Long-term outcomes of titanium-nitride-oxide coated stents and drug-eluting stents in acute coronary syndrome:A systematic review and meta-analysis

BACKGROUND In severe cases of coronary artery disease,percutaneous coronary intervention provide promising results.The stent used could be a drug-eluting stent(DES)or a titanium-nitride-oxide coated stent(TiNOS).AIM To compare the 5-year effectiveness and safety of the two stent types.METHODS The following systematic review and meta-analysis was conducted in accordance with the preferred reporting items for systematic reviews and meta-analysis guidelines,and PubMed/MEDLINE,Scopus,and Cochrane Central were searched from inception till August 2023.Primary outcomes were major adverse cardiac events(MACE),cardiac death,myocardial infarction(MI),cardiac death or MI,and ischemia-driven total lesion revascularization(ID-TLR).RESULTS Four randomized controlled trials(RCT),which analyzed a sum total of 3045 patients with acute coronary syndrome(ACS)after a median follow-up time of 5 years were included.Though statistically insignificant,an increase in the ID-TLR was observed in patients receiving TiNOSs vs DESs.In addition,MI,cardiac death and MI,and definite stent thrombosis(DST)were significantly decreased in the TiNOS arm.Baseline analysis revealed no significant results with meta-regression presenting non-ST elevated MI(NSTEMI)as a statistically significant covariate in the outcome of MACE.CONCLUSION TiNOS was found to be superior to DES in terms of MI,cardiac death or MI,and DST outcomes,however,the effect of the two stent types on ID-TLR and MACE was not significant.A greater number of studies are required to establish an accurate comparison of patient outcomes in TiNOS and DES.

Prolonged dual antiplatelet therapy after drug-eluting stent implantation improves long-term prognosis for acute coronary syndrome:five-year results from a large cohort study

BACKGROUND:To investigate the most appropriate dual antiplatelet therapy(DAPT)duration for patients with acute coronary syndrome(ACS)after drug-eluting stent(DES)implantation in the largest cardiovascular center of China.METHODS:We enrolled 5,187 consecutive patients with ACS who received DES from January to December 2013.Patients were divided into four groups based on DAPT duration:standard DAPT group(11-13 months,n=1,568)and prolonged DAPT groups(13-18 months[n=308],18-24 months[n=2,125],and>24 months[n=1,186]).Baseline characteristics and 5-year clinical outcomes were recorded.RESULTS:Baseline characteristics were similar across the four groups.Among the four groups,those with prolonged DAPT(18-24 months)had the lowest incidence of major adverse cardiovascular and cerebrovascular events(MACCEs)(14.1%vs.11.7%vs.9.6%vs.24.2%,P<0.001),all-cause death(4.8%vs.3.9%vs.2.1%vs.2.6%,P<0.001),cardiac death(3.1%vs.2.6%vs.1.4%vs.1.9%,P=0.004),and myocardial infarction(MI)(3.8%vs.4.2%vs.2.5%vs.5.8%,P<0.001).The incidence of bleeding was not different among the four groups(9.9%vs.9.4%vs.11.0%vs.9.4%,P=0.449).Cox multivariable analysis showed that prolonged DAPT(18-24 months)was an independent protective factor for MACCEs(hazard ratio[HR]0.802,95%confidence interval[CI]0.729-0.882,P<0.001),all-cause death(HR 0.660,95%CI 0.547-0.795,P<0.001),cardiac death(HR 0.663,95%CI 0.526-0.835,P<0.001),MI(HR 0.796,95%CI 0.662-0.957,P=0.015),and target vessel revascularization(HR 0.867,95%CI 0.755-0.996,P=0.044).Subgroup analysis for high bleeding risk showed that prolonged DAPT remained an independent protective factor for all-cause death and MACCEs.CONCLUSION:For patients with ACS after DES,appropriately prolonging the DAPT duration may be associated with a reduced risk of adverse ischemic events without increasing the bleeding risk.

Meta-analysis of outcomes from drug-eluting stent implantation in infrapopliteal arteries

BACKGROUND Percutaneous drug-eluting stent implantation(DESI)is an emerging and promising treatment modality for infrapopliteal artery diseases(IPADs).This systematic review and meta-analysis summarizes and quantitatively analyzes the outcomes of DESI in IPADs considering the hazard ratio(HR),which is a more accurate and appropriate outcome measure than the more commonly used relative risk and odds ratio.AIM To explore the superiority of drug-eluting stents(DESs)vs traditional treatment modalities for IPADs.METHODS The following postoperative indicators were the outcomes of interest:All-cause death(ACD)-free survival,major amputation(MA)-free survival,target lesion revascularization(TLR)-free survival,adverse event(AE)-free survival,and primary patency(PP)survival.The outcome measures were then compared according to their respective HRs with 95%confidence intervals(CIs).The participants were human IPAD patients who underwent treatments for infrapopliteal lesions.DESI was set as the intervention arm,and traditional percutaneous transluminal angioplasty(PTA)with or without bare metal stent implantation(BMSI)was set as the control arm.A systematic search in the Excerpta Medica Database(Embase),PubMed,Web of Science,and Cochrane Library was performed on November 29,2022.All controlled studies published in English with sufficient data on outcomes of interest for extraction or conversion were included.When studies did not directly report the HRs but gave a corresponding survival curve,we utilized Engauge Digitizer software and standard formulas to convert the information and derive HRs.Then,meta-analyses were conducted using a random-effects model.RESULTS Five randomized controlled trials and three cohort studies involving 2639 participants were included.The ACDfree and MA-free survival HR values for DESI were not statistically significant from those of the control treatment(P>0.05);however,the HR values for TLR-free,AE-free,and PP-survival differed significantly[2.65(95%CI:1.56-4.50),1.57(95%CI:1.23-2.01),and 5.67(95%CI:3.56-9.03),respectively].CONCLUSION Compared with traditional treatment modalities(i.e.,PTA with or without BMSI),DESI for IPADs is superior in avoiding TLR and AEs and maintaining PP but shows no superiority or inferiority in avoiding ACD and MA.

Drug-eluting balloons versus new generation drug-eluting stents for the management of in-stent restenosis: an updated meta-analysis of randomized studies

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.

Ureteral stent technology:Drug-eluting stents and stent coatings

Ureteral stents are commonly used following urological procedures to maintain ureteral patency.However,alongside the benefits of the device,indwelling stents frequently cause significant patient discomfort(pain,urgency,frequency)and can become encrusted and infected.The importance of these sequelae is that they are not only bothersome to the patient but can lead to significant morbidity,urinary retention,ureteral damage,recurrent infections,pyelonephritis and sepsis.When these problems occur,stent removal or replacement alongside antibiotic,analgesic and/or other symptom-modifying therapies are essential to successfully treat the patient.In an attempt to prevent such morbidity,numerous approaches have been investigated over the past several decades to modify the stent itself,thereby affecting changes locally within the urinary tract without significant systemic therapy.These strategies include changes to device design,polymeric composition,drug-elution and surface coatings.Of these,drug-elution and surface coatings are the most studied and display the most promise for advancing ureteral stent use and efficacy.This article reviews these two strategies in detail to determine their clinical potential and guide future research in the area.

Domestic versus imported drug-eluting stents for the treatment of patients with acute coronary syndrome

BACKGROUND:The application of coronary stents,especially drug-eluting stents(DESs),has made percutaneous coronary intervention(PCI) one of important therapeutic methods for CHD. DES has reduced the in-stent restenosis to 5%–9% and signifi cantly improved the long-term prognosis of patients with CHD. The study aimed to investigate the long-term eff icacy and safety of domestic drugeluting stents(DESs) in patients with acute coronary syndrome(ACS).METHODS:All patients with ACS who had undergone successful percutaneous coronary intervention(PCI) in the First Aff iliated Hospital of Zhengzhou University from July 2009 to December 2010 were included in this study. Patients were excluded from the study if they were implanted with bare metal stents or different stents(domestic and imported DESs) simultaneously. The included patients were divided into two groups according to different stents implanted:domestic DESs and imported DESs.RESULTS:In the 1 683 patients of this study,1 558(92.6%) patients were followed up successfully for an average of(29.1±5.9) months. 130(8.3%) patients had major adverse cardiovascular events(MACEs),including cardiac death in 32(2.1%) patients,recurrent myocardial infarction in 16(1%),and revascularization in 94(6%). The rates of cardiac death,recurrent myocardial infarction,revascularization,in-stent restenosis,stent thrombosis and other MACEs were not signif icantly different between the two groups(all P>0.05). Multivarite logistic regression revealed that diabetes mellitus(OR=1.75,95%CI:1.09–2.82,P=0.021),vascular numbers of PCI(OR=2.16,95%CI:1.22–3.83,P=0.09) and PCI with left main lesion(OR=9.47,95%CI:2.96–30.26,P=0.01) were independent prognostic factors of MACEs. The Kaplan-Meier method revealed that there was no significant difference in cumulative survival rates and survival rates free from clinical events between the two groups(all P>0.05).CONCLUSIONS:The incidences of clinical events and cumulative survival rates are not statistically different between domestic DESs and imported DESs. Domestic DES is effective and safe in the treatment of patients with ACS.

Drug-eluting stents and acute myocardial infarction:A lethal combination or friends?

Primary percutaneous coronary intervention is the preferred reperfusion strategy for patients presenting with ST-segment elevation myocardial infarction(STEMI). First generation drug-eluting stents(DES),(sirolimus drug-eluting stents and paclitaxel drug-eluting stents), reduce the risk of restenosis and target vessel revascularization compared to bare metal stents. However, stent thrombosis emerged as a major safety concern with first generation DES. In response to these safety issues, second generation DES were developed with different drugs, improved stent platforms and more biocompatible durable or bioabsorbable polymeric coating. This article presents an overview of safety and efficacy of the first and second generation DES in STEMI.

Five-year clinical outcomes of first-generation versus second-generation drug-eluting stents following coronary chronic total occlusion intervention

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.

Nine-year clinical outcomes of drug-eluting stents vs. bare metal stents for large coronary vessel lesions

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.

Duration of dual antiplatelet treatment in the era of next generation drug-eluting stents

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.

Revisiting endovascular treatment in below-the-knee disease. Are drug-eluting stents the best option？

Patients with below-the-knee arterial disease are primarily individuals suffering from critical limb ischemia(CLI), while a large percentage of these patients are also suffering from diabetes or chronic renal failure or both. Available data from randomized controlled trials and their meta-analysis demonstrated that the use of infrapopliteal drug-eluting stents(DES), in short-to medium-length lesions, obtains significantly better results compared to plain balloon angioplasty and bare metal stenting with regards to vascular restenosis, target lesion revascularization, wound healing and amputations. Nonetheless, the use of this technology in every-day clinical practice remains limited mainly due to concerns regarding the deployment of a permanent metallic scaffold and the possibility of valid future therapeutic perspectives. However, in the majority of the cases, these concerns are not scientifically justified. Large-scale, multicenter randomized controlled trials, investigating a significantly larger number of patients than those already published, would provide more solid evidence and consolidate the use of infrapopliteal DES in CLI patients. Moreover, there is still little evidence on whether this technology can be as effective for longer below-the-knee lesions, where a considerable number of DES is required. The development and investigation of new, longer balloon-expanding or perhaps selfexpanding DES could be the answer to this problem.

Efficacy of Short-term Dual Antiplatelet Therapy after Implantation of Second-generation Drug-eluting Stents:A Meta-analysis and Systematic Review

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.

Role of Second-Generation Drug-Eluting Stents and Bypass Grafting in Coronary Artery Disease:A Systematic Review and Meta-analysis

Background:The safety and efficacy of coronary artery bypass grafting(CABG)and second-generation drug-eluting stents(DESs)in patients with coronary artery disease(CAD)remain controversial.Therefore we aimed to compare the outcomes of CAD patients treated with CABG and second-generation DESs.Methods:We systematically searched the PubMed,Cochrane Library,Ovid,and Elsevier databases.Studies comparing second-generation DESs with CABG in CAD patients were included.RevMan 5.3 was used to extract and pool the data from the applicable studies.Results:Six trials(N=6604 participants)were included in this meta-analysis.Among all of the CAD patients,second-generation DESs were associated with no differences in the risks of all-cause death[risk ratio(RR)1.18,95% confi dence interval(CI)0.98–1.43,P=0.09],cardiovascular death(RR 1.14,95% CI 0.81–1.59,P=0.45),myocardial infarction(RR 1.22,95% CI 0.98–1.54,P=0.08),and stroke(RR 0.83,95% CI 0.59–1.17,P=0.29),but increased the risks of revascularization(RR 1.95,95% CI 1.66–2.30,P<0.001)and major adverse cardiac and cerebrovascular events(RR 1.72,95% CI:1.31–2.26,P<0.001)when compared with CABG.Conclusions:In the treatment of CAD patients,second-generation DESs was not associated with increased risks of all-cause death,cardiovascular death,myocardial infarction,and stroke,but increased the risks of revascularization and major adverse cardiac and cerebrovascular events when compared with CABG.

COMPARISON OF SHORT- AND LONG-TERM OUTCOMES BETWEEN CYPHER AND TAXUS DRUG-ELUTING STENTS FOR IN-STENT RESTENOSIS

Objective To compare the short- and long-term clinical outcomes between sirolimus-eluting stent （ Cypher stent） and paclitaxel-eluting stent （TAXUS stent） in patients with in-stent restenosis （ISR） lesions of the coronary arteries. Methods From December 2002 to March 2005, 253 patients with ISR lesions of the coronary arteries were selected and divided into two groups. Cypher group （152 cases） was treated with Cypher or Cypher Select stents, and TAXUS group （101 cases） with TAXUS stents. A total of 262 ISR lesions in these patients were treated with 308 drog-eluring stents （DESs）, including 176 Cypher or Cypher Select stents and 132 TAXUS stents. All patients were followed up for 10 months. Procedure success rates of DES implantation in both groups were observed. Major adverse cardiac events （MACE） rates in hospital and at 10 months follow-up, as well as in-DES restenosis observed using coronary angiography at follow-up were compared between two groups. Results Success rate of DES implantation was 100% in both groups. No significant difference in MACE rate during hospitalization was found between the two groups. However, at 10 months follow-up, MACE rate was higher in TAXUS group than in Cypher group （ 16.00% vs. 6.67%, P =0. 031 ）. As for coronary angiography at 10 months follow-up, we observed an increasing tendency of in-DES restenosis rate in TAXUS group compared with Cypher group （29.41% vs. 14.04%, P=0.075）. Conclusions Cypher and TAXUS DESs both have good short- and long-term outcomes in treating ISR. Cypher DES proved better long-term clinical outcome than TAXUS DES.

Biodegradable polymer drug-eluting stents versus second-generation drug-eluting stents in patients with and without diabetes mellitus:a single center study

Objective It remains undetermined whether biodegradable polymer drug-eluting stents(BP-DES)are superior to second generation drugeluting stents(G2-DES)in patients with and without diabetes mellitus(DM).The study aims to evaluate the efficacy and safety of G2-DES and BP-DES in patients with and without DM in a high-volume cardiovascular center in China.

Are Newer-Generation Drug-Eluting Stents More Effective in Women than Early-Generation Ones?

Evidence-based research is increasingly aimed at differentiating between no proof of difference (failed demonstration of superiority) and proof of no difference (demonstration of equivalence). The latter requires that equivalence margins are incorporated in the analysis of outcomes. We applied an analysis of equivalence to study the incremental benefit of newer-generation vs early-generation drug-eluting stents (DES) in women receiving percutaneous coronary intervention. The clinical material was derived from published data. Our equivalence testing was focused on the end-point of target-lesion revascularisation (TLR). Results were expressed as rate differences (RDs), while the equivalence margins (±2.9%) were derived from the statistical power calculations of a recent trial. Our results clearly indicated that, in women, there was an equivalent effectiveness between newer-generation and early-generation of DES.

Clinical significance of provoked coronary spasm at chronic stage in patients who underwent successful complete coronary revascularization with first-generation drug-eluting stents

Background: Provoked spasm might have influence on cardiovascular events even after successful DES implantation. Methods and results: A consecutive 122 patients who underwent first-generation DES (CypherTM, and TaxusTM) implantation and had no residual stenosis at follow-up coronary angiography were included. All patients also underwent acetylcholine provocation test (ACh) at follow-up angiography. Age, sex, coronary risk factors (smoking, hypertension, diabetes mellitus, dyslipidemia), medication (calcium channel blockers, angiotensin receptor blockers, angiotensin converting enzyme inhibitors, nitrates, β blockers, statins), duration from stent implantation to follow-up angiography (15.5 ± 14.5 months), old myocardial infarction, Ach + were included as variables for multivariate analysis for cardiovascular events (angina pectoris without intervention, target lesion revascularization, acute myocardial infarction, definite or probable stent thrombosis, cardiac death, and stroke). ACh provocation test was positive in 64.8%. The following events occurred during a mean follow-up period of 26.9 ± 9.5 months;angina pectoris without intervention in 12, very late stent thrombosis in 1, acute myocardial infarction in 1, sudden death in 1, and stroke in 4. By Adjusted Cox hazard model, age was the independent predictor of future cardiovascular events. ACh was unbalanced data for Cox hazard model, and by logistic regression model, ACh was the strongest predictor. Conclusions: Coronary endothelial dysfunction at chronic stage is the strongest predictor of further prognosis in patients with first-generation DES.

COMPARISON BETWEEN CORONARY ARTERY BYPASS SURGERY AND DRUG-ELUTING STENTS IMPLANTATION TO DIABETIC PATIENTS WITH MULTIVESSEL CORONARY ARTERY DISEASE

Objective To evaluate the safety and efficacy of drug-elating stents （DES） implantation in diabetic patients with multivessel coronary artery disease （MVD） compared with coronary artery bypass graft （CABG） on the clinical outcomes. Methods From May 2003 to April 2005, 150 consecutive type 2 diabetic patients with MVD underwent revascularization, 84 by percutaneous coronary intervention （PC1） with DES and 66 by CABG. The study end point was the incidence of major adverse cardiovascular events （MACEs） during hospital interval after procedure and follow-up. Results Most preoperative characteristics were similar in two groups, but left main disease （30% vs 4%, P = 0. 001 ） and three-vessel disease （ 70% vs 54%, P = 0. 045 ） were more prevalent in CABG group. Complete revascularization was achieved in more patients in CABG group than that in PC1 group （82% vs 67%, P =0. 037）. Cumulative incidence of MACEs in hospital was similar between two groups （2.4% PC1 vs 9. 1% CABG , P =0. 069） despite the higher early morbidity （6. 1% vs 0%, P =0. 022） associated with CABG. Patients were followed up clinically for a mean of 18 - 8 months （ range 13- 36 months）. The incidence of MACEs remained higher after PC1 with multiple DES （21.4% vs 9. 1%, P =0. 041 ） mainly driven by a more require for repeat revascularization （ 13. 1% vs 3. 0%, P = 0. 030 ）. Conclusion PC1 with DES implantation, combined with tight glycemic control, aggressive cardiovascular risk factor modification and antiplatelet treatment, may be a safe and feasible alternative to CABG for selected diabetic patients with multivessel disease.

Drug-eluting fully covered self-expanding metal stent for dissolution of bile duct stones in vitro

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.

Real-world five-year outcomes of FlexyRap®cobalt-chromium rapamycin-eluting stents with biodegradable polymer in patients with de-novo coronary artery disease

BACKGROUND The use of biodegradable polymer drug-eluting stents(BP-DES)has been proven to minimize restenosis and stent thrombosis.The current post-marketing monitoring was observed at the 5-year clinical outcomes of individuals who had been treated with FlexyRap®DES in the real world.AIM To assess the safety and effectiveness of FlexyRap®DES at the 5-year follow-up in real-world settings.METHODS Findings from a retrospective,multi-center,observational,post-market clinical follow-up study of patients treated with FlexyRap®DES for de novo coronary artery disease(CAD)were reported.During the 12-mo follow-up,the primary endpoint was target lesion failure,which was defined as the composite of cardiovascular death, target vessel myocardial infarction(TV-MI), and clinically driven target lesion revascularization.RESULTS The data of 500 patients received with FlexyRap®DES was obtained at the completion of the surveillance timeline of 5-year.After the implantation of FlexyRap®DES,the device success rate was 100%.Adverse events that led to major bleeding,permanent disability,or death were not experienced in the patients.The major adverse cardiac event rate at 12-mo,3-year,and 5-year follow-up was 1(0.2%),0(0%),and 1(0.2%)respectively with 0(0%)cardiovascular death,2(0.4%)TV-MI,and 0(0%)TLR compositely.Furthermore,late stent thrombosis was found in 2(0.4%)patients at the follow-up of 12-mo,very late stent thrombosis was observed in 2 patients(0.4%)at 3-year follow-up.CONCLUSION FlexyRap®DES was proved to be safe and efficacious in real-world patients with de novo CAD,indicating a lowered rate of cardiac events and stent thrombosis at 5-year follow-up.