Meta-analysis of angiographic versus intravascular ultrasound parameters of drug-eluting stent efficacy (from TAXUS IV, V, and VI).

Both quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS) are currently used to assess in-stent restenosis. This study aimed to use standardized imaging and clinical follow-up to compare QCA parameters with several IVUS parameters to evaluate their strengths and weaknesses for detecting in-stent restenosis in a drug-eluting stent population. A subset of patients from the TAXUS IV, V, and VI studies was evaluated. The subset, which included 216 TAXUS-treated patients and 191 bare-metal stent-treated patients, had complete IVUS and QCA performed at baseline and follow-up. As expected, all QCA and IVUS parameters were consistent with less intimal hyperplasia in TAXUS patients than controls. The overall incidence of QCA binary restenosis was 14.0%, which was 9.3% in TAXUS-treated patients and 19% in bare-metal stent-treated patients (p = 0.0008). Regression analysis showed that QCA late lumen loss and percentage of diameter stenosis correlated only moderately with the various IVUS measures of neointimal hyperplasia for the combined group of patients (TAXUS + bare-metal stent), as well as for the TAXUS-treated and bare-metal stent-treated patients separately. However, in general, correlations within the control (bare-metal stent) group tended to be stronger than within the TAXUS group. The strongest correlation was between QCA percentage of diameter stenosis and IVUS percentage of intimal hyperplasia in the overall group and the control group. The strongest IVUS predictor of QCA binary restenosis at 9 months was maximum percentage of intimal hyperplasia, with an overall C = 0.91 and p <0.001. In conclusion, the QCA and IVUS parameters used to evaluate drug-eluting stent efficacy showed a moderate correlation with IVUS percentage of intimal hyperplasia, reliably predicting QCA binary in-stent restenosis.

Impact of mild or moderate renal insufficiency on the intravascular ultrasonic analysis of chronic vascular response to paclitaxel-eluting and bare-metal stents (from the TAXUS IV, V, and VI trials).

The presence of even mild renal insufficiency is usually associated with an increased rate of cardiovascular events after coronary stenting. The aim of this study was to evaluate the impact of mild to moderate renal insufficiency on the chronic vascular responses to the implantation of paclitaxel-eluting stents (PES; Taxus) and bare-metal stents (BMS). In the TAXUS IV, TAXUS V, and TAXUS VI trials, patients with serum creatinine levels >2.0 mg/dl were excluded. In the present analysis, 816 patients with serum creatinine levels or=80 ml/min/1.73 m(2)). For all levels of Ccr, patients with PES compared with those with BMS had less intimal hyperplasia area (group 1: 0.97 +/- 0.98 vs 2.94 +/- 1.89; group 2: 0.94 +/- 0.86 vs 2.30 +/- 1.21; group 3: 0.99 +/- 1.02 vs 2.53 +/- 1.29; group 4: 0.87 +/- 0.95 vs 2.12 +/- 1.29 mm(2), all p values <0.0001) and greater increases in peristent plaque and media area (group 1: 0.90 +/- 0.98 vs -0.02 +/- 0.98 mm(2), p = 0.03; group 2: 0.57 +/- 1.43 vs 0.20 +/- 1.14 mm(2), p = 0.11; group 3: 1.20 +/- 1.95 vs 0.02 +/- 1.17, p <0.0001; group 4: 0.35 +/- 1.44 vs -0.19 +/- 1.08 mm(2), p = 0.08). Neointimal growth and vessel remodeling were not affected by variations in Ccr after either BMS or PES implantation over the range studied. The incidence of incomplete stent apposition at follow-up was lowest in patients with the greatest renal impairment after BMS and PES implantation. In conclusion, neointimal proliferation was less prominent and expansive vessel remodeling was more prominent after PES than BMS implantation, independent of the severity of renal dysfunction.

Effect of the polymer-based, paclitaxel-eluting TAXUS Express stent on vascular tissue responses: a volumetric intravascular ultrasound integrated analysis from the TAXUS IV, V, and VI trials.

AIMS: The TAXUS Express stent has been shown to reduce angiographic restenosis, repeat revascularizations, and neointimal hyperplasia when compared with bare metal stent (BMS) control (TAXUS IV, V, and VI) in individual TAXUS trials. Since intravascular ultrasound (IVUS) methodology and core laboratory were consistent among all three TAXUS trials, an integrated analysis of 956 patients across all IVUS cohorts can be performed providing superior power. METHODS AND RESULTS: In the TAXUS randomized trials, patients received an Express BMS or paclitaxel-eluting TAXUS Express stent. Volumetric analysis was performed on a selected subgroup at implantation and 9 months. Compared with BMS control, TAXUS increased 9-month lumen volumes (144 +/- 79 vs. 179 +/- 95 mm(3); P < 0.0001) due to reduced neointimal volume (66 +/- 49 vs. 27 +/- 30 mm(3); P < 0.0001). This corresponded to a 61% decrease in net lumen volume obstruction (31 +/- 15 vs. 12 +/- 12 mm(3); P < 0.0001). Lumen loss was similar between groups for the proximal 5 mm outside the stent but was reduced in TAXUS at the distal edge (P = 0.0056). Neointimal hyperplasia was significantly reduced in the double-strut region of overlapping TAXUS vs. BMS control and in high-risk patients with diabetes, long lesions, multiple stents, and multiple overlapping stents. Late-acquired incomplete stent apposition (ISA) was more common with moderate-release TAXUS stents. Importantly, there were no major adverse cardiac events or stent thromboses in any late-acquired ISA patient through 2 years. Univariate and multivariable analyses revealed that longer lesion length and previous myocardial infarction are risk factors for late-acquired ISA. CONCLUSION: Integrated analysis of the TAXUS trials shows that the paclitaxel-eluting TAXUS Express stent effectively inhibits in-stent neointimal proliferation, even in high-risk and overlapping stent patients.

Polymer-based, paclitaxel-eluting TAXUS Liberté stent in de novo lesions: the pivotal TAXUS ATLAS trial.

OBJECTIVES: The goal of this research was to assess non-inferiority of the next-generation TAXUS Liberté stent (Boston Scientific Corp., Natick, Massachusetts) versus the TAXUS Express stent (Boston Scientific Corp.). BACKGROUND: The introduction of drug-eluting stents (DES) has shifted clinical practice towards more complex lesion subsets, prompting the need for more deliverable DES. TAXUS Liberté was designed to combine the established polymer-based, paclitaxel-elution TAXUS technology with the more advanced Liberté stent platform. METHODS: The TAXUS ATLAS study is a global, prospective, single-arm trial evaluating outcomes in 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 an entry-criteria-matched population of TAXUS Express patients from the TAXUS IV and V trials. The primary end point is non-inferiority of TAXUS Liberté versus TAXUS Express for 9-month target vessel revascularization. RESULTS: Despite similar inclusion criteria, quantitative coronary angiography-determined baseline lesion characteristics were significantly more complex for TAXUS Liberté than TAXUS Express. The primary non-inferiority end point was met with the 1-sided 95% confidence bound of 2.98% less than the pre-specified non-inferiority margin of 3% (p = 0.0487). CONCLUSIONS: Despite the treatment of more complex lesions with TAXUS Liberté, the primary end point was met, demonstrating that TAXUS Liberté is non-inferior to TAXUS Express. The successful transfer of the proven TAXUS technology to the more advanced TAXUS Liberté platform was demonstrated. (TAXUS ATLAS: TAXUS Liberté-SR Stent for the Treatment of De Novo Coronary Artery Lesions; http://www.clinicaltrials.gov/ct/show/NCT00371709?order=1; NCT00371709).