Objectives To evaluate the very long-term safety and effectiveness of drug-eluting stents (DES) compared to bare-metal stents (BMS) for patients with large coronary vessels. Methods From April 2004 to October 2006...Objectives To evaluate the very long-term safety and effectiveness of drug-eluting stents (DES) compared to bare-metal stents (BMS) for patients with large coronary vessels. Methods From April 2004 to October 2006, 2407 consecutive patients undergoing de novo lesion percutaneous coronary intervention with reference vessel diameter greater than or equal to 3.5 mm at Fu Wai Hospital in Beijing, China, were prospectively enrolled into this study. We obtained 9-year clinical outcomes including death, myocardial infarction (MI), thrombosis, target lesion revascularization (TLR), target vessel revascularization (TVR), and major adverse cardiac events (MACE, the composite of death, MI, and TVR). We performed Cox's proportional-hazards models to assess relative risks of all the outcome measures after propensity match. Results After propensity scoring, 514 DES-treated patients were matched to 514 BMS-treated patients. The patients treated with BMS were associated with higher risk ofTLR (HR: 2.55, 95%CI: 1.520-4.277, P = 0.0004) and TVR (HR: 1.889, 95%CI: 1.185-3.011, P = 0.0075), but the rates of death/MI and MACE were not statistically different. All Academic Research Consortium definition stent thrombosis at 9-year were comparable in the two groups. Conclusions During long-term follow-up through nine years, use of DES in patients with large coronary arteries was still associated with significant reductions in the risks of TLR and TVR.展开更多
BACKGROUND A transjugular intrahepatic portosystemic shunt(TIPS)is widely placed to treat portal hypertension.Because the Viatorr®stent(W.L.Gore and Associates,Flagstaff,AZ,United States)is not available in all h...BACKGROUND A transjugular intrahepatic portosystemic shunt(TIPS)is widely placed to treat portal hypertension.Because the Viatorr®stent(W.L.Gore and Associates,Flagstaff,AZ,United States)is not available in all hospitals in China,the bare metal stent(BMS)/stent-graft combination technique is still popular for TIPS construction.Stent fracture is a complication after TIPS placement using this technique,with limited available literature focusing on it.AIM To assess the incidence of stent fracture after TIPS placement using the BMS/stent-graft combination technique and to identify the risk factors for stent fracture.We proposed technique modifications to improve the clinical results of TIPS placement with the BMS/stent-graft combination technique.METHODS We retrospectively analyzed the computed tomography(CT)data of all patients with portal hypertension who underwent the TIPS procedure between June 2011 and December 2021 in a single center.Patients implanted with the BMS/stent graft and had follow-up imaging data available were included.We identified patients with stent fracture and analyzed their characteristics.Multivariable logistic regression was applied to identify the potential predictors of stent fracture.RESULTS Of the 68 included patients,stent fracture occurred in seven(10.3%)patients.Based on CT images,the stent fractures were categorized into three types.Our study consisted of four(57.1%)type I fractures,one(14.3%)type II fracture,one(14.3%)type IIIa fracture,and one(14.3%)type IIIb fracture.After adjusting for covariates,multivariable logistic regression revealed that the risk factors for stent fracture were the implantation of a greater number of stents[adjusted odds ratio(aOR)=22.2,95%confidence interval(CI):1.2-415.4,P=0.038]and a larger proximal sagittal stent bending angle(aOR=1.1,95%CI:1.0-1.3,P=0.020).CONCLUSION Stent fracture occurred in approximately 10%of patients with portal hypertension who underwent TIPS with the BMS/stent-graft combination technique.The number of implanted stents and stent bending angle at the inferior vena cava end were predictors of stent fracture,which suggests that the incidence of stent fracture could potentially be reduced by procedural modifications.展开更多
Background: Though drug-eluting stent is widely used during coronary angioplasty, still there are conditions in which bare metal stents possess a priority role. Objectives: The aim of FLEXUS study is to investigate th...Background: Though drug-eluting stent is widely used during coronary angioplasty, still there are conditions in which bare metal stents possess a priority role. Objectives: The aim of FLEXUS study is to investigate the safety and efficacy of Flexinnium stent in unselected real-life patients. Methods: The FLEXUS is a single-centric, observational, non-randomized, retrospective study performed from January to August 2014 in 216 patients who received Flexinnium stent. The end-point of study included device-oriented and patient-oriented clinical outcomes as per Academic Research Consortium consensus. These end-points were observed at in-hospital stay and 12-month follow-up. Results: Of 216 patients, 174 (80.6%) patients were male;there were 76 (35.2%) and 84 (38.9%) patients of diabetes and hypertension, respectively. Type B2 and C lesions accounted for 27 (11.3%) and 122 (50.8%), respectively. A total of 241 Flexinnium stents were implanted with an average diameter and length of 2.7 ± 0.2 mm and 21.6 ± 8.0 mm, respectively. The cumulative device-oriented composite at 12-month follow-up included 2.31% cardiac death, 1.39% myocardial infarction (MI) attributed to the target vessel, and 3.70% target lesion revascularization (TLR). Conclusion: FLEXUS study gives an idea about favorable safety and efficacy of the Flexinnium in unselected real-life patients with both simple and complex coronary lesions.展开更多
Background: In the present study, it was aimed to compare the stent grafts and bare-metal stents in terms of post-procedural patency, clinical recovery and complications in the subjects with symptomatic aorto-iliac ar...Background: In the present study, it was aimed to compare the stent grafts and bare-metal stents in terms of post-procedural patency, clinical recovery and complications in the subjects with symptomatic aorto-iliac arterial disease. Methods: A total of 79 subjects with symptomatic aorto-iliac arterial disease treated with endovascular methods were included in the present study. Forty three subjects received self-expendable bare metal stent (ev3 Protégé stent system, Endovascular Inc., Plymouth, Minnesota, USA) and 36 subjects received PTFE-covered stent graft (Fluency Plus Stent Graft, Bard Peripheral Vascular, Tempe, Arizona). The subjects were compared after and at Months 1, 6, and 12 following the procedure in terms of Rutherford’s classification, ankle-arm index (AAI), patency rates, and complications. Results: The subjects receiving bare metal stent and stent graft for aorto-iliac arterial disease were followed for averagely 15 months. For the subjects receiving bare metal stent, primary patency rates at months 1, 6, and 12 were 98%, 81%, and 70%, respectively, while secondary patency rate at month 12 was found to be 84%. For the group of stent graft, primary patency rates were found as 97%, 97%, and 92%, respectively and secondary patency rate at month 12 was found to be 94%. Stent grafts were applied at the same time in 2 patients who had metal bare metal because the rupture occurred during the procedure. In the comparison between two groups, the group of stent graft was found to be statistically superior to the other in terms of patency, clinical and post-procedural complications. Conclusion: In conclusion, it was found that the stent grafts were superior to the bare metal stents in terms of patency and complication rates in the subjects with symptomatic aortoiliac disease.展开更多
Background Recently, numerous randomized and controlled trials have demonstrated great advantages of drug eluting stents (DES) with respect to significant reduction of restenosis and recurrence of symptoms and impro...Background Recently, numerous randomized and controlled trials have demonstrated great advantages of drug eluting stents (DES) with respect to significant reduction of restenosis and recurrence of symptoms and improvement of clinical outcomes after percutaneous coronary intervention (PCI). Little is known about the comparative effects between DES and bare metal stents (BMS) for bifurcation angioplasty in the Chinese population. We compared the inpatient and 7-month follow-up outcomes between DES and BMS for the treatment of bifurcation lesions. Methods From April 2004 to October 2005, 291 Chinese patients [85.9% male, mean age (57.8± 10.4) years] underwent DES (387 lesions) and/or BMS (297 lesions) implantation for bifurcation lesions. Clinical and angiographic follow-up was performed at 7 months. Results Compared with BMS group, patients in DES group had significantly lower rates of restenosis at main branch (9.5% vs 28.7%, P 〈 0.001) or side branch (14.5% vs 37.0%, P 〈 0.001) and major adverse cardiac events (MACE) (14.0% vs 26.3%, P = 0.000). The occurrence rate of late in-stent thrombosis did not differ between the two groups in both main (0.8% vs 0, P = 0.224) and side branches (1.4% vs 0, P =0.198). Target lesion revascularization (TLR) was less frequent in DES group for main branch (8.3% vs 21.3%, P 〈 0.001) and for side branch (7.6% vs 23.5%, P 〈 0.001). Multivariate regression analysis revealed that total stent length (OR = 1.029, P = 0.01), postprocedural in-stent minimum lumen diameter (OR = 0.476, P = 0.03) and stent type (OR = 3.988, P = 0.0001) were independent predictors of TLR for main branch. Prior history of coronary intervention (OR = 2.424, P =0.041), angulated lesion (OR = 2.337, P = 0.033), postdilation (OR = 0.267, P = 0.035) and stent type (DES vs BMS, OR = 5.459, P = 0.000) were independent predictors of TLR for side branch. Conclusion The implantation of DES may be associated with greater reduction of restenosis and TLR than BMS in bifurcations angioplasty.展开更多
Background The long-term safety and efficacy of drug-eluting stents (DES) versus bare metal stents (BMS) are unclear and controversial issues in patients with acute ST-elevation myocardial infarction (STEMI) und...Background The long-term safety and efficacy of drug-eluting stents (DES) versus bare metal stents (BMS) are unclear and controversial issues in patients with acute ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). The purpose of this study was to compare the long-term outcome of STEMI patients undergoing primary PCI with DES versus BMS implantation. Methods A total of 191 patients with acute STEMI undergoing PCI from Jan. 2005 to Dec. 2007 were enrolled. Patients received DES (n=83) or BMS (n=108) implantation in the infarction related artery according to physician's discretion. The primary outcome was the occurrence of major adverse cardiac events (MACE), which was defined as a composite of death, myocardial infarction (MI), target vessel revascularization (TVR) and stent thrombosis. The difference of MACE was observed between DES and BMS groups. Results The clinical follow-up duration was 3 years ((41.7±16.1) months). MACE occurred in 20 patients during three years follow-up. Logistic regression analysis showed that the left ventricular ejection fraction (LVEF) was an independent predictor for MACE in the follow-up period (P=0.0301). There was no significant difference in all-cause mortality (3.61% vs. 7.41%, P=0.2647), the incidence of myocardial infarction (0 vs. 0.93%, P=-0.379) and stent thrombosis (1.20% vs. 1.85%, P=0.727) between the DES group and BMS group. The incidence of MACE was significantly lower in the DES group compared to the BMS group (4.82% vs. 14.81%, P=0.0253). The rate of TVR was also lower in the DES group (0 vs. 5.56%, P=0.029). In the DES group, there was no significant difference in the incidence of MACE between sirolimus eluting stents (SES, n=73) and paclitaxel-eluting stents (PES, n=10) subgroups (2.74% vs. 20.00%, P 〉0.05). Conclusions This finding suggested that drug-eluting stents significantly reduced the need for revascularization in patients with acute STEMI, without increasing the incidence of death or myocardial infarction. Use of DES significantly decreased the incidence of MACE compared with BMS during the 3-year follow-up.展开更多
Background Drug-eluting stents (DES) have revolutionized the field of interventional cardiology by dramatically improving clinical and angiographic outcomes. Patients with diabetes mellitus (DM) are associated wit...Background Drug-eluting stents (DES) have revolutionized the field of interventional cardiology by dramatically improving clinical and angiographic outcomes. Patients with diabetes mellitus (DM) are associated with an increased risk of adverse clinical outcomes after a percutaneous coronary intervention (PCI). Available information on the efficacy and safety of DES and bare metal stent (BMS) in diabetic patients remains scarce. Methods From April 2004 to October 2006, 1565 patients with diabetes, who successfully underwent elective stenting at Fu Wai Hospital in Beijing, China, were enrolled in this study. All enrolled patients were assigned to a drug eluting stent group and a bare metal stent group. We obtained follow-up data: death, myocardial infarction (MI), thrombus, target lesion revascularization (TLR), and target vessel revascularization (TVR) at 30 days and 12 and 24 months, as defined by the Academic Research Consortium (ARC). We calculated and compared all the unadjusted cumulative frequencies of the various adverse events in the two groups. Cox's proportional-hazards models adjusted with the propensity score were used to assess the relative risks of all the outcome measures at 24 months. Results At 24 months, all ARC defined stent thrombosis in the two groups were similar; at 30 days, a more definite thrombosis was found in the BES group (0.08% vs 0.81%, P=0.016). Patients treated with DES showed a significant lower risk of TLR (3.88% vs 10.89%; hazard ratio (HR) 0.159 (95% CI: 0.151-0.444), P 〈0.001), TVR (5.48%vs 11.69%; HR 0.383 (95% CI: 0.232-0.633), P 〈0.001), and any revascularization (12.47% vs 18.55%; HR 0.555 (95% CI: 0.370-0.831), P=0.0004) at 24 months. No significant difference was apparent in terms of all-cause mortality, MI, and all-cause mortality/MI. Conclusions In contemporary society's large, diabetic population, the use of DES is associated with long-term significant reductions in the risks of TLR, TVR, and any revascularization. There is no significant difference in all-cause mortality, MI, and thrombosis between DES and BMS in the patients with diabetes at 24-month follow-up.展开更多
Background Some larger scale, randomized studies have demonstrated the superiority of drug-eluting stents (DES) over bare metal stents (BMS) for the treatment of acute myocardial infarction (AMI). This study aim...Background Some larger scale, randomized studies have demonstrated the superiority of drug-eluting stents (DES) over bare metal stents (BMS) for the treatment of acute myocardial infarction (AMI). This study aimed to investigate the impact of DES, in comparison with BMS, on the 2-year clinical outcomes in patients with ST-elevation myocardial infarction (STEMI).Methods From January 2002 to December 2008, a total of 1301 consecutive STEMI patients treated with coronary stenting in Shenyang Northern Hospital were prospectively registered. Patients received BMS (n=868) or DES (n=435) implantation in the infarction related artery according to physician's discretion. A propensity score analysis was performed and two well matched subgroups were selected (BMS, n=288; DES, n=288) to evaluate the 2-year clinical outcomes. The primary outcome was the occurrence of major adverse cardiac events (MACE), which was defined as a composite of all-cause death, myocardial infarction (MI), or target vessel revascularization (TVR).Results Survival salvage analysis showed that 2-year cumulative hazards were not significantly different between the two groups with respect to TVR (2.8% vs. 3.1%, log-rank P=0.780), stent thrombosis (1.7% vs. 4.2%, log-rank P=0.079) and MACE (8% vs. 10.8%, log-rank P=0.236). Multivariate analysis showed that DES was an independent protective factor of MI (HR: 0.211, 95% CI: 0.049 to 0.908) and stent thrombosis (HR: 0.327, 95% CI: 0.107 to 0.994).Conclusion DES was associated with similar 2-year clinical outcomes to those of BMS for the treatment of STEMI in daily practice.展开更多
Background Randomized studies have shown beneficial effects of drug-eluting stent (DES) in reducing the risk of repeated revascularization. Other studies have shown higher proportion of death, myocardial infarction ...Background Randomized studies have shown beneficial effects of drug-eluting stent (DES) in reducing the risk of repeated revascularization. Other studies have shown higher proportion of death, myocardial infarction (MI) and increased cost concerning DES. However the long term safety and effectiveness of DES have been questioned recently.Methods To compare long term clinical outcomes, health-related quality of life (HRQOL) and cost-utility after sirolimus-eluting stent (SES) and bare metal stent (BMS) implantation in angina patients in China, 1241 patients undergoing percutaneous coronary revascularization (PCl) with either SES (n=632) or BMS (n=609) were enrolled continuously in this prospective, nonrandomized, multi-center registry study.Results Totally 1570 stents were implanted for 1334 lesions. Follow-up was completed in 1205 (97.1%) patients at 12 months. Rates of MI, all causes of death were similar between the two groups. Significant differences were found at rate of cardiovascular re-hospitalization (136 (22.4%) in BMS group vs. 68 (10.8%) in SES group, P=0.001) and recurrent angina (149 (24.5%) vs. 71 (11.3%), P=0.001). Dramatic difference was observed when compared the baseline and 9-month HRQOL scores intra-group (P 〈0.001). However no significant difference was found inter-group either in baseline or follow-up HRQOL. Compared with SES, the total cost in BMS was significantly lower on discharge (62 546.0 vs. 78 245.0 Yuan, P=0.001). And follow-up expenditure was remarkably higher in the BMS group than that in the SES group (13 412.0 vs. 8 812.0 Yuan, P=0.0001).Conclusions There were no significant differences on death, in-stent thrombosis, MI irrespective of stent type. SES was superior to BMS on improvement of life quality. SES was with higher cost-utility compared to BMS.展开更多
Objective To study the effect of self-expanding bare metal stents on the trachea of dogs,and therefore to provide useful information for choice of airway stents by interventional physicians.Methods In this experiment,...Objective To study the effect of self-expanding bare metal stents on the trachea of dogs,and therefore to provide useful information for choice of airway stents by interventional physicians.Methods In this experiment,8beagles were randomly divided into 4 groups.Four selfexpanding metal stents of different diameters(16,18。展开更多
Background The benefits and safety of sirolimus-eluting stent (SES) have not been systematically quantified in different trials in ST-segment elevation myocardial infarction (STEMI) patients with primary or rescue...Background The benefits and safety of sirolimus-eluting stent (SES) have not been systematically quantified in different trials in ST-segment elevation myocardial infarction (STEMI) patients with primary or rescue percutaneous coronary intervention (PCI). A meta-analysis of randomised trials comparing SES and bare-metal stent (BMS) was performed. Methods A systematic literature search was conducted to identify all randomized clinical trials. The primary outcome was the rate of major adverse cardiac events (MACEs). The secondary outcomes included death, recurrent myocardial infarction, recurrent revascularization, and stent thrombosis.Results Totally, 1973 STEMI patients were enrolled in seven eligible randomized trials comparing SES with BMS. The pooled rate of major adverse cardiac events was significantly lower in the SES group than in the BMS group (9.7% vs 20.3%, OR 2.45, 95% Cl 1.88-3.19, P 〈 0.00001). No significant difference in all causes of death was found between the SES and BMS groups, as well as in the pooled recurrent myocardial infarction rates. The pooled recurrent revascularization rate was significantly lower in the SES group than in the BMS group (5.1% vs 14.8%, OR 3.30, 95%CI 2.37-4.60, P 〈 0.00001). No significant difference was found between the pooled rates of stent thrombosis (1.2% in the SES group and 2.0% in the BMS group, OR 1.61, 95%CI 0.79-3.26, P = 0.19).Conclusions SES is associated with a decreased risk of major adverse cardiac events compared with BMS by the greater reduction in repeat revascularization in STEMI patients. Larger trials with longer follow up are warranted to better define the role of SES in STEMI.展开更多
Objective To study the safety of the novel high nitrogen nickel-free austenitic stainless steel bare metal stents (BMS) in a recognized porcine coronary model and to select a better grid structure of it. Methods Th...Objective To study the safety of the novel high nitrogen nickel-free austenitic stainless steel bare metal stents (BMS) in a recognized porcine coronary model and to select a better grid structure of it. Methods Three types of stents were randomly implanted in different coronary arteries of the same pig: 316L stainless steel BMS (316L-BMS) (n=12), novel high nitrogen nickel-free stents Grid A (NF-A-BMS) (n=12) and novel high nitrogen nickel-free stents Grid B (NF-B-BMS) (n=12). In total, eighteen animals underwent successful random placement of 36 oversized stents in the coronary arteries. Coronary angiography was performed after 36 d of stents implantation. Nine animals were respectively sacrificed after 14 d and 36 d for histomorphologic analysis. 〈br〉 Results Quantitative coronary angiography (QCA) showed similar luminal loss (LL) in the three groups:(0.21±0.17) mm for 316L-BMS, (0.16±0.12) mm for NF-A-BMS, (0.24±0.15) mm for NF-B-BMS (P=0.05). Histomorphomeric analysis after 15 d and 36 d revealed that there was also no significant difference among the three groups in neointimal area (NA) with similar injury scores respectively. High magnification histomorphologic examination showed similar inflammation scores in the three groups, but NF-A-BMS group had poorer endothelialization scores compared with NF-B-BMS group, 2.00±0.63 vs. 2.83±0.41 (P=0.015) at 15 d, which also could be proved by the scanning electron microscope. However, the difference could not been observed at 36 d. Conclusion The novel NF-BMS showed similar safety as 316L-BMS during the short-term study. NF-B-BMS had better endothelialization than NF-A-BMS and this may owe to the specific strut units.展开更多
In the last few decades, the recommended treatment for coronary artery disease has been dramatically improved by percutaneous coronary intervention(PCI) and the use of balloon catheters, bare metal stents(BMSs), and d...In the last few decades, the recommended treatment for coronary artery disease has been dramatically improved by percutaneous coronary intervention(PCI) and the use of balloon catheters, bare metal stents(BMSs), and drug-eluting stents(DESs). Catheter balloons were burdened by acute vessel occlusion or target-lesion restenosis. BMSs greatly reduced those problems holding up the vessel structure, but showed high rates of instent re-stenosis, which is characterized by neo-intimal hyperplasia and vessel remodeling leading to a renarrowing of the vessel diameter. This challenge was overtaken by first-generation DESs, which reduced restenosis rates to nearly 5%, but demonstrated delayed arterial healing and risk for late in-stent thrombosis, with inflammatory cells playing a pivotal role. Finally, new-generation DESs, characterized by innovations in design, metal composition, surface polymers, and antiproliferative drugs, finally reduced the risk for stent thrombosis and greatly improved revascularization outcomes. New advances include bioresorbable stents potentially changing the future of revascularization techniques as the concept bases upon the degradation of the stent scaffold to inert particles after its function expired, thus theoretically eliminating risks linked with both stent thrombosis and re-stenosis. Talking about DESs also dictates to consider dual antiplatelet therapy(DAPT), which is a fundamental moment in view of the good outcome duration, but also deals with bleeding complications. The better management of patients undergoing PCI should include the use of DESs and a DAPT finely tailored in consideration of the potentially developing bleeding risk in accordance with the indications from last updated guidelines.展开更多
For patients suffering from both biliary and duodenal obstruction,endoscopic retrograde cholangiopancreatography(ERCP) with stent placement is the treatment of choice.ERCP through an already existing duodenal prosthes...For patients suffering from both biliary and duodenal obstruction,endoscopic retrograde cholangiopancreatography(ERCP) with stent placement is the treatment of choice.ERCP through an already existing duodenal prosthesis is an uncommon procedure and furthermore no studies have reported installing a covered metal stent onto an already existing bare metal stent in the common bile duct(CBD).We describe a rare case of a stent-in-stent dilatation of the CBD through an already existing self-expanding metal stent in the second part of duodenum for the patient presenting with jaundice in setting of biliary and duodenal obstruction from pancreatic adenocarcinoma.The biliary obstruction was relieved with a decrease in bilirubin levels post-stenting.展开更多
Objectives: The study was designed to evaluate the efficacy and safety of drug eluting stents (DESs) in aorto-ostial (A-O) coronary artery lesions, in terms of early and late restenosis rate;including clinical assessm...Objectives: The study was designed to evaluate the efficacy and safety of drug eluting stents (DESs) in aorto-ostial (A-O) coronary artery lesions, in terms of early and late restenosis rate;including clinical assessment, non-invasive stress testing and angiographic follow-up. Also, the study was aimed to compare the results of implantation of drug eluting stents (DES) to that of bare metal stents (BMS) in aortoostial lesions done over a previous 5 years in Royal Brompton Hospital. Background: The safety and effectiveness of DESs for the treatment of aortoostial lesions. Methods: We included 161 consecutive patients with symptoms subjective of angina pectoris or objective evidence of myocardial ischemia;who underwent percutaneous coronary interventions (PCI) in coronary ostial lesions using DES. The patients were divided into two groups based on the site of ostial lesion. The control group consisted of 125 consecutive patients who underwent percutaneous coronary intervention for ostial lesions using bare metal stents (BMS) implantation in the period immediately before the introduction of DES. The incidence of major adverse cardiac events (MACE), including death or Q-wave myocardial infarction (MI), need for repeated revascularization procedure CABG or angioplasty, were recorded in-hospital and at twelve months ± 3 months. Follow-up angiography was only performed in case of recurrent symptoms subjective of myocardial ischemia or if there was objective evidence of myocardial ischemia by stress testing. Results: The initial procedure was successful in 149 patients (92.5%) in the DES arm. There were no statistically significant major in-hospital complications in the DES group, compared to BMS group which showed 4 cases of in-hospital deaths (p = 0.017). At Twelve months ± 3 months follow-up, MACE were significantly less frequent in the DES group compared to the BMS group, including death (0.8% vs. 6.4%, p = 0.004) and need for CABG (1.7% vs. 10%, p = 0.012). Conclusions: The main finding of our study is that, compared to the BMS, implantation of the DES in coronary ostial lesions appears safe and effective. It is associated with high procedural success rate, low immediate and in-hospital complication rate, infrequent late adverse events and favourable long-term clinical and angiographic outcomes compared with bare metal stents implantation at 12-month follow-up. Advanced age, previous myocardial infarction and acute coronary syndromes at presentation were all found to be independent positive predictors for clinical events after drug eluting stent implantation in ostial lesions.展开更多
Background In response to the increasing concern with the safety of the drug-eluting stent (DES), the present study aimed to evaluate the long-term safety and efficacy of DES used for a Chinese patient population. M...Background In response to the increasing concern with the safety of the drug-eluting stent (DES), the present study aimed to evaluate the long-term safety and efficacy of DES used for a Chinese patient population. Methods All patients, who underwent an index elective percutaneous coronary intervention with an implantation of either DES or bare-metal stent (BMS) in a single institution from April 2004 to December 2006, were included in the analysis. A propensity-score matching technique was applied to adjust and to minimize the impact of confounding factors. Results Overall, there were 1465 patients (20.2%) who had undergone an implantation of only BMS, and 5769 patients (79.8%) of only DES. The propensity-score matching technique set up 1321 pairs of patients for analysis. There were no significant differences between the rates of stent thrombosis (definite and probable) of the two groups (1.06% vs 1.21%, P=0.8580). Although rates of mortality and myocardial infarction (MI) during the 2-year follow-up period had not differed significantly, rates of death/MI (3.0% vs 4.5%, P=0.0263), target-lesion revascularization (TLR, 3.2% vs 8.5, P=0.0001), target-vessel revascularization (TVR, 5.8% vs 9.5%, P 〈0.0001) and any revascularization (10.0% vs 13.3%, P=0.0066) were significantly lower for the DES group than for the BMS group. Among the patients in whom devices were implanted for off-label indications, the propensity-score matched rates of stent thrombosis, mortality, MI, and death/MI were not significantly different, while rates of TLR, TVR and any revascularization were significantly lower for the DES group than for the BMS group. Conclusions During the 2 years of follow-up post stenting, DES use is associated with lower rates of death/MI, TLR, TVR and any revascularization, compared with BMS, in propensity-score matched Chinese patient populations. In the setting of off-label usage, DES use is also associated with similar advantages.展开更多
Very late stent thrombosis (VLST) is increasingly being regarded as a complication of drug-eluting stents (DES), and delayed endothelization, local hypersensitivity reactions, and late stent malapposition due to e...Very late stent thrombosis (VLST) is increasingly being regarded as a complication of drug-eluting stents (DES), and delayed endothelization, local hypersensitivity reactions, and late stent malapposition due to excessive positive remodeling have been postulated as mechanisms. Considering that stent endothelialization seems to be completed within 4 weeks following bare-metal stent (BMS) placement and that BMS do not possess antiproliferative coating, the mechanism of VLST may differ between patients with DES and those with BMS. We report a case of VLST 9 years after BMS implantation, in which thrombus from the ruptured neointima was confirmed by intravascular ultrasound. This finding suggests that de novo plaque rupture at the neointimal layer within the stent may be one of the explanations for VLST.展开更多
文摘Objectives To evaluate the very long-term safety and effectiveness of drug-eluting stents (DES) compared to bare-metal stents (BMS) for patients with large coronary vessels. Methods From April 2004 to October 2006, 2407 consecutive patients undergoing de novo lesion percutaneous coronary intervention with reference vessel diameter greater than or equal to 3.5 mm at Fu Wai Hospital in Beijing, China, were prospectively enrolled into this study. We obtained 9-year clinical outcomes including death, myocardial infarction (MI), thrombosis, target lesion revascularization (TLR), target vessel revascularization (TVR), and major adverse cardiac events (MACE, the composite of death, MI, and TVR). We performed Cox's proportional-hazards models to assess relative risks of all the outcome measures after propensity match. Results After propensity scoring, 514 DES-treated patients were matched to 514 BMS-treated patients. The patients treated with BMS were associated with higher risk ofTLR (HR: 2.55, 95%CI: 1.520-4.277, P = 0.0004) and TVR (HR: 1.889, 95%CI: 1.185-3.011, P = 0.0075), but the rates of death/MI and MACE were not statistically different. All Academic Research Consortium definition stent thrombosis at 9-year were comparable in the two groups. Conclusions During long-term follow-up through nine years, use of DES in patients with large coronary arteries was still associated with significant reductions in the risks of TLR and TVR.
文摘BACKGROUND A transjugular intrahepatic portosystemic shunt(TIPS)is widely placed to treat portal hypertension.Because the Viatorr®stent(W.L.Gore and Associates,Flagstaff,AZ,United States)is not available in all hospitals in China,the bare metal stent(BMS)/stent-graft combination technique is still popular for TIPS construction.Stent fracture is a complication after TIPS placement using this technique,with limited available literature focusing on it.AIM To assess the incidence of stent fracture after TIPS placement using the BMS/stent-graft combination technique and to identify the risk factors for stent fracture.We proposed technique modifications to improve the clinical results of TIPS placement with the BMS/stent-graft combination technique.METHODS We retrospectively analyzed the computed tomography(CT)data of all patients with portal hypertension who underwent the TIPS procedure between June 2011 and December 2021 in a single center.Patients implanted with the BMS/stent graft and had follow-up imaging data available were included.We identified patients with stent fracture and analyzed their characteristics.Multivariable logistic regression was applied to identify the potential predictors of stent fracture.RESULTS Of the 68 included patients,stent fracture occurred in seven(10.3%)patients.Based on CT images,the stent fractures were categorized into three types.Our study consisted of four(57.1%)type I fractures,one(14.3%)type II fracture,one(14.3%)type IIIa fracture,and one(14.3%)type IIIb fracture.After adjusting for covariates,multivariable logistic regression revealed that the risk factors for stent fracture were the implantation of a greater number of stents[adjusted odds ratio(aOR)=22.2,95%confidence interval(CI):1.2-415.4,P=0.038]and a larger proximal sagittal stent bending angle(aOR=1.1,95%CI:1.0-1.3,P=0.020).CONCLUSION Stent fracture occurred in approximately 10%of patients with portal hypertension who underwent TIPS with the BMS/stent-graft combination technique.The number of implanted stents and stent bending angle at the inferior vena cava end were predictors of stent fracture,which suggests that the incidence of stent fracture could potentially be reduced by procedural modifications.
文摘Background: Though drug-eluting stent is widely used during coronary angioplasty, still there are conditions in which bare metal stents possess a priority role. Objectives: The aim of FLEXUS study is to investigate the safety and efficacy of Flexinnium stent in unselected real-life patients. Methods: The FLEXUS is a single-centric, observational, non-randomized, retrospective study performed from January to August 2014 in 216 patients who received Flexinnium stent. The end-point of study included device-oriented and patient-oriented clinical outcomes as per Academic Research Consortium consensus. These end-points were observed at in-hospital stay and 12-month follow-up. Results: Of 216 patients, 174 (80.6%) patients were male;there were 76 (35.2%) and 84 (38.9%) patients of diabetes and hypertension, respectively. Type B2 and C lesions accounted for 27 (11.3%) and 122 (50.8%), respectively. A total of 241 Flexinnium stents were implanted with an average diameter and length of 2.7 ± 0.2 mm and 21.6 ± 8.0 mm, respectively. The cumulative device-oriented composite at 12-month follow-up included 2.31% cardiac death, 1.39% myocardial infarction (MI) attributed to the target vessel, and 3.70% target lesion revascularization (TLR). Conclusion: FLEXUS study gives an idea about favorable safety and efficacy of the Flexinnium in unselected real-life patients with both simple and complex coronary lesions.
文摘Background: In the present study, it was aimed to compare the stent grafts and bare-metal stents in terms of post-procedural patency, clinical recovery and complications in the subjects with symptomatic aorto-iliac arterial disease. Methods: A total of 79 subjects with symptomatic aorto-iliac arterial disease treated with endovascular methods were included in the present study. Forty three subjects received self-expendable bare metal stent (ev3 Protégé stent system, Endovascular Inc., Plymouth, Minnesota, USA) and 36 subjects received PTFE-covered stent graft (Fluency Plus Stent Graft, Bard Peripheral Vascular, Tempe, Arizona). The subjects were compared after and at Months 1, 6, and 12 following the procedure in terms of Rutherford’s classification, ankle-arm index (AAI), patency rates, and complications. Results: The subjects receiving bare metal stent and stent graft for aorto-iliac arterial disease were followed for averagely 15 months. For the subjects receiving bare metal stent, primary patency rates at months 1, 6, and 12 were 98%, 81%, and 70%, respectively, while secondary patency rate at month 12 was found to be 84%. For the group of stent graft, primary patency rates were found as 97%, 97%, and 92%, respectively and secondary patency rate at month 12 was found to be 94%. Stent grafts were applied at the same time in 2 patients who had metal bare metal because the rupture occurred during the procedure. In the comparison between two groups, the group of stent graft was found to be statistically superior to the other in terms of patency, clinical and post-procedural complications. Conclusion: In conclusion, it was found that the stent grafts were superior to the bare metal stents in terms of patency and complication rates in the subjects with symptomatic aortoiliac disease.
文摘Background Recently, numerous randomized and controlled trials have demonstrated great advantages of drug eluting stents (DES) with respect to significant reduction of restenosis and recurrence of symptoms and improvement of clinical outcomes after percutaneous coronary intervention (PCI). Little is known about the comparative effects between DES and bare metal stents (BMS) for bifurcation angioplasty in the Chinese population. We compared the inpatient and 7-month follow-up outcomes between DES and BMS for the treatment of bifurcation lesions. Methods From April 2004 to October 2005, 291 Chinese patients [85.9% male, mean age (57.8± 10.4) years] underwent DES (387 lesions) and/or BMS (297 lesions) implantation for bifurcation lesions. Clinical and angiographic follow-up was performed at 7 months. Results Compared with BMS group, patients in DES group had significantly lower rates of restenosis at main branch (9.5% vs 28.7%, P 〈 0.001) or side branch (14.5% vs 37.0%, P 〈 0.001) and major adverse cardiac events (MACE) (14.0% vs 26.3%, P = 0.000). The occurrence rate of late in-stent thrombosis did not differ between the two groups in both main (0.8% vs 0, P = 0.224) and side branches (1.4% vs 0, P =0.198). Target lesion revascularization (TLR) was less frequent in DES group for main branch (8.3% vs 21.3%, P 〈 0.001) and for side branch (7.6% vs 23.5%, P 〈 0.001). Multivariate regression analysis revealed that total stent length (OR = 1.029, P = 0.01), postprocedural in-stent minimum lumen diameter (OR = 0.476, P = 0.03) and stent type (OR = 3.988, P = 0.0001) were independent predictors of TLR for main branch. Prior history of coronary intervention (OR = 2.424, P =0.041), angulated lesion (OR = 2.337, P = 0.033), postdilation (OR = 0.267, P = 0.035) and stent type (DES vs BMS, OR = 5.459, P = 0.000) were independent predictors of TLR for side branch. Conclusion The implantation of DES may be associated with greater reduction of restenosis and TLR than BMS in bifurcations angioplasty.
文摘Background The long-term safety and efficacy of drug-eluting stents (DES) versus bare metal stents (BMS) are unclear and controversial issues in patients with acute ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). The purpose of this study was to compare the long-term outcome of STEMI patients undergoing primary PCI with DES versus BMS implantation. Methods A total of 191 patients with acute STEMI undergoing PCI from Jan. 2005 to Dec. 2007 were enrolled. Patients received DES (n=83) or BMS (n=108) implantation in the infarction related artery according to physician's discretion. The primary outcome was the occurrence of major adverse cardiac events (MACE), which was defined as a composite of death, myocardial infarction (MI), target vessel revascularization (TVR) and stent thrombosis. The difference of MACE was observed between DES and BMS groups. Results The clinical follow-up duration was 3 years ((41.7±16.1) months). MACE occurred in 20 patients during three years follow-up. Logistic regression analysis showed that the left ventricular ejection fraction (LVEF) was an independent predictor for MACE in the follow-up period (P=0.0301). There was no significant difference in all-cause mortality (3.61% vs. 7.41%, P=0.2647), the incidence of myocardial infarction (0 vs. 0.93%, P=-0.379) and stent thrombosis (1.20% vs. 1.85%, P=0.727) between the DES group and BMS group. The incidence of MACE was significantly lower in the DES group compared to the BMS group (4.82% vs. 14.81%, P=0.0253). The rate of TVR was also lower in the DES group (0 vs. 5.56%, P=0.029). In the DES group, there was no significant difference in the incidence of MACE between sirolimus eluting stents (SES, n=73) and paclitaxel-eluting stents (PES, n=10) subgroups (2.74% vs. 20.00%, P 〉0.05). Conclusions This finding suggested that drug-eluting stents significantly reduced the need for revascularization in patients with acute STEMI, without increasing the incidence of death or myocardial infarction. Use of DES significantly decreased the incidence of MACE compared with BMS during the 3-year follow-up.
文摘Background Drug-eluting stents (DES) have revolutionized the field of interventional cardiology by dramatically improving clinical and angiographic outcomes. Patients with diabetes mellitus (DM) are associated with an increased risk of adverse clinical outcomes after a percutaneous coronary intervention (PCI). Available information on the efficacy and safety of DES and bare metal stent (BMS) in diabetic patients remains scarce. Methods From April 2004 to October 2006, 1565 patients with diabetes, who successfully underwent elective stenting at Fu Wai Hospital in Beijing, China, were enrolled in this study. All enrolled patients were assigned to a drug eluting stent group and a bare metal stent group. We obtained follow-up data: death, myocardial infarction (MI), thrombus, target lesion revascularization (TLR), and target vessel revascularization (TVR) at 30 days and 12 and 24 months, as defined by the Academic Research Consortium (ARC). We calculated and compared all the unadjusted cumulative frequencies of the various adverse events in the two groups. Cox's proportional-hazards models adjusted with the propensity score were used to assess the relative risks of all the outcome measures at 24 months. Results At 24 months, all ARC defined stent thrombosis in the two groups were similar; at 30 days, a more definite thrombosis was found in the BES group (0.08% vs 0.81%, P=0.016). Patients treated with DES showed a significant lower risk of TLR (3.88% vs 10.89%; hazard ratio (HR) 0.159 (95% CI: 0.151-0.444), P 〈0.001), TVR (5.48%vs 11.69%; HR 0.383 (95% CI: 0.232-0.633), P 〈0.001), and any revascularization (12.47% vs 18.55%; HR 0.555 (95% CI: 0.370-0.831), P=0.0004) at 24 months. No significant difference was apparent in terms of all-cause mortality, MI, and all-cause mortality/MI. Conclusions In contemporary society's large, diabetic population, the use of DES is associated with long-term significant reductions in the risks of TLR, TVR, and any revascularization. There is no significant difference in all-cause mortality, MI, and thrombosis between DES and BMS in the patients with diabetes at 24-month follow-up.
基金This study was supported by grants from the National Natural Science Foundation of China (NSFC) (No. 30800465) and Science and Technical Foundation of Liaoning Province (No. 20092090).
文摘Background Some larger scale, randomized studies have demonstrated the superiority of drug-eluting stents (DES) over bare metal stents (BMS) for the treatment of acute myocardial infarction (AMI). This study aimed to investigate the impact of DES, in comparison with BMS, on the 2-year clinical outcomes in patients with ST-elevation myocardial infarction (STEMI).Methods From January 2002 to December 2008, a total of 1301 consecutive STEMI patients treated with coronary stenting in Shenyang Northern Hospital were prospectively registered. Patients received BMS (n=868) or DES (n=435) implantation in the infarction related artery according to physician's discretion. A propensity score analysis was performed and two well matched subgroups were selected (BMS, n=288; DES, n=288) to evaluate the 2-year clinical outcomes. The primary outcome was the occurrence of major adverse cardiac events (MACE), which was defined as a composite of all-cause death, myocardial infarction (MI), or target vessel revascularization (TVR).Results Survival salvage analysis showed that 2-year cumulative hazards were not significantly different between the two groups with respect to TVR (2.8% vs. 3.1%, log-rank P=0.780), stent thrombosis (1.7% vs. 4.2%, log-rank P=0.079) and MACE (8% vs. 10.8%, log-rank P=0.236). Multivariate analysis showed that DES was an independent protective factor of MI (HR: 0.211, 95% CI: 0.049 to 0.908) and stent thrombosis (HR: 0.327, 95% CI: 0.107 to 0.994).Conclusion DES was associated with similar 2-year clinical outcomes to those of BMS for the treatment of STEMI in daily practice.
文摘Background Randomized studies have shown beneficial effects of drug-eluting stent (DES) in reducing the risk of repeated revascularization. Other studies have shown higher proportion of death, myocardial infarction (MI) and increased cost concerning DES. However the long term safety and effectiveness of DES have been questioned recently.Methods To compare long term clinical outcomes, health-related quality of life (HRQOL) and cost-utility after sirolimus-eluting stent (SES) and bare metal stent (BMS) implantation in angina patients in China, 1241 patients undergoing percutaneous coronary revascularization (PCl) with either SES (n=632) or BMS (n=609) were enrolled continuously in this prospective, nonrandomized, multi-center registry study.Results Totally 1570 stents were implanted for 1334 lesions. Follow-up was completed in 1205 (97.1%) patients at 12 months. Rates of MI, all causes of death were similar between the two groups. Significant differences were found at rate of cardiovascular re-hospitalization (136 (22.4%) in BMS group vs. 68 (10.8%) in SES group, P=0.001) and recurrent angina (149 (24.5%) vs. 71 (11.3%), P=0.001). Dramatic difference was observed when compared the baseline and 9-month HRQOL scores intra-group (P 〈0.001). However no significant difference was found inter-group either in baseline or follow-up HRQOL. Compared with SES, the total cost in BMS was significantly lower on discharge (62 546.0 vs. 78 245.0 Yuan, P=0.001). And follow-up expenditure was remarkably higher in the BMS group than that in the SES group (13 412.0 vs. 8 812.0 Yuan, P=0.0001).Conclusions There were no significant differences on death, in-stent thrombosis, MI irrespective of stent type. SES was superior to BMS on improvement of life quality. SES was with higher cost-utility compared to BMS.
文摘Objective To study the effect of self-expanding bare metal stents on the trachea of dogs,and therefore to provide useful information for choice of airway stents by interventional physicians.Methods In this experiment,8beagles were randomly divided into 4 groups.Four selfexpanding metal stents of different diameters(16,18。
文摘Background The benefits and safety of sirolimus-eluting stent (SES) have not been systematically quantified in different trials in ST-segment elevation myocardial infarction (STEMI) patients with primary or rescue percutaneous coronary intervention (PCI). A meta-analysis of randomised trials comparing SES and bare-metal stent (BMS) was performed. Methods A systematic literature search was conducted to identify all randomized clinical trials. The primary outcome was the rate of major adverse cardiac events (MACEs). The secondary outcomes included death, recurrent myocardial infarction, recurrent revascularization, and stent thrombosis.Results Totally, 1973 STEMI patients were enrolled in seven eligible randomized trials comparing SES with BMS. The pooled rate of major adverse cardiac events was significantly lower in the SES group than in the BMS group (9.7% vs 20.3%, OR 2.45, 95% Cl 1.88-3.19, P 〈 0.00001). No significant difference in all causes of death was found between the SES and BMS groups, as well as in the pooled recurrent myocardial infarction rates. The pooled recurrent revascularization rate was significantly lower in the SES group than in the BMS group (5.1% vs 14.8%, OR 3.30, 95%CI 2.37-4.60, P 〈 0.00001). No significant difference was found between the pooled rates of stent thrombosis (1.2% in the SES group and 2.0% in the BMS group, OR 1.61, 95%CI 0.79-3.26, P = 0.19).Conclusions SES is associated with a decreased risk of major adverse cardiac events compared with BMS by the greater reduction in repeat revascularization in STEMI patients. Larger trials with longer follow up are warranted to better define the role of SES in STEMI.
文摘Objective To study the safety of the novel high nitrogen nickel-free austenitic stainless steel bare metal stents (BMS) in a recognized porcine coronary model and to select a better grid structure of it. Methods Three types of stents were randomly implanted in different coronary arteries of the same pig: 316L stainless steel BMS (316L-BMS) (n=12), novel high nitrogen nickel-free stents Grid A (NF-A-BMS) (n=12) and novel high nitrogen nickel-free stents Grid B (NF-B-BMS) (n=12). In total, eighteen animals underwent successful random placement of 36 oversized stents in the coronary arteries. Coronary angiography was performed after 36 d of stents implantation. Nine animals were respectively sacrificed after 14 d and 36 d for histomorphologic analysis. 〈br〉 Results Quantitative coronary angiography (QCA) showed similar luminal loss (LL) in the three groups:(0.21±0.17) mm for 316L-BMS, (0.16±0.12) mm for NF-A-BMS, (0.24±0.15) mm for NF-B-BMS (P=0.05). Histomorphomeric analysis after 15 d and 36 d revealed that there was also no significant difference among the three groups in neointimal area (NA) with similar injury scores respectively. High magnification histomorphologic examination showed similar inflammation scores in the three groups, but NF-A-BMS group had poorer endothelialization scores compared with NF-B-BMS group, 2.00±0.63 vs. 2.83±0.41 (P=0.015) at 15 d, which also could be proved by the scanning electron microscope. However, the difference could not been observed at 36 d. Conclusion The novel NF-BMS showed similar safety as 316L-BMS during the short-term study. NF-B-BMS had better endothelialization than NF-A-BMS and this may owe to the specific strut units.
文摘In the last few decades, the recommended treatment for coronary artery disease has been dramatically improved by percutaneous coronary intervention(PCI) and the use of balloon catheters, bare metal stents(BMSs), and drug-eluting stents(DESs). Catheter balloons were burdened by acute vessel occlusion or target-lesion restenosis. BMSs greatly reduced those problems holding up the vessel structure, but showed high rates of instent re-stenosis, which is characterized by neo-intimal hyperplasia and vessel remodeling leading to a renarrowing of the vessel diameter. This challenge was overtaken by first-generation DESs, which reduced restenosis rates to nearly 5%, but demonstrated delayed arterial healing and risk for late in-stent thrombosis, with inflammatory cells playing a pivotal role. Finally, new-generation DESs, characterized by innovations in design, metal composition, surface polymers, and antiproliferative drugs, finally reduced the risk for stent thrombosis and greatly improved revascularization outcomes. New advances include bioresorbable stents potentially changing the future of revascularization techniques as the concept bases upon the degradation of the stent scaffold to inert particles after its function expired, thus theoretically eliminating risks linked with both stent thrombosis and re-stenosis. Talking about DESs also dictates to consider dual antiplatelet therapy(DAPT), which is a fundamental moment in view of the good outcome duration, but also deals with bleeding complications. The better management of patients undergoing PCI should include the use of DESs and a DAPT finely tailored in consideration of the potentially developing bleeding risk in accordance with the indications from last updated guidelines.
文摘For patients suffering from both biliary and duodenal obstruction,endoscopic retrograde cholangiopancreatography(ERCP) with stent placement is the treatment of choice.ERCP through an already existing duodenal prosthesis is an uncommon procedure and furthermore no studies have reported installing a covered metal stent onto an already existing bare metal stent in the common bile duct(CBD).We describe a rare case of a stent-in-stent dilatation of the CBD through an already existing self-expanding metal stent in the second part of duodenum for the patient presenting with jaundice in setting of biliary and duodenal obstruction from pancreatic adenocarcinoma.The biliary obstruction was relieved with a decrease in bilirubin levels post-stenting.
文摘Objectives: The study was designed to evaluate the efficacy and safety of drug eluting stents (DESs) in aorto-ostial (A-O) coronary artery lesions, in terms of early and late restenosis rate;including clinical assessment, non-invasive stress testing and angiographic follow-up. Also, the study was aimed to compare the results of implantation of drug eluting stents (DES) to that of bare metal stents (BMS) in aortoostial lesions done over a previous 5 years in Royal Brompton Hospital. Background: The safety and effectiveness of DESs for the treatment of aortoostial lesions. Methods: We included 161 consecutive patients with symptoms subjective of angina pectoris or objective evidence of myocardial ischemia;who underwent percutaneous coronary interventions (PCI) in coronary ostial lesions using DES. The patients were divided into two groups based on the site of ostial lesion. The control group consisted of 125 consecutive patients who underwent percutaneous coronary intervention for ostial lesions using bare metal stents (BMS) implantation in the period immediately before the introduction of DES. The incidence of major adverse cardiac events (MACE), including death or Q-wave myocardial infarction (MI), need for repeated revascularization procedure CABG or angioplasty, were recorded in-hospital and at twelve months ± 3 months. Follow-up angiography was only performed in case of recurrent symptoms subjective of myocardial ischemia or if there was objective evidence of myocardial ischemia by stress testing. Results: The initial procedure was successful in 149 patients (92.5%) in the DES arm. There were no statistically significant major in-hospital complications in the DES group, compared to BMS group which showed 4 cases of in-hospital deaths (p = 0.017). At Twelve months ± 3 months follow-up, MACE were significantly less frequent in the DES group compared to the BMS group, including death (0.8% vs. 6.4%, p = 0.004) and need for CABG (1.7% vs. 10%, p = 0.012). Conclusions: The main finding of our study is that, compared to the BMS, implantation of the DES in coronary ostial lesions appears safe and effective. It is associated with high procedural success rate, low immediate and in-hospital complication rate, infrequent late adverse events and favourable long-term clinical and angiographic outcomes compared with bare metal stents implantation at 12-month follow-up. Advanced age, previous myocardial infarction and acute coronary syndromes at presentation were all found to be independent positive predictors for clinical events after drug eluting stent implantation in ostial lesions.
文摘Background In response to the increasing concern with the safety of the drug-eluting stent (DES), the present study aimed to evaluate the long-term safety and efficacy of DES used for a Chinese patient population. Methods All patients, who underwent an index elective percutaneous coronary intervention with an implantation of either DES or bare-metal stent (BMS) in a single institution from April 2004 to December 2006, were included in the analysis. A propensity-score matching technique was applied to adjust and to minimize the impact of confounding factors. Results Overall, there were 1465 patients (20.2%) who had undergone an implantation of only BMS, and 5769 patients (79.8%) of only DES. The propensity-score matching technique set up 1321 pairs of patients for analysis. There were no significant differences between the rates of stent thrombosis (definite and probable) of the two groups (1.06% vs 1.21%, P=0.8580). Although rates of mortality and myocardial infarction (MI) during the 2-year follow-up period had not differed significantly, rates of death/MI (3.0% vs 4.5%, P=0.0263), target-lesion revascularization (TLR, 3.2% vs 8.5, P=0.0001), target-vessel revascularization (TVR, 5.8% vs 9.5%, P 〈0.0001) and any revascularization (10.0% vs 13.3%, P=0.0066) were significantly lower for the DES group than for the BMS group. Among the patients in whom devices were implanted for off-label indications, the propensity-score matched rates of stent thrombosis, mortality, MI, and death/MI were not significantly different, while rates of TLR, TVR and any revascularization were significantly lower for the DES group than for the BMS group. Conclusions During the 2 years of follow-up post stenting, DES use is associated with lower rates of death/MI, TLR, TVR and any revascularization, compared with BMS, in propensity-score matched Chinese patient populations. In the setting of off-label usage, DES use is also associated with similar advantages.
文摘Very late stent thrombosis (VLST) is increasingly being regarded as a complication of drug-eluting stents (DES), and delayed endothelization, local hypersensitivity reactions, and late stent malapposition due to excessive positive remodeling have been postulated as mechanisms. Considering that stent endothelialization seems to be completed within 4 weeks following bare-metal stent (BMS) placement and that BMS do not possess antiproliferative coating, the mechanism of VLST may differ between patients with DES and those with BMS. We report a case of VLST 9 years after BMS implantation, in which thrombus from the ruptured neointima was confirmed by intravascular ultrasound. This finding suggests that de novo plaque rupture at the neointimal layer within the stent may be one of the explanations for VLST.