New generation of cardiac interventions, therapies optimize heart disease careResearch presented today at the American College of Cardiology's 55th Annual Scientific Session and the inaugural Innovation in Intervention: i2 Summit 2006 in Atlanta, Ga., highlights critical advances in the treatment of cardiovascular disease. The studies define add-on therapies that improve the treatment of heart attack and increase the long-term success of stenting, bolster the promise of stem-cell therapy in patients with chronic heart disease, and underscore the skill of community interventionalists in treating diseased arteries supplying blood to the brain.
ACC.06 is the premier cardiovascular medical meeting, bringing together more than 30,000 cardiologists to further breakthroughs in cardiovascular medicine. Innovation in Intervention: i2 Summit is an annual meeting for practicing cardiovascular interventionalists sponsored by the American College of Cardiology in partnership with the Society for Cardiovascular Angiography and Interventions.
Prospective Randomized Trial of Direct Endomyocardial Implantation of Bone Marrow Cells for Therapeutic Angiogenesis in Coronary Artery Diseases (PROTECT-CAD)
The first randomized, controlled trial to evaluate the clinical effects of direct injection of bone marrow cells into blood- and oxygen-starved heart muscle using a catheter-based technique rather than open-chest surgery has shown significant improvements in both exercise capacity and the heart's ability to effectively pump blood. The findings strengthen evidence that direct injection of bone marrow cells offers relief to patients with advanced coronary artery disease (CAD), severe chest pain, and no other therapeutic options.
"The heart disease in these patients follows an inexorable downhill course with disabling symptoms and progressive cardiac failure," said Hung-Fat Tse, M.D., F.A.C.C., an associate professor of medicine and deputy director of the Research Center of Heart, Brain, Hormone and Healthy Aging at the University of Hong Kong. "Grafting healthy cells into the diseased heart holds enormous potential to induce new blood vessels and strengthen weak hearts in patients with coronary heart disease."
To test the effectiveness of direct injection of bone marrow cells, Dr. Tse and his colleagues in Hong Kong and Australia removed bone marrow cells from 28 patients with severe CAD, then randomly assigned them to receive low-dose or high-dose injections of bone marrow mononuclear cells or plasma directly into oxygen-deprived--or ischemic--areas of the heart. A catheter-mounted electromechanical mapping system was used to identify ischemic regions of the heart and guide the injections.
After six months, patients who were treated with bone marrow cells were able to exercise, on average, more than one minute longer on a treadmill and showed a four percent increase in left ventricular ejection fraction (LVEF), both significant changes. The control group showed no improvement in these measures. Researchers observed improvements in the ability to do daily activities and the severity and frequency of chest pain in both groups. Data on blood flow within the heart muscle and long-term safety, including the presence of calcification, tumors, and rhythm abnormalities, are under analysis.
Dr. Tse will present the PROTECT-CAD study at a Late Breaking Clinical Trials session on Tuesday, March 14, at 3:00 p.m.
Late Clinical Events Related to Late Stent Thrombosis After Stopping Clopidogrel: Prospective Randomized Comparison Between Drug-Eluting Versus Bare-Metal Stenting
To prevent blood clots from forming in the weeks or months after stent implantation--a complication known as late stent thrombosis--interventional cardiologists prescribe two medications: aspirin and a stronger drug, clopidogrel. Both inhibit the function of platelets, the blood cells that clump together to begin the clotting process. Typically patients take these medications for one month after treatment with a bare metal stent and three to six months after treatment with a drug-eluting stent, a newer device that slowly releases medication to prevent renarrowing of the stented artery. In the case of drug-eluting stents, physicians may be stopping antiplatelet therapy too soon.
"Based on observational data, there is growing concern that late stent thrombosis after discontinuation of clopidogrel may be more frequent with drug-eluting stents," said Matthias E. Pfisterer, M.D., a professor of cardiology and head of the cardiology division at University Hospital, Basel, Switzerland. "This is an important question, as these events have been characterized by myocardial infarction in up to 40 percent of patients and death in up to 25 percent."
To determine the risk of late stent thrombosis after discontinuation of clopidogrel, Dr. Pfisterer and his colleagues analyzed data from the Basel Stent Cost Effectiveness Trial (BASKET), a randomized study that compared bare-metal and drug-eluting stents. The new analysis focused on 746 patients from the BASKET study who experienced no cardiac complications within the first six months of stent implantation and were advised to discontinue clopidogrel at that time. Investigators continued to follow-up with these patients for another 12 months.
The BASKET follow-up study will determine the comparative rates of late stent thrombosis in patients treated with bare-metal and drug-eluting stents and the clinical consequences of this complication, including cardiac death, heart attack, and the need for a procedure to re-establish blood flow through the stented artery.
Dr. Pfisterer will present the BASKET follow-up data at a Late Breaking Clinical Trials session on Tuesday, March 14, at 2:30 p.m.
CAPTURE 3000: Report of the Largest US Multicenter Experience in Carotid Stenting for High Surgical Risk Patients As community interventionalists increasingly adopt carotid stenting for the treatment of high-risk patients with plaque build-up in the arteries supplying blood to the brain, the procedure is proving to be just as safe and effective as it was in the hands of pioneering researchers. A registry of patients treated with carotid stenting since its commercial approval by the Food and Drug Administration has found no unexpected problems with the stent, and has even documented a lower combined rate of death, stroke, and heart attack within 30 days of stenting than was observed in the research studies that proved the value of carotid stenting.
"The transfer of carotid stenting technology from clinical trial sites to clinical practice sites appears to have been successful with the same, or even better, outcomes in the clinical setting," said William A. Gray, M.D., an associate professor of medicine and director of endovascular services at New York-Presbyterian Hospital/Columbia University Medical Center, New York City.
Dr. Gray and his colleagues collected data on more than 3,000 patients treated by 240 interventionalists at 118 medical centers throughout the United States, as part of an observational study required by the FDA following market approval of the Guidant carotid stent. Patients were also evaluated by a neurologist immediately before and after stenting, and again 30 days later. An early analysis of 1,600 patients demonstrated excellent results. Evaluation of the clinical results from all 3,000 patients is underway, as are separate analyses of the influence of patient characteristics and interventionalist experience on outcomes.
Dr. Gray will report the findings of the CAPTURE 3000 Registry at a Late Breaking Clinical Trials session on Tuesday, March 14, at 3:15 p.m.
The American College of Cardiology (www.acc.org) represents the majority of board certified cardiovascular physicians in the United States. Its mission is to advocate for quality cardiovascular care through education, research, promotion, development and application of standards and guidelines- and to influence health care policy. ACC.06 and the ACC inaugural i2 Summit, the first-ever meeting for interventional cardiologists, will bring together more than 30,000 cardiologists and cardiovascular specialists to share the newest discoveries in treatment and prevention, while helping the ACC achieve its mission to address and improve issues in cardiovascular medicine.
Innovation in Intervention: i2 Summit is an annual meeting for those practicing coronary and non-coronary interventions. Sponsored by the American College of Cardiology, in partnership with the Society for Cardiovascular Angiography and Interventions and other professional associations, i2 Summit 2006 offers late-breaking interventional clinical trials, peripheral, vascular, coronary and valvular education, live cases from Europe, Asia and the United States, emerging technology / state-of-the-art lectures, expert simulation demonstrations, interactive Laptop Learning and general cardiovascular education at ACC.06, held concurrently with i2 Summit, for a dynamic, complete cardiovascular educational experience. i2 Summit consolidates all clinical, educational, practical and community needs into one event and delivers unsurpassed needs-based learning with true objectivity
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