The transradial approach for carotid artery stenting.

BACKGROUND: Carotid artery stenting (CAS) is an alternative to carotid endarterectomy (CEA) for revascularization of the internal carotid artery (ICA). CAS from the femoral approach may be problematic due to peripheral vascular disease, anatomical variations of the aortic arch, and access site complications. The purpose of this study was to evaluate the right radial approach (RRA) for CAS. METHODS: A retrospective analysis of all patients who had undergone transradial (TR) CAS at two centers was performed. Demographics, the technique used to deploy the sheath in the common carotid, procedural details, results, and complications were evaluated. RESULTS: CAS was attempted from TR in 382 patients (mean age 68, 70% male). CAS was successful in 347/382 (91%) patients; 201/216 (93%) right CA, 14/16 (88%) bovine left CA, 132/150 (88%) left CA. The specific technique varied with the anatomy. Seven different carotid artery stents (51% Xact) and seven different distal embolic protection devices were used. Adverse events included two major strokes (0.6%) one of whom died, three minor strokes (1%), and no myocardial infarction at 30 days. No bleeding complications occurred although 23 (6%) of patients had asymptomatic postprocedure radial occlusion. Inadequate catheter support at the origin of the CCA was the technical cause of failure in the unsuccessful cases which were then completed from femoral access as part of the same procedure. CONCLUSION: The transradial approach is an alternative for CAS in the presence of factors that increase the risk or difficulty of femoral access.

Hand ischemia resulting from a transradial intervention: successful management with radial artery angioplasty.

We describe a case of hand ischemia resulting from transradial catheterization. This was successfully treated with angioplasty of the radial artery occlusion, but stresses the importance of a preprocedure evaluation of the dual blood supply to the hand before transradial access.

Is glycoprotein IIb/IIIa antagonism as effective in women as in men following percutaneous coronary intervention?. Lessons from the ESPRIT study.

OBJECTIVE: The study was done to determine whether eptifibatide, a platelet glycoprotein (GP) IIb/IIIa antagonist, prevents ischemic complications following percutaneous coronary interventions (PCIs) in women as well as in men. BACKGROUND: Eptifibatide reduces ischemic complications after nonurgent coronary stent interventions. METHODS: We compared outcomes in women (n = 562) and men (n = 1,502) enrolled in the Enhanced Suppression of the Platelet GP IIb/IIIa Receptor with Integrilin Therapy (ESPRIT) trial of double-bolus eptifibatide during PCI. RESULTS: Women in the ESPRIT trial were older, and more frequently had hypertension, diabetes mellitus, or acute coronary syndromes, but were less likely to have prior PCI or coronary artery bypass graft surgery. The primary end point, a composite at 48 h of death, myocardial infarction (MI), urgent target vessel revascularization (TVR), and unplanned GP IIb/IIIa use, occurred in 10.5% of women and 7.9% of men (p = 0.082). The composite of death, MI, or TVR after one year occurred in 24.5% of women compared with 18% of men (p = 0.0008). At 48 h, eptifibatide reduced the composite of death, MI, and TVR from 14.5% to 6.0% in women versus 9.0% to 6.8% in men. At one year, these differences persisted: 28.9% versus 20.0% for women and 19.5% versus 16.6% for men. No statistical interaction existed between treatment and gender at either 48 h (p = 0.063) or one year (p = 0.2). Bleeding occurred more commonly in women (5.5% vs. 2.6%, p = 0.002), and was more common in eptifibatide-treated women. After adjustment for age, weight, and hypertension, no interaction between treatment and gender was present. CONCLUSION: Eptifibatide is effective to prevent ischemic complications of PCI in women and may eliminate gender-related differences in PCI outcomes.

A novel point-of-care enoxaparin monitor for use during percutaneous coronary intervention. Results of the Evaluating Enoxaparin Clotting Times (ELECT) Study.

OBJECTIVES: The aim of this study was to discern a target range of anticoagulation for enoxaparin during percutaneous coronary intervention (PCI) as measured by the Rapidpoint ENOX (Pharmanetics Inc., Morrisville, North Carolina), a new point-of-care test. BACKGROUND: In the U.S., enoxaparin has been used in only a small proportion of PCI procedures, partly because a rapid enoxaparin-specific assay was unavailable. METHODS: We analyzed data from 445 enrolled patients receiving subcutaneous or intravenous enoxaparin in a prospective, multicenter study. Serial anticoagulation measurements and clinical outcomes were recorded. RESULTS: The in-hospital composite occurrence of death, myocardial infarction, and urgent target vessel revascularization was 5.4%, and Thrombolysis In Myocardial Infarction (TIMI) major bleeding, minor bleeding, and any reported bleeding occurred in 0.2%, 1.3%, and 7.9% of patients, respectively. No significant association between procedural ENOX times and ischemic events was observed (p = 0.222), although the event rate was 4.0% among those with ENOX times between 250 to 450 s versus 7.2% for those outside this range (p = 0.134). Increasing ENOX time at sheath removal was correlated with any bleeding (p = 0.010) with a 1% increase for every approximately 30-s rise. CONCLUSIONS: Ischemic events were infrequent, and the rate appeared lowest in the mid-range of ENOX times. Bleeding events increased with increasing ENOX times. These observations, combined with a suggested procedural anti-Xa level of 0.8 to 1.8 IU/ml, translate into a recommended ENOX time range of 250 to 450 s for PCI and <200 to 250 s for sheath removal.

Transradial management of saphenous vein bypass graft disease using rheolytic thrombectomy and coronary stenting.

We report a case of successful treatment of a severely diseased saphenous vein graft from the transradial approach. Initial rheolytic thrombectomy was performed followed by coronary stenting through a 6 French guide catheter. Continuing miniaturization of interventional devices increases the utility of the transradial approach.

Skin to Skin: Transradial Carotid Angiography and Stenting.

Carotid artery stenting (CAS) is a proven alternative to carotid endarterectomy in patients with significant carotid disease. The femoral artery is the conventional access site for CAS procedures. However, this approach may be problematic because of peripheral vascular disease and anatomic variations. Access site complications are the most common adverse event after CAS from the transfemoral approach (TFA) and most technical failures are related to a complex aortic arch. The transradial approach has been evaluated to address the shortcomings of TFA. In cases involving a complex arch, transradial access may be a viable alternative strategy.

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.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Meta-analysis comparing bivalirudin versus heparin monotherapy on ischemic and bleeding outcomes after percutaneous coronary intervention.

With femoral access, bivalirudin decreases risks of major bleeding after percutaneous coronary intervention (PCI) and provides better net clinical benefit compared to unfractionated heparin (UFH) plus planned glycoprotein IIb/IIIa inhibitors. Whether this benefit exists compared to UFH monotherapy is less clear. We performed a systematic review and meta-analysis to compare outcomes in patients undergoing transfemoral PCI with UFH or bivalirudin. Randomized trials (n = 3) and observational studies (n = 13) comparing bivalirudin to UFH monotherapy were reviewed. Primary outcomes were 30-day rates of major adverse cardiovascular events (MACEs) including death, myocardial infarction (MI), urgent revascularization, as well as all-cause mortality, MI, major bleeding, and blood transfusion. We collected data from 16 studies involving 32,492 patients undergoing PCI. Most observational studies were performed in the United States, whereas all randomized trials were done in Europe. Compared to UFH monotherapy, bivalirudin was associated with similar risk of MACEs (odds ratios [OR] 0.92, 95% confidence interval [CI] 0.75 to 1.12), a substantial 45% relative decrease in major bleeding (OR 0.55, 95% CI 0.43 to 0.72), and a trend in the decrease of transfusion (OR 0.87, 95% CI 0.70 to 1.08). A decrease in mortality was seen in observational studies (OR 0.62, 95% CI 0.45 to 0.85) but remained inconclusive in randomized trials (OR 0.63, 95% CI 0.20 to 2.01). MI rate was similar with the 2 anticoagulants. In conclusion, in patients undergoing transfemoral PCI, the benefit of bivalirudin over UFH monotherapy is driven by a significant decrease in major bleeding with similar rates of MACE. As PCI practice moves toward other bleeding-avoidance strategies such as the radial approach, future studies should focus on the interaction between anticoagulant strategy and access-site choice.

Systemic hypothermia to prevent radiocontrast nephropathy (from the COOL-RCN Randomized Trial).

Radiocontrast nephropathy (RCN) develops in a substantial proportion of patients with chronic kidney disease (CKD) after invasive cardiology procedures and is strongly associated with subsequent mortality and adverse outcomes. We sought to determine whether systemic hypothermia is effective in preventing RCN in patients with CKD. Patients at risk for RCN (baseline estimated creatinine clearance 20 to 50 ml/min) undergoing cardiac catheterization with iodinated contrast ≥50 ml were randomized 1:1 to hydration (control arm) versus hydration plus establishment of systemic hypothermia (33°C to 34°C) before first contrast injection and for 3 hours after the procedure. Serum creatinine levels at baseline, 24 hours, 48 hours, and 72 to 96 hours were measured at a central core laboratory. The primary efficacy end point was development of RCN, defined as an increase in serum creatinine by ≥25% from baseline. The primary safety end point was 30-day composite rate of adverse events consisting of death, myocardial infarction, dialysis, ventricular fibrillation, venous complication requiring surgery, major bleeding requiring transfusion ≥2 U, or rehospitalization. In total 128 evaluable patients (mean creatinine clearance 36.6 ml/min) were prospectively randomized at 25 medical centers. RCN developed in 18.6% of normothermic patients and in 22.4% of hypothermic patients (odds ratio 1.27, 95% confidence interval 0.53 to 3.00, p = 0.59). The primary 30-day safety end point occurred in 37.1% versus 37.9% of normothermic and hypothermic patients, respectively (odds ratio 0.97, 95% confidence interval 0.47 to 1.98, p = 0.93). In conclusion, in patients with CKD undergoing invasive cardiology procedures, systemic hypothermia is safe but is unlikely to prevent RCN.

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.

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.

A prospective evaluation of the safety and efficacy of TAXUS Element paclitaxel-eluting coronary stent implantation for the treatment of de novo coronary artery lesions in small vessels: the PERSEUS Small Vessel trial.

AIMS: Small reference vessel diameter predicts adverse outcomes following coronary stenting. TAXUS Express and TAXUS Liberté paclitaxel-eluting stents (PES) reduce restenosis compared to bare metal stents (BMS) in small diameter vessels. TAXUS Element is a novel thin-strut, platinum chromium stent designed to enhance visibility, conformability, and drug delivery in small diameter vessels. METHODS AND RESULTS: The PERSEUS Small Vessel (SV) prospective, single-arm, superiority trial evaluates the TAXUS Element PES in 224 subjects with target lesion length≤20 mm and vessel diameter≥2.25 to <2.75 mm, compared to 125 lesion-matched historical Express BMS control subjects from the TAXUS V trial. The primary endpoint was nine-month in-stent late loss. The secondary endpoint was 12-month target lesion failure (TLF) compared to a pre-specified performance goal (PG). Outcomes were analysed with and without propensity-score adjustment. TAXUS Element was superior to the Express BMS for late loss (0.38±0.51 versus 0.80±0.53 mm respectively; P<0.001), and TLF (7.3%) was significantly less than the 19.5% PG (P<0.001). No differences in mortality, myocardial infarction, or stent thrombosis were observed through 12 months. Results were similar after adjustment. CONCLUSIONS: PERSEUS SV supports the efficacy and safety of the platinum chromium, thin-strut TAXUS Element stent in small coronary vessels.

Transradial approach for coronary angiography and interventions: results of the first international transradial practice survey.

OBJECTIVES: The aim of this study was to evaluate practice of transradial approach (TRA). BACKGROUND: TRA has been adopted as an alternative access site for coronary procedures. METHODS: A questionnaire was distributed worldwide with Internet-based software. RESULTS: The survey was conducted from August 2009 to January 2010 among 1,107 interventional cardiologists in 75 countries. Although pre-TRA dual hand circulation testing is not uniform in the world, >85% in the U.S. perform Allen or oximetry testing. Right radial artery is used in almost 90%. Judkins catheters are the most popular for left coronary artery angiographies (66.5%) and right coronary artery angiographies (58.8%). For percutaneous coronary intervention (PCI), 6-F is now standard. For PCI of left coronary artery, operators use standard extra back-up guiding catheters in >65% and, for right coronary artery 70.4% use right Judkins catheters. Although heparin remains the routine antithrombotic agent in the world, bivalirudin is frequently used in the U.S. for PCI. The incidence of radial artery occlusion before hospital discharge is not assessed in >50%. Overall, approximately 50% responded that their TRA practice will increase in the future (68.4% in the U.S.). CONCLUSIONS: TRA is already widely used across the world. Diagnostic and guiding-catheters used for TRA remain similar to those used for traditional femoral approach, suggesting that specialized radial catheters are not frequently used. However, there is substantial variation in practice as it relates to specific aspects of TRA, suggesting that more data are needed to determine the optimal strategy to facilitate TRA and optimize radial artery patency after catheterization.

Long-term safety and efficacy with paclitaxel-eluting stents: 5-year final results of the TAXUS IV clinical trial (TAXUS IV-SR: Treatment of De Novo Coronary Disease Using a Single Paclitaxel-Eluting Stent).

OBJECTIVES: The pivotal TAXUS IV (TAXUS IV-SR: Treatment of De Novo Coronary Disease Using a Single Paclitaxel-Eluting Stent) trial evaluated the long-term safety and effectiveness of the paclitaxel-eluting stent (PES) compared with an otherwise identical bare-metal stent (BMS) in a relatively uncomplicated population of patients with a single de novo lesion in a native coronary vessel, treated between March and July 2002. BACKGROUND: Long-term follow-up is required to determine whether the early safety and efficacy of drug-eluting stents are maintained. METHODS: The primary end point of this prospective, randomized, double-blind trial was 9-month ischemia-driven target vessel revascularization (TVR) for PES versus the BMS control. Follow-up was complete in 1,230 (95.1%) of 1,294 randomized evaluable patients at 5 years. RESULTS: Compared with BMS, PES significantly reduced TVR at 9 months (12.1% vs. 4.7%; p < 0.0001); this benefit was maintained through 5 years (27.4% vs. 16.9%; p < 0.0001), given comparable TVR rates for BMS and PES between years 1 and 5 (4.1%/year vs. 3.3%/year; respectively, p = 0.16). Similar patterns were observed for composite major adverse cardiac events (MACE) (32.8% BMS vs. 24.0% PES, p = 0.0001 at 5 years). Stent thrombosis was comparable for PES and BMS at 9 months (0.8% BMS vs. 0.8% PES; p = 0.98) and at 5 years (2.1% BMS vs. 2.2% PES, p = 0.87). The overall revascularization benefits of PES were consistent across multiple subgroups, including sex, diabetes, left anterior descending artery lesion location, reference vessel diameter, lesion length, and multiple stents. CONCLUSIONS: These 5-year results demonstrate the long-term safety and sustained efficacy of PES compared with BMS in patients with noncomplex lesions. (TAXUS IV-SR: Treatment of De Novo Coronary Disease Using a Single Paclitaxel-Eluting Stent; NCT00292474).

Choice of arterial access site and outcomes in patients with acute coronary syndromes managed with an early invasive strategy: the ACUITY trial.

AIMS: The purpose of this study was to evaluate the impact of arterial access site on bleeding and ischaemic outcomes, overall and by treatment strategy, in patients with acute coronary syndromes (ACS). METHODS AND RESULTS: In the ACUITY trial, 13,819 patients with moderate and high-risk ACS were randomised to either heparin (unfractionated or enoxaparin) plus a glycoprotein IIb/IIIa inhibitor (GPI), bivalirudin plus a GPI, or bivalirudin alone. Per operator choice, femoral access was utilised in 11,989 patients (93.8%) and radial access in 798 patients (6.2%). There was no significant difference in composite ischaemia between the radial and femoral approaches at 30 days (8.1% vs 7.5%, p=0.18) or 1 year (14.7% vs 15.5%, p=0.77), although fewer major bleeding complications occurred with the use of radial access (3.0%vs4.8%, p=0.03). Use of bivalirudin monotherapy was associated with significantly less 30-day major bleeding than heparin plus GPI after femoral access (3.0% vs 5.8%, p<0.0001), but not with radial access (4.2% vs 2.2%, P=0.19). Major or minor organ bleeding was reduced with bivalirudin monotherapy compared to heparin plus GPI to a similar extent with both femoral (4.1% vs 7.4%, P<0.0001) and radial (4.9% vs 7.2%, P=0.26) access. CONCLUSIONS: Transradial compared to femoral arterial access is associated with similar rates of composite ischaemia and with fewer major bleeding complications in patients with ACS managed invasively. Bivalirudin monotherapy compared to heparin plus GPIs significantly reduces access site related major bleeding complications with femoral but not radial artery access, though non-access site related bleeding is reduced by bivalirudin monotherapy in all patients.

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).

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.

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).

Late coronary stent infection: a unique complication after drug-eluting stent implantation.

A 75-year-old male developed late coronary stent infection with symptoms presenting months after the initial procedure. This presentation was notably different than that of other cases in the literature, which typically presented days to a few weeks after stent implantation. Persistently unendothelialized stent struts may be a nidus for late infection.

Transradial approach for carotid artery stenting: a feasibility study.

BACKGROUND: Carotid artery stenting (CAS) has become accepted as an alternative to carotid endarterectomy for revascularization of the internal carotid artery (ICA) among high risk patients. CAS from the femoral approach can be problematic due to access site complications as well as technical difficulties related to peripheral vascular disease (PVD) and/or anatomical variations of the aortic arch. The purpose of the present study is to evaluate the feasibility of the radial artery as an alternative approach for CAS. METHODS: Forty-two patients (mean age 71 +/- 1, 26 male) underwent CAS. All had a CA stenosis greater than 80% and comorbid conditions increasing the risk of carotid endarterectomy. The target common carotid artery (CCA) was initially cannulated via the radial artery using a 5F Simmons 1 diagnostic catheter which was then advanced to the external CA (ECA) over an extra support 0.014" coronary guidewire. After removing the coronary guidewire, a 0.035" guidewire was advanced into the ECA, and the Simmons 1 was exchanged for a 5F or 6F shuttle sheath and positioned in the distal CCA. In four patients with a bovine aortic arch, the left CCA was accessed with a 5F Amplatz R2 catheter which was then exchanged for a shuttle sheath over a 0.035" guidewire. CAS was performed using standard techniques with weight-based bivalirudin for anticoagulation. RESULTS: CAS was successful in 35/42 (83%) patients, including 28/29 (97%) right CA, 4/5 (80%) bovine left CA, 7/13 (54%) left CA. Mean interventional time was 30 +/- 3 minutes. The sheath was removed immediately after the procedure. There were no radial access site complications. One patient sustained a stroke 24 hrs after the procedure with complete resolution of symptoms (Mean NIH stroke scale 2.0 +/- 0.3 before, 1.9 +/- 0.3 after). Median hospital stay was 2 +/- 0.6 days. Inadequate catheter support at the origin of the CCA was the technical cause of failure in the seven unsuccessful cases. CONCLUSION: CAS using the transradial approach appears to be safe and technically feasible. The technique may be particularly useful in patients with right ICA lesions and severe PVD or unfavorable arch anatomy, and among patients with a bovine aortic arch.