TAXUS ATLAS Research Articles

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.

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.

Rationale and design of the TAXUS Libertē Post-Approval Study: Examination of patients receiving the TAXUS Liberté stent with concomitant prasugrel therapy in routine interventional cardiology practice

Observational studies of new coronary stents are necessary to assess performance in a variety of complex patient and lesion types. Furthermore, the optimal dose and duration of thienopyridine treatment is unclear, particularly in patients with complex clinical conditions. The TAXUS Libertē Post-Approval Study is designed to provide 5-year data on the TAXUS Liberté paclitaxel-eluting stent with concomitant prasugrel therapy in routine clinical practice and to contribute data to the DAPT study. The TAXUS Libertē Post-Approval Study is a prospective, multicenter, observational study. Enrollment of approximately 4,200 patients receiving ≥1 TAXUS Liberté stents is planned. All patients without a contraindication will be prescribed prasugrel plus aspirin for 1 year. The 12-month primary end point of cardiac death or myocardial infarction in on-label stent patients will be compared with historical TAXUS Express stent data from the TAXUS ATLAS and TAXUS ARRIVE studies. Secondary clinical end points include stent thrombosis, all-cause death, stroke, revascularization, and bleeding in all patients. In addition, this study will be the first to evaluate prasugrel use in a routine practice setting (including 5 and 10 mg daily doses) and will contribute data to the DAPT Study, comparing 12 versus 30 months of dual antiplatelet therapy after drug-eluting stent placement. The TAXUS Libertē Post-Approval Study will be the first to provide long-term real-world data on use of the TAXUS Liberté Stent with prasugrel treatment. The study is currently enrolling, and primary end point data are expected in mid 2013.

Propensity-Matched Patient-Level Comparison of the TAXUS Liberté and TAXUS Element (ION) Paclitaxel-Eluting Stents

Stent design, metal alloy composition, and strut thickness may influence late lumen loss and clinical outcomes after bare metal stent deployment; however, their impact on outcomes after drug-eluting stent deployment is unknown. Although the TAXUS Liberté and ION paclitaxel-eluting stents use similar polymer and drug, the ION stent incorporates a novel thin-strut platinum chromium metal alloy and cell design. We therefore compared patient-level data from 2,298 subjects enrolled into the TAXUS ATLAS (TAXUS Liberté) and PERSEUS (ION) clinical trials. Propensity-score (1:1) matching was performed to adjust for covariate imbalance between stent types. Twelve-month major adverse cardiac events were less frequent after use of the ION compared to the TAXUS Liberté (12.7% vs 8.3%, p <0.001, unadjusted; 12.0% vs 7.5%, p = 0.007, propensity matched) largely because of decreased non-Q-wave myocardial infarction (MI; 2.9% vs 1.4%, p = 0.01, unadjusted; 3.2% vs 0.9%, p = 0.004, propensity matched). The MI difference was predominantly periprocedural and in patients treated with a single stent. In conclusion, this exploratory post hoc analysis demonstrated that the ION was associated with fewer adverse clinical events than the TAXUS Liberté because of decreased non-Q-wave MI. Stent platform-related variables may influence clinical outcomes after drug-eluting stent use despite similar polymer and drug elution. Differences in adjunctive pharmacotherapy and/or stenting technique may also be contributory.

Evaluating cost-effectiveness using an economic model: analysis from the TAXUS ATLAS long lesion trial

Objective: Drug-eluting stents (DES) are known to impact vascular functions. The impact of the polymers and the drugs used in DES on the pathways regulating vascular reactivity is not well understood. The objective of the present study was to investigate the effect of rapamycin class of DES on vascular reactivity and the genes involved in the vasoregulating nitric oxide pathway. Methods: A porcine model of stent implantation was used. Bare-metal stents (BMS), DES, sirolimus, zotarolimus or other limus stents were placed in two epicardial vessels of each animal with S/A ratio of 1.1:1 and overlapping segment of 1/3 to 1/2 of single stent length. After 28 days, vascular function was determined by acetylcholine (Ach) challenge. Tissue samples from the stented segment of four arteries from each group were collected. RNA and proteins were isolated. Selected genes and proteins regulating the nitric oxide pathway were further analyzed by real-time polymerase chain reaction (PCR) and western blotting. Results and conclusions: As compared to the BMS, the vascular reactivity to Ach challenge was significantly impaired and super oxide generation was significantly increased in vessels implanted with DES. Quantitative reverse transcriptase PCR analysis of genes involved in vascular reactivity and nitric oxide pathway indicated changes in the expression of VEGF, DDAH and Arginase genes. Western blotting showed that the total or phosphorylated forms of eNOS were similar in BMSand DES-implanted vessels. However, the phosphorylated form of the eNOS regulating protein kinase AKT was significantly increased in zotarolimus stent but not in sirolimus stent. The latter results suggest that nitric oxide pathway sites in addition to eNOS gene expression or protein level may play a role in modulating vascular reactivity in response to DES. Our studies suggest that an interplay between multiple vascular genes including AKT may play an important role in the impairment of vascular response by DES. Further studies will delineate the role of various genes in the pathophysiology of DES leading to vascular dysfunction.

Long-Term Benefit of the TAXUS Liberte Stent in Small Vessels and Long Lesions - TAXUS ATLAS Program -

The long-term impact of treating de novo coronary lesions in native vessels and challenging small vessel and long lesion subsets with TAXUS Liberté stents is unknown. This report examines the 3-year efficacy and safety from the TAXUS ATLAS program. TAXUS ATLAS WH, Small Vessel, and Long Lesion are non-randomized studies comparing TAXUS Liberté (n = 871), TAXUS Liberté 2.25 mm (n = 261), and TAXUS Liberté 38 mm (n = 150) stents, respectively, to case-matched TAXUS Express historical controls. TAXUS Liberté demonstrated comparable 3-year rates of major adverse cardiac events (19.0% vs. 20.2%, P = 0.51) in de novo lesions, reduced target lesion revascularization (TLR, 10.0% vs. 22.1%, P = 0.008) in small vessels, and reduced myocardial infarction (MI, 2.9% vs. 10.4%; P = 0.01) and stent thrombosis (ST, 0.0% vs. 3.9%, P = 0.03) in long lesions vs. TAXUS Express. After propensity score adjustment, no statistically significant effect of TAXUS Liberté on TLR (9.7% vs. 16.9%, P = 0.12) in small vessels or MI (2.9% vs. 7.9%, P = 0.05) in long lesions was noted, although reduced ST (0.0% vs. 2.7%, P = 0.02) remained in long lesions. Multivariate analyses demonstrated that TAXUS Liberté treatment significantly reduced TLR by 66% in small vessels, and MI by 75% in long lesions, vs. TAXUS Express. TAXUS Liberté suggests durable 3-year effectiveness in reducing restenosis and improved clinical outcomes in small vessels and long lesions compared with TAXUS Express.

Improved strut coverage and less late incomplete apposition with thin-strut TAXUS Liberté vs. TAXUS Express: the importance of stent platform design for drug-eluting stents

The objective of this intravascular ultrasound (IVUS) analysis was to evaluate the vascular response of the thin-strut TAXUS Liberté stent compared with the otherwise identical TAXUS Express stent. The TAXUS ATLAS and TAXUS ATLAS Long Lesion studies are nonrandomized trials comparing the thin-strut TAXUS Liberté stent to historical TAXUS Express controls from the TAXUS IV and TAXUS V trials. A total of 377 patients enrolled in the two TAXUS ATLAS studies were randomly selected for the IVUS subset and compared to 314 TAXUS Express IVUS controls. Despite increased lesion complexity in the TAXUS Liberté group, neointimal formation at 9 months was similar in both stents (TAXUS Liberté 13.8±11.0%; TAXUS Express 13.1±13.8%, P=.56). However, this neointima covered more of the overall stent in the TAXUS Liberté (67.9±32.5%) compared with the TAXUS Express (54.4±37.2%, P<.001), suggesting more uniform neointimal distribution. TAXUS Liberté also showed less pronounced negative remodeling at both stent edges and had significantly less (4.3% vs. 9.6%, P=.04) late incomplete stent apposition (ISA). Despite identical polymer and drug release characteristic, the thin-strut TAXUS Liberté stent demonstrates improved neointimal coverage, better edge remodeling, and less late ISA vs. TAXUS Express, hereby highlighting the importance of the platform design for drug-eluting stents.

New stent design for use in small coronary arteries during percutaneous coronary intervention

Patients with diabetes mellitus, of female gender, increased age, and/or with peripheral vascular disease often develop coronary stenoses in small caliber vessels. This review describes treatment of these lesions with the paclitaxel-eluting 2.25 mm TAXUS® Liberté® Atom™ stent. Given the same stent composition, polymer, antirestenotic drug (paclitaxel), and release kinetics as the first-generation 2.25 mm TAXUS® Express® Atom™ stent, the second-generation TAXUS Liberté Atom stent incorporates improved stent design characteristics, including thinner struts (0.0038 versus 0.0052 inches), intended to increase conformability and deliverability. In a porcine noninjured coronary artery model, TAXUS Liberté Atom stent implantation in small vessels demonstrated complete strut tissue coverage compared with the bare metal stent control, suggesting a similar degree of tissue healing between the groups at 30, 90, and 180 days. The prospective, single-armed TAXUS ATLAS Small Vessel trial demonstrated improved instent late loss (0.28 ± 0.45 versus 0.84 ± 0.57 mm, P < 0.001), instent binary restenosis (13.0% versus 38.1%, P < 0.001), and target lesion revascularization (5.8% versus 17.6%, P < 0.001) at nine months with the TAXUS Liberté Atom stent as compared with the bare metal Express stent control, with similar safety measures between the two groups. The TAXUS Liberté Atom also significantly reduced nine-month angiographic rates of both instent late loss (0.28 ± 0.45 versus 0.44 ± 0.61 mm, P = 0.03) and instent binary restenosis (13.0% versus 25.9%, P = 0.02) when compared with the 2.25 mm TAXUS Express Atom control. The observed reduction in target lesion revascularization with the TAXUS Liberté Atom compared with the TAXUS Express Atom at nine months (5.8% versus 13.7%, P = 0.02) was sustained through three years (10.0% versus 22.1%, P = 0.008) with similar, stable safety outcomes between the groups. In conclusion, these data confirm the safety and favorable performance of the TAXUS Liberté Atom stent in the treatment of small coronary vessels.

TCT-272: Durable Effectiveness of the Taxus Liberté Stent: Final 5-year Follow-up of the Taxus Atlas Trial

TCT-272: Durable Effectiveness of the Taxus Liberté Stent: Final 5-year Follow-up of the Taxus Atlas Trial

Comparative angioscopic evaluation of neointimal coverage and thrombus between TAXUS-Express and TAXUS-Liberté stents: Is the stent platform type associated with the vascular response?

Current drug-eluting stent (DES) has demonstrated marked reductions in restenosis following stenting [ [1] Morice M.C. Serruys P.W. Sousa J.E. et al. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002; 346: 1773-1780 Crossref PubMed Scopus (3846) Google Scholar ]. However, very late stent thrombosis (VLST) has become a major clinical problem as a catastrophic complication of DES [ [2] McFadden E.P. Stabile E. Regar E. et al. Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy. Lancet. 2004; 364: 1519-1521 Abstract Full Text Full Text PDF PubMed Scopus (1325) Google Scholar ]. DES caused the substantial impairment in arterial healing characterized by the lack of complete re-endothelialization and the presence of uncovered stent struts without endothelialization is considered a principal mechanism of VLST after DES placement [ [3] Finn A.V. Joner M. Nakazawa G. et al. Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization. Circulation. 2007; 115: 2435-2441 Crossref PubMed Scopus (1140) Google Scholar ]. DES consists of three elements: drug, polymer and stent platform. One factor affecting the vascular response was the non-uniform distribution of stent struts [ [4] Takebayashi H. Mintz G.S. Carlier S.G. et al. Nonuniform strut distribution correlates with more neointimal hyperplasia after sirolimus-eluting stent implantation. Circulation. 2004; 110: 3430-3434 Crossref PubMed Scopus (137) Google Scholar ]. The open-cell-design DES tends to cause the mal-distribution of the drug and might be unfavorable for the arterial healing process. Two types of paclitaxel-eluting stents (PES) are available: the open-cell-design TAXUS-Express (TAXUS-Express [ [2] McFadden E.P. Stabile E. Regar E. et al. Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy. Lancet. 2004; 364: 1519-1521 Abstract Full Text Full Text PDF PubMed Scopus (1325) Google Scholar ]; Boston Scientific Corp., Natick, MA, USA) and the recently available closed-cell-design TAXUS-Liberté (Taxus®-Liberté™; Boston Scientific Corp.) [ [5] Turco M.A. Ormiston J.A. Popma J.J. et al. Polymer-based, paclitaxel-eluting TAXUS Liberté stent in de novo lesions: the pivotal TAXUS ATLAS trials. J Am Coll Cardiol. 2007; 49: 1676-1683 Abstract Full Text Full Text PDF PubMed Scopus (106) Google Scholar ]. To compare the vascular response between the TAXUS-Express and TAXUS-Liberté stent platforms, their effect on the vessel wall could be examined. Coronary angioscopy is a useful technique to evaluate detailed information about the neointimal stent coverage and the thrombus [ 6 Takano M. Ohba T. Inami S. et al. Angioscopic differences in neointimal coverage and in persistence of thrombus between sirolimus-eluting stents and bare metal stents after a 6-months implantation. Eur Heart J. 2006; 27: 2189-2195 Crossref PubMed Scopus (77) Google Scholar , 7 Yamamoto M. Okamatsu K. Inami S. et al. Relationship between neointimal coverage of sirolimus-eluting stents and lesion characteristics: a study with serial coronary angioscopy. Am Heart J. 2009; 158: 99-104 Abstract Full Text Full Text PDF PubMed Scopus (19) Google Scholar , 8 Takano M. Yamamoto M. Murakami D. et al. Lack of association large angiographic late loss and low risk of in-stent thrombus: angioscopic comparison between paclitaxel- and sirolimus-eluting stent. Circ Cardiovasc Intervent. 2008; 1: 20-27 Crossref PubMed Scopus (26) Google Scholar ]. Therefore, we investigated the influence of the neointimal stent coverage and the prevalence of in-stent thrombus by angioscopy using the different TAXUS stent platforms.

Serum levels of soluble receptor for advanced glycation end products (sRAGE) in Takayasu's arteritis

stent thrombosis: strut coverage as a marker of endothelialization. Circulation 2007;115:2435–41. [4] Takebayashi H, Mintz GS, Carlier SG, et al. Nonuniform strut distribution correlates with more neointimal hyperplasia after sirolimus-eluting stent implantation. Circulation 2004;110:3430–4. [5] Turco MA, Ormiston JA, Popma JJ, et al. Polymer-based, paclitaxel-eluting TAXUS Liberte stent in de novo lesions: the pivotal TAXUS ATLAS trials. J Am Coll Cardiol 2007;49:1676–83. [6] TakanoM, Ohba T, Inami S, et al. Angioscopic differences in neointimal coverage and in persistence of thrombus between sirolimus-eluting stents and bare metal stents after a 6-months implantation. Eur Heart J 2006;27:2189–95. [7] YamamotoM, Okamatsu K, Inami S, et al. Relationship between neointimal coverage of sirolimus-eluting stents and lesion characteristics: a study with serial coronary angioscopy. Am Heart J 2009;158:99–104. [8] Takano M, Yamamoto M, Murakami D, et al. Lack of association large angiographic late loss and low risk of in-stent thrombus: angioscopic comparison between paclitaxeland sirolimus-eluting stent. Circ Cardiovasc Intervent 2008;1:20–7. [9] Coats AJ. Ethical authorship and publishing. Int J Cardiol 2009;131:149–50.

Long-Term Impact of Routinely Detected Early and Late Incomplete Stent Apposition: An Integrated Intravascular Ultrasound Analysis of the TAXUS IV, V, and VI and TAXUS ATLAS Workhorse, Long Lesion, and Direct Stent Studies

We sought to determine the 2-year impact of early and late-acquired incomplete stent apposition (ISA) on clinical events. The late clinical impact of early or late-acquired ISA in bare-metal stents (BMS) and TAXUS stents (Boston Scientific, Natick, Massachusetts) is debatable. We evaluated 1,580 patients enrolled in the intravascular ultrasound (IVUS) substudies of TAXUS IV, V, VI and TAXUS-ATLAS WH, LL, and DS trials. There were 96 cases of early ISA in 26 (7.2%) BMS patients, 35 (9.7%) TAXUS Express patients (p = 0.28 vs. BMS), and 35 (7.3%) TAXUS Liberté patients (p = 0.21 vs. TAXUS Express, and p = 1.00 vs. BMS). Major adverse cardiovascular events were similar at 9 months in patients with early ISA versus control subjects with no ISA for BMS (3.8% vs. 15.2%, p = 0.13) and for TAXUS (11.6% vs. 8.8%, p = 0.45). There was no impact of early ISA on stent thrombosis. At 9-month follow-up, there were 36 cases of late-acquired ISA in 7 (2.7%) BMS patients, 17 (3.1%) patients with TAXUS slow-release (TAXUS Express or TAXUS Liberté), and 12 (15.4%) patients receiving TAXUS moderate-release. Over 2 ensuing years, major adverse cardiovascular events were similar in patients with late-acquired ISA versus control subjects with no ISA for BMS (14.3% vs. 7.9%, p = 0.54), TAXUS (overall, 8.3% vs. 8.1% p = 0.87), or TAXUS slow-release formulation (0% vs. 7.9%, p = 0.28). There was no impact of late-acquired ISA on stent thrombosis. Neither routinely detected acute ISA nor routinely detected late-acquired ISA in BMS or TAXUS patients was associated with adverse clinical events over long-term follow-up.

A Novel Paclitaxel-Eluting Stent With an Ultrathin Abluminal Biodegradable Polymer: 9-Month Outcomes With the JACTAX HD Stent

The JACTAX HD trial ("JACTAX" Trial Drug Eluting Stent Trial) evaluated the safety and clinical performance of a novel JACTAX HD (Boston Scientific Corporation, Natick, Massachusetts) paclitaxel-eluting stent (PES) in de novo coronary lesions. The JACTAX HD (Boston Scientific) stent consists of a pre-crimped bare-metal Liberté (Boston Scientific) stent coated on its abluminal aspect with an ultrathin (<1 microm) 1/1 mixture of biodegradable polylactide polymer and paclitaxel applied as discrete microdots (nominal totals of 9.2 microg each of polymer and paclitaxel per 16-mm stent). In this prospective, single-arm, multicenter, first-human-use study (n = 103), the primary end point of 9-month major adverse cardiac events (MACE) (cardiac death, myocardial infarction, ischemia-related target vessel revascularization) was compared with an objective performance criterion (OPC) of 17% (11% MACE based on TAXUS ATLAS [TAXUS Liberté-SR Stent for the Treatment of de Novo Coronary Artery Lesions] trial results plus a pre-specified noninferiority margin of 6%). The composite primary end point occurred in 7.8% of JACTAX HD patients with an upper 1-sided 95% confidence limit of 13.6%, thus meeting the pre-specified criteria for noninferiority. There was no death, Q-wave myocardial infarction, or stent thrombosis through 9 months. In-stent late loss was 0.33 +/- 0.45 mm, with an in-stent binary restenosis of 5.2% and net volume obstruction by intravascular ultrasound of 11.4 +/- 11.2%. The JACTAX HD stent with an abluminal biodegradable polymer showed 9-month MACE, in-stent late loss, restenosis, and net volume obstruction comparable to that observed with the TAXUS Liberté (Boston Scientific) stent coated with a conformal durable polymer. Further studies are underway to better evaluate the potential of this new PES design, which might allow for more rapid endothelialization and improved vessel healing. ("JACTAX" Trial Drug Eluting Stent Trial; NCT00754728).

Impact of Post-Intervention Minimal Stent Area on 9-Month Follow-Up Patency of Paclitaxel-Eluting Stents: An Integrated Intravascular Ultrasound Analysis From the TAXUS IV, V, and VI and TAXUS ATLAS Workhorse, Long Lesion, and Direct Stent Trials

We investigated the predictive value of the intravascular ultrasound (IVUS) measured post-intervention minimum stent area (MSA) on 9-month follow-up paclitaxel-eluting stent (PES) patency compared with bare-metal stents (BMS). Stent underexpansion is a strong predictor for restenosis after sirolimus-eluting stent implantation, but the implication of underexpansion in PES is still unknown. From the combined TAXUS IV, V, and VI and TAXUS ATLAS Workhorse, Long Lesion, and Direct Stent trials, 1,580 patients (PES 1,098, BMS 482) in IVUS substudies were analyzed. The MSA that best predicted angiographic in-stent restenosis (ISR) (% diameter stenosis > or =50%) was determined. The post-intervention IVUS MSA was similar in PES and BMS (6.6 +/- 2.5 mm(2) vs. 6.7 +/- 2.3 mm(2), p = 0.92). At 9-month follow-up, ISR was lower in the PES group versus the BMS group (10% vs. 31%, p < 0.0001). Using multivariable logistic regression analysis, post-intervention IVUS MSA was the independent predictor of subsequent ISR in both the PES and BMS groups (p = 0.0002 for PES and p = 0.0002 for BMS). The ability of the post-intervention IVUS MSA to predict ISR was further assessed using receiver operating characteristic analysis. The post-intervention IVUS MSA was found to be a faithful discriminator between patients with and without ISR in both PES (c = 0.6382) and BMS (c = 0.6373). Finally, the optimal thresholds of post-intervention IVUS MSA that best predicted stent patency at 9 months were 5.7 mm(2) for PES and 6.4 mm(2) for BMS. Post-intervention MSA measured by IVUS can predict 9-month follow-up stent patency after both PES and BMS implantation. (Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stents to Treat De Novo Coronary Lesions; NCT00301522) (Direct Stenting of TAXUS Liberté-SR Stent for the Treatment of Patients With de Novo Coronary Artery Lesions; NCT00371423) (A Study of the TAXUS Liberté Stent for the Treatment of Long De Novo Coronary Artery Lesions; NCT00371475) (A Study of the TAXUS Liberté Stent for the Treatment of de Novo Coronary Artery Lesions in Small Vessels; NCT00371748).

TCT-380: TAXUS ATLAS SMALL VESSEL and TAXUS ATLAS LONG LESION trials: long-term benefit of TAXUS Liberté versus TAXUS Express in Small Vessels and Long Lesions

TCT-380: TAXUS ATLAS SMALL VESSEL and TAXUS ATLAS LONG LESION trials: long-term benefit of TAXUS Liberté versus TAXUS Express in Small Vessels and Long Lesions

TCT-371: Impact of Post-intervention Minimal Stent Area on Long-Term Patency of Paclitaxel-Eluting Stents: An Integrated Intravascular Ultrasound Analysis from the TAXUS IV, V, and VI and TAXUS ATLAS WH, LL, and DS Trials

TCT-371: Impact of Post-intervention Minimal Stent Area on Long-Term Patency of Paclitaxel-Eluting Stents: An Integrated Intravascular Ultrasound Analysis from the TAXUS IV, V, and VI and TAXUS ATLAS WH, LL, and DS Trials

TAXUS Liberté Attenuates the Risk of Restenosis in Patients With Medically Treated Diabetes Mellitus: Results From the TAXUS ATLAS Program

The aim of this study was to assess the relative efficacy and safety of the second-generation TAXUS Liberté paclitaxel-eluting stent (PES) in patients with and without diabetes mellitus. Diabetic patients suffer from accelerated atherosclerosis and increased risk of restenosis after coronary interventions; however, prior data suggest that PES might blunt this effect, providing equal benefit in diabetic and nondiabetic patients. A pooled analysis of all 4 TAXUS ATLAS studies was conducted that included 413 diabetic and 1,116 nondiabetic subjects treated with the TAXUS Liberté stent for de novo coronary lesions. Angiographic and intravascular ultrasound outcomes at 9 months and clinical outcomes at 9 and 12 months were compared in patients with and without diabetes. Propensity score and multivariate adjustments were performed to correct for baseline differences. In-stent angiographic restenosis (13.0% vs. 9.6%, p = 0.12), late luminal loss (0.40 mm vs. 0.38 mm, p = 0.58), and intimal hyperplasia (14.8% vs. 13.4%, p = 0.29) were similar for diabetic and nondiabetic subjects. After propensity adjustment, 12-month target lesion revascularization rates were similar for diabetic and nondiabetic subjects (6.4% vs. 4.7%, p = 0.18), with no differences in mortality, myocardial infarction, or stent thrombosis. However, the rate of target vessel revascularization (TVR) was higher for diabetic subjects due to increased TVR outside the target lesion (TVR Remote). Similar clinical, angiographic, and intravascular ultrasound outcomes were observed for both diabetic and nondiabetic subjects treated with TAXUS Liberté, suggesting that this PES attenuates the effect of diabetes on restenosis after percutaneous coronary intervention, yielding comparable efficacy and safety in diabetic and nondiabetic patients. (TAXUS ATLAS; NCT00371709, NCT00371423, NCT00371748, and NCT00371475).

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).

Direct Stenting With the TAXUS Liberté Drug-Eluting Stent: Results From the TAXUS ATLAS DIRECT STENT Study

This study was conducted to determine whether direct stenting with TAXUS Liberté is noninferior to stenting after pre-dilation. Direct stenting is performed in approximately 30% of patients, but data on clinical and angiographic outcomes with drug-eluting stents are limited. The TAXUS ATLAS DIRECT STENT is a single-arm, multicenter study that enrolled patients with de novo coronary lesions visually estimated to be 10 to 28 mm in length in vessels 2.5 to 4.0 mm in diameter. The control group is the quantitative coronary angiography (QCA) subset of the TAXUS ATLAS trial, which used identical inclusion and exclusion criteria but mandated pre-dilation. The primary end point is 9-month analysis-segment percent diameter stenosis (%DS). Baseline patient characteristics were similar between the groups. On QCA analysis, significantly shorter lesions with larger lumen diameter and less calcification were observed in the direct stent group. Direct stenting was successful in 97.6% of patients and was associated with a shorter procedure time and fewer complications. Follow-up %DS was noninferior for direct stent (26.41%) versus pre-dilation (29.14%) with a 1-sided 95% confidence interval of the difference between the groups (-0.34%) well below the pre-specified noninferiority margin (6.75%). Additionally, significantly lower restenosis (5.9% vs. 11.4%, p = 0.0229) and target lesion revascularization (TLR) 2.9% vs. 7.8%, p = 0.0087) rates were seen for direct stent versus pre-dilation. Direct stenting of TAXUS Liberté is feasible and highly successful in carefully selected lesions. Direct stenting is noninferior to stenting after pre-dilation on the basis of %DS and can significantly reduce procedural time, procedural complications, and possibly angiographic restenosis and TLR.

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.