药物洗脱支架治疗支架内再狭窄

20世纪初,随着以Cypher(Cordis公司, Johnson & Johnson)和TAXUS为代表的药物洗脱支架应用于临床,在降低再狭窄发生率和改善冠心病介入治疗预后上取得了显著的进展,被誉为冠心病介入治疗史上的第三个里程碑[1,2],但是,药物洗脱支架在高危复杂病变中的疗效尚有待进一步证实.本研究旨在评价雷帕霉素药物洗脱支架(SES)在支架内再狭窄(ISR)治疗中的价值.     

药物洗脱支架置入后再狭窄

尽管药物涂层支架较金属裸支架可以明显降低再狭窄率,但随着临床中的广泛应用,药物支架术后亦有10%发生支架内再狭窄,具体机制不明,主要与介入手术操作和涂层药物、支架本身等有关,多发生支架内局限性狭窄,亦有弥漫病变,最佳治疗手段尚存在争议,再次药物支架置入及血管内放射治疗等都是不错的选择。     

紫杉醇药物洗脱球囊与西罗莫司药物洗脱支架治疗再狭窄的比较

目的:本研究旨在对中国人群中紫杉醇药物洗脱球囊(PEB)和西罗莫司洗脱支架(SES)治疗支架内再狭窄(ISR)的有效性进行比较。方法:连续入选2014年9月至2015年6月,经冠状动脉造影确诊ISR并接受PEB或SES治疗的患者,根据所接受的治疗策略将患者分别纳入PEB组和SES组。观察两组患者住院期间主要不良心血管事件(MACE)发生率,术后12个月进行电话或门诊随访了解两组MACE发生情况。结果:共纳入患者166例,其中PEB组63例,SES组103例;两组中药物洗脱支架再狭窄(DES-ISR)患者116例,包括PEB组44例和SES组72例;根据Mehran分型,点状病变患者33例,非点状病变患者133例。住院期间两组患者均未发生MACE。(13±2)个月临床随访发现,PEB组共发生MACE 6例,包括非致死性心肌梗死(MI)2例和靶血管血运重建(TVR)5例;SES组MACE 9例,包括全因死亡3例和TVR 7例;两组间MACE发生率差异无统计学意义(9.7%vs.9.2%,P=0.92)。两组间的全因死亡、非致死性心肌梗死、靶病变血运重建和靶血管血运重建发生率均差异无统计学意义(P0.05)。DES-ISR患者中,PEB组和SES组的MACE发生率差异无统计学意义(7.0%vs.10.3%,P=0.74)。而在点状病变和非点状病变患者中,两组间MACE发生率均差异无统计学意义(P0.05)。结论:中国人群中紫杉醇药物洗脱球囊与西罗莫司药物洗脱支架,治疗支架内再狭窄的有效性差异无统计学意义,且在DES-ISR、点状病变和非点状病变患者中两种治疗方式也无明显差异。     

药物洗脱支架内再狭窄研究进展

药物洗脱支架大幅度减少了支架内再狭窄的发生率,然而随着药物洗脱支架的广泛应用,再狭窄患者的绝对数量是一个不容忽视的庞大数字。再狭窄的临床表现常常是再发心绞痛,但是有些患者表现为急性心肌梗死。再狭窄的发生可能和生物因素、机械因素、技术因素有关。再狭窄的类型主要是局限性的。     

药物洗脱球囊治疗支架内再狭窄的研究进展

正经皮冠状动脉介入治疗(percutaneous coronary intervention,PCI)经历了30年的发展历程,而减少术后再狭窄一直是人们努力的方向。单纯经皮冠状动脉腔内成形术(percutaneous transluminal coronary angioplasty,PTCA)再狭窄高达39%~67%[1],裸金属支架(bare-metal stent,BMS)置入术后再狭窄可达5%~35%[2],药物洗脱支架(drug-eluting stent,DES)置入术后再狭窄仍达5%~10%[3]。近些年来出现了预防介入治疗术后血管再狭窄的新技术—药物洗脱球囊     

药物洗脱支架置入治疗不同时期冠状动脉支架内再狭窄对比研究

目的 比较药物洗脱支架(DES)治疗早期(≤1年)、晚期(＞1年)支架内再狭窄病变(ISR)患者的长期临床疗效。方法 收集2008年10月至2011年12月在北京安贞医院因ISR接受DES置入治疗并完成临床随访的患者资料,根据DES术后发生ISR的时间是否大于1年分为早期ISR组与晚期组。比较两组组患者术后1年的主要不良心血管事件［MACE,包括全因死亡、心肌梗死(MI)和靶病变再次血运重建(TLR)］。结果 早期ISR组入选患者80例,晚期ISR组入选患者124例。早期ISR组不稳定型心绞痛发生率明显低于晚期ISR组,差异有统计学意义(27.5%对63.7%,P<0.01);其余基线资料差异无统计学意义(P>0.05)。两组在病变部位、病变类型、病变长度方面比较差异均无统计学意义(P>0.05)。早期ISR组MACE发生率明显高于晚期ISR组(30%对15.3%,P<0.01),其中早期ISR组TLR明显高于晚期ISR组,差异有统计学意义(26.3%对12.1%,P<0.01)。结论 DES治疗ISR患者安全有效,但治疗早期ISR组病变TLR发生率高于晚期ISR组。     

冠状动脉药物洗脱支架内再狭窄的最新研究进展

药物洗脱支架（DES）的诞生和不断优化已经大大提高了经皮冠状动脉介入治疗（PCI）的安全性和有效性,但随着病例复杂性的增加和DES的超适应证应用,术后再狭窄率正逐年上升。因此,当前DES时代下,支架内再狭窄（ISR）仍是临床上亟待解决的一大难题。本文将主要就DES置入后ISR发生发展的病理机制、组织病理学及治疗策略的最新研究成果及进展进行综述。     

药物洗脱支架与支架内再狭窄

随着药物洗脱支架(Drug Eluting Stent, DES)的出现,再狭窄的问题得到进一步的有效控制,目前的临床证据表明DES总的再狭窄率已经在10%以下.但DES的支架内再狭窄ISR仍是临床介入治疗面临的重要问题.     

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.     

雷公藤内酯醇洗脱支架与雷帕霉素洗脱支架对冠状动脉支架内再狭窄作用的对比研究

目的 比较雷公藤内酯醇洗脱支架与西罗莫司（sirolimus,雷帕霉素）洗脱支架预防冠状动脉支架植入术后再狭窄的作用.方法 选用杂种幼猪30只,随机分成裸支架组、雷公藤内酯醇洗脱支架组和西罗莫司洗脱支架组,每组各植入支架10枚.术后28 d,进行冠状动脉造影、组织病理检查以及免疫组化检测血管平滑肌细胞中增殖细胞核抗原（proliferating cell nuclear antigen,PCNA）.结果 雷公藤内酯醇洗脱支架组与西罗莫司洗脱支架组支架内最小内径相似（P＞0.05）,均大于裸支架组（P＜0.01）;雷公藤内酯醇洗脱支架组新生内膜面积与西罗莫司洗脱支架组相似（P＞0.05）,均小于裸支架组（P＜0.01）.雷公藤内酯醇洗脱支架组与西罗莫司洗脱支架组的PCNA阳性细胞数相似（P＞0.05）,均少于裸支架组（P＜0.01）.结论 雷公藤内酯醇洗脱支架能抑制平滑肌细胞增殖,其预防冠状动脉支架内再狭窄的作用与西罗莫司洗脱支架相似.     

Everolimus-eluting versus paclitaxel-eluting stents for treatment of bare metal stent restenosis

First-generation drug-eluting stents have been proved to be very effective for the treatment of bare metal stent in-stent restenosis (BMS ISR). The efficacy of second-generation drug-eluting stents in this setting remains less well defined. The present study compared the long-term clinical outcome after treatment of BMS ISR using the second-generation everolimus-eluting stent (EES) to that after treatment using the paclitaxel-eluting stent (PES). A total of 174 patients with BMS ISR underwent percutaneous coronary intervention using a PES (95 patients) or an EES (79 patients) from 2003 to 2010. The patients in the PES and EES groups were followed up for 42.2 ± 22.2 and 18.3 ± 8.2 months, respectively. The primary end point of the study was survival free of major adverse cardiac events at 1 year. The secondary end points were survival free of the need for revascularization of the target lesion and definite stent thrombosis. The baseline clinical and angiographic parameters were comparable between the 2 groups. The freedom from major adverse cardiac event rate at 1 year of follow-up was 4.5% and 13.6% (p = 0.0663) for the EES and PES groups, respectively. The target lesion revascularization (TLR) rates were greater in the PES group at 1 year of follow-up compared to the EES group (1% vs 11.5%, p = 0.0193). The rate of myocardial infarction, death, and definite stent thrombosis for the EES and PES groups at 1 year of follow-up was 0% versus 4.2% (p = 0.0984), 3% versus 2.1% (p = 0.6855), and 0% versus 2.1% (p = 0.2382), respectively. The use of a PES for treatment of ISR was the only independent predictor of recurrent TLR at 1 year of follow-up (odds ratios 1.11, 95% confidence interval 1.05 to 1.18; p = 0.0193). During the complete follow-up period, the rates of TLR, myocardial infarction, death, major adverse cardiac events, and definite stent thrombosis were not different between the 2 treatment groups. In conclusion, EES resulted in reduced rates of TLR at 1 year of follow-up compared to PES when used for treatment of BMS ISR. However, at long-term follow-up, the event rates between EES and PES were comparable after treatment of BMS ISR.     

Drug-eluting stents vs. intracoronary brachytherapy for in-stent restenosis: a meta-analysis

Background:

It has been reported that drug‐eluting stents (DES) were superior to intracoronary brachytherapy (ICBT) in patients with in‐stent restenosis (ISR). However, it is unknown whether there might be differences between DES and ICBT in terms of efficacy and safety in large sample size and long‐term follow‐up.

Hypothesis:

The aim of this study was to determine whether DES implantation remains favorable in large sample size and long‐term follow‐up when compared with ICBT among patients with ISR.

Methods:

We conducted a search in MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials without language restrictions. A meta‐analysis of 1942 cases from 12 controlled trials of DES vs ICBT for ISR was performed.

Results:

Drug‐eluting stents were significantly more effective in reducing target‐vessel revascularization (TVR) (odds ratio [OR]: 0.44, 95% confidence interval [CI]: 0.23–0.81, P = 0.009) and binary restenosis (OR: 0.34, 95% CI: 0.26–0.46, P<0.00001) compared with ICBT at midterm follow‐up. There were no significant differences between DES and ICBT in cardiac death, myocardial infarction (MI), and late stent thrombosis at midterm follow‐up. A statistical significance has been found between the 2 groups in TVR (OR: 0.61, 95% CI: 0.43–0.86, P = 0.005) at long‐term follow‐up. There were no significant differences in cardiac death and MI between the 2 groups at long‐term follow‐up.

Conclusions:

These findings provide evidence that DES is superior to ICBT for the treatment of ISR in TVR and binary restenosis reduction, but not in cardiac death, MI, and late stent thrombosis reduction. © 2011 Wiley Periodicals, Inc. Yong‐Guang Lu, MD, and Yan‐Mei Chen, MD, contributed equally to this work. The authors have no funding, financial relationships, or conflicts of interest to disclose.     

Comparison of thrombosis and restenosis risk from stent length of sirolimus-eluting stents versus bare metal stents

Selection of coronary stent length varies from covering only the zone of maximum obstruction to stenting from normal- to normal-appearing vessels. With bare metal stenting, for any given lesion there is a high restenotic risk associated with longer stent length. With drug-eluting stents, the relation between stent length and restenosis has not been evaluated. In the angiographic follow-up cohort of the SIRIUS trial that compared the sirolimus-eluting Bx Velocity stent with the standard Bx Velocity stent (n = 699), we constructed a multiple regression model to predict 8-month percent diameter stenosis using the main effects of lesion length and excess stent length beyond the lesion length and adjusting for known predictors of restenosis. Stent length exceeded lesion length in 94% of lesions overall. Mean difference in length was 8.3 +/- 8.3 mm (mean lesion length 14.6 +/- 5.9 mm, mean stent length 22.9 +/- 9.6 mm). Stented lesion length and excess stent length were associated with absolute increases in percent diameter stenosis per 10 mm of 9.1% (p <0.0001) and 3.6% (p = 0.053) in the bare metal arm and 3.5% (p = 0.047) and 2.1% (p = 0.040) in the sirolimus-eluting stent arm. Although the effects of lesion length and excess stent length on restenosis were markedly decreased with sirolimus-eluting stents (vs bare metal stents), a small restenotic penalty is still paid for excessive stent length. Longer stent-to-lesion length strategies should be used only when a shorter stent is likely to result in incomplete lesion coverage and edge dissection, a strong determinant of stent thrombosis.     

Everolimus- and zotarolimus-eluting stents for bare metal stent in-stent restenosis treatment: a prospective study

Background: Treatment of in‐stent restenosis (ISR) is a challenging clinical problem. Recent studies have verified the safety and efficacy of first‐generation DES for the treatment of ISR. The safety and effectiveness of new‐generation drug‐eluting stents (nDES) for ISR has not been previously investigated. The aim of the present study was to prospectively evaluate the clinical outcomes after treatment with nDES implantation in patients with bare metal stent (BMS) ISR. Methods: Consecutive patients with ISR after BMS implantation were included. Primary end‐point was a major adverse cardiac event (MACE), defined as death, myocardial infarction (MI), or target vessel revascularization (TVR). The incidence of stent thrombosis was also evaluated. Results: A total of 46 consecutive patients were enrolled for the treatment of ISR, 23 patients from ZES and 23 from EES group. There were two (8.7%) cases of TVR in ZES cohort due to proliferative ISR at 6 and 7 months after DES implantation, and none in EES. One (4.3%) patient underwent percutaneous coronary intervention and the other (4.3%) was treated surgically. Neither acute nor subacute thrombosis was observed during the 13.3±6.3 months follow‐up period. In all other patients, stress test was negative for ischemia at 6 months. Conclusions: In this prospective study, we showed that direct nDES implantation is highly effective for ISR and seems to be a promising management for the treatment of ISR.     

Intravascular brachytherapy versus drug-eluting stents for the treatment of patients with drug-eluting stent restenosis

Drug-eluting stents (DESs), although promising technology, still are associated with restenosis; therefore, we evaluated the safety and efficacy of intravascular radiation therapy for the treatment of DES in-stent restenosis (ISR). Treatment of DES ISR has not been established, although intravascular radiation therapy is an effective treatment for patients with ISR of bare metal stents. Other modalities are conventional percutaneous coronary intervention (PCI), including restenting with DES. Radiation for Eluting Stents in Coronary FailUrE (RESCUE) is an international, Internet-based registry of 61 patients who presented with ISR of a DES and were assigned to intravascular radiation therapy with commercially available systems after PCI. Outcomes of these patients were compared with those of a consecutive series of 50 patients who presented with ISR of a DES and were assigned to repeat DES (r-DES) treatment. Baseline clinical and angiographic characteristics were similar between groups, except for more Cypher stents as the initial DES that restenosed in the r-DES group than in the intravascular radiation therapy group (88.5% vs 69%, p = 0.01). At 8 months there were fewer overall major adverse cardiac events in the intravascular radiation therapy group compared with the r-DES group (9.8% vs 24%, p = 0.044). The need for target vessel and target lesion revascularizations was similar in the 2 groups at 8 months. There has been no report of subacute thrombosis in either group. In conclusion, intravascular radiation therapy as adjunct therapy to PCI for patients presenting with ISR of a DES is safe and should be considered an alternative therapeutic option for this difficult subset of patients.