit in small-vessel disease. Differences in study results are not only due to variations in DCB technology but also to disparity in procedural approach, “leave nothing behind” or “combination therapy,” and vessel size. This review focuses on the available evidence from randomized trials and proposes a design for future clinical trials.     

缬沙坦预防冠脉支架术后再狭窄的研究进展

冠状动脉介入治疗是目前冠状动脉性心脏病治疗的重要方法,主要包括经皮腔内血管成形术和支架植入术,但术后再狭窄成为另一个难以解决的问题。研究发现,新生内膜过度增长是支架植入术后再狭窄的主要原因,主要与血管平滑肌细胞的过度增殖与迁移以及分泌大量的细胞外基质有关,而且,血管紧张素Ⅱ能促进再狭窄的发展。目前的一些研究显示血管紧张素Ⅱ受体拮抗剂缬沙坦可能降低支架术后的再狭窄率。现对缬沙坦预防冠状动脉支架术后再狭窄的最新进展作一综述。     

Drug‐coated balloons for de novo lesions in small coronary arteries: rationale and design of BASKET‐SMALL 2

The treatment of coronary small vessel disease (SVD) remains an unresolved issue. Drug‐eluting stents (DES) have limited efficacy due to increased rates of instent‐restenosis, mainly caused by late lumen loss. Drug‐coated balloons (DCB) are a promising technique because native vessels remain structurally unchanged. Basel Stent Kosten‐Effektivitäts Trial: Drug‐Coated Balloons vs. Drug‐Eluting Stents in Small Vessel Interventions (BASKET‐SMALL 2) is a multicenter, randomized, controlled, noninferiority trial of DCB vs DES in native SVD for clinical endpoints. Seven hundred fifty‐eight patients with de novo lesions in vessels <3 mm in diameter and an indication for percutaneous coronary intervention such as stable angina pectoris, silent ischemia, or acute coronary syndromes are randomized 1:1 to angioplasty with DCB vs implantation of a DES after successful initial balloon angioplasty. The primary endpoint is the combination of cardiac death, nonfatal myocardial infarction, and target‐vessel revascularization up to 1 year. Secondary endpoints include stent thrombosis, Bleeding Academic Research Consortium (BARC) type 3 to 5 bleeding, and long‐term outcome up to 3 years. Based on clinical endpoints after 1 year, we plan to assess the noninferiority of DCB compared to DES in patients undergoing primary percutaneous coronary intervention for SVD. Results will be available in the second half of 2018. This study will compare DCB and DES regarding long‐term safety and efficacy for the treatment of SVD in a large all‐comer population.     

Opportunities and limitations of drug-coated balloons in interventional therapies

Drug-coated balloons (DCB) represent a novel clinical treatment modality for coronary and peripheral artery disease. Advantages over standard angioplasty and stent technologies including homogeneous drug delivery to the vessel wall, immediate drug release without the use of a polymer, the option of using balloon catheters alone or in combination with a bare metal stent, no foreign object that remains in the body, the potential of reducing antiplatelet therapy, and lower restenosis rates in some indications. As with drug-eluting stents (DES), one cannot assume a class effect for DCB. So far, data from randomized clinical trials identify the treatment of coronary in-stent restenosis (ISR) and of de novo and restenotic lesions in peripheral artery disease as viable options. Furthermore, treatment of de novo lesions in small coronary vessels, bifurcation lesions, long lesions, pediatric interventions, and cerebrovascular applications are potential beneficial indications. In the coronary application, a strategy of DCB angioplasty with provisional spot-stenting in the case of severe dissections may become a better alternative in long and complex lesions, bifurcations, or in patients with contraindications for DES.     

生物可吸收支架的前景与挑战

支架置入术是目前广泛应用的冠心病治疗手段,可成功恢复血管血运,但再狭窄一直影响着远期效果,血管内膜过度增生是主要原因。药物洗脱支架预防再狭窄的同时也存在着诸多不足,最突出的是晚期血栓形成。新生内膜增生过度导致的再狭窄,与支架涂层药物对正常内皮细胞的非特异性抑制导致的晚期血栓形成,是支架置入术面临的主要矛盾。生物可吸收支架,包括可吸收聚合物支架以及可吸收金属支架,有望解决这一难题,应用前景十分广阔。     

Role of vessel size as a predictor for the occurrence of in-stent restenosis in patients with diabetes mellitus

Intracoronary stents have been shown to reduce the rate of restenosis when compared with balloon angioplasty, but in-stent restenosis continues to be an important clinical problem. It was therefore the aim of this registry to identify procedural and angiographic predictors for the occurrence of in-stent restenosis. We analyzed 368 patients with 421 lesions who underwent coronary stent implantation between January 1998 and February 2000. Indications for the placement of a coronary stent were severe dissections (37%), suboptimal angiographic results (38%), restenotic lesions (20%), and graft lesions (4%). Angiographic follow-up was obtained in 270 patients (73%) with 293 lesions after 6 months. Clinical and angiographic variables were analyzed by univariate and multivariate models for the ability to predict the occurrence of in-stent restenosis, defined as a diameter stenosis >50%. In-stent restenosis was angiographically documented in 67 patients and 68 lesions (23%). Under all tested variables the reference luminal diameter before stent implantation (p = 0.006) and diabetes mellitus (p = 0.023) were identified as independent predictors for the occurrence of in-stent restenosis. The comparison of diabetic and nondiabetic patients according to vessel size revealed a 2 times higher rate of in-stent restenosis in small vessels (44% vs 23%, p = 0.002), whereas in vessels >3.0 mm the rate of in-stent restenosis was not significantly different between the 2 groups. In this registry, the clinical variable diabetes and the procedural variable reference vessel size were independent predictors for the occurrence of in-stent restenosis. In these patients, the rate of in-stent restenosis was as high as 45%.     

双源CT对冠状动脉支架靶血管再狭窄的诊断价值

目的:探讨双源CT（DSCT）对冠状动脉支架置入靶血管再狭窄的诊断价值。方法:对我院69例冠状动脉支架置入患者（共111枚支架）进行DSCT,评价支架图像质量得分与靶血管级别的相关性;并对部分患者同期进行冠状动脉造影（CAG）检查,对比分析DSCT对冠状动脉支架置入靶血管病变的真实性。结果:DSCT支架图像质量得分与靶血管级别正相关;DSCT对支架靶血管再狭窄诊断的灵敏度82%、特异度98%、和准确度95%;DSCT与CAG对不同直径支架的靶血管再狭窄检出率差异无统计学意义,但DSCT对直径≥3.0 mm支架靶血管再狭窄检出的特异度和准确度明显高于直径＜3.0 mm支架靶血管的相应指标（均P＜0.05）,而灵敏度的差异未达到显著水平。结论:DSCT可清晰的显示冠状动脉支架靶血管的病变情况,能较准确地评价冠状动脉支架靶血管再狭窄的发生,具有临床应用价值。     

A Non-inferiority,Randomized Clinical Trial Comparing Paclitaxel-Coated Balloon Versus New-Generation Drug-Eluting Stents on Angiographic Outcomes for Coronary De Novo Lesions

Cardiovascular Drugs and Therapy - Drug-coated balloon (DCB) has been proved efficacy for coronary small vessel disease, but data regarding outcomes of DCB in common de novo lesions (including...     

冠心病合并2型糖尿病患者置入药物洗脱支架的疗效评价

目的 评价冠心病合并2型糖尿病患者冠状动脉病变置入药物洗脱支架后的疗效。方法 选择我院2004年4月至2005年8月连续接受置入药物洗脱支架（DES）或金属裸支架（BMS）治疗并且进行了冠状动脉造影随访的139例的冠心病合并2型糖尿病患者。所有患者在支架术后6个月后接受冠状动脉造影随访。结果共139例患者（男性114例,女性25例）221处病变完成随访。其中C型病变94处（42．5％）,完全闭塞病变42处（19．0％）,平均每个病变支架长度（26．53±14．72）mm,平均参考血管直径（2．80±0．43）mm。两组患者在性别比例和年龄方面差异无统计学意义。两组在冠心病的危险因素如：高血压病、高脂血症、吸烟等方面差异无统计学意义。两组病变的复杂程度基本相当。DES组的参考血管直径比BMS组小[（2．71±0．41）mm比（2．98±0．53）mm,P〈0．001]。6个月后随访,DES组的支架内再狭窄率（10．6％比38．6％,P〈0．001）和病变内晚期腔径丢失[（0．24±0．56）mm比（0．91±0．77）mm,P〈0．001]明显低于BMS组。DES组的靶病变血管重建率显著低于BMS组（8．6％比30．0％,P〈0．001）。DES组有4例晚期支架内血栓。结论 本研究显示药物洗脱支架对于冠心病合并2型糖尿病患者冠状动脉病变的介入治疗有着良好的治疗效果,明显优于金属裸支架。     

Drug-Coated Balloons for Coronary Artery Disease: Third Report of the International DCB Consensus Group

Although drug-eluting stents are still the default interventional treatment of coronary artery disease, drug-coated balloons (DCBs) represent a novel alternative therapeutic strategy in certain anatomic conditions. The effect of DCBs is based on the fast and homogenous transfer of antiproliferative drugs into the vessel wall during single balloon inflation by means of a lipophilic matrix without the use of permanent implants. Although their use is established for in-stent restenosis of both bare-metal and drug-eluting stents, recent randomized clinical data demonstrate a good efficacy and safety profile in de novo small-vessel disease and high bleeding risk. In addition, there are other emerging indications (e.g., bifurcation lesions, large-vessel disease, diabetes mellitus, acute coronary syndromes). Because the interaction among the different delivery balloon designs, doses, formulations, and release kinetics of the drugs used is important, there seems to be no “class effect” of DCBs. On the basis of the amount of recently published data, the International DCB Consensus Group provides this update of previous recommendations summarizing the historical background, technical considerations such as choice of device and implantation technique, possible indications, and future perspectives.