心肌梗死患者抗醛固酮治疗心功能变化的临床研究

Objective:To evaluate the effect of diabetes on outcome of sirolimus-eluting stent.Methods:From December 2002 to May 2005,262 diabetes and 262 non-diabetics treated with sirolimus-eluting stents were studied.The follow-up angiography was performed in 8-month.Major adverse cardiac events(MACE)defined as death,myocardial infarction,or target lesion revascularization and follow-up angiography were analyzed.Results:Successful rate of stent implantation was 100%.There was no death during the procedure,hospitalization,and follow-up period.Acute myocardial infarction occurred in 1 diabetic at 2 days after PCI,and in 2 non-diabetics at follow-up period.Angiographic follow up at 8 months showed that absolute late lumen loss was 0.06 vs 0.04mm(P>0.05),relative late lumen loss was 2.32% vs 1.63%,and TLR rate was 12.60% vs 9.92% in diabetic group and non-diabetic group respectively.Logistic regression analysis showed that reference vessel lumen and relative late lumen loss were significantly associated with restenosis.Conclusion:Cypher stent implantation in diabetes is safe and effective,while relative late lumen loss may be related to restenosis.In a word,diabetes with small vessel may be considered to be risk factor for restenosis after Cypher stents implantation.     

糖尿病患者植入雷帕霉素药物洗脱支架的疗效分析

目的:评价糖尿病对雷帕霉素药物洗脱支架临床疗效的影响。方法:选择2002年12月至2005年5月应用雷帕霉素药物洗脱支架(Cypher)的冠心病合并糖尿病患者262例(糖尿病组)和非糖尿病患者262例(对照组),平均随访8个月,患者均复查冠状动脉造影,分析不良心脏事件(心性死亡,急性心肌梗死或靶病变重建)和冠状动脉造影复查结果,评价糖尿病对Cypher支架临床近远期疗效的影响。结果:1.2组支架植入成功率均为100%,糖尿病组无死亡,6例于术后第2天发生急性心肌梗死,对照组无死亡,11例于随访6个月时发生急性心肌梗死;2.复查冠状动脉造影显示糖尿病组和对照组晚期管腔绝对内径丢失分别为(0.06±0.02)mmvs(0.04±0.02)mm(P>0.05),相对内径丢失分别为(2.32±0.19)%vs(1.63±0.14)%(P=0.03)。因再狭窄行靶血管重建者分别为33例(12.60%)和26例(9.92%)(P>0.05)。回归分析显示,相关血管大小和相对管腔内径丢失与再狭窄有关。结论:糖尿病患者应用Cypher支架安全有效,但相对内径丢失明显,糖尿病合并小血管可能是雷帕霉素药物洗脱支架再狭窄的影响因素。     

糖尿病急性ST段抬高心肌梗死应用雷帕霉素药物洗脱支架1年随访分析

目的探讨雷帕霉素药物洗脱支架在糖尿病急性ST段抬高心肌梗死(STEMI)患者急诊经皮冠状动脉介入治疗(PCI)中应用的安全性和有效性。方法选择2002年11月至2005年10月间首都医科大学附属北京朝阳医院心脏中心收治的糖尿病急性STEMI患者106例,于发病12h内行急诊PCI治疗,置入雷帕霉素药物洗脱支架。记录术后1个月和12个月随访终点时的心血管事件发生率、支架内血栓发生率及支架内再狭窄发生率。结果105例患者急诊PCI治疗获得成功。106支梗塞相关血管(IRA)的110处罪犯病变处置入雷帕霉素药物洗脱支架134枚,未发生与介入治疗有关的并发症。1个月随访终点时死亡4例(3.77%),发生急性心肌梗死1例,心血管事件总发生率为4.72%;发生支架内血栓1例;血运重建1例。12个月随访终点时除1个月时死亡的4例外未再发生死亡病例,共发生心血管事件11例(10.38%),发生支架内血栓2例(1.89%),52例接受冠状动脉造影复查患者中发生支架内再狭窄6例(11.54%)。结论雷帕霉素药物洗脱支架在STEMI急诊PCI中应用有较高的安全性和有效性,并可以明显降低再狭窄率。     

紫杉醇微孔载药支架与进口雷帕霉素药物洗脱支架治疗冠心病的临床效果比较

目的:比较紫杉醇微孔载药支架和进口雷帕霉素药物洗脱支架在经皮冠状动脉介入治疗中的临床疗效。方法: 筛选73例行经皮冠状动脉介入治疗术的冠心病患者,随机分为两组,紫杉醇微孔载药支架组（紫杉醇组,35例）和进口雷帕霉素药物洗脱支架组（雷帕霉素组,38例）。支架植入术后6个月复查冠状动脉造影（CAG）。随访6个月,对比两组支架内血栓形成、主要心血管不良事件（包括心源性死亡、非致死性心肌梗死、靶病变血运重建）和支架内再狭窄发生率。结果: 随访6个月,两组均未出现急性、亚急性和晚期支架内血栓形成、非致死性心肌梗死和心源性死亡。心绞痛、支架内再狭窄和靶病变血运重建发生率均无统计学差异。结论: 紫杉醇微孔载药支架与进口雷帕霉素药物洗脱支架在治疗冠状动脉简单病变时具有相同的近、中期临床疗效和安全性。     

Sirolimus-eluting stents inhibit neointimal hyperplasia in diabetic patients. Insights from the RAVEL Trial.

Patients with diabetes mellitus have less favourable outcomes after percutaneous coronary intervention (PCI) than non-diabetics. We performed a subgroup analysis of the multicentre RAVEL trial to examine the impact of the sirolimus-eluting stent (SES) on outcomes in diabetic patients. The RAVEL study randomized 238 patients to treatment with either sirolimus-eluting or bare metal stents. Forty-four patients were diabetic; 19 received sirolimus-eluting stents and 25 were treated with bare metal stents. The differences in outcomes between diabetic and non-diabetic patients treated with SES (n=101) were also assessed. Follow-up angiography was performed at 6 months. Major adverse cardiac events (MACE) defined as death, myocardial infarction (MI), or target lesion revascularization (TLR) were analysed at 12-month follow-up. Six-month in-stent late lumen loss was significantly lower for the diabetic SES than the bare stent group (0.07+/-0.2 vs 0.82+/-0.5mm; P<0.001) and similar to that in non-diabetics treated with SES (-0.03+/-0.27mm). There was zero restenosis in the SES groups (diabetic and non-diabetic) compared to a 42% rate in the diabetic population assigned to bare metal stents (P=0.001). After 12 months, there was one non-Q-wave MI and one non-cardiac death in the diabetic SES group, while 12 patients in the bare metal stent group had MACE (one death, two MI, nine TLR) (P=0.01)-an event-free survival rate of 90% vs 52%, respectively (P<0.01). There were no TLRs in both SES groups compared to 36% rate in the diabetic bare metal stent group (P=0.007).Conclusion Diabetics treated with SES were associated with a virtual abolition of neointimal proliferation and low event rates at long-term follow-up.     

急性心肌梗死患者药物支架置入术后支架贴壁不良特征及对预后的影响

目的探讨急性心肌梗死患者置入西罗莫司药物洗脱支架后,支架贴壁不良(ISA)的特征及ISA对临床预后的影响。方法选择197例冠心病(300处病变)患者置入西罗莫司药物洗脱支架。根据临床表现分为急性心肌梗死组(67例,117处病变),不稳定性心绞痛组(73例,99处病变),稳定性心绞痛组(57例,84处病变)。术后1年血管造影时利用血管内超声观察各组患者支架置入处ISA的发生率和特征.根据ISA造声情况又分为贴壁不良患者和非贴壁不良患者.并在复查后1年临床随访主要不良心脏事件(包括靶病变再次血运重建,非致命性心肌梗死,心源性死亡和全因死亡)。结果急性心肌梗死组支架置入后,有17例患者(17处病变.25.4%)在1年随访检查时存在ISA,明显高于不稳定性心绞痛组(7例患者,7处病变,9.6%)和稳定性心绞痛组[(4例患者,4处病变,7.0%),P=0.005]。多因素回归分析显示,病变长度(OR=1.068,P=0.037)、急性心肌梗死(OR=2.399,P=0.031)和非糖尿病(OR=6.472.P=0.013)是晚期ISA的独立危险因素。对ISA患者1年临床随访显示,ISA患者与非ISA患者主要心脏不良事件无统计学差异(7.1% vs 2.4%,P=0.203)。结论急性心肌梗死患者置入西罗莫司药物洗脱支架后ISA的发生率较高。支架置入后晚期ISA与临床事件的关系仍需进一步研究。     

Restenosis and stent fracture following sirolimus-eluting stent (SES) implantation.

BACKGROUND: Restenosis still occurs, even with the sirolimus-eluting stent (SES), and the precise mechanisms and the impact of stent fracture on restensosis have not yet been elucidated. METHODS AND RESULTS: Intravascular ultrasound (IVUS)-guided SES implantation was performed in 184 lesions in 151 patients with stable and unstable angina. Serial (pre-, post- and follow-up) quantitative coronary angiography analysis was obtained in 169 lesions in 138 patients (angiographic follow-up rate: 91%) and 12-month clinical follow-up was done in all patients. Restenosis occurred in 13 (7.7%) of 169 lesions. Stent fracture occurred in 4 (2.4%) of 169 lesions at follow-up. Of the 13 restenotic lesions, 8 had intimal hyperplasia, 4 had stent fracture, and 1 had late stent thrombosis at 7 months. Although multivariate logistic regression analysis revealed that minimal lumen area (min-LA) post (p=0.027), total stent length (p=0.003) and diabetes (p=0.032) were significant independent predictors of restenosis, univariate analysis showed that stent fracture was more common in the restenosis than in the non-restenosis groups (p=0.001). CONCLUSIONS: Although min-LA post by IVUS, total stent length by QCA and diabetes are independent predictors for angiographic restenosis, stent fracture occurred in 4 lesions (2.4%) and all of them resulted in restenosis (31% of the restenosis). The impact of stent fracture and its potential role in the development of restenosis deserves further study.     

Cause of death with bare metal and sirolimus-eluting stents.

AIMS: Although drug-eluting stents have assumed a dominant role in interventional cardiology, concern has been raised about the potential for long-term adverse outcomes, including death. The aim of the present study was to compare the incidence and cause of death between patients who received sirolimus-eluting or bare metal stents. METHODS AND RESULTS: An integrated analysis was performed on 1748 patients enrolled in four prospective double-blind trials that randomly assigned patients to receive either a sirolimus-eluting or a bare metal stent for treatment of a single de novo coronary stenosis. During a mean follow-up of 2.6+/-0.6 years, 64 patients (3.7%) died. Total mortality was 3.2% among 870 bare metal stent patients and 4.1% among 878 sirolimus-eluting stent patients (P=0.37); there was no difference in cardiac mortality (1.4 vs. 1.3%; P=0.55) or causes of death between these two groups. The predominant cause of death was non-cardiac. Cardiac death was most frequently assigned owing to unwitnessed death. Death due to acute myocardial infarction, congestive heart failure, and stent thrombosis occurred infrequently. CONCLUSION: At a mean follow-up of 2.6 years in percutaneous coronary intervention patients, the predominant cause of death was non-cardiac. There was no significant difference in either the frequency or the cause of death with implantation of either sirolimus-eluting or bare metal stents.     

西罗莫司洗脱支架(CypherTM)治疗支架内再狭窄

目的探讨CypherTM药物洗脱支架治疗支架内再狭窄的安全性和有效性。方法11例支架内再狭窄患者共置入CypherTM药物洗脱支架15枚,所有患者随访6个月,并于术后6个月复查冠状动脉造影。结果介入手术成功率100%,未发生与介入治疗相关的并发症。术后所有患者临床症状明显改善,6个月复查冠状动脉造影,无一例发生再狭窄。结论西罗莫司(雷帕霉素)洗脱支架治疗支架内再狭窄有很强的安全性、有效性。     

Adverse clinical events in patients treated with sirolimus-eluting stents: the impact of Type D personality.

BACKGROUND: Little is known about the impact of psychological risk factors on cardiac prognosis in the drug-eluting stent era. We examined whether the distressed personality (Type D) moderates the effect of percutaneous coronary intervention with sirolimus-eluting stent implantation on adverse clinical events at 2-year follow-up. Type D is an emerging risk factor in patients with cardiovascular disease. DESIGN: Prospective follow-up study. METHODS: Three hundred and fifty-eight patients with ischemic heart disease, who consecutively underwent percutaneous coronary intervention with sirolimus-eluting stent as part of the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital registry, completed the Type D Scale (DS14) post-percutaneous coronary intervention (PCI). The end-point was a composite of death and non-fatal myocardial infarction 2 years after PCI. RESULTS: At follow-up, there were 22 events (12 deaths and 11 myocardial infarctions). Type D patients had a greater than two-fold risk of an event at follow-up compared with non-Type D patients (10.4 vs. 4.4%, P=0.031). In multivariable analysis, Type D remained an independent predictor of adverse outcome (hazard ratio: 2.61; 95% confidence interval: 1.12-6.09; P=0.027) adjusting for sex, age, and history of coronary artery disease, multivessel disease, diabetes, hypercholesterolemia, hypertension, renal impairment and smoking. Previous cardiac history was also an independent predictor of death or myocardial infarction (hazard ratio: 2.83; 95% confidence interval: 1.00-7.96; P=0.049). CONCLUSIONS: Type D personality moderated the effect of percutaneous coronary intervention on hard clinical events despite treatment with the latest innovation in interventional cardiology. The inclusion of psychological risk factors in general and personality factors in particular may optimize risk stratification in the drug-eluting stent era.     

Use of sirolimus-eluting stents in complex lesions: clinical and angiographic follow-up

INTRODUCTION AND OBJECTIVES: The RAVEL and SIRIUS studies have demonstrated important reductions in clinical and angiographic restenosis in lesions treated with sirolimus-eluting stents. However, inclusion criteria in both studies excluded complex lesions. We studied immediate and long-term results with this stent in these complex lesions. PATIENTS AND METHOD: Prospective, observational study with clinical and angiographic follow-up of patients who met the exclusion criteria used in the RAVEL and SIRIUS studies. All patients were treated in our catheterization laboratory between June 2002 and April 2003 with the Cypher stent, and 57 patients (68 lesions) were studied in all. The most frequent lesion characteristics were excessive length 26.5%; ostial lesions 25%, bifurcations 23.5%, and severe calcifications 22.1%. Almost half (47%) of the patients had diabetes and 68% had multivessel disease. RESULTS: PTCA was successful in all patients. There was one major adverse cardiovascular event (MACE) before discharge (1 acute Q-wave myocardial infarction). Two episodes of subacute thrombosis occurred during the first week. During long-term clinical follow-up (8.7 [3.1] months) of all patients, there were 4 MACE (7%): 1 cardiac death, 1 acute myocardial infarction and 2 revascularizations of the target vessel. Intersegmental restenosis was observed by angiography in 4 lesions (8%). CONCLUSIONS: Implantation of the Cypher stent in complex lesions is safe and is associated, after 6 months of follow-up, with a low incidence of clinical events and a very low percentage of angiographic restenosis.     

Stents liberadores de rapamicina sin polímero frente a stents liberadores de paclitaxel con polímero: un análisis de datos de pacientes procedentes de ensayos aleatorizados

Introduction and objectives

The angiographic and clinical efficacy of polymer-free sirolimus-eluting stents vs polymer-based paclitaxel-eluting stents remain a matter of debate. We sought to investigate angiographic and clinical measures of efficacy of polymer-free sirolimus-eluting stents vs polymer-based paclitaxel-eluting stents.

Methods

Patient data from the randomized intracoronary stenting and angiographic restenosis-test equivalence between the 2 drug-eluting stents (ISAR-TEST) clinical trial and the LIPSIA Yukon clinical trial (randomized comparison of a polymer-free sirolimus-eluting stent vs a polymer-based paclitaxel-eluting stent in patients with diabetes mellitus) were pooled. The angiographic (primary) endpoint was in-stent late lumen loss at 6 months to 9 months. The clinical (secondary) endpoints were death or myocardial infarction, cardiac death or myocardial infarction, target lesion revascularization, and myocardial infarction.

Results

A total of 686 patients (polymer-free sirolimus-eluting stents, n=345 vs polymer-based paclitaxel-eluting stents, n=341) and 751 lesions (polymer-free sirolimus-eluting stents, n=383 vs polymer-based paclitaxel-eluting stents, n=368) were included in the study. Control angiography (606 lesions, 80.6%) showed comparable in-stent late lumen loss for polymer-free sirolimus-eluting stents vs polymer-based paclitaxel-eluting stents (0,53 [0,59] mm vs 0,46 [0,57] mm; P=.15). Median follow-up was 34.8 months. Polymer-free sirolimus-eluting stents and polymer-based paclitaxel-eluting stents were associated with comparable risk of death or myocardial infarction (relative risk=1.17; 95% confidence interval, 0,49-2.80; P=.71), cardiac death or myocardial infarction (relative risk=1.17; 95% confidence interval, 0,72-1.89; P=.50), target lesion revascularization (relative risk=0,98; 95% confidence interval, 0,65-1.47; P=.93), and myocardial infarction (relative risk=1.79; 95% confidence interval, 0,85-3.76; P=.12).

Conclusions

In this pooled analysis, polymer-free sirolimus-eluting stents were comparable to polymer-based paclitaxel-eluting stents with respect to both angiographic and clinical efficacy.Full English text available from:www.revespcardiol.org.     

Ruptured-plaque-like appearance of restenotic tissue following sirolimus-eluting stent implantation: an optical coherence tomography case study

A 57-year-old man was admitted for exertional angina pectoris. Coronary angiography showed a 99% stenosis in the left circumflex artery. A sirolimus-eluting stent was deployed in the culprit lesion and excellent angiographic results were obtained. Six-month routine follow-up coronary angiography showed a 90% focal restenosis at the proximal edge of the stent. At this site, optical coherence tomography imaging revealed restenotic tissue with a ruptured-plaque-like appearance overlying the stent struts. Also, a low intensity area suggestive of the presence of a lipid core was evident within the neointimal tissue in another cross section.     

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.     

Dark side of drug-eluting stent: multiple stent fractures and sudden death

Recently reported stent fractures after sirolimus-eluting stent (SES) implantation were found several months later during the follow-up of coronary angiogram (CAG) and single fracture mostly. The study reports a case of sequential, continuous, multiple coronary stent fracture and sudden death.     

Randomized trial of paclitaxel- and sirolimus-eluting stents in small coronary vessels.

AIMS: Sirolimus- and paclitaxel-eluting stents effectively reduce restenosis in small coronary vessels. The relative efficacy of these drug-eluting stents in this high-risk subset is not known. METHODS AND RESULTS: A total of 360 patients undergoing percutaneous coronary intervention for de novo lesions in native coronary vessels with a diameter of <2.80 mm received randomly paclitaxel-eluting stents (n=180) or sirolimus-eluting stents (n=180). The primary endpoint was in-stent late luminal loss. Secondary endpoints were angiographic restenosis and need of target lesion revascularization. The study intended to show that the paclitaxel-eluting stent is not inferior to the sirolimus-eluting stent with respect to the primary endpoint. The non-inferiority margin was set at 0.16 mm. Follow-up angiography was performed in 87% of the patients. In-stent late luminal loss in the paclitaxel-eluting stent group was 0.32 mm (upper 95% boundary, 0.42 mm), which was greater than that in the sirolimus-eluting stent group, failing to show the non-inferiority of the paclitaxel-eluting stent to the sirolimus-eluting stent (P>0.99). Angiographic restenosis was found in 19.0% of the lesions in the paclitaxel-eluting stent group and 11.4% of the lesions in the sirolimus-eluting stent group (P=0.047). Target lesion revascularization was performed in 14.7% of the lesions treated with paclitaxel-eluting stents and 6.6% of the lesions treated with sirolimus-eluting stents (P=0.008). CONCLUSION: The paclitaxel-eluting stent is associated with a greater late luminal loss and is less effective in reducing restenosis in small coronary vessels than the sirolimus-eluting stent.     

Late restenosis following sirolimus-eluting stent implantation

Despite encouraging results from randomized trials, concerns exist about long-term results of sirolimus-eluting stent implantation. We sought to determine whether in-stent restenosis occurring >1 year ("late") after sirolimus-eluting stent implantation is a real clinical entity. We analyzed data on all sirolimus-eluting stents implanted in our institution before March 2003. During the study period 928 lesions in 433 patients were treated. Angiographic follow-up was performed in 306 patients (70.6%) with 679 lesions (73.2%). Angiography after 1 year was performed only in symptomatic patients. We considered restenosis "early" if it occurred during the first year and late if after 1 year. Late restenosis required demonstration of a widely patent stent at 6 to 9 months, with repeat angiography after 1 year demonstrating restenosis. Restenosis occurred in 160 lesions overall (23.5%). Of the 31 (4.6%) that were documented after 1 year, 13 were excluded from analysis due to absence of 6- to 9-month angiography; the remaining 18 (2.6%, 1.7 to 4.2) fulfilled our criteria for late restenosis (median time of documentation 607 days, interquartile range 511 to 923). In conclusion, late restenosis is an infrequent but real entity; its existence implies we should not discount the possibility of restenosis as the cause of symptoms that develop >1 year after sirolimus-eluting stent implantation.     

Is there delayed restenosis in patients with coronary artery disease treated with sirolimus-eluting stent?

BACKGROUND: Although long-term follow-up after sirolimus-eluting stent implantation shows a sustained clinical benefit in several randomized and registered trials, little is known about the pattern of neointimal growth beyond the first 6 to 9 months. In this study, we therefore evaluated the possible delayed restenosis in patients with coronary artery disease treated with sirolimus-eluting stent. METHODS: A total of consecutive 333 patients with 453 lesions were enrolled in this study (among 782 consecutive patients with 1023 lesions). Lesions were subjected to follow-up by quantitative coronary angiography, and patients were divided into two groups according to the time of follow-up by quantitative coronary angiography: early group (< or =270 days, n=270 with 369 lesions) and late group (>270 days, n=63 with 84 lesions). Binary restenosis was defined as stenosis of more than 50% of the lumen diameter in the target lesion. RESULTS: Baseline clinical, demographic or angiographic characteristics were well balanced between the two groups. The in-stent restenosis rate was not significant between the early group and the late group (3.5 vs. 6.0%; P>0.05). The late loss and target lesion revascularization appeared higher in late group but there were no significant differences (0.15+/-0.38 mm vs. 0.24+/-0.44 mm; and 4.9 vs. 9.5%, P>0.05, respectively). Similarly, overall thrombosis rate was also same in both groups. In-segment restenosis was, however, higher in late group compared with that in early group (7.9 vs. 16.7%, P=0.013). CONCLUSION: In this unrestricted population, the beneficial effects of sirolimus-eluting stent implantation extend out more than 1 year in real world practice, that has been confirmed by the results of the large randomized clinical trials. The late in-segment restenosis could, however, be found, suggesting that a prolonged clinical and angiographic surveillance in this subset of patients seems to be warranted.     

Seguimiento de 3 años de pacientes con lesiones de bifurcación tratados con stents liberadores de sirolimus o everolimus: estudio de colaboración de SEAside y CORpal

Introduction and objectives

To compare the 3-year incidence of major events in patients with bifurcation lesions treated with provisional sirolimus-eluting stents vs everolimus-eluting stents.

Methods

A pooled analysis of 2 prospective randomized trials with similar methodology (SEAside and CORpal) was performed. In these trials, 443 patients with bifurcation lesions were randomly assigned to treatment with either sirolimus-eluting stents or everolimus-eluting stents. The clinical follow-up was extended up to 3 years to assess major adverse cardiovascular events (death or acute myocardial infarction or target vessel revascularization).

Results

At 3 years, survival free of major adverse cardiovascular events was 93.2% vs 91.3% in the everolimus-eluting stent group vs the sirolimus-eluting stent group (P = .16). Exploratory land-mark analysis for late events (occurring after 12 months) showed significantly fewer major adverse cardiovascular events in the everolimus-eluting stent group: 1.4% vs 5.4% in the sirolimus-eluting stent group (P = .02).

Conclusions

Provisional stenting with either sirolimus-eluting stents or everolimus-eluting stents in bifurcation lesions is associated with low rates of major adverse events at 3-years’ follow-up. The results of a subanalysis of events beyond 1 year, showing a lower event rate with everolimus-eluting stents than with sirolimus-eluting stents, suggest that studies exploring the long-term clinical benefit of the latest generation of drug-eluting stents are warranted.Full English text available from: www.revespcardiol.org/en     

雷帕霉素洗脱支架对糖尿病患者经皮冠状动脉介入治疗的远期影响

目的分析雷帕霉素洗脱支架(SES)对糖尿病患经皮冠状动脉介入治疗后的远期影响。方法采用回顾性研究方法,在1004．例接受冠状动脉内支架术治疗的冠心病患中,84例糖尿病和250例非糖尿病患置入SES;168例糖尿病和502例非糖尿病患置入普通支架。记录并比较一般临床资料、冠状动脉造影及冠状动脉内支架术情况、远期心脏事件发生率和1年无心脏事件生存率。结果随访期间(平均16．2个月),SES组中糖尿病亚组和非糖尿病亚组的远期心脏事件发生率为4．8％比3．6％,P=0．744;1年无心脏事件生存率为95．0％比96．7％,P=0．602,两亚组差异均无统计学意义。但BMS组中,糖尿病亚组的远期心脏事件发生率显高于非糖尿病组(31.0%比21．7％,P=0．015);两亚组的1年无心脏事件生存率分别为74．2％比86．8％(P=0．001)。结论SES能显改善糖尿病患冠状动脉支架术的远期疗效,降低靶病变再狭窄和远期心脏事件的发生率,提高1年无心脏事件生存率。