EVToday News

Preliminary 30-Day
ARCHeR Trial Results Presented

At last month’s American College of Cardiology meeting in Chicago and the Society of Interventional Radiology meeting in Salt Lake City, the 30-day results for the ARCHeR (ACCULINK for Revascularization of Carotids in High Risk patients) trial were presented. The ARCHeR trial is a study designed to evaluate the safety and efficacy of carotid stenting as a minimally invasive alternative for treating carotid artery disease in patients who are ineligible for surgery or at high surgical risk.

Forty-one investigational sites enrolled 437 consecutive patients who underwent carotid artery stenting using the ACCULINK Carotid Stent System (Guidant Corporation, Indianapolis, IN); 278 of the patients were also treated with the ACCUNET Embolic Protection System (Guidant). Clinical follow-up visits were scheduled for 30 days, and every 6 months thereafter. The 30-day total major adverse event rate, which was defined as all-cause stroke, death, and myocardial infarction, was 7.8%. The stroke rate alone was 5.3%, 3.7% of which were minor strokes and 1.6% of which were major strokes. Device success for the ACCULINK stent, which was defined as successful deployment and less than 50% residual stenosis, was 97.8%. ACCUNET device success (delivery, placement, and retrieval) was 92.7%. All patients in the trial exhibited at least one risk factor that made them poor candidates for surgery, and 45% had two or more such factors.

Dr. Mark H. Wholey, ARCHeR’s coprincipal investigator, commented that the 30-day results are very promising. “We hope that when available, the long-term results of the ARCHeR study will establish less-invasive carotid stenting as an important therapy for this large group of patients suffering from carotid artery disease who are not well-treated by standard carotid surgery,” he said.

“Expedited Review” Status Granted to Boston Scientific’s TAXUS Drug-Eluting Stent

Boston Scientific Corporation (Natick, MA) received notification on March 13 from the FDA that its TAXUS paclitaxel-eluting coronary stent system had been granted “expedited review status.” This designation indicates that the device’s marketing application will receive priority review before other pending applications. According to Boston Scientific, the FDA’s notification stated that TAXUS may represent a “breakthrough technology” that offers an alternative to current FDA-approved technologies for treating coronary artery disease.

FDA Panel Unanimously Recommends Approval of Cook’s AAA Endograft

The FDA’s Public Advisory Circulatory System Devices Panel on April 10 unanimously recommended the approval of Cook Incorporated’s (Bloomington, IN) Zenith AAA Endovascular Graft System. The panel’s approval of the third-generation stent-graft system included conditions such as the exclusion of isolated iliac aneurysms from the indications for use and the establishment of a 5-year follow-up program for patients in the US pivotal trial of the device. The panel hearing featured a testimonial by former US Senator Bob Dole, who was treated with the Zenith device in June 2001.

Drug-Eluting Stent Trial Results Announced

Boston Scientific Corporation (Natick, MA), Guidant Corporation (Indianapolis, IN), and Cordis Corporation (a Johnson & Johnson company, Miami, FL), each presented clinical results for their respective drug-eluting stent platforms at the American College of Cardiology meeting last month in Chicago. Boston Scientific announced that 12-month follow-up data from its TAXUS II trial supported safety, as demonstrated by rates of MACE, specifically rates of target lesion revascularization. Clinicians reported that the benefits observed in patients who received a paclitaxel-eluting stent at 6 months were maintained at 12 months when compared to patients who received a bare metal stent.

Guidant announced 6-month results for the FUTURE I clinical trial that is evaluating the safety of an everolimus-eluting coronary stent utilizing a bioabsorbable drug-delivery coating versus a bare metal stent platform in de novo lesions. The company reports that follow-up analyses for patients in both the study and control groups demonstrated a significant reduction in lesion regrowth within the stent. Patients receiving the drug-eluting stent had a statistically significant reduction in percent neointimal volume at 6 months, compared to the control group, and no in-stent binary restenosis was observed in the study group.

Cordis reported long-term results from three clinical trials on the performance of its CYPHER Sirolimus-eluting Coronary Stent in patients with de novo coronary artery blockages. According to the company, the data show a significant and sustained benefit in reducing the need for reintervention in patients treated with the investigational stent versus conventional bare metal stents. The SIRIUS study, one of the three trials evaluating the CYPHER stent, reportedly showed minimal in-stent lumen loss (0.17 mm) at 8 months in patients treated with the drug-eluting stent. Additionally, the 3.2% rate of angiographic in-stent restenosis observed represents a 91% reduction versus the control arm. At 1 year, 91.7% of study-arm patients were reported to be free from death, MI, or retreatment, versus 77.4% in the control group. At 2 years, Cordis’ RAVEL trial reports 0% restenosis, 0% target lesion revascularization, 2.5% reintervention, and 0% thrombosis. Also announced were the 3-year follow-up data for the 30 patients enrolled in the original CYPHER pilot study in Sao Paolo, Brazil. Clinicians reported that there have been no new coronary events in the past year, and the results continue to hold with 93.3% event-free survival.

Vascular Architects’ Launches Its aSpire Covered Stent and Delivery System With a 15-cm Stent

After receiving FDA 510(k) clearance, Vascular Architects, Inc. (San Jose, CA), has announced the US release of its aSpire Covered Stent and Controlled Expansion Delivery System with a 15-cm-long stent. The device is cleared in the United States for use in the treatment of tracheobronchial strictures produced by malignant neoplasms and for the treatment of benign strictures after all alternative therapies have been exhausted. The aSpire device is a spiral nitinol stent covered by a thin layer of PTFE, which the company states provides greater lumen wall coverage than metallic stents, with no exposed metal. This stent is currently available in lengths of 2.5 cm, 5.0 cm and 10 cm, and in diameters from 6 mm to 12 mm, and will now also be available in 15 cm length in both 6 mm and 7 mm diameters.

CryoVascular Reports Promising Interim Results for PolarCath With CryoPlasty System

At last month’s Society of Interventional Radiology meeting in Salt Lake City, CryoVascular Systems (Los Gatos, CA) announced the interim results of a multicenter study evaluating the PolarCath System with CryoPlasty. The system is designed to open blocked blood vessels by cooling and dilating them. At 9 months after treatment with CryoPlasty, 38 of 45 treated lesions (85%) in 45 patients remained open. “About 40% of patients treated with angioplasty or stenting need to be treated again, or revascularized, within a year,” comments John R. Laird, MD, Director of Peripheral Vascular Interventions at the Cardiovascular Research Institute in Washington, DC. “The CryoPlasty revascularization rate is 15%, which is a significant improvement.”