Sirolimus-eluting stents for treatment of drug-eluting versus bare-metal stents restenosis: 42-month clinical outcomes from a Chinese single center

Background  Restenosis of bare-metal stents (BMS) and drug-eluting stents (DES) has been increasingly treated with sirolimus-eluting stents (SES), but the long-term outcomes are unknown.

Methods  In our study, 388 consecutive patients (144 DES restenosis and 244 BMS restenosis) with 400 lesions (147 DES restenosis and 253 BMS restenosis) treated with SES were included. The rates of target lesion revascularization (TLR) and major adverse cardiac events (MACE) at 42 months were analyzed.

Results  At the mean follow-up of 42 months, the rates of death (3.5% vs. 3.3%, P=1.000) and myocardial infarction (2.8% vs. 1.2%, P=0.431) in the DES group and BMS group were comparable. Compared with the BMS group, ischemia-driven TLR occurred with a higher frequency in the DES group (18.8% vs.10.7%, P=0.024). This translated into an increased rate of MACE in the DES group (22.2% vs. 14.0%, P=0.034). Stent thrombosis occurred with a similar frequency in both groups (2.8% vs. 1.6%, P=0.475). Multivariate analysis showed that DES restenosis (OR=1.907, 95% CI 1.108–3.285, P=0.020) and smoking (OR=2.069; 95% CI 1.188–3.605; P=0.010) were independent predictors of MACE.

Conclusions  Although SES implantation appears to be safe and effective, it was associated with higher TLR recurrence for DES than BMS restenosis.

     

COMPARISON OF SHORT- AND LONG-TERM OUTCOMES BETWEEN CYPHER AND TAXUS DRUG-ELUTING STENTS FOR IN-STENT RESTENOSIS

IN-STENT restenosis (ISR) is the overriding factorthat influences therapeutic effect of interventionaltherapy.Although balloon dilation, especially for thecutting balloon, showed some effects on ISR lesions, therestenosis rate after balloon dilation remai…     

Endovascular interventions for TransAtlantic InterSociety Consensus II C and D femoropopliteal lesions

Background  Peripheral artery disease accounts for more than 400 000 hospitalizations in the USA and results in symptoms ranging from claudication to gangrene. Recent advances in endovascular techniques have led to a more aggressive approach for treating peripheral artery disease. The aim of this retrospective study was to evaluate the outcomes of endovascular interventions on TransAtlantic InterSociety Consensus (TASC) II C and D femoropopliteal occlusive disease.

Methods  Data for all patients undergoing endovascular interventions for femoropopliteal occlusive disease from December 2007 through December 2010 were reviewed. Demographic data, risk factor data, preprocedural and postprocedural ankle-brachial indices, technical success rates, and complication rates were obtained. Primary, assisted primary, and secondary patency were determined by Kaplan-Meier survival analysis. Univariate and multivariate analyses were performed to identify factors adversely affecting primary patency.

Results  The study group included 52 TASC II C and 106 TASC II D limbs in 126 patients (mean age, (68.0±18.0) years). The technical success rate was 91.1%. Complications occurred in 19 limbs (12.0%), including 8 (5.1%) major complications. The mean follow-up period was (17.6±5.1) months (range, 12.0–48.0 months). Primary patency rates at 1, 2, 3, and 4 years were 95%, 78%, 74%, and 74% in TASC II C lesions and 89%, 62%, 52%, and 52% in TASC II D lesions, respectively. Secondary patency rates at 1, 2, 3, and 4 years were 97%, 94%, 94%, and 94% in TASC II C lesions and 97%, 95%, 83%, and 83% in TASC II D lesions, respectively. It is significantly different between primary patency rates (P <0.05) but not secondary patency rates of TASC II C and D groups (P >0.05). Predictors of restenosis/occlusion included hyperlipidemia, lesion length, and popliteal artery involvement.

Conclusions  Endovascular treatment of TASC II C and D femoropopliteal artery occlusion has a high technical success rate with favorable mid-term secondary patency rate. Hyperlipidemia, lesion length, and popliteal artery involvement were independent risk factors for in-stent restenosis.

     

A case of stent thrombosis occurred at 5 years after sirolimus-eluting stent implantation

Drug-eluting stents (DES) have reduced the rate of repeated revascularization of target lesions. For this reason, DES are considered to be superior to bare-metal stents in reducing the restenosis rate. However, some problems have been reported after implantation of DES. One of them, stent thrombosis, has arisen as a fatal complication. Dual antiplatelet therapy is recommended for at least 12 months after implantation of DES to prevent stent thrombosis. Here, we report a case of very late stent thrombosis that occurred 1 week after discontinuation of clopidogrel at 5 years (1832 days) after implantation of a sirolimus-eluting stent.     

Six-month angiographic and one-year clinical outcomes of polymer free paclitaxel-eluting stent in patients with ST-segment elevation myocardial infarction: a comparison with permanent polymer sirolimus-eluting stent

Background  Since permanent polymer is implicated in adverse events associated with delayed vessel healing after drug eluting stents (DES) implantation, great efforts have been made to develop more biocompatible DES with biodegradable polymer or without polymer. The present study aimed to evaluate the safety and efficacy of polymer free paclitaxel-eluting stents (PF-PES) in comparison with permanent polymer sirolimus-eluting stents (PP-SES) in patients with acute ST-segment elevation myocardial infarction (STEMI).

Methods  Patients with STEMI were randomly assigned to receive PP-SES (n=55), and PF-PES (n=50). The 6-month angiographic and 1-year clinical outcomes were compared between the two groups. Target lesion failure (TLF) was defined as the composite of cardiac death, recurrent nonfatal myocardial infarction (Re-MI), or target lesion revascularization (TLR).

Results  Follow-up angiography at six months was performed in 72.7% of the PP-SES group and 70.0% of the PF-PES group (P=0.757). The two groups had comparable angiographic outcomes including minimal luminal diameter, diameter stenosis, late loss and binary restenosis. All patients were clinically followed up to one year. The two groups had similar clinical outcomes with relatively low rates of target lesion failure (10.9% PP-SES vs. 12.0% PF-PES, P=0.861) and definite or probable stent thrombosis (1.8% PP-SES vs. 2.0% PF-PES, P=1.000) at one year.

Conclusions  The present study suggests that the safety and efficacy of PF-PES in the setting of STEMI are comparable to PP-SES. Further randomized trials with larger study populations are needed to get definite conclusions.

     

Outcomes of Second Revascularization Procedures after Stent Implantation

Drug-eluting stents (DES) reduce subsequent revascularization procedures. Although randomized trials have compared DES to brachytherapy and balloon angioplasty (PTCA) for in-stent restenosis, few long-term comparisons have been made to bare metal stents (BMS) or bypass surgery (CABG), particularly following second procedures. We sought to assess the association between revascularization modality and long-term clinical outcomes of patients receiving a second procedure for coronary artery disease. Between January 2000 and July 2005, 4,666 consecutive patients underwent initial coronary stent implantation (DES or BMS). From this population we identified 569 patients undergoing a second target vessel revascularization (DES, BMS, PTCA or CABG). Outcomes were assessed at 6, 12, and 24 months after the second procedure, with follow-up through September 2006. Adjusted cumulative incidence rates were calculated using inverse probability weighted estimators. We found that at 24 months, there were no significant differences in death or myocardial infarction for PTCA, BMS, DES, and CABG (17.7%, 14.9%, 7.5%, and 10.2%, p = 0.26[3df]). DES patients had lower rates of death or myocardial infarction or third target vessel procedures than patients receiving PTCA (14.6% vs. 30.0%, p = 0.01) and BMS (14.6% vs. 42.2%, p < 0.01), but rates similar to CABG patients (14.6% vs. 14.6%, p = 0.99). For patients undergoing a second revascularization procedure, PTCA, BMS, DES, and CABG are associated with a similar risk of death or non-fatal myocardial infarction. DES and CABG are associated with lower rates of third revascularization procedures compared to PTCA and BMS. Further studies are needed to determine the optimum application for CABG vs. DES as a second or third revascularization procedure.     

A comparison of angiographic and clinical outcomes after sirolimus-eluting versus paclitaxel-eluting stents for the treatment of in-stent restenosis

Background In-stent restenosis （ISR） remains a challenge for interventional cardiologists. Some data suggest that drug-eluting stents （DES） represent a promising new option for the treatment of patients with ISR. Currently, 2 DES platforms are available [sirolimus-eluting stents （SES） and paclitaxel-eluting stents （PES） ], but the superiority of either approach for treating ISR has not been convincingly demonstrated. The aim of the present study was to retrospectively compare angiographic and clinical outcomes after treatment of ISR with SES or PES in a series of consecutive patients with ISR.     

Long-term effects of drug-eluting stents versus bare metal stents on patients with acute ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention: outcomes of 3-year clinical follow-up

Background  The long-term safety and efficacy of drug-eluting stents (DES) versus bare metal stents (BMS) are unclear and controversial issues in patients with acute ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). The purpose of this study was to compare the long-term outcome of STEMI patients undergoing primary PCI with DES versus BMS implantation.  

Methods  A total of 191 patients with acute STEMI undergoing PCI from Jan. 2005 to Dec. 2007 were enrolled. Patients received DES (n=83) or BMS (n=108) implantation in the infarction related artery according to physician’s discretion. The primary outcome was the occurrence of major adverse cardiac events (MACE), which was defined as a composite of death, myocardial infarction (MI), target vessel revascularization (TVR) and stent thrombosis. The difference of MACE was observed between DES and BMS groups.

Results  The clinical follow-up duration was 3 years ((41.7±16.1) months). MACE occurred in 20 patients during three years follow-up. Logistic regression analysis showed that the left ventricular ejection fraction (LVEF) was an independent predictor for MACE in the follow-up period (P=0.0301). There was no significant difference in all-cause mortality (3.61% vs. 7.41%, P=0.2647), the incidence of myocardial infarction (0 vs. 0.93%, P=0.379) and stent thrombosis (1.20% vs. 1.85%, P=0.727) between the DES group and BMS group. The incidence of MACE was significantly lower in the DES group compared to the BMS group (4.82% vs. 14.81%, P=0.0253). The rate of TVR was also lower in the DES group (0 vs. 5.56%, P=0.029). In the DES group, there was no significant difference in the incidence of MACE between sirolimus eluting stents (SES, n=73) and paclitaxel-eluting stents (PES, n=10) subgroups (2.74% vs. 20.00%, P >0.05).

Conclusions  This finding suggested that drug-eluting stents significantly reduced the need for revascularization in patients with acute STEMI, without increasing the incidence of death or myocardial infarction. Use of DES significantly decreased the incidence of MACE compared with BMS during the 3-year follow-up.     

A case of a zotarolimus-eluting stent fracture in the left anterior descending artery in a patient undergoing hemodialysis

Although stent fracture after implantation of a drug-eluting stent (DES) is a rare complication, it has been suggested to be a cause of restenosis. To date, most DES fractures have been associated with sirolimus-eluting stents. We describe here a case of a zotarolimus-eluting stent fracture after 8 months of stent placement in a calcified left anterior descending artery lesion in a patient undergoing hemodialysis.     

49例冠状动脉介入治疗再狭窄高危患者药物洗脱支架的临床应用

目的:分析经皮冠状动脉介入治疗(PCI)后再狭窄高危患者应用两种药物洗脱支架的临床疗效.方法:在17个月期间对49例再狭窄高危患者行雷帕霉素(Cypher)和/或紫杉醇(Taxus)药物洗脱支架置入术.24例患者接受Cypher支架置入术;25例患者接受Taxus支架置入术.结果:24例患者26支血管的27处病变共置入27个Cypher支架;25例患者36支血管的42处病变共置入42个Taxus支架.对49例患者平均随访7.3个月(1个月～17个月),没有1例发生术后再狭窄或进行靶血管重建或靶病变重建,但有2例在PCI后5 d(Cypher支架)和45 d(Taxus支架)分别发生了亚急性支架内血栓形成.结论:药物洗脱支架置入术即刻成功率高,在再狭窄高危患者的术后近期再狭窄发生率很低,但是术后亚急性支架内血栓形成是一个需要引起特别关注的问题.     

冠状动脉药物支架再狭窄形式分析

目的:分析冠状动脉支架置入后造影复查的影像资料,寻找不同药物支架再狭窄的特点。方法:收集冠状动脉介入治疗后造影复查再狭窄患者121例,共159处病变,进行再狭窄形式分析。结果:裸支架(BMS)和药物支架(DES)后再狭窄病变局限性再狭窄分别占39.80%和70.49%(P<0.001);弥漫性再狭窄病变分别占60.20%和29.51%(P<0.001);三种不同类型DES(Cypher,Taxus和Firebird)再狭窄形式没有差异,局限性再狭窄分别为83.33%,55.56%和75.00%(P=0.070);弥漫性再狭窄分别占16.67%,44.44%和25.00%,(P=0.070)。结论:①DES改变了以往BMS再狭窄模式,由弥漫型转为局限型;②不同种类的药物支架再狭窄形式没有差异。     

联合应用多种血管内支架治疗肌纤维发育不良性颈内动脉狭窄

目的：报告采用多支架治疗肌纤维发育不良笥颈内动脉狭窄1例。方法：采用2个球囊膨胀支架及1个自膨胀支架治疗1例肌纤维发育不良性颈内动脉狭窄,串珠样狭窄从颅外颈内动脉起始部到颅内海绵窦段,长约82mm。结果：一次性植入3个支架,成功进行血管成形,患症状消失,临床短期随访无脑缺血事件发生,5个月血管造影随访显示支架植入段血管通畅,无再狭窄。结论：血管内支架成形术治疗肌纤维发育不良性颈内动脉狭窄安全有效。     

Drug-eluting coronary stents--a note of caution

There are two types of coronary stents: bare-metal stents (BMS) that cost about $800 each, and drug-eluting stents (DES) that cost about $3,300 each. DES reduce the rate of restenosis but have a higher incidence of late stent thrombosis, particularly if dual antiplatelet therapy with aspirin and clopidogrel is interrupted. Stent thrombosis has a myocardial infarction rate of 70% and a mortality rate of 31%-45%. Randomised studies of BMS versus DES show no increase in myocardial infarction or death with DES in simple coronary lesions, but in clinical practice, DES are mainly used in complex coronary disease where the rate of stent thrombosis is higher. Registry data suggest an increased rate of death and myocardial infarction of 0.5%-1.0% per annum with DES. Clinicians need to be aware of the risks associated with prematurely ceasing dual antiplatelet therapy in patients with DES.     

Drug-eluting stent for the treatment of small coronary lesion: comparison between sirolimus- and paclitaxel-eluting stent

Background  Patients with small coronary lesions are at increased risk for repeat interventions after coronary angioplasty and stenting. The efficacy of drug-eluting stents (DES) has been demonstrated to improve the outcomes of these patients and is a focus of interest. Currently, two platforms of DES are available (sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES)). However, it has less been known that DES, SES vs PES, is superior for the treatment of small coronary lesions.
Methods  In this retrospective study, 87 consecutive patients with 151 lesions underwent implantation of coronary SES (n=68) and PES (n=83). Quantitative coronary angiography (QCA) was performed at the time of stent implantation and subsequently at 8 months post-stenting. Small vessel disease was defined as lesions in vessels with diameter 2.5 mm measured by QCA. Major adverse cardiac events (MACE) including death, thrombosis, nonfatal myocardial infarction and target lesion revascularization (TLR) were compared between the two groups.
Results  Baseline clinical characteristics and angiographic parameters were similar between the two groups. At clinical and angiographic follow-up, overall thrombosis rates were similar in both groups (0 vs 1.2%, P>0.05). The TLR and in-segment restenosis were not significantly different (19.1% vs 25.3%; 10.3% vs 10.8%, P=0.365 and P=0.913 respectively) between the two groups. The in-stent restenosis rate, however, was significantly higher in the PES group (4.4% vs 21.7%; P=0.002). Similarly, the late loss was significantly higher in the PES group ((0.140.38) mm vs (0.490.61) mm; P<0.001).
Conclusions  In this small sample-size, non-randomized study, the data indicated that implantation of SES for the treatment of patients with small coronary lesion showed more favorable results in respect of restenosis compared with PES implantation.

     

Safety and efficacy of cobalt chromium alloy based sirolimus-eluting stent with bioabsorbable polymer in porcine model

Background  First generation drug-eluting stents (DESs) were based on 316L stainless steel and coated with a permanent polymer. The vessel wall of these DESs was inflammatory and late in-stent thrombosis was reported. Hence, cobalt chromium based DES coated with a bioabsorbable polymer was an alternate choice.

Methods  Cobalt chromium based DES with bioabsorbable polymer (Simrex stent) as well as control stents (Polymer stent and EXCEL^TM stent) were implanted into porcine arteries. At a designated time, angiography, quantitative coronary angiography (QCA) analysis, histomorphometry, and electron-microscopical follow-up were performed.

Results  A total of 98 stents of all the three groups were harvested. At week 24, percent diameter stenosis (%DS), late loss (LL), and percent area stenosis (%AS) of Simrex was (12.9±0.4)%, (0.35±0.02) mm, and (24.5±4.2)%, respectively, without significant difference in comparison to commercialized EXCEL^TM stent. Slight inflammatory reaction was seen around the stent strut of Simrex, just as in the other two groups. Electron-microscopical follow-up suggested that it might take 4–12 weeks for Simrex to complete its re-endothelialization process.

Conclusions  Cobalt chromium based, bioabsorbable polymer coated sirolimus-eluting stent showed excellent biocompatibility. During 24 weeks observation in porcine model, it was proved that this novel DES system successfully inhibited neointima hyperplasia and decreased in-stent stenosis. It is feasible to launch a clinical evaluation to improve the current prognosis of DES implantation.

     

Cockett综合征的腔内介入治疗疗效分析

目的 评估腔内介入治疗Cockett综合征的疗效.方法 回顾性分析53例Cockett综合征患者(女性49例,男性4例)的临床资料.41例患者表现为急性或亚急性下肢深静脉血栓形成,予以导管引导下溶栓+球囊扩张+支架植入术;12例患者表现为慢性静脉高压,予以球囊扩张+支架植入术.术后随访时间6～36个月,平均随访时间(21±15)个月.术后1个月、6个月及以后每年进行一次临床和造影评估.结果 术后所有患者左髂静脉均完全畅通,41例深静脉血栓形成患者中37例(90.2％)患者血栓完全溶解.在术后随访中,49例患者(92.5％)症状完全缓解,4例患者症状明显缓解(7.5％),50例患者(94.3％)支架完全畅通,3例患者(5.7％)出现了支架再狭窄.无死亡患者.结论 腔内介入治疗Cockett综合征可明显缓解患者症状,具有较高的早-中期通畅率,且安全有效.     

药物洗脱支架内再狭窄的介入治疗

目的评价药物洗脱支架(DES)内再狭窄患者中根据再狭窄模式选择介入治疗的远期预后。方法选择2006年6月—2009年12月因DES内再狭窄于上海交通大学附属胸科医院行再次介入治疗的冠状动脉性心脏病患者,根据再狭窄部位及类型选择介入治疗方案。对于累及DES节段的再狭窄者行再次植入DES术;对于狭窄部位局限于DES内的Ⅰ型病变者行高压球囊扩张术;对于狭窄部位局限于DES内的Ⅱ～Ⅳ型病变者先行球囊扩张,再根据扩张后的结果由术者决定是否再次植入DES。所有患者均前瞻性随访主要心血管不良事件(MACE),包括死亡、靶病变重建(TLR)和心肌梗死(MI)。结果共88例行介入治疗,其中42例行单纯球囊血管成形(POBA)术(POBA组),46例行再次植入DES(DES组)。两组间各靶病变部位及各种原植入DES的涂层药物类型构成比的差异均无统计学意义(P值均>0.05),两组间再狭窄病变部位及类型构成比的差异均有统计学意义(P值均<0.05)。POBA组、DES组的支架内再狭窄(ISR)的发生率分别为(72.5±11.9)%、(76.2±9.1)%,两组间的差异无统计学意义(P>0.05)。平均随访时间为(2.2±1.0)年,两组间MACE、TLR、MI的发生率及病死率的差异均无统计学意义(P值均>0.05)。结论根据DES内再狭窄部位及类型选择介入治疗方案是有效的。对于局灶型ISR可行POBA术,而对于非局灶型或节段内ISR病变则需要再次植入DES。     

The effect of magnetic stent on coronary restenosis after percutaneous transluminal coronary angioplasty in dogs

探讨磁化支架对经皮经腔冠状埃及成形术 (PTCA)后冠状动脉再狭窄的防治作用。方法　 2 0只健康杂种犬 ,超大球囊反复扩张损伤靶血管 (前降支或旋支中段 )制备PTCA术后冠状动脉狭窄模型(>5 0 % ) ,后随机分成对照组和实验组各 10只。对照组靶血管置入普通Palmaz支架 ,实验组靶血管置入磁化Palmaz支架。手术前后不用抗血小板药和抗凝药 ,术后 6个月冠状动脉造影 ,并处死犬切取靶血管 3cm进行组织病理学检查。结果　冠状动脉造影冠状动脉再狭窄率对照组 30 % ,实验组 0 ;组织病理学检查靶血管平均内膜厚度 (对照组 2 .98± 0 .5 6mm) ,(实验组 1.13± 0 .4 1mm)有显著差异 ,P <0 .0 5。结论　磁化支架对犬PTCA术后冠状动脉再狭窄可能具有防治作用。     

Comparison of drug eluting stents with bare metal stents in daily practice for bifurcation lesions in Chinese patients

Background Recently, numerous randomized and controlled trials have demonstrated great advantages of drug eluting stents (DES) with respect to significant reduction of restenosis and recurrence of symptoms and improvement of clinical outcomes after percutaneous coronary intervention (PCI). Little is known about the comparative effects between DES and bare metal stents (BMS) for bifurcation angioplasty in the Chinese population. We compared the inpatient and 7-month follow-up outcomes between DES and BMS for the treatment of bifurcation lesions. Methods From April 2004 to October 2005, 291 Chinese patients [85.9% male, mean age (57.8±10.4) years] underwent DES (387 lesions) and/or BMS (297 lesions) implantation for bifurcation lesions. Clinical and angiographic follow-up was performed at 7 months. Results Compared with BMS group, patients in DES group had significantly lower rates of restenosis at main branch (9.5% vs 28.7%, P < 0.001) or side branch (14.5% vs 37.0%, P < 0.001) and major adverse cardiac events (MACE) (14.0% vs 26.3%, P = 0.000). The occurrence rate of late in-stent thrombosis did not differ between the two groups in both main (0.8% vs 0, P = 0.224) and side branches (1.4% vs 0, P = 0.198). Target lesion revascularization (TLR) was less frequent in DES group for main branch (8.3% vs 21.3%, P < 0.001) and for side branch (7.6% vs 23.5%, P < 0.001). Multivariate regression analysis revealed that total stent length (OR = 1.029, P = 0.01), postprocedural in-stent minimum lumen diameter (OR = 0.476, P = 0.03) and stent type (OR = 3.988, P = 0.0001) were independent predictors of TLR for main branch. Prior history of coronary intervention (OR = 2.424, P = 0.041), angulated lesion (OR = 2.337, P = 0.033), postdilation (OR = 0.267, P = 0.035) and stent type (DES vs BMS, OR = 5.459, P = 0.000) were independent predictors of TLR for side branch. Conclusion The implantation of DES may be associated with greater reduction of restenosis and TLR than BMS in bifurcations angioplasty.     

Coronary stents in the management of coronary artery disease review of first 100 stents

This is a review of the first 100 coronary stents implanted for the indications of PTCA restenosis, acute or threatened closure and De Novo lesions. The success rates were high and complications rates were low. Subacute stent thrombosis rates were low and stenting for De Novo lesions in > 3.0 mm arteries provide the best short and long term results. Six months restenosis rate was low. Stent assisted high pressure balloon angioplasty is an important advance.