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Objectives: The multicenter, single-arm BEACH (Boston Scientific EPI: A Carotid Stenting Trial for High-Risk Surgical Patients) evaluated outcomes in high-surgical-risk patients with carotid artery stenosis treated with the Carotid WALLSTENT plus FilterWire EX/EZ Emboli Protection System (Boston Scientific, Natick, Massachusetts). Background: Carotid artery stent (CAS) placement offers a less invasive alternative for high-risk surgical carotid endarterectomy (CEA) patients. Methods: The trial enrolled 480 pivotal patients who were candidates for carotid revascularization but considered high surgical risk due to pre-specified anatomic criteria and/or medical comorbidities. The primary end point (all stroke, death, or Q-wave myocardial infarction [MI] through 30 days; non-Q-wave MI through 24 h; and ipsilateral stroke or neurologic death through 1 year) was compared with a proportionally weighted objective performance criterion (OPC) of 12.6% for published surgical endarterectomy results in similar patients, plus a pre-specified noninferiority margin of 4%. Results: Among pivotal patients, 41.2% were at high surgical risk due to comorbid risk factors, and 58.8% due to anatomic risk factors; 76.7% were asymptomatic with flow-limiting carotid stenosis >80%. At 1 year, the composite primary end point occurred in 8.9% (40 of 447), with a repeat revascularization rate of 4.7%. With an upper 95% confidence limit of 11.5% for the primary composite end point, the BEACH trial results met the pre-specified criteria for noninferiority relative to the calculated OPC plus noninferiority margin (16.6%) for historical surgical CEA outcomes in similar patients (p < 0.0001 for noninferiority). Conclusions: The BEACH trial results demonstrate that CAS with the WALLSTENT plus FilterWire embolic protection is non-inferior (equivalent or better than) to CEA at 1-year in high-surgical-risk patients (Boston Scientific Embolic Protection, Inc. [EPI]: A Carotid Stenting Trial for High-Risk Surgical Patients [BEACH]; http://clinicaltrials.gov/ct2/show/NCT00316108?term=NCT00316108r NCT00316108).

Objectives We report intravascular ultrasound (IVUS) findings after crush-stenting of bifurcation lesions. Background Preliminary results with the crush-stent technique are encouraging; however, isolated reports suggest that restenosis at the side branch (SB) ostium continues to be a problem. Methods Forty patients with bifurcation lesions underwent crush-stenting with the sirolimus-eluting stent. Postintervention IVUS was performed in both branches in 25 lesions and only the main vessel (MV) in 15 lesions; IVUS analysis included five distinct locations: MV proximal stent, crush area, distal stent, SB ostium, and SB distal stent. Results Overall, the MV minimum stent area was larger than the SB (6.7 ± 1.7 mm2vs. 4.4 ± 1.4 mm2, p 60% of non-left main lesions. Conclusions In the majority of bifurcation lesions treated with the crush technique, the smallest minimum stent area appeared at the SB ostium. This may contribute to a higher restenosis rate at this location.

ObjectivesWe evaluated the long-term influence of intramural delivery of advanced c-myc neutrally charged antisense oligonucleotides (Resten-NG) on neointimal hyperplasia after stenting in a pig model.BackgroundNeointimal hyperplasia after percutaneous coronary interventions is one of the key components of the restenotic process. The c-myc is a critical cell division cycle protein involved in the formation of neointima.MethodsIn short-term experiments, different doses (from 500 μg to 5 mg) of Resten-NG or saline were delivered to the stent implantation site with an infiltrator delivery system (Interventional Technologies, San Diego, California). Animals were euthanized at 2, 6 and 18 h after interventions, and excised vessels were analyzed for c-myc expression by Western blot. In long-term experiments, either saline or a dose of 1, 5 or 10 mg of Resten-NG was delivered in the same fashion, and animals were euthanized at 28 days after the intervention.ResultsWestern blot analysis demonstrated inhibition of c-myc expression and was dose dependent. Morphometry showed that the intimal area was 3.88 ± 1.04 mm2in the control. There was statistically significant reduction of intimal areas in the 5 and 10 mg groups (2.01 ± 0.66 and 1.95 ± 0.91, respectively, p < 0.001) but no significant reduction in the 1 mg group (2.81 ± 0.56, p > 0.5) in comparison with control.ConclusionsThis study demonstrated that intramural delivery of advanced c-myc neutrally charged antisense morpholino compound completely inhibits c-myc expression and dramatically reduces neointimal formation in a dose dependent fashion in a porcine coronary stent restenosis model, while allowing for complete vascular healing.

The multicenter, single-arm BEACH (Boston Scientific EPI: A Carotid Stenting Trial for High-Risk Surgical Patients) evaluated outcomes in high-surgical-risk patients with carotid artery stenosis treated with the Carotid WALLSTENT plus FilterWire EX/EZ Emboli Protection System (Boston Scientific, Natick, Massachusetts).Carotid artery stent (CAS) placement offers a less invasive alternative for high-risk surgical carotid endarterectomy (CEA) patients.The trial enrolled 480 pivotal patients who were candidates for carotid revascularization but considered high surgical risk due to pre-specified anatomic criteria and/or medical comorbidities. The primary end point (all stroke, death, or Q-wave myocardial infarction [MI] through 30 days; non-Q-wave MI through 24 h; and ipsilateral stroke or neurologic death through 1 year) was compared with a proportionally weighted objective performance criterion (OPC) of 12.6% for published surgical endarterectomy results in similar patients, plus a pre-specified noninferiority margin of 4%.Among pivotal patients, 41.2% were at high surgical risk due to comorbid risk factors, and 58.8% due to anatomic risk factors; 76.7% were asymptomatic with flow-limiting carotid stenosis80%. At 1 year, the composite primary end point occurred in 8.9% (40 of 447), with a repeat revascularization rate of 4.7%. With an upper 95% confidence limit of 11.5% for the primary composite end point, the BEACH trial results met the pre-specified criteria for noninferiority relative to the calculated OPC plus noninferiority margin (16.6%) for historical surgical CEA outcomes in similar patients (p0.0001 for noninferiority).The BEACH trial results demonstrate that CAS with the WALLSTENT plus FilterWire embolic protection is non-inferior (equivalent or better than) to CEA at 1-year in high-surgical-risk patients.

OBJECTIVES The aim of this study was to evaluate the feasibility and safety of carotid artery stenting (CAS) with a filter protection system. BACKGROUND Neurologic events linked to the embolization of particulate matter to the cerebral circulation may complicate CAS. Strategies designed to capture embolic particles during carotid intervention are being evaluated for their efficacy in reducing the risk of these events. METHODS Between September 1999 and July 2001, a total of 162 patients (164 hemispheres) underwent CAS with filter protection (NeuroShield, MedNova Ltd., Galway, Ireland) according to prospective protocols evaluating the filter system at three institutions. RESULTS Angiographic success was achieved in 162 of the procedures (99%) and filter placement was successful in 154 (94%) procedures. Carotid access was unsuccessful in two cases (1%) and filter placement in eight cases (5%). Of the latter, five procedures were completed with no protection and three were completed using alternative protection devices. On an intention-to-treat basis, the overall combined 30-day rate of all-stroke and death was 2% (four events: two minor strokes and two deaths). This includes one minor stroke in a patient with failed filter placement and CAS completed without protection. There was one cardiac arrhythmic death and one death from hyperperfusion-related intracerebral hemorrhage. There were no major embolic strokes. CONCLUSIONS Carotid artery stenting with filter protection is technically feasible and safe. Early clinical outcomes appear to be favorable and need to be confirmed in a larger comparative study.

PTA of the carotid and vertebral arteries remains a challenging area of vascular intervention and optimal techniques have yet to be determined. We describe our initial experience with a novel approach to carotid PTA utilizing: 1) “active” perfusion, as is done during coronary angioplasty, which allows prolonged balloon inflations without cerebral ischemia; 2) transcranial doppler (TCD) monitoring, when anatomically feasible, during PTA to assess antegrade flow and detect cerebral emboli; 3) temporary pacing for bradycardia during intra-Carotid balloon inflation; and 4) magnetic resonance angiography (MRA) for screening and follow-up. We have also used the previously described “protected” carotid PTA technique using an additional occluding balloon to prevent cerebral emboli. Six symptomatic patients had 7 PTAs (6 carotids, 1 vertebral). Pt. # Angioplasty Technique Transcrania Doppler StenosisPre→Post Complications Stenosis 3m. F/U 1 Protected 73 emboli 90%→20% none 10% 2 Protected 40 emboli 90%→0% none 0% 3 Active Perf. no window 95%→0% none 0% 4 Active Perf. 10 emboli 99%→0% none 0% 5 Active Perf. no window 99%→0% hemorrh→death 6 Standard no window 100%→30%→ none pending (vertebral) stent→0% Active Perf. 70%→dissec, none pending (carotid) 20%→stent→0% Maintenance of cerebral perfusion during PTA by “active” perfusion and cardiac pacing allows prolonged balloon inflations which minimize residual stenosis; when feasible, TCD monitoring is a valuable adjunct. Ongoing studies with more patients will elucidate the value of this approach for carotid angioplasty.

In an effort to maximize the acute gain in luminal dimensions following stent deployment, high pressure (12–16 bar) inflations within the stented segments were performed using a non compliant balloon. Stents were deployed at pressures just enough to completely expand the highly compliant stent balloon (4–6 bar). Using intravascular ultrasound (IVUS) luminal diameters in major and minor axis and luminal cross sectional area (CSA) at the narrowest segment within the stent were assessed before and after high pressure balloon inflation(s) (30 MHz; CVIS). The results in 16 patients receiving 19 stents for acute or threatened closure complicating PTCA are shown below (Mean ± S.D) Quantatitive angiographic analysis for each stent size group was performed using electronic digital calipers. Stent Size Inflation Pressure (ATM) Minor Axis (mm) Major Axis(mm) CSA (mm2) 3.0 mm LP 2.4 ± 0.20 2.67 ± 0.31 5.23 ± 1.30 (n = 5) HP 2.77 ± 0.11 2.97 ± 0.15 6.97 ± 0.42 3.5mm LP 2.6 ± 0.33* 2.75 ± 0.25* 6.65 ± 1.62* (n = 9) HP 2.9 ± 017 3.2 ± 0.14 8.40 ± 0.76 4.0 mm LP 3.0 ± 0.23* 3.3 ± 0.37* 8.34 ± 1.9* (n = 5) HP 3.6 ± 0.20 3.8 ± 0.25 11.44 ± 1.6 * P ≤ 0.05 by paired t test LP vs HP Full-size table Table options View in workspace Download as CSV There were no statistically significant angiographic differences before and after high pressure dilatations in all 3 stent size groups. Conclusions 1) The less than expected luminal diameter and cross sectional area following stent deployment at low pressures can be significantly improved by post deployment high pressure dilatation(s) with a non compliant balloon and should be incorporated into the stent deployment protocol. 2) Luminal improvement after high pressure inflation is not recognized by conventional angiography.