生物可降解涂层药物洗脱支架在急性心肌梗死中的应用

目的探讨国产生物可降解涂层药物洗脱支架(Excel支架)在急性ST段抬高心肌梗死急诊PCI中应用的安全性和有效性。方法选择确诊为急性ST段抬高心肌梗死患者35例,于发病12h内行急诊冠状动脉造影和PCI治疗,冠状动脉造影后明确病变,然后于梗死相关血管的靶病变置入Excel支架。术后常规口服阿司匹林和氯吡格雷两联抗血小板药。观察术中、住院、出院后1个月和6个月及12个月随访终点时的主要心脏不良事件发生率、支架内血栓发生率、支架内再狭窄发生率。结果 35例患者急诊PCI治疗均获成功,35支梗死相关血管的35处病变共置入Excel支架42枚,手术过程中未发生与介入治疗有关的并发症。1个月随访终点时无死亡病例,无支架内亚急性血栓病例,主要心脏不良事件发生率0%。出院后12个月随访终点时无死亡病例,其中有1例因心功能不全入院,主要心脏不良事件发生率2.7%,支架内血栓发生率0%;共有34例患者在支架术后12个月复查冠状动脉造影,支架内再狭窄发生率0%。结论生物可降解涂层药物洗脱支架在急性ST段抬高心肌梗死急诊PCI中应用是安全和有效的。     

A Comparison of Drug-Eluting Balloon Versus Cutting Balloon in Patients With Primary Coronary Stenosis Of Small Vessel

目的 比较紫杉醇涂层球囊（DEB）对比切割球囊治疗直径2．5mm以下冠状动脉原发开口病变的疗效。 方法 用前瞻性研究方法,入选2014年10月至2018年10月在中国医学科学院阜外深圳医院应用PCB或切割球囊行冠状动脉原发病变介入治疗的冠心病患者66例(冠状动脉原发开口病变,所有病变参考血管直径均2.0mm0．05。(2) 介入治疗前DEB与切割球囊参考血管内径分别为2.76±0.4 mm和2.81±0.6mm,两组比较无显著性差异(P> 0.05);两组术前血管最小管腔直径无统计学显著性差异（分别为1.01 ±0.3mm vs 0.96±0.5 mm,P>0．05)）;两治疗组间术前直径狭窄率(%)也无明显差异, P>0．05)。 (3) DEB组患者住院期间未发生主要不良心血管事件;切割球囊组1例患者在术后当天因对角支靶病变D型夹层累计前降支主干,行前降支补救性支架植入后好转。（4）两组患者前期血管造影：两组术后即刻最小管腔直径(2.42±0.38 mm vs 2.33±0.41 mm)、直径狭窄率（15.6%±7.82vs 16.3% ±8.1）,差异无统计学意义(P>0．05))。（5）9-12月随访,相比于切割球囊组,DEB组的段内分析的最小管腔直径更大（1.97 ±0.75mm vs 1.78±0.73 mm,p <0.05）,且直径狭窄百分数更低（18.8% ±16v25.2% ±19,p <0.01）;DEB组靶病变再狭窄发生率更低（6.1% vs 15.2% ,P<0.05）,血管造影晚期管腔丢失平均值更小（ 0.34±0.04mm vs 0.46±0.05mm,P<0.05）随访期间两组再发心绞痛差异无统计学意义(9.1% vs 15.1%,P> 0.05);切割球囊组有1例发生急性心肌梗死,两组患者均无死亡。结论 在小血管原位开口病变患者中,药物球囊和切割球囊处理均得到良好的介入效果,相比于切割球囊,药物球囊治疗小血管原位开口病变的晚期血管造影结果更优。     

小血管支架的临床应用

目的　评价具有磷酸胆碱涂层的小血管支架治疗细小冠状动脉病变 (≤ 3 0mm)的疗效。方法　选择 4 5例冠心病患者 ,男 35例 ,女 10例 ,年龄 (5 4 2± 10 5 )岁。常规行冠状动脉造影 ,以美国GE公司研制的血管造影机 (GEAdvantx)测量系统实时测量病变血管直径。小于 3 0mm的病变血管共 5 4支 ,平均血管直径为 (2 0± 0 4 5 )mm ,植入PC涂层 (BiodivYsioSV)支架 5 9个。结果　 5 4支病变血管均经球囊扩张后植入支架 ,手术成功率为 10 0 %。支架植入后平均狭窄直径减至 0 %～10 %,无一例急性或亚急性支架内血栓形成。全部病例随访 (6± 2 4 )个月 ,无一例死亡。 10例于术后(4± 1 2 )个月出现心绞痛复发 ,经冠状动脉造影证实 8例为支架内再狭窄 ,2例出现其他部位血管病变。结论　应用具有磷酸胆碱涂层的支架治疗小血管病变 ,再狭窄率低 ,临床疗效肯定。     

载Rapamycin多聚物涂层支架在猪冠状动脉模型预防再狭窄的实验研究

目的　评价载Rapamycin(RAP)新型可降解多聚物涂层支架在小型猪冠状动脉模型的可行性、安全性和预防再狭窄的疗效。方法　体外模拟测定从药物从膜释放的持续时间。支架多聚乳酸 /多聚羟基乙酸 (PLGA)涂层包埋RAP药物剂量为 4 0 0 μg(小剂量 )或 80 0 μg(大剂量 )。小型猪冠状动脉置入过大的裸支架、单PLGA涂层支架或含RAP涂层支架并形成冠状动脉损伤模型 ,术后第 5周重复定量冠状动脉造影术 (QCA)后处死动物 ,测定三组支架血管段的损伤积分、冠状动脉横断面积、管腔面积、内膜厚度和面积 ,并作比较。同时观察支架边缘段 5mm内血管组织。结果　药物从涂层膜释放时间达 30d。三组分别为裸支架组 (置入支架数n =5 ) ,单涂层组 (n =7)和RAP组 (n =8,其中小剂量为 3只 ,大剂量组为 5只 )。三组冠状动脉大小和血管损伤程度基本相同 ,裸支架组、单涂层组和RAP组的血管平均损伤积分分别为 1 84± 0 32 ,1 83± 0 35和 1 83± 0 2 6 (P =0 996 )。术后 5周 ,三组的管腔面积分别为 (6 7± 1 5 )mm2 ,(5 8± 4 0 )mm2 和 (9 7± 2 1)mm2 (P <0 0 5 ) ,RAP组最大。平均内膜厚度分别为 (0 5 1± 0 12 )mm ,(0 6 4± 0 46 )mm和 (0 2 0± 0 11)mm(P <0 0 5 ) ,RAP组最小。三组均未见支架边缘狭窄和     

紫杉醇洗脱支架在冠心病介入治疗中的临床应用

目的观察紫杉醇洗脱支架(商品名TAXUS)治疗冠心病的疗效及安全性。方法选择77例冠心病患者,包括36例稳定型心绞痛、40例急性冠状动脉综合征、1例急性心肌梗死,对其92处病变(1处A型病变.91处B型和C型病变)植入92枚TAXUS。于术后住院期间、术后30日及12个月检查手术部位再狭窄及心脏不良事件。结果全部病例成功植入TAXUS;术前靶病变狭窄程度为(77±10)%,术后残余狭窄程度为(6.2±0.8)%;目标血管的参考直径及长度分别为(3.6±0.4)mm和(15.0±2.0)mm,植入支架的平均直径及长度分别为(3.2±0.4)mm和(24±15)mm。术后30日发生支架内再狭窄1例,术后第4日亚急性血栓形成1例,6个月在观察终点发生支架边缘再狭窄1例。再狭窄发生率2.6%,心脏不良事件发生率3.9%,靶血管血运重建率3.3%。结论TAXUS可有效地预防冠心病介入治疗术后再狭窄,心脏不良事件发生率低。     

药物涂层球囊在治疗冠状动脉药物涂层支架内再狭窄病变中的疗效

目的 研究药物涂层球囊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 运用随机数字表法,将2020年1月至2023年1月该院收治的冠状动脉药物涂层支架再狭窄患者（n=60）分为对照组（n=30,实施药物洗脱支架治疗）和研究组（n=30,实施药物涂层球囊治疗）。比较各组干预疗效、不良事件发生情况。结果 研究组干预总有效率97.38%高于对照组75.95%(P<0.05)。两组不良事件发生率对比无差异（P>0.05）。结论 药物涂层球囊可显著提高冠状动脉药物涂层支架再狭窄的总体干预效果,且不会增加不良事件发生风险。     

可生物降解涂层药物洗脱支架介入治疗的近期疗效

目的 评估国产新型西罗莫司可生物降解涂层支架在急性心肌梗死患者介入治疗(percutaneous coronary intervention,PCI)中的疗效及安全性.方法 急性心肌梗死患者56例,其中ST段抬高性心肌梗死48例,非ST段抬高性心肌梗死8例,均置人西罗莫司可生物降解涂层洗脱支架,观察手术成功率、支架内血栓等并发症及主要不良心脏事件(main adverse coronary events,MACE)发生率,术后随访1～14个月,6～9个月行冠状动脉造影复查.结果 成功行PCI 55例,手术即刻成功率98%.82处病变共置入西罗莫司支架98枚,其中17枚(17.3%)为直接支架术.4例出现无复流现象,1例使用主动脉气囊反搏.1例术后6 h猝死,考虑急性支架内血栓.术中及住院期间无其他严重并发症发生.50例(89.3%)随访1～14个月,无晚期支架内血栓发生,无MACE;复查冠状动脉造影19例,1例发生支架内再狭窄,无需血运重建.结论 国产西罗莫司可生物降解涂层支架在急性心肌梗死患者行PCI治疗有较好疗效及安全性.     

Mytrolimus药物洗脱支架预防支架内再狭窄的实验研究

目的评价新型聚烯烃类高分子化合物涂层携载雷帕霉素衍生物-Mytrolimus(CCI-779)洗脱支架在小型猪冠状动脉模型预防再狭窄的疗效。方法小型猪冠状动脉分别置入裸支架、单纯聚烯烃类高分子化合物涂层支架和Mytrolimus洗脱支架(160μg/18mm)。术后4周重复冠状动脉造影后处死动物,测定3组支架血管段的损伤指数、冠状动脉横截面积、管腔面积、支架上平均内膜厚度、支架间平均内膜厚度、新生内膜面积、面积再狭窄百分比,并作比较。结果裸支架组(置入支架数n=10)、单纯聚烯烃类高分子化合物涂层支架组(n=10)和Mytrolimus洗脱支架组(n=8)3组冠状动脉大小和血管损伤程度基本相同,术后4周,单纯聚烯烃类高分子化合物涂层组与裸支架比较多项参数差异均无统计学意义。Mytrolimus药物洗脱支架组和裸支架组的支架上内膜厚度分别为(0.18±0.08)mm和(0.33±0.25)mm(P<0.05);支架间内膜厚度分别为(0.14±0.05)mm和(0.28±0.23)mm(P<0.05);新生内膜面积分别为(1.09±0.24)mm2和(2.44±1.59)mm2(P<0.05)。上述多项参数在Mytroliums洗脱支架组均显著少于裸支架组。Mytrolimus组新生内膜面积比裸支架组少了55.33%,且Mytrolimus组无一例再狭窄。结论Mytrolimus洗脱支架在置入小型猪冠状动脉4周时可有效抑制内膜增生、预防冠状动脉实验性支架内再狭窄。     

功能性药物洗脱支架对冠状动脉介入治疗后内膜增生及TFPI-2的影响

目的 探讨新型双面复合药物涂层支架体内抑制血管平滑肌细胞增殖及促进内皮修复的作用。方法65只中华小型猪非高脂饮食喂养4周,随机分为假手术组、球囊损伤+双面涂层支架植入组和球囊损伤组,造模后继续喂养4周,抽血检查血浆TFPI-2水平,行冠状动脉OCT检查后处死并取冠状动脉血管组织行分子生物学检测。结果 OCT图像可见球囊损伤组斑块明显扩大,内膜增厚,纤维帽厚度明显增加,假手术组基本正常,支架植入组居中;内膜/中膜面积比球囊损伤组（2.23±0.72）,支架植入组（2.01±0.56）稍高于假手术组（1.89±0.27）;内膜/中膜厚度比分别为球囊损伤组（2.12±0.74）,支架植入组（1.74±0.66）与假手术组（1.52±0.47）。支架植入组较球囊损伤组下降,差异有统计学意义（P<0.05）。假手术组、支架植入组、球囊损伤组三组血浆TIFI-2水平分别为135.2±22.6 μg/L、127.2±23.4 μg/L和52.4±22.6 μg/L前两组基本相仿,但球囊损伤组明显下降,差异有统计学意义（P<0.01）。假手术组、支架植入组、球囊损伤三组TIFI-2与β-actin比值分别为2.45±0.22、2.22±0.26、1.27±0.33、TFPI-2在正常动脉血管组织中较少表达,支架植入组表达水平与假手术组比较差异无显著性（P>0.05）,而球囊损伤组则表达明显下降,差异有统计学意义（P<0.01）。结论 双面药物涂层支架较球囊损伤组比较能降低血管内膜增生;同时促进冠状动脉内膜表达TFPI-2,血浆TFPI-2水平升高,进而可能减少支架内血栓的形成。     

203枚碳化硅涂层冠状动脉支架-TENAX的临床观察

旨在观察碳硅涂层冠状动脉支架在临床应用中的安全性 ,亚急性血栓及近期靶再狭窄发生率。一、资料与方法1 研究对象 :在 2 0 0 2年 1月～ 10月期间 ,共192例患者置入由德国百多力公司生产的 2 0 3枚碳硅涂层冠状动脉支架 -TENAX支架。其中男 15 6例 ,女 36例 ,平均年龄 ( 62 5± 9 1)岁 ;直接冠状动脉介入术 15 0例 ,延迟冠状动脉介入术 10例 ,择期冠状动脉介入术 32例 ;临床诊断为急性心肌梗死160例 ,不稳定性心绞痛 32例 ;靶血管 197支 ,其中左前降支 95例 ,占 4 8%,左回旋支 14例 ,占 7%,右冠状动脉 88例 ,占 4 6%,靶病变 2 0 3处。对…     

药物涂层支架的研究进展

冠状动脉支架的应用极大地降低了再狭窄率,使经皮冠状动脉介入治疗有了质的飞越.冠状动脉支架发展至今已多种多样,其中药物涂层支架应用最为广泛,但药物涂层支架在降低支架内再狭窄的同时存在增加支架内血栓的风险.因此,不断改进药物支架是目前的研究热点,且药物支架向可降解支架逐渐发展.现就主要的药物涂层支架进行综述,介绍药物涂层支架的发展过程并大胆预测其发展趋势.     

Drug-eluting Stents bei Patienten mit Diabetes mellitus

BACKGROUND AND PURPOSE: Patients with coronary artery disease (CAD) and diabetes mellitus represent a peculiar high-risk population because of their specific characteristics of atherosclerotic disease. In conjunction with the diabetes-related comorbidities, percutaneous coronary intervention (PCI) often leads not only to a worse acute result but - also as compared to nondiabetics - to significantly worse long-term results due to the higher restenosis rates. The rapid introduction of effective drug-eluting stents (DES), which undoubtedly reduce the restenosis rates as compared with bare-metal stents (BMS), brought great hope of providing diabetic patients better and longer-lasting interventional solutions. This overview compiles the currently available data from randomized trials and meta-analyses. METHODS: Altogether, 86 randomized DES studies were identified in 34,677 patients. None of these with an adequate primary clinical endpoint had diabetes as an inclusion criterion. The high standard of an adequate primary clinical endpoint for comparing BMS versus DES in patients with predominantly stable CAD and de novo lesions was met by only five pivotal trials: SIRIUS (Cypher stent), TAXUS-IV, -V, -VI (Taxus stent) and ENDEAVOR II (Endeavor stent). Patients with diabetes were represented in these trials only in smaller subgroups. Three studies with a primary surrogate endpoint had diabetes as an inclusion criterion (DIABETES, SCORPIUS and ISAR-DIABETES, totaling 610 patients). The efficacy parameter TLR (target lesion revascularization) was chosen to compare these studies and the subgroup analyses. RESULTS: In the subgroup analyses for diabetic patients in the pivotal trials, TLR was reduced at the time of the primary endpoint after 9 months as compared with BMS as follows (p < 0.05): Cypher stent (279 patients): 22.3% versus 6.9%; Taxus stent (318 patients): 16.0% versus 5.2%; Endeavor stent (239 patients): 15.2% versus 7.5%. 5-year follow-up data are available only for the Cypher and Taxus stents with 33.1% versus 13.7% and 26.9% versus 13.4%. As compared with BMS, the three above-mentioned studies studies with a primary surrogate endpoint and diabetes as an inclusion criterion showed a significant reduction of TLR after 9 months of 31.3% versus 7.3% and after 8 months of 25.0% versus 5.3%, respectively. The TLR between Taxus (12.0%) and Cypher (6.4%), however, was not statistically different. Meta-analyses of 627 Cypher patients and 814 Taxus patients corroborated these findings with 1-year TLR of 24.8% versus 7.9% and 20.5% versus 8.0%. CONCLUSION: Of the 22 DES having received a CE certificate, long-term data over 5 years for patients with diabetes are available only for the Cypher and the Taxus stents. Compared with BMS, patients with diabetes and their characteristically small vessels and long lesions predominantly benefit from effective DES. The sometimes postulated differences between Cypher and Taxus in diabetic patients could not be convincingly demonstrated; larger randomized trials with a primary clinical endpoint are required for this. PCI cannot be considered a scientifically sound and evidence- based alternative to bypass surgery in diabetic patients with multivessel disease and/or unprotected left main stenosis until we have the results of the SYNTAX, COMBAT and FREEDOM trials.     

Die Stentthrombose im Fokus von Drug-eluting Stents

Coronary stent thrombosis is frequently associated with death or myocardial infarction (MI). New definitions according to the Academic Research Consortium (ARC) were proposed to serve as standard criteria for stent thrombosis. According to these definitions, stent thrombosis was classified as acute (within 24 h post implantation), subacute (1-30 days), late (31 days to 1 year), and very late (later than 1 year). Furthermore, stent thrombosis was differentiated in definite with angiographic or autoptic verification, probable, and possible. In meta-analyses using the ARC criteria, the occurrence of subacute stent thrombosis did not differ between drug-eluting stents (DES; Cypher, Taxus) or bare-metal stents (BMS) with < 1%. Very late stent thrombosis occurred 0.4-0.6% more frequently with DES compared to BMS. Available follow-up periods are limited to 4 years. The occurrence of death and MI did not differ between DES and BMS within the total follow-up period. In the meta-analysis of the Taxus studies, the event rates (death and MI) were initially lower with DES compared to BMS based on the reduced need for target vessel revascularization. Nevertheless, this was compensated in the following period by a higher event rate due to very late stent thrombosis. In real-world registries, the event rates are higher than in the first randomized studies. With DES implantation as a routine strategy, the occurrence of angiographically documented stent thrombosis was 2.9% within a period of 3 years. Classic predictors for stent thrombosis with BMS remain relevant also in the DES era. The delayed endothelialization with DES in combination with suboptimally implanted DES takes the patients to a higher and longer risk for stent thrombosis. Several guidelines recommend dual antiplatelet therapy for 12 months after DES implantation in noncomplex lesions. In complex lesions combined antiplatelet treatment should be prescribed 24 months or longer (e.g., DES after brachytherapy). Patients scheduled for surgical procedures or patients with reduced compliance should not be treated with DES.     

药物洗脱支架防治再狭窄的研究进展

目前,经皮腔内冠状动脉成形术和冠状动脉内支架置入术已广泛应用于临床,成为冠心病常规介入治疗的方法之一,但术后再狭窄率仍然居高不下;药物洗脱支架的出现则改变了这种局面,随着近两年来药物洗脱支架防治再狭窄临床实验结果的陆续公布,使药物洗脱支架成为目前防治再狭窄的最佳办法。现根据医学研究的最新结果,从药物洗脱支架的作用机制、临床疗效和安全性等方面作一综述。     

三种国产雷帕霉素药物洗脱支架植入对血清sPLA2及hs-CRP水平的影响

目的　探讨三种国产雷帕霉素药物洗脱支架（普通药物洗脱支架、可降解药物涂层支架及无载体药物涂层支架）植入对血清分泌型磷脂酶A2（sPLA2）和高敏C反应蛋白（hs-CRP）的影响。方法　连续收集我院既往无支架植入史的不稳定型心绞痛（UAP）患者126例，根据植入支架不同分为Firebird　2代支架组（33例）、Excel支架组（43例）及Nano支架组（50例），另选取同期经冠状动脉造影证实为非冠心病患者48例为对照组，分别于术前、术后24　h抽血测定血清sPLA2及hs-CRP水平。结果　四组患者术前一般临床资料、3个支架组支架植入情况均无明显差异（P>0.05）；术前、术后24　h　3个支架组血清sPLA2和hs-CRP水平较对照组明显升高（P<0.01），但三组间比较均无明显差异；术后24　h，四组血清sPLA2和hs-CRP水平较术前均有所升高（P<0.05）；3个支架组血清sPLA2和hs-CRP水平术后较术前升高幅度比较无明显差异（P>0.05），但明显高于对照组（P<0.01）。结论　上述三种国产雷帕霉素药物洗脱支架植入均会导致短期血清sPLA2和hs-CRP水平升高，但三组间炎症因子水平均无明显差异。     

药物洗脱支架在急性冠脉综合征中应用的思考

药物洗脱支架的出现在冠心病血运重建史上具有里程碑式的意义,目前冠心病的介入治疗(PCI)已处于药物洗脱支架(DES)时代。急性冠脉综合征(ACS)有特殊的病理生理机制。如何利用现有初步的DES治疗经验,改进ACS的PCI策略,是目前学术界十分关注的热点问题。现根据循证医学的最新结果,评价了DES在ACS中应用的疗效、安全性,以及在特殊人群中的应用,探讨了药物洗脱支架在ACS治疗中的问题和最新进展。     

Drug-eluting Stents Versus Bare-metal Stents for Saphenous Vein Graft Interventions: A Systematic Review and Meta-analysis of Studies With Longer Follow-up

Randomized controlled trials comparing drug eluting stents (DES) with bare-metal stents (BMS) for saphenous vein graft (SVG) interventions have shown conflicting results. We conducted this meta-analysis to evaluate the cumulative evidence for long-term efficacy and safety of DES vs BMS in SVG lesions. A systematic search was conducted of Randomized controlled trials comparing DES vs BMS in patients undergoing percutaneous interventions for SVG lesions. End-points of interest were all-cause death, cardiac death, myocardial infarction, target lesion revascularization and target vessel revascularization at longest available follow-up. Random effects meta-analysis was conducted to estimate risk ratio with 95% confidence intervals for individual end-points. Seven studies with 1639 patients were included in the final analysis. Mean follow-up period was 32 months. Compared with BMS, DES was associated with similar risks of all-cause death (risk ratio 1.06; 95% confidence intervals 0.76-1.48) and cardiac death (0.95; 0.59-1.54). Similarly, there were no differences between DES and BMS in terms of myocardial infarction (0.81; 0.50-1.29), target vessel revascularization (0.73; 0.48-1.110 or target lesion revascularization (1.05; 0.76-1.43). Current analysis suggests no strong evidence for routine DES use in patients undergoing SVG intervention. Future studies should evaluate if SVG lesion characteristics could influence these results.