TAXUS Express Stent Research Articles

Impact of coronary artery calcification in percutaneous coronary intervention with paclitaxel-eluting stents: Two-year clinical outcomes of paclitaxel-eluting stents in patients from the ARRIVE program.

The purpose of this study was to evaluate clinical outcomes after percutaneous coronary intervention (PCI) in patients with coronary artery calcification (CAC). Smaller studies have reported worse clinical outcomes in patients with CAC who undergo PCI. The impact of CAC in the drug-eluting stent era is unclear. Data from 7,492 patients treated by PCI with ≥1 TAXUS Express stent in the ARRIVE registry with no inclusion/exclusion criteria were stratified by the severity of CAC, as determined by the operator. Endpoints were independently adjudicated. All major adverse cardiac events were assessed at 2 years. Moderate/severe CAC was present in 19.6%. The nil/mild CAC group had higher rate of current smokers. The moderate/severe CAC group was older and had a higher prevalence of hypertension, kidney disease, prior coronary artery bypass grafting, congestive heart failure, and left main disease. After adjustment for imbalanced baseline variables, patients with moderate/severe CAC had higher 2year rates of major adverse cardiac events (18.3% vs 13.5%, p=0.01) and death (10.3% vs 5.6%, p=0.02). Moderate/severe CAC was associated with increased clinical events in patients who underwent PCI with TAXUS stents. This may be explained in part due to differences important baseline characteristics including more patients with more comorbidities and more complex lesions. After adjustment for imbalanced baseline variables, the moderate/severe CAC group had a higher risk of major adverse cardiac events and death. Improvements in treatment strategies are needed for this high-risk group of patients who undergo PCI. © 2016 Wiley Periodicals, Inc.

Computational Modelling and Analysis of Latest Commercially Available Coronary Stents During Deployment

Coronary artery disease (CAD), especially atherosclerosis is the major contributor of untimely and abrupt death of the maximum population of the world. Balloon angioplasty has become a popular choice of cardiac intervention owing to its minimal invasive quality for the treatment of stenosis. Of the various available commercial coronary stents in the market we have taken six commercial stents for our experimental study namely: PS stent, CYPHER stent (Cordis, J & J), S670 stent, Driver stent (Medtronic, USA), Taxus Express stent, Element stent (Boston Scientific, USA). Geometry modeling, meshing and computational simulation is done to mimic real life biological conditions (with assumptions). Of the total 192 simulation results, Element stent design has come up to be the better stent design among others and cobalt alloys specially cobalt alloy MP35N (ASTM F562) has shown the best performance by developing least von mises stress, in terms of material perspective.

Propensity-matched lesion-based comparison of midterm outcomes of TAXUS Express and TAXUS Liberté stents for de novo native coronary stenosis

BackgroundWe examined the implication of the revised platform of TAXUS Liberté (TAXUS-Lib; Boston Scientific, Natick, MA, USA) from TAXUS Express (TAXUS-Exp; Boston Scientific) stents, after stent placements in a daily practice environment, on midterm clinical and angiographic outcomes. Methods and resultsBy adjusting historically different baselines with propensity score matching analysis in 1358 de novo native coronary stenoses, the incidence of the clinical safety endpoint (700-day cardiac death, nonfatal recurrent myocardial infarction, and definite stent thrombosis) after placement of TAXUS-Lib (0.60%; mean follow-up, 683±64 days) was not significantly different from that in the TAXUS-Exp group (1.20%; 677±96 days, p=0.182). Cardiac dysfunction (ejection fraction of left ventricle less than 40%) was the predictor of primary endpoint [odds ratio (OR), 17.8; 95% CI, 4.39–71.9; p<0.001]. In the baseline-adjusted angiographic followed-up lesions (n=443 in each arm), the incidence of secondary endpoint [binary in-stent restenosis: percent diameter stenosis (%DS) >50% at the follow-up angiography] in the TAXUS-Lib group (11.3%) was not significantly different from that in the TAXUS-Exp group (13.5%, p=0.368). TAXUS-Exp was not the predictor of secondary endpoint (OR, 1.20; 95% CI, 0.77–1.85; p=0.424). ConclusionsThe midterm clinical and angiographic outcomes after placement of the new TAXUS-Lib stent for de novo coronary stenosis in a daily practice environment were statistically equivalent compared to the former TAXUS-Exp.

Final 5-year results of the TAXUS ATLAS, TAXUS ATLAS Small Vessel, and TAXUS ATLAS Long Lesion clinical trials of the TAXUS Liberté paclitaxel-eluting stent in de-novo coronary artery lesions

To report the final, cumulative, 5-year outcomes from the TAXUS ATLAS program, which studied the use of the TAXUS Liberté paclitaxel-eluting stent in de-novo coronary artery lesions. TAXUS ATLAS Workhorse, Small Vessel, and Long Lesion are nonrandomized studies comparing TAXUS Liberté (N=871), TAXUS Liberté 2.25 mm (N=261), and TAXUS Liberté 38 mm (N=150) stents, respectively, with case-matched TAXUS Express historical controls. In the unadjusted analysis, TAXUS Liberté showed comparable 5-year rates of major adverse cardiac events (27.1% TAXUS Express vs. 26.2% TAXUS Liberté, P=0.70) in workhorse lesions and greater 5-year cumulative freedom from target lesion revascularization (78.4 vs. 87.3%, P=0.03) in small vessels. In addition, a lower periprocedural myocardial infarction rate (MI, 4.1 vs. 0.0%; P=0.01) was observed in long lesions versus TAXUS Express. After propensity score adjustment, no statistically significant effect of TAXUS Liberté on the 5-year rates of TLR in small vessels (17.9 vs. 13.3%, P=0.36) or MI in long lesions (9.1 vs. 7.0%, P=0.53) was found, although the rates remained numerically lower with TAXUS Liberté. Cumulative 5-year results of the TAXUS ATLAS studies suggest that the TAXUS Liberté stent provides similar safety and effectiveness in workhorse lesions, and may provide lower revascularization rates in small vessels and lower periprocedural MI rates in long lesions compared with the TAXUS Express stent, although no statistically significant differences were found following propensity adjustment.

Clinical outcomes between different stent designs with the same polymer and drug: comparison between the Taxus Express and Taxus Liberte stents

Background/AimsThe Taxus Liberte stent (Boston Scientific Co.) evolved from the Taxus Express stent, with enhanced stent deliverability and uniform drug delivery. This study was designed to compare angiographic and clinical outcomes in real-world practice between the Taxus Liberte and Taxus Express stents.MethodsBetween 2006 and 2008, 240 patients receiving the Taxus Liberte stent at three centers were registered and compared to historical control patients who had received the Taxus Express stent (n = 272). After propensity score matching, 173 patients treated with the Taxus Liberte stent and the same number of patients treated with the Taxus Express stent were selected. The primary outcome was a composite of major adverse cardiac events (MACE), including cardiac death, myocardial infarction (MI), ischemia driven target vessel revascularization (TVR), and stent thrombosis (ST) at 1 year. An additional angiographic assessment was conducted at 9 to 12 months.ResultsThe study showed no significant difference between the Taxus Express and Taxus Liberte stents (death, 1.73% vs. 2.31%, p = 1.000; MI, 0% vs. 1.73%, p = 0.2478; TVR, 2.31% vs. 1.16%, p = 0.6848; and ST, 0% vs. 1.16%, p = 0.4986). The total MACE rate at 1 year did not differ between the groups (4.05% in Taxus Express vs. 4.05% in Taxus Liberte, p = 1.000). In addition, the binary restenosis rate did not differ (2.25% in Taxus Express vs. 1.80% in Taxus Liberte, p = 0.6848).ConclusionsIn real-world experience with the two Taxus stent designs, both stents showed similarly good clinical and angiographic outcomes at 1 year. A long-term follow-up study is warranted.

Economic Modeling of New Stent Platforms to Evaluate Cost Effectiveness: Analysis of the TAXUS Liberté Versus TAXUS Express Stents

With the changing health care environment, cost effectiveness is an important adjunct to clinical investigation when assessing new medical devices. This study presents an economic model to evaluate cost effectiveness of coronary stents. Markov modeling was developed comparing total costs (Medicare payer perspective) between TAXUS Liberté and TAXUS Express based on 3-year clinical outcomes from the TAXUS ATLAS Small Vessel and Long Lesion trials. The TAXUS Liberté 2.25-mm stent provided cost savings relative to TAXUS Express from a payer perspective ($17,605 vs. $20,281), driven by reduced target vessel revascularization (0.16 events/patient vs. 0.33 events/patient). In probabilistic sensitivity analyses, TAXUS Liberté was less costly with fewer major adverse cardiac events in over 99% of parameter sets. The TAXUS Liberté Long (38 mm) stent was cost neutral relative to TAXUS Express from a payer perspective ($18,545 vs. $18,551) with fewer myocardial infarctions and cardiac deaths. Accounting for angiography-driven revascularizations, TAXUS Liberté 2.25 mm still provided cost savings relative to TAXUS Express ($16,822 vs. $19,139), although TAXUS Liberté Long was more expensive than TAXUS Express ($17,886 vs. $17,652). From a hospital perspective, TAXUS Liberté Long provided cost savings up to a price premium of $671/stent, driven by fewer stents employed per patient. This analysis confirms the utility of economic modeling in assessing new stent platforms. TAXUS Liberté 2.25 mm is economically dominant relative to TAXUS Express when treating small vessels. TAXUS Liberté Long is cost neutral to modestly more costly than TAXUS Express 2.25 mm from a payer perspective.

Very late thrombosis of a paclitaxel-eluting stent after 72 months in a patient on dual anti-platelet therapy

Very late thrombosis continues to be a major cause of concern in the era of drug-eluting stents. The duration of vulnerability to this complication remains undefined. A 62-year-old diabetic male underwent primary percutaneous coronary intervention with a Taxus Express stent (Boston Scientific, Natick, Mass) implantation in 2003 for anterior wall myocardial infarction (AWMI). The patient was on dual anti-platelet treatment. He was asymptomatic and his stress test was negative in 2008. After 72 months, the patient was admitted with acute AWMI resulting from stent thrombosis, which was treated successfully. This case underscores the importance of realising that very late stent thrombosis may occur when patients present with angina symptoms.

Two-year clinical outcomes of paclitaxel-eluting stents for in-stent restenosis in patients from the ARRIVE programme

To examine the incidence of clinical events after implantation of the TAXUS Express paclitaxel-eluting stent (PES) for in-stent restenosis (ISR) in an unselected patient population. Implantation of bare metal stents in native coronary vessels can result in ISR rates exceeding 50%. PES significantly reduces ISR-lesion restenosis and improves event-free survival versus vascular brachytherapy. The 7,492-patient ARRIVE registry enrolled patients receiving ≥1 TAXUS Express stent at procedure initiation with no inclusion/exclusion criteria, including 489 patients with ISR. Endpoints were independently adjudicated. All major cardiac events were monitored plus a 10%-20% sample per site. ISR patient 2-year follow-up was 94% complete (462/489). Compared to simple-use patients undergoing native coronary intervention (N=2698) or other, non-ISR expanded-use cases (N=4305), ISR patients had significantly more baseline comorbidities/complex disease. They had higher 2-year rates for mortality (8.6% vs. 4.2%, P<0.001), myocardial infarction (5.0% vs. 2.2%, P<0.001), definite/probable stent thrombosis (4.0% vs. 1.4%, P<0.001), and target lesion revascularisation (12.3% vs. 5.4%, P<0.001) versus simple-use. Safety outcomes were comparable between the ISR and non-ISR expanded-use subgroups but target vessel revascularisation (TVR) was significantly higher for ISR (16.0% vs. 10.9%, P=0.003). ISR was independently associated with increased risk for TVR (1.4-fold). ARRIVE ISR, one of the largest studied cohorts of patients receiving DES for ISR, had higher risk for clinical events versus simple-use patients but comparable safety outcomes versus other expanded-use patients except for significantly higher revascularisation. ARRIVE provides a detailed estimate of 2-year outcomes in these real-world patients.

Should stent selection in diabetic patients be considered as a special case?

■Interventional cardiologists are very aware of the additional challenges of treating patients with diabetes. They recognise the likelihood of increased procedural complexity due to more diffuse vascular disease and the reduced certainty of long-term clinical outcomes due to accelerated rates of atheroma progression combined with increased rates of bare metal stent restenosis 1 and stent thrombosis 2 . However despite this solid knowledge base, diabetic patients entering the catheterisation laboratory are commonly treated with remarkably little additional consideration. Many operators decide revascularisation strategies based predominantly on anatomical characteristics and the choice of which type of stent to implant can appear to be arbitrary. In this edition of EuroIntervention, colleagues present comparative IVUS analysis following DES implantation in diabetics 3 and a cost-efficiency analysis of data from comparative randomised DES trials enrolling diabetic patients 4 . When we consider these new data, should we conclude that the outcomes associated with use of alternative DES in diabetic patients are sufficiently diverse to mandate a particular stent for this “special” group of patients? It is easy to forget that DES technology entered our clinical practice less than ten years ago. Initial trial data from randomised trials of focal lesions in larger vessels demonstrated the additional benefits of drug elution compared with bare metal stents 5 . Intravascular ultrasound was an important part of these early DES trials. Measurement of neointimal volume allowed ready comparison of drug efficacy and insights into the moderated healing process. However, there was considerable debate concerning the clinical relevance of differing neointimal volume, the “optimal amount” of neointima and the desirability of stent strut coverage to minimise the risk of stent thrombosis. In their paper Jensen and colleagues show substantial differences in the median volume obstruction in diabetic patients after implantation of either the sirolimus-eluting Cypher stent or the first generation zotarolimus-eluting Endeavour stent (median volume obstruction 0% vs. 13%, respectively) 3 . They also make comparison with their previous similar investigations in diabetic patients undergoing implantation of either the Cypher or the paclitaxel eluting Taxus Express stent (median volume obstruction 0% vs. 7.5%, respectively) 6 . Interest

Economic modeling of new stent platforms to evaluate cost effectiveness: analysis of the TAXUS Liberté vs. TAXUS Express stents in small vessel coronary stenting

Economic modeling of new stent platforms to evaluate cost effectiveness: analysis of the TAXUS Liberté vs. TAXUS Express stents in small vessel coronary stenting

The Petal dedicated bifurcation stent

Description of the Petal dedicated bifurcation drug-eluting stent The Taxus Petal (Boston Scientific Corporation, Natick, MA, USA) dedicated bifurcation device is a paclitaxel-eluting, side-branch access stent delivered over two coronary guidewires, enabling maintenance of side-branch access throughout the procedure. The body of the stent is deployed by inflation of a standard cylindrical balloon, and the side-branch “petal” struts are expanded by inflation of a smaller elliptical balloon (Figure 1). The balloon lumens (main and side-branch) are connected, permitting simultaneous balloon inflation using a single inflation device (Figure 1). The petal strut elements (Figure 1) project approximately 2 mm into the side branch providing mechanical support and applying anti-proliferative drug to the side-branch ostium, a common site for restenosis after bifurcation stenting procedures. When the Petal is delivered to a bifurcation lesion, separation of markers confirms rotational alignment of the SB elements with the SB (Figures 1 and 2). The Boston Scientific Petal stent is an improved version of a bare metal Petal stent made by Advanced Stent Technologies. The current laser cut design uses a novel, more radio-opaque platinum chromium alloy that is associated with greater visibility than stainless steel or cobalt chromium (Figure 3). The alloy is also stronger, allowing construction of stents with thinner struts but with maintained radial strength and minimal recoil. The drug (paclitaxel) and polymer (translute) are the same as those coating the Taxus Express and Taxus Liberte stents and evaluated in clinical trials. The stent/ delivery system profile allows delivery through a 7 Fr guide catheter.

Outcomes After Implantation of the TAXUS Paclitaxel-Eluting Stent in Saphenous Vein Graft Lesions: Results From the ARRIVE (TAXUS Peri-Approval Registry: A Multicenter Safety Surveillance) Program

The aim of this study was to examine the incidence of clinical events after implantation of the TAXUS Express (Boston Scientific Corporation, Natick, Massachusetts) paclitaxel-eluting stent in saphenous vein graft (SVG) lesions in an unselected patient population. Saphenous vein grafts have 1-year occlusion rates of 12% to 20%, with >50% failure by 7 to 10 years. Many diseased SVGs are treated by percutaneous coronary intervention to avoid higher-risk reoperation, but bare-metal stents have 35% to 40% historical SVG restenosis rates by 18 months. Reported outcomes of drug-eluting stents in SVG lesions are limited and mainly retrospective. The ARRIVE (TAXUS Peri-Approval Registry: A Multicenter Safety Surveillance) program compiled data on 7,492 patients receiving > or =1 TAXUS Express (Boston Scientific) stent, including 474 patients with SVG. All cardiac events were monitored with independent adjudication of end points. Patients enrolled at procedure start with no mandated inclusion/exclusion criteria. The ARRIVE SVG patient 2-year follow-up was 96% complete (457 of 474). The SVG patients had significantly more baseline comorbidities/complex disease than simple-use patients (n = 2,698) undergoing native coronary intervention or other expanded-use patients (n = 4,320 without SVG patients). They had higher 2-year rates of mortality (10.9% vs. 4.2%, p < 0.001), myocardial infarction (5.3% vs. 2.2%, p < 0.001), and Academic Research Consortium definite/probable stent thrombosis (4.7% vs. 1.4%, p < 0.001) than the simple-use group. They also had higher 2-year adverse event rates, including significantly more mortality (10.9% vs. 7.5%, p = 0.008) than other expanded-use patients. The ARRIVE SVG patients have significantly different baseline risk and higher clinical risk through 2 years than simple-use and other expanded-use patients. Nonetheless, compared with historical SVG revascularization rates, treatment with paclitaxel-eluting stent seems to offer a reasonable therapeutic option in this high-risk group. (TAXUS ARRIVE: TAXUS Peri-Approval Registry: A Multicenter Safety Surveillance Program; NCT00569491) and (TAXUS ARRIVE 2: A Multicenter Safety Surveillance Program; NCT00569751).

2-Year Results of the AUTAX (Austrian Multivessel TAXUS-Stent) Registry: Beyond the SYNTAX (Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery) Study

The multicenter AUTAX (Austrian Multivessel TAXUS-Stent) registry investigated the 2-year clinical/angiographic outcomes of patients with multivessel coronary artery disease after implantation of TAXUS Express stents (Boston Scientific, Natick, Massachusetts), in a "real-world" setting. The AUTAX registry included patients with 2- or 3-vessel disease, with/without previous percutaneous coronary intervention (PCI) and concomitant surgery. Patients (n = 441, 64 +/- 12 years, 78% men) (n = 1,080 lesions) with possible complete revascularization by PCI were prospectively included. Median clinical follow-up was 753 (quartiles 728 to 775) days after PCI in 95.7%, with control angiography of 78% at 6 months. The primary end point was the composite of major adverse cardiac (nonfatal acute myocardial infarction [AMI], all-cause mortality, target lesion revascularization [TLR]) and cerebrovascular events (MACCE). Potential risk factor effects on 2-year MACCE were evaluated using Cox regression. Complete revascularization was successful in 90.5%, with left main PCI of 6.8%. Rates of acute, subacute, and late stent thrombosis were 0.7%, 0.5%, and 0.5%. Two-year follow-up identified AMI (1.4%), death (3.6%), stroke (0.2%), and TLR (13.1%), for a composite MACCE of 18.3%. The binary restenosis rate was 10.8%. The median of cumulative SYNTAX score was 23.0 (range 12.0 to 56.5). The SYNTAX score did not predict TLR or MACCE, due to lack of scoring of restenotic or bypass stenoses (29.8%). Age (hazard ratio [HR]: 1.03, p = 0.019) and acute coronary syndrome (HR: 2.1, p = 0.001) were significant predictors of 2-year MACCE. Incomplete revascularization predicted death or AMI (HR: 3.84, p = 0.002). With the aim of complete revascularization, TAXUS stent implantations can be safe for patients with multivessel disease. The AUTAX registry including patients with post-PCI lesions provides additional information to the SYNTAX (Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery) study. (Austrian Multivessel TAXUS-Stent Registry; NCT00738686).

Expanded use of the TAXUS Express Stent: two-year safety insights from the 7,500 patient ARRIVE Registry programme

We report 2-year outcomes in a large unselected drug-eluting stent population (N=7,492) in the TAXUS Express2 ARRIVE post-market surveillance programme (101 U.S. sites). No specific inclusion/exclusion criteria were mandated; patients enrolled at procedure initiation. Two-year follow-up was 94%, with independent adjudication of major cardiac events, monitoring of patients with cardiac events and an additional 10-20% sample by site. Most ARRIVE cases (64%, n=4,794) typified expanded use based on patient/lesion characteristics outside the simple use (single vessel/stent) pivotal trial populations. These expanded use patients had higher 2-year rates than simple use patients for mortality (7.8% vs. 4.2%, P<0.001), myocardial infarction (MI, 3.9% vs. 2.2%, P<0.001), target lesion revascularisation (TLR, 9.2% vs. 5.4%, P<0.001), and stent thrombosis (3.3% vs. 1.4%, P<0.001). Among subgroups with renal disease, chronic total occlusion (CTO), lesion >28 mm, reference vessel diameter (RVD) <2.5 mm, multivessel stenting, acute MI, bifurcation, vein graft, or in-stent restenosis, TLR ranged from 3.8% to 8.9% in year one, and from 1.3% to 6.0% during year two. Mortality and stent-related events were higher in expanded use than simple use patients in the pivotal trials. ARRIVE provides a detailed estimate of procedural and 2-year outcomes in such real-world patients.

Two-Year Results of Paclitaxel-Eluting Stents in Patients With Medically Treated Diabetes Mellitus from the TAXUS ARRIVE Program

Drug-eluting stents decrease revascularization compared with bare metal stents in diabetic patients, but few studies have compared drug-eluting stent use in diabetic versus nondiabetic patients. The objective of this study was to assess whether paclitaxel provides equivalent revascularization decrease in diabetic and nondiabetic patients. The ARRIVE registries enrolled 7,492 patients receiving TAXUS Express stents, including 2,112 with medically treated diabetes; results were compared with those in the remaining 5,380 nondiabetic patients. Two-year target lesion revascularization (TLR) was comparable in diabetic and nondiabetic patients (8.2% vs 7.7%, p = 0.59) and remained similar after multivariate adjustment for baseline differences (7.1% vs 6.8%, p = 0.41). There were no significant TLR differences between diabetic and nondiabetic patients with small vessels (9.7% vs 9.5%, p = 0.96) or left main coronary artery, 3-vessel, or bifurcation stenting (10.7% vs 13.1%, p = 0.41). Diabetes was not a significant TLR predictor (hazard ratio 0.92, 95% confidence interval 0.77 to 1.12, p = 0.41). Stent thrombosis (2.6% vs 2.4%, p = 0.55) and myocardial infarction (3.8% vs 3.0%, p = 0.09) rates were also similar for diabetic and nondiabetic patients. However, 2-year mortality was significantly increased in diabetic compared with nondiabetic patients (9.7% vs 5.3%, p <0.001). Increased mortality drove significantly increased major cardiac events in diabetics; however, there was no difference in stent-related major cardiac events (8.9% vs 10.1%, p = 0.13). In conclusion, these results suggest that TAXUS paclitaxel-eluting stents abrogate the increased diabetic risk of clinical restenosis previously reported with bare metal stents, with similar low risk of myocardial infarction or stent thrombosis for diabetic and nondiabetic patients. However, diabetic patients still have increased risk of 2-year mortality.

Reduced Risk of Restenosis in Small Vessels and Reduced Risk of Myocardial Infarction in Long Lesions With the New Thin-Strut TAXUS Liberté Stent: 1-Year Results From the TAXUS ATLAS Program

The TAXUS ATLAS Small Vessel (SV) and Long Lesion (LL) multicenter studies compared the performance of the thin-strut (0.0038 inch) TAXUS Liberté 2.25-mm stent (Boston Scientific; Natick, Massachusetts) and the TAXUS Liberté 38-mm long stent (Boston Scientific; Natick, Massachusetts) with the earlier paclitaxel-eluting TAXUS Express (Boston Scientific) stent that has identical polymer, drug dosage, and release kinetics but different stent geometry and thicker struts (0.0052 inch). The TAXUS Liberté stent was designed with thinner and more even strut spacing to provide more uniform drug distribution, as well as increased flexibility and conformability. Clinical benefits of the new stent design have not been evaluated. The TAXUS ATLAS SV and LL studies are nonrandomized studies comparing outcomes of the TAXUS Liberté 2.25 mm (N = 261) and TAXUS Liberté 38 mm (N = 150) stents to TAXUS Express historical control groups derived from the TAXUS IV and V trials. Inclusion/exclusion criteria for TAXUS Express and Liberté groups were similar in both studies. Each study met its primary end point of noninferiority of 9-month in-segment diameter stenosis. Furthermore, TAXUS Liberté 2.25 mm, when compared with TAXUS Express, significantly reduced the rate of both 9-month angiographic restenosis (18.5% vs. 32.7%, p = 0.0219) and 12-month target lesion revascularization (6.1% vs. 16.9%, p = 0.0039). In addition, TAXUS Liberté 38 mm significantly reduced the risk of 12-month myocardial infarction compared with TAXUS Express (1.4% vs. 6.5%, p = 0.0246). The thinner-strut TAXUS Liberté stent improved outcomes compared with the earlier TAXUS Express stent in both SVs and LLs (A Study of the TAXUS Liberté Stent for the Treatment of de Novo Coronary Artery Lesions in Small Vessels; NCT00371748; A Study of the TAXUS Liberté Stent for the Treatment of Long De Novo Coronary Artery Lesions; NCT00371475).

Restenosis of the CYPHER-Select, TAXUS-Express, and Polyzene-F Nanocoated Cobalt-Chromium Stents in the Minipig Coronary Artery Model

To date no direct experimental comparison between the CYPHER-Select and TAXUS-Express stents is available. Therefore, we investigated late in-stent stenosis, thrombogenicity, and inflammation, comparing the CYPHER-Select, TAXUS-Express, and custom-made cobalt chromium Polyzene-F nanocoated stents (CCPS) in the minipig coronary artery model. The three stent types were implanted in the right coronary artery of 30 minipigs. The primary endpoint was in-stent stenosis assessed by quantitative angiography and microscopy. Secondary endpoints were inflammation and thrombogenicity evaluated by scores for inflammation and immunoreactivity (C-reactive protein and transforming growth factor beta). Follow-up was at 4 and 12 weeks. Stent placement was successful in all animals; no thrombus deposition occurred. Quantitative angiography did not depict statistically significant differences between the three stent types after 4 and 12 weeks. Quantitative microscopy at 4 weeks showed a statistically significant thicker neointima (p = 0.0431) for the CYPHER (105.034 +/- 62.52 microm) versus the TAXUS (74.864 +/- 66.03 microm) and versus the CCPS (63.542 +/- 39.57 microm). At 12 weeks there were no statistically significant differences. Inflammation scores at 4 weeks were significantly lower for the CCPS and CYPHER compared with the TAXUS stent (p = 0.0431). After 12 weeks statistical significance was only found for the CYPHER versus the TAXUS stent (p = 0.0431). The semiquantitative immunoreactivity scores for C-reactive protein and transforming growth factor beta showed no statistically significant differences between the three stent types after 4 and 12 weeks. The CCPS provided effective control of late in-stent stenosis and thrombogenicity in this porcine model compared with the two drug-eluting stents. Its low inflammation score underscores its noninflammatory potential and might explain its equivalence to the two DES.

Short- and long-term effects of a novel paclitaxel coated stent in the porcine coronary model

Drug eluting stents (DES) are unique in allowing sustained release for weeks after a single short intervention. The challenge with DES still remaining is the combination of a biocompatible drug-eluting matrix including an antiproliferative drug showing efficacy and safety in restenosis prevention. The aim of the present animal studies was to evaluate the novel paclitaxel coated Coroflex. Please stent in the porcine coronary model. Stents were implanted into LAD and CX arteries of 49 domestic pigs. After 5 days, 4 weeks, 3 months, or 6 months, the animals underwent control angiography including dissection of the stented coronary arteries for histology. After 5 days, 3 and 6 months the Coroflex. Please stent was compared with its uncoated counterpart and a paclitaxel free but polymer coated version. After 28 days, an additional group received the Taxus Express(2) stent. After 5 days, healing with the paclitaxel coated stent was comparable to the uncoated bare metal stent as reflected in a similar neointimal proliferation. Compared to the Taxus stent, the new Coroflex. Please stent showed a similar neointimal proliferation after 4 weeks. Inflammatory reaction was comparable among the bare stent and polymer coated stent groups. Paclitaxel coating was associated with a slightly increased inflammatory reaction with both DES. After 3 and 6 months, all groups showed a similar neointimal proliferation and inflammatory reaction. The present porcine studies demonstrate excellent safety of the new paclitaxel coated Coroflex stent in the porcine coronary stent model.

Comparison of in-hospital and long-term outcomes between a Cypher stent and a Taxus stent in Chinese diabetic patients with coronary artery disease

The sirolimus and paclitaxel distribution patterns and tissue residence time may be modified in atherosclerotic lesions for patients with diabetes, and the biological mechanisms of action for these agents differ significantly. Previous clinical trials have yielded discrepant results of major adverse cardiac events and restenosis between a sirolimus-eluting stent and a paclitaxel-eluting stent in coronary artery disease. Therefore, this study was conducted to compare in-hospital and long-term clinical outcomes between patients receiving sirolimus-eluting stent (Cypher or Cypher Select stent) and paclitaxel-eluting stent (Taxus Express stent) after percutaneous intervention (PCI) in Chinese patients with diabetes. One hundred and sixty-four consecutive diabetic patients underwent PCI in Fuwai Hospital from April 2004 to December 2004. Of them, 101 patients received Cypher or Cypher Select stents (Cypher group, 145 stents) and 63 patients received Taxus Express stents (Taxus group, 129 stents). Repeat coronary angiography was performed at 6-month and clinical outcomes were evaluated at 1- and 3-year follow-up. Stent thrombosis was classified according to Academic Research Consortium (ARC). The two groups did not differ significantly with respect to cardiac death, recurrent myocardial infarction (re-MI), target vessel revascularization (TVR) and occurrence of major adverse cardiac events (MACE). And the MACE-free cumulative survival at 1- and 3-year follow-up and early, late and very late thrombosis rates were also similar in the two groups (all P > 0.05). There was a trend favoring PES over SES with regard to reducing cardiac death (0 vs 2.0%, P = 0.524), re-MI (0 vs 2.0%, P = 0.524), the composite of the cardiac death and re-MI (0 vs 4.0%, P = 0.299) and very late thrombosis (0 vs 3.0%, P = 0.295) between 1-year and 3-year follow-up. The study indicates that PCI with either Cypher or Taxus stents is associated with similar efficacy and safety in the small population of Chinese diabetic patients during long-term follow-up.

Abstract 2153: Taxus Atlas Long Lesion: First Report of 9-Month Clinical and Angiographic Outcomes for the TAXUS Liberté 38 mm Stent for Long Lesions

Background : The TAXUS Liberté (TL) 38 mm stent, the longest drug-eluting stent, was designed with more uniform drug distribution, thinner struts and increased flexibility and conformability for use specifically in very long lesions. Long lesions have been identified as a risk factor for instent restenosis, stent thrombosis and incomplete apposition. Thus, TAXUS ATLAS Long Lesion (LL) assesses the performance of the TL 38 mm stent vs the TAXUS Express (TE) stent. Methods : TAXUS ATLAS LL is a prospective, non-randomized trial enrolling 150 pts from 24 global sites. Pts undergoing single TL stent implantation of a de novo lesion visually estimated to be 26 – 34 mm in length, with a reference vessel diameter of 2.7 – 4.0 mm, were enrolled. A subset of patients underwent IVUS at 9m. The TE Control consists of a lesion-matched cohort derived from TAXUS IV and TAXUS V. The primary endpoint is non-inferiority of 9m % diameter stenosis (%DS) of the analysis segment as determined by quanitative coronary angiography (QCA). Results : Baseline pt characteristics were well-matched between the TL and TE arms. However, the TL pts presented with longer and more complex lesions (by QCA). Procedure time was significantly shorter for TL, and the use of multiple stents was significantly less in TL vs TE. Compared to TE, TL demonstrated non-inferiority for 9m %DS, analysis segment (pre-specified non-inferiority margin = 6.89%, difference = −0.93%, upper 1-sided 95% Confidence Interval = 3.19%, p=0.0010); thus, the primary endpoint objective was met. The cardiac death or MI rate was significantly lower for TL, while other clinical and angiographic parameters were similar between the groups. There were no stent thromboses for TL. The incidence of early or late incomplete apposition was low and comparable between TL and TE. Conclusions : The TL 38 mm stent, the longest drug-eluting stent, demonstrated similar efficacy in reducing stenosis but an enhanced safety profile in very long lesions vs TE.