An angiographic evaluation of restenosis rate at a six-month follow-up of patients with ST-elevation myocardial infarction submitted to primary percutaneous coronary intervention

BACKGROUND: Percutaneous coronary intervention (PCI) is considered to be the optimal type of revascularization in patients with ST-segment elevation myocardial infarction (STEMI). However, the long-term effectiveness of this procedure can be reduced by restenosis. This investigation was aimed at a prospective evaluation, in a group of STEMI patients of "the real world" (not involved in randomised trials), of the angiographic restenosis rate at a 6-month follow-up, and at identifying the relationship between restenosis and the patients' characteristics. MATERIALS AND METHODS: Our study population consisted of 123 patients with STEMI submitted to primary PCI to then undergo stress echocardiography 3 months after PCI and an angiographic evaluation at a 6-month follow-up. RESULTS: a) In real life the restenosis rate is quite high (42.3%); b) no correlation was found between patients' clinical characteristics and restenosis; c) restenosis rate was higher in patients with bare metal stents than in those with drug-eluting stents (55.8% vs. 11.1%; p<0.001); in patients with longer stents (21.6+/-8.62 vs 18.1+/-6.34 mm, p=0.015) and when more than one stent was implanted. Moreover, a consistent number of patients showed restenosis though asymptomatic. CONCLUSIONS: Our data suggest that primary PCI is associated with a high incidence of angiographic restenosis. No correlation was found between patients' clinical characteristics and restenosis. The length and the number of implanted stents seem to be associated with a more probable restenosis at six-month angiographic evaluation. Drug-eluting stent implantation seems to be associated with a lower incidence of restenosis even in STEMI patients.     

Treatment of lesions with a high risk of stenosis. Comparative study in 300 patients of rapamycin- and Paclitaxel-eluting polymer-based stents, and bare metal stents

INTRODUCTION AND OBJECTIVES: Rapamycin- and taxol-eluting stents have been shown to reduce restenosis, but there are no large-scale studies of their usefulness in lesions with a high risk of restenosis, or of the relative merits of the two devices. This prospective study compared their safety and efficacy in lesions with a high risk of restenosis. PATIENTS AND METHOD: We included consecutive patients with lesions to treat that met at least one of the following criteria: a) in-stent restenosis; b) diffuse (>20 mm) restenosis; c) small vessel (< or =2.5 mm) restenosis; or d) total occlusion. Patients received different devices along three consecutive study periods: bare metal (conventional) stents, sirolimus-eluting (rapamycin) stents and paclitaxel-eluting (taxol) stents. RESULTS: One hundred patients in each group were included, for a total of 300 patients. In the sirolimus group, after 8.5+/-2 months of follow-up, there were 2 late thromboses (2%) and only 1 patient (1%) required target lesion revascularization. In the paclitaxel group 2 patients (2%) had in-hospital stent thrombosis (1 acute, 1 subacute), and after 9+/-2.5 months of follow-up only 1 patient (1%) needed target lesion revascularization. In the conventional group, after 8+/-2 months of follow-up, there was 1 subacute thrombosis (1%) and 15 patients (15%) had clinical restenosis requiring target lesion revascularization. Event-free survival curves were significantly better with drug-eluting stents (P<.01 vs conventional stents). CONCLUSION: Rapamycin- and taxol-eluting stents were safe for lesions with a high risk of restenosis. These stents were associated with a lower rate of target lesion revascularization during follow-up compared to bare metal stents.     

Comparison of sirolimus versus paclitaxel eluting stents for treatment of coronary in-stent restenosis

In patients with in-stent restenosis (ISR) inside bare metal stents, drug-eluting stents reduce the recurrence of restenosis compared with balloon angioplasty. However, few data are available about this therapeutic modality in the case of diffuse restenosis. The aim of this study was to evaluate the immediate and mid-term outcome of sirolimus- and paclitaxel-eluting stent implantation in diffuse ISR and determine the predictors of clinical and angiographic restenosis recurrence. A series of 161 consecutive patients with 194 diffuse ISR lesions (>10 mm) treated with drug-eluting stent implantation were evaluated. Major adverse cardiac events were defined as death, myocardial infarction, and the need for target lesion revascularization. During a mean follow-up of 8.2 +/- 3.4 months, the cumulative incidence of major adverse cardiac events was 19% in the SES group and 24% in the PES group (p = 0.56). Angiographic follow-up was performed in 80% of the lesions. The overall restenosis rate was 22% and was not significantly different between lesions treated with sirolimus-eluting (20%) or paclitaxel-eluting (25%, p = 0.55) stents. The incidence of restenosis was higher in diabetics (32%) than in nondiabetics (16%, odds ratio 2.5, 95% confidence interval 1.1 to 5.5, p = 0.02). By multivariate analysis, diabetes was confirmed to be the only independent predictor of recurrent restenosis (odds ratio 3.53, 95% confidence interval 1.39 to 9.02, p = 0.008). In conclusion, drug-eluting stent implantation for diffuse ISR is associated with acceptable clinical and angiographic results. The association of diffuse restenosis and diabetes mellitus is an unfavorable condition leading to a high risk of recurrence.     

EXCEL支架在慢性闭塞病变介入治疗中的应用及疗效观察

目的总结冠状动脉性心脏病(冠心病)慢性完全闭塞(chronic total occlusion,CTO)病变经皮冠状动脉介入(percutaneous coronary intervention,PCI)治疗中EXCEL生物降解药物涂层支架的应用及3年随访结果,评价其在CTO病变的疗效及安全性。方法2006年1月至2009年3月入住成都军区昆明总医院,冠状动脉造影确诊CTO病变并行PCI治疗患者185例,靶病变均植入EXCEL支架,常规二联抗血小板治疗至少6个月。术后6个月、1年、2年、3年临床及冠状动脉造影随访,以主要心血管事件(major adverse cardiac events,MACE)发生率、再狭窄率(in-stent restenosis,ISR)、血运重建率为研究终点,同时了解亚急性及晚期支架内血栓发生率。结果共147例CTO病变血管开通,即刻血管开通率为79.5%(147/185);共201处闭塞病变中,26处导丝无法通过,8处导丝通过闭塞病变后球囊无法跨越病变部位,靶血管开通率83.1%;闭塞时间12个月以内及超过12个月的靶血管开通率分别为87.5%、62.4%,有桥侧支存在者PCI治疗成功率低于无桥侧支者,断端呈刀切状的成功率低于鼠尾状(P0.05)。术中无死亡病例;术后6个月、1年、2年、3年冠状动脉造影复查率分别为30.8%、19.5%、15.1%、10.3%,MASE发生率分别为3.2%、2.3%、1.95、4.0%,再狭窄率分别为8.8%、8.3%、7.1%、5.3%;发生亚急性、晚期支架内血栓各1例,发生率分别为0.6%、0.1%,无急性支架内血栓事件。结论EXCEL支架应用于CTO病变PCI治疗中安全有效,没有增加MACE发生率及支架内血栓事件。     

可生物降解涂层药物洗脱支架介入治疗的近期疗效

目的 评估国产新型西罗莫司可生物降解涂层支架在急性心肌梗死患者介入治疗(percutaneous coronary intervention,PCI)中的疗效及安全性.方法 急性心肌梗死患者56例,其中ST段抬高性心肌梗死48例,非ST段抬高性心肌梗死8例,均置人西罗莫司可生物降解涂层洗脱支架,观察手术成功率、支架内血栓等并发症及主要不良心脏事件(main adverse coronary events,MACE)发生率,术后随访1～14个月,6～9个月行冠状动脉造影复查.结果 成功行PCI 55例,手术即刻成功率98%.82处病变共置入西罗莫司支架98枚,其中17枚(17.3%)为直接支架术.4例出现无复流现象,1例使用主动脉气囊反搏.1例术后6 h猝死,考虑急性支架内血栓.术中及住院期间无其他严重并发症发生.50例(89.3%)随访1～14个月,无晚期支架内血栓发生,无MACE;复查冠状动脉造影19例,1例发生支架内再狭窄,无需血运重建.结论 国产西罗莫司可生物降解涂层支架在急性心肌梗死患者行PCI治疗有较好疗效及安全性.     

Angiographic and clinical outcomes of a pharmacokinetic study of sirolimus-eluting stents: lesson from restenosis cases.

BACKGROUND: A pharmacokinetic (PK) study was conducted to evaluate sirolimus-eluting stents (SES) in Japanese people, representing the first clinical trial of the use of drug-eluting stents in Japan. METHODS AND RESULTS: The PK study was conducted in 20 patients with 30 lesions treated with sirolimus-coated BX Velocity stents. All lesions were treated with a single SES (3 x 18 mm). Angiographic follow-up was performed at 8 months after SES implantation, and the clinical outcomes were evaluated at 1 year in all cases. All procedures were successful, and all patients were discharged without any adverse cardiac events. The total restenosis rate was 10% (3 lesions) and target vessel revascularization was performed in those 3 cases (15%). Restenoses occurred at the proximal and distal stent margins. Intravascular ultrasound examination of restenosis cases revealed abundant plaque burden at the stent edges even though the luminal area was preserved. CONCLUSIONS: The sirolimus-eluting BX Velocity stent is safe and useful for Japanese patients with coronary artery disease. However, restenosis at proximal stent edge seems to be a problem.     

药物洗脱支架和金属裸支架治疗弥漫病变的比较研究

目的比较冠心病患者弥漫病变采用药物洗脱支架和金属裸支架治疗的近期和远期预后,分析影响这类病变介入治疗预后的危险因素。方法研究对象为我院2004年4月至2005年8月接受置入单个长度>25.0mm支架治疗并且进行冠状动脉造影随访的205例患者,排除支架置入失败及支架置入位置不理想者。分为置入药物洗脱支架(DES)组(n=128)和置入金属裸支架(BMS)组(n=77)。所有的患者术后均接受阿司匹林300mg、氯吡格雷75mg等规范药物治疗。手术成功判定标准为至少用相互垂直的两个投照体位行冠状动脉造影,肉眼判定残余狭窄<20%和前向血流TIMI3级。再狭窄判定标准以复查冠状动脉造影定量分析支架内或支架邻近血管管腔直径狭窄程度≥50%。患者在支架术后6个月左右接受冠状动脉造影随访。结果共205例患者(男性181例,女性24例)227个靶病变置入382枚支架完成造影随访。其中C型病变占总数的93.8%,B2型病变为6.2%。双支或双支以上血管病变的患者比例达到86.8%。平均术前参考血管直径(2.88±0.43)mm。平均每个病变支架长度(40.09±12.94)mm,54.2%的病变接受了重叠置入支架。比较置入DES组和置入BMS组,两组的患者基本条件差异无统计学意义,在病变基本条件方面,DES组术前参考血管直径明显小于BMS组[(2.80±0.37)mm比(3.10±0.48)mm,P=0.005]。6个月随访结果显示再狭窄率DES组(15.4%)小于BMS组(48.4%),P<0.001。晚期支架内腔径丢失BMS组明显大于DES组[(0.94±0.76)mm比(0.39±0.53)mm,P<0.001]。靶病变血管重建率DES要明显好于BMS(11.6%比38.5%,P<0.001)。支架内再狭窄在置入DES组的局限性再狭窄比例大于置入BMS组(33.3%比18.2%,P=0.029)。对影响复杂弥漫病变支架再狭窄因素的多元logistic回归分析发现,采用支架重叠置入(OR=2.82,P=0.017)和支架类型(OR=5.71,P<0.001)是对复杂弥漫病变支架内再狭窄影响最大的危险因素。结论我们的研究发现对于复杂弥漫病变的治疗,药物洗脱支架有着良好的治疗效果,较金属裸支架能明显减低再狭窄率。对于弥漫病变,我们应该使用长支架,尽可能减少支架重叠置入的数量。     

药物涂层支架在复杂冠脉病变中的临床应用

复杂冠脉病变是冠心病介入治疗中的难点及热点,近年来的研究及临床实践表明,药物涂层支架在其中的临床应用取得了令人鼓舞的成绩,但也暴露出了许多问题。现主要针对药物涂层支架在复杂冠脉病变中应用的一些研究结果作一综述。     

Drug-eluting stents in primary angioplasty long-term clinical outcomes.

INTRODUCTION: The use of drug-eluting stents in the context of mechanical reperfusion following ST-segment elevation myocardial infarction (MI) was initially viewed with concern. The main fear was that the drugs' action in unstable lesions could increase the risk of thrombotic stent occlusion. Furthermore, there was no evidence that the proven benefit of reduced instent restenosis could be extended to such patients, since they were excluded from the initial clinical trials. OBJECTIVES: To assess the safety and long-term clinical outcomes of the use of drug-eluting stents in primary angioplasty. METHODS: The first 100 consecutive and non-selected patients admitted for MI and treated by primary angioplasty with drug-eluting stent implantation in the target lesion were analyzed retrospectively. The efficacy and safety of the procedure, in-hospital clinical evolution and the occurrence of major adverse cardiac events in the first year were assessed. RESULTS: Patients' mean age was 58.2 +/- 11.5 years, and 78 were male. The success rate of primary angioplasty was 99%. Stents coated with sirolimus were used in 67 patients, paclitaxel in 19 and dexamethasone in 16. In-hospital mortality was 3%. The follow-up rate at 12 months was 98%. During this period, the rate of target vessel revascularization was 1% (with no patient requiring target lesion revascularization), MI 2%, and overall mortality 3.9%. Fourteen patients had clinical indication for repeat coronary angiography, which showed no significant in-stent restenosis. One event was considered to be due to acute stent thrombosis. The incidence of major adverse events was 5.9%. CONCLUSION: The use of drug-eluting stents in MI patients undergoing primary mechanical revascularization is safe and is associated with a reduced incidence of major adverse events, thrombosis and clinical restenosis at one year.     

应用双药物洗脱支架治疗分叉病变的近远期临床疗效

目的探讨应用双药物洗脱支架（DES）治疗分叉病变的临床疗效。方法选择分支开口有严重狭窄且分支口径≥2．50mm的分叉病变患者为本研究的入选对象。2003年10月至2005年6月共入选应用双DES治疗分叉病变的患者112例,113处病变。分叉病变的类型为前降支／对角支62例（54．9％）,左冠状动脉主干分叉病变32例（28．3％）,回旋支／钝缘支18例（15．9％）,右冠状动脉远端分叉病变1例。113处分叉病变中采用Crush技术64处,“T”型支架置入27处;改良“Y”型支架置入11处;对吻支架置入5处;“V”型支架置入和Culotte技术置入各3处。结果入选112例患者113处分叉病变中（226处病变）使用Cypher或Cypher select DES 91个,TAXUS DES 74个,Firebird DES 67个。64处分叉病变采用Crush技术置入双支架后60处（93．7％）完成了最后的对吻球囊扩张技术。手术成功率为100％。住院期间1例发生亚急性血栓致急性心肌梗死（AMI）,再次介入治疗成功。住院期间心脏事件发生率（MACE,包括死亡、AMI、再次血管重建）为0．89％（1／112）。112例均完成了9个月的临床随访,无死亡发生,1例发生AMI由晚期血栓形成所致。48例完成了9个月的冠状动脉造影随访（42．9％）,8例发生了支架内再狭窄,其中1例进行了冠状动脉旁路移植术,5例再次行介入治疗,总再狭窄发生率为16．7％（8／48）。随访期间MACE发生率为8．04％（9／112）。结论本研究结果显示对于分支口径≥2．5mm且口部有严重狭窄性病变的分叉病变,采用双DES治疗是安全的,近、远期临床疗效是满意的。与Cypher DES相比较,TAXUS DES的再狭窄发生率有增加的趋势。     

Provisional stenting for multivessel PCI

Background: Bare stents reduce acute complications and repeat revascularization following percutaneous coronary intervention (PCI), but are costly and may lead to in‐stent restenosis. It remains unclear whether stents should be universally implanted or whether provisional stenting mainly to suboptimal balloon dilatation results is an acceptable approach for multivessel PCI. Objective: To compare the long‐term clinical restenosis and target lesion revascularization (TLR) of stented and non‐stented coronary artery lesions in patients who had multivessel PCI. Methods: We performed retrospective analysis of matched data from 129 consecutive patients who underwent multivessel PCI (at least optimal balloon angioplasty to one coronary artery segment and balloon angioplasty plus stenting to another coronary artery in the same patient, all lesions are de novo native coronary artery lesions with vessel diameter ?2.5?mm). The study endpoint was restenosis and repeat revascularization at one‐year follow‐up. Results: Baseline characteristics were similar in both groups. Low in‐hospital MACE (3.1%). Acute myocardial infarction, emergency revascularization via either PCI or CABG was detected and angiographic success was achieved in 99.3% of lesions in both groups. The rate of clinically driven angiographic restenosis and TLR at one‐year (follow‐up?100%) was similar (17.1% versus 18.6%, P?=?0.871, and 13.9% versus 16.3%, P?=?0.728, for optimal balloon angioplasty versus provisional stenting. Conclusions: The main findings from this study are that long‐term angiographic restenosis and TLR was comparable for optimal balloon angioplasty and provisional stenting, suggesting that provisional stenting is an acceptable approach for multivessel PCI.     

药物洗脱支架在冠心病无保护左主干病变中的应用

目的评价药物洗脱支架治疗经选择冠心病无保护左主干病变的安全性和有效性。方法2003年1月~2005年6月间,共有48例经选择的冠心病患者,年龄39~81岁,经冠状动脉造影证实为无保护左主干病变(左主干狭窄均≥75%)行介入治疗置入药物洗脱支架。结果48例患者介入治疗均获得成功,共置入药物洗脱支架75枚(51 Cypher,18 Taxus,6 Firebird)。其中左主干开口部狭窄5例(10.4%,5/48),体部狭窄6例(12.5%,6/48),远端分叉部位狭窄37例(77.1%,37/48)。37例远端分叉部位狭窄患者中,主支支架加边支经皮冠状动脉介入治疗(PCI)10例,双支架术27例,最后成功对吻球囊扩张30例(81.1%,30/37)。所有患者治疗后临床症状明显缓解或消失,住院及6个月随访期间无严重心血管事件发生,43例患者术后6个月行冠状动脉造影随访,2例患者再狭窄(均为分叉病变)行冠状动脉旁路移植术(CABG),冠状动脉造影随访率89.6%,再狭窄率4.7%。结论药物洗脱支架介入治疗冠心病无保护左主干病变安全有效,近中期效果良好。     

Revascularization for coronary artery disease in diabetes mellitus: Angioplasty,stents and coronary artery bypass grafting

Patients with diabetes mellitus (DM) are prone to a diffuse and rapidly progressive form of atherosclerosis, which increases their likelihood of requiring revascularization. However, the unique pathophysiology of atherosclerosis in patients with DM modifies the response to arterial injury, with profound clinical consequences for patients undergoing percutaneous coronary intervention (PCI). Multiple studies have shown that DM is a strong risk factor for restenosis following successful balloon angioplasty or coronary stenting, with greater need for repeat revascularization and inferior clinical outcomes. Early data suggest that drug eluting stents reduce restenosis rates and the need for repeat revascularization irrespective of the diabetic state and with no significant reduction in hard clinical endpoints such as myocardial infarction and mortality. For many patients with 1- or 2-vessel coronary artery disease, there is little prognostic benefit from any intervention over optimal medical therapy. PCI with drug-eluting or bare metal stents is appropriate for patients who remain symptomatic with medical therapy. However, selection of the optimal myocardial revascularization strategy for patients with DM and multivessel coronary artery disease is crucial. Randomized trials comparing multivessel PCI with balloon angioplasty or bare metal stents to coronary artery bypass grafting (CABG) consistently demonstrated the superiority of CABG in patients with treated DM. In the setting of diabetes CABG had greater survival, fewer recurrent infarctions or need for re-intervention. Limited data suggests that CABG is superior to multivessel PCI even when drug-eluting stents are used. Several ongoing randomized trials are evaluating the long-term comparative efficacy of PCI with drug-eluting stents and CABG in patients with DM. Only further study will continue to unravel the mechanisms at play and optimal therapy in the face of the profoundly virulent atherosclerotic potential that accompanies diabetes mellitus.     

The paclitaxel-eluting stent in percutaneous coronary intervention: Part II. Comparison with the sirolimus-eluting stent, economics, and unanswered questions

The paclitaxel- and sirolimus-eluting stents are currently the only drug-eluting stents approved for use in the United States. These 2 stents differ in terms of mechanism of drug action, the construct of the stent itself, and the drug delivery polymer. Clinical trials have demonstrated superiority of both paclitaxel- and sirolimus-eluting stents when compared with bare-metal stents in terms of reducing restenosis and the need for target vessel revascularization. Recently published head-to-head trials have not conclusively shown 1 drug-eluting stent to be superior to the other, but have demonstrated more favorable angiographic results with the sirolimus-eluting stent compared with the paclitaxel-eluting stent; however, no significant difference has been demonstrated in clinical outcomes such as myocardial infarction or death. In terms of economics, the paclitaxel-eluting stent is substantially more expensive than the bare-metal stent. However, by significantly reducing the risk of restenosis and need for repeat revascularization, the higher direct cost of the paclitaxel-eluting stent may in theory be offset by lower overall healthcare costs, although economic analyses have yet to definitively establish that the paclitaxel-eluting stent is truly cost-effective. There is still much to be discovered regarding the paclitaxel-eluting stent, specifically the optimal stent design and drug release mechanism, the relative safety and efficacy of the paclitaxel-eluting stent compared with other drug-eluting stents, the long-term effects of the paclitaxel-eluting stent, the ideal antiplatelet regimen to use in patients with a paclitaxel-eluting stent, the safety and efficacy of the paclitaxel-eluting stent in various high-risk patient groups, and the ultimate cost-effectiveness of this device.     

Sirolimus-eluting stents for percutaneous coronary intervention in acute myocardial infarction Lesson from a case-controlled comparison of bare metal versus drug-eluting stents in thrombus-laden lesions

BACKGROUND: Given the encouraging results on early restenosis rate with drug-eluting coronary stents, both safety and 6 months outcomes of PCI with sirolimus-eluting stents (SES) in acute myocardial infarction are scarce. METHODS AND RESULTS: Fifty consecutive patients with acute myocardial infarction were subjected to acute PCI with SES and compared to 50 matched control patients who received a bare metal stent (BMS). All patients were followed over 6 months; in addition repeat angiography was obtained in 88.0% of SES and 92.0% of BMS patients. As a result of matching both groups were similar with regard to demographic, clinical, and infarction characteristics, as well as procedural data and adjunctive medication. SES diameter was 3.0 +/- 0.1 versus 3.3 +/- 0.5 mm with BMS, while the length of stented segment was 24 +/- 11 mm with SES versus 16 +/- 8 mm with BMS (p<0.05). No subacute stent thrombosis occurred in either group. At 6 months, all-cause mortality was 2.0% with SES, and 4.0% with BMS (n. s.); reinfarction rate was 2.0% in both groups, but binary restenosis rate (4.0 versus 18.0%; p<0.05) and target vessel revascularization (TVR) were improved with SES (2.0 versus 16.0%; p<0.05) resulting in lower MACE rate of 6.0 versus 22.0% with BMS (p<0.05). CONCLUSION: Placement of SES with PCI for myocardial infarction is feasible and as safe as BMS; 6-month outcome is superior with SES due to the lower rate of both angiographic restenosis and TVR.     

Drug-eluting stents: from randomized trials to the real world

Drug-eluting stents have been developed to prevent in-stent restenosis following percutaneous coronary revascularization. In a number of randomized trials, polymer-coated sirolimus- and paclitaxel-eluting stents have been proven to markedly reduce the incidence of angiographic restenosis and repeat revascularization when compared to bare metal stents. Effectiveness of sirolimus-eluting stents in the prevention of restenosis has been confirmed in many subsets of patients and lesions not included in randomized trials, such as in-stent restenosis, chronic total occlusion, acute myocardial infarction, and others. Very promising data in the real world are emerging for utilization of paclitaxel-eluting stents as well. Other drug-eluting stents gave less brilliant results or even true failures, whilst a number of new drugs and stent platforms are under clinical or preclinical evaluation. In this review we describe the main clinical trials on drug-eluting stents, and the most recent informations derived from observational studies and registries. Moreover, preliminary results on new drug-eluting stents are summarized.     

多支冠状动脉病变患者1911例PCI二年疗效

目的评价多支冠状动脉病变（MVD）通过经皮冠状动脉介入（PCI）进行血运重建的长期疗效。方法1995年6月2003年12月连续2028例在我院成功接受PCI的MVD患者,对其心绞痛复发率、造影复查再狭窄率和主要不良心脏事件（MACE）的发生率进行回顾分析。结果2028例MVD患者,完全性血运重建率86.2%（1748/2028）,住院期间共死亡26例（总病死率1.3%）,对存活出院的2002例患者中的1911例随访24个月,随访率95.5%,其心绞痛复发率、造影复查再狭窄率和MACE发生率分别为10.7%、14.6%、25.4%,其中1754例植入普通金属支架（BMS）,157例植入药物洗脱支架（DES）。尽管DES组患者冠心病危险因素多、病变程度复杂,不稳定心绞痛占61.8%、糖尿病占41.4%、慢性完全闭塞病变（CTO）占37.6%、3支病变占58.0%,但心绞痛复发率、造影复查再狭窄率和MACE发生率均显著低于BMS组（分别为4.5%vs11.2%,3.2%vs15.7%,8.9%vs26.9%,均P<0.01）。结论PCI进行血运重建是治疗MVD的有效方法,但仍存在BMS支架术后不良事件发生率高,DES用于治疗MVD具有更好的长期疗效。     

Comparison of long-term clinical and angiographic outcomes following implantation of bare metal stents and drug-eluting stents in aorto-ostial lesions

Percutaneous coronary intervention (PCI) to aorto-ostial (AO) lesions is technically demanding and associated with high revascularization rates. The aim of this study was to assess outcomes after bare metal stent (BMS) compared to drug-eluting stent (DES) implantation after PCI to AO lesions. A retrospective cohort analysis was conducted of all consecutive patients who underwent PCI to AO lesions at 2 centers. Angiographic and clinical outcomes in 230 patients with DES from September 2000 to December 2009 were compared to a historical control group of 116 patients with BMS. Comparison of the baseline demographics showed more diabetics (32% vs 16%, p = 0.001), lower ejection fractions (52.3 ± 9.7% vs 55.0 ± 11.5%, p = 0.022), longer stents (17.55 ± 7.76 vs 14.37 ± 5.60 mm, p <0.001), and smaller final stent minimum luminal diameters (3.43 ± 0.53 vs 3.66 ± 0.63 mm, p = 0.001) in the DES versus BMS group. Angiographic follow-up (DES 68%, BMS 66%) showed lower restenosis rates with DES (20% vs 47%, p <0.001). At clinical follow-up, target lesion revascularization rates were lowest with DES (12% vs 27%, p = 0.001). Cox regression analysis with propensity score adjustment for baseline differences suggested that DES were associated with a reduction in target lesion revascularization (hazard ratios 0.28, 95% confidence interval 0.15 to 0.52, p <0.001) and major adverse cardiac events (hazard ratio 0.50, 95% confidence interval 0.32 to 0.79, p = 0.003). There was a nonsignificantly higher incidence of Academic Research Consortium definite and probable stent thrombosis with DES (n = 9 [4%] vs n = 1 [1%], p = 0.131). In conclusion, despite differences in baseline characteristics favoring the BMS group, PCI with DES in AO lesions was associated with improved outcomes, with lower restenosis, revascularization, and major adverse cardiac event rates.     

Long-term clinical outcome after implantation of medium Palmaz (biliary) stents in very large native coronary arteries.

Intracoronary stenting has been shown to improve acute and long-term clinical results compared with coronary angioplasty. However, clinical outcome after medium Palmaz biliary (PB) stent implantation in very large native coronary arteries (> 4 mm in diameter) is unknown. This study evaluated restenosis and long-term clinical outcome after PB stenting in large native coronary arteries. Between June 1993 and December 1998, 55 patients with 56 lesions were treated with PB stents. Intracoronary stent deployment was successful in all 56 vessels attempted (100%). The mean stenosis was reduced from 65% +/- 10% to 4% +/- 14%. In 48 of the 56 vessels (86%), vessel size was greater than 4.0 mm in diameter and the mean reference vessel diameter was 4.73 +/- 0.7 mm after stenting. Angiographic success was achieved in 100%. Five patients had postprocedural cardiac enzyme elevation. There was no periprocedural death, emergency coronary artery bypass surgery, repeat target lesion revascularization, or acute stent thrombosis. Long-term clinical follow-up at mean of 28 +/- 15 months was obtained in 96% of the patients. Clinical restenosis rate occurred in 18% of ostial (6/34) and 0% of nonostial (0/22) lesions (P < 0.0001) with an overall clinical restenosis rate of 11%. Repeat angioplasty were performed in these six patients. There were three cardiac and three noncardiac deaths. The overall event-free survival at 1 and 3 years was 92% +/- 4% and 80% +/- 6%, respectively. PB stent implantation in very large native coronary arteries can be performed with a high degree of procedural success and low in-hospital complications. The long-term clinical outcome of patients undergoing PB stenting is associated with excellent event-free survival. However, stenting of ostial lesions remains as an important factor for restenosis even in very large coronary artery stenting.     

Drug-eluting stent-supported percutaneous coronary intervention for chronic total coronary occlusion.

OBJECTIVES: This study sought to determine the clinical and angiographic outcomes after drug-eluting stent (DES)-supported percutaneous coronary intervention (PCI) for chronic total coronary occlusion (CTO). BACKGROUND: There are few data about the efficacy of DES-supported PCI for CTO. METHODS: All consecutive patients who had a sirolimus-eluting stent or a paclitaxel-eluting stent implanted for CTO from December 2003 to December 2004 were analyzed. Clinical and angiographic outcomes of patients treated with DES were compared with a case-matched control group of patients treated with bare metal stents (BMS) in the 12 months before the routine use of DES. RESULTS: Successful DES-supported PCI was performed in 92 patients and 104 CTO. The case-matched control group consisted of 26 patients and 27 CTO successfully treated with BMS. There were no differences between groups in baseline clinical and angiographic characteristics. Stent length in the DES group was higher as compared with that of BMS group (51+/-28 mm vs. 40+/-19 mm, P=0.073). The 6-month major adverse cardiac event (MACE) rate was lower in the DES group as compared with that of BMS group (9.8% vs. 23%, P=0.072). The angiographic follow-rate was 80% in the DES group and 81% in the BMS group. The 6-month restenosis rate was 19% in the DES group and 45% in the BMS group (P<0.001). By multivariate analysis, it was found that in the DES group, the only predictors of restenosis were stented segment length (OR 1.031, 95% CI 1.01-1.06, P=0.009) and a target vessel reference diameter<2.5 mm (OR 6.48, 95% CI 1.51-27.83, P=0.012), while the only predictor of MACE was stent length (OR 1.04, 95% CI 1.01-1.08, P=0.006). CONCLUSIONS: DES implantation for CTO decreases the risk of mid-term restenosis and MACE. Small vessels and diffuse disease requiring the implantation of multiple stents and very long stents for full coverage of the target lesion are still associated with a relatively high risk of restenosis.