Head-to-Head Comparison of Sirolimus-Eluting Stents versus Paclitaxel-Eluting Stents in Patients Undergoing Percutaneous Coronary Intervention: A Meta-Analysis of 76 Studies

Background

The relative short-, long- and overall-term efficacy and safety of sirolimus-eluting stents (SES, Cypher) compared with paclitaxel-eluting stents (PES, Taxus) in large head-to-head comparisons still remain to be defined.

Methods

We searched Pubmed, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL) for articles comparing outcomes of interest between SES and PES without language restriction. Short- (≤1 year), long- (>1 year), and overall-term (the longest follow-up of each study) outcomes were evaluated. The primary endpoint was target lesion revascularization (TLR). Other outcomes of interest were target vessel revascularization (TVR), myocardial infarction, all-cause death, cardiac death, stent thrombosis, major adverse cardiac events (MACEs), restenosis and late lumen loss.

Results

Seventy-six studies including more than 15000 patients in randomized controlled trials and over 70000 patients in adjusted observational studies were included. At overall-term follow-up, SES significantly reduced TLR (relative risk [RR]: 0.61; 95% confidence interval [CI]: 0.49–0.76), TVR (RR: 0.67; 95% CI: 0.54–0.83), MACE (RR: 0.79; 95% CI: 0.72–0.87), myocardial infarction (RR: 0.85; 95% CI: 0.73–0.99), in-segment restenosis (RR: 0.50; 95% CI: 0.38–0.65), and in-segment late lumen loss (weighted mean difference [WMD]: −0.19; 95% CI: −0.24–−0.14) in randomized controlled trials compared with PES. In addition, lower rates of death (RR: 0.91; 95% CI: 0.83–1.00), any stent thrombosis (RR: 0.62; 95% CI: 0.45–0.86), definite stent thrombosis (RR: 0.59; 95% CI: 0.45–0.77) were found in patients receiving SES in adjusted observational studies. Largely similar results were found at short- and long-term follow-up, and in patients with diabetes, acute myocardial infarction or long lesions.

Conclusions

SES significantly reduced the short-, long- and overall-term risk of TLR/TVR, MACE, and restenosis, and overall-term risk of myocardial infarction in randomized controlled trials, as compared with PES. Lower rates of death and stent thrombosis were also observed in observational studies in SES-treated patients.     

Results of coronary stenting in relation to the length of an implanted stent

The paper considers the impact of the length of an implanted stent on the early and late outcomes of intracoronary stenting. The study included 177 patients on a retrospective basis. They all underwent intracoronary stenting of 215 stenoses. All the patients were divided into three groups in relation to the length of an implanted segment (under 20 mm, 20-30 mm, and under 30 mm). In 16 (9.04%) of the 177 patients, for complete stenosis correction, several, but not one, stents were inserted, i.e. multiple stenting of a coronary stenting was performed. The stents were implanted by the conventional procedure. There was no significant difference in clinical and angiographic success rates between the patients of all three groups. There were no complications, such as transmural myocardial infarction and deaths in any groups. Acute stent thrombosis was noted only in 1 (1.8%). There was no significant difference in the incidence of subacute stent thrombosis between Groups 2 and 3 patients. No case of subacute thrombosis of implanted stents was noted in Group 1 patients. Thus, acute and subacute stent thromboses were observed in 4 (2.3%) patients, they being all from Groups 2 and 3. There was no significant difference in the development of restenosis between Groups 1 and 2 and Groups 2 and 3. At the same time, restenosis significantly more frequently developed in patients from Group 3 than in those from Group 1. Thus, the findings indicate that the length of a stented segment is an important factor that influence both early and late outcomes of intracoronary stenting.     

Clinical trends in stent treatment of simple and complex coronary disease

This is a retrospective analysis of a consecutive group of patients from a single medical center who underwent stent implantation. It describes 316 patients who constituted 53% of the angioplasty procedures carried out in a single year. The authors describe the complications and their 1-year follow-up. We aimed to study the short and long-term results of stenting in our centre in relation to multiple clinical and angiographic variables. During 1996, 316 consecutive patients were treated with stent implantation for a total of 381 coronary lesions. The pharmacological protocol methods of stent implantation and patient characteristics were used. Clinical variables were: age 59.1 3 10.7 years, diabetes mellitus 25.3%, hypertension 33.0% and angina pectoris 88.7% (unstable in 44.1%). Previous coronary surgery had been undergone by 9.2%. Multivessel disease was present in 56% of the patients. The indications for stenting were: primary 58.5%, suboptimal results 33.0% and threatened or acute occlusion 8.5%. Angiographic success was 98.9% and clinical success 96.8%. The major in-hospital complications were acute myocardial infarction (2.2%), acute revascularization (0.3%) and major bleeding (0.6%). All occurred within 24 h of revascularization. Repeated angiography was performed in 115 cases (30.2%) at 160.3 3 109.4 days after stent procedure for unstable angina (38.7%), stable angina (26.1%) and other causes (35.2%). The restenosis rate in those catheterized was 38.1%, with an overall clinical restenosis rate of 11.3% during the follow-up period. Restenosis was more prevalent among diabetic patients (17.9 vs 9.15%, P 3 0.02) and patients with prior balloon angioplasty (18.6 vs 9.75%, P 3 0.046). Clinical follow-up was available in 90.8% of the patients for 291 3 112 days. The actuarial survival at the end of the follow-up period was 93.8%. Death/myocardial infarction was associated with unstable angina pectoris (P 3 0.006), hypertension (P 3 0.001), smoking (P 3 0.046) and threatened or acute occlusion (P < 0.001). In the first year of extensive stent use, stenting is associated with high technical and clinical success rates. Long-term results after stent implantation are associated with the occurrence of acute or threatened occlusion, and the in-hospital complications diabetes mellitus and hypertension.     

Initial and long-term results with the CrossFlex stent--data from a national registry

The Cordis CrossFlex trade mark stent is a balloon expandable helical coil made of stainless steel. OBJECTIVE: To assess the short- and long-term safety and efficacy of this stent by conducting a multi-center national registry. METHODS: One hundred and sixteen stents were implanted in 109 patients (mean age 59 3 10 years, 95 males). The lesions were classified as type B2 or C in 56 patients (51%). Successful deployment was achieved in 103 patients (94.5%). Failure was due to damage to the stent (two patients) or inability to reach the lesion (four patients). High-pressure deployment (>14 atm) was used in 68% of cases. RESULTS: Edge dissections occurred in nine patients after high-pressure deployment and necessitated implantation of a second stent. One patient with a large acute myocardial infarction died during hospitalization. Side branch occlusion occurred in five patients (4.6%). Subacute thrombosis occurred in two patients (1.8%) during the first four weeks. During a six-month follow-up period, 18 patients (16.5%) were rehospitalized with recurrent angina. Fifteen patients had coronary angiography and 13 (12.1%) needed additional target lesion revascularization (TLR). Twelve patients required a second PTCA for in-stent restenosis, and one needed a coronary artery bypass graft operation. CONCLUSIONS: The CrossFlex coronary stent can successfully be used in complex coronary lesions, with few short-term complications and a low TLR rate. Operators should be aware of the possibility of edge dissection during high-pressure implantation.     

Clinical and angiographic results with the NIR stent: First International NIR Endovascular Stent Study (FINESS-II)

BACKGROUND: Although safety and efficacy of the NIR trade mark stent have been reported, the long-term angiographic and clinical outcomes have yet to be investigated. The FINESS-II study (First International NIR Endovascular Stent Study) was designed to assess the procedural safety of single 9 and 16 mm NIR stent implantation, the six-month restenosis rate and finally the six- and 12-month clinical outcome of patients treated with this novel coronary stent. METHODS: Patients with angina and a single de novo lesion in a native coronary artery of >3 and <5 mm diameter were included in this multicentre, prospective, observational trial. Clinical follow-up was obtained at one, six and 12 months. Angiography was performed before and after the stent implantation and at six months. The primary endpoint included major adverse cardiac events (death, myocardial infarction and target lesion revascularization) within 30 days after the procedure. Major bleeding complications and subacute stent thrombosis within the first 30 days were also reported as specific endpoints. Secondary endpoints were major cardiac-event-free survival at six- and 12-month follow-up and angiographic restenosis at six months. RESULTS: A total of 156 patients (81% male, mean age 60 +/- 10 years), with stable (54%), unstable (40%) angina pectoris or silent ischemia (6%) were enrolled. The target vessel diameter was 2.94 +/- 0.54 mm. The minimal lumen diameter pre, post and at follow-up was 1.04 +/- 0.32 mm, 2.64 +/- 0.42 mm and 1.88 +/- 0.63 mm, respectively. Restenosis rate according to the >50% diameter stenosis criterion at six month follow-up was 19% (26/136). At 12 months, the event-free survival rate was 83% (two deaths, one Q-wave and three non-Q-wave myocardial infarctions, four bypass surgery and 17 target lesion revascularizations), while 87% of the patients were free of angina pectoris. CONCLUSION: the outcome of the FINESS-II trial is comparable to those observed in previous stent trials (Benestent II), indicating that the coronary NIR stent is safe and effective as a primary device for the treatment of native coronary artery lesions in patients with (un)stable angina pectoris.     

Efficiency of endovascular re-interventions for evolving restenosis of different types of stents

The paper compares the results of different treatment options (balloon angioplasty and restenting) for in-stent restenosis in case of evolving restenosis of drug- and nondrug eluting stents. The investigation enrolled 496 coronary heart disease patients with clinical presentation of angina pectoris and/or signs of myocardial ischemia, as well as hemodynamic restenosis of a previously implanted stent. Of them, 216 and 280 patients had restenosis of previously implanted drug- and nondrug-eluting stents, respectively. In the patients with non-drug-eluting stent restenosis, recurrent angina pectoris and the frequency of repeated restenosis were significantly more frequently observed after balloon dilatation than after drug-eluting stent implantation (28.4 and 10.2%; p < 0.05; 19.9 and 8.7%; p < 0.05). In those with drug-eluting stent restenosis, recurrent angina pectoris and the frequency of repeated restenosis did not differ significantly between balloon dilatation of restenosis and implantation of a second drug-eluting stent.     

Use of "Cypher" sirolimus-eluting stents in coronary heart disease patients with different types of coronary arterial lesions

The purpose of our study was to assess the immediate and late results of treatment with Cypher drug-eluting stents (Cordis, Johnson & Johnson, USA) in patients with coronary heart disease (CHD). This was a prospective study that included 738 patients who had been implanted Cypher stents in May 2002 to March 2006. The patients' mean age was 56 +/- 9 years; there were 87% of males. The patients were randomly included into the study and they underwent coronary stenting in the routine laboratory setting. A control group comprised 162 patients who had undergone Velocity or Sonic nondrug-eluting stents of the same firm, which had the similar structure. The groups did not differ in clinical characteristics. 827 stenoses in the eluting stent group and 225 stenoses in the control group were subject to revascularization. The immediate cure rate was 95 and 94%, respectively. The total number of events (myocardial infarction, emergency coronary bypass surgery, subacute occlusion of a stented segment) was 2.3% in the eluting stent group and 2.4% in the control group. A repeated examination 1 year after surgery was made in 482 and 119 patients in the drug-eluting and nondrug-eluting groups, respectively. During the follow-up, one patient died of a extracardiac cause and 3 (0.6%) patients underwent coronary bypass surgery in the nondrug-eluting stent group; there were no deaths and 2 (1.6%) patients had coronary bypass surgery in the control group. In the eluting stent group, there were fewer cases of repeated endovascular procedures of target stenosis revascularization than in the control group (3.7% versus 11.7%; p < 0.0005). In the eluting stent group, the total number of unfavorable cardiovascular events was significantly less than that in the control group and it amounted to 3.3% as compared with 15.9% in the non-eluting stent group; p < 0.0005. Cardiovascular event-free survival was significantly higher in the eluting stent group: 92% versus 77% in the non-eluting stent group (p < 0.0005).     

Clinical outcomes of long coronary stents: a single-center experience

BACKGROUND: Coronary artery stenting is particularly useful during percutaneous coronary intervention for long lesions previously associated with a low procedural success rate and a high complication rate of dissection and occlusion. Current treatment options include implantation of a single long stent, multiple contiguous stents, or 'spot' stenting. However, multiple stent implantation may result in sections of overlapping stent or gaps of unstented segments and is an independent predictor of restenosis. The early and intermediate clinical outcome of single and multiple long stent (>/= 30 mm) implantation is not established. METHODS AND RESULTS: The authors retrospectively identified 123 consecutive patients who had undergone stenting using one or more long coronary stents. Baseline clinical data, procedural outcomes and completed clinical follow-up to 52 weeks were obtained by case-note review. The majority (69%) required intervention for stable coronary disease. Seventy-seven per cent of lesions were either type B2 or C and only 2% were in saphenous vein grafts. The procedural success rate was 94%. A total of 15 major events occurred in 13 patients (11%). Ten acute events occurred and five events were during the follow-up period from 30 days to 52 weeks. Two patients died, one from uncontrolled bleeding secondary to the use of antithrombotic agents and one at four weeks due to sudden death. One patient had a postprocedural infarct. Two patients required in-hospital repeat revascularization for acute vessel closure and eight required revascularization during follow-up (three cases of occlusion/thrombosis and five cases of restenosis). CONCLUSIONS: The use of long coronary stents (>/= 30 mm) for the treatment of long diffuse native vessel disease, saphenous vein graft disease and long coronary dissections is associated with a reasonable procedural success rate and acceptable early and intermediate-term clinical outcomes.     

No influence of hemochromatosis-related gene mutations on restenosis rate in a retrospective study of 137 patients after coronary stent implantation

BACKGROUND: Recent publications have shown an increased risk of coronary artery disease and myocardial infarction in patients with alteration of the hemochromatosis-related gene (HFE gene). The HFE gene mutation is associated with elevated iron uptake and serum iron overloading. Iron plays an important role in promoting the oxidation of LDL cholesterol. The iron deposition in the endothelium and in the media is closely associated with the progression of atherosclerosis. However, it is unclear whether the mutation of the HFE gene also influences the rate of restenosis after coronary stent implantation. METHODS: In a retrospective analysis, 137 patients (pts.) who underwent elective coronary stent implantation were angiographically reevaluated after six months. All patients were part of the OPTICUS-study population which investigated optimized stent implantation guided by intravascular ultrasound. Computerized quantitative analysis was performed in all procedures in a double-blinded fashion. At six-month follow-up, DNA fragments containing the substitution of tyrosine for cytosine at codon 282 were amplified by PCR. The results were analyzed by polyacrylamide gel electrophoresis. Statistical analysis was performed by multivariate linear regression. RESULTS: According to the HFE gene polymorphism we formed two subgroups: 129 pts. (94%) did not show changes in HFE gene (NH), 8 pts. (6%) were heterozygous for HFE Cys282Tyr (H). The groups did not differ in age, gender, extent of coronary artery disease, initial degree and length of stenosis and all patients underwent re-angiography. At six-month follow-up the average luminal narrowing in the stented vessel was 36.2 +/- 20.3% in the NH group compared with 27.8 +/- 20.0% in the H group which was statistically not significant (n. s.). The minimal luminal diameter was 1.9 +/- 0.71 mm in the NH group and 2.2 +/- 0.66 mm in the H group respectively (n. s.). 33 pts (26%) in the NH group versus 2 pts (25%) in the H group had >/= 50% diameter narrowing at follow-up (n. s.). The odds ratio of stent restenosis in H patients was 0.932. CONCLUSIONS: The authors did not find any association between restenosis rate and HFE gene alteration and therefore, we conclude that the polymorphism of the HFE gene is not a risk factor for restenosis after coronary stent implantation.     

Stent thrombosis in patients treated with thienopyridines: clinical description of 10 cases

Subacute stent thrombosis (SAST) is a major thrombotic complication of coronary stenting. Its occurrence has been substantially reduced by thienopyridine treatment. However, information on clinical profile of patients with SAST in clopidogrel era is limited. In order to define the incidence and factors predisposing to stent thrombosis, we analyzed the computerized angiographic database of three interventional cardiology centers. Out of a total number of 5903 percutaneous coronary interventions (PCIs) with stent implantation, we found 10 patients with SAST (0.17%). The indication for PCI was usually an early invasive approach (90%) during an acute coronary syndrome. All patients were treated with an apparently optimal antithrombotic regimen (90% received heparin or LMWH and 70% received IIb/IIIa receptor inhibitors and all given aspirin). In each of the patients, we could identify high-risk angiographic findings. SAST presentation was always clinically significant with definite myocardial infarction in 100% of cases. 80% of cases occurred during the first six days post PCI. Two patients had a recurrent event. Finally, despite earlier reports of atorvastatin-mediated inhibition of clopidogrel activation we did not find any patient with SAST taking both drugs. Thus, patients with stent thrombosis during thienopyridine treatment usually exhibit high-risk angiographic features. Prospective studies should be performed to elucidate drug interactions that may reduce clopidogrel efficacy and contribute to stent thrombosis.     

Stent implantation in acute myocardial infarction using a heparin-coated stent: a pilot study as a preamble to a randomized trial comparing balloon angioplasty and stenting

Preliminary experience with primary stenting in myocardial infarction has suggested a greater benefit in clinical outcome than has been obtained with direct balloon angioplasty. However, subacute thrombosis (SAT) remains a limitation for this new mode of therapy. In the BENESTENT II Pilot and main trials, the incidence of SAT with the heparin-coated Palmaz-Schatz stent was only 0.15%. Therefore, as a preamble to a large randomized trial, the feasibility and safety of the use of the Heparin-Coated Palmaz-Schatz trade mark Stent in Acute Myocardial Infarction (AMI) was tested in 101 patients enrolled between April and September 1996 in 18 clinical centres. In 101 stent-eligible AMI patients, as dictated by protocol, a heparin-coated stent was implanted. The primary objectives were to determine the in-hospital incidence of major adverse cardiac events (MACE: death, MI, target lesion revascularization) and bleeding complications, while the secondary objectives were the procedural success rate and the MACE, the restenosis and reocclusion rates at 6.5 months. Stent implantation (n 3 129 stents) was successful in 97 patients of the 101 who were included in this trial. During their hospital stay, two patients died and no patient experienced re-infarction, ischaemia prompting re-PTCA or CABG. Four patients suffered a bleeding complication, three major and one minor, of whom three required surgical repair. At 210 days follow-up, 81% of the patients were event free. At 6.5 months restenosis was documented in 18% of the 88 patients who underwent follow-up angiography, including three total occlusions. The results, both with respect to QCA and the occurrence of MACE, compare favourably with studies using elective stenting in both stable and unstable angina patients. As a result of this pilot study, a large randomized trial comparing direct balloon angioplasty with direct stenting in 900 patients with AMI was initiated in December 1996.     

Stent Thrombosis is the Primary Cause of ST-Segment Elevation Myocardial Infarction following Coronary Stent Implantation: A Five Year Follow-Up of the SORT OUT II Study

Background

The widespread use of coronary stents has exposed a growing population to the risk of stent thrombosis, but the importance in terms of risk of ST-segment elevation myocardial infarctions (STEMIs) remains unclear.

Methods

We studied five years follow-up data for 2,098 all-comer patients treated with coronary stents in the randomized SORT OUT II trial (mean age 63.6 yrs. 74.8% men). Patients who following stent implantation were readmitted with STEMI were included and each patient was categorized ranging from definite- to ruled-out stent thrombosis according to the Academic Research Consortium definitions. Multivariate logistic regression was performed on selected covariates to assess odds ratios (ORs) for definite stent thrombosis.

Results

85 patients (4.1%), mean age 62.7 years, 77.1% men, were admitted with a total of 96 STEMIs, of whom 60 (62.5%) had definite stent thrombosis. Notably, definite stent thrombosis was more frequent in female than male STEMI patients (81.8% vs. 56.8%, p = 0.09), and in very late STEMIs (p = 0.06). Female sex (OR 3.53 [1.01–12.59]) and clopidogrel (OR 4.43 [1.03–19.01]) was associated with increased for definite stent thrombosis, whereas age, time since stent implantation, use of statins, initial PCI urgency (STEMI [primary PCI], NSTEMI/unstable angina [subacute PCI] or stable angina [elective PCI]), and glucose-lowering agents did not seem to influence risk of stent thrombosis.

Conclusion

In a contemporary cohort of coronary stented patients, stent thrombosis was evident in more than 60% of subsequent STEMIs.     

Endovascular brachytherapy in coronary arteries: the Rotterdam experience

Purpose: The use of endovascular coronary brachytherapy to prevent restenosis following percutaneous transluminal coronary angioplasty (PTCA) began in April 1997 at the Department of Interventional Cardiology of the Thoraxcenter at the University Hospital of Rotterdam. This article reviews the more than 250 patients that have been treated so far.Methods and Materials: The Beta-Cath System (Novoste), a manual, hydraulic afterloader with 12 90Sr seeds, was used in the Beta Energy Restenosis Trial (BERT-1.5, n=31), for compassionate use (n=25), in the Beta-Cath System trial (n=27) and in the Beta Radiation in Europe (BRIE, n=14). Since the Beta-Cath System has been commercialized in Europe, 57 patients have been treated and registered in RENO (Registry Novoste). In the Proliferation Reduction with Vascular Energy Trial (PREVENT), 37 patients were randomized using the Guidant-Nucletron remote control afterloader with a 32P source wire and a centering catheter. Radioactive 32P coated stents have been implanted in 102 patients. In the Isostent Restenosis Intervention Study 1 (IRIS 1), 26 patients received a stent with an activity of 0.75-1.5 μCi, and in the IRIS 2 (European 32P dose response trial), 40 patients were treated with an activity of 6-12 μCi. In two consecutive pilot trials, radioactive stents with non-radioactive ends (cold-end stents) and with ends containing higher levels of activity (hot-end stents) were implanted in 21 and 17 patients, respectively.Results: In the BERT-1.5 trial, the radiation dose, prescribed at 2 mm from the source train (non-centered), was 12 Gy (10 patients), 14 Gy (10 patients) and 16 Gy (11 patients). At 6-month follow-up, 8 out of 28 (29%) patients developed restenosis. The target lesion revascularization rate (TLR) was 7 out of 30 (23%) at 6 months and 8 out of 30 (27%) at 1 year. Two patients presented with late thrombosis in the first year. For compassionate use patients, a restenosis rate (RR) of 53% was observed. In the PREVENT trial, 34 of 37 patients underwent an angiographic 6-month follow-up. The doses prescribed at 0.5 mm depth into the vessel wall were 0 Gy (8), 28 Gy (9), 35 Gy (11) and 42 Gy (8). TLR was 14% in the irradiated patients and 25% in the placebo group. One patient developed late thrombosis. In the IRIS 1 trial, 23 patients showed an RR of 17% (in-stent). In the IRIS 2 trial, in-stent restenosis was not seen in 36 patients at 6-month follow-up. However, a high RR (44%) was observed at the stent edges.Conclusions: The integration of vascular brachytherapy in the catheterization laboratory is feasible and the different treatment techniques that are used are safe. Problems, such as edge restenosis and late thrombotic occlusion, have been identified as limiting factors of this technique. Solutions have been suggested and will be tested in future trials.     

Effect of Pioglitazone on In-Stent Restenosis after Coronary Drug-Eluting Stent Implantation: A Meta-Analysis of Randomized Controlled Trials

Background

In-stent restenosis (ISR) remains a common life-threatening complication and some studies have shown that pioglitazone can reduce the incidence of ISR in patients with drug-eluting stents (DES) implantation. We conducted a meta-analysis to assess the effect of pioglitazone in preventing ISR after DES implantation.

Methods

Randomized controlled trials (RCTs) investigating the effects of pioglitazone for ISR after DES implantation were identified by systematic searches of multiple online databases and manual searches of related reference lists of identified trials through May 2014. The primary endpoint was the rate of ISR. Secondary endpoints included minimum lumen diameter, percentage stenosis of stented vessels, late loss, in-stent neointimal volume, target vessel revascularization (TVR), target lesion revascularization, myocardial infarction, stent thrombosis and death.

Results

Five studies, comprising 255 pioglitazone-treated patients and 245 controls, were identified in the current meta-analysis. Pioglitazone did not significantly reduce the rate of ISR (P = 0.20) with low heterogeneity (I² = 13.3%, P = 0.32). For the secondary outcomes, pioglitazone did not substantially affect the pooled estimates of these endpoints except late loss (P = 0.01) and TVR (P = 0.04).

Conclusions

The limited evidence indicates that pioglitazone does not demonstrate markedly beneficial effect in patients subjected to coronary DES implantation. However, the results should be interpreted with care given the small sample size. Further large-scale RCTs are needed.     

药物涂层支架与金属裸支架治疗ST段抬高型心肌梗死的临床价值比较

目的：评价药物涂层支架（DES）与金属裸支架（BMS）在急性心肌梗死患者中应用的安全性和有效性。方法：选择2003年1月-2010年12月,在我院确诊的急性sT段抬高型心肌梗死（STEMI）167例患者,其中使用BMS65例,DES102例。对比分析两组患者住院期间和出院后1年内的主要心血管或脑血管事件（MAACE）的发生情况及支架内血栓形成的发生率。结果：至随访结束,BMS组有1例患者猝死,5例出现复发心绞痛。DES组有1例突发急性左心衰后死亡,1例复发心绞痛和1例发生亚急性支架内血栓。结论：DES应用于STEMI具有较好的安全性,其术后MAACE发生率较BMS低。     

One-year clinical follow-up of a registry evaluating a percutaneous revascularisation strategy combining a pre-specified simple selection process with the use of a new thin-strut bare cobalt-chromium stent

Objectives. To evaluate clinical events in a specifically selected cohort of patients with obstructive coronary artery disease (CAD), using a new generation thin-strut bare cobalt-chromium coronary stent. Methods. Patients with single- or multi-vessel, stable or unstable CAD eligible for percutaneous implantation of at least one bare cobalt-chromium stent were evaluated in a single-centre registry. Prospective pre-specified criteria for bare cobalt-chromium stent implantation in our centre were: any acute ST-elevation myocardial infarction (MI), otherwise 1) de novo coronary lesion, and 2) lesion length <20 mm, and 3) reference vessel diameter >2.6 mm, and 4) no diabetes, unless reference vessel diameter >3.5 mm. Endpoints, retrospectively collected, were death, MI and clinically driven target-lesion revascularisation (TLR) and target-vessel revascularisation (TVR) after 12 months. Results. Between September 2005 and June 2007, 712 patients (48.7% one-vessel, 29.9% two-vessel, 20% three-vessel and 1.4% left main disease; 7.9% diabetics) were treated with 800 bare cobalt-chromium stents, for stable angina (40.9%), unstable angina (20.9%) or acute ST-elevation MI (38.2%). The procedural success rate was 99.3%. Peri-procedural MI rate was 2.2% in the semi-elective group. At 12 months there were 17 deaths (2.4%), of which nine non-cardiac, 20 (2.8%) MI, 19 (2.7%) TLR and 29 (4.1%) TVR. Early and late definite stent thrombosis occurred in four (0.6%) and three (0.4%) patients, respectively. Conclusion. A strategy aimed at minimising drug-eluting stent use and combining a pre-specified simple selection process with the use of a new thin-strut bare cobalt-chromium stent is safe and effective at one-year clinical follow-up. (Neth Heart J 2010;18:486-92.)     

Intravascular brachytherapy to prevent restenosis: dosimetric considerations.

Acute myocardial infarction is often the result of occlusion of one or more coronary arteries. Occlusion and restenosis (re-closing of the vessel) are principal reasons that percutaneous transluminal coronary angioplasty (PTCA) may fail to provide long-term benefit. PTCA has been a popular treatment, which is less invasive than surgeries involving revascularization of the myocardium, promising a better quality of life for patients. Unfortunately, the rate of restenosis after balloon angioplasty is high (approximately 30-50% in the first year after treatment). Recent data suggest that intraluminal irradiation of coronary arteries in conjunction with balloon angioplasty and/or stent implantation reduces the proliferation of smooth muscle cells and neointima formation, thereby inhibiting restenosis. In order to study radiation dosimetry in the patient and for this therapy, dose distributions for electrons and photons, with discrete energies, were simulated for blood vessels of diameter 1.5, 3 and 4.5 mm irradiated with balloon and wire sources. Electron and photon transport was performed in a simple model representing the system used for irradiation using the MCNP 4B code (Monte Carlo N-Particles). Specific calculations for balloon and wire sources were also carried out for a few radionuclides. In this work, strengths and drawbacks conceming the use of each radionuclide simulated, as well as source geometries are discussed. The dosimetry performed in this study will improve understanding of the benefit-to-risk ratio in intracoronary brachytherapy.     

Preliminary experience with the Tsunami coronary stent: immediate and six-month clinical and angiographic results

The Tsunami is a new, balloon-expandable, stainless steel, tubular coronary stent whose design is based on a number of radial, diamond-shaped cells joined by double connectors. The aim of this two-centre, prospective, nonrandomized study was to examine the procedural, in-hospital, and long-term clinical and angiographic outcomes of patients undergoing angioplasty with the Tsunami stent. Sixty-one consecutive unselected patients were treated by means of the implantation of 74 Tsunami stents in 72 coronary lesions. Most of the patients (64%) had unstable angina or acute myocardial infarction. The baseline lesion morphology was complex in 76% of cases, and the mean lesion length was 14 +/- 6 mm. The procedural success rate was 98%. Mean percentage diameter of the stenosis decreased after the intervention from 79 +/- 12% to 10 +/- 6%. The in-hospital major adverse cardiac event rate was 3.3%. During the six-month follow-up, there was one cardiac death and nine subjects (14.5%) underwent target vessel revascularization. The six-month event-free survival rate was 80%. The angiographic restenosis rate was 17%: a focal or limited pattern (class I or II) was found in 43% of cases, whereas the remaining 57% had a proliferative morphology (class III or IV). In conclusion, this study indicates the good clinical and angiographic performance of the Tsunami coronary stent system in consecutive unselected patients.     

Short versus long duration of dual antiplatelet therapy following drug-eluting stents: a meta-analysis of randomised trials

Background

Dual antiplatelet therapy (DAPT) remains the cornerstone therapy in the prevention of ischaemic events following drug-eluting stent (DES) implantation. Mandatory duration of DAPT after DES however, is a matter of debate. We aimed to evaluate safety and efficacy of short-term (up to 6 months) versus long-term (12 months) DAPT after DES implantation.

Methods

We searched PubMed, EMBASE, Cochrane databases, and international meetings for randomised clinical trials (RCTs) comparing short with long DAPT. We performed a systematic review and meta-analysis of major trials with primary outcomes: all-cause death, myocardial infarction, definite or probable stent thrombosis, stroke, and major bleeding event.

Results

Nine RCTs with a total number of 19,099 patients were pooled in the present meta-analysis. When compared with long DAPT, short DAPT was associated with a significant reduction in major bleeding events (0.62% vs. 1.10%, risk ratio (RR) 0.58, 95% confidence interval (CI) 0.39 to 0.86, p?<?0.007, I²?=?21%), whereas all-cause death (1.65% vs. 1.84%, RR 0.90, 95% CI 0.73 to 1.11, p?=?0.34, I2?=?0%), myocardial infarction (1.91% vs. 1.68%, RR 1.14, 95% CI 0.92 to 1.40, p?=?0.23, I2?=?0%), definite or probable stent thrombosis (0.62% vs. 0.47%, RR 1.25, 95% CI 0.84 to 1.86, p?=?0.27, I2?=?0%), and stroke (0.60% vs. 0.67%, RR 0.91, 95% CI 0.63 to 1.31, p?=?0.61, I2?=?0%) were similar.

Conclusions

Short DAPT following DES implantation results in a significant reduction of major bleeding events with no apparent increase in all-cause death, myocardial infarction, stent thrombosis, or stroke. Future dedicated trials should investigate the optimal strategies for patient-tailored DAPT in various subgroups.

     

Results of intracoronary stenting made in different periods after diagnostic coronary angiography

The high cost of tools and expendable materials and its associated necessity of solving organizational issues force to delay the implementation of stenting for nonmedical reasons in many cases. This gives a convenient way to evaluate how much effective and safe stenting would be made just after coronary angiography or delayed intervention would be performed and at the same time to consider the way delay in stenting may affect its clinical and angiographic results. The study covered 136 patients with coronary heart disease who had been implanted an intracoronary stent. All this patients were divided into 3 groups. Group 1 included 16 patients who had undergone stent implantation just after diagnostic coronary angiography, Group 2 comprised 42 patients who had the similar procedure no later than a month after coronary angiography, and Group 3 consisted of 78 patients who had it a month or later following angiography. The angiographic success rates of stenting was 100% in Group 1, 97.6% in Group 2, and 92.3% in Group 3. The causes of poor results were evolving myocardial infarction (2.4%) and technical failure (2.4%) in Group 2; evolving myocardial infarction (2.6%), emergency aortocoronary bypass surgery (1.3%), and technical failure (3.8%) in Group 3. In Group 2, 4.8% cases of those undergone delayed stenting showed more significant stenosis than those having diagnostic intervention. In Group 3, there was more progressive stenosis in 16.7% and a transition of stenosis to occlusion in 7.8%. There were no complications (such as hemorrhage, retroperitoneal hematoma, etc.) at the site of puncture in Group 1, but in Group 2 and 3 they were 3.8 and 6.5%, respectively. Delayed stenting frequently adversely affects the outcomes of endovascular treatment due to the higher incidence of complication and to the increasing technical sophistication of the procedure no late than a month after diagnostic coronary angiography.