Paclitaxel-eluting Stents Group Research Articles

Paclitaxel-eluting stents versus paclitaxel-coated balloons in coronary artery disease: a meta-analysis of randomized controlled trials.

The efficacy of drug-coated balloons (DCB) versus drug-eluting stents (DES) for coronary artery disease (CAD) remains inconclusive. Despite paclitaxel's common use in both DES and DCB, there is a lack of meta-analyses comparing paclitaxel-eluting stents (PES) and paclitaxel-coated balloons (PCB). This meta-analysis aimed to evaluate and compare the outcomes of DES and DCB with paclitaxel. A systematic literature search of the Medline and Cochrane databases yielded six randomized controlled trials with 951 patients (1:1 ratio). Primary endpoints were mortality, target lesion vascularization (TLV), myocardial infarction (MI), target vessel revascularization (TVR), and major adverse cardiovascular events (MACEs). Secondary endpoints included in-device binary stenosis, in-segment binary stenosis, late luminal loss (LLL), post-minimal lumen diameter (MLD), and post-diameter stenosis. Within the study populations, the incidence of previous MI was significantly lower in the PES group than in the PCB group (26.70% vs. 39.22%, OR:0.56, 95% CI [0.41-0.76], p=0.0002). The meta-analysis results showed that mortality (OR:1.57, 95% CI [0.67-3.66], p=0.29), TLV (OR:0.74, 95% CI [0.37-1.48], p=0.39), MI (OR:1.76, 95% CI [0.79-3.88], p=0.16), TVR (OR:0.76, 95% CI [0.51-1.12], p=0.16), and MACEs (OR, 1.11; 95% CI [0.48-2.58]; p=0.81) did not exhibit significant differences between the PES and PCB groups in CAD. Furthermore, in stent or in balloon binary stenosis (OR:0.80, 95% CI [0.34-1.87], p=0.60), in segment binary stenosis (OR:1.16, 95% CI [0.48-2.80], p=0.74), LLL (MD:0.03, 95% CI [-0.11 to 0.17], p=0.65), post MLD (MD:0.04, 95% CI [-0.23 to 0.30], p=0.77), and post diameter stenosis (MD:-5.48, 95% CI [-13.88 to 2.92], p=0.20) were similar in both groups. Our comprehensive analysis concludes that both PES and PCB manifest comparable effectiveness and safety in CAD management.

Prophylactic paclitaxel-eluting stent placement does not improve covered femoropopliteal stent patency

ObjectiveCovered stents are an important tool in managing femoropopliteal peripheral arterial disease. However, their performance is impaired by edge neointimal hyperplasia and restenosis. We examined the effectiveness of prophylactic deployment of paclitaxel-eluting stents to prevent edge restenosis. MethodsA retrospective case–control study was performed. Patients with femoropopliteal peripheral arterial disease who were treated with Viabahn stent placement were compared to patients treated with Viabahn stents deployed in conjunction with paclitaxel-eluting stents (PTX). The primary outcome was time to loss of stent primary patency. The Kaplan–Meier method was used. ResultsA total of 36 Viabahn and 25 Viabahn + paclitaxel-eluting stent procedures were evaluated, with mean follow-up periods of 27 and 18 months, respectively. The Viabahn + paclitaxel-eluting stent group had a longer length of vessel stented (P = .0023). Twelve-month primary patency was 74% in the Viabahn group and 75% in the Viabahn + paclitaxel-eluting stent group. Pre-existing dyslipidemia correlated with earlier loss of primary patency across the combined cohort (P = .0193). ConclusionViabahn stent primary patency is unaffected by the addition of paclitaxel-eluting stents.

Biodegradable drug-eluting urethral stent in limiting urethral stricture formation after urethral injury: An experimental study in rabbit

In this study, a reproducible urethral injury animal model was developed and the role of the biodegradable drug-eluting urethral stent in limiting urethral stricture formation after urethral injury was evaluated. A total of 22 rabbits were used, and 20 rabbits were randomly chosen to develop urethral injury animal model. Bulbar urethral injury was made by a self-designed explosion device in the 20 rabbits. The urethral injury animal model was then randomly assigned to 2 groups of 10 each, which received a treatment of biodegradable paclitaxel-eluting urethral stent or only end-to-end anastomosis. Other two rabbits served as normal control group. Stents were surgically implanted into the injured urethras of rabbits under direct vision. Reparative effects, including stent degradation, were evaluated by urethroscopy, retrograde urethrography, and histology at different intervals at weeks 4, 8, and 12. In stent-free group, 8 of 10 rabbits developed obvious urethral stricture which was demonstrated by urethroscopy and retrograde urethrography, while in biodegradable paclitaxel-eluting stent group, urethral stricture was absent in all animals (p < 0.05). Histological follow-up indicated that the drug-eluting stents can also minimize the inflammatory reactions and fibrosis formation compared with the stent-free groups. Scanning electron microscope demonstrated that the biodegradable drug-eluting stent can gradually degrade in 12 weeks. The biodegradable paclitaxel-eluting urethral stent is effective in limiting urethral stricture formation after urethral injury.

Clinical outcomes of second-generation limus-eluting stents compared to paclitaxel-eluting stents for acute myocardial infarction with cardiogenic shock

ObjectiveWhether the cardiovascular (CV) outcomes of second-generation limus-eluting stents (LESs) differ from those of paclitaxel-eluting stents (PESs) in patients with acute myocardial infarction (AMI) complicated by cardiogenic shock (CS) is still unclear.MethodsWe used the Taiwan National Health Insurance Research Database to analyse data of 516 patients with AMI and CS diagnosed from January 2007 to December 2011. We used propensity score matching to adjust for the imbalance in covariate baseline values between these two groups. We evaluated clinical outcomes by comparing 197 subjects who used second-generation LESs to 319 matched subjects who used PESs.ResultsThe risk of the primary composite outcomes (i.e., myocardial infarction, coronary revascularisation or CV death) was significantly lower in the second-generation LES group than in the PES group [37.3% vs. 51.8%; hazard ratio (HR), 0.73; 95% CI: 0.56–0.95] at the 12-month follow-up. The patients who received second-generation LESs had a lower risk of coronary revascularisation (HR 0.62; 95% CI: 0.41–0.93) than those who used PESs. However, the risks of myocardial infarction (HR 0.56; 95% CI: 0.26–1.24), ischemic stroke (HR 0.73; 95% CI: 0.23–2.35), or CV death (HR 0.90; 95% CI: 0.63–1.28) were not significantly different between the two groups.ConclusionsAmong patients with CS-complicating AMI, second-generation LES implantation significantly reduced the risk of coronary revascularisation and composite CV events compared to PES implantation at the 12-month follow-up.

Five‐year follow‐up of the endothelial progenitor cell capturing stent versus the paxlitaxel‐eluting stent in de novo coronary lesions with a high risk of coronary restenosis

To assess the long-term safety and clinical efficacy of the Genous endothelial progenitor cell capturing stent (ECS) compared with the TAXUS Liberté paclitaxel-eluting stent (PES) in lesions with a high risk of restenosis. Instead of the use of cytotoxic or cytostatic drugs in drug-eluting stents, a "pro-healing" approach in ECS may overcome impeded healing response due to delayed functional endothelialization of the stent struts. In the prospective, randomized TRIAS pilot study 193 patients with coronary artery lesions carrying a high risk of restenosis were included (ECS: n = 98, PES: n = 95). The primary focus of this analysis was target vessel failure (TVF) at 5 years. Dual antiplatelet therapy was prescribed for ≥1 month after ECS and for ≥6 months after PES. At 5 years follow-up, no significant differences were found in TVF (ECS 24% vs. PES 29%, risk difference 95% confidence interval (RDCI) -17.3% to 7.4%). Between 2 and 5 years after the index procedure, low numbers of TVF were observed in ECS compared with PES (ECS 4% vs. PES 16%, RDCI -20.8% to -2.3%). There was no definite stent thrombosis in ECS compared with four patients in the PES group. This is the first randomized study providing very long-term clinical efficacy and safety of the ECS in lesions carrying a high risk of restenosis. At 5 years follow-up, TVF rates in ECS group are numerically lower compared with PES due to an increase of events between 2 and 5 years after the index procedure.

Paclitaxel Drug-eluting Tracheal Stent Could Reduce Granulation Tissue Formation in a Canine Model.

Background:Currently available silicone and metallic stents for tracheal stenosis are associated with many problems. Granulation proliferation is one of the main complications. The present study aimed to evaluate the efficacy of paclitaxel drug-eluting tracheal stent in reducing granulation tissue formation in a canine model, as well as the pharmacokinetic features and safety profiles of the coated drug.Methods:Eight beagles were randomly divided into a control group (bare-metal stent group, n = 4) and an experimental group (paclitaxel-eluting stent group, n = 4). The observation period was 5 months. One beagle in both groups was sacrificed at the end of the 1st and 3rd months, respectively. The last two beagles in both groups were sacrificed at the end of 5th month. The proliferation of granulation tissue and changes in tracheal mucosa were compared between the two groups. Blood routine and liver and kidney function were monitored to evaluate the safety of the paclitaxel-eluting stent. The elution method and high-performance liquid chromatography were used to characterize the rate of in vivo release of paclitaxel from the stent.Results:Compared with the control group, the proliferation of granulation tissue in the experimental group was significantly reduced. The drug release of paclitaxel-eluting stent was the fastest in the 1st month after implantation (up to 70.9%). Then, the release slowed down gradually. By the 5th month, the release reached up to 98.5%. During the observation period, a high concentration of the drug in the trachea (in the stented and adjacent unstented areas) and lung tissue was not noted, and the blood test showed no side effect.Conclusions:The paclitaxel-eluting stent could safely reduce the granulation tissue formation after stent implantation in vivo, suggesting that the paclitaxel-eluting tracheal stent might be considered for potential use in humans in the future.

Two-year results and subgroup analyses of the PEPCAD China in-stent restenosis trial: A prospective, multicenter, randomized trial for the treatment of drug-eluting stent in-stent restenosis.

The PEPCAD China ISR trial investigated the safety and efficacy of paclitaxel-coated balloon (PCB) angioplasty in an Asian patient population with coronary drug-eluting stent in-stent restenosis (DES-ISR). A total of 220 patients with coronary DES-ISR were treated with PCB angioplasty or with paclitaxel-eluting stents (PES). This randomized (1:1), single-blind prospective multicenter trial in a Chinese population used 9-month in-segment late lumen loss (LLL) as the primary endpoint. Secondary endpoints included the 24-month clinical event rates. Both treatment groups were similar in terms of patient, lesion, or procedural characteristics. After the 12-month follow-up evaluation, additional clinical events only occurred in the PES study group. The combined rate of all-cause mortality and myocardial infarction (MI) in the PCB group was significantly lower than that in the PES group (3.7% vs. 11.8%, P = 0.03). Additional subgroup analyses of 9-month in-segment LLL and 2-year target lesion failure in patients with diabetes, small vessels, diffuse ISR, and stent margin restenosis did not show more favorable results for one specific treatment group. The 2-year follow-up demonstrated sustained long-term clinical efficacy for both devices. PCB angioplasty was associated with significantly lower overall and cardiovascular mortality/MI rates in patients with DES-ISR lesions while avoiding the use of additional metal layers for drug release (ClinicalTrials.gov identifier: NCT 01622075).

Paclitaxel-Eluting versus Everolimus-Eluting Coronary Stents in Diabetes

BackgroundThe choice of drug-eluting stent in the treatment of patients with diabetes mellitus and coronary artery disease who are undergoing percutaneous coronary intervention (PCI) has been debated. Previous studies comparing paclitaxel-eluting stents with stents eluting rapamycin (now called sirolimus) or its analogues (everolimus or zotarolimus) have produced contradictory results, ranging from equivalence between stent types to superiority of everolimus-eluting stents.MethodsWe randomly assigned 1830 patients with diabetes mellitus and coronary artery disease who were undergoing PCI to receive either a paclitaxel-eluting stent or an everolimus-eluting stent. We used a noninferiority trial design with a noninferiority margin of 4 percentage points for the upper boundary of the 95% confidence interval of the risk difference. The primary end point was target-vessel failure, which was defined as a composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization at the 1-year follow-up.ResultsAt 1 year, paclitaxel-eluting stents did not meet the criterion for noninferiority to everolimus-eluting stents with respect to the primary end point (rate of target-vessel failure, 5.6% vs. 2.9%; risk difference, 2.7 percentage points [95% confidence interval, 0.8 to 4.5]; relative risk, 1.89 [95% confidence interval, 1.20 to 2.99]; P=0.38 for noninferiority). There was a significantly higher 1-year rate in the paclitaxel-eluting stent group than in the everolimus-eluting stent group of target-vessel failure (P=0.005), spontaneous myocardial infarction (3.2% vs. 1.2%, P=0.004), stent thrombosis (2.1% vs. 0.4%, P=0.002), target-vessel revascularization (3.4% vs. 1.2%, P=0.002), and target-lesion revascularization (3.4% vs. 1.2%, P=0.002).ConclusionsIn patients with diabetes mellitus and coronary artery disease undergoing PCI, paclitaxel-eluting stents were not shown to be noninferior to everolimus-eluting stents, and they resulted in higher rates of target-vessel failure, myocardial infarction, stent thrombosis, and target-vessel revascularization at 1 year. (Funded by Boston Scientific; TUXEDO–India Clinical Trials Registry–India number, CTRI/2011/06/001830).

Two-year clinical outcome in patients with small coronary artery disease treated with everolimus- versus paclitaxel-eluting stenting

BackgroundPercutaneous coronary interventions involving small coronary vessels represent a true challenge because of the increased risk of restenosis and adverse outcomes. We evaluated the 2-year clinical outcomes between single everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) in small coronary artery disease. MethodsFrom the data of SACRA (SmAll CoronaRy Artery treated by TAXUS Liberté) and PLUM (PROMUS/Xience V Everolimus-ELUting Coronary Stent for sMall coronary artery disease) registries, 245 patients with 258 lesions and 264 patients with 279 lesions, respectively, were enrolled in this study. ResultsThe 2-year clinical driven target lesion revascularization (4.5% vs. 10.6%, p=0.01) and target vessel revascularization (8.0% vs. 13.9%, p=0.03) rates were significantly lower in the EES group compared with the PES group. Major adverse cardiac events in the EES group tended to be lower than those in the PES group (8.7% vs. 14.3%, p=0.05). On the other hand, all new lesions for remote target vessel revascularization were observed at the proximal site of target lesions in both groups and those rates were not different between the two groups (3.4% vs. 3.3%, p>0.99). ConclusionEES showed better clinical results at 2-year follow-up compared with PES in small coronary artery diseases, however, new lesions at the proximal remote site of the target lesion remain problematic.

Clinical outcomes of chronic kidney disease patients treated with everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES)

BackgroundThe target lesion revascularization of paclitaxel-eluting stents (PES) has been reported to be lower than that of sirolimus-eluting stents in patients on hemodialysis (HD). However, the comparison of PES and second generation drug-eluting stents in CKD patients has not been fully investigated. We compared clinical outcomes of everolimus-eluting stents (EES) and PES in CKD patients. MethodsHundred and forty seven CKD patients (eGFR<60mLmin−11.73m−2) treated with PES (n=74, from May 2007 to December 2009) and EES (n=73, from January 2010 to January 2013) were enrolled in the study. Major adverse cardiac events (MACEs) were defined as death, non-fatal myocardial infarction, and ischemia driven target lesion revascularization. ResultsThe incidence of 36-month MACE was significantly lower in EES, non-HD group compared to PES, non HD group (0% in EES group and 13.5% in PES group, respectively, P<0.01). There was no significant difference in MACE between EES and PES in HD patients (5.4% in PES group and 5.5% in EES group, P=0.98). In multivariate analysis, PES group and PES ISR were independent factors for worse incidence of MACE. ConclusionsIn CKD patients, PES was associated with worse clinical outcomes in non-HD patients as compared with EES.

Comparisons of everolimus and Paclitaxel-eluting stents in patients with acute myocardial infarction.

It has been established that the newer-generation drug-eluting stent (DES) everolimus-eluting stent (EES) is superior to the first-generation DES paclitaxel-eluting stent (PES). However, the advantages of EES over PES in the setting of acute myocardial infarction (AMI) need to be fully elucidated. The present analysis enrolled 2,911 AMI patients receiving PES (n = 1,210) or EES (n = 1,701) in a large-scale, prospective, multicenter Korea Acute Myocardial Infarction Registry (KAMIR). Propensity score matching was used to adjust for baseline biases in clinical and angiographic characteristics, yielding a total of 2,398 patients (1,199 receiving PES and 1,199 receiving EES). Various clinical outcomes at 1 year were compared between the two propensity score matched groups. Target lesion failure (TLF) was defined as the composite of cardiac death, recurrent nonfatal myocardial infarction (Re-MI), or target lesion revascularization (TLR). Baseline clinical and angiographic characteristics were comparable between the two groups after propensity score matching. Clinical outcomes of the propensity score matched patients showed that the rates of in-hospital and 1-year cardiac and all-cause death were similar between the two groups. But patients in the EES group had significantly lower incidences of Re-MI (1.4% vs 2.8%, P = 0.002), TLR (1.2% vs 3.1%, P = 0.001), TLF (6.4% vs 10.2%, P = 0.001), and probable or definite stent thrombosis (0.3% vs 1.8%, P < 0.001) than did those in the PES group. The present propensity matched analysis suggests that the use of EES in the setting of AMI appears to be superior to PES in reducing TLF, and stent thrombosis.

A 2-year follow-up of a randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessels the BELLO study

Background/objectivesA prospective, multi-center, randomized trial, BELLO (Balloon Elution and Late Loss Optimization), showed that the primary endpoint of in-stent (in-balloon) late loss was significantly less with drug-eluting balloons (DEB) as compared with paclitaxel-eluting stents (PES). At 6months, DEB and PES were associated with similar rates of angiographic restenosis, target lesion revascularization (TLR), and major adverse cardiac events (MACE) defined as death, myocardial infarction and target vessel revascularization. The aim of this study was to report 2-year clinical outcomes after treatment of de novo small vessel disease with DEB as compared with PES. MethodsA total of 182 patients were enrolled and randomized to treatment with DEB (n=90) in 94 lesions or PES (n=92) in 98 lesions. The study endpoint was the incidence of MACE at 2-year follow-up. ResultsTwo-year follow-up was achieved in almost all cases (97.8% in DEB group vs. 98.9% in PES group). There was a trend towards a lower incidence of MACE in the DEB group as compared with the PES group (14.8% vs. 25.3%; p=0.08). TLR rates in the DEB group were acceptable at 6months, 1year and 2years and did not differ significantly from the PES group (4.4% vs. 7.6%, p=0.37; 6.7% vs. 12.1%, p=0.23; 6.8% vs. 12.1%, p=0.25, respectively). ConclusionsOur results suggest that treatment of small vessel disease with a paclitaxel DEB is associated with a trend for improved clinical outcomes as compared with PES up to 2years. Late catch-up phenomenon requiring repeat intervention after treatment with DEB was not evident in this study.

Very late outcomes of drug-eluting stents coated with biodegradable polymers: insights from the 5-year follow-up of the randomized PAINT trial.

Few studies have examined the very long-term outcomes after implantation of drug-eluting stents (DES) coated with biodegradable polymers (BP). This report presents the 5-year clinical follow-up of patients treated with BP-DES in the randomized PAINT trial. The PAINT study is a prospective, multicenter randomized controlled trial that allocated 274 patients for treatment with two BP-DES formulations [paclitaxel-eluting stents (PES) or sirolimus-eluting stents (SES)] or bare metal stents (BMS) in a 1:2:2 ratio, respectively. The primary end-point of this sub-study was defined as the composite of the major cardiac adverse events (MACE) cardiac death, myocardial infarction (MI) or ischemia-driven target vessel revascularization (TVR) at 5 years. The 5-year MACE rates were different among the groups: 35.3%, 22.5% and 16.9% for BMS, PES and SES, respectively (P<0.05 for both DES vs. bare stent comparisons). The primary end-point was mainly driven by TVR: 31.8%, 14.1% and 12.2% for bare stents, PES and SES, respectively (P<0.05 for both DES vs. bare stent comparisons). The incidence of stent thrombosis (ST) was null for BMS during the entire follow-up. There was no definite or probable ST in the SES group after the second year, while one patient (1.0%) presented with a definite ST episode in the PES group between 4 and 5 years. The tested biodegradable-polymer coated stents releasing either paclitaxel or sirolimus, compared with same bare metal platform, sustained their effectiveness in reducing combined major adverse cardiac events and re-intervention without an increase in ST during 5 years of follow-up.

Long-term follow-up results in patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents: results from a single high-volume PCI centre

ObjectiveTo assess both short-term and long-term prognosis in consecutive patients with coronary heart disease treated with drug-eluting stents in a high-volume percutaneous coronary intervention (PCI) centre.DesignObservational cohort study.SettingA hospital in...

A Prospective, Multicenter, Randomized Trial of Paclitaxel-Coated Balloon Versus Paclitaxel-Eluting Stent for the Treatment of Drug-Eluting Stent In-Stent Restenosis: Results From the PEPCAD China ISR Trial

The intention of the PEPCAD China ISR (A Prospective, Multicenter, Randomized Trial of Paclitaxel-Coated versus Paclitaxel-Eluting Stent for the Treatment of Drug-Eluting Stent In-Stent Restenosis) was to demonstrate the efficacy of paclitaxel-coated balloon (PCB) angioplasty in a non-European patient population with coronary drug-eluting stent in-stent restenosis (DES-ISR). The treatment of DES-ISR is still challenging with no established best strategy. Moreover, there is no study on the effect of PCB in the treatment of ISR in the Chinese population. PEPCAD China ISR was a 220-patient randomized (1:1), single-blind prospective multicenter trial conducted in China. Patients with coronary DES-ISR received either PCB (SeQuent Please, B. Braun Melsungen AG, Melsungen, Germany) or paclitaxel-eluting stent (Taxus Liberté, Boston Scientific, Natick, Massachusetts) treatment. The primary endpoint was in-segment late lumen loss at 9 months. There were no significant baseline differences between both treatment groups in terms of patient, lesion, or procedural characteristics. At 9 months, in-segment late lumen loss in the PCB group was noninferior to that of the paclitaxel-eluting stent group (0.46 ± 0.51 mm vs. 0.55 ± 0.61 mm; difference: -0.06 mm with 95% confidence interval: -0.23 to 0.10; p for noninferiority= 0.0005). The 9-month rate of binary restenosis and 12-month composite clinical event rates were not significantly different between groups. In a randomized trial of 220 patients, angioplasty with a PCB was noninferior to paclitaxel-eluting stent implantation when used to treat DES-ISR. On the basis of these, as well as previous randomized trial data, PCB angioplasty offers an effective treatment for DES-ISR without the necessity of implanting additional metal layers for drug release. (A Safety and Efficacy Study of Paclitaxel-Eluting Balloon to Paclitaxel-Eluting Stent [PEPCAD]; NCT01622075).

Comparison of Two Biodegradable Polymer Coated, Drug-Eluting Coronary Stents Paclitaxel vs. Sirolimus, with 6-Years Clinical Follow-Up: BIOPRESS (BIOdegradable Polymer REgistry Smt Stents) Infinnium vs. Supralimus

Background : The safety and efficacy of drug-eluting stents has been shown in randomized trials, but some controversy exists regarding which stent, sirolimus-eluting or paclitaxel-eluting is more effective in unselected real-world patients. Therefore, we investigated, long term safety and efficacy of paclitaxel-eluting stents (PES) compared to sirolimus-eluting stents (SES) when used without restriction in unselected real-world patients. Methods : We created a prospective, open label, non-randomized, multicenter registry and analyzed data on a consecutive series of all patients who presented to our institution with symptomatic coronary artery disease between July-2004 and June-2006 and who were treated with the Infinnium ® PES or the Supralimus ® SES. All enrolled patients were divided into two groups based on stent type. By outpatient clinic visit and telephone interview, we obtained up to 6-years clinical outcomes including death, myocardial infarction (MI), stent thrombosis (ST), target lesion revascularization (TLR), target vessel revascularization (TVR), and major adverse cardiac events (MACE, the composite of cardiac death, TLR, TVR and ST). Results : In total, 571 patients were treated with either the Infinnium ® PES (n=276) or the Supralimus ® SES (n=295). Baseline clinical and angiographic characteristics were almost similar in the two groups. The six-year clinical follow-up was completed in 529 patients (92.6%). Total 1.4% in-hospital major adverse cardiac event (MACE) were recorded (1.8% Infinnium ® PES vs. 1.0% Supralimus ® SES) with 99% procedural success. At 6-years, all-cause death was significantly lower in Supralimus ® SES group than in Infinnium ® PES group (3.1% vs. 6.9%, p =0.03). The incidence of cardiac death (4.3% vs. 2.7%, p =0.29), TLR (3.6% vs. 3.7%, p =0.95, TVR (4.0% vs. 2.4%, p =0.27) and ST (2.5 vs. 1.0, p =0.17) was more frequent in the Infinnium ® PES group compare to Supralimus ® SES group, but it did not reach statistical significance. Conclusion : The long-term follow-up of 6-years, demonstrated the safety and efficacy of both Infinnium ® PES and Supralimus ® SES biodegradable polymer coated drug-eluting stents (Sahajanand Medical Technologies Pvt. Ltd., Surat, India) in real-world practice. Also superiority of Supralimus ® SES proved on long term follow-up with complex lesions.

A Clinical and Angiographic Study of the XIENCE V Everolimus-Eluting Coronary Stent System in the Treatment of Patients With Multivessel Coronary Artery Disease: The EXECUTIVE Trial (EXecutive RCT: Evaluating XIENCE V in a Multi Vessel Disease)

This study sought to investigate the efficacy and performance of the XIENCE V everolimus-eluting stent (EES) (Abbott Vascular, Santa Clara, California) in the treatment of de novo coronary lesions in patients with 2- to 3-vessel multivessel coronary artery disease (MV-CAD). Drug-eluting stents (DES) have emerged as an alternative to conventional coronary artery bypass surgery in patients with MV-CAD although first-generation DES yielded inferior efficacy and safety compared with surgery. Prospective, randomized (1:1), multicenter feasibility trial was designed to assess angiographic efficacy of EES compared with the TAXUS paclitaxel-eluting stent (PES) in 200 patients, and a prospective, open-label, single-arm, controlled registry was designed to analyze the clinical outcome of EES at 1-year follow-up in 400 MV-CAD patients. For the randomized trial, the primary endpoint was in-stent late loss at 9 months. For the registry, the primary endpoint was a composite of all-cause death, myocardial infarction, and ischemia-driven target vessel revascularization at 12 months. The primary endpoint per single lesion was significantly lower in the EES group compared with the PES group (-0.03 ± 0.49 mm vs. 0.23 ± 0.51 mm, p = 0.001). Similar results were observed when analyzing all lesions (0.05 ± 0.51 mm vs. 0.24 ± 0.50 mm, p < 0.001). Clinical outcome at 1 year yielded a composite of major adverse cardiac events of 9.2% in the single-arm registry, and 11.1% and 16.5% in the EES and PES randomized groups, respectively (p = 0.30). The EXECUTIVE trial was a randomized pilot trial dedicated to the comparison of the efficacy of 2 different DES among patients with 2- to 3-vessel MV-CAD. The study shows lower in-stent late loss at 9 months with the EES XIENCE V compared with the PES TAXUS Libertè, and a low major adverse cardiac event rate at 1 year in patients with 2-to 3-vessel MV-CAD. (EXECUTIVE [EXecutive RCT: Evaluating XIENCE V in a Multi Vessel Disease]; NCT00531011).

Differential responses of local coagulation after implantation of everolimus-eluting and zotarolimus-eluting stents compared with early-generation drug-eluting stents in patients with stable angina

Purpose: We have previously demonstrated local persistent hypercoagulability after sirolimus-eluting stent (SES) implantation by measuring plasma prothrombin fragment F1+2 (frF1+2) levels. The aim of this study is to examine local coagulation response after everolimus-eluting stent (EES) and zotarolimus-eluting stent (ZES) implantation compared with early-generation drug-eluting [SES and paclitaxel-eluting stent (PES)] and bare metal stents (BMS). Methods: Eighty-five patients who were treated about eight months earlier with stents to the mid-segment of the left anterior descending coronary artery, with no evidence of restenosis, were studied (EES:12, ZES:15, PES:18, SES:20, and BMS:20). We measured plasma levels of frF1+2 sampled in coronary sinus (CS) and sinus of Valsalva (V). The transcardiac frF1+2 gradients (ΔfrF1+2) were defined as CS level minus V level. Results: A larger percent diameter stenosis (%DS) was observed in the ZES and BMS groups than in the SES (17.1±13.2, 25.1±15.6 vs 7.1±16.5%, p<0.05, respectively). There were no significant differences in %DS among SES, PES, and EES groups (7.1±16.5, 10.5±15.2, 12.6±12.9%, NS). There were no significant differences in ΔfrF1+2 among BMS, ZES, and EES groups (4.7±13.4, 5.5±8.4, 3.3±11.7 pmol/l, NS). The ΔfrF1+2 was smaller in the ZES and EES group, and larger in the PES group than in the SES group (5.5±8.4, 3.3±11.7, 32.3±24.2 vs 23.4±21.1 pmol/l, p<0.05, respectively). The ΔfrF1+2 significantly correlated with the total stent length in the SES group (r=0.53, p<0.05), however, it did not correlate in the EES, ZES, and PES groups. Conclusions: A decreased response of local coagulation after ZES and EES implantation and an increased one after PES implantation were observed, as compared to SES implantation. These findings might be associated with lower strut thickness, unique characteristics of polymer, and lower cytotoxic effect of eluted drug in second-generation drug-eluting stents.

Tissue coverage of paclitaxel and sirolimus eluting stents in long term follow-up: Optical coherence tomography study

Implantation of drug eluting stents (DES) has become a standard treatment of patients undergoing percutaneous coronary intervention (PCI). Incomplete strut coverage is a potential risk factor for late stent thrombosis. Optical coherence tomography (OCT) enables in vivo identification of incomplete neointimal coverage. Study included 62 patients after sirolimus eluting stents (SES) or paclitaxel eluting stents (PES) implantation. OCT examination was performed at least 24 months after the initial procedure (35.4± 9.4 months). In cross-sectional still frames selected from each 1 mm of analyzed stents a total number of visible struts and number of struts with or without complete neointimal coverage was assessed. Measurements of neointimal coverage, presented as a mean thickness of tissue, were performed. Patients were followed up for 3 years and the frequency ofmajor adverse cardiac events was recorded. In the analyzed 28 SES and 37 PES 9998 struts were identified. Complete neointimalcoverage was observed in 83.5% and 79.2% of SES and PES struts respectively (p = 0.48).There was no difference in incidence of not covered or malapposed struts between SES and PES groups. Mean thickness of the tissue covering SES struts was 0.165 ± 0.095 mm, and 0.157 ± 0.121 mm for PES. The mean neointimal thickness difference (SES vs. PES) was notstatistically significant. In a 36 months follow-up 1 death was observed - potentially attributed to stent thrombosis. A long term OCT follow-up after DES implantation shows high incidence ofuncovered struts regardless of the stent type. Clinical significance of this finding remains questionable and requires further large scale trials.

Clinical Outcomes after Treating Acute Coronary Syndrome Patients with a Drug-Eluting Stent: Results from REWARDS-EMI (Endeavor® for Myocardial Infarction Registry)

Drug-eluting stents have shown promising clinical results in the treatment of acute coronary syndrome (ACS) patients. We aimed to evaluate the long-term outcome of Endeavor zotarolimus-eluting stent (EZES) implantation in an ACS population and to compare these results with those obtained in patients treated with sirolimus-eluting (SES) and paclitaxel-eluting stents (PES). This prospective study included 1481 consecutive ACS patients (72% myocardial infarction, age 65 ± 13 years, 62% male) treated with a drug-eluting stent: (SES, n=925; PES, n=417; EZES, n=139). The primary end point was major adverse cardiac events (MACE) at 2 years, defined as the composite of death, myocardial infarction, and target vessel revascularization. Two-year follow-up was obtained in all patients. Baseline clinical and angiographic characteristics were mostly similar. Unadjusted 2-year MACE and death rates were lower in the EZES group than in the SES and PES groups (MACE: 18.7% vs. 25.3% vs. 30.2%, p=0.02; death: 10.1% vs. 16.4% vs. 22.2%, p=0.002, respectively). The rate of definite stent thrombosis at 2 years was lower in the EZES group without statistically significant difference (0.7% vs. 2.9% SES vs. 1.7% PES, p=0.16). After adjusting for differences in baseline characteristics, EZES use was an independent correlate for 2-year MACE (vs. SES, hazard ratio 0.65, p=0.049; vs. PES, hazard ratio 0.57, p=0.01). In an ACS patient population, a lower long-term MACE rate was observed in patients treated with an EZES when compared to treatment with first-generation drug-eluting stents. The use of EZES in contemporary practice has excellent long-term outcome in terms of low rates of revascularization and clinical events.