国产雷帕霉素药物洗脱支架的临床应用

目的观察应用国产雷帕霉素药物洗脱支架治疗冠心病的近期疗效及安全性。方法观察接受国产雷帕霉素药物洗脱支架治疗的冠心病患者,即刻疗效和随访结果。结果本组111例患者,137个血管段,植入190枚国产雷帕霉素药物洗脱支架,其中13个血管段为支架内再狭窄,分叉病变23个,慢性闭塞病变7个;单支血管病变56例,二支血管病变38例,三支血管病变17病。平均血靶管直径2.92±0.31mm,平均靶病变长度30.3±8.15mm。在(7.2±4.1)个月的随访期内,无急性和亚急性支架内血栓形成,无再发心肌梗死及死亡,有18例冠状动脉造影复查,无支架及节段内再狭窄。结论国产雷帕霉素药物洗脱支架治疗冠心病安全有效。     

雷帕霉素和紫杉醇药物洗脱支架治疗冠状动脉开口病变的临床疗效比较

目的:评价雷帕霉素和紫杉醇两种药物洗脱支架治疗冠状动脉开口处病变的临床效果。方法:选择我院2004年4月12日至2006年04月30日期间连续于冠状动脉开口处置入雷帕霉素或紫杉醇药物洗脱支架,并在6个月后完成冠状动脉造影随访的92例(95个病变)患者进入该研究。分成紫杉醇药物洗脱支架组(紫杉醇组,美国Boston公司Taxus支架)45例(47个病变)和雷帕霉素药物洗脱支架组(雷帕霉素组,美国Cordis公司Cypher支架)47例(48个病变)。对两组患者的主要心脏不良事件包括死亡、心肌梗死及靶病变血运重建率进行比较。结果:紫杉醇组47处病变共置入47个支架,雷帕霉素组48处病变共置入49个支架,两组手术成功率均100%。定量冠状动脉造影显示紫杉醇组和雷帕霉素组术前参考血管直径分别为(2.85±0.53)mm和(2.96±0.41)mm,病变长度为(15.7±14.1)mm和(18.1±11.6)mm;术后支架总长度为(19.68±14.26)mm和(23.87±12.17)mm,最大扩张压力为(14.2±2.9)atm和(15.0±2.7)atm,两组比较均没有差异。术后30天随访无主要心脏不良事件发生,无急性和亚急性血栓形成。6个月随访时雷帕霉素组和紫杉醇组的主要心脏不良事件分别为6.4%和11.1%,没有显著差异(P=0.184)。两组平均造影随访时间相似〔(225±84)天vs(210±50)天〕。紫杉醇组的节段内和支架内再狭窄率分别为22.2%(10/45)和15.5%(7/45),雷帕霉素组为4.3%(2/47)和0%(0/47),两组比较有显著差异(P<0.01);边缘再狭窄率分别为6.7%(3/45)和4.3%(2/47),两组无差异(P>0.05)。紫杉醇组6个月后的靶病变血运重建率8.9%,雷帕霉素组4.3%,无显著差异(P>0.05)。紫杉醇组的支架内和节段内的晚期管腔丢失〔(0.65±0.67)mm,(0.68±0.65)mm〕明显高于雷帕霉素组〔(0.16±0.18)mm,(0.15±0.24)mm(P<0.001)〕。结论:两种药物洗脱支架治疗冠状动脉开口病变均安全有效。雷帕霉素支架的造影再狭窄率和晚期管腔丢失明显低于紫杉醇支架,但两种药物洗脱支架6个月后的靶病变血运重建没有显著差异。     

雷帕霉素-巴曲酶复合药物涂层支架预防支架内再狭窄的实验研究

目的评价雷帕霉素-巴曲酶复合药物涂层支架对再狭窄和支架内血栓的防治作用及安全性,减少术后抗血小板药物的应用及并发症的发生率。方法采用随机、双盲试验在16头微型猪的冠状动脉前降支或左旋支分别置入支架1枚,其中雷帕霉素涂层支架（每枚支架药物剂量1.2μg/mm2）共8枚,为对照组;雷帕霉素-巴曲酶复合药物涂层支架（每枚支架含雷帕霉素1.2μg/mm2、巴曲酶0.3μg/mm2）共8枚,为实验组。对照组术前3 d起每天口服氯吡格雷75 mg和阿司匹林0.3 g直至28 d处死;实验组术前3 d至术后7 d每天口服氯吡格雷75 mg和阿司匹林0.3 g,此后改为每天口服阿司匹林0.3 g,直至28 d处死。28 d时进行冠状动脉造影随访,术后处死动物,取出支架血管,进行组织学分析。结果再狭窄率:对照组为0,实验组为0。管腔丢失率:对照组为（7±5）%,实验组为（4±3）%。新生内膜面积:对照组为（1.0±0.8）mm2,实验组为（0.9±0.7）mm2。结论雷帕霉素-巴曲酶复合药物涂层支架与单纯雷帕霉素涂层支架比较可以减少支架置入术后的口服氯吡格雷总量及用药时间。     

血管内超声联合雷帕霉素洗脱支架在冠心病合并糖尿病患者中的治疗效果

目的探讨血管内超声(IVUS)联合雷帕霉素洗脱支架在冠状动脉粥样硬化性心脏病(冠心病)合并糖尿病患者中的疗效。方法选取2015年5月至2018年8月于安庆市立医院心血管内科住院治疗的77例冠心病合并糖尿病患者为研究对象,依据术中有无采用IVUS检查,将其分为观察组(IVUS联合雷帕霉素洗脱支架治疗)41例,对照组(单纯雷帕霉素洗脱支架治疗)36例,并分析患者的临床资料。结果观察组手术时间为(52.27±6.03)min,长于对照组的(29.94±5.05)min(P0.05);术后随访1年观察组支架内再狭窄以及血栓形成发生率分别为2.44%和0,均明显低于对照组的19.44%和13.89%(P0.05)。两组患者治疗后狭窄程度较术前显著降低,最小血管直径较术前显著增加,且观察组明显优于对照组(P0.05)。其余指标无统计学差异(P0.05)。结论 IVUS联合雷帕霉素洗脱支架用于冠心病合并糖尿病患者的治疗,提升了支架置入治疗效果的同时,又可降低再狭窄等远期并发症的发生率。     

药物洗脱支架治疗支架内再狭窄的对照研究

目的 比较3种药物洗脱支架(DES)治疗支架内再狭窄的长期临床效果.方法 回顾性分析阜外医院对支架内再狭窄病例用DES行经皮冠状动脉介入治疗(PCI)的390例患者,其中雷帕霉素药物洗脱支架(Cypher)组187例(C组),紫杉醇药物涂层支架(Taxus)组89例(T组),国产雷帕霉素涂层支架(Firebird)组114例(F组).结果 T组不稳定性心绞痛比率高于另2组,F组左主干病变比率低于另2组,而3支病变比率高于另2组.3组平均临床随访时间为864、848和719 d,主要不良心脏事件发生率差异无统计学意义(P=0.081),3组总的支架内血栓发生率差异无统计学意义(P=0.605).7个月造影随访支架内和血管段再狭窄率T组有增高的趋势(17.9%比29.4%比13.6%.P=0.214和21.8%比35.3%比15.9%,P=0.132).支架内和血管段的晚期丢失T组均明显大于另外2组[(0.31±0.12)mm比(0.75±0.24)mm比(0.31±0.13)mm,P=0.000和(0.33±0.18)mm比(0.61±0.23)mm比(0.31±0.14)mm,P=0.001].结论 3种DES治疗支架内再狭窄病变的长期疗效相似,Cypher和Firebird抑制内膜增生的作用更强.     

雷帕霉素-替罗非班复合药物涂层支架预防支架内血栓和再狭窄的实验研究

目的探讨雷帕霉素-替罗非班复合药物涂层支架预防支架内血栓和再狭窄的疗效及机制。方法8只小型猪随机分为单纯雷帕霉素涂层支架（RES）组和雷帕霉素-替罗非班复合药物涂层支架（RTES）组,每只动物于冠状动脉中置入支架2枚。术后RES组服用阿司匹林300 mg/d和氯吡格雷75 mg/d,3个月;RTES组服用阿司匹林300 mg/d,3个月,氯吡格雷75 mg/d,1个月。实验期间对动物行为学和出凝血障碍等并发症进行观察。3月后复查冠状动脉造影,处死动物,取出支架血管段,行组织病理学分析。结果①两组均未发现急性、亚急性和远期血栓,无出凝血等并发症发生。②支架部位血管腔面积:雷帕霉素涂层支架组为（4.89±0.46）mm2,雷帕霉素-替罗非班复合涂层支架组为（4.96±0.35）mm2;新生内膜面积:雷帕霉素涂层支架组为（1.05±0.09）mm2,雷帕霉素-替罗非班复合涂层支架组为（1.12±0.10）mm2;管腔面积丢失率:雷帕霉素涂层支架组为（21±7）%,雷帕霉素-替罗非班复合药物涂层支架组为（19±9）%。结论①雷帕霉素-替罗非班复合药物涂层支架可有效预防PC I术后支架内血栓形成。②雷帕霉素-替罗非班复合药物涂层支架防治支架内再狭窄的疗效与单纯雷帕霉素支架无差异。     

国产西罗莫司洗脱支架与紫杉醇洗脱支架抑制血管内膜增生的血管内超声比较研究

目的利用血管内超声（IVUS）方法比较国产西罗莫司洗脱支架（Firebird^TM）与紫杉醇洗脱支架（Taxus^TM）对冠心病患者新生内膜增生的抑制作用。方法自2003年5月至2007年6月,203例冠心病患者（283处病变）行药物洗脱支架术并在术后1年行冠状动脉造影和血管内超声（IVUS）检查。其中136例患者（185处病变）置入Firebird^TM支架（Firebird组）,67例患者（98处病变）置入TaxusTM支架（Taxus组）。结果203例患者（283处病变）中168例患者（236处病变）接受了一年随访造影和血管内超声检查,其中Firebird组108例患者（147处病变）,Taxus组60例患者（89处病变）。两组患者基础临床情况及造影特征相似。Firebird组支架内晚期管腔丢失（0.17±0.29mm比0.43±0.51mm,P〈0.0001）和节段内晚期管腔丢失（0.18±0.36mm比0.38±0.33mm,P=0.003）明显小于Taxus组,而两组近端参考血管晚期管腔丢失（0.11±0.27mm比0.15±0.32mm,P=0.321）和远端参考血管晚期管腔丢失（0.08±0.10mm比0.09±0.16mm,P=0.483）差异并无统计学意义。IVUS分析显示,两组间平均支架面积、平均管腔面积、最小支架面积、平均支架体积、平均管腔体积比较,差异均无统计学意义。但Firebird组平均内膜增生面积（0.35±0.58mm^2比1.29±1.26mm^2,P〈0.0001）、平均内膜增生面积百分数（5.45%±9.26%比17.38%±13.75%,P〈0.0001）、内膜增生最大面积百分数（9.41%±14.15%比31.56%±20.99%,P〈0.0001）、平均内膜增生容积（2.09±5.46mm^3比13.43±18.59mm^3,P〈0.0001）和平均内膜增生容积百分数（1.68%±5.84%比8.62%±9.90%,P〈0.0001）较Taxus组均明显减少。结论国产西罗莫司洗脱支架（Firebird^TM）置入术后再狭窄发生率较低,与TaxusTM支架相比,抑制内膜增生作用更显著。     

雷帕霉素和甲氨蝶呤涂层支架预防支架内再狭窄的实验研究

目的　评价雷帕霉素涂层支架、甲氨蝶呤涂层支架以及雷帕霉素和甲氨蝶呤混合涂层支架抑制血管新生内膜的作用和预防支架内再狭窄的有效性。方法　本实验采用随机、双盲试验 ,在2 5头微型猪的冠状动脉前降支或左旋支分别置入支架 1枚 ,其中金属裸支架 8枚、甲氨蝶呤涂层支架(每枚支架药物剂量 2 5 0～ 30 0 μg) 5枚、雷帕霉素涂层支架 (每枚支架药物剂量 6 8～ 96 μg) 7枚、雷帕霉素和甲氨蝶呤混合涂层支架 (每枚支架含雷帕霉素 5 8～ 81μg、甲氨蝶呤 12 0～ 170 μg) 5枚。 2 8d后进行冠状动脉造影随访 ,术后处死动物 ,取出支架血管 ,进行组织学分析。结果　再狭窄率 :对照组为2 5 % ( 2 8) ,甲氨蝶呤组为 80 % ( 4 5 ) ,其余 2组为 0。平均狭窄程度 :对照组为 31%± 2 2 % ,甲氨蝶呤涂层支架组为 6 4 %± 2 5 % (P <0 0 5 ) ,雷帕霉素涂层支架组为 8%± 17% (P <0 0 5 ) ,雷帕霉素和甲氨蝶呤混合涂层支架组为 3%± 4 % (P <0 0 5 )。新生内膜面积 :对照组为 ( 2 18± 1 0 3)mm2 ,甲氨蝶呤涂层支架组为 ( 3 93± 1 4 8)mm2 (P =0 0 6 9) ;雷帕霉素涂层支架组为 ( 0 94± 0 88)mm2 (P <0 0 5 ) ,雷帕霉素和甲氨蝶呤混合涂层支架组为 ( 0 4 7± 0 2 4 )mm2 (P <0 0 5 )。结论　在本实验中     

冠心病患者药物洗脱支架植入术后球囊高压后扩张疗效观察

目的观察冠心病患者药物洗脱支架（DES）植入术后球囊高压后扩张的临床疗效。方法选择冠心病患者656例,其中332例（观察组）冠状动脉DES植入术后予非顺应性球囊高压后扩张,324例（对照组）仅行DES植入术,记录术中及术后情况。结果两组血管病变情况、血管病变数量、植入DES数量、支架植入后管腔狭窄程度、术中并发症比较,P均〉0．05。对照组支架植入后管腔最小直径为（2．74±0．32）mm、绝对内径获得为（2．25±0．40）mm,观察组分别为（3．13±0．34）、（2．63±0．47）mm,P均〈0．05;对照组术后随访亚急性支架内血栓发生率为1．54％、晚期支架内血栓发生率为1．85％,观察组分别为0．30％、0．30％,P均〈0．05。对照组术后12个月主要心脏不良事件发生率为6．79％、支架内再狭窄发生率为6．10％、支架最小内径为（2．37±0．38）mm、支架绝对内径丢失为（0．38±0．19）mm、管腔狭窄程度为18．70％±9．28％,观察组分别为2．41％、2．28％、（2．78±0．42）mm、（0．23±0．13）mm、13．50％±8．67％,P均〈0．05。结论冠心病患者DES植入术后行球囊高压后扩张治疗可明显减轻管腔狭窄、减少绝对内径丢失,主要心脏不良事件发生率和支架内再狭窄发生率也明显降低。     

同期植入国产永久涂层支架和生物可吸收涂层支架后1年临床观察

目的　比较国产永久涂层支架（Partner支架）和生物可吸收涂层支架（Excel支架）的疗效。方法　冠心病患者同期接受Partner支架和Excel支架植入,记录术后心绞痛、心肌梗死和支架内血栓发生情况,1年后冠状动脉造影观察血管再狭窄和分支血管开口的变化情况。结果　107例患者共植入Partner支架128枚和Excel支架117枚,支架长度分别为26.4±12.4　mm和28.2±11.5　mm（P>0.05）,支架直径分别为3.035±0.455　mm和3.076±0.432　mm（P>0.05）。经皮冠状动脉介入治疗（PCI）术后无支架内血栓和急性心肌梗死发生。两组1年的再狭窄率分别为8.4%和7.5%（P>0.05）,边支血管开口直径变化无统计学意义（P>0.05）。结论　国产永久涂层支架和生物可吸收涂层支架PCI术后1年冠状动脉造影随访结果相似。     

The effect of paclitaxel-eluting stents on restenosis]

OBJECTIVE: In our study we aimed to investigate the effects of paclitaxel-eluting stent on restenosis. METHODS: Sixteen porcine were randomly assigned to two groups (n=8 per group): control group animals received conventional stent implantation and study group animals -paclitaxel-eluting stent implantation. Both groups were treated with 300 mg acetylsalicylic acid and 75 mg clopidogrel daily. The degree of neointimal proliferation and effect of drug-eluting stent on restenosis were evaluated 6 weeks after by angiography and intravascular ultrasound (IVUS). RESULTS: Angiographic in-stent restenosis was lower in paclitaxel-eluting stent group (12.50 +/- 7.07% versus 41.25 +/- 28.50%, p=0.001). The IVUS data demonstrated that paclitaxel group animals had larger minimal lumen area (8.76 +/- 1.09 mm2 versus 6.23 +/- 3.10 mm2, p=0.028), smaller mean neointimal proliferation area (1.03 +/- 0.75 mm2 versus 3.55 +/- 2.86 mm2, p=0.01) and mean percent stenosis (10.71 +/- 8.10% versus 36.85 +/- 30.93%, p=0.01). CONCLUSION: This study suggests that drug-eluting stents may also have a preventive effect for the in-stent restenosis.     

Polymer-based paclitaxel-eluting stents are superior to nonpolymer-based paclitaxel-eluting stents in the treatment of de novo coronary lesions

Although polymer coating of coronary stents enables sufficient loading and release of incorporated drugs, it has also been associated with potentially negative effects. This study compared the clinical, angiographic, and intravascular ultrasound (IVUS) outcomes of patients treated with polymer- versus nonpolymer-based paclitaxel-eluting stents (PESs). Sixty-five consecutive patients (70 de novo lesions) treated with polymer-based PESs (TAXUS, 1 microg/mm2 of paclitaxel; Boston Scientific Corp.) and 65 consecutive patients (65 de novo lesions) treated with nonpolymer-based PESs (V-Flex Plus, 2.7 microg/mm2 of paclitaxel; Cook, Inc.) were enrolled in the study. Six-month angiographic follow-up was performed on 54 lesions of the polymer-based PES group and 51 lesions of the nonpolymer-based PES group. IVUS at angiographic follow-up was performed in 61 of the first 70 included lesions. At 6-month IVUS follow-up, mean intimal hyperplasia cross-sectional area was 2.36 +/- 1.60 mm2 in the nonpolymer-based PES group versus 0.62 +/- 0.41 mm2 in the polymer-based PES group (p = 0.003). Implantation of polymer-based PESs resulted in significantly lower in-stent late lumen loss (0.22 +/- 0.27 vs 0.74 +/- 0.61 mm, respectively, p <0.001). In-stent binary restenosis rate was 5% versus 20%, respectively (p <0.001). Target lesion revascularization rate was 9% after implantation of polymer-based PES versus 18% (p = 0.128) after implantation of nonpolymer-based PES, and the major adverse cardiac event rate was 9% versus 23%, respectively (p = 0.032). In conclusion, polymer-based PESs result in superior angiographic and IVUS follow-up findings compared with nonpolymer-based PESs.     

Sirolimus- and paclitaxel-eluting stents in comparison with balloon angioplasty for treatment of in-stent restenosis.

This study evaluated the acute and follow-up effectiveness of sirolimus-eluting stents (SESs) and nonpolymer-based paclitaxel-eluting stents (PESs) in comparison will balloon angioplasty for treatment of complex in-stent restenosis (ISR) lesions. Drug-eluting stents have been demonstrated to be highly effective for treatment of de novo lesions. The use of drug-eluting stents for treatment of complex ISR is less well defined. Eighty one lesions with in-stent restenosis (lesion length < 30 mm in a native coronary artery) were treated with either PTCA alone (n = 26 lesions in 25 patients), PES (n = 27 lesions in 24 patients; Achieve, Cook; 3,1 mug paclitaxel/mm(2) nonpolymer-based coating), SES (n = 28 lesions in 28 patients; Cypher, Cordis; 140 mug sirolimus/cm(2) metal surface area). Nine-month MACE rates were 32%, 8%, and 14% (all due to repeated revascularization procedures, except one death in the SES group) in the PTCA, PES, and SES group, respectively. Postintervention minimal lumen diameter in stent was significantly greater in the SES and the PES group in comparison with the PTCA group (2.37 +/- 0.26, 2.54 +/- 0.42, 1.78 +/- 0.23 mm; P < 0.001). At 6-month angiographic follow-up, late loss in stent was 0.77 +/- 0.45, 0.43 +/- 0.53, and 0.29 +/- 0.52 mm for the PTCA, PES, and SES group, respectively (P = 0.005). In-lesion restenosis rate was 61% for the PTCA group, 20% for the PES group, and 13% for the SES group (P = 0.042). The implantation of SES as well as nonpolymer PES proved to be effective for treatment of ISR. The combination of improved acute gain and reduced late loss results in a significantly improved angiographic follow-up result in comparison with PTCA.     

Treatment of lesions with a high risk of stenosis. Comparative study in 300 patients of rapamycin- and Paclitaxel-eluting polymer-based stents, and bare metal stents

INTRODUCTION AND OBJECTIVES: Rapamycin- and taxol-eluting stents have been shown to reduce restenosis, but there are no large-scale studies of their usefulness in lesions with a high risk of restenosis, or of the relative merits of the two devices. This prospective study compared their safety and efficacy in lesions with a high risk of restenosis. PATIENTS AND METHOD: We included consecutive patients with lesions to treat that met at least one of the following criteria: a) in-stent restenosis; b) diffuse (>20 mm) restenosis; c) small vessel (< or =2.5 mm) restenosis; or d) total occlusion. Patients received different devices along three consecutive study periods: bare metal (conventional) stents, sirolimus-eluting (rapamycin) stents and paclitaxel-eluting (taxol) stents. RESULTS: One hundred patients in each group were included, for a total of 300 patients. In the sirolimus group, after 8.5+/-2 months of follow-up, there were 2 late thromboses (2%) and only 1 patient (1%) required target lesion revascularization. In the paclitaxel group 2 patients (2%) had in-hospital stent thrombosis (1 acute, 1 subacute), and after 9+/-2.5 months of follow-up only 1 patient (1%) needed target lesion revascularization. In the conventional group, after 8+/-2 months of follow-up, there was 1 subacute thrombosis (1%) and 15 patients (15%) had clinical restenosis requiring target lesion revascularization. Event-free survival curves were significantly better with drug-eluting stents (P<.01 vs conventional stents). CONCLUSION: Rapamycin- and taxol-eluting stents were safe for lesions with a high risk of restenosis. These stents were associated with a lower rate of target lesion revascularization during follow-up compared to bare metal stents.     

冠心病支架内再狭窄患者血浆脂联素水平的观察

目的 观察冠心病患者支架置入术后再狭窄与血浆脂联素水平之间的关系.方法 对65例支架置入术后9～12个月无支架内再狭窄(A组)和54例存在支架内再狭窄≥50%(B组)的冠心病患者进行研究,复查冠状动脉造影当天取空腹12 h以上的股动脉血,采用ELISA法测定血浆脂联素水平;同时对支架置入前、置入术后即刻及9～12个月后的冠状动脉造影结果进行QCA评价.结果 A、B两组的靶血管病变部位及病变的复杂程度均相似,使用金属裸支架分别为8例(12.31%)和6例(11.11%);使用紫杉醇药物洗脱支架分别为11例(16.92%)和10例(18.52%);使用雷帕霉素药物洗脱支架分别为46例(70.77%)和38例(70.37%),术后用药两组之间无明显差异.A组脂联素水平明显高于B组[(15.16±5.02)mg/L比(10.01±4.93)ms/L,P<0.05];两组的病变长度相似[(15.82±6.67)mm比(13.40±4.20)mm,P>0.05];术前及术后即刻的最小管腔直径(MLD)、狭窄程度两组差异无统计学意义(P>0.05),但9～12个月时的QCA显示:A组的MLD为(2.55±0.53)mm,平均狭窄程度为(24.21±11.23)%,B组的MLD为(0.57±0.60)mm,平均狭窄程度为(81.00±19.11)%,P<0.01;即刻获得的管腔直径两组间比较无统计学意义[(1.48±0.65)mm 比(1.19±0.37)mm,P>0.05];A组的晚期丢失明显小于B组[(0.50±0.34)mm比(1.60±0.54)mm,P<0.01].结论 血浆脂联素水平降低可能是支架术后再狭窄的原因之一.     

Use and long-term outcome of bare metal stent implantation in the drug-eluting stent era

BACKGROUND: Although drug-eluting stents (DES) are widely used today, bare metal stents (BMS) are still frequently employed. We investigated the utilization and clinical outcomes of BMS implantation since we first began using DES. METHODS: The clinical course following percutaneous intervention with de novo implantation of BMS was studied beginning in July 2004, when sirolimus-eluting stents (SES) were first used in our hospital, to August 2006. Outcomes following BMS and SES implantation were compared. RESULTS: BMS implantation was carried out in 160 lesions and SES implantation in 242 lesions. Follow-up coronary angiography was performed for 208 lesions (78 lesions in which BMS were implanted and 130 lesions in which SES were implanted) within 1 year. There were no significant differences in patient characteristics between the SES and BMS groups. Regardless of the reason for BMS implantation, the rates of in-stent restenosis and target lesion revascularization were higher in the BMS group than in the SES group. However, the rate of in-stent restenosis and target lesion revascularization of BMS in lesions with a diameter of 4.0mm or greater was 0%. CONCLUSIONS: In order to reduce the risk of in-stent restenosis and target lesion revascularization, we recommend implantation of BMS with a diameter of 4.0 mm or greater or SES unless it is contraindicated.     

First human experience with angiopeptin-eluting stent: a quantitative coronary angiography and three-dimensional intravascular ultrasound study.

Angiopeptin has been shown to reduce in-stent restenosis in various animal models. Meanwhile, BiodivYsio DD phosphorylcholine (PC)-coated stent provides a platform for local delivery of antiproliferative agents to the coronary artery. We studied the feasibility, safety, and impact on tissue growth of angiopeptin-eluting BiodivYsio DD PC-coated stents in human native de novo coronary lesions. We enrolled 14 patients (16 lesions) who underwent intravascular ultrasound (IVUS)-guided angiopeptin-eluting stent implantation in native coronary arteries between 3.0 and 4.0 mm in diameter with lesion length相似文献   

新型生物可降解聚合物雷帕霉素靶向洗脱支架预防支架内狭窄的动物实验研究

目的:评价新型的生物可降解聚合物雷帕霉素靶向洗脱支架—Firehawk在小型猪冠状动脉模型预防支架内狭窄的疗效。方法:将Firehawk支架(Firehawk组,n=10)和采用永久聚合物涂层雷帕霉素洗脱支架Firebird 2(Firebird 2组,n=8)置入健康小型猪冠状动脉。术后4周时测定两组支架血管段的平均内膜厚度、新生内膜面积、面积狭窄百分比等参数,以比较其内膜增生的情况。结果:术后4周,Firehawk组和Firebird 2组平均内膜厚度分别为(0.15±0.10)mm和(0.14±0.06)mm,新生内膜面积分别为(1.12±0.57)mm2和(1.04±0.36)mm2,面积狭窄百分比分别为(24.58±14.85)%和(26.80±10.64)%,差异均无统计学意义(P均>0.05)。两组均无支架内狭窄发生。结论:Firehawk支架可有效抑制支架置入后4周时的内膜增生,预防冠状动脉实验性支架内狭窄,效果与传统的永久聚合物涂层药物洗脱支架相当。长期效果有待进一步观察。     

雷帕霉素药物洗脱支架对糖尿病小型猪冠状动脉支架置入后内膜增生的影响

目的:评估雷帕霉素药物洗脱支架(SES)对糖尿病小型猪冠状动脉支架置入后内膜增生的作用.方法:建立链脲菌素诱导的糖尿病小型猪模型(糖尿病组,n=12),随机选取2支冠状动脉置入SES,共计置入24枚支架,术后饲养6个月,与非糖尿病置入SES支架的小型猪模型(对照组,n=12)比较冠状动脉造影、血管内超声及组织切片检查结果.结果:两组动物支架置入冠状动脉分布,术前参照血管直径[糖尿病组:(2.78±0.35)mm,对照组:(2.81±0.29)mm]及术后即刻最小管腔内径[糖尿病组:(2.90±0.42)mm,对照组:(2.89±0.33)mm]均相似(P均>0.05).术后6个月糖尿病组支架内狭窄程度[(35.6±9.2)%和(7.9±3.1)%,P<0.001]、支架内晚期管腔丢失[(0.32±0.09)mm和(0.09±0.04)mm,P<0.001]、新生内膜厚度[血管内超声:(0.35±0.12)mm和(0.11±0.08)mm,P<0.05]及新生内膜面积[血管内超声:(1.29±0.51)mm~2和(0.26±0.11)mm~2,P<0.001;组织切片:(1.24±0.76)mm~2和(0.19±0.08)mm~2,P<0.05]均显著高于对照组.结论:糖尿病小型猪冠状动脉置入SES后内膜增生程度显著高于无糖尿病模型.     

Angiographic and intravascular ultrasound predictors of in-stent restenosis

Objectives. This study was performed to determine predictors of in-stent restenosis from a high volume, single-center practice.Background. Intracoronary stents have been shown to reduce the restenosis rate as compared with balloon angioplasty, but in-stent restenosis continues to be an important clinical problem.Methods. Between April 1993 and March 1997, 1,706 patients with 2,343 lesions were treated with a variety of intracoronary stents. The majority of stents were placed with high pressure balloon inflations and intravascular ultrasound (IVUS) guidance. Angiographic follow-up was obtained in 1,173 patients with 1,633 lesions (70%). Clinical, angiographic and IVUS variables were prospectively recorded and analyzed by univariate and multivariate models for the ability to predict the occurrence of in-stent restenosis defined as a diameter stenosis ≥50%.Results. In-stent restenosis was angiographically documented in 282 patients with 409 lesions (25%). The restenosis group had a significantly longer total stent length, smaller reference lumen diameter, smaller final minimal lumen diameter (MLD) by angiography and smaller stent lumen cross-sectional area (CSA) by IVUS. In lesions where IVUS guidance was used, the restenosis rate was 24% as compared with 29% if IVUS was not used (p < 0.05). By multivariate logistic regression analysis, longer total stent length, smaller reference lumen diameter and smaller final MLD were strong predictors of in-stent restenosis. In lesions with IVUS guidance, IVUS stent lumen CSA was a better independent predictor than the angiographic measurements.Conclusions. Achieving an optimal stent lumen CSA by using IVUS guidance during the procedure and minimizing the total stent length may reduce in-stent restenosis.