西罗莫司洗脱支架治疗急性心肌梗死的临床及冠状动脉造影随访观察

目的评价西罗莫司洗脱支架(CypherTM支架)治疗急性心肌梗死的安全性及远期疗效。方法78例急性心肌梗死患者行急诊介入术时接受了CypherTM支架治疗,78处靶病变共置入97枚CypherTM支架。观察手术成功率、并发症、随访期间心脏不良事件发生率、再狭窄率及晚期管腔丢失等。结果在78处靶病变中,完全闭塞病变占82·3%,狭窄达95%以上的病变占17·7%。所有支架均成功置入,无残余狭窄或残余狭窄<10%,未见任何并发症。临床随访10·0±3·6(6~15)个月,临床随访率100%,有2例症状复发,后经冠状动脉造影证实为支架内再狭窄所致,需再次血运重建,其余患者均未发生任何心脏不良事件,无1例死亡。64例患者术后9±2·2(6~14)个月复查了冠状动脉造影,造影随访率82·1%,支架近端边缘节段平均晚期管腔丢失(0·24±0·05)mm;支架内平均晚期管腔丢失(0·19±0·03)mm,支架远端边缘节段平均晚期管腔丢失(0·10±0·02)mm。靶病变再狭窄率为3·1%(2/64),病例复发率为3·1%(2/64),再次血运重建率为3·1%(2/64)。结论CypherTM支架治疗急性心肌梗死是安全可行的,其近期及术后9个月内的疗效是满意的,它能显著降低9个月内的支架内再狭窄率及再次血运重建率。     

雷帕霉素洗脱支架治疗冠状动脉复杂病变的临床及冠状动脉造影随访观察

目的:评价雷帕霉素洗脱支架(CYPHER支架)治疗冠状动脉(冠脉)复杂病变的安全性及疗效。方法:143例复杂病变且有临床缺血症状的患者接受了CYPHER支架治疗,196处靶病变共置入231个CYPHER支架。观察手术成功率、并发症、随访期间心脏不良事件发生率、再狭窄率及晚期管腔丢失情况等。结果:所有支架均成功置入,无残余狭窄或残余狭窄<10%,未见任何并发症。临床随访11±4·4(5~22)个月,临床随访率94%,有7例(5·2%)症状再发,后经冠状动脉造影证实其中4例为支架内再狭窄所致,需再次血运重建,其余患者均未发生任何心脏不良事件,无一例死亡。术后6~18(9±2·3)个月共109例患者复查冠脉造影,造影随访率76·2%,支架近端边缘节段平均晚期管腔丢失(0·22±0·02)mm,支架内平均晚期管腔丢失(0·25±0·04)mm,支架远端边缘节段(0·10±0·02)mm;病变再狭窄率2·6%,病例复发率5·2%,再次血运重建率3·4%。结论:CY-PHER支架治疗冠脉复杂病变安全、有效,能明显降低6个月后的支架内再狭窄率及再次血运重建率。     

载雷帕霉素可降解聚合物涂层支架治疗冠心病的临床观察

目的以Cypher支架为标准,评价载雷帕霉素可降解聚合物涂层支架(EXCEL支架)治疗冠心病(CAD)的安全性和临床效果。方法采用前瞻性、非随机对比研究方法,根据入选和剔除标准入选60例CAD患者,根据所置入支架分为EXCEL组(n=32)和Cypher组(n=28);相同方法进行冠状动脉造影(CAG)和支架置入;以6个月主要不良心脏事件(MACE)、再狭窄率、直径狭窄程度和晚期管腔丢失(LLL)为研究终点评价EXCEL支架治疗CAD的安全性和临床效果。结果平均随访(6.04±2.12)个月,两组MACE发生率均为0;EXCEL组27例(84.38%)和Cypher组10例(35.71%)于术后平均(6.04±2.12)个月接受了定量冠状动脉造影随访。各组再狭窄率均为0;直径再狭窄率分别为(5.98±5.52)%和(5.21±6.3)%,LLL分别为-(0.02±0.09)mm和-(0.01±0.07)mm,上述各项指标差异均无统计学意义(P>0.05)。两组均未发现与雷帕霉素及其聚合物相关的不良反应。结论EXCEL支架治疗CAD安全有效。在降低主要心脏不良事件、预防再狭窄和LLL方面可获得与Cypher支架同样满意的临床效果。     

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。     

雷帕霉素洗脱支架冠状动脉造影随访结果分析

目的通过对接受雷帕霉素洗脱支架(sirolimus-eluting stent,SES)治疗的冠心病患者冠状动脉造影随访,观察其临床实际应用的效果。方法339例患者接受治疗,所有患者均接受了临床随访,165例患者于置入术后6~12个月行冠状动脉造影复查。结果冠状动脉造影随访时,支架近端边缘晚期管腔丢失显著高于支架内及支架远端边缘(0.17 mmvs0.08 mmvs0.09 mm),再狭窄率为9.7%,再血管化率4.84%,再狭窄以局限性狭窄为主。在339例患者中,有4例患者于支架置入后5天~4个月发生猝死。猝死发生率为1.18%。1例于支架置入后14天发生支架内亚急性血栓形成,发生率0.50%。晚期血栓形成1例(术后12个月),主要心血管不良事件为1.70%。结论对复杂的冠状动脉病变SES有较好的疗效,能显著降低支架后再狭窄,减少靶血管的再血管化率。     

冠状动脉内超声评价支架再狭窄

目的探讨冠状动脉内支架再狭窄的机制.方法50例确诊冠心病患者接受65个支架置入术,10个月后复查冠状动脉造影和血管内超声成像检查.根据冠状动脉造影结果将患者分为支架再狭窄组(26个支架)和无支架再狭窄组(39个支架),分别对其冠状动脉造影和血管内超声进行定量测量分析.同时观察支架内再狭窄的方式.结果血管内超声定量测量发现支架再狭窄组最小血管内膜腔面积和支架最小截面积[分别为(2.5±1.2)mm2和(4.2±1.8)mm2]明显小于无支架再狭窄组[分别为(5.2±1.4)mm2和(6.8±1.7)mm2](P分别＜0.001和＜0.01),但两组新生内膜截面积比较差异无显著性[分别为(1.7±1.0)mm2和(1.5±0.9)mm2,P＞O.05].支架内再狭窄以局灶性狭窄为多见(69.2%).结论支架扩张程度是决定支架内再狭窄的重要因素,而支架内内膜增生并不明显.支架内再狭窄以局灶性狭窄为多见.     

支架重建血运治疗上肢动脉狭窄

目的评估支架置入治疗上肢动脉狭窄的安全性及近中期疗效.方法21例23条严重狭窄的上肢动脉经股动脉和(或)肱动脉路径置入支架,并随诊观察手术的疗效.结果支架置入术(PTAS)均获成功(100%),23处病变狭窄程度从术前的(90±6)%降至(4±7)%,病变处血管直径从术前的(0.7±0.5)mm升至(6.7±0.9)mm,有非常显著差异(P均＜0.0001).未发生严重的并发症.术后总显效率85.7%(18/21),有效率14.3%(3/21).术后随访3～29(12.9±7.7)个月,19例患者疗效稳定,2例大动脉炎患者2条动脉再狭窄.结论支架置入治疗上肢动脉狭窄安全,近中期疗效好.     

支架置入治疗主动脉狭窄

目的 :评估经皮支架置入治疗主动脉狭窄的疗效和安全性。方法 :8例患者 ,年龄 14～ 5 2 ( 31± 13)岁 ,均有严重的高血压、主动脉明显狭窄。经股动脉路径置入球囊扩张支架及自膨胀支架各 4例。结果 :8例患者的病变均位于胸主动脉。支架置入技术成功 7例 ,术后狭窄从 ( 83± 12 ) %降至 ( 2 4± 8) % ,狭窄远近端压差从 5 8± 2 6mmHg( 1mmHg =0 133kPa)降至 6± 9mmHg。上肢血压从 181± 30 /94± 2 7mmHg降至 131± 9/74±16mmHg ,降压药从 3± 1种降至 1± 1种 ,踝—肱血压指数则从 0 42± 0 19升至 0 99± 0 12 ,均有极显著性差异 (P均 <0 0 0 1)。随访 8～ 2 7( 18 5± 7 2 )个月 ,疗效维持稳定 ,未发生并发症。结论 :在经选择的主动脉狭窄患者 ,经皮支架置入治疗有效。其远期疗效和支架再狭窄需进一步调查     

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

目的:利用血管内超声(IVUS)方法比较西罗莫司洗脱支架(CypherTM)与紫杉醇洗脱支架(TaxusTM)对冠心病患者新生内膜增生的抑制作用.方法:自2003-05至2007-04,167例冠心病患者(227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IVUS检查.其中107例患者(138处病变)置入CypherTM支架(Cypher组),60例患者(89处病变)置入TaxusTM支架(Taxus组).结果:两组患者基础临床情况及病变特征相似.造影结果分析显示,Cypher组支架内晚期管腔丢失、节段内晚期管腔丢失明显小于Taxos组[分别为(0.16±0.27)mm比(0.43±0.51)mm,P<0.01;和(0.20±0.32)mm比(0.38±0.33)mm,P=0.01],而两组近端和远端参考血管晚期管腔丢失差异无统计学意义[分别为(0.13±0.29)mm比(0.15±0.32)mm,P=0.689;和(0.08±0.12)mm比(0.09±0.16)mm,P=00500].IVUS分析显示,两组平均支架面积、平均管腔面积、最小支架面积、平均支架体积、平均管腔体积差异均无统计学意义,而Cypher组与Taxus组比平均内膜增生面积[(0.33±0.45)mm2比(1.29±1.26)mm2]、平均内膜增生面积百分数[(5.42±7.33)%比(17.38±13.75)%]、内膜增生最大面积百分数[(10.13±13.85)%比(31.56±20.99)%]、平均内膜增生容积[(2.23±6.50)mm3比(13.43±18.59)mm3]和平均内膜增生容积百分数[(1.59±4.10)%比(8.62±9.90)%],Cypher组均较Taxus组明显减小(P<0.0001),差异均有统计学意义.结论:CypherTM支架治疗冠心病一年再狭窄发生率较低,与TzxusTM支架相比,抑制内膜增生作用更显著.     

西罗莫司和紫杉醇洗脱支架治疗支架内再狭窄的临床近期及10个月疗效

目的比较西罗莫司洗脱支架（Cypher或Cypher select）和紫杉醇洗脱支架（TAXUS）治疗支架内再狭窄的临床近期及10个月疗效。方法自2002年12月至2005年3月,对253例支架内再狭窄的患者采用了药物洗脱支架（DES）治疗并完成了10个月的临床随访和冠状动脉造影复查。253例中男性218例,女性35例,年龄30～80岁,平均年龄57．2岁。结果253例（262处病变）中152例使用Cypher支架176个,101例使用TAXUS支架132个。使用的Cypher和TAXUS支架的平均直径分别为（2．96±0．27）mm和（3．05±0,35）mm,P=0．04,平均长度分别为（23.31±6．68）mm和（23．56±6．54）mm,P=0．745。支架内再狭窄表现为100％闭塞29处,≥90％狭窄143处,〈90％狭窄90处。病变类型为A、B1、B2和C型各为9处、45处、73处和135处。PCI的成功率两组均为100％,住院期间无死亡,Cypher组主要心脏不良事件（MACE）发生率为2．63％,TAXUS组为2．97％,P=0．872。10个月临床造影显示在Cypher支架和TAXUS支架组中造影再狭窄率分别为14．0％和29．4％,P=0．075,MACE发生率分别为6．7％和16．0％,P=0．031。结论应用Cypher和TAXUS支架治疗支架内再狭窄有良好的近期临床疗效,10个月疗效Cypher支架优于TAXUS支架。     

Angiographic and intravascular ultrasound findings of the late catch-up phenomenon after intracoronary beta-radiation for the treatment of in-stent restenosis

We report one-year angiographic and intravascular ultrasound (IVUS) outcomes of in-stent restenosis (ISR) patients treated with intravascular brachytherapy (IVBT). The benefit of IVBT for treating ISR is well documented. However, few data exist on significant angiographic and intravascular ultrasonic in-stent lumen deterioration beyond the habitual 6-month analysis after the index radiation procedure or so-called late catch-up process in the treatment of ISR. Twenty-five consecutive patients with ISR were treated with IVBT using the Beta-Cath System (a 40 mm 90 Sr per 90 gamma source). Quantitative angiographic and IVUS analysis was performed in all of them at 6 and 12 months. IVBT was successful in all patients. Four patients (16%) developed recurrent angiographic binary restenosis at 6-month follow-up, all located within the adjacent reference segments, with 2 being associated with geographical miss. An additional 4 patients (16%) presented with recurrent ISR at 12-month follow-up, all within the stented segment. Significant in-stent lumen loss (0.16 +/- 0.42 mm to 0.34 +/- 0.46 mm; p = 0.008) and in-stent intimal hyperplasia growth (+11.2 +/- 0.48 mm3; p = 0.03) was observed between 6 and 12 months. Intracoronary beta-radiation for the treatment of ISR was associated with significant luminal deterioration (late catch-up) within the stents between 6 and 12 months due to an important late progression of in-stent intimal hyperplasia.     

Mechanisms of acute lumen gain and recurrent restenosis after rotational atherectomy of diffuse in-stent restenosis: a quantitative angiographic and intravascular ultrasound study.

OBJECTIVES: This quantitative angiographic and intravascular ultrasound study determined the mechanisms of acute lumen enlargement and recurrent restenosis after rotational atherectomy (RA) with adjunct percutaneous transluminal coronary angioplasty in the treatment of diffuse in-stent restenosis (ISR). BACKGROUND: In-stent restenosis remains a significant clinical problem for which optimal treatment is under debate. Rotational atherectomy has become an alternative therapeutic approach for the treatment of diffuse ISR based on the concept of "tissue-debulking." METHODS: Rotational atherectomy with adjunct angioplasty of ISR was used in 45 patients with diffuse lesions. Quantitative coronary angiographic (QCA) analysis and sequential intravascular ultrasound (IVUS) measurements were performed in all patients. Forty patients (89%) underwent angiographic six-month follow-up. RESULTS: Rotational atherectomy lead to a decrease in maximal area of stenosis from 80+/-32% before intervention to 54+/-21% after RA (p < 0.0001) as a result of a significant decrease in intimal hyperplasia cross-sectional area (CSA). The minimal lumen diameter after RA remained 15+/-4% smaller than the burr diameter used, indicating acute neointimal recoil. Additional angioplasty led to a further decrease in area of stenosis to 38+/-12% due to a significant increase in stent CSA. At six-month angiographic follow-up, recurrent restenosis rate was 45%. Lesion and stent length, preinterventional diameter stenosis and amount of acute neointimal recoil were associated with a higher rate of recurrent restenosis. CONCLUSIONS: Rotational atherectomy of ISR leads to acute lumen gain by effective plaque removal. Adjunct angioplasty results in additional lumen gain by further stent expansion and tissue extrusion. Stent and lesion length, severity of ISR and acute neointimal recoil are predictors of recurrent restenosis.     

Sirolimus-eluting stent for treatment of complex in-stent restenosis: the first clinical experience

OBJECTIVES: In this study, we assess the value of sirolimus eluting stent (SES) implantation in patients with complex in-stent restenosis (ISR). BACKGROUND: The treatment of ISR remains a therapeutic challenge, since many pharmacological and mechanical approaches have shown disappointing results. The SESs have been reported to be effective in de-novo coronary lesions. METHODS: Sixteen patients with severe, recurrent ISR in a native coronary artery (average lesion length 18.4 mm) and objective evidence of ischemia were included. They received one or more 18 mm Bx VELOCITY SESs (Cordis Waterloo, Belgium). Quantitative angiographic and three-dimensional intravascular ultrasound (IVUS) follow-up was performed at four months, and clinical follow-up at nine months. RESULTS: The SES implantation (n = 26) was successful in all 16 patients. Four patients had recurrent restenosis following brachytherapy, and three patients had totally occluded vessels preprocedure. At four months follow-up, one patient had died and three patients had angiographic evidence of restenosis (one in-stent and two in-lesion). In-stent late lumen loss averaged 0.21 mm and the volume obstruction of the stent by IVUS was 1.1%. At nine months clinical follow-up, three patients had experienced four major adverse cardiac events (two deaths and one acute myocardial infarction necessitating repeat target vessel angioplasty). CONCLUSIONS: The SES implantation in patients with severe ISR lesions effectively prevents neointima formation and recurrent restenosis at four months angiographic follow-up.     

Intravascular ultrasound evaluation after sirolimus eluting stent implantation for de novo and in-stent restenosis lesions.

AIMS: The aim of this study is to compare the efficacy of sirolimus-eluting stents (SES) on neointimal growth and vessel remodelling for in-stent restenosis versus de novo coronary artery lesions using serial intravascular ultrasound (IVUS). METHODS AND RESULTS: The study population consisted of 86 patients with in-stent restenosis (ISR) (n=41) or de novo lesions (n=45) treated with SES and evaluated by IVUS post-procedure and at follow-up. One 18-mm SES was used for de novo lesions while 16 patients with ISR received >1SES (total stented length 17.9 mm vs 22.0 mm respectively; P=0.004). At follow-up, no differences were observed between the ISR and de novo groups with respect to changes in the mean external elastic membrane (1.7% vs 1.3%; P=0.53), plaque behind the stent (1.2% vs 3.4%; P=0.49), and lumen areas (0.7% vs 1.9%; P=0.58). No positive remodelling or edge effect was observed. A gap between stents was observed in two patients with ISR, where more prominent, though non-obstructive, neointimal proliferation was noted. CONCLUSION: Sirolimus-eluting stenting is equally effective at inhibiting neointimal proliferation in de novo and ISR lesions without inducing edge restenosis or positive vascular remodelling.     

Use of Taxus polymer-coated paclitaxel-eluting stents for treatment of in-stent restenosis in real world patients: results of clinical and angiographic follow-up at six months in a single-center registry.

OBJECTIVE: To evaluate the safety and efficacy of Taxus paclitaxel-eluting stents in a real world group of unselected patients with coronary in-stent restenosis (ISR) lesions. METHODS: This is a prospective single-center registry of a consecutive series of 94 patients with 104 ISR lesions, without previous brachytherapy, over a period of 1 year. Quantitative coronary angiographic analyses were performed at baseline and at 6-month angiographic follow-up. Clinical follow-up were obtained at 6 months. RESULTS: Pre-intervention mean reference vessel diameter was 2.62 +/- 0.50 mm and mean lesion length was 13.95 +/- 6.78 mm. Baseline ISR patterns were mostly either Type I focal (32.7%) or Type II diffuse intrastent (48.1%). At 6-month angiographic follow-up, the in-stent and in-segment binary restenosis was 3.8% (4/105) and 7.6% (8/105) respectively, and the in-stent and in-segment late loss was 0.30 +/- 0.50 mm and 0.57 +/- 0.54 mm, respectively. Seven of these eight restenosed lesions had a diffuse or proliferative ISR pattern prior to intervention. Lesions that restenosed had longer mean stent length per lesion (37.3 mm vs. 22.5 mm in nonrestenosed group; P = 0.001) and more likely to have had a pattern of total occlusion pre-intervention (25.0% vs. 3.1% in nonrestenosed group; P = 0.046). At 6-month clinical follow-up, the MACE rate was 8.5% and target lesion revascularization rate was 7.4%. There was no death but subacute stent thrombosis occurred in 1 patient (1.1%) at 3 days after intervention. CONCLUSIONS: Paclitaxel-eluting Taxus stent for the treatment of ISR effectively suppresses recurrent neointimal proliferation, and was safe and efficacious at 6-month follow-up.     

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.     

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   

Sirolimus-eluting stent in chronic total occlusion: the SICTO study

Coronary stenting can significantly reduce the restenosis and reocclusion rates after successful balloon angioplasty for chronic total occlusions (CTO). Nevertheless, recanalization of CTO remains among the worst predictors for in-stent restenosis and reocclusion. This multicenter, nonrandomized study assessed the safety and effectiveness of the CYPHER sirolimus-eluting stent in reducing angiographic in-stent late loss in totally occluded native coronary arteries. A total of 25 eligible patients were treated with the CYPHER sirolimus-eluting stent. Baseline clinical and angiographic data were collected and 6-month follow-up angiography and intravascular ultrasound (IVUS) were performed. Clinical follow-up was required at 30 days, 6, 12, 18, and 24 months. Study stent implantation was successful in all patients, with a mean stent length of 28.4 +/- 11 mm. Six-month angiographic outcomes showed that mean lumen diameter stenosis did not change (2.22 +/- 0.56 mm postprocedure; 2.26 +/- 0.60 mm at 6 months follow-up; P = NS). Similarly, mean percent diameter stenosis did not change significantly (15.7 +/- 8.6% postprocedure, 19.3 +/- 11% at follow-up; P = NS). The absolute late lumen loss was -0.03 +/- 0.28 mm with a 6-month in-stent restenosis rate of 0%. IVUS follow-up revealed in-stent obstruction volume of only 4.9 +/- 6.8%. Long-term clinical follow-up showed target lesion revascularization at 12 months was only 4%, with target vessel revascularization of only 12%. The CYPHER sirolimus-eluting stent was safe and effective in the treatment of CTO compared to historical data with bare metal stents.     

Lack of neointimal proliferation after implantation of sirolimus-coated stents in human coronary arteries: a quantitative coronary angiography and three-dimensional intravascular ultrasound study

BACKGROUND: Restenosis remains an important limitation of interventional cardiology. Therefore, we aimed to determine the safety and efficacy of sirolimus (a cell-cycle inhibitor)-coated BX Velocity stents. METHODS AND RESULTS: Thirty patients with angina pectoris were electively treated with 2 different formulations of sirolimus-coated stents (slow release [SR], n=15, and fast release [FR], n=15). All stents were successfully delivered, and patients were discharged without clinical complications. Independent core laboratories analyzed angiographic and 3D volumetric intravascular ultrasound data (immediately after procedure and at 4-month follow-up). Eight-month clinical follow-up was obtained for all patients. There was minimal neointimal hyperplasia in both groups (11.0+/-3.0% in the SR group and 10.4+/-3.0% in the FR group, P:=NS) by ultrasound and quantitative coronary angiography (in-stent late loss, 0.09+/-0.3 mm [SR] and -0.02+/-0.3 mm [FR]; in-lesion late loss, 0.16+/-0.3 mm [SR] and -0.1+/-0.3 mm [FR]). No in-stent or edge restenosis (diameter stenosis >or=50%) was observed. No major clinical events (stent thrombosis, repeat revascularization, myocardial infarction, or death) had occurred by 8 months. CONCLUSIONS: The implantation of sirolimus-coated BX Velocity stents is feasible and safe and elicits minimal neointimal proliferation. Additional placebo-controlled trials are required to confirm these promising results.     

Intracoronary brachytherapy with beta-radiation for the treatment of long diffuse in-stent restenosis

OBJECTIVE: To assess the efficacy of intracoronary brachytherapy with beta-radiation (Sr/Y) for the treatment of long diffuse in-stent restenosis (ISR). METHODS: As recurrent ISR depends on intimal injury after coronary angioplasty, long in-stent restenotic lesions were defined as lesions with a treatment length >26 mm (lesion length >20 mm plus a treatment margin of 3 mm at each end). Seventy-eight patients with long ISR were treated at our institution with beta-brachytherapy after coronary angioplasty. Patients were irradiated with either an approximate dose of 12 Gy at 1 mm vessel wall depth or with 18 Gy at 1 mm vessel wall depth. Clinical follow-up was available for 69 patients and angiographic follow-up for 65 patients. Late lumen loss (LLL), binary restenosis (stenosis >50%), target lesion revascularization (TLR) and major adverse cardiac events (MACE) were assessed for a follow-up time of 6.6+/-2.2 months. RESULTS: Mean interventional treatment length was 46+/-18 mm. TLR was performed in all 23 patients with binary restenosis (33%). Death of cardiac cause was reported for two patients, one of whom did not undergo TLR. Thus, overall MACE rate was 35%. Recurrent ISR was significantly more frequent in patients with geographic miss. Comparison of the different radiation dose regimens revealed significantly lower LLL in patients irradiated with the higher dose (0.20+/-0.68 mm compared with 0.65+/-0.96 mm, P=0.03). CONCLUSION: Intracoronary brachytherapy with beta-radiation (Sr/Y) is a safe and effective therapeutic option for the reduction of recurrent ISR in long diffuse lesions. We recommend a high-dose irradiation with 18 Gy at 1 mm vessel wall depth.