雷帕霉素药物洗脱支架治疗冠状动脉小血管病变的临床即刻效果

目的评价国产雷帕霉素药物洗脱支架(Firebird支架)治疗冠状动脉小血管病变(直径≤2.5mm)的临床即刻效果。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,连续入选2004年6月~2007年2月我院行冠状动脉造影(CAG)确诊,首次接受经皮冠状动脉介入治疗(PCI)的靶血管为小血管病变且达到完全血运重建的160例患者,根据所置入的支架分为Firebird组(82例)和Cypher组(78例);支架置入后以相同的方法进行CAG,观察对比反映临床即刻效果的相关参数。结果术中全部Cypher及Firebird支架均顺利到达并释放于靶病变部位。两组支架的PCI手术成功率均为100%。Firebird组病变部位狭窄程度由术前的(78.7±15.6)%减至(7.20±10.69)%,P=0.0005;而Cypher组病变部位狭窄程度由术前的(79.8±15.8)%减至(7.10±10.61)%,P=0.0004。在急性管腔直径获得方面,Firebird组(1.76±0.52)mm与Cypher组(1.77±0.53)mm之间无显著差异(P=0.46)。结论Cypher和Firebird支架治疗冠状动脉小血管病变安全可行,临床即刻效果好。     

Comparison of the effectiveness of sirolimus- and paclitaxel-eluting stents for small coronary artery lesions.

BACKGROUND: The sirolimus-eluting stent (SES) and the paclitaxel-eluting stent (PES) reduce restenosis in small coronary artery lesions. However, it is not clear which of these stents is superior in terms of clinical outcomes. METHODS: The authors retrospectively examined 197 patients with 245 de novo small coronary artery lesions (相似文献   

Comparison of the efficacy and safety of paclitaxel-eluting coroflex please stents and paclitaxel-eluting stents in patients with coronary artery disease: A randomized PIPA trial

Objectives : To compare the safety and efficacy of the new Coroflex? Please stents with conventional Taxus? Liberte stents in patients with coronary artery lesions. Background : The Coroflex? Please stent is a new version of paclitaxel‐eluting stent, and observational cohort studies have reported similar angiographic and clinical outcomes as with the first‐generation stents. However, it has not been directly compared with the early generation paclitaxel‐eluting stents in a multicenter, prospective, and randomized study. Methods : We randomly assigned 319 patients to receive Coroflex? Please stents (159 patients; 198 lesions) or Taxus? Liberte stents (160 patients; 232 lesions). The primary end point was angiographic in‐segment late luminal loss at 9 months. Results : Most baseline clinical and angiographic characteristics were similar between these two groups. The Coroflex? Please and Taxus? Liberte stents showed similar in‐segment late loss (0.40 ± 0.53 mm vs. 0.39 ± 0.52 mm, P = 0.98) and rates of in‐segment binary restenosis (22.2% vs. 18.8%, P = 0.48) at 9 months. After clinical follow‐up for 12 months, the two groups had similar rates of death (1.3% vs. 1.3%, P > 0.99), myocardial infarction (3.8% vs. 7.5%, P = 0.22), stent thrombosis (2.5% vs. 1.9%, P = 0.72), and target‐lesion revascularization (7.5% vs. 7.5%, P = 0.99). Conclusions : The Coroflex? Please stent resulted in similar angiographic and clinical outcomes as the Taxus? Liberte stent in patients with coronary artery lesions. © 2012 Wiley Periodicals, Inc.     

Randomized comparative trial of a thin-strut bare metal cobalt-chromium stent versus a sirolimus-eluting stent for coronary revascularization.

OBJECTIVES: To see whether use of a sirolimus-eluting stent (SES) is superior to a third-generation thin-strut, cobalt-chromium stent (CCS) in terms of in-segment late loss at 9 months in patients with symptomatic coronary artery disease. BACKGROUND: Stent-strut thickness has been shown to be strictly related with risk of in-stent restenosis, but available demonstrations of the angiographic efficacy of SES have been based on comparisons with thick-strut bare metal control stents. METHODS: The primary outcome measure of this single-center, single-blind randomized comparative trial was 9-month in-segment late loss. Eligibility criteria were symptomatic coronary artery disease and target vessel diameter appropriate for implantation a 3-mm stent. Based on a power calculation, 104 patients were randomly assigned to receive a SES (Cypher) or a CCS (Vision). RESULTS: In-segment late loss was significantly lower in the SES group (0.18 +/- 0.40 mm vs 0.58 +/- 0.51 mm, P < 0.001). Regarding subsidiary outcome measures, in-segment restenosis (at 9 months) was recorded in 10% (5/50) patients treated with SES and 23% (11/48) receiving CCS (P = 0.14). No clinical difference between the two groups was apparent at 12 months. Freedom from target vessel failure at 12 months was 72% for SES patients and 68% for CCS patients (P = 0.65). CONCLUSIONS: In patients with de-novo coronary lesions at medium risk of restenosis the anti-proliferative effect of SES is greater than that of a thin-strut CCS. Nevertheless, the angiographic results of the CCS were rather good. It remains to be seen whether the angiographic superiority of SES can translate into clinical superiority.     

"Head-to-head comparison between sirolimus-eluting and paclitaxel-eluting stents in patients with complex coronary artery disease: an intravascular ultrasound study".

BACKGROUND: The aim of this study was to assess neointimal hyperplasia following sirolimus-eluting (SES) and paclitaxel-eluting stents (PES) implantation in a patients with complex coronary disease. METHOD: Between January to December 2004, 70 patients were enrolled in this study (SES = 37; PES = 33. The primary objective was to assess the efficacy of SES and PES on neointimal proliferation inhibition in patients with complex coronary lesions by volumetric 3D intravascular ultrasound (IVUS) assessment at six-month follow-up. RESULTS: Baseline clinical, demographic or angiographic characteristics were well balanced in both groups. All procedures as well as hospitalisation were uneventful. The percentage of B2/C lesions in our study was > 90% in both groups. The IVUS-assessed in-stent mean neointimal hyperplasia volume was significantly lower in lesions treated with SES compared to PES (4.1 +/- 11 mm3 vs. 17.4 +/- 23 mm3, p < 0.002) at 6 month follow-up. No difference in both MACE (3.0 versus 6.0%, p = NS) and restenosis (5.4 versus 9.1%, p = NS) were found. The in-segment late loss at six month was 0.26 mm in the SES and 0.48 mm in the PES group (p = NS). CONCLUSIONS: The present study showed reduced neointimal proliferation after sirolimuseluting as compared to paclitaxel-eluting stents in patients with complex coronary artery disease. Both SES and PES were associated with low rate of angiographic restenosis or major adverse cardiovascular events.     

佐他莫司和西罗莫司支架在老年冠心病患者介入治疗中的对比研究

目的 比较佐他莫司支架和西罗莫司支架治疗老年冠心病的临床效果. 方法回顾性分析2006年8月至2007年5月我院对635例老年冠心病患者连续支架植入治疗的临床资料.其中植入佐他莫司(佐他莫司组)支架334例,西罗莫司(西罗莫司组)支架301例.比较两组治疗成功率、主要心脏不良事件等临床情况,并进行对比分析. 结果两组基线临床特点佐他莫司组高脂血症和左主干病变少于西罗莫司组,佐他莫司组再狭窄病变、支架长度、支架最大释放压和后扩张比率均小于西罗莫司组.两组介入成功率均为100%.主要心脏不良事件发生率与佐他莫司组比较(分别为4.5%(15例)与4.3%(13例)],差异无统计学意义,其中心原性死亡、非致死性心肌梗死和靶血管重建率两组比较,差异无统计学意义.支架内血栓发生率佐他莫司组和西罗莫司组分别为0.3%(1例)和0.7%(2例),差异无统计学意义.早期、晚期支架内血栓发生率两组比较,差异无统计学意义.7个月随访,佐他莫司组和两罗莫司组支架内和血管段再狭窄率[分别为5.9%(4/68)和3.5%(3/36),7.4%(5/65)和4.7%(4/86)]比较,差异无统计学意义.但支架内和血管段的晚期丢失佐他莫司组均大于西罗莫司组,分别为(0.48±0.12)mm与(0.24±0.09)mm和(0.44±0.13)mm与(0.26±0.09)mm,均P< 0.01. 结论7个月随访结果证实,佐他莫司和西罗莫司支架对于老年冠心病患者具有相似的疗效.     

Ten-year outcomes of early generation sirolimus- versus paclitaxel-eluting stents in patients with left main coronary artery disease

To compare 10-year outcomes after implantation of sirolimus-eluting stents (SES) versus paclitaxel-eluting stents (PES) for left main coronary artery (LMCA) stenosis. Very long-term outcome data of patients with LMCA disease treated with drug-eluting stents (DES) have not been well described. In 10-year extended follow-up of the MAINCOMPARE registry, we evaluated 778 patients with unprotected LMCA stenosis who were treated with SES (n = 607) or PES (n = 171) between January 2000 and June 2006. The primary composite outcome (a composite of death, myocardial infarction [MI] or target-vessel revascularization [TVR]) was compared with an inverse-probability-of-treatment-weighting (IPTW) adjustment. Clinical events have linearly accumulated over 10 years. At 10 years, there were no significant differences between SES and PES in the observed rates of the primary composite outcome (42.0% vs. 47.4%; hazard ratio [HR] 0.85; 95% confidence interval [CI] 0.66–1.10), and definite stent thrombosis (ST) (1.9% vs. 1.8%; HR 1.02, 95% CI 0.28–3.64). In the IPTW-adjusted analyses, there were no significant differences between SES and PES in the risks for the primary composite outcome (HR 0.89, 95% CI 0.65–1.14) or definite ST (adjusted HR 1.05, 95% CI 0.29–3.90). In patients who underwent DES implantation, high overall adverse clinical event rates (with a linearly increasing event rate over time) were observed during extended follow-up. At 10 years, there were no measurable differences in outcomes between patients treated with SES vs. PES for LMCA disease. The incidence of stent thrombosis was quite low and comparable between the groups.     

Emergency endoluminal stenting for abrupt vessel closure following coronary angioplasty: A randomized comparison of the wiktor and palmaz-schatz stents

In order to compare the efficacy of two different stent types in case of bailout stenting, 65 patients, with abrupt or threatened vessel closure following coronary angioplasty, were randomly assigned to either Wiktor (Medtronic Inc., Minneapolis, MN, 33 patients) or Palmaz-Schatz (Johnson & Johnson Interventional, Warren, NJ, 32 patients) stent implantation. Stenting was technically feasible in all except one patient and immediately successful in reverting ischemia and vessel closure in 60 patients (92%). At hospital discharge, complication rates were comparable: early vessel closure, 18% (Wiktor) versus 13% (Palmaz-Schatz) (P=0.53); any clinical event (such as death, myocardial infarction, and surgical revascularization): 18% (Wiktor) versus 22% (Palmaz-Schatz) (P=0.71). At 6 months follow-up, these complication rates remained equal: restenosis, 38% (Wiktor) versus 27% (Palmaz-Schatz) (P=0.42); any clinical and angiographic (vessel closure and restenosis) event: 45% (Wiktor) and 41% (Palmaz-Schatz) (P=0.69). Baseline, direct postprocedural, and follow-up quantitative coronary analysis data were similar, with, however, an exception for the postprocedural residual stenosis [28% (24-32%) (Wiktor) and 21% (18-23%) (Palmaz-Schatz] (means and 95% confidence intervals). In conclusion, despite a discrete postprocedural angiographic benefit observed with the Palmaz-Schatz stent, the long-term clinical and angiographic outcome is similar in both treatment groups. The choice whether to implant a Wiktor or Palmaz-Schatz stent may probably be left to the discretion of the operator and his experience with one particular device.     

Clinical and angiographic performance of a new-generation modular stent design for treatment of de novo coronary lesions.

The objectives of the Race Car study were to assess the safety and efficacy of the Medtronic AVE S670 stent, a new-generation stent with a modular design consisting of interconnected sinusoidal rings allowing improved flexibility with good conformability and scaffolding. A total of 285 stents were implanted in 267 patients with (un)stable angina pectoris who underwent angioplasty of a single de novo lesion in a native coronary artery with a diameter between 3.0 and 4.0 mm. Available stent lengths were 9, 12, and 15 mm. The primary endpoint was the 6-month restenosis rate. Secondary endpoints were device and procedural success and major adverse cardiac event (MACE)-free survival at 1 and 6 months. All patients received the study stents and no other stents were used (angiographic success: 100%). Eight patients experienced a MACE during hospital admission (Q-wave MI in 2, non-Q-wave MI in 4, TLR in 2). A procedural success was obtained in 97% of the patients. There were no additional events at 1 month. The clinical endpoints encountered at 6 months were Q-wave MI in 1, bypass surgery in 3, and repeat angioplasty in 25 (MACE-free survival: 86.5%). Quantitative angiographic results were the minimum lumen diameter increased from 1.05 +/- 0.32 before to 2.73 +/- 0.39 mm after stent implantation. At follow-up, the loss in diameter was 0.74 +/- 0.50 mm. The loss index was 0.45 +/- 0.31 and restenosis rate was 13.4%. This study has demonstrated that the S670 stent in patients with (un)stable angina pectoris requiring intervention of a single lesion has a low acute and 6-month major event rate and a low angiographic restenosis rate.     

Use of sirolimus-eluting coronary stents in routine clinical practice.

Restenosis has long remained the major limitation of intracoronary stenting, but several randomized trials have recently shown that the use of drug-eluting stents appear to reduce markedly the risk of recurrence following treatment of de novo lesions. To evaluate whether the results of randomized trials can be generalized to routine clinical practice, all patients receiving at least one sirolimus-eluting stent (SES) in two Swiss hospitals were entered into a prospective registry. Only target vessels with a reference diameter > 3.5 mm were excluded. Clinical follow-up was obtained after 6 months. A total of 183 patients were included. The procedural success was 97.8% and the incidence of in-hospital MACE was 2.2%. At 7 +/- 2 months, 95.6% of the patients were event-free, and target lesion revascularization was required in only three patients (1.6%). The excellent medium-term results obtained with the SES in randomized trials can be replicated in routine clinical practice.     

Effectiveness and safety of the sirolimus-eluting stents coated with bioabsorbable polymer coating in human coronary arteries.

BACKGROUND: Although the sirolimus-eluting stent (CYPHER, Cordis, USA) has shown a dramatic reduction of restenosis, there are still some concerns about its efficacy and safety. Its durable polymer coating may enhance neointimal proliferation and residual sirolimus, which cannot be released from polymer, may result in incomplete reendothelization. As a drug reservoir, bioabsorbable polymer (polylactic acid, PLA) is more rational. OBJECTIVE: We aimed to determine the safety and efficacy of sirolimus-eluting stent coated with PLA (EXCEL, JW Medical Systems, China) in the treatment of human coronary arterial diseases. METHODS: The study included 31 patients with de novo coronary lesions, with vessels 2.5-3.5 mm in diameter. The primary end points included the percentage of in-stent restenosis of the luminal diameter and in-stent late luminal loss at 6 months, as determined by quantitative angiography. The secondary end point was the major adverse cardiac events (MACE) 30 days and 6 months after the index procedure. RESULTS: Forty-eight EXCEL stents were successfully delivered in the 34 lesions, and multiple stents were implanted in 35.3% of lesions. All patients were discharged without clinical complications and completed clinical follow-up at 1 and 6 months. No MACE had occurred. Twenty patients (30 stents) completed 6 months of angiographic follow-up. No in-stent or in-lesion restenosis (diameter stenosis > or =50%) was observed. In-stent late loss was (0.07 +/- 0.17) mm. CONCLUSIONS: The implantation of EXCEL stent is feasible and safe and elicits minimal neointimal proliferation. This new stent has potential advantages regarding the long-long-term result over the commercially stent as the new stent has no sustained stimulation to the local tissue.     

雷帕霉素洗脱支架治疗冠状动脉特长病变的临床研究

目的研究雷帕霉素洗脱支架(SES)治疗冠状动脉(冠脉)特长病变的疗效。方法对41例冠脉特长病变患者置入SES并对其进行随访,于6个月时行冠脉造影检查。结果41例患者完成该研究,共45处病变。病变长度平均(52.60±15.40)mm,直径平均(2.74±0.10)mm,每处病变平均置入2.5枚支架。6个月造影随访显示,支架近端狭窄由13%上升到15%,支架内狭窄由15%上升到22%,支架远端狭窄由25%下降到20%。6个月内的主要心脏事件有1例非致死性心肌梗死和2例心绞痛,无死亡。结论SES治疗冠脉特长病变是安全可靠的,效果优于金属裸支架。     

冠状动脉分叉病变单支架术及双支架术临床疗效对比

目的探讨分叉病变单支架术和双支架术的临床疗效。方法分析冠状动脉分叉病变102例的临床资料,其中52例行单支架术（单支架植入组）、50例行双支架术（双支架植入组）。单支架植入组仅主支植人支架,边支不植入支架;双支架植入组运用mini-crushing技术行双支架植入术。观察两组分叉病变的手术即刻及术后6个月临床疗效及主要心血管事件的发生情况。结果术后即刻冠状动脉造影结果显示两组主支血管心肌梗死溶栓试验（thrombolysisinmyocardialinfarction．TIMI）血流3级、分支血管TIMI血流3级、主支血管残余狭窄〉30％、分支血管残余狭窄〉50％四个指标比较,均差异无统计学意义（P〉0．05）。随访6个月后对两组进行冠状动脉造影后发现,分支血管残余狭窄〉50％在单支架植入组发生率高于双支架植入组,差异有统计学意义[25．0％（13／52）vs．12．0％（6／50）,P〈0．05];其余几项两组比较,差异无统计学意义（P〉0．05）。住院期间单支架植入组1例（1．92％）发生主要心血管事件,双支架植入组2例（4．00％）发生主要心血管事件。6个月后．单支架植入组8例（15．38％）发生主要心血管事件,双支架植入组7例（14．00％）发生主要心血管事件。结论单支架术与双支架术治疗分叉病变短期观察临床疗效基本无差异,其长期疗效还需进一步研究。     

Sirolimus PK trial: a pharmacokinetic study of the sirolimus-eluting Bx velocity stent in patients with de novo coronary lesions.

This study was conducted to assess the systemic drug release and distribution of sirolimus-eluting stents. Early results with sirolimus-eluting stents have demonstrated a favorable outcome for reducing restenosis post coronary intervention. However, the clinical systemic pharmacokinetics of sirolimus released from these stents has not been investigated. Sirolimus-eluting stents (150-178 mcg/18 mm stent) were implanted in 19 patients with coronary artery disease using standard techniques. Blood samples were obtained at multiple times to determine the kinetics of sirolimus release and elimination. Non-compartmental analysis showed that the maximum blood concentration of sirolimus occurred between 3 and 4 hr after implantation, with a peak concentration of 0.57 +/- 0.12 ng/mL (mean +/- SD) and 1.05 +/- 0.39 ng/mL in patients receiving one or two stents, respectively. Terminal-phase elimination half-life was independent of the number of stents and averaged at 213 hr, a value longer than that seen in patients following oral dosing. The apparent clearance was 1.46 +/- 0.45 L/hr with an apparent volume of distribution in the terminal phase of 407 +/- 111 L (data for both stent doses pooled). Minimal measurable blood levels were detectable at 7 days. Peak whole blood level following sirolimus stent implantation in humans is proportional to the number of stents implanted. The prolonged terminal half-life may reflect kinetics of blood clearance combined with continued drug elution and secondary local tissue release.     

Efficacy and safety of zotarolimus-eluting stents compared with sirolimus-eluting stents in patients undergoing percutaneous coronary interventions — A meta-analysis of randomized controlled trials

Background

Whether ZES can further improve angiographic and clinical outcomes compared to SES still remains uncertain.

Objectives

The aim of this study was to assess the efficacy and safety of zotarolimus-eluting stents (ZES) compared with sirolimus-eluting stents (SES) in patients undergoing percutaneous coronary interventions (PCI).

Methods

Major electronic information sources were explored for randomized controlled trials comparing ZES with SES among patients undergoing PCI during at least 9 months follow-up. The primary efficacy outcomes were target lesion revascularization (TLR), target vessel revascularization (TVR), and major adverse cardiac events (MACE); safety outcomes were stent thrombosis (ST), myocardial infarction (MI), and cardiac death.

Results

Seven comparative studies were identified (a total of 5983 patients). When compared with ZES at 12-month follow‐up, SES significantly reduced risk of MACE (relative risk [RR]: 0.74, 95% confidence interval [CI]: 0.61 to 0.89, p = 0.002), and TLR (RR:0.39; 95% CI: 0.29 to 0.52; p < 0.00001), without significant differences in terms of TVR (RR:0.68, 95% CI: 0.38 to 1.20; p = 0.18), ST (RR:0.71; 95% CI: 0.39 to 1.31; p = 0.28), cardiac death (RR:0.83; 95% CI: 0.49–1.42, p = 0.50) or MI (RR:1.08; 95%CI: 0.80 to 1.45; p = 0.62).

Conclusions

At 12-month follow-up, SES are superior to ZES in reducing the incidences of TLR and MACE in patients undergoing PCI, without significant differences in terms of TVR, ST, cardiac death, and MI.     

Concept of the homemade coronary stent: Experimental results and initial clinical experience

To defray the escalating cost of coronary stenting, we handmade a balloon expandable coil stent with stainless steel wire. Preliminary comparison with the Palmaz-Schatz stent showed that, when implanted in porcine illac arteries, there was no difference in immediate angiographic results or in the degree of foreign body reaction at 6 wk. Subsequently, a total of 73 stents were implanted in 52 patients, either as a bailout device (54%) or for suboptimal angiographic results (46%). All but two implantations were successful. The postprocedural regimen consisted of heparin 1,000 IU/hr, aspirin 250 mg daily, and ticlopidine 500 mg daily. In-hospital complications were limited to two groin hematomas, one necessitating blood transfusion. Importantly, stent thrombosis was not observed. While 6-mo follow-up is pending, we already conclude that a balloon expandable coil stent can be handmade easily at low cost and implanted safely in patients. © 1996 Wiley-Liss, Inc.     

Stenting with the half (disarticulated) palmaz-schatz stent

A total of 110 half (disarticulated) Palmaz-Schatz coronary stents were implanted in 102 patients. Procedural success rate was 98%. Elective stenting was performed in five patients. The others received half stents for bail-out situations, including short dissections, relapsing stenoses, dissections not adequately covered by a full stent, ostial stenoses, and thrombus containing lesions. Seventeen patients received no anticoagulation except aspirin. Complications included one procedural death, three acute occlusions (resulting in one Q and two non-Q wave myocardial infarctions), and one non-Q wave infarction related to side branch closure. Stenting with the half Palmaz-Schatz coronary stent is an effective technique. It allows stenting in situations where a full stent may not be ideally suited. Use of only half a stent reduces thrombogenicity and halves costs.