小血管支架术290例临床疗效观察

目的　观察小血管支架术手术成功率、术后即刻效果、术后主要临床不良事件发生情况及远期再狭窄率。方法　观察我院 1997年 4月至 2 0 0 2年 3月所纳入的 2 90例小血管支架患者的 2 99支血管 30 4处病变共 316个小血管支架 (支架直径 <3 0mm)术后的手术成功率 ,术后即刻效果 ,主要临床不良事件发生情况及远期再狭窄率。随访 1个月至 4年 ,其中 12 2例行冠状动脉造影术复查。结果　手术成功率 10 0 % ,支架全部顺利置入。血管狭窄率由 89%± 12 %改善至术后的 5 %± 5 % (直径法 ) ,术后 1个月随访 2 0 2例( 6 9 7% ) ,存活 197例 ,5例于术后 3h～ 7d死亡。 2例死于术后持续低血压 ,1例死于急性左心衰 ,2例猝死。 180例随访 5个月至 4年 ,无事件存活率 (NES) 73 3% ( 132 / 180 )。其中 12 2例行冠状动脉造影复查 ,39例发生支架内再狭窄( 30 3% ) ,37例二次行PCI,2例行CABG ,再狭窄患者中 2例二次PCI后再次发作心绞痛 ,经冠脉造影证实再次再狭窄1例行第 3次PTCA ,1例行CABG。 1例患者术后 2年死于心衰 ,1例术后 3年再发急性心肌梗死 (为支架术相关动脉 )。结论　小血管支架术手术成功率高 ,术后即刻效果好 ,术后主要不良事件率 (死亡、AMI及TLR)未增高 ,术后远期无事件存活率较高 ,再狭窄率较大血管支架     

Clinical and angiographic outcome after angiography-guided stent placement in small coronary vessels

BACKGROUND: Although it is widely accepted that stenting confers favorable angiographic and clinical results in coronary arteries >/=3.0 mm in diameter, the outcome of stent placement in smaller vessels remains largely unclear. METHODS AND RESULTS: We sought to specifically determine the early and long-term clinical outcomes in a large series of 197 consecutive patients who underwent stent placement in 207 vessels <3.0 mm in diameter. Procedural success, accomplished in 97.3%, was accompanied by a significant reduction in lesion severity from 85% +/- 9% before to 3% +/- 7% diameter stenosis after the procedure (P =.0001) and a 0.5% incidence of subacute stent thrombosis. At 1 and 2 years of follow-up, survival rate without major target lesion-driven events was observed in 77.3% and 73.9% of patients, respectively. Repeat revascularization procedures accounted for most of these events; cardiac deaths (including those related to subacute stent thrombosis) and late (>30 days) myocardial infarctions were infrequent (2.4% and 1.0%, respectively). The 6-month angiographic binary instent restenosis rate was 30.1%. On multivariate analysis, diabetes mellitus (P =. 0275), small baseline reference vessel size (P =.0300), and stent size 相似文献   

Clinical and angiographic outcomes after Tsunami coronary stent placement

STUDY AIM: The aim of this study was to determine six months restenosis rate measured by off-line quantitative coronary angiography, and to assess the efficacy and safety of newly developed six cells Tsunami stent system for the treatment of symptomatic, de novo, native coronary artery lesions. STUDY DESIGN AND METHODS: Between January and August 2001, 100 patients with 120 lesions were included at four clinical sites in this prospective, non-randomized, single arm study. In 35% of the patients two or more stents were implanted, 15% of the lesions were stented with more than one stent and 46% of the lesions were in small vessels (相似文献   

冠状血管病变特征对支架术后再狭窄的预测价值

目的 :探讨冠状血管病变特征对支架术后再狭窄的影响。方法 :冠状动脉造影 (CAG)随访支架术后患者共 110例 ,定量 (QCA)分析术前、术后即刻和随访时靶血管造影结果 ;比较支架术前靶血管及患者临床资料 ,应用单因素和多因素回归法分析术前靶血管解剖学和临床危险因素与再狭窄的相关性。结果 :再狭窄组中术前甘油三酯有增高趋势 ,但与无再狭窄组比较差异无显著性意义 (P >0 .0 5 )。单因素分析表明 ,再狭窄组血管术前狭窄程度、靶血管最小管腔直径和病变分型与无再狭窄组比较差异显著 (P <0 .0 5 ) ;多因素逐步回归分析表明 ,术前靶血管最小管腔直径和病变分型是再狭窄形成的独立危险因素 ,其OR值分别为 0 .12 0和 2 .6 4 2。结论 :冠状血管病变特征对支架术后再狭窄具重要预测价值。     

Mid-term clinical and angiographic follow-up outcome after placement of a new balloon expandable stent in native coronary arteries.

The widely disparate characteristics that exist among the different stent designs currently available for clinical use may impact on their acute and late angiographic and clinical results. The BeStent (Medtronic Instent, MN) is a relatively new stainless steel, laser-cut, serpentine stent design with only very limited data regarding its performance. In this report, we examined the results of 74 consecutive patients (54 men, 20 women; mean age, 58 years) treated with 76 BeStents in 75 native coronary arteries with a mean reference size of 2.8 mm. Successful stenting without 30-day major adverse cardiac complications was achieved in 97.3% of procedures, resulting in a significant improvement in diameter stenosis from 85% to 2% (P = 0.0001). Six-month angiographic restudy in 88% of patients revealed a per-lesion in-stent restenosis rate of 27%. At a mean follow-up period of 9.3 months, there were no deaths or myocardial infarctions. In summary, the present study demonstrates that the BeStent has an excellent performance profile, is associated with a low risk of stent thrombosis, and yields an acceptable restenosis rate despite the inclusion of a high proportion of patients with diabetes (41%) and small vessels (< 3.0 mm in diameter; 77%).     

Effects of cilostazol on angiographic restenosis after coronary stent placement

This study evaluates the impact of cilostazol on post-stenting restenosis. Cilostazol is a potent antiplatelet agent with antiproliferative properties. Few data are available about the effect of cilostazol on poststenting restenosis. Four hundred nine patients (494 lesions) who were scheduled for elective stenting were randomized to receive aspirin plus ticlopidine (group I, n = 201, 240 lesions) or aspirin plus cilostazol (group II, n = 208, 254 lesions), starting 2 days before stenting. Ticlopidine was given for 1 month and cilostazol for 6 months. Follow-up angiography was performed at 6 months, and clinical evaluation at regular intervals. Baseline characteristics were similar between the 2 groups. The procedural success rate was 99.6% in group I and 100% in group II. There were no cases of stent thrombosis after stenting. Angiographic follow-up was performed in 380 of the 494 eligible lesions and the angiographic restenosis rate was 27% in group I and 22.9% in group II (p = NS). However, diffuse type in-stent restenosis was more common in group I than in group II (54.2% vs 26.8%, respectively, p <0.05). In diabetic patients, the angiographic restenosis rate was 50% in group I and 21.7% in group II (p <0.05). Clinical events during follow-up did not differ between the 2 groups. In conclusion, aspirin plus cilostazol seems to be an effective antithrombotic regimen with comparable results to aspirin plus ticlopidine, but it does not reduce the overall angiographic restenosis rate after elective coronary stenting.     

Usefulness of predictors of angiographic restenosis to predict clinical restenosis after coronary stent placement

INTRODUCTION: After coronary stenting, several predictors of angiographic in-stent restenosis have been identified in different studies, however, little is known about predictors of clinical restenosis, a more functional aspect of coronary restenosis. AIM: To assess whether risk factors for angiographic restenosis previously described, are able to predict clinical restenosis and at what rate in current practice. PATIENTS AND METHODS: 216 consecutive patients (271 stents in 256 lesions) with procedural success were followed-up for 17.6 +/-10 months during periodic visits. Clinical restenosis was defined as the presence of symptoms or signs of myocardial ischemia, associated with >= 50% diameter stenosis on the angiogram. RESULTS: Clinical restenosis occurred in 33 lesions (13%), which were revascularized with 34 stents associated with unstable angina in 29, acute myocardial infarction in three and death in one case. Multivariate analysis identified as independent predictors of clinical restenosis, a vessel diameter less than 3 mm (p < 0.001, OR 4.5), a restenotic lesion (p = 0.01, OR 2.9) and the presence of residual stenosis by visual estimate (> 0%) after implantation (p = 0. 02, OR 2.5). These three risk factors explained most clinical restenosis (73%), with rates of 22% when at least one was present and 4% in absence of all these. The presence of diabetes mellitus, the location in the anterior descending coronary artery or at coronary ostium, and the number or total length of stents per lesion did not achieve an independent, significant association as predictors of clinical restenosis. CONCLUSIONS: Most clinical restenosis after coronary stenting can be predicted by the restenotic character of the revascularized lesion, the diameter of the vessel being less than 3 mm and the presence of residual stenosis by visual estimate at the end of procedure.     

Long-term clinical and angiographic follow-up after placement of Palmaz-Schatz coronary stent: a single center experience

The purpose of this study is to evaluate long-term clinical and angiographic follow-up results after placement of the Palmaz-Schatz stent and angiographic follow-up results of repeat interventions for stent restenosis. From June 1990 to September 1993, the Palmaz-Schatz stent was placed in 411 patients, 427 lesions. Follow-up angiography was performed in 307 lesions at 3-6 months and in 189 lesions at 1 year. Palmaz-Schatz stent implantation resulted in 97.2% procedure success and 94.6% clinical success. Stent thrombosis was observed in 2.2%. Angiographic restenosis rate was 16.3% at 3-6 months study. At 1 year study, "new" restenosis occurred only in 2.3%. Minimal lumen diameter did not change between 6 months and 1 year (2.32 +/- 0.51 mm vs 2.30 +/- 0.54 mm). With the mean follow-up interval of 22 +/- 9 months, cardiac event-free survival was achieved in 74.3%. Among 50 lesions with restenosis, stent restenosis occurred diffusely in 15 lesions (30%), focally inside the stent in 22 lesions (44%) and focally at the stent border in 13 lesions (26%). Repeat interventions were performed in 35 lesions. Restenosis at 3 months after repeat intervention was demonstrated in 9 (32.1%) out of 28 lesions restudied. Restenosis rate after repeat intervention for diffuse stent restenosis was significantly higher than that for focal in-stent restenosis (75% vs 7.7%). Palmaz-Schatz stent implantation was associated with a high initial success rate and a low late restenosis rate. Luminal renarrowing did not occur beyond 6 months up to 1 year.     

Long-term angiographic and clinical outcome after implantation of a ballon-expandable stent in the native coronary circulation

Objectives. The purpose of this study was to examine the long-term clinical and angiographic outcome after coronary implantation.Background. Previous reports haw shown a discordance between the excellent initial angiographic results and subsequent adverse clinical events after coronary artery stenting.Methods. Single Palmaz-Schatz stents were electively implanted in the native coronary arteries of 300 consecutive patients. Angiograms were obtained at baseline, after balloon angioplasty, after stent implantation and at 6 months after implantation. Films were analyzed by a panel of engiographers utilizing en automated edge detection program, Clinical events, including death, myocardial infarction, coronary bypass surgery and repeat angioplasty, were recorded for 1 year.Results. Although there were no acute in-laboratory vessel closures, stent thrombosis occurred in 14 patients (4.7%) at a mean ±SD of 5 ± 3 days after implantation. Two hundred fifty-eight (90%) of 286 eligible patients had follow-up angiography at 6.1 ± 2.2 months after stent implantation. Minimal lumen diameter increased from 0.80 ± 039 mm at baseline to 1.65 +- 0.51 mm after angioplasty and further increased to 2.55 ± 0.49 mm after stent placement (p = 0.0001). At follow-up there was a 0.85-mm late loss in lumen diameter, with a final minimal lumen diameter at 6 months of 1.70 ± 0.71 mm. Restenosis, defined as ≥ 50% diameter stenosis at follow-up, occurred in 14% of patients with previously untreated lesions and in 39% of patients with previous angioplasty (p < 0.001). Clinical events after 1 year for the entire group of 300 patients included death in 0.7%, myocardial infarction in 3.7%, bypass grafting in 8% and repeat angioplasty in 13%. Freedom from any adverse clinical event was 80% for all treated patients and 87% for those with previously untreated lesions.Conclusions. Elective use of this balloon-expandable stent in the native coronary circulation is associated with a low restenosis rate by quantitative angiography in previously untreated lesions and a favorable clinical outcome with an excellent event-free survival rate at 1 year.     

Restenosis detected by routine angiographic follow-up and late mortality after coronary stent placement

Background

Routine 6-month follow-up angiography (FU angio) is the most sensitive tool to detect restenosis. Thus, FU angio protocols have been a pivotal part of trials on long-term efficacy of stents. However, it is unclear if such protocols supply data relevant for the prognosis of individual patients. The purpose of this study was to assess the impact of angiographic restenosis detected by FU angio on late mortality after coronary stent placement.

Methods and results

We analyzed 2272 consecutive patients with successful stent placement performed from May 1992 through December 1996. All patients were scheduled for 6-month FU angio and contacted again after 4 years. FU angio was performed in 1958 patients. Of those, 557 patients (28.4%) had restenosis. After 4 years, 8.8% of patients with restenosis died, compared to 6.0% without (P = .02). There were several significant differences in clinical and angiographic characteristics between the 2 groups. In a multivariate analysis including those characteristics plus restenosis, only older age and restenosis were independent risk factors for late mortality. In patients with severe restenosis (>75% of lumen diameter; n = 231), late mortality was 7.6% in those with target vascular revascularization, compared to 14.9% without (P = not significant).

Conclusions

In this analysis, mortality 4 years after stent placement was higher in patients with angiographic restenosis. Restenosis was an independent risk factor for late mortality, with a potential benefit after target vessel revascularization in severe restenoses. These data suggest that routine FU angio after stenting provides data relevant for long-term prognosis of patients.     

Early and mid-term angiographic and clinical results after intracoronary duet stent placement.

The Duet stent (Guidant/Advanced Cardiovascular Systems) is a new stent with a corrugated ring design and very limited data on its short- and mid-term performance. Accordingly, in this study we sought to determine the early and mid-term clinical and angiographic outcomes in a moderate-sized series of 86 consecutive patients who underwent placement of 108 premounted Duet stents in 98 coronary lesions. Procedural success, accomplished in all patients, was accompanied by a significant reduction in lesion severity from 89% +/- 11% before to 5% +/- 3% diameter stenosis after the procedure (P = 0.0001) and a 0.9% incidence of subacute stent thrombosis. Angiographic restudy at 5.7 months in 89% of eligible patients revealed a binary in-stent restenosis rate of 26%. Coronary stenting with the new Duet stent confers a low risk of stent thrombosis and a favorable mid-term clinical and angiographic outcome despite the presence of a large proportion of patients at high risk of in-stent restenosis.     

Predictive factors for early cardiac events and angiographic restenosis after coronary stent placement in small coronary arteries

OBJECTIVES: The rationale of this study was to identify risk factors that predict early thrombotic events and angiographic restenosis after stenting in small coronary arteries. BACKGROUND: Rates of cardiac complications and restenosis after percutaneous coronary intervention are higher in patients with small versus large coronary arteries. Because of discordant results, randomized studies comparing stent placement with balloon angioplasty could not establish the best interventional approach to use in this high-risk subset of patients. This study of predictive factors, with special focus on stent design, may provide particular help in this regard. METHODS: Clinical, lesion-related, and procedural data of a large and unselected population of 3,156 consecutive patients were analyzed in a logistic regression model for both early and late complications. Repeat angiography at six months was performed in 80.8% of eligible patients. RESULTS: The strongest risk factors for early thrombotic events (cumulative incidence of 4.2%) were the presence of an acute coronary syndrome and reduced left ventricular function. The stent design had no influence on early thrombotic complications. Restenosis (overall rate of 38.4%) was predominantly influenced by procedure-related variables, including the stent design and stented segment length. The incidence of restenosis varied from 29.6% to 55.8%, depending on the stent design used. CONCLUSIONS: Clinical factors known before the procedure are predominant risk factors for early thrombotic complications, underscoring the need for potent antiplatelet regimens in these patients. In contrast, our findings suggest a major impact of procedural factors, including the choice of stent type, on restenosis.     

Cinical and angiographic outcome after implantation of a home-made stent for complicated coronary angioplasty

To defray the escalating costs of coronary stenting, we handmade a balloon-expandable, stainless steel stent, which after experimental evaluation, was implanted in 156 patients undergoing PTCA complicated by a major dissection. The procedural success rate was 98%. The in-hospital course was characterized by a 1.3% cardiopulmonary mortality and a 4.5% nonfatal myocardial infarction rate, while emergency bypass surgery and early repeat PTCA were necessary in only one patient each (0.6%). Clinical 6-mo follow-up in 150 patients revealed no deaths and no myocardial infarctions, and the event-free survival rate was 82%. Six-month control angiography was performed in 93.3% of eligible patients and revealed a restenosis rate of 20%. Cathet. Cardiovasc. Diagn. 42:339–347, 1997. © 1997 Wiley-Liss, Inc.     

Impact of metabolic syndrome on clinical and angiographic outcome after sirolimus-eluting stent implantation

BACKGROUND: Patients with metabolic syndrome (MetS) are at increased risk of cardiovascular events. The impact of MetS on clinical events and restenosis after drug-eluting stent placement is not well defined. METHODS: Two hundred and seventy-four consecutive patients with 298 de-novo coronary lesions (<50 mm lesion length, reference diameter<3.5 mm) successfully treated with sirolimus-eluting stents (SES) were enrolled in the study. Bifurcation lesions, left main lesions and ST-segment elevation myocardial infarcts were excluded. Patients were categorized into three groups: (i) diabetes, (ii) MetS without diabetes, (iii) controls without MetS or diabetes. MetS was defined as presence of > or =3 of the following criteria: obesity, hypertension, hypertriglyceridemia, low high-density lipoprotein cholesterol, raised fasting glucose. RESULTS: One hundred and twenty-one patients (44%) with 134 lesions had neither MetS nor diabetes, 84 patients (31%) with 89 lesions had MetS without diabetes and 69 patients (25%) with 75 lesions had diabetes. Baseline angiographic parameters were comparable between the three groups. Clinically driven target lesion revascularization rates and major adverse cardiac event rates at 12 months were 1, 1, 7% (P=0.039) and 3, 6 and 14% (P=0.032), respectively, for controls, patients with MetS/no diabetes and diabetic patients. Follow-up angiography at 6 months demonstrated late loss in lesion, which was 0.10+/-0.33 mm in the controls, 0.10+/-0.20 mm in patients with MetS/no diabetes and 0.36+/-0.66 mm in diabetic patients (P=0.009). CONCLUSION: MetS without diabetes does not result in an increase in target lesion revascularization, major adverse cardiac event rates or angiographic late loss compared with control patients after implantation of SES in de-novo coronary lesions.     

A comparison of clinical and angiographic outcome after implantation of a Wiktor stent in large and small coronary arteries]

The objective of this study was to investigate the mid term influence of vessel size in clinical and angiographic outcome, after Wiktor stent implantation in arteries larger and smaller than 3 mm. METHOD: A total of 188 stents were implanted in 167 patients divided in two groups. Group 1: stents implanted in arteries smaller than 3 mm, 40 stents in 38 patients. Group 2: in arteries larger than 3 mm. 148 stents in 129 patients. Clinical follow up and a repeated coronary angiographic study were carried out after six months. RESULTS: Angiographic success was achieved in 97% and 98% cases, with clinical success in 92% and 95% respectively. Acute occlusion occurred in 2 patients of group 1 (5%), and in four patients in group 2 (2.7%); one patient died and four patients suffered a non-fatal myocardial infarction. During clinical follow up, nine patients presented a major complication, two in group 1 and seven in group 2 (5.5% vs. 5.6%). Asymptomatic survival was 86% and 84% respectively. In angiographic follow up we observed a restenosis rate of 41% of the patients in group 1 and 25% of those in group 2. Immediate gain was similar in both groups, but late loss (1.06 +/- 0.85 vs 0.97 +/- 0.86) and loss rate (0.60 vs 0.46) were greater in group 1. CONCLUSION: The frequency of stent thrombosis as well as the incidence of restenosis were higher in arteries smaller than 3 mm. No differences were observed in the incidence of major ischemic events.     

Operator volume and outcome of patients undergoing coronary stent placement

Objectives. The aim of this study was to assess the relation between operator experience in coronary stent placement procedures and the clinical outcome of patients.Background. The results of coronary balloon angioplasty are closely related to the experience of the operator performing the procedure. Data on the effect of operator experience on the results after coronary stent placement are missing.Methods. The study included 3,409 consecutive patients undergoing coronary stent placement for the management of coronary artery disease. A composite end point of cardiac death, myocardial infarction and aortocoronary bypass surgery during the first 30 days after the intervention, was the primary end point and the procedural failure was the secondary end point of the study.Results. Adverse clinical outcome occurred in 2.99% of the 3,409 patients undergoing coronary stent placement. Procedural failure was recorded in 2.08% of the patients. Operator volumes above 483 procedures were associated with a risk-adjusted adverse outcome rate of 1.70% ± 1.28%, which is significantly lower than the overall rate of 2.99%. Operator yearly volumes of under 90 procedures were associated with a risk-adjusted adverse outcome rate of 4.59% ± 1.17%, which is significantly higher than the overall rate of 2.99%. The operator experience was an independent predictor even after adjusting for the effect of other risk factors. The analysis demonstrated that an experience of at least 100 procedures is required to obtain better outcome even in patients with simple coronary lesions and that operators should perform at least 70 procedures annually to expect a better outcome in patients with both simple and complex coronary lesions.Conclusions. Operator experience is a significant and independent predictor of the outcome of patients undergoing coronary stent placement. An experience of at least 100 procedures and an annual volume of at least 70 procedures are required to ensure a significantly better outcome after coronary stent implantation.