Long-term benefit of the TAXUS Liberté stent in small vessels and long lesions. TAXUS ATLAS program.

BACKGROUND: 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. METHODS AND RESULTS: 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. CONCLUSIONS: 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.

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.

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.

Intracoronary bolus administration of eptifibatide during percutaneous coronary stenting for non ST elevation myocardial infarction and unstable angina.

BACKGROUND: Distal embolization of thrombotic debris may occur during and after percutaneous coronary intervention (PCI) for acute coronary syndromes. This may lead to impaired microvascular perfusion, myocardial infarction and increased morbidity and mortality. In vitro studies suggest that high local concentrations of a glycoprotein IIb/IIIa inhibitor may be effective in disaggregating thrombus and thereby prevent microvascular compromise. We hypothesized that intracoronary (IC) administration of eptifibatide during stent implantation for unstable angina/non ST elevation myocardial infarction (UA/NSTEMI) would be safe and would lead to an acceptable rate of normal myocardial perfusion. METHODS: In 54 patients with UA/NSTEMI, 2 boluses of 180 mcg/kg of eptifibatide each were administered via the IC route during PCI. Data were retrospectively collected and reviewed by an independent core laboratory. RESULTS: No adverse events including arrhythmias occurred during IC administration of eptifibatide. There were no deaths or urgent revascularizations among patients treated with IC eptifibatide. One patient (2.0%) sustained a post-procedure myocardial infarction. One patient sustained a TIMI major bleeding event due to a gastrointestinal bleed. There were no TIMI minor bleeding events. Normal post PCI TIMI Myocardial Perfusion Grade was observed in 54% of patients. CONCLUSION: IC bolus administration of eptifibatide was feasible and safe among patients with UA/NSTEMI. Larger prospective and randomized studies are warranted to further explore the efficacy of this strategy. Intracoronary eptifibatide administration during PCI for UA/NSTEMI is feasible and safe.