A randomized comparison of a novel bioabsorbable vascular closure device versus manual compression in the achievement of hemostasis after percutaneous femoral procedures: the ECLIPSE (Ensure's Vascular Closure Device Speeds Hemostasis Trial).

OBJECTIVES: This trial compared the performance of a novel bioabsorbable vascular closure device (VCD) versus manual compression (MC) for access site hemostasis in patients undergoing percutaneous trans-femoral coronary or peripheral procedures. BACKGROUND: From a patient's perspective, access site management after percutaneous procedures remains challenging. METHODS: Patients enrolled in this multicenter, nonblinded trial underwent 6-F diagnostic or interventional procedures were randomly assigned 2:1 to VCD versus MC. The primary efficacy end points were time to hemostasis (TTH) and time to ambulation (TTA), and the primary safety end points were periprocedural and 30-day incidence of arterial access-related complications. RESULTS: The trial assigned 401 patients (mean age 62.7 +/- 10.9 years, 66.1% men) to VCD (n = 267) versus MC (n = 134) after 87 "roll-in" patients treated at 17 participating institutions. The baseline characteristics of the groups were similar. Procedural success was 91.8% in the VCD versus 91.0% in the MC group (p = NS). Mean TTH was 4.4 +/- 11.6 min in the VCD versus 20.1 +/- 22.5 min in the MC group (95% confidence interval: 19.0 to 12.3; p < 0.0001). Likewise, TTA was significantly shorter in the VCD (2.5 +/- 5.0 h) than in the MC (6.2 +/- 13.3 h) group (95% confidence interval: 5.5 to 1.9; p = 0.0028). No patient died or suffered a major access-site-related adverse event. Minor adverse events were few among all study groups. CONCLUSIONS: After 6-F percutaneous invasive procedures, TTH and TTA were both significantly shorter in patients assigned to VCD than in patients managed with MC. The 30-day rates of access-site-related complications were remarkably low in all groups. (Safety and Effectiveness Study of the Ensure Medical Vascular Closure Device; NCT00345631).

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.

Safety and efficacy of the 2.25-mm sirolimus-eluting Bx Velocity stent in the treatment of patients with de novo native coronary artery lesions: the SIRIUS 2.25 trial.

Smaller reference vessel diameter is a recognized determinant of in-stent restenosis. The SIRIUS 2.25 trial was a prospective, nonrandomized study including 100 patients (mean age 63.4 years; 64% men, 40% with diabetes mellitus) assessing the safety and efficacy of the 2.25-mm sirolimus-eluting Bx Velocity stent in patients with de novo native coronary lesions. Using propensity score matching for gender, diabetes mellitus, left anterior descending artery target vessel, lesion length, and reference vessel diameter, the outcomes were compared with historical control groups (angioplasty and Palmaz-Schatz stent arms from the STRESS/BENESTENT I/II trials and the Bx Velocity bare metal stent arm from the RAVEL and SIRIUS trials having a reference vessel diameter <3 mm). Use of the 2.25-mm sirolimus-eluting Bx Velocity stent was associated with a high rate of procedural success (97%) and a low rate of in-hospital major adverse cardiac events (2%). The primary end point, 6-month in-lesion binary angiographic restenosis, occurred less frequently in patients treated with the 2.25-mm sirolimus-eluting Bx Velocity stent than in each of 3 historical controls (16.9% vs 30.6%, p = 0.12; 36.5%, p <0.001; 45.9%, p <0.001, respectively). This translated into lower rates of 6-month target lesion revascularization in the 2.25-mm sirolimus-eluting Bx Velocity stent group (4.0% vs 15.0% in each of 3 control groups, p = 0.01 to <0.001). By multivariate analysis, in-lesion binary restenosis was predicted by multiple implanted stents (odds ratio 10.4, p = 0.002). Four of 13 patients who developed restenosis (30.8%) had a diffuse pattern of restenosis. In the long lesion tertile (mean lesion length 19.5 mm), the in-lesion binary restenosis rate was 27.6%. In conclusion, use of the 2.25-mm sirolimus-eluting Bx Velocity stent was safe and provided favorable 6-month clinical outcomes. Use of multiple stents (in longer lesions) was an independent predictor of in-lesion restenosis.

Six-month outcomes after percutaneous intervention for lesions in aortocoronary saphenous vein grafts using distal protection devices: results from the FIRE trial.

BACKGROUND: The filter-based FilterWire EX (Boston Scientific, Natick, MA) embolic protection system and the GuardWire (Medtronic, Santa Rosa, CA) balloon occlusion and aspiration device have been previously shown to reduce periprocedural complication rates of percutaneous coronary intervention for saphenous vein graft (SVG) disease and are considered the standard of care in this setting. The late clinical course after treatment with these devices has not been reported. METHODS: In the FIRE trial, 651 patients undergoing SVG intervention were randomized to either the FilterWire EX or GuardWire. Six-month rates of the primary end point (composite major adverse cardiac events [MACE]) and its components (death, myocardial infarction [MI], or target vessel revascularization) were studied. RESULTS: MACE at 30 days occurred in 9.9% of patients randomized to the FilterWire EX compared with 11.6% with the GuardWire, P = .53. By 6 months, MACE had increased to 19.3% and 21.9% in FilterWire EX and GuardWire groups, respectively, (relative risk 0.88, 95% CI 0.65-1.19; P = .44). All-cause 6-month mortality in the entire population was 3.5% (3.0% with FilterWire EX vs 4.1% with GuardWire, P = .53, with all deaths occurring after hospital discharge). MI occurred in 12.0% of patients at 6 months (12.1% vs 11.9% with the FilterWire EX and GuardWire, respectively, P = .99), and target vessel revascularization was required in 9.1% (8.2% vs 10.0%, respectively, P = .42). CONCLUSIONS: SVG intervention with the FilterWire EX and GuardWire distal protection devices resulted in similar outcomes at 6 months, although the clinical course after hospital discharge was not benign, with significant rates of death, MI, and repeat intervention.

Influence of vessel diameter on the efficacy of distal protection devices during saphenous vein graft intervention.

We sought to determine the influence of vessel diameter on the efficacy of distal protection devices during saphenous vein graft intervention. From the Filterwire EX Randomized Evaluation trial, in which patients who underwent saphenous vein graft stenting were randomized to distal protection with the GuardWire or FilterWire EX, outcomes in 572 patients were examined in vessel size tertiles. The 30-day composite incidence of major adverse cardiac events (MACEs) increased with vessel size and was 6.9%, 9.7%, and 14.9% in the smallest, middle, and largest tertiles, respectively (p = 0.04). MACE rates were relatively vessel size independent for the GuardWire but increased steadily with vessel size with the FilterWire EX. In the smallest tertile, MACEs were reduced by 71% with the FilterWire EX compared with the GuardWire (p = 0.05), with the devices showing similar event rates in the other tertiles.

Randomized comparison of distal protection with a filter-based catheter and a balloon occlusion and aspiration system during percutaneous intervention of diseased saphenous vein aorto-coronary bypass grafts.

BACKGROUND: The high rate of periprocedural complications resulting from atherothrombotic embolization after percutaneous intervention in diseased saphenous vein grafts is reduced by distal microcirculatory protection using a balloon occlusion and aspiration system. Whether filter-based catheters, which offer the inherent advantages of maintained perfusion and ease of use, are as effective for this purpose has not been established. METHODS AND RESULTS: A total of 651 patients undergoing percutaneous intervention of 682 saphenous vein graft lesions were prospectively randomized to distal protection with the filter-based FilterWire EX versus the GuardWire balloon occlusion and aspiration system. Device success was 95.5% and 97.2% with the FilterWire EX and GuardWire, respectively (P=0.25). Postprocedural measures of epicardial flow and angiographic complications were similar between the 2 groups, although bailout IIb/IIIa inhibitors were required slightly less frequently in the FilterWire EX group (0% versus 1.5%, P=0.03). The primary end point, the composite incidence of death, myocardial infarction, or target vessel revascularization at 30 days, occurred in 9.9% of FilterWire EX patients and 11.6% of GuardWire patients (difference [95% CI]=-1.7% [-6.4%, 3.1%]; P for superiority=0.53, P for noninferiority=0.0008). CONCLUSIONS: Distal protection with the FilterWire EX may be safely used as an adjunct to percutaneous intervention of diseased saphenous vein grafts and, compared with distal protection with the GuardWire balloon occlusion and aspiration system, results in similar rates of major adverse cardiac events at 30 days.