雷帕霉素洗脱支架治疗多支冠状动脉病变的临床研究

目的:探讨多支冠状动脉病变患者置入雷帕霉素洗脱支架(Cypher支架)预防再狭窄的疗效及安全性。方法:2001年12月-2004年5月连续725例接受多支冠状动脉支架置入术的冠心病患者,剔除急性心肌梗死及再次血运重建患者。Cypher支架组187例,普通金属支架(普通支架)组538例。比较两组支架术后的近期及远期结果。结果:除糖尿病患者比例在Cypher支架组较高外,两组患者冠心病危险因素、心功能、冠状动脉病变严重程度、介入手术成功率及并发症发生率均无显著差异。690例患者平均随访(18.8±11.7)个月,Cypher支架组和普通支架组造影随访率分别为52.4%vs58.2%(P>0.05)。尽管Cypher支架组患者冠心病危险因素多、平均年龄63.5岁、不稳定性心绞痛占66.3%、糖尿病占41.6%、3支血管病变占57.8%、B2/C型复杂病变占86.2%,但造影复查再狭窄率和主要不良心脏事件(MACE)发生率均明显低于普通支架组(3.1%vs16.6%,5.5%vs16.7%,P均<0.01),心功能改善率高于普通支架组(63.1%vs30.6%,P<0.01)。两组完全血运重建率无显著差异(81.3%vs86.8%,P>0.05),但发生MACE的患者中,Cypher支架组不完全血运重建者比例高于普通支架组(60.0%vs23.5%,P<0.05);两组发生MACE的患者中完全血运重建患者比例均低于本组总的完全血运重建率(Cypher支架组:40.0%     

雷帕霉素与紫杉醇洗脱支架术治疗多支病变冠心病患者疗效的比较

目的比较雷帕霉素洗脱支架(CYPHER)与紫杉醇洗脱支架(TAXUS)治疗多支冠状动脉病变患者的疗效及安全性。方法2003年6月至2004年12月在我院置入药物洗脱支架的416例多支病变冠心病患者,剔除合并左主干病变、急性心肌梗死、再次血管重建及合用普通支架者。随机分为两组:CYPHER支架组210例,TAXUS支架组206例。比较两组支架术后近期及远期疗效。结果支架置入术前两组患者冠心病危险因素、心功能状况及冠状动脉病变特征无统计学差异。两组PCI手术成功率、平均支架置入数(3.24±1.25)比(3.19±1.38)枚/例及并发症发生率均无统计学差异。术后平均随访(19.5±8.9)个月,总随访率、心绞痛复发率、造影复查再狭窄率、主要不良心脏事件发生率、心功能改善率及无事件存活率均无统计学差异。与CYPHER支架组比较TAXUS支架组术后亚急性血栓发生率有增高趋势,但无统计学差异(1.0%比0.5%,P>0.05)。用QCA测量术后6～9个月冠状动脉造影结果,支架内最小管腔直径(MLD)、节段内MLD、支架内晚期管腔丢失及节段内晚期管腔丢失两组间比较均无统计学差异。结论多支冠状动脉病变患者置入CYPHER和TAXUS两种药物洗脱支架均能达到成功率高,再狭窄率低,远期临床疗效好的结果,两者疗效及安全性无统计学差异。     

药物洗脱支架在冠心病无保护左主干病变中的应用

目的评价药物洗脱支架治疗经选择冠心病无保护左主干病变的安全性和有效性。方法2003年1月~2005年6月间,共有48例经选择的冠心病患者,年龄39~81岁,经冠状动脉造影证实为无保护左主干病变(左主干狭窄均≥75%)行介入治疗置入药物洗脱支架。结果48例患者介入治疗均获得成功,共置入药物洗脱支架75枚(51 Cypher,18 Taxus,6 Firebird)。其中左主干开口部狭窄5例(10.4%,5/48),体部狭窄6例(12.5%,6/48),远端分叉部位狭窄37例(77.1%,37/48)。37例远端分叉部位狭窄患者中,主支支架加边支经皮冠状动脉介入治疗(PCI)10例,双支架术27例,最后成功对吻球囊扩张30例(81.1%,30/37)。所有患者治疗后临床症状明显缓解或消失,住院及6个月随访期间无严重心血管事件发生,43例患者术后6个月行冠状动脉造影随访,2例患者再狭窄(均为分叉病变)行冠状动脉旁路移植术(CABG),冠状动脉造影随访率89.6%,再狭窄率4.7%。结论药物洗脱支架介入治疗冠心病无保护左主干病变安全有效,近中期效果良好。     

药物洗脱支架与金属裸支架对非糖尿病患者冠状动脉局限病变的8个月疗效

目的评估非糖尿病冠心病患者,药物洗脱支架与金属裸支架对于治疗冠状动脉局限病变的8个月疗效.方法自身冠状动脉首次介入治疗病变(在线定量冠状动脉造影分析直径≥3.0 mm,长度≤15 mm)的非糖尿病患者入选本研究,148例患者分为药物洗脱支架组(n=81)和金属裸支架组(n=67),两组的基本临床特征和冠状动脉造影结果无显著差异.术前、术后和8个月随访时进行定量冠状动脉造影分析,并在住院期间,30天和8个月时观察不良心脏事件的发生.结果支架置入成功率均为100%.住院期间靶病变重复血管重建率,在药物洗脱支架组和金属裸支架组无显著性差异(1.2%和0%,P=0.36).在术后30天时两组均无支架内血栓形成.8个月随访时,定量冠状动脉造影分析显示,支架内最小管腔直径药物洗脱支架组明显大于金属裸支架组,有极显著性差异(P＜0.01);支架内远期管腔丢失、病变内远期管腔丢失、支架内狭窄直径、病变内狭窄直径药物洗脱支架组明显低于金属裸支架组有显著性差异(P＜0.05～0.001).两组支架内再狭窄率(8.64% vs 17.91%,P=0.09)和病变节段再狭窄率(11.11% vs 17.91%,P=0.24)均无显著性差异,但支架内再狭窄率比数比为0.8985(95%的可信区间0.7887;1.0237).结论药物洗脱支架对于治疗非糖尿病、自身冠状动脉局限病变患者安全有效,两组支架内再狭窄率虽无显著性差异,但药物洗脱支架有降低再狭窄率的趋势.     

应用雷帕霉素药物洗脱支架治疗小冠状动脉病变98例疗效观察

目的评价西罗莫可(雷帕霉素)药物洗脱支架治疗小冠状动脉病变(<3.0mm)的临床疗效。方法选择2004年1月—2004年12月入院的98例冠心病病人,常规行冠状动脉造影,获得直径小于3.0mm的病变血管共107支,前降支49支,回旋支18支,右冠状动脉15支,对角支18支,钝缘支7支,血管直径2.74mm±0.23mm。107支病变血管共植入Cypher支架118个。结果107支病变血管中,75支血管经球囊预扩张后植入支架,32支血管行直接支架术,手术成功率100%,无急性/亚急性支架内血栓形成。术后全部病例症状消失。随访14个月±3个月,全部存活。其中53例在术后10个月接受冠状动脉造影随访,5例经造影证实为支架内再狭窄,再狭窄率9.4%。4例出现新部位血管病变,再次经皮冠状动脉成形术(PTCA)治疗,随访6个月,无心绞痛症状发生。结论雷帕霉素药物洗脱支架可以明显降低小冠状动脉病变支架内再狭窄率,临床疗效肯定。     

药物洗脱支架与金属裸支架对冠状动脉临界病变的远期疗效

目的:评估药物洗脱支架与金属裸支架对于治疗冠状动脉临界病变的远期疗效。方法:自身冠状动脉首次介入治疗病变(在线定量冠状动脉造影分析50%≤管腔狭窄直径≤70%)的患者入选本研究,共计151例患者分为药物洗脱支架组(n=102)和金属裸支架组(n=49),两组的基本临床特征和冠状动脉造影结果差异无统计学意义。术前、术后和随访6～12个月时进行定量冠状动脉造影分析,并在住院期间、30天和6～12个月时观察严重不良心脏事件的发生。结果:151例患者支架置入成功率均为100%。住院期间严重不良心脏事件发生率,在药物洗脱支架组和金属裸支架组差异无统计学意义(0%和2.0%,P=0.15)。在随访30天时,两组均无死亡和支架内血栓形成。6～12个月随访期间,药物洗脱支架组和金属裸支架组比较①严重不良心脏事件发生率(3.9%vs8.1%,P=0.97),②靶病变重复血管重建率(2.9%vs6.1%,P=0.39),③急性心肌梗死发生率(1.96%vs2.04%,P=0.95),差异均无统计学意义。12个月时药物洗脱支架组和金属裸支架组比较,支架内血栓发生率和病死率差异也无统计学意义(1.96%vs0%,P=0.34;0%vs4.08%,P0.05)。定量冠状动脉造影分析显示:远期管腔丢失药物洗脱支架组明显低于金属裸支架组[(0.23±0.73)mmvs(0.95±0.94)mm,P=0.01],两组比较差异有统计学意义;而支架内再狭窄率两组比较差异无统计学意义(12.9%vs25.0%,P=0.34)。结论:药物洗脱支架和金属裸支架对于治疗自身冠状动脉临界病变安全有效,两组远期严重不良心脏事件发生率差异无统计学意义。     

Firebird支架治疗冠心病140例临床观察

观察国产Firebird支架在冠心病患者介入治疗中的临床疗效。方法共140例冠心病患者常规冠状动脉造影后行经皮冠状动脉介入(PCI)治疗,其中64例患者植入Firebird支架,76例患者置入普通支架,术前术后除常规使用阿司匹林和波立维外,同时给予严格的内科强化治疗,术后进行随访。结果冠状动脉造影显示2支以上血管病变占70.56%,一共植入Firebird支架114枚,普通支架105枚,所有患者均获得成功。平均随访(10.2±3.3)个月,其中药物支架组复发心绞痛18例,10例发生心肌梗死;普通组复发心绞痛40例,16例发生心肌梗死。部分患者行冠脉造影复查,Firebird支架组发生再狭窄2例,普通支架组发生再狭窄8例,均进行了靶病变重建术。结论Firebird支架对冠心病患者近期疗效确切,能减少再狭窄的发生。     

国产与进口药物洗脱支架治疗前降支开口病变的临床疗效比较

目的:比较国产与进口药物洗脱支架治疗前降支开口病变的临床疗效。方法:回顾性分析95例前降支开口病变的患者置入国产支架(国产支架组,n=68)和进口支架(进口支架组,n=27),所有患者均行临床随访,部分患者进行了冠状动脉造影(CAG)复查。结果:国产支架组的急性心肌梗死患者多于进口支架组,但无统计学差异(46%vs.33%)。两组的介入成功率均为100%。国产支架组的冠脉钙化率、偏心斑块率和C型病变率均高于进口支架组(分别为20%vs.4%;14%vs.0%;28%vs.7%,均P0.05)。两组CAG随访的支架内和血管段再狭窄率无统计学差异;两组的主要不良事件发生率也无统计学差异。结论:国产药物洗脱支架治疗前降支开口病变是安全的,与进口药物洗脱支架具有相似的良好疗效。     

冠心病合并轻中度慢性肾脏病患者PCI后支架内再狭窄的相关因素分析

目的 分析冠状动脉粥样硬化性心脏病(冠心病)合并轻中度慢性肾脏病患者冠状动脉(冠脉)药物洗脱支架术后支架内再狭窄(ISR)的相关因素.方法 选择陕西省人民医院心内科自2015年11月至2018年9月行药物洗脱支架置入且合并轻中度慢性肾脏病的冠心病患者189例,术后9～15月复查冠脉造影后,分为支架术后再狭窄组和无再狭窄...     

冠心病并糖尿病患者使用药物支架与普通支架初步随访结果比较

目的 :观察药物支架在冠心病并糖尿病患者介入治疗的临床疗效。方法 :并发糖尿病的冠心病患者70例常规冠状动脉造影 ,进行经皮冠状动脉介入治疗 ,其中 32例置入雷帕霉素药物涂层支架 ,38例置入普通支架 ,术前术后常规使用阿司匹林和噻氯吡啶 ,术后进行随访。结果 :冠状动脉造影显示 2支以上血管病变占70 .5 6 % ,一共置入雷帕霉素药物涂层支架 5 4枚 ,普通支架 6 2枚 ,所有患者均获得成功。平均随访 (10 .2± 3.5 )个月 ,其中药物支架组复发心绞痛 9例 ,5例发生心肌梗死 ;普通组复发心绞痛 2 0例 ,8例发生心肌梗死 ,所有患者均再次进行冠状动脉造影 ,药物支架内发生再狭窄 4例 ,普通支架内发生再狭窄 2 0例 ,均进行了靶病变重建术。结论 :药物涂层支架对冠心病并发糖尿病患者近期和远期疗效确切 ,能减少再狭窄的发生     

Estrogen-Eluting Stents

Coronary stenting is routinely utilized to treat symptomatic obstructive coronary artery disease. However, the efficacy of bare metal coronary stents has been historically limited by restenosis, which is primarily due to excessive neointima formation. Drug-eluting stents (DES) are composed of a stainless steel backbone encompassed by a polymer in which a variety of drugs that inhibit smooth muscle cell proliferation and excessive neointima formation are incorporated. DES have significantly reduced the incidence of restenosis but are also associated with a small (~0.5% per year) but significant risk of late stent thrombosis. In that regard, estrogen-eluting stents have also undergone clinical evaluation in reducing restenosis with the additional potential benefit of enhancing reendothelialization of the stent surface to reduce stent thrombosis. Estrogen directly promotes vasodilatation, enhances endothelial healing, and prevents smooth muscle cell migration and proliferation. Due to these mechanisms, estrogen has been postulated to reduce neointimal hyperplasia without delaying endothelial healing. In animal studies, estrogen treatment was effective in decreasing neointimal hyperplasia after both balloon angioplasty and stenting regardless of the method of drug delivery. The first uncontrolled human study using estrogen-coated stents demonstrated acceptable efficacy in reducing late lumen loss. However, subsequent randomized clinical trials did not show superiority of estrogen-eluting stents over bare metal stents or DES. Further studies are required to determine optimal dose and method of estrogen delivery with coronary stenting and whether this approach will be a viable alternative to the current DES armamentarium.     

Absorbierbare Stents

Coronary stent implantation started in Germany 20 years ago. In the beginning, the progress was very slow and accelerated 10 years later. Meanwhile, coronary stent implantation is a standard procedure in interventional cardiology. From the beginning of permanent stent implantation, research started to provide temporary stenting of coronary arteries, first with catheter-based systems, later with stent-alone technology. Stents were produced from polymers or metal.The first polymer stent implantation failed except the Igaki-Tamai stent in Japan. Newly developed absorbable polymer stents seem to be very promising, as intravascular ultrasound (IVUS) and optical coherence tomography have demonstrated.Temporary metal stents were developed based on iron and magnesium. Currently, the iron stent is tested in peripheral arteries. The absorbable magnesium stent (Biotronik, Berlin, Germany) was tested in peripheral arteries below the knee and meanwhile in the multicenter international PROGRESS-AMS (Clinical Performance and Angiographic Results of Coronary Stenting with Absorbable Metal Stents) study. The first magnesium stent implantation was performed on July 30, 2004 after extended experimental testing in Essen. The magnesium stent behaved like a bare-metal stent with low recoil of 5-7%. The stent struts were absorbed when tested with IVUS. Stent struts were not visible by fluoroscopy or computed tomography (CT) as well as magnetic resonance imaging (MRI). That means, that the magnesium stent is invisible and therefore CT and MRI can be used for imaging of interventions. Only using micro-CT the stent struts were visible. The absorption process could be demonstrated in a patient 18 days after implantation due to suspected acute coronary syndrome, which was excluded. IVUS showed a nice open lumen. Stent struts were no longer visible, but replaced by tissue indicating the previous stent location. Coronary angiography after 4 months showed an ischemia-driven target lesion revascularization rate of 23.8% which was below the 30% cut point of the study protocol. No myocardial Q wave infarction or death were reported. The primary endpoint was reached.During the follow-up period, vasomotion was tested in some of the patients. The proof of principle was confirmed: restoration of vasomotion during acetylcholine testing.The development of the absorbable magnesium stent, which was pushed forward by B. Heublein, Hanover, Germany, has been successful and opens new possibilities for treatment of coronary arteries. Permanent foreign-body implantation is avoided allowing further revascularization procedures in the future, bypass grafting, and restoration of vasomotion. Even prophylactic stenting in nonsignificant stenosis, like vulnerable lesions, may become a regular procedure. Noninvasive coronary imaging by CT and MRI is now possible. Stenting of children and in peripheral arteries may become a standard procedure. Currently, the degradation process of the magnesium stent has to be prolonged, and the neointima proliferation rate has to be reduced so that the DREAM (Drug-Eluting Absorbable Magnesium Stent) concept of Ron Waksman, Washington, DC, USA, can be realized.     

Enterale Stents

Stenosis of the duodenum is a common complication of malignancy of the pancreatic head or the biliary system. The resulting gastroduodenal outlet obstruction has a significant morbidity and lowers the patient’s quality of life. In addition to the palliative surgical gastroenterostomy, the endoscopic application of enteral stents has been established as a treatment. This method is efficient for symptom relief and causes few complications. There is a lack of large prospective randomized studies comparing the two methods, but the palliative endoscopic method seems to be effective and efficient, and in advanced tumor stages, probably even superior to surgical gastroenterostomy.     

药物洗脱支架与金属裸支架内血栓发生率比较

目的:了解置入药物洗脱支架(DES)患者在经皮冠状动脉(冠脉)介入治疗(PCI)术后各期支架血栓(ST)的发生情况,并与置入金属裸支架(BMS)患者进行比较,探讨影响支架血栓发生的危险因素.方法:连续入选2001-07至2002-06和2003-07至2005-06期间接受PCI并置入支架的所有患者,共入选3 893例.随访至少2年.根据所使用支架分为DES组(n=2 930,至少置入1枚DES)和BMS组(n=963,单纯置入BMS).记录所有患者住院期和随访期内临床资料,并根据美国和欧洲学者组成的学术研究联盟(ARC)正式发表的支架血栓定义判定支架血栓事件.结果:与BMS组相比,DES组患者的平均年龄较大,而白细胞数、甘油三脂水平和空腹血糖水平较低,既往有冠脉血运重建病史者较多,但吸烟、糖尿病和ST段抬高型心肌梗死(STEMI)发生率较低;在DES组患者的冠脉病变中,多支病变、开口病变、前降支(LAD)近段病变和左主干(LM)病变发生率较高,但慢性完全闭塞性(CTO)病变所占的发生率较低,造影成功率及完全血运重建率均较高,差异均有统计学意义(P均＜0.05～0.001).两组患者PCI术后无论在住院期还是之后的随访期内,所有的不良心脑血管事件发生率均无显著差异,而支架血栓发生率在急性期、亚急性期、晚期和晚晚期均无差异(P均＞0.05).Cox回归分析结果提示,DES组患者发生支架血栓的危险因素为:氯吡格雷疗程短和冠脉多支病变(P均＜0.001);而BMS组患者发生支架血栓的危险因素为:血清肌酐值升高和合并高血压(P均＜0.05).结论:尽管DES时代患者的病变更为复杂,所置入的DES数更多,但支架血栓的发生率并不比BMS时代更高.但术后双联抗血小板治疗的疗程过短和冠脉多支病变是支架血栓发生的危险因素,应引起重视.     

新型药物支架

药物支架治疗冠状动脉性心脏病在临床上已经取得了良好的效果。然而,支架术后血栓问题困扰着人们。新型药物支架的研发不断进行,现分别对选用不同支架材料、药物载体、涂层药物及药物释放方式的新型药物支架的研究进展进行综述。     

Biodegradable Polymeric Stents

To overcome several problems of conventional metallic stents, there have been many attempts to manufacture stents made of biodegradable materials. Although some studies have noted various degrees of inflammatory responses after biodegradable stent implantation, stents made of poly-l-lactic acid (PLLA) showed high biocompatibility with minimal inflammatory response and neointimal formation in porcine coronary arteries. Therefore, PLLA materials are more likely to cover the specific need for human coronary arteries in terms of biodegradation period and scaffolding ability over 6 months. A clinical study of PLLA self-expanding stent implantation is underway in Japan. The initial and 6-month results are favorable and suggest the feasibility, safety, and efficacy of the PLLA biodegradable stent in humans. However, long-term follow-up with larger numbers of patients will be required to validate the long-term efficacy of PLLA stents.