News from the Transcatheter Cardiovascular Therapeutics Meeting (TCT): Part II

continued from previous page Heartlab Provides Global DICOM Connectivity for the 2004 TCT Conference Hospital sites performing live cases utilize Heartlab’s CardioNow DICOM study-sharing software to electronically transfer cases to the Washington Convention Center. Heartlab’s CardioNow web-based technology for DICOM study sharing was utilized during the 2004 TCT conference to connect sites broadcasting live cases from around the world with conference attendees in Washington, D.C. One of the most anticipated events of this conference was the live case sessions that involved the broadcasting of interventional studies from leading cardiovascular centers around the world. This year, twenty-five sites from countries including France, Germany, Korea and the United States, performed live cases that were simultaneously broadcast to conference attendees. Post-procedure, sites broadcasting live cases utilized Heartlab’s CardioNow WebSend PC-based DICOM study-sharing software to electronically transfer complete angiograms of studies performed at their site to the Washington Convention Center. Studies were then able to be reviewed in native DICOM format, via Heartlab Encompass review stations at the Heartlab booth or via standard PCs with Internet access. The technology enabled attendees to review, discuss and analyze complete cases they may have missed during concurrent live sessions. Guidant Announces Plans to Initiate Vulnerable Plaque Study Guidant Corporation plans to conduct a study designed to increase clinical understanding of vulnerable plaques that may cause most heart attacks. The study will include 700 acute coronary syndrome patients receiving stents in the United States and Europe. The study, called PROSPECT (Providing Regional Observations to Study Predictors of Events in the Coronary Tree), will utilize intravascular imaging technology from Volcano Therapeutics, Inc. to collect data about characteristics of lesions not causing symptoms at the time of treatment. The study will correlate lesion characteristics, patient risk factors and biomarker measurements with subsequent heart attacks and other cardiac events, potentially paving the way for physicians to identify and treat at-risk patients before a heart attack occurs. "Guidant is initiating the first prospective natural history study that will provide highly anticipated data to help further the search for evidence-based clinical assessment of patient risk," said principal investigator Gregg W. Stone, MD, Professor of Medicine at Columbia University Medical Center. Dr. Stone presented the trial design at TCT. Spectranetics Products Featured in Live Case Sessions at TCT Spectranetics Corporation announced that its products were used in two separate live case sessions at the TCT, attended by more than 9,000 physicians. The first live case session featured a 2.3 millimeter diameter CLiRpath® excimer laser catheter recently cleared in the United States by the Food and Drug Administration to treat a total occlusion in the popliteal artery of the leg. The blockage was successfully treated by Professor Giancarlo Biamino, MD and Dierk Schienert, MD of Leipzig Heart Center in Leipzig, Germany. Dr. Biamino pioneered the use of laser technology for the treatment of peripheral vascular disease and has performed more than 5,000 peripheral cases utilizing the excimer laser system. The second live case featured a patient with a chronic total occlusion (CTO) in the left anterior descending (LAD) coronary artery that was successfully crossed using a Prima® Laser Wire and a Quick-Cross® support catheter. The female patient treated had triple-vessel disease, with the target lesion having previously failed crossing attempts with mechanical wires. Jaap N. Hamburger, MD, PhD, of Vancouver General Hospital, British Columbia, performed the successful crossing of the CTO, which was approximately 20 millimeters in length, in roughly 10 minutes. Siemens Technology Offers 3D Visualization of Coronary Vessels The Angiography and X-ray Division of Siemens Medical Solutions announced Interventional Cardiac 3D (IC3D) technology to create three dimensional (3D) images of the coronary vessels in the heart. When paired with an AXIOM Artis imaging system from Siemens, IC3D allows cardiologists to view the coronaries in 3D with as few as two images, leading to great precision in determining appropriate stent size and length, faster examination times, the use of less contrast medium and lower radiation dosages. "The IC3D technology has definitely enhanced digital imaging by allowing cardiologists to view 3D images of coronary and peripheral arteries, helping to achieve optimal diagnostic and interventional outcomes for our patients," said Neal Kleiman, MD, medical director of the catheterization lab at the Methodist DeBakey Heart Center in Houston. "The system has proven to be an excellent tool for quality patient evaluation and accurate determination of appropriate stent size and placement." Cordis Announces First Patient Enrolled in Surveillance Study of Carotid Artery Stenting System Cordis Endovascular, a division of Cordis Corporation, a Johnson & Johnson company, announced that a patient in Newport Beach, California is the first to enroll in the company’s surveillance study of its carotid artery stenting system for treatment of patients with carotid artery disease at high-risk for adverse events from carotid endarterectomy. "Through this surveillance study we seek to corroborate findings of the landmark SAPPHIRE study, the only randomized clinical trial conducted to validate the potential of carotid artery stent placement in high surgical-risk patients," said Subbarao Myla, MD, Medical Director, Cardiovascular Research and Vascular Interventions, Hoag Memorial Hospital Presbyterian, Newport Beach, CA. "We are proud to be the first center to enroll a patient in this study." The launch of this study follows the approvable letter that Cordis received in August from the U.S. Food and Drug Administration (FDA) for the Cordis Precise® Emboli Capture Guidewire System, the second component of the Cordis Carotid System, under a 510K process. The company is currently working with the FDA to fulfill requirements for final marketing approval of Cordis Precise and Cordis Angioguard. The FDA granted permission to Cordis Endovascular to initiate a surveillance study that will provide ongoing data about the carotid stenting procedure. When fully implemented, the surveillance study will enroll 1,500 patients at 112 sites in the United States. These centers are being selected based on criteria agreed upon by the FDA and will represent a cross section of physicians who will be performing the procedure. As part of the surveillance study, the FDA also granted permission to Cordis Endovascular to launch its comprehensive training program for physicians and other relevant healthcare professionals called CASES (Cordis Carotid Artery Stenting Education System). This training will include didactic review, case observations and simulation training, and hands-on experience at a one of the Regional Education Centers across the country. "Cordis CASES was developed by multiple thought-leaders in the industry and was reviewed by the FDA and the Center for Medicaid/Medicare Services (CMS)," said Dennis Donohoe, MD, Vice President, Clinical and Regulatory Affairs, Cordis Endovascular. In addition to clinical outcomes, the surveillance study will serve to validate the CASES program. Beyond the company’s clinical commitment to this field, Cordis worked to gain reimbursement for the carotid artery system procedure. CMS accepted the Cordis request to remove the National Non-Coverage Policy for the procedure, and this process is now underway. Initial Results Presented for the RULE-Carotid and RULE-SVG Europe Clinical Study of the Rubicon Filter Rubicon Medical Corporation announced that the adverse event rate 30 days following the procedures involving 51 initial patients enrolled in its RULE-Carotid, Europe study of the Rubicon Filter was 6.1 percent, an announcement made in connection with the TCT 2004 conference, in Washington, D.C. The RULE-Carotid study involved the testing of the Rubicon Filter, a distal embolic protection device, specifically in carotid arteries. The studies were performed by cardiologists at three hospitals in Germany, with Prof. Dr. Joachim Schofer, co-founder of the Center of Cardiology and Vascular Intervention in Hamburg, Germany, serving as the principal investigator. The RULE-SVG, Europe study involved the testing of the Rubicon Filter in both saphenous vein grafts (SVGs) and native coronary arteries including high-risk stenting procedures. The studies were performed by cardiologists at four hospitals in Germany and one hospital in Italy, with many of the studies being conducted by Dr. Eberhard Grube, principal investigator for the study and chief of interventional cardiology at Heart Centrum Siegburg in Siegburg, Germany. The major adverse cardiac event (MACE) rate 30 days following the procedures involving 44 initial patients enrolled in its RULE-SVG, Europe study was 4.5 percent. The constraint and remote actuating technology (Carat) platform allows Rubicon Medical to externally constrain the filter portion of the Rubicon Filter on its guidewire and to deploy the filter without the use of a delivery catheter. As a result, the Rubicon Filter is designed with an ultra-low crossing profile. Rubicon received approval for up to 60 patients in the RULE-Carotid, Europe clinical study and will continue to collect data on additional patients. The company plans to use the collected data to generate the necessary reports as part of the clinical study protocol and file for regulatory approval for marketing clearance for the Rubicon Filter and its use in carotid arteries in Europe. It is currently expected that CE Mark clearance for use in carotid arteries will be obtained in 2004. The Rubicon Filter is a guidewire-based filter that is deployed without the use of a catheter. Rubicon believes the Rubicon Filter is the world’s smallest-profile embolic filtration device. Guidant Reports Positive Six-Month Results from the SPIRIT FIRST Everolimus Eluting Coronary Stent Trial Guidant Corporation announced positive six-month adjudicated results from the company’s 60-patient SPIRIT FIRST study. SPIRIT FIRST is a prospective, randomized, single-blind trial evaluating Guidant’s Multi-Link Vision®-based everolimus eluting coronary stent system utilizing a durable polymer versus an uncoated Multi-Link Vision Coronary Stent System control in de novo lesions. Angiographic in-stent late loss at six months, the study’s primary endpoint, was 0.10 mm for the Multi-Link Vision-based everolimus-eluting stent system and 0.84 mm for the control arm. The in-stent angiographic binary restenosis rate for the everolimus-eluting stent arm was 0 percent. The six-month MACE rate for the everolimus eluting stent was 7.7 percent, and there were no new MACE events between 30 days and six months. As defined in SPIRIT FIRST, the MACE rate includes any deaths, heart attacks or clinically driven target lesion revascularizations within the six-month period. These results are consistent with the outstanding results from the FUTURE I and FUTURE II clinical trials utilizing a stainless steel stent platform with everolimus and a bioabsorbable polymer. Additional angiographic, intravascular ultrasound and clinical data will be presented after the completion of one year of follow-up. Pharmacyclics Announces Data From Phase 1 Clinical Trial of Antrin® Phototherapy Phase 1 trial results describing the use of Antrin® (motexafin lutetium) phototherapy for the treatment of coronary atherosclerosis were presented by Dr. Alan Yeung at TCT 2004. The presentation included data from intravascular ultrasound (IVUS) imaging studies showing that Antrin prevented plaque build-up following balloon angioplasty and stent placement in patients receiving optimum doses of drug and light therapy. Angiographic data from the Phase 1 study, published in the September 16, 2003 issue of Circulation, provided initial evidence of the safety and feasibility of Antrin phototherapy in patients undergoing balloon angioplasty with stent deployment. The current study, reported at TCT, presented quantitative and qualitative results from IVUS imaging studies and represents the first observations detailing the morphological changes of the coronary arterial wall subjected to phototherapy with various doses of Antrin and light. "Antrin phototherapy is safe and feasible as an adjunctive therapy after coronary stenting in patients with coronary artery disease," stated Dr. Yeung, division head of Cardiovascular Medicine and Professor at Stanford University and one of the investigators on the trial. "One study cohort showed suppression of plaque volume increase using an optimal drug-light regimen. The potential of this dose combination for atraumatic stabilization of vulnerable plaque should be further evaluated in a randomized controlled study to determine clinical efficacy." During the open label multi-center drug and light dose escalation study, Antrin was administered intravenously to 79 patients 18-24 hours prior to balloon angioplasty and stent insertion for coronary atherosclerosis. Intravascular photoactivation of Antrin was accomplished using an optical fiber inserted into the coronary artery at the time of balloon angioplasty. In a sub-study involving 39 patients, careful qualitative and quantitative IVUS imaging was performed immediately after the procedure and at six months follow-up. Analysis of the IVUS data was based on serial slices through the treated arterial segment and untreated boundaries. The design of the trial was based on preclinical studies, which suggest that Antrin may localize to plaque, prevent cell proliferation following arterial injury, selectively deplete macrophages (inflammatory cells) from plaque, and cause regression in plaque volume without damaging the vascular wall. The IVUS analysis provided additional data that suggests Antrin does not have deleterious effects on the vessel wall. In the group of patients (N=7) receiving 2-4 mg/kg of Antrin and 100 Joules of light, no atherosclerotic plaque volume increase was observed at the stented site at six month follow-up (average plaque area 8.01+/-4.33mm2 post stent to 7.86+/-3.24mm2 at six months, not significant, P=0.79). Statistically significant plaque volume increases were observed in the stented arterial segments in the two other patient cohorts receiving lower doses of Antrin (0-1.0 mg/kg, N=9, average plaque area 6.59+/-2.28 mm2 post stent to 7.17+/-2.47mm2 at six months, P=0.028) and higher doses of light (200-600 Joules, N=23, average plaque area 7.76+/-3.70mm2 post stent to 8.91+/-3.87mm2 at six months, P

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