可降解涂层雷帕霉素洗脱支架(Tivoli支架)治疗冠状动脉性心脏病的疗效

目的 评价国产可降解涂层雷帕霉素洗脱支架(Tivoli支架)用于冠状动脉性心脏病(CHD)患者介入治疗的安全性和近期疗效.方法 2010年9-11月于第二军医大学附属长海医院心血管内科单一植入Tivoli支架的CHD患者167例.术后接受双联抗血小板治疗9个月,观察主要心血管不良事件(MACE)的发生情况,并在术后12个月复查冠状动脉造影.结果 223处靶血管病变共使用Tivoli支架267枚,植入支架成 功率达100％.术后12个月冠状动脉造影随访结果显示,支架内再狭窄的发生率为1.9％(4/211),无1例发生MACE.结论 Tivoli支架治疗CHD是可行的,且具有良好的安全性和满意的近期临床效果.     

国产和进口雷帕霉素洗脱支架治疗急性心肌梗死的疗效比较

目的探讨国产雷帕霉素药物洗脱支架Firebird在急性ST段抬高心肌梗死(STEMI)患者急诊经皮冠状动脉介入治疗(PCI)中应用的安全性和近、远期疗效。方法选择我院心内科2005年3月￣2006年6月收治的STEMI且在发病12h内接受急诊置入雷帕霉素药物洗脱支架的患者105例,分为Cypher组(33例)和Firebird组(72例)。比较2组住院期间和随访10个月时心脏事件(MACE)的发生率。结果Cypher组33例梗死相关血管的33处病变置入42枚Cypher支架,Firebird组72处梗死相关病变置入113枚Firebird支架。支架置入成功率为100%。无再流现象:Cypher1例,Firebird组2例(P=1.000)。Cypher组心脏破裂死亡1例,Firebird组亚急性支架内血栓形成死亡1例。住院期间MACE发生率Firebird组为1.4%(1/72),Cypher组3.0%(1/33)(P>0.1),临床PCI成功率91.4%(96/105)。对86例患者进行了平均[10.2±4.2(6￣20)]个月随访,Cypher组28例和Firebird组58例;再发心绞痛3例,Cypher组1例和Firebird组2例;Firebird组术后3个月心衰死亡1例;随访时MACE发生率:Firebird组3.4%(2/59),Cypher组3.4%(1/29)(P=1.000)。结论国产雷帕霉素药物洗脱支架Firebird在STEMI急诊PCI中应用安全有效,近、远期疗效与Cypher支架相近。     

国产雷帕霉素洗脱支架置入安全性及近期临床疗效观察

目的:评价Rapamycin涂层的Firebird药物支架的即刻置入成功率、安全性及随访临床事件的发生情况。方法:对使用Firebird药物支架的患者,采用门诊和电话的方式进行随访,随访的时间为1~6个月。结果:共入选30例患者,其中男性23例(76.6%),女性7例(23.3%),年龄37~78岁,平均年龄(61.76±9.76)岁;共使用Firebird药物支架58枚。1例因病变血管迂曲,Firebird支架不能通过,其余全部成功置入,支架的即刻置入成功率为99.3%。手术过程及住院期间无并发症发生,随访6个月无心血管事件、亚急性血栓及新出现的缺血性心电图改变。结论:Firebird药物支架即刻置入成功率高,安全有效,近期效果较好。     

雷帕霉素洗脱支架治疗冠心病的近期疗效研究

目的评价冠心病患者接受雷帕霉素洗脱支架(SES)的近斯安全性及有效性。方法对160例接受雷帕霉素洗脱支架植入术患者实施即刻疗效和临床随访。结果160例中共处理病变210处,植入支架216枚。其中B2型以上复杂病变145处(69.0%),小管径支架(2.5mm~2.75mm)44例(27.5%),长支架58例(36.3%),术中无严重并发症发生,手术成功率100%。130例(81.3%)随访1~17个月,6例患者类似胸痛发作,其中3例复查了冠状动脉造影,无支架及节段内再狭窄,未发生心肌梗死及死亡。结论雷帕霉素洗脱支架治疗冠心病患者近期疗效安全有效。     

国产生物可降解涂层雷帕霉素药物支架临床应用长期随访观察

目的：观察国产生物可降解涂层雷帕霉素洗脱支架治疗冠心病原发病变的长期有效性和安全性。方法：88例冠心病住院患者经单一国产生物可降解涂层雷帕霉素洗脱支架介入治疗,并予长期随访。主要研究终点为术后1年的主要不良心脏事件,次要研究终点为术后长期随访中的各种不良事件及平均14个月冠脉造影判定的支架内再狭窄发生率。结果：88例患者105处病变共植入131枚支架,术后1年内有3例患者复发心绞痛住院,复查造影2例证实为支架内再狭窄,1年主要心脏不良事件发生率为3.4%;术后平均随访22个月,其中2例患者非心源性死亡,2例心源性死亡,无美国学术研究联合会（ARC）定义的血栓事件发生;31例（35%）患者（45处病变）术后平均14个月接受冠脉造影复查,定量冠脉造影测量4处靶病变再狭窄,再狭窄率为8.8%。结论：国产生物可降解涂层雷帕霉素药物支架用于冠状动脉原发病变的介入治疗是有效且安全的。     

国产生物可降解涂层雷帕霉素洗脱支架的临床研究

目的观察国产生物可降解涂层雷帕霉素洗脱支架植入后的有效性和安全性。方法连续观察169例冠心病住院患者病情变化,常规进行冠状动脉造影及支架植入。主要观察术后（14．0±7．4）个月无主要不良心脏事件（MACE）生存率,术后急性、亚急性及晚期迟发支架血栓发生率,以及术后6～12个月冠脉造影随访。结果169例患者214支血管247处病变共植入287枚支架。术后（14．0±7．4）个月无MACE生存率98．8％;可能的亚急性支架血栓发生率0．6％,晚期迟发支架血栓发生率0．6％。术后乱12个月冠状动脉造影随访的支架再狭窄为0。结论国产生物可降解涂层雷帕霉素药物支架用于冠状动脉病变的介入治疗是有效且安全的。     

冠脉内药物洗脱支架植入术的护理体会

随着冠心病介入治疗研究的迅速进展，经皮冠状动脉腔内成形术（PTCA）及冠脉支架植入术已被广泛应用于临床。而PTCA是用球囊挤压的原理，使冠状动脉狭窄段病变内膜和粥样斑块撕裂，粥样斑块压缩、中层延长，使血管腔扩大。血管内金属支架的植入则起到支撑血管壁，防止PTCA术后血管急性闭塞、夹层形成和慢性再狭窄的作用。但经长期研究表明，PTCA并冠脉内金属支架植入术再狭窄率仍高达约20％。药物洗脱支架的开发和应用能有效降低再狭窄的发生，我院自2004年11月-2005年12月应用雷帕霉素药物洗脱支架对27例冠心病患者行介入治疗，经随访6个月无一例发生再狭窄，效果满意。现将其手术前后护理体会总结如下。     

国产雷帕霉素药物洗脱支架的临床应用观察

目的评价国产雷帕霉素药物洗脱支架的安全性和有效性。方法对32例冠心病患者,予以置入56个国产雷帕霉素药物洗脱支架(Firebird)治疗,并进行6个月以上随访。结果即刻成功率为100%。6个月以上随访,无重要心脏不良事件,无病变靶血管重建术,再狭窄率为0%。结论Firebird能有效预防冠脉支架术后再狭窄,并具有很高的安全性。     

国产Firebird雷帕霉素药物洗脱支架的临床观察

目的:评价国产Firebird雷帕霉素药物洗脱支架的安全性和有效性.方法:68例冠心病患者,予以置入100个国产Firebird雷帕霉素药物洗脱支架治疗,并进行6月以上至2年随访.结果:即刻成功率为100%.6月以上至2年随访无重要心脏不良事件,无病变靶血管重建术,再狭窄率为0%,无支架内血栓形成.结论:国产Firebird雷帕霉素洗脱支架治疗冠心病安全有效,能有效预防冠脉支架术后再狭窄.     

雷帕霉素药物洗脱支架治疗冠状动脉长病变的临床应用

再狭窄是目前限制冠心病介入治疗的一个难点.研究表明进口雷帕霉素药物洗脱支架(Cypher)能有效降低患者的支架内及支架所在节段的再狭窄的发生率[1].本文旨在研究国产雷帕霉素药物洗脱支架(Firebird)在冠心病患者中进行冠脉介入治疗的安全性及疗效.     

国产Firebird 2TM与进口Endeavor-Sprint药物洗脱支架临床应用比较

目的对比研究国产Firebird 2TM雷帕霉素药物洗脱钴基合金支架与进口Endeavor-Sprint药物洗脱支架临床应用的安全性及疗效。方法对100例冠心病患者进行介入治疗,随机分为Firebird组和Endeavor组,每组50例,比较两组支架植入后效果。结果两组患者血管病变单支、双支、三支、分叉、慢性闭塞、左主干数比较差异无统计学意义(P>0.05),平均血管直径和平均靶病变长度比较差异无统计学意义(P>0.05);两组手术成功率为100%。Firebird组无血栓形成事件发生,Endeavor组发生1例亚急性血栓形成事件,且进行血运重建。Firebird组28例复查冠状动脉造影,1例再狭窄;Endeavor组19例复查冠状动脉造影,2例有再狭窄,两组比较差异无统计学意义(P>0.05)。结论 Firebird 2TM雷帕霉素药物洗脱钴基合金支架具有良好的安全性和满意的近、中期疗效。其与进口Endeavor-Sprint药物洗脱支架比较无明显差别。     

Inflammatory response, drug-eluting stent and restenosis

Cardiovascular diseases are the major cause of mortality in the Western world and it is expected that this will rem-ain so during the foreseeable future. 1 Among them, coronary artery disease （CAD） is the most important underlying cause of death due to cardiovascular disease.^2 Current treatment of pattents with CAD includes mainly risk factor management, drug therapy and revascularization techniques.     

国产药物洗脱支架在急性冠脉综合征中的应用

目的：探讨国产药物洗脱支架（Firebird支架）在急性冠脉综合征急诊介入治疗中应用的安全性和有效性.方法：2004年10月～2005年7月间治疗急性冠脉综合征患者86例,所有患者均于发病12h内行急诊经皮冠状动脉介入治疗（PCI）.治疗时随机置入Firebird支架或Cypher支架.Firebird支架组46例,Cypher支架组40例.结果：86例患者急诊PCI治疗均获得成功.Firebird组46支罪犯血管置入53枚Firebird支架,Cypher组40支罪犯血管置入49枚Cypher支架.其中1例置入Cypher支架者术后出现脑出血而死亡.Firebird支架组和Cypher支架组比较,PCI术后TIMI3级率和并发症发生率无显著性差异.对85例患者进行了3～6个月的随访,两组患者均未发生任何心血管事件,术后6个月Firebird支架组有20例（43%）行冠状动脉造影检查,无一例发生支架内再狭窄;Gypher支架组有19例（49%）行冠状动脉造影检查,1例发生支架内再狭窄,两组再狭窄率无显著性差异.结论：Firebird支架在急性冠脉综合征急诊介入治疗中应用有较好的安全性和有效性.     

Very late stent thrombosis due to multiple stent fracture and stent malapposition

Coronary stent fracture (SF) is a rare but potentially serious complication of coronary artery stenting.Here we report a case of acute myocardial infarction as a consequence of very late in-stent thrombosis due to multiple steut fractures at 8 sites and multiple stent malapposition formation four years after a sirolimus-eluting stent implantation (Firebird,Microport,Shanghai,China). A 43-year-old man with hyperlipidemia and a smoking history was referred for coronary angiography (CAG)following repeated exertion associated chest pain in January 2007.CAG revealed a diffused tortuous stenosis at the proximal segment and a total occlusion at the mid-segment of the left anterior descending (LAD) artery,a 90％ stenosis at the proximal segnent of the left circumflex artery (LCX),and a diffused lesion with a maximal 60％ stenosis of the right coronary artery (RCA).     

Very late coronary aneurysm formation with subsequent stent thrombosis secondary to drug-eluting stent

Drug-eluting stents have changed the practice in interventional cardiology. With the widespread use of these stents important safety concerns regarding stent thrombosis and formation of coronary artery aneurysm have been expressed. While the majority of attention was focused on stent thrombosis, the formation of coronary aneurysm was only described in anecdotal reports. We report on a patient who suffered from very late stent thrombosis in association with coronary artery aneurysm formation secondary to drug-eluting stent but not to bare-metal stent.

     

Short-term safety and efficacy of the biodegradable iron stent in mini-swine coronary arteries

Background Iron can potentially serve as the biomaterial for biodegradable stents. This study aimed to assess the short-term safety and efficacy of a biodegradable iron stent in mini-swine coronary arteries.

Methods Eight iron stents and eight cobalt chromium alloy (VISION) stents as control were randomly implanted into the LAD and RCA of 8 healthy mini-swine, respectively. Two stents of the same metal base were implanted into one animal. At 28 days the animals were sacrificed after coronary angiography, and histopathological examinations were performed.

Results Histomorphometric measurements showed that mean neointimal thickness ((0.46±0.17)mm vs. (0.45±0.18)mm, P＝0.878), neointimal area ((2.55±0.91)mm² vs. (3.04±1.15)mm², P＝0.360) and percentage of area stenosis ((44.50±11.40)% vs. (46.00±17.95)%, P=0.845) were not significantly different between the iron stent and VISION stent groups. There was no inflammation, thrombosis or necrosis in either group. The SEM intimal injury scores ((0.75±1.04) vs. (0.88±0.99), P＝0.809) and rate of proliferating cell nuclear antigen (PCNA) positive staining cells were not significantly different between the two groups. The percentage of neointimal coverage by SEM examination was numerically higher in iron stents than in VISION stents ((84.38±14.50)% vs. (65.00±22.04)%, P＝0.057), but there was no significant difference statistically between the two groups. At 28 days iron staining in the tissue surrounding iron stents was positive and the vascular wall adjacent to the iron stent had a brownish tinge, consistent with iron degradation. No abnormal histopathological changes were detected in coronary arteries and major organs.

Conclusions The biodegradable iron stent has good biocompatibility and short-term safety and efficacy in the mini-swine coronary artery. Corrosion of iron stent is observed at 4 weeks and no signs of organ toxicity related to iron degradation are noted.

     

Short-term safety and efficacy of the biodegradable iron stent in mini-swine coronary arteries

Background To overcome the drawbacks of permanent years. The bioabsorbable polymer vascular scaffold （BVS） stents, biodegradable stents have been studied in recent was the first bioabsorbable stent to undergo clinical trials, demonstrating safety and feasibility in the ABSORB studies. Iron can potentially serve as the biomatedal for biodegradable stents. This study aimed to assess the short4erm safety and efficacy of a biodegradable iron stent in mini-swine coronary arteries. Methods Eight iron stents and eight cobalt chromium alloy （VISION） control stents were randomly implanted into the LAD and RCA of eight healthy mini-swine, respectively. Two stents of the same metal base were implanted into one animal. At 28 days the animals were sacrificed after coronary angiography, and histopathological examinations were performed. Results Histomorphometric measurements showed that mean neointimal thickness （（0.46±0.17） mm vs. （0.45±0.18） mm, P=0.878）, neointimal area （（2.55±0.91） mm2 vs. （3.04±1.15） mm2, P=0.360） and percentage of area stenosis （（44.50±11.40）% vs. （46.00±17.95）%, P=0.845） were not significantly different between the iron stents and VISION stents. There was no inflammation, thrombosis or necrosis in either group. The scanning electron microscopy （SEM） intimal injury scores （0.75±1.04 vs. 0.88±0.99, P=0.809） and number of proliferating cell nuclear antigen （PCNA） positive staining cells were not significantly different between the two groups. The percentage of neointimal coverage by SEM examination was numerically higher in iron stents than in VISION stents （（84.38±14.50）% vs. （65.00±22.04）%, P=0.057）, but the difference was not statistically significant. Iron staining in the tissue surrounding the iron stents at 28 days was positive and the vascular wall adjacent to the iron stent had a brownish tinge, consistent with iron degradation. No abnormal histopathological changes were detected in coronary arteries or major organs. Conclusions The biodegradable iron stent has good biocompatibility and short-term safety and efficacy in the mini- swine coronary artery. Corrosion of iron stents is observed at four weeks and no signs of organ toxicity related to iron degradation were noted.     

介入治疗肠系膜上动脉缺血性疾病的疗效评价

 目的评价经导管溶栓及支架植入术治疗肠系膜上动脉缺血性疾病的有效性及安全性。方法回顾性分析26例肠系膜上动脉（SMA）缺血并接受介入治疗病例。其中,粥样硬化所致SMA狭窄14例,夹层所致狭窄4例,栓塞和（或）血栓形成8例。所有患者先行SMA造影,判定病变性质、范围、程度,再进一步置管溶栓和（或）支架植入治疗。术后观察症状改善程度,必要时行外科处理。结果26例患者均完成介入治疗,18例患者术中植入1枚支架,8例患者行置管溶栓治疗,其中2例溶栓后各植入1枚支架。术后24h内所有病例腹痛症状均逐渐缓解,无手术相关并发症发生。随访7~18个月（平均13.5个月）,1例患者术后8个月腹痛复发,行置管溶栓及球囊扩张治疗后症状消失。结论介入治疗作为一项微创技术,是SMA缺血性疾病安全有效的治疗手段。     

A single center investigation of bare-metal or drug-eluting stent restenosis from 1633 consecutive Chinese Han ethnic patients

Background Stents are widely used in China but the clinical impression is somehow that restenosis is less common because of the lower prevalence of coronary artery disease (CAD) and associated risk factors in Chinese populations. However, no large-sample published studies are available on angiographic stent restenosis including those of bare-metal stent (BMS) or drug-eluting stent (DES) in Chinese Han ethnic population.Mothods A total of 1633 consecutive patients with CAD who had undergone coronary stenting, quantitative coronary angiography (QCA) were retrospectively studied. At the time of stent implantation and at 7 months post-stenting 675 patients had a follow-up angiography. Statistical analysis was made with the chi-square test for categorical variables, unpaired t test for continuous variables, univariate or multivariate regression for baseline and angiographic characteristics and the Kaplan-Meier method for rate of target lesion revascularization (TLR).Results Stent restenosis was defined as ≥50% diameter stenosis in the dilated segment. A total of 675 patients with 1074 lesions were subjected to angiographic follow-up for 7 months on average. Of these lesions, 448 were implanted with BMS whereas 626 lesions with DES. At 7 months, bare-metal in-stent restenosis occured in 148 lesions (33.0%), and bare metal in-segment restenosis in 155 lesions (34.6%) in contrast to drug-eluting in-stent restenosis in 48 lesions (7.7%) and drug-eluting in-segment restenosis in 73 lesions (11.7%) (P<0.001 compared with BMS respectively). Late loss in both in-stent and in segment was higher in BMS than in DES groups [(1.00±0.69) vs (0.28±0.52); (0.78±0.71) vs (0.21±0.52), P<0.001 respectively]. Angulated lesion, lesion length, pre-procedural minimal luminal diameter (MLD), and BMS were independent predictors for TLR, (P<0.01 respectively), whereas current smoker, ostial lesion, and stent overlapping, post-procedure in-stent MLD, lesion length, and stent types were independent predictors for in-segment restenosis (P<0.01 respectively). Standard coronary risk factors such as hypertension, hyperlipidemia, diabetes, and history of CAD were not associated with a higher rate of restenosis caused by BMS or DES implantation in our Chinese Han ethnic population.Conclusions Coronary stenting including BMS or DES implantation in Chinese Han ethnic patients is associated with a restenosis rate comparable to that demonstrated in previous studies from the western countries, and predictors of stent restenosis are somehow different from those in the western population.     

Long-term outcomes of drug-eluting versus bare-metal stent implantation in patients with chronic total coronary artery occlusions

Background There are limited data on the efficacy of drug-eluting stents （DES） for treatment of chronic total occlusions （CTO）. The aim of the study was to evaluate the long-term clinical outcomes of DES implantation for CTO compared with bare-metal stent （BMS） implantation.
Methods Between June 1995 and December 2006, a total of 1184 patients with successful recanalization of at least one de novo CTO lesion were consecutively registered, including 660 （55.7%） who underwent DES and 524 （44.3%） who underwent BMS implantation. All patients were followed up for up to 5 years for occurrence of major adverse cardiac events （MACE）. Long-term survival rates were estimated with the Kaplan-Meier method.
Results Baseline clinical and angiographic characteristics were comparable between the two groups except that patients in the DES group received longer dual antiplatelet therapy （（7.4±2.5） months vs （1.7±0.8） months, P 〈0.001）. Average follow-up periods were （4.7±0.89） and （3.2±1.3） years for the BMS and DES groups, respectively. There was no significant difference in 5-year survival rates between the two groups （90.3% for DES group vs 89.6% for BMS group, Log-rank P=0.38）, but the 5-year target vessel revascularization （TVR）-free survival rate in the DES group was significantly higher than that in the BMS group （81.6% vs 73.5%, Log-rank P 〈0.001）. The cumulative MACE-free survival in the DES group was also significantly higher than that in the BMS group （80.6% vs 71.5%, Log-rank P〈0.001）. The rates of readmission caused by cardiovascular disease （27.0% vs 37.8%, P 〈0.001） and the need for bypass surgery were significantly lower in the DES group （1.5% vs 3.4%, P 〈0.05）. By multivariable analysis, DES implantation could significantly lower the long-term MACE risk of PCI for CTO patients （HR： 0.492; 95% Cl 0.396-0.656, P 〈0.001）. Left ventricular ejection fraction 〈50% and elderly （〉65 years） were identified as independent predictors of long-term MACE during follow-up.
Conclusion This study demonstrates the long-term （up to 5 years） efficacy of DES for treatment of CTO, which is superior to BMS implantation in reducing the rates of TVR and MACE, as well as the need of re-admission and bypass surgery.