BACKGROUND Drug-eluting stents(DES)are used to treat lower extremity arterial disease.During DES treatment,aneurysmal degeneration occasionally occurs,especially with fluoropolymer-based DES.However,the incidence of p...BACKGROUND Drug-eluting stents(DES)are used to treat lower extremity arterial disease.During DES treatment,aneurysmal degeneration occasionally occurs,especially with fluoropolymer-based DES.However,the incidence of pseudoaneurysms after DES placement is rarely reported in the lower extremity region,although there have been several reports on pseudoaneurysm formation after DES placement in the coronary artery region.CASE SUMMARY We report the case of a 64-year-old man who presented with fever and pain in his left hand after dialysis.Bacteremia was diagnosed by blood culture,and after admission,he developed pain on the medial side of the right thigh.A pseudoaneurysm was observed in the right superficial femoral artery(SFA)at the proximal end of a previously placed DES.The bacteremia was thought to have been caused by a pseudoaneurysm of the left superficial brachial artery,and the pseudoaneurysm of the left superficial brachial artery was removed after antibiotic treatment.The pseudoaneurysm of the right SFA rapidly expanded after admission,but the expansion rate was reduced after infection control.Seven months after the first admission,the pseudoaneurysm of the left SFA was re-moved and in situ revascularization performed using a rifampicin-soaked Dacron graft.CONCLUSION Although pseudoaneurysm after DES placement in the lower extremity region is rare,it must be considered in patients with bacteremia.展开更多
Background Rotational atherectomy (RA) could facilitate the percutaneous coronary intervention (PCI) in heavily coronary calcified patients. The effectiveness and safety of this technique needs to be further evalu...Background Rotational atherectomy (RA) could facilitate the percutaneous coronary intervention (PCI) in heavily coronary calcified patients. The effectiveness and safety of this technique needs to be further evaluated. Methods & Results Eighty patients who underwent RA in our center from September 2011 to June 2014 were enrolled. The mean age was 72.4 ± 10.4 years. The left ventricular ejection frac- tion (LVEF) was average 52.3% ± 8.48% and the estimated glomerular filtration rate was 73.2 ± 3.20 mL/min per 1.73 m2. The coronary lesions were complex, with Syntax score 29.5 ± 9.86. The diameter of reference vessel was 3.4 ± 0.45 mm and the average diameter stenosis of target vessels was 80% ~ 10%. All the patients were deployed with drug eluting stents (DES) successfully aiter RA. The patients were followed up for 12-18 months. Kaplan-Meier plots estimated the survival rate was 93.4% and the cumulative incidence of major adverse cardiac and cerebral events (MACCE) was 25.4%. Bleeding and procedural-related complications were quite low. COX proportional hazards model for multivariate analysis demonstrated that diabetes, LVEF and maximum pressure of postdilatation were the predictors of MACCE. Conclusions RA followed by implantation of DES was effective and safe for heavily coronary calcified patients. Diabetes, LVEF and maximum pressure ofpostdilatation were predictive for MACCE.展开更多
Objective: We explored the impact of increasing number of off-label patient and lesion character-istics on 5-year clinical outcome following implantation of first generation drug eluting stents. Furthermore we tried t...Objective: We explored the impact of increasing number of off-label patient and lesion character-istics on 5-year clinical outcome following implantation of first generation drug eluting stents. Furthermore we tried to assess if stent performance might be improved if the off-label character-istics present were taken into account to guide the stent brand selection. Design: A total of 2888 coronary lesions treated with first generation drug eluting stents were classified for eventual presence of 18 different off-label characteristics and correlated to the 5-year clinical outcome by multiple stepwise Cox regression analysis. Results: The composite of cardiac death, myocardial infarction and target vessel revascularization (major adverse cardiac event, MACE) was 16.7% in cases with zero off-label characteristics and showed a stepwise increased rate up to 32.7% in cases with 5 off-label characteristics. The MACE rate for the sirolimus eluting stent appears to be 10% lower than the paclitaxel stent group and it may be further reduced by 10% - 18% if the off-label characteristics present in each case were taken into account to guide the stent brand selection. Conclusion: With increasing number of concomitantly appearing off-label characteristics there is a stepwise increase in MACE rate. The MACE rate may be reduced if the off-label characteristics were used to guide the stent brand selection.展开更多
Coronary angioplasty with drug-eluting stent(DES)implantation is currently the most common stent procedure worldwide.Since the introduction of DES,coronary restenosis as well as the incidence of target vessel and targ...Coronary angioplasty with drug-eluting stent(DES)implantation is currently the most common stent procedure worldwide.Since the introduction of DES,coronary restenosis as well as the incidence of target vessel and target lesion revascularization have been significantly reduced.However,the incidence of very late stent thrombosis beyond the first year after stent deployment has more commonly been linked to DES than to baremetal stent(BMS)implantation.Several factors have been associated with very late stent thrombosis after DES implantation,such as delayed healing,inflammation,stent mal-apposition and endothelial dysfunction. Some of these adverse events were associated with the presence of durable polymers,which were essential to allow the elution of the immunosuppressive drug in the first DES designs.The introduction of erodable polymers in DES technology has provided the potential to complete the degradation of the polymer simultaneously or immediately after the release of the immunosuppressive drug,after which a BMS remains in place.Several DES designs with biodegradable(BIO)polymers have been introduced in preclinical and clinical studies, including randomized trials.In this review,we analyze the clinical results from 6 observational and randomized studies with BIO polymers and discuss advantages and disadvantages of this new technology.展开更多
Patients listed for organ transplant frequently have severe coronary artery disease(CAD), which may be treated with drug eluting stents(DES). Everolimus and zotarolimus eluting stents are commonly used. Newer generati...Patients listed for organ transplant frequently have severe coronary artery disease(CAD), which may be treated with drug eluting stents(DES). Everolimus and zotarolimus eluting stents are commonly used. Newer generation biolimus and novolimus eluting biodegradable stents are becoming increasingly popular. Patients undergoing transplant surgery soon after the placement of DES are at increased risk of stent thrombosis(ST) in the perioperative period. Dual antiplatelet therapy(DAPT) with aspirin and a P2Y12 inhibitor such as clopidogrel, prasugrel and ticagrelor is instated post stenting to decrease the incident of ST. Cangrelor has recently been approved by Food and Drug Administration and can be used as a bridging antiplatelet drug. The risk of ischemia vs bleeding must be considered when discontinuing or continuing DAPT for surgery. Though living donor transplant surgery is an elective procedure and can be optimally timed, cadaveric organ availability is unpredictable, therefore, discontinuation of antiplatelet medication cannot be optimally timed. The type of stent and timing of transplant surgery can be of utmost importance. Many platelet function point of care tests such as Light Transmittance Aggregrometry, Thromboelastography Platelet Mapping, VerifyN ow, Multiple Electrode Aggregrometry are used to assess bleeding risk and guide perioperative platelet transfusion. Response to allogenic platelet transfusion to control severe intraoperative bleeding may differ with the antiplatelet drug. In stent thrombosis is an emergency where management with either a drug eluting balloon or a DES has shown superior outcomes. Post-transplant complications often involved stenosis of an important vessel that may need revascularization. DES are now used for endovascular interventions for transplant orthotropic heart CAD, hepatic artery stenosis post liver transplantation, transplant renal artery stenosis following kidney transplantation, etc. Several antiproliferative drugs used in the DES are inhibitors of mammalian target of rapamycin. Thus they are used for post-transplant immunosuppression to prevent acute rejection in recipients with heart, liver, lung and kidney transplantation. This article describes in detail the various perioperative challenges encountered in organ transplantation surgery and patients with drug eluting stents.展开更多
AIM: To evaluate the premise, that biodegradable polymer drug eluting stents(BD-DES) could improve clinical outcomes compared to second generation permanent polymer drug eluting stents(PP-DES), we pooled the data from...AIM: To evaluate the premise, that biodegradable polymer drug eluting stents(BD-DES) could improve clinical outcomes compared to second generation permanent polymer drug eluting stents(PP-DES), we pooled the data from all the available randomized control trials(RCT) comparing the clinical performance of both these stents.METHODS: A systematic literature search of Pub Med, Cochrane, Google scholar databases, EMBASE, MEDLINE and SCOPUS was performed during time period of January 2001 to April 2015 for RCT and comparing safety and efficacy of BD-DES vs second generation PP-DES. The primary outcomes of interest were definite stent thrombosis, target lesion revascularization, myocardial infarction, cardiac deaths and total deaths during the study period. RESULTS: A total of 11 RCT's with a total of 12644 patients were included in the meta-analysis, with 6598 patients in BD-DES vs 6046 patients in second generation PP-DES. The mean follow up period was 16 mo. Pooled analysis showed non-inferiority of BD-DES, comparing events of stent thrombosis(OR = 1.42, 95%CI: 0.79-2.52, P = 0.24), target lesion revascularization(OR = 0.99, 95%CI: 0.84-1.17, P = 0.92), myocardial infarction(OR = 1.06, 95%CI: 0.86-1.29, P = 0.92), cardiac deaths(OR = 1.07, 95%CI 0.82-1.41, P = 0.94) and total deaths(OR = 0.96, 95%CI: 0.80-1.17, P = 0.71).CONCLUSION: BD-DES, when compared to second generation PP-DES, showed no significant advantage and the outcomes were comparable between both the groups.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 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 Because no large prospective studies are available, this study evaluated the clinical outcomes of two drug eluting stents in bifurcation lesions. Methods Lesions with diameter of side branch ≥2.5 mm were s...Background Because no large prospective studies are available, this study evaluated the clinical outcomes of two drug eluting stents in bifurcation lesions. Methods Lesions with diameter of side branch ≥2.5 mm were selected. From October 2003 to June 2005, 112 patients with 113 bifurcation lesions were treated by two drug eluting stents (DESs), technique. The location of bifurcation lesions were left anterior descending coronary artery/diagonal in 62 patients, left main distal bifurcation in 32, left circumflex coronary artery/obtute marginal branch in 18 and right coronary artery distal bifurcation in 1. Procedures for bifurcation lesions were crush or modified crush technique in 64, "T" stenting technique in 27, modified "Y" stenting, kiss stenting, "V" stenting as well as culotte stenting technique in 11, 5, 3 and 3, respectively. Among 226 lesions, 91 Cypher or Cypher select stents, 74 TAXUS and 67 Firebird were used. Final kiss balloon dilation was performed in 60 (93.7%) with crush technique after stenting. Results Success rate of percutaneous coronary intervention for the bifurcation lesions was 100%. One patient, who developed inhospital acute myocardial infarction due to subacute thrombosis, was successfully treated by a second intervention. Major adverse cardiac events rate in-hospital was 0.89% (1/112) and during followup was 7.14% (8/112), No death occurred during the followup of all patients. Angiographic followup was effected for 46 patients, restenosis for eight, coronary artery bypass grafting for 1 and a repeat intervention for 5. Restenosis involving TAXUS, Cypher and Firebird was 5 (5/18, 27.8%), 2 (2/17, 11.8%) and 1 (1/11, 9.1%), respectively (P〉0.05). Total restenotic rate was 17.4% (8/46). Conclusions When ostium of side branch has severe stenosis and 〉12.5 mm in diameter, two-stent strategy in this bifurcation lesion is safe and effective, and the outcomes are satisfactory. Restenotic rates were not different between TAXUS, Cypher and Firebird DESs.展开更多
Small diameter renal artery refers to the renal artery with the cross-section diameter less than 5 mm, the incidence of which is approximately 8%' Small diameter renal artery is common in patients with congenital mul...Small diameter renal artery refers to the renal artery with the cross-section diameter less than 5 mm, the incidence of which is approximately 8%' Small diameter renal artery is common in patients with congenital multi-branch renal arteries, diabetes and multi-coronary artery lesions. Renal artery bare-mental stent (BMS) implantation is the standard treatment for ostial renal展开更多
Background In patients with chronic total occlusion (CTO) and multivessel coronary artery disease, the comparison of surgical and the percutaneous revascularization strategies has rarely been conducted. The aim of t...Background In patients with chronic total occlusion (CTO) and multivessel coronary artery disease, the comparison of surgical and the percutaneous revascularization strategies has rarely been conducted. The aim of this study was to compare long term clinical outcomes of drug eluting stent (DES) implantation with coronary artery bypass surgery (CABG)in the patients with CTO and multivessel disease.Methods From a prospective registry of 6000 patients in our institution, we included patients with CTO and multivessel coronary artery disease who underwent either CABG (n=679) or DES (n=267) treatment. Their propensity risk score was used for adjusting baseline differences.Results At a median follow-up of three years, propensity score adjusted Cox regression analysis showed that the rate of major adverse cardiac cerebrovascular events (MACCE) was lower in CABG group (12.7% vs. 24.3%, hazard ratio (HR) 1.969, 95% Cl 1.219-3.179, P=0.006) mainly due to lower rate of target vessel revascularization in CABG group than in DES group (3.1% vs. 17.2%, HR 16.14, 95% CI 5.739-45.391, P <0.001). The incidence of cardiac death or myocardial infarction (composite end point) was not significantly different between these two groups. On multivariate analysis, the significant predictors of MACCE were only the type of revascularization. Age, left ventricular ejection fraction (LVEF), and complete revascularization were identified as significant predictors of composite end points.Conclusions Our study shows that in patients with CTO and multivessel coronary disease, DES can offer comparable long term outcomes in cardiac death and myocardial infraction free survival in comparison with CABG. However, there is an increased rate of MACCE which results from more repeat revascularizations. Obtaining a complete revascularization is crucial for decreasing adverse cardiac events.展开更多
Background:Permanent polymer drug eluting stents (PP-DES) may induce inflammation of the vessel wall due to the existence of the polymer,which may delay intimal healing.Polymer-free DES (PF-DES) that eliminate the pol...Background:Permanent polymer drug eluting stents (PP-DES) may induce inflammation of the vessel wall due to the existence of the polymer,which may delay intimal healing.Polymer-free DES (PF-DES) that eliminate the polymeric carrier may potentially lead to safer DES.However,the safety and efficacy of PF-DES remains controversial.Methods:Randomized controlled trials comparing PF-DES with PP-DES were searched in online database including MEDLINE,Excerpta Medica Database (EMBASE) and Cochrane Library.Studies reporting late lumen loss (LLL),all-cause death,myocardial infarction (MI),target lesion revascularization (TLR) and late stent thrombosis (LST) were enrolled and quantitatively analyzed.Results:Ten studies enrolling 6575 patients were included in this meta-analysis.The PF-DES showed a benefit in reducing all-cause death (OR =0.77,95% CI:0.61 to 0.98,P =0.03) and long-term LLL (weighted mean difference (WMD)-0.16 mm,95% CI:-0.22 to -0.11 mm,P < 0.001),while no superiority was found in reducing short-term LLL (WMD 0.03 mm,95% CI:-0.07-0.13 mm,P =0.57),MI (OR =1.12,95% CI:0.19 to 23.18,P=0.39),TLR (OR =1.19,95% CI:0.42 to 3.38,P=0.83)and LST (OR =0.92,95%CI:0.05 to 5.71,P =0.74).Conclusion:PF-DES showed benefits in reducing long-term LLL and mortality compared with PP-DES,but no superiority was found in short-term LLL,MI,TLR and LST.These findings provide a sound basis for the wide application of PF-DES in the future.展开更多
BACKGROUND We performed a meta-analysis on observational studies since randomized control trials are not available.We studied intracoronary brachytherapy(ICBT)and recurrent drug eluting stent in-stent restenosis(DES-I...BACKGROUND We performed a meta-analysis on observational studies since randomized control trials are not available.We studied intracoronary brachytherapy(ICBT)and recurrent drug eluting stent in-stent restenosis(DES-ISR)to evaluate the procedural success,target lesion revascularization(TLR),incidence of myocardial infarction(MI)and all-cause mortality at 2 years follow-up.AIM To perform meta-analysis for patients undergoing ICBT for recurrent DES-ISR.METHODS We performed a systematic search of the PubMed/MEDLINE,Cochrane and DARE databases to identify relevant articles.Studies were excluded if intracoronary brachytherapy was used as a treatment modality for initial ISR and studies with bare metal stents.We used a random-effect model with DerSimonian&Laird method to calculate summary estimates.Heterogeneity was assessed using I2 statistics.RESULTS A total of 6 observational studies were included in the final analysis.Procedural angiographic success following intra-coronary brachytherapy was 99.8%.Incidence of MI at 1-year was 2%and 4.1%at 2-years,respectively.The incidence of TLR 14.1%at 1-year and 22.7%at 2-years,respectively.All-cause mortality at 1-and 2-year follow-up was 3%and 7.5%,respectively.CONCLUSION Given the observational nature of the studies included in the analysis,heterogeneity was significantly higher for outcomes.While there are no randomized controlled trials or definitive guidelines available for recurrent ISR associated with DES,this analysis suggests that brachytherapy might be the alternative approach for recurrent DES-ISR.Randomized controlled trials are required to confirm results from this study.展开更多
Durable polymers used for first-generation drug-eluting stents potentially contribute to persistent inflammation and late stent thrombosis. BICARE (Lepu Medical Technology Co., Ltd, Beijing, China) is a novel polyme...Durable polymers used for first-generation drug-eluting stents potentially contribute to persistent inflammation and late stent thrombosis. BICARE (Lepu Medical Technology Co., Ltd, Beijing, China) is a novel polymer-free stent system with nanotechnology and elutes rapamycin (1.6 μg/mm2) and probucol (0.8 μg/mm2). The millpores on the surface of the stents were produced by nanotechnology. Studies on in-vitro release profile and the preliminary feasibility and safety of the BICARE stent were conducted. The results of release profile study demonstrated the ability of dual-drug polymer-free loading stents to release rapamycin and probucol in a controlled and sustained manner. The preliminary feasibility and safety of BICARE dual-drug polymer-free stent are demonstrated firstly in human study. Optical coherence tomography (OCT) findings indicated excellent stent strut coverage at 4-month. Further pivotal randomized trial will confirm if this early results could translate into longer term safety and efficacy benefits.展开更多
BACKGROUND The treatment of difficult common bile duct stones(CBDS)remains a big challenge around the world.Biliary stenting is a widely accepted rescue method in patients with failed stone extraction under endoscopic...BACKGROUND The treatment of difficult common bile duct stones(CBDS)remains a big challenge around the world.Biliary stenting is a widely accepted rescue method in patients with failed stone extraction under endoscopic retrograde cholangiopancreatography.Fully covered self-expanding metal stent(FCSEMS)has gained increasing attention in the management of difficult CBDS.AIM To manufacture a drug-eluting FCSEMS,which can achieve controlled release of stone-dissolving agents and speed up the dissolution of CBDS.METHODS Customized covered nitinol stents were adopted.Sodium cholate(SC)and disodium ethylene diamine tetraacetic acid(EDTA disodium,EDTA for short)were used as stone-dissolving agents.Three different types of drug-eluting stents were manufactured by dip coating(Stent I),coaxial electrospinning(Stent II),and dip coating combined with electrospinning(Stent III),respectively.The drugrelease behavior and stone-dissolving efficacy of these stents were evaluated in vitro to sort out the best manufacturing method.And the selected stonedissolving stents were further put into porcine CBD to evaluate their biosecurity.RESULTS Stent I and Stent II had obvious burst release of drugs in the first 5 d while Stent III presented controlled and sustainable drug release for 30 d.In still buffer,the final stone mass-loss rate of each group was 5.19%±0.69%for naked FCSEMS,20.37%±2.13%for Stent I,24.57%±1.45%for Stent II,and 33.72%±0.67%for Stent III.In flowing bile,the final stone mass-loss rate of each group was 5.87%±0.25%for naked FCSEMS,6.36%±0.48%for Stent I,6.38%±0.37%for Stent II,and 8.15%±0.27%for Stent III.Stent III caused the most stone mass-loss no matter in still buffer or in flowing bile,which was significantly higher than those of other groups(P<0.05).In vivo,Stent III made no difference from naked FCSEMS in serological analysis(P>0.05)and histopathological examination(P>0.05).CONCLUSION The novel SC and EDTA-eluting FCSEMS is efficient in diminishing CBDS in vitro.When conventional endoscopic techniques fail to remove difficult CBDS,SC and EDTA-eluting FCSEMS implantation may be considered a promising alternative.展开更多
Background New-generation drug-eluting stents (DES) was more effective in the treatment of in-stent restenosis (ISR) compared with the first-generation DES. Drug-eluting balloons (DEB) and new-generation DES had been ...Background New-generation drug-eluting stents (DES) was more effective in the treatment of in-stent restenosis (ISR) compared with the first-generation DES. Drug-eluting balloons (DEB) and new-generation DES had been available strategies in treatment of bare-metal stents/DES ISR (BMS/DES-ISR). Six new randomized trials have recently examined the angiographic outcomes and one-year clinical outcomes of DEB and new generation DES in BMS/DES-ISR. However, the optimal management for BMS/DES-ISR lesions remains controversial. Methods We searched the randomized clinical trials evaluating the angiographic outcomes and one-year clinical outcomes of DEB and new-generation DES in patients with BMS/DES-ISR. The primary endpoints were the angiographic outcomes, including the minimal luminal diameter (MLD), diameter stenosis %(DS%), late lumen loss (LLL), and binary restenosis (BR). Results A total of six randomized clinical trials with 1177 BMS/DES-ISR patients were included in our meta-analysis. For angiographic outcomes, there were significantly less MLD and more DS% with DEB compared to new-generation DES (MLD: MD =?0.18, 95% CI:?0.31– ?0.04, P < 0.001;DS%: MD = 5.68, 95% CI: 1.00–10.37, P < 0.001). Moreover, for one-year clinical outcomes, DEB was associated with a significant increase risk in target lesion revascularization (TLR)(RR = 2.93, 95% CI: 1.50–5.72, P = 0.002). However, DEB was associated with higher risks of major adverse cardiac event, target vessel revascularization, TLR, BR, and more DS% only in DES-ISR group. Conclusions DEB and new-generation DES have the similar clinical efficacy for the treatment of BMS-ISR. However, DES showed more MLD, less DS%, and a decreased risk of TLR for the treatment of DES-ISR.展开更多
Background There are limited data comparing long-term clinical outcomes between first-generation (1G) and second-generation (2G) drug-eluting stents (DESs) in patients who underwent successful percutaneous coronary in...Background There are limited data comparing long-term clinical outcomes between first-generation (1G) and second-generation (2G) drug-eluting stents (DESs) in patients who underwent successful percutaneous coronary intervention (PCI) for coronary chronic total occlusion (CTO) lesion. Methods A total of 840 consecutive patients who underwent PCI with DESs for CTO lesion from January 2004 to November 2015 were enrolled. Finally, a total of 324 eligible CTO patients received 1G-DES (Paclitaxel-eluting stent or Sirolimus-eluting stent, n = 157) or 2G-DES (Zotarolimus-eluting stent or Everolimus-eluting stent, n = 167) were enrolled. The clinical endpoint was the occurrence of major adverse cardiac events (MACE) defined as all-cause death, recurrent myocardial infarction (re-MI), total repeat revascularization [target lesion revascularization (TLR), target vessel revascularization (TVR), and non-TVR]. We investigated the 5-year major clinical outcomes between 1G-DES and 2G-DES in patient who underwent successful CTO PCI. Results After propensity score matched (PSM) analysis, two well-balanced groups (111 pairs, n = 222, C-statistic = 0.718) were generated. Up to the 5-year follow-up period, the cumulative incidence of all-cause death, re-MI, TLR, TVR and non-TVR were not significantly different between the two groups. Finally, MACE was also similar between the two groups (HR = 1.557, 95% CI: 0.820–2.959, P = 0.176) after PSM. Conclusions In this study, 2G-DES was not associated with reduced long-term MACE compared with 1G-DES following successful CTO revascularization up to five years.展开更多
Current percutaneous coronary intervention guidelines recommend dual antiplatelets(aspirin 100 mg + clopidogrel 75 mg daily) for at least 12 mo following drugeluting stent(DES) implantation if patients are not at high...Current percutaneous coronary intervention guidelines recommend dual antiplatelets(aspirin 100 mg + clopidogrel 75 mg daily) for at least 12 mo following drugeluting stent(DES) implantation if patients are not at high risk of bleeding.Several reports have tried to shorten the dual antiplatelet therapy to 3-6 mo,especially following next-generation DES implantation,for cost-effectiveness.However,the clinical results are inconsistent and the data regarding next-generation DESs limited.In this report,recently published important pivotal reports regarding the optimal duration of dual antiplatelets following DES implantation are summarized.展开更多
Coronary artery ectasia is well-known but relatively uncommon finding with prevalence ranging from 1.2% to 5.3%. Coronary artery ectasia has been associated with atherosclerosis in approximately half of the cases. Her...Coronary artery ectasia is well-known but relatively uncommon finding with prevalence ranging from 1.2% to 5.3%. Coronary artery ectasia has been associated with atherosclerosis in approximately half of the cases. Here, we are presenting a case of male patient who experienced myocardial infarction and was diagnosed with coronary artery ectasia in proximal-mid junction of left anterior descending artery with stenotic lesion. The patient was successfully treated with percutaneous transluminal coronary angioplasty.展开更多
Objective The benefit of short-term dual antiplatelet therapy(DAPT) following second-generation drug-eluting stents implantation has not been systematically evaluated. To bridge the knowledge gap,we did a meta-analysi...Objective The benefit of short-term dual antiplatelet therapy(DAPT) following second-generation drug-eluting stents implantation has not been systematically evaluated. To bridge the knowledge gap,we did a meta-analysis to assess the efficacy of ≤6 months versus ≥12 months DAPT among patients with second-generation drug-eluting stents. Methods We searched online databases and identified randomized controlled trials that assess the clinical impact of short-term DAPT(≤6 months) published before March 3,2016. The efficacy endpoints included the incidence of all-cause death,myocardial infarction,cerebrovascular accidents,and definite or probable stent thrombosis. Safety endpoint defined as major bleeding was also evaluated and discussed. Results We included 5 trials that randomized 9473 participants(49.8%,short-term DAPT duration vs. 50.2%,standard duration). A total of 9445(99.7%) patients reported the efficacy endpoints,and the safety endpoint was available from 4 studies(n=8457). There was no significant difference in efficacy endpoints between short-term and standard DAPT duration(≥12 months) [risk ratio(RR) 0.96; 95% confidence intervals(CI),0.80-1.15]. Short-term DAPT duration did not significantly increase the individual risk of all-cause death,myocardial infarction,cerebrovascular accidents,or definite or probable stent thrombosis. Although short-term DAPT obviously reduced risk of major bleeding compared with standard DAPT(RR 0.53; 95% CI,0.29-0.96),significant publication bias was found when accessing the safety endpoint of the 4 studies(Egger's test,P=0.009). Conclusions The efficacy of short-term DAPT was comparable with that of standard duration DAPT.DAPT less than 6 months may be appropriate for patients receiving second-generation drug-eluting stents implantation.展开更多
文摘BACKGROUND Drug-eluting stents(DES)are used to treat lower extremity arterial disease.During DES treatment,aneurysmal degeneration occasionally occurs,especially with fluoropolymer-based DES.However,the incidence of pseudoaneurysms after DES placement is rarely reported in the lower extremity region,although there have been several reports on pseudoaneurysm formation after DES placement in the coronary artery region.CASE SUMMARY We report the case of a 64-year-old man who presented with fever and pain in his left hand after dialysis.Bacteremia was diagnosed by blood culture,and after admission,he developed pain on the medial side of the right thigh.A pseudoaneurysm was observed in the right superficial femoral artery(SFA)at the proximal end of a previously placed DES.The bacteremia was thought to have been caused by a pseudoaneurysm of the left superficial brachial artery,and the pseudoaneurysm of the left superficial brachial artery was removed after antibiotic treatment.The pseudoaneurysm of the right SFA rapidly expanded after admission,but the expansion rate was reduced after infection control.Seven months after the first admission,the pseudoaneurysm of the left SFA was re-moved and in situ revascularization performed using a rifampicin-soaked Dacron graft.CONCLUSION Although pseudoaneurysm after DES placement in the lower extremity region is rare,it must be considered in patients with bacteremia.
文摘Background Rotational atherectomy (RA) could facilitate the percutaneous coronary intervention (PCI) in heavily coronary calcified patients. The effectiveness and safety of this technique needs to be further evaluated. Methods & Results Eighty patients who underwent RA in our center from September 2011 to June 2014 were enrolled. The mean age was 72.4 ± 10.4 years. The left ventricular ejection frac- tion (LVEF) was average 52.3% ± 8.48% and the estimated glomerular filtration rate was 73.2 ± 3.20 mL/min per 1.73 m2. The coronary lesions were complex, with Syntax score 29.5 ± 9.86. The diameter of reference vessel was 3.4 ± 0.45 mm and the average diameter stenosis of target vessels was 80% ~ 10%. All the patients were deployed with drug eluting stents (DES) successfully aiter RA. The patients were followed up for 12-18 months. Kaplan-Meier plots estimated the survival rate was 93.4% and the cumulative incidence of major adverse cardiac and cerebral events (MACCE) was 25.4%. Bleeding and procedural-related complications were quite low. COX proportional hazards model for multivariate analysis demonstrated that diabetes, LVEF and maximum pressure of postdilatation were the predictors of MACCE. Conclusions RA followed by implantation of DES was effective and safe for heavily coronary calcified patients. Diabetes, LVEF and maximum pressure ofpostdilatation were predictive for MACCE.
文摘Objective: We explored the impact of increasing number of off-label patient and lesion character-istics on 5-year clinical outcome following implantation of first generation drug eluting stents. Furthermore we tried to assess if stent performance might be improved if the off-label character-istics present were taken into account to guide the stent brand selection. Design: A total of 2888 coronary lesions treated with first generation drug eluting stents were classified for eventual presence of 18 different off-label characteristics and correlated to the 5-year clinical outcome by multiple stepwise Cox regression analysis. Results: The composite of cardiac death, myocardial infarction and target vessel revascularization (major adverse cardiac event, MACE) was 16.7% in cases with zero off-label characteristics and showed a stepwise increased rate up to 32.7% in cases with 5 off-label characteristics. The MACE rate for the sirolimus eluting stent appears to be 10% lower than the paclitaxel stent group and it may be further reduced by 10% - 18% if the off-label characteristics present in each case were taken into account to guide the stent brand selection. Conclusion: With increasing number of concomitantly appearing off-label characteristics there is a stepwise increase in MACE rate. The MACE rate may be reduced if the off-label characteristics were used to guide the stent brand selection.
文摘Coronary angioplasty with drug-eluting stent(DES)implantation is currently the most common stent procedure worldwide.Since the introduction of DES,coronary restenosis as well as the incidence of target vessel and target lesion revascularization have been significantly reduced.However,the incidence of very late stent thrombosis beyond the first year after stent deployment has more commonly been linked to DES than to baremetal stent(BMS)implantation.Several factors have been associated with very late stent thrombosis after DES implantation,such as delayed healing,inflammation,stent mal-apposition and endothelial dysfunction. Some of these adverse events were associated with the presence of durable polymers,which were essential to allow the elution of the immunosuppressive drug in the first DES designs.The introduction of erodable polymers in DES technology has provided the potential to complete the degradation of the polymer simultaneously or immediately after the release of the immunosuppressive drug,after which a BMS remains in place.Several DES designs with biodegradable(BIO)polymers have been introduced in preclinical and clinical studies, including randomized trials.In this review,we analyze the clinical results from 6 observational and randomized studies with BIO polymers and discuss advantages and disadvantages of this new technology.
文摘Patients listed for organ transplant frequently have severe coronary artery disease(CAD), which may be treated with drug eluting stents(DES). Everolimus and zotarolimus eluting stents are commonly used. Newer generation biolimus and novolimus eluting biodegradable stents are becoming increasingly popular. Patients undergoing transplant surgery soon after the placement of DES are at increased risk of stent thrombosis(ST) in the perioperative period. Dual antiplatelet therapy(DAPT) with aspirin and a P2Y12 inhibitor such as clopidogrel, prasugrel and ticagrelor is instated post stenting to decrease the incident of ST. Cangrelor has recently been approved by Food and Drug Administration and can be used as a bridging antiplatelet drug. The risk of ischemia vs bleeding must be considered when discontinuing or continuing DAPT for surgery. Though living donor transplant surgery is an elective procedure and can be optimally timed, cadaveric organ availability is unpredictable, therefore, discontinuation of antiplatelet medication cannot be optimally timed. The type of stent and timing of transplant surgery can be of utmost importance. Many platelet function point of care tests such as Light Transmittance Aggregrometry, Thromboelastography Platelet Mapping, VerifyN ow, Multiple Electrode Aggregrometry are used to assess bleeding risk and guide perioperative platelet transfusion. Response to allogenic platelet transfusion to control severe intraoperative bleeding may differ with the antiplatelet drug. In stent thrombosis is an emergency where management with either a drug eluting balloon or a DES has shown superior outcomes. Post-transplant complications often involved stenosis of an important vessel that may need revascularization. DES are now used for endovascular interventions for transplant orthotropic heart CAD, hepatic artery stenosis post liver transplantation, transplant renal artery stenosis following kidney transplantation, etc. Several antiproliferative drugs used in the DES are inhibitors of mammalian target of rapamycin. Thus they are used for post-transplant immunosuppression to prevent acute rejection in recipients with heart, liver, lung and kidney transplantation. This article describes in detail the various perioperative challenges encountered in organ transplantation surgery and patients with drug eluting stents.
文摘AIM: To evaluate the premise, that biodegradable polymer drug eluting stents(BD-DES) could improve clinical outcomes compared to second generation permanent polymer drug eluting stents(PP-DES), we pooled the data from all the available randomized control trials(RCT) comparing the clinical performance of both these stents.METHODS: A systematic literature search of Pub Med, Cochrane, Google scholar databases, EMBASE, MEDLINE and SCOPUS was performed during time period of January 2001 to April 2015 for RCT and comparing safety and efficacy of BD-DES vs second generation PP-DES. The primary outcomes of interest were definite stent thrombosis, target lesion revascularization, myocardial infarction, cardiac deaths and total deaths during the study period. RESULTS: A total of 11 RCT's with a total of 12644 patients were included in the meta-analysis, with 6598 patients in BD-DES vs 6046 patients in second generation PP-DES. The mean follow up period was 16 mo. Pooled analysis showed non-inferiority of BD-DES, comparing events of stent thrombosis(OR = 1.42, 95%CI: 0.79-2.52, P = 0.24), target lesion revascularization(OR = 0.99, 95%CI: 0.84-1.17, P = 0.92), myocardial infarction(OR = 1.06, 95%CI: 0.86-1.29, P = 0.92), cardiac deaths(OR = 1.07, 95%CI 0.82-1.41, P = 0.94) and total deaths(OR = 0.96, 95%CI: 0.80-1.17, P = 0.71).CONCLUSION: BD-DES, when compared to second generation PP-DES, showed no significant advantage and the outcomes were comparable between both the groups.
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 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 Because no large prospective studies are available, this study evaluated the clinical outcomes of two drug eluting stents in bifurcation lesions. Methods Lesions with diameter of side branch ≥2.5 mm were selected. From October 2003 to June 2005, 112 patients with 113 bifurcation lesions were treated by two drug eluting stents (DESs), technique. The location of bifurcation lesions were left anterior descending coronary artery/diagonal in 62 patients, left main distal bifurcation in 32, left circumflex coronary artery/obtute marginal branch in 18 and right coronary artery distal bifurcation in 1. Procedures for bifurcation lesions were crush or modified crush technique in 64, "T" stenting technique in 27, modified "Y" stenting, kiss stenting, "V" stenting as well as culotte stenting technique in 11, 5, 3 and 3, respectively. Among 226 lesions, 91 Cypher or Cypher select stents, 74 TAXUS and 67 Firebird were used. Final kiss balloon dilation was performed in 60 (93.7%) with crush technique after stenting. Results Success rate of percutaneous coronary intervention for the bifurcation lesions was 100%. One patient, who developed inhospital acute myocardial infarction due to subacute thrombosis, was successfully treated by a second intervention. Major adverse cardiac events rate in-hospital was 0.89% (1/112) and during followup was 7.14% (8/112), No death occurred during the followup of all patients. Angiographic followup was effected for 46 patients, restenosis for eight, coronary artery bypass grafting for 1 and a repeat intervention for 5. Restenosis involving TAXUS, Cypher and Firebird was 5 (5/18, 27.8%), 2 (2/17, 11.8%) and 1 (1/11, 9.1%), respectively (P〉0.05). Total restenotic rate was 17.4% (8/46). Conclusions When ostium of side branch has severe stenosis and 〉12.5 mm in diameter, two-stent strategy in this bifurcation lesion is safe and effective, and the outcomes are satisfactory. Restenotic rates were not different between TAXUS, Cypher and Firebird DESs.
文摘Small diameter renal artery refers to the renal artery with the cross-section diameter less than 5 mm, the incidence of which is approximately 8%' Small diameter renal artery is common in patients with congenital multi-branch renal arteries, diabetes and multi-coronary artery lesions. Renal artery bare-mental stent (BMS) implantation is the standard treatment for ostial renal
文摘Background In patients with chronic total occlusion (CTO) and multivessel coronary artery disease, the comparison of surgical and the percutaneous revascularization strategies has rarely been conducted. The aim of this study was to compare long term clinical outcomes of drug eluting stent (DES) implantation with coronary artery bypass surgery (CABG)in the patients with CTO and multivessel disease.Methods From a prospective registry of 6000 patients in our institution, we included patients with CTO and multivessel coronary artery disease who underwent either CABG (n=679) or DES (n=267) treatment. Their propensity risk score was used for adjusting baseline differences.Results At a median follow-up of three years, propensity score adjusted Cox regression analysis showed that the rate of major adverse cardiac cerebrovascular events (MACCE) was lower in CABG group (12.7% vs. 24.3%, hazard ratio (HR) 1.969, 95% Cl 1.219-3.179, P=0.006) mainly due to lower rate of target vessel revascularization in CABG group than in DES group (3.1% vs. 17.2%, HR 16.14, 95% CI 5.739-45.391, P <0.001). The incidence of cardiac death or myocardial infarction (composite end point) was not significantly different between these two groups. On multivariate analysis, the significant predictors of MACCE were only the type of revascularization. Age, left ventricular ejection fraction (LVEF), and complete revascularization were identified as significant predictors of composite end points.Conclusions Our study shows that in patients with CTO and multivessel coronary disease, DES can offer comparable long term outcomes in cardiac death and myocardial infraction free survival in comparison with CABG. However, there is an increased rate of MACCE which results from more repeat revascularizations. Obtaining a complete revascularization is crucial for decreasing adverse cardiac events.
文摘Background:Permanent polymer drug eluting stents (PP-DES) may induce inflammation of the vessel wall due to the existence of the polymer,which may delay intimal healing.Polymer-free DES (PF-DES) that eliminate the polymeric carrier may potentially lead to safer DES.However,the safety and efficacy of PF-DES remains controversial.Methods:Randomized controlled trials comparing PF-DES with PP-DES were searched in online database including MEDLINE,Excerpta Medica Database (EMBASE) and Cochrane Library.Studies reporting late lumen loss (LLL),all-cause death,myocardial infarction (MI),target lesion revascularization (TLR) and late stent thrombosis (LST) were enrolled and quantitatively analyzed.Results:Ten studies enrolling 6575 patients were included in this meta-analysis.The PF-DES showed a benefit in reducing all-cause death (OR =0.77,95% CI:0.61 to 0.98,P =0.03) and long-term LLL (weighted mean difference (WMD)-0.16 mm,95% CI:-0.22 to -0.11 mm,P < 0.001),while no superiority was found in reducing short-term LLL (WMD 0.03 mm,95% CI:-0.07-0.13 mm,P =0.57),MI (OR =1.12,95% CI:0.19 to 23.18,P=0.39),TLR (OR =1.19,95% CI:0.42 to 3.38,P=0.83)and LST (OR =0.92,95%CI:0.05 to 5.71,P =0.74).Conclusion:PF-DES showed benefits in reducing long-term LLL and mortality compared with PP-DES,but no superiority was found in short-term LLL,MI,TLR and LST.These findings provide a sound basis for the wide application of PF-DES in the future.
文摘BACKGROUND We performed a meta-analysis on observational studies since randomized control trials are not available.We studied intracoronary brachytherapy(ICBT)and recurrent drug eluting stent in-stent restenosis(DES-ISR)to evaluate the procedural success,target lesion revascularization(TLR),incidence of myocardial infarction(MI)and all-cause mortality at 2 years follow-up.AIM To perform meta-analysis for patients undergoing ICBT for recurrent DES-ISR.METHODS We performed a systematic search of the PubMed/MEDLINE,Cochrane and DARE databases to identify relevant articles.Studies were excluded if intracoronary brachytherapy was used as a treatment modality for initial ISR and studies with bare metal stents.We used a random-effect model with DerSimonian&Laird method to calculate summary estimates.Heterogeneity was assessed using I2 statistics.RESULTS A total of 6 observational studies were included in the final analysis.Procedural angiographic success following intra-coronary brachytherapy was 99.8%.Incidence of MI at 1-year was 2%and 4.1%at 2-years,respectively.The incidence of TLR 14.1%at 1-year and 22.7%at 2-years,respectively.All-cause mortality at 1-and 2-year follow-up was 3%and 7.5%,respectively.CONCLUSION Given the observational nature of the studies included in the analysis,heterogeneity was significantly higher for outcomes.While there are no randomized controlled trials or definitive guidelines available for recurrent ISR associated with DES,this analysis suggests that brachytherapy might be the alternative approach for recurrent DES-ISR.Randomized controlled trials are required to confirm results from this study.
文摘Durable polymers used for first-generation drug-eluting stents potentially contribute to persistent inflammation and late stent thrombosis. BICARE (Lepu Medical Technology Co., Ltd, Beijing, China) is a novel polymer-free stent system with nanotechnology and elutes rapamycin (1.6 μg/mm2) and probucol (0.8 μg/mm2). The millpores on the surface of the stents were produced by nanotechnology. Studies on in-vitro release profile and the preliminary feasibility and safety of the BICARE stent were conducted. The results of release profile study demonstrated the ability of dual-drug polymer-free loading stents to release rapamycin and probucol in a controlled and sustained manner. The preliminary feasibility and safety of BICARE dual-drug polymer-free stent are demonstrated firstly in human study. Optical coherence tomography (OCT) findings indicated excellent stent strut coverage at 4-month. Further pivotal randomized trial will confirm if this early results could translate into longer term safety and efficacy benefits.
基金the National Natural Science Foundation of China,No.81470904and Shanghai Committee of Science and Technology,No.14411963000
文摘BACKGROUND The treatment of difficult common bile duct stones(CBDS)remains a big challenge around the world.Biliary stenting is a widely accepted rescue method in patients with failed stone extraction under endoscopic retrograde cholangiopancreatography.Fully covered self-expanding metal stent(FCSEMS)has gained increasing attention in the management of difficult CBDS.AIM To manufacture a drug-eluting FCSEMS,which can achieve controlled release of stone-dissolving agents and speed up the dissolution of CBDS.METHODS Customized covered nitinol stents were adopted.Sodium cholate(SC)and disodium ethylene diamine tetraacetic acid(EDTA disodium,EDTA for short)were used as stone-dissolving agents.Three different types of drug-eluting stents were manufactured by dip coating(Stent I),coaxial electrospinning(Stent II),and dip coating combined with electrospinning(Stent III),respectively.The drugrelease behavior and stone-dissolving efficacy of these stents were evaluated in vitro to sort out the best manufacturing method.And the selected stonedissolving stents were further put into porcine CBD to evaluate their biosecurity.RESULTS Stent I and Stent II had obvious burst release of drugs in the first 5 d while Stent III presented controlled and sustainable drug release for 30 d.In still buffer,the final stone mass-loss rate of each group was 5.19%±0.69%for naked FCSEMS,20.37%±2.13%for Stent I,24.57%±1.45%for Stent II,and 33.72%±0.67%for Stent III.In flowing bile,the final stone mass-loss rate of each group was 5.87%±0.25%for naked FCSEMS,6.36%±0.48%for Stent I,6.38%±0.37%for Stent II,and 8.15%±0.27%for Stent III.Stent III caused the most stone mass-loss no matter in still buffer or in flowing bile,which was significantly higher than those of other groups(P<0.05).In vivo,Stent III made no difference from naked FCSEMS in serological analysis(P>0.05)and histopathological examination(P>0.05).CONCLUSION The novel SC and EDTA-eluting FCSEMS is efficient in diminishing CBDS in vitro.When conventional endoscopic techniques fail to remove difficult CBDS,SC and EDTA-eluting FCSEMS implantation may be considered a promising alternative.
基金supported by the National Natural Science Foundation of China(No.81671731)the Capital Clinical Feature Research Project(Z171100001017158)
文摘Background New-generation drug-eluting stents (DES) was more effective in the treatment of in-stent restenosis (ISR) compared with the first-generation DES. Drug-eluting balloons (DEB) and new-generation DES had been available strategies in treatment of bare-metal stents/DES ISR (BMS/DES-ISR). Six new randomized trials have recently examined the angiographic outcomes and one-year clinical outcomes of DEB and new generation DES in BMS/DES-ISR. However, the optimal management for BMS/DES-ISR lesions remains controversial. Methods We searched the randomized clinical trials evaluating the angiographic outcomes and one-year clinical outcomes of DEB and new-generation DES in patients with BMS/DES-ISR. The primary endpoints were the angiographic outcomes, including the minimal luminal diameter (MLD), diameter stenosis %(DS%), late lumen loss (LLL), and binary restenosis (BR). Results A total of six randomized clinical trials with 1177 BMS/DES-ISR patients were included in our meta-analysis. For angiographic outcomes, there were significantly less MLD and more DS% with DEB compared to new-generation DES (MLD: MD =?0.18, 95% CI:?0.31– ?0.04, P < 0.001;DS%: MD = 5.68, 95% CI: 1.00–10.37, P < 0.001). Moreover, for one-year clinical outcomes, DEB was associated with a significant increase risk in target lesion revascularization (TLR)(RR = 2.93, 95% CI: 1.50–5.72, P = 0.002). However, DEB was associated with higher risks of major adverse cardiac event, target vessel revascularization, TLR, BR, and more DS% only in DES-ISR group. Conclusions DEB and new-generation DES have the similar clinical efficacy for the treatment of BMS-ISR. However, DES showed more MLD, less DS%, and a decreased risk of TLR for the treatment of DES-ISR.
文摘Background There are limited data comparing long-term clinical outcomes between first-generation (1G) and second-generation (2G) drug-eluting stents (DESs) in patients who underwent successful percutaneous coronary intervention (PCI) for coronary chronic total occlusion (CTO) lesion. Methods A total of 840 consecutive patients who underwent PCI with DESs for CTO lesion from January 2004 to November 2015 were enrolled. Finally, a total of 324 eligible CTO patients received 1G-DES (Paclitaxel-eluting stent or Sirolimus-eluting stent, n = 157) or 2G-DES (Zotarolimus-eluting stent or Everolimus-eluting stent, n = 167) were enrolled. The clinical endpoint was the occurrence of major adverse cardiac events (MACE) defined as all-cause death, recurrent myocardial infarction (re-MI), total repeat revascularization [target lesion revascularization (TLR), target vessel revascularization (TVR), and non-TVR]. We investigated the 5-year major clinical outcomes between 1G-DES and 2G-DES in patient who underwent successful CTO PCI. Results After propensity score matched (PSM) analysis, two well-balanced groups (111 pairs, n = 222, C-statistic = 0.718) were generated. Up to the 5-year follow-up period, the cumulative incidence of all-cause death, re-MI, TLR, TVR and non-TVR were not significantly different between the two groups. Finally, MACE was also similar between the two groups (HR = 1.557, 95% CI: 0.820–2.959, P = 0.176) after PSM. Conclusions In this study, 2G-DES was not associated with reduced long-term MACE compared with 1G-DES following successful CTO revascularization up to five years.
文摘Current percutaneous coronary intervention guidelines recommend dual antiplatelets(aspirin 100 mg + clopidogrel 75 mg daily) for at least 12 mo following drugeluting stent(DES) implantation if patients are not at high risk of bleeding.Several reports have tried to shorten the dual antiplatelet therapy to 3-6 mo,especially following next-generation DES implantation,for cost-effectiveness.However,the clinical results are inconsistent and the data regarding next-generation DESs limited.In this report,recently published important pivotal reports regarding the optimal duration of dual antiplatelets following DES implantation are summarized.
文摘Coronary artery ectasia is well-known but relatively uncommon finding with prevalence ranging from 1.2% to 5.3%. Coronary artery ectasia has been associated with atherosclerosis in approximately half of the cases. Here, we are presenting a case of male patient who experienced myocardial infarction and was diagnosed with coronary artery ectasia in proximal-mid junction of left anterior descending artery with stenotic lesion. The patient was successfully treated with percutaneous transluminal coronary angioplasty.
文摘Objective The benefit of short-term dual antiplatelet therapy(DAPT) following second-generation drug-eluting stents implantation has not been systematically evaluated. To bridge the knowledge gap,we did a meta-analysis to assess the efficacy of ≤6 months versus ≥12 months DAPT among patients with second-generation drug-eluting stents. Methods We searched online databases and identified randomized controlled trials that assess the clinical impact of short-term DAPT(≤6 months) published before March 3,2016. The efficacy endpoints included the incidence of all-cause death,myocardial infarction,cerebrovascular accidents,and definite or probable stent thrombosis. Safety endpoint defined as major bleeding was also evaluated and discussed. Results We included 5 trials that randomized 9473 participants(49.8%,short-term DAPT duration vs. 50.2%,standard duration). A total of 9445(99.7%) patients reported the efficacy endpoints,and the safety endpoint was available from 4 studies(n=8457). There was no significant difference in efficacy endpoints between short-term and standard DAPT duration(≥12 months) [risk ratio(RR) 0.96; 95% confidence intervals(CI),0.80-1.15]. Short-term DAPT duration did not significantly increase the individual risk of all-cause death,myocardial infarction,cerebrovascular accidents,or definite or probable stent thrombosis. Although short-term DAPT obviously reduced risk of major bleeding compared with standard DAPT(RR 0.53; 95% CI,0.29-0.96),significant publication bias was found when accessing the safety endpoint of the 4 studies(Egger's test,P=0.009). Conclusions The efficacy of short-term DAPT was comparable with that of standard duration DAPT.DAPT less than 6 months may be appropriate for patients receiving second-generation drug-eluting stents implantation.