NEW ORLEANS, Louisiana Even as Johnson & Johnson's (New Brunswick, New Jersey) Cordis (Miami Lakes, Florida) unit was rolling out results of a three-year trial of its Cypher drug-eluting stent (DES) during the American College of Cardiology meeting, another study was being reported comparing Cypher with another DES being used in Europe. Cardiologists who participated in a small European study comparing the Cypher with Boston Scientific's (Natick, New Jersey) Taxus DES system said there was "no significant difference" in the number of adverse events for patients in whom one or the other of the stents had been implanted. The admittedly small study involves 192 patients, 77 of whom have completed nine months following implantation of Cypher or Taxus stents. The 77 are nearly evenly divided between the two devices. Two of the patients with the Cordis stent had experienced a major cardiac event compared to five with the Boston Scientific product. One case of thrombosis occurred in a Taxus patient, the researchers said. No patient in either group died. The Cypher group had one incident of target lesion revascularization, while the Taxus group had two such cases.
In their report, the researchers said, "In this small sample size patient population treated in a real-life environment, no significant difference in the incidence of major adverse cardiac events between the sirolimus group and paclitaxel group could be demonstrated." Sirolimus is the drug that coats the Cypher stent, while paclitaxel is the drug coating for the Taxus device. Cordis has a much larger trial under way comparing the two stents. The REALITY study involves 1,386 patients at 90 centers in Europe, Asia and Latin America.
On the same day the European study results were reported, data from a three-year trial of the Cypher stent showed 85% of patients survived and did not suffer an adverse cardiac event compared with 77.1% in the control group. Cordis said that nine patients who received a Cypher stent died during the trial, compared with five in the control group, but most of those deaths were unrelated to a cardiac event and had nothing to do with the stent, the company said in its presentation. Over the three years of the trial, 95% of the patients who received a Cypher stent did not need target lesion revascularization, against 85.6% for the control group. However, four cases of revascularization in the Cypher patients occurred after the first year, while there were none after the first year in the control group. After one year, 94.2% of Cypher patients were event-free, compared with 81.4% for the control group.
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Medtronic (Minneapolis, Minnesota) reported preliminary data from a clinical trial showing that stem cells were successfully deployed into damaged heart tissue by using the company's catheter system. Results from the trial indicate that the stem cell delivery procedure was performed safely in nine of 10 patients, with one procedure suspended because of an inability to place a guide wire. Medtronic said the preliminary study, which included 10 patients, evaluated the safety of delivering autologous skeletal myoblast stem cells into heart attack patients. Once implanted, the stem cells are expected to regenerate and restore damaged heart tissue caused by heart attacks. They also could be helpful in reducing possible future heart failure.
In another trial involving Medtronic equipment, 280 patients with mostly single-vessel coronary disease were randomly assigned to receive a stent or bypass surgery performed while the heart continues to beat, using the company's Octopus system. Such beating-heart or "off-pump" surgery avoids the increased risks, time and costs of rerouting blood through a heart-lung machine while surgeons operate on a temporarily stopped heart.
In the OCTOPUS trial, patients in the two groups showed statistically similar one-year rates of event-free survival and freedom from cardiac chest pain, but Dr. Peter de Jaegere of University Medical Center (Utrecht, the Netherlands) said stenting was associated with a significantly shorter hospital stay and costs. "Cardiac outcomes and quality of life were not different between stenting and off-pump surgery," said de Jaegere. But stenting, he added, was more cost-effective and can be recommended as the first choice of revascularization for the kind of patients entered into the study.
Rubicon Medical's (Salt Lake City, Utah) Rubicon Filter was featured in three separate presentations. Eberhard Grube, MD, chief of cardiology at Heart Center Siegburg (Siegburg, Germany), cited the advantages of the Rubicon Filter compared to the performance of other distal protection devices during a session titled "Managing Percutaneous Coronary Intervention Complications." Grube is the principal investigator for the CE mark clinical study in Europe of the Rubicon Filter's use in coronary arteries. Simon Dixon, MD, an interventional cardiologist at William Beaumont Hospital (Royal Oak, Michigan), also discussed the Rubicon Filter in an "Embolic Protection" session.
Jeffrey Popma, MD, director of interventional cardiology at Brigham and Women's Hospital and associate professor of medicine at Harvard Medical School (both Boston, Massachusetts), presented the Rubicon Filter in a "Distal Protection Devices" session, describing the device as "the next generation in embolic protection." The Rubicon Filter is designed for use in medical procedures downstream from a blockage in a bloodstream to allow the capture and removal of dislodged embolic material. It is deployed on a guide wire without a catheter, making it smaller and easier to navigate through blood vessels.
CardioDynamics (San Diego, California), developer of Impedance Cardiography (ICG) technology and the BioZ system, said Clyde Yancy MD, medical director of heart failure/heart transplantation at the University of Texas Southwestern Medical Center and St. Paul University Hospital (both Dallas, Texas), discussed ICG's accuracy, clinical applications for identification, titration and management of drugs, recently released clinical studies and upcoming clinical trial work demonstrating new clinical applications for ICG in a "Point of Care Heart Failure" session.
Also presented were the results of a clinical study by Marcellus Francis Ramirez, MD, of the University of Santo Tomas (Manila, the Philippines), that demonstrated the value of ICG in the detection of left ventricular systolic dysfunction and correlation with an echocardiogram. The study concluded that impedance cardiography "is useful in the noninvasive hemodynamic assessment of heart failure patients. Patients with systolic dysfunction demonstrate a low acceleration index and a low velocity index by ICG, while those with normal systolic function show normal values in both parameters."
Trial data supported cardiac imaging, or stress myocardial perfusion imaging (MPI), a technique that evaluates the degree to which the heart lacks blood flow, as a method to help physicians assess the treatment needs of heart attack survivors and the risk of a second heart attack. The data resulted from the Adenosine Sestamibi Post-Infarction Evaluation (INSPIRE) trial led by researchers at the Baylor College of Medicine (BCM; Houston, Texas). John Mahmarian, lead investigator and professor of medicine at BCM, presented the data at a late-breaking clinical trial. "Because we are able to test patients so early after a heart attack, this study revealed that MPI can help physicians assess the likelihood of a follow-up heart attack or readmission for cardiac reasons and more precisely guide subsequent treatment from medical therapy to coronary revascularization," said Mahmarian, medical director of the nuclear cardiology laboratories at Methodist DeBakey Heart Center and the Baylor Heart Clinic.
"This is a significant breakthrough because the current perception is that a heart attack sufferer needs to undergo coronary angiography or surgical procedure to evaluate the damage of the heart," Mahmarian said. "This study demonstrated that patients found to be at low risk by MPI also are at low risk of a second heart attack and therefore unlikely to benefit from coronary angiography."
The multicenter trial evaluated 728 patients whose post-heart attack condition had stabilized. All patients underwent a baseline MPI, using adenosine and sestamibi within 10 days of a heart attack, to assess the extent of jeopardized heart muscle and left ventricular ejection fraction. Adenosine is a commonly used substitute for patients who cannot perform exercise stress testing and can safely be delivered intravenously even shortly after a heart attack. Sestamibi is a cardiac imaging agent that enables physicians to simultaneously evaluate heart function and blood flow to the heart muscle. It is marketed by Bristol-Myers Squibb Medical Imaging (North Billerica, Massachusetts) as Cardiolite.
"These data show that MPI using adenosine and sestamibi is a safe and effective technique to determine patient risk and thereby help physicians assess who might benefit from coronary angiography and revascularization vs. [those] who would benefit from intensive drug therapy," Mahmarian said.
SonoSite (Bothell, Washington), a global leader in hand-carried ultrasound products, introduced new cardiology capabilities to the Titan system, its newest-generation, high-resolution system. SonoSite said customer deliveries are scheduled for mid-June and that current customers will be able to upgrade to the enhanced Titan system capabilities. Kevin Goodwin, president and chief executive officer, said, "This release will enable physicians to use Titan's high-performance capabilities to perform full echocardiography and vascular studies in the clinic or at the point of care, allowing for earlier diagnosis and treatment." He added that the enhancement "also addresses the need of many of our international customers who require a shared service system that can perform both radiology and cardiology examinations." Goodwin said the shared-service market is estimated to account for at least 20% of the $2.3 billion international ultrasound market.
The Titan system is based on SonoSite's ASIC (Application Specific Integrated Circuit) technology, which integrates millions of transistors onto one circuit. The cardiology upgrade will offer full cardiac and vascular calculation packages, pulsed and steerable continuous wave Doppler, Tissue Harmonic Imaging, velocity-based color Doppler, M-mode and image storage to compact flash cards and the ability to export video to storage devices. The company said these features enable the user to perform echocardiography studies that meet the standards required by payers for a complete echocardiography examination. The Titan system weighs just 7.7 pounds.
Volcano Therapeutics (Rancho Cordova, California) reported the global launch of its Eagle Eye intravascular ultrasound (IVUS) imaging catheter. The company said the Eagle Eye IVUS catheter provides improved overall image quality and superior catheter handling and deliverability. IVUS is a catheter-based technology that provides high-resolution images of vessel geometry and atherosclerotic plaque morphology from within coronary and peripheral arteries. IVUS images are displayed in grayscale on a computer console in the cardiac catheterization lab. The Eagle Eye IVUS imaging catheter is used with the Volcano Therapeutics In-Vision ultrasound console system.
Schering-Plough (Kenilworth, New Jersey) and Merck and Co. (Whitehouse Station, New Jersey) said their experimental cholesterol drug Vytorin, which combines Merck's Zocor (simvastatin) with a new drug, ezetimibe, outperformed Pfizer's (New York) sector-leading Lipitor in a trial. The companies said ezetimibe with simvastatin cut LDL cholesterol (so-called "bad" cholesterol) levels by 46% to 61%. Vytorin also inhibited both cholesterol production in the liver and absorption in the intestine, they said. When Vytorin was compared to Lipitor in a six-week treatment period, the patients taking ezetimibe/simvastatin combinations had LDL reductions of 46% and 50%. Patients taking Lipitor (atorvastatin) had a 37% reduction in LDL. Schering-Plough and Merck said patients taking Vytorin also showed greater average increases of HDL ("good" cholesterol) than patients taking Lipitor. The study involved 788 patients with initial LDL levels of about 180, well above national cholesterol guidelines. The joint venture between Schering-Plough and Merck is already selling ezetimibe internationally under the brand name Zetia. It is approved for use either by itself or with any statin.
For its part, Pfizer said the Aggressive Lipid-Lowering Initiation Abates New Cardiac Events (ALLIANCE) trial indicated that patients taking Lipitor experienced 47% fewer non-fatal heart attacks compared to patients receiving standard care. Patients taking Lipitor in the trial also experienced a 17% reduction in overall negative cardiovascular outcomes, including cardiac death, heart attacks, strokes and hospitalizations. Patients treated with standard care received cholesterol-lowering therapies prescribed by their physicians, including lifestyle changes such as modifications in diet, weight loss, exercise and drug treatment, if necessary. Donald Hunninghake, MD, professor of medicine and pharmacology at the University of Minnesota (Minneapolis, Minnesota), principal investigator of the ALLIANCE study, said, "This study provides new insights for physicians in how to effectively manage patients who have high cholesterol especially those who have not succeeded in reaching their recommended cholesterol goal levels with usual care."