Jack J. Hall

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

OBJECTIVES 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). BACKGROUND 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. METHODS 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. RESULTS 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). CONCLUSIONS 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).

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

OBJECTIVES 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. BACKGROUND 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. METHODS 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. RESULTS 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). CONCLUSIONS 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).

Three-Year Results Comparing Platinum-Chromium PROMUS Element and Cobalt-Chromium XIENCE V Everolimus-Eluting Stents in De Novo Coronary Artery Narrowing (from the PLATINUM Trial)

In the randomized PLATINUM trial, the PROMUS Element platinum-chromium everolimus-eluting stent (PtCr-EES; Boston Scientific, Natick, Massachusetts) was noninferior to the XIENCE V cobalt-chromium everolimus-eluting stent (CoCr-EES; Boston Scientific and Abbott Vascular, Santa Clara, California) for the primary end point of 1-year target lesion failure. This study reports the 3-year outcomes. Patients (n=1,530) with 1 or 2 de novo native coronary artery lesions (baseline vessel diameter≥2.50 mm to ≤4.25 mm and length≤24 mm) were randomized 1:1 to PtCr-EES versus CoCr-EES. Three-year follow-up was available in 93.9% (703 of 749) of patients with CoCr-EES and 96.7% (733 of 758) of patients with PtCr-EES. Comparing CoCr-EES with PtCr-EES, 3-year rates of death (4.3% vs 3.7%, hazard ratio [HR] 0.88, 95% confidence interval [CI] 0.52 to 1.48, p=0.62), cardiac death (1.9% vs 1.2%, HR 0.63, 95% CI 0.27 to 1.45, p=0.27), myocardial infarction (2.5% vs 2.3%, HR 0.92, 95% CI 0.48 to 1.79, p=0.81), ischemia-driven target lesion revascularization (4.9% vs 3.5%, HR 0.72, 95% CI 0.43 to 1.20, p=0.21), and Academic Research Consortium definite or probable stent thrombosis (0.5% vs 0.7%, HR 1.23, 95% CI 0.33 to 4.57, p=0.76) were not significantly different. In conclusion, 3-year results of the PLATINUM randomized, controlled, clinical trial demonstrate comparable safety and efficacy outcomes of the PROMUS Element PtCr-EES and the XIENCE V CoCr-EES.

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

OBJECTIVES This study was conducted to determine whether direct stenting with TAXUS Liberté is noninferior to stenting after pre-dilation. BACKGROUND Direct stenting is performed in approximately 30% of patients, but data on clinical and angiographic outcomes with drug-eluting stents are limited. METHODS 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). RESULTS 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. CONCLUSIONS 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.

Ultrasound imaging of the radial artery following its use for cardiac catheterization.

Our experience suggests transradial arterial access with 5Fr catheters can be used for cardiac angiography with a low incidence of clinical complications, and supports the findings of previous investigators. Subclinical complications at the catheterization site were infrequent in this study (1 patient with asymptomatic radial artery occlusion). The presence of a palpable radial pulse may not be a reliable estimate of artery patency as evidenced by our patient with a palpable pulse due to retrograde flow. The theoretical advantage of the procedure is derived from the dual vascular supply to the hand. Radial artery occlusion, while uncommon, results in no ischemic sequelae in the setting of a patent ulnar artery.

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

BACKGROUND 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. METHODS AND MATERIALS 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. RESULTS 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). CONCLUSIONS 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.

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.

ObjectiveTo 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. MethodsTAXUS 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. ResultsIn 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. ConclusionCumulative 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.