Safety and efficacy of the Yukon Choice Flex sirolimus-eluting coronary stent in an all-comers population cohort

Aims

The use of biodegradable-polymer drug-eluting stents has been shown to provide favorable results when compared with durable polymer drug-eluting stents and long-term follow up data have recently shown significant reductions in terms of very late stent thrombosis.Aim of the present study was to assess the safety and efficacy profile of a novel biodegradable polymer DES, the Yukon Choice Flex sirolimus-eluting stent.

Methods

We report here the one-year clinical outcomes associated with the use of the Yukon Choice Flex sirolimus-eluting stent in an all-comers patient population. The present stent represents a further refinement of the stent platform tested in the ISAR TEST 3 and 4 randomized clinical trials. A total of 778 consecutive patients undergoing implantation of this stent were enrolled in the present observational study and prospectively followed for one year.

Results

The use of the Yukon Choice Flex stent in a patient population with complex coronary lesion morphology was associated with optimal immediate angiographic results. At one year follow up the rates of death, myocardial infarction, definite stent thrombosis and ischemia-driven target lesion revascularization were respectively 2.4%, 1.9%, 0.3% and 11.3%.

Conclusions

The use of the sirolimus-eluting biodegradable polymer Yukon Choice Flex stent in an all-comers population of patients with complex coronary artery disease is associated with a favorable safety and efficacy profile up to one year follow up.     

Treatment of in-stent restenosis with sirolimus-eluting-stents: results from the prospective German Cypher stent registry

Aims  Drug-eluting stents have been reported to effectively reduce in-stent restenosis (ISR). However, the effectiveness and safety have yet been investigated only in small trials or case series. The aim of this prospective large scale registry was to show that treatment of ISR with sirolimus eluting stents (SES) is safe, effective and feasible in daily routine. Methods and results  The German Cypher registry prospectively enrolled 6,555 patients undergoing implantation with SES for various indications, including 1,533 patients treated for ISR. Follow-up data (median 6.6 months) of this cohort was available for 1,531 patients (99.8%). Of these patients 75.8% were male. Of these patients 36.5% (n = 552) presented with acute coronary syndromes. In total, 1,932 SES were used with successful implantation in 98.9%. MI during hospitalization was observed in 0.7% (n = 11) while in-hospital mortality was only 0.1% (n = 2). MACE-rate at follow-up was 13.8% (n = 211) including a mortality of 1.3% (n = 20) and MI in 1.9% (n = 29). Total revascularization procedures including CABG (1.7%) were necessary in 12.3% (n = 186). Target vessel revascularization (TVR) rate was 9.3% (n = 139) and thus similar to patients with de novo lesions (8.1%, P = 0.69). Ten patients (0.65%) suffered from subacute stent thrombosis Vs. 0.24% observed in patients with de novo lesions (P = 0.03). Conclusion  This large registry confirms that treatment of ISR with sirolimus-eluting-stents is effective and save with good clinical results at index procedure and follow-up. TVR was not different from de novo lesions.     

多支架植入治疗恶性高位梗阻性黄疸

目的:评价高位恶性梗阻性黄疸多支架治疗的疗效及临床价值。材料与方法:26例高位恶性梗阻性黄疸。经单侧穿刺放置2枚支架18例,双侧穿刺放置支架8例,其中5例放置2枚支架,3例放置3枚支架,共植入支架51枚。结果:所有病例均一次完成支架植入,技术成功率100%。治疗后总胆红素由318.5±67.7μmol/L降至142.6±49.3μmol/L,无严重并发症发生。结论:多支架植入有利于提高高位恶性梗阻性黄疸的减黄效果,有利于进一步提高病人的生存质量和延长生存期。     

Restenosis of a drug eluting stent on the previous bioresorbable vascular scaffold successfully treated with a drug-coated balloon: A case report

BACKGROUNDThe in-stent restenosis (ISR) rates are reportedly inconsistent despite the increased use of second-generation drug eluting stent (DES). Although bioresorbable vascular scaffold (BVS) have substantial advantages with respect to vascular restoration, the rate of scaffold thrombosis is higher with BVS than with DES. Optimal treatment strategies have not been established for DES-ISR to date.CASE SUMMARYWe report on a case of a 60-year-old man patient with acute coronary syndrome. He had a history of ST-segment elevation myocardial infarction associated with very late scaffold thrombosis and treated with a DES. Coronary angiography revealed significant stenosis, suggesting DES-ISR on the previous BVS. Optical coherence tomography (OCT) identified a plaque rupture and a disrupted scaffold strut in the neointimal proliferation of DES. To treat the DES-ISR on the previous BVS, we opted for a drug-coated balloon (DCB) after a balloon angioplasty using a semi-compliant and non-compliant balloon. The patient did not experience adverse cardiovascular events on using a DCB following the use of intensive dual antiplatelet therapy and statin for 24 mo. CONCLUSIONThis case highlights the importance of OCT as an imaging modality for characterizing the mechanism of target lesion failure. The use of a DCB following the administration of optimal pharmacologic therapy may be an optimal strategy for the treatment and prevention of recurrent BVS thrombosis and DES-ISR.     

FX miniRAIL球囊成形术治疗冠状动脉支架内再狭窄

目的 :采用血管腔内超声 (IVUS)研究经皮冠状动脉 (冠脉 )内FXminiRAILTM球囊成形术 (FXBA)治疗冠脉支架内再狭窄 (ISR)的疗效及其安全性。方法 :冠脉内支架植入术后单支ISR >70 %的病人 171例 (男性 12 4例 ,女性 4 7例 ,年龄 6 1± 11岁 ) ,分为FXBA组 (n =10 6 )和普通球囊成形术 (PTCA)组 (n =6 5 )。所有病例术前、术后即刻以及术后随访期行定量冠脉造影 (QCA)及IVUS。QCA分析病变长度 ,最小管腔直径 (MLD) ,参照管腔直径 (RLD)和管腔直径狭窄百分比 (DS) ;IVUS分析血管总横截面积 (TVA) ,外弹力膜内横截面积 (EEMA) ,支架横截面积 (SA) ,最小管腔横截面积 (MLA) ,支架内的再狭窄面积(RA)。随访靶血管再次成形率 (TVR)和主要不良心血管事件 (MACE)发生率。结果 :FXBA治疗ISR和PTCA一样易于操作 ,两组的操作成功率均为 10 0 %。IVUS显示FXBA组治疗ISR后即刻管腔面积的获得大于PTCA组 (5 .4 3± 0 .6 3mm2 对4 .92± 0 .4 6mm2 ,P <0 .0 5 ) ,而随访期 (平均随访时间 5 .4± 1.6个月 )管腔面积的丢失则小于PTCA组 (0 .5 1± 0 .2 1mm2 对0 .91± 0 .2 3mm2 ,P <0 .0 5 ) ;两组术后即刻SA均较术前增加。随访期FXBA组的ISR复发率 (2 1.1%± 7.6 % )明显低于PT CA组 (38.3%± 4 .3% ) ,P <0 .0 0 1;FXBA     

经桡动脉冠状动脉介入治疗老年冠心病患者的临床观察

目的:评价经桡动脉行冠状动脉介入(PCI)治疗老年冠心病患者的临床疗效及安全性。方法:选择256例老年(年龄≥70岁)冠心病患者,分为桡动脉组(164例)和股动脉组(92例),比较2组临床基线、PCI成功率、造影剂用量、手术时间及并发症的发生率。结果:桡动脉组手术成功率为98.2%。股动脉组手术成功率为98.9%,2组手术时间和造影剂用量比较,差异无统计学意义,桡动脉组4例出现血管并发症,股动脉组9例出现并发症,2组比较有统计学意义,桡动脉组和股动脉组患者术后6个月时严重心脏不良事件发生率比较,差异无统计学意义。结论:经桡动脉冠状动脉介入治疗老年冠心病患者是安全有效的治疗方法。     

载有匹伐他汀的纳米涂层支架的研究

目的探讨新型载有他汀药物的纳米涂层支架的有效性及安全性。方法选用生物可吸收性高分子聚合物聚乳酸-羧基乙酸共聚体(PLGA)为原料制作纳米粒子,并用自行研发的阳离子电镀涂层技术将载有荧光标记物异硫氰酸荧光素(FITC)的PLGA纳米粒子均匀涂层于支架表面。先在体外培养人冠状动脉平滑肌细胞及人脐带静脉内皮细胞,比较研究他汀类药物、雷帕霉素和紫杉醇对平滑肌细胞和内皮细胞增殖能力的影响。同时,选择猪作为实验动物行冠状动脉支架植入术,观察载有他汀的纳米涂层支架对内膜增生及内皮再生的影响。结果体外实验发现,在24 h内FITC从纳米粒子内释放出约40%,在30 d后完全释放。FITC纳米粒子56 d以后从涂层支架完全释放。与其他他汀类药物相比,匹伐他汀对平滑肌细胞增殖有明显的抑制作用(P<0.001),并对内皮细胞再生有促进作用(p<0.05)。尽管雷帕霉素和紫杉醇也都能抑制平滑肌细胞的增殖,但匹伐他汀可在最低浓度(0.01μmol/L)即可达到抑制效果(P<0.05)。匹伐他汀纳米粒子涂层支架组与非药物涂层支架组相比内膜增生明显减少(P<0.01)。与雷帕霉素支架组相比,匹伐他汀纳米粒子涂层支架组的内膜增生程度相近(P>0.05),且炎症、纤维沉积及内皮再生延迟作用均明显减少(P值均<0.01)。结论成功开发载有匹伐他汀纳米粒子涂层支架,初步结果显示该支架既可抑制支架内再狭窄,也可减少支架内血栓形成。     

应变率成像评价冠心病患者支架置入术后局部心肌功能的临床价值

目的 探讨应变率成像(SRI)技术评价冠心病患者冠状动脉支架置入术后局部心肌功能的临床价值.方法 应用应变率成像技术测定28例冠心病患者冠状动脉支架置入术前、术后(20±5)d及20例正常人左室壁各节段收缩期、收缩期后及舒张早期的纵向峰值应变率SRS、SRPSS、SRE,计算收缩期后收缩波(PSS)发生率及SRPSS/SRS比值.结果 与正常对照组相比,冠心病组缺血节段的SRS和SRE显著降低(P<0.01),PSS发生率,SRPSS和SRPSS/SRS显著增高(P<0.05).冠心病组缺血节段支架置入术前、术后PSS发生率,SRPSS、SRS和SRE的改变均无统计学意义(P>0.05),而SRPSS/SRS术后较术前显著减低(JP<0.01).结论 SRPSS/SRS比SRS、SRE、SRPSS更能敏感地评价支架置入术后局部心肌功能改善状况.     

Budd-Chiari综合征合并下腔静脉长节段血栓及上消化道出血的介入治疗

目的探讨Budd-Chiari综合征(BCS)合并下腔静脉长节段血栓及上消化道出血的介入治疗方法,评价下腔静脉多支架顺序置入固定血栓+下腔静脉成形术+肝静脉成形术的治疗价值。资料与方法搜集2009年1月至2011年3月6例BCS合并下腔静脉长节段血栓及上消化道出血患者。上消化道出血控制稳定1周后,均以如下介入方法治疗:下腔静脉多支架顺序置入固定血栓+下腔静脉成形术+必要时肝静脉成形术。术后予以抗凝并随访。结果 6例患者以下腔静脉多支架顺序置入压迫血栓+下腔静脉成形术+必要时肝静脉成形术治疗,均获成功。近中期临床疗效明显。主要并发症为无症状性肺栓塞,共2例。无手术致死病例。结论下腔静脉多支架顺序置入固定血栓+下腔静脉成形术+肝静脉成形术,对治疗BCS合并下腔静脉长节段血栓及上消化道出血是安全、有效的,可以作为BCS伴下腔静脉长节段血栓及上消化道出血的治疗选择。