February 2008 News
A comparison of use of the first two commercially available drug-eluting coronary stents (for the medications sirolimus and paclitaxel) among patients in “everyday clinical practice” indicates no significant differences for outcomes such as heart attack or cardiac death, according to a study in the January 30 issue of Journal of the American Medical Association.
Anders M. Galløe, MD, of the University of Copenhagen, Denmark, and colleagues compared the efficacy and safety of sirolimus-eluting and paclitaxel-eluting stents in a study designed to reflect everyday clinical practice. The SORT OUT II trial included 2,098 men and women treated with PCI and randomized to receive either sirolimus-eluting (n = 1,065) or paclitaxel-eluting (n = 1,033) stents at five university hospitals in Denmark. The patients were initially treated for ST-segment elevation myocardial infarction (STEMI), non-STEMI or unstable angina pectoris, and stable angina.
The researchers found that the proportion of patients experiencing major adverse cardiac events, such as cardiac death, heart attack, target lesion revascularization, or target vessel revascularization, were 98 (9.3 percent) for the sirolimus-eluting stent group and 114 (11.2 percent) for the paclitaxel-eluting stent group. The stent thrombosis rates were 27 (2.5 percent) in the sirolimus-eluting stent group and 30 (2.9 percent) in the paclitaxel- eluting stent group.
“In conclusion, the SORT OUT II trial found no statistical significant differences in the primary or secondary end points between the sirolimus-eluting stent and paclitaxel-eluting stent in everyday clinical practice among patients undergoing PCI for ST-segment elevation myocardial infarction, non–ST- segment elevation myocardial infarction or unstable angina pectoris, and stable angina. The rates of serious adverse events, cardiac death, acute myocardial infarction, and stent thrombosis were low, suggesting that, at least when considering 18 months of follow-up, the use of drug-eluting stents in the general population may be safe,” the authors write.
In an accompanying editorial, Debabrata Mukherjee, MD, and David J. Moliterno, MD, of the University of Kentucky, Lexington, comment on the findings of Galløe and colleagues regarding the comparison of stents.
“In 2008, clinicians will have additional choices of drug-eluting stents with the availability of second-generation devices — namely, the everolimus-eluting stent, which yielded similar or fewer major adverse cardiac events among patients as compared with the paclitaxel-eluting stent, and the zotarolimus-eluting stent, which was shown to be noninferior to the paclitaxel-eluting stent. The ongoing choice of a drug-eluting stent will likely depend on multiple factors that will include safety, effectiveness, deliverability, and — given recent cuts in reimbursement — cost of the device.”
“The current literature for drug-eluting stents can be challenging to interpret because of differing criteria for study enrollment, definitions for acute stent thrombosis and other clinical end points, and varied intervals of dual antiplatelet therapy and follow-up after stent implantation. Similarly, current real-world registries are usually limited by lack of valid control groups and often use historical controls. A large longitudinal database for patients receiving these various drug-eluting stents with open entry to fully capture all procedures may help determine the safest and most effective revascularization practice possible and should help guide future recommendations,” they write.
Source: JAMA. 2008;299[4]:409-416;454-455.
Terumo Partners with GHX for More Efficient Electronic Ordering Capabilities Terumo
Interventional Systems, a strategic business unit of Terumo Medical Corporation (TMC), announces a new partnership between TMC and Global Health Exchange (GHX). Working with GHX and its Electronic Data Interchange (EDI) system, Terumo Interventional Systems offers an e-commerce platform with a streamlined process. Hospitals are now easily able to place orders, generate receipts, and change and track orders with Terumo.
In addition, Nate Letcher, Supplier Account Manager at GHX, says that “unlike traditional Value Added Network’s (VAN) solutions, GHX is dedicated to the healthcare market.”
GHX brings suppliers and hospitals together through an automated electronic ordering interface. Because GHX customizes this interface based on the specific needs of providers, hospitals can actually reduce or eliminate the need to maintain individual EDI connections to their suppliers, saving $5,000 to $30,000 per connection. Synchronization also helps to reduce purchase order errors that may result in costly discrepancies for both buyers and sellers.
“In addition to needing to increase efficiencies, hospitals are under increasing pressure to lower costs and decrease manual errors,” says Rick Larrieu, Terumo CIO. “By offering an integrated ordering system, hospitals are able to see an immediate cost-savings benefit on top of the improved order-to-invoice process.”
Terumo believes that this partnership with GHX will enable it to strengthen relationships with its customers, improve efficiencies and ensure quality throughout the entire electronic ordering process.
Among the first to utilize GHX’s services for Terumo orders was Florida Hospital. Teri Long, Florida’s EDI Information Systems Coordinator, commented that its relationship with GHX has been a success in terms of both time- savings and error reduction.
“GHX is our primary VAN system, because we can depend on them to keep things running smoothly,” says Long. Even as Florida Hospital has grown with more campuses and new vendors, they have not had to expand their purchasing department partly because of GHX’s involvement.
According to Long, “They (GHX) do the programming for us, which helps us coordinate our unique requirements with the vendor’s needs. GHX makes electronic ordering easier for everyone involved.”
For more information, customers can contact Terumo Interventional Systems by calling its Inside Sales Customer Care Team at 800-862-4143 or by visiting www.terumois.com.
CABG Best for Multivessel Disease
Bypass surgery remains the best option for heart patients with more than one clogged artery, according to the first big study to compare coronary artery bypass graft (CABG) surgery with drug-eluting stents. The new research dims hopes that the less drastic stent procedure would prove to be just as good for people with multiple blockages.
In the study, heart attack and death rates were lower among people who had surgery than those given balloon angioplasty and stents.
A second study gave stent makers some good news, finding that using these devices “off label,” in non-approved situations, is not as dangerous as many had feared.
Both studies were published in The New England Journal of Medicine. Neither is definitive enough to resolve these issues, but they help guide physicians and patients confused about which treatment is best for whom.
The CABG study is “a sobering reality check” for people hoping that the newer drug-eluting stents “would level the playing field” and make these treatments equally effective, Harvard University cardiologist Dr. Joseph Carrozza wrote in an accompanying editorial.
CABG has become less common as angioplasty has risen dramatically. In 2005, about 469,000 bypasses were performed on 261,000 patients. More than 1.2 million angioplasties were done, though many people had more than one procedure.
In 2005, Edward Hannan of the State University of New York at Albany published a study that found CABG to be better than angioplasty with bare metal stents for patients with multiple blockages. His new study makes a similar comparison, but with the newer drug-eluting stents, which came out in 2003.
Researchers analyzed two state databases of 17,400 New York residents treated for multiple blockages in 2003 and 2004, and compared deaths and complications 18 months later.
Survival rates for both treatments were excellent, but CABG still showed a significant advantage after researchers took into account differences in how sick or old the patients were.
People with three clogged arteries had a survival rate of 94 percent after bypass compared with about 93 percent after stenting, which translated to a 20 percent lower risk of death. Those with two blockages had a survival rate of 96 percent after the operation compared with roughly 95 percent after stenting — about a 30 percent lower risk of death. The CABG group also needed fewer repeat procedures and suffered fewer heart attacks after treatment.
The New York State Department of Health helped pay for the study. The research covered the period in 2004 when former President Bill Clinton had quadruple bypass surgery, but it isn't known if his case was included, or if angioplasty was an option.
Stents still might be better for older patients and others who face greater risks from surgery, or for people who strongly prefer a less drastic treatment, Carrozza wrote. Some types of blockages also cannot be treated with stents.
In the second study, a team of U.S. and Canadian scientists looked at 6,551 patients who received either drug-eluting stents or plain metal ones. Among those who received stents off-label, no difference in heart attacks or deaths was seen, though the bare-metal stent group needed more repeat procedures. The findings “appear to validate off-label use” of drug-eluting stents, but this single observational study is not enough to declare that safe, Carrozza wrote.
To read the studies online (abstracts are free to view), visit www.nejm.com.
HemCon Medical Technologies’ Battle-Tested Bandages Called to Action in Hospitals
HemCon® Bandage and ChitoFlex® Dressings Improve Wound Care Solutions for Patients A new hemorrhage control bandage from HemCon Medical Technologies Inc., first used on the battlefields of Afghanistan and Iraq, is in use by health care professionals in emergency rooms, trauma care and cardiac catheterization labs around the world. The bandages, synthesized from chitosan, a natural substance found in shrimp shells, offer a new and more effective wound care alternative.
HemCon dressings control bleeding within two to five minutes by becoming extremely adherent when in contact with blood. The adhesive-like action seals the wound and attracts red blood cells to the bandage, forming a seal that stops hemorrhaging independent of the body’s natural clotting process. The bandages are anti-bacterial and effective on high-pressure, high-flow arterial bleeds. Current methods of hemorrhage control can involve gels, granules or thrombin, which can lead to severe health risks like second degree burns or increased risk of infection.
The hemostatic HemCon Bandages and stuffable ChitoFlex dressings are already being used in numerous medical facilities across the nation such as UNC Memorial Hospital in Chapel Hill, NC, Vanderbilt Medical Center in Nashville and Rush University Medical Center in Chicago.
“I have used the HemCon Bandage for a number of cardiac procedures at Rush University Medical Center,” said Dr. Ziyad M. Hijazi, director of the Center for Congenital & Structural Heart Disease at Rush University Medical Center. “I’m impressed with the product and believe it improves patient care by offering medical staff an effective and safe way to quickly control bleeding.”
HemCon products have been used by the U.S. military since 2003, and according to the U.S. Army Surgeon General’s office, the HemCon Bandage has a 97 percent effective rate in controlling bleeding on the battlefield. The HemCon Bandage is credited with saving more than 100 lives on the battlefield, and the company recently redesigned its bandages to meet the specific needs of civilian trauma and emergency medicine.
All HemCon dressings are fabricated from chitosan, a naturally occurring, biocompatible polysaccharide derived from shrimp shells. The shrimp shells are processed, chemically treated, made into bandage form and then sterilized.
The HemCon® Bandage was developed in collaboration with the Oregon Medical Laser Center and Providence St. Vincent’s Hospital. HemCon’s manufacturing and corporate headquarters are located in Portland, Oregon.
For more information, please visit www.hemcon.com.
Boston Scientific Announces Upgrade to ilab® Ultrasound Imaging System
Boston Scientific Corporation announced a third software enhancement to its iLab Ultrasound Imaging System, which was launched in May of 2006. The iLab System 1.3 System Software Enhancement is designed to strengthen physician confidence in the diagnosis and intervention of percutaneous coronary intervention (PCI) and increase workflow efficiency. The company said the software upgrade is available effective immediately in the U.S. Boston Scientific has introduced enhancements to the iLab System that give physicians the ability to preview device sizing decisions, colorize plaque and blood flow, and overlay color to enrich viewing the IVUS image. Specifically, the iSize™ Feature allows the user to preview device sizing decisions by displaying area and length measurement graphics in the cross-sectional and Longview™ images, and assists the physician to determine appropriate sized devices for use in coronary procedures. The iColor™ Feature enhances image interpretation by adding color to the cross-sectional view, coloring plaque and lumen based on Trace Assist™ for quick image interpretation. The iTint™ Feature overlays color to the IVUS screen at the discretion of the physician. Additional features include the ability to perform a new run with the push of a button and an icon magnification tool.
“The enhanced iSize™ Feature is designed to allow improved precision in predicting the appropriate stent length and diameter for the particular lesion being evaluated,” said Lowell Satler, MD of Washington Cardiology Center in Washington D.C. “The added features of the iLab 1.3 System Software, in particular the iSize and iColor Features, preserve the enhanced gray scale image that iLab system is known for while assisting in image interpretation.”
For more information, please visit www.bostonscientific.com.
OrbusNeich’s Genous™ Bio-engineered R Stent™ has Lower MACE Rate than Paclitaxel-eluting Stents and Sirolimus-eluting Stents in Clinical Trial
Patients who received OrbusNeich’s pro-healing stent, the Genous Bio-engineered R stent, had significantly fewer major cardiac adverse events (MACE) than patients who received a paclitaxel-eluting stent (PES) (Boston Scientific's Taxus) or a siroliumus-eluting stent (SES (Johnson & Johnson’s Cypher) in a study conducted at Federico II University of Naples in Naples, Italy. The results of the study were presented recently at the XXVIII National Congress of the Italian Society of Invasive Cardiology by Federico Piscione, MD, the study’s principal investigator and a professor with the university’s Division of Cardiology, Department of Clinical Medicine and Cardiovascular Sciences.
At clinical follow-up of 10 months, the cumulative MACE rate for the Genous group (GRS) was 4% versus 22% for the combined PES and SES group (drug-eluting stent group, or DES). For the MACE components, the cumulative rate of target vessel revascularization (TVR) was 1% for GRS versus 11.8% for the DES group, the cumulative rate of myocardial infarction (MI) was 1% for GRS versus 7.8% for the DES group, and the cumulative mortality rate was 2% for GRS versus 7.8% for the DES group. In addition, the cumulative rate for stent thrombosis was 2% for GRS versus 5.8% for the DES group.
“Our findings suggest that the deployment of Genous stents in a consecutive series of high-risk patients is safe and effective, with a significantly lower in-hospital incidence of MACE and a better long-term clinical outcome when compared to drug-eluting stents,” said Piscione. “Genous is a viable alternative to drug-eluting stents, which have raised many safety concerns among the interventional cardiology community. Unlike PES and SES that elute cytotoxic agents to inhibit neointimal proliferation, Genous attracts circulating endothelial progenitor cells to rapidly build a layer of healthy tissue and promote long-term natural healing.”
The study involved 195 consecutive high-risk patients who underwent percutaneous coronary intervention (PCI) with either GRS or DES implantation at the university's cath lab. After PCI, patients who received GRS were prescribed dual antiplatelet therapy for one month, and patients who received DES were prescribed the same therapy for nine months. Complete clinical follow-up was obtained for 100% of the patient population. High risk was defined as advanced age, high rate of conventional risk factors for coronary artery disease, multivessel disease, multivessel stenting, and depressed left ventricular ejection fraction.
Genous is coated with an antibody to capture a patient's endothelial progenitor cells, and, therefore, accelerate the natural healing process. EPCs circulate in the bloodstream and are involved in the repair of blood vessels. When attracted to the surface of the Genous stent, EPCs can form an endothelial layer over the stent to provide protection against thrombus and minimize restenosis. The stent was developed by OrbusNeich, a global medical device company. For more information about the study, call +390817462234 or send an e-mail to piscione@unina.it. Note: Cath Lab Digest interviewed Dr. Robbert de Winter about the Genous stent in the September 2007 issue.
Read the article at: https:// cathlabdigest.com/article/7676
Heart and Stroke Death Rates Steadily Decline; Risks Still Too High
In 1999, the American Heart Association set a strategic goal of reducing the death rates from coronary heart disease and stroke, and reducing the risk factors for these diseases by 25 percent by 2010. The new CDC data notes early success in meeting the coronary heart disease death rate goal, and shows that success is near for the 25 percent reduction in stroke. However, American Heart Association president Dan Jones, MD, said the victory could be short-lived if the risk factors that lead to heart disease and stroke are not also reduced.
“This progress in the reduction of death rates is a landmark achievement, and has come about as a result of tremendous efforts from many partners in research, healthcare, government, business and communities,” Jones said. “As encouraging as it is, heart disease and stroke remain the No. 1 and No. 3 causes of death in the United States. We still have remaining goals that we haven’t yet met — reductions in the risk factors that lead to heart disease and stroke, as well as eliminating the striking disparities in care for women and minority populations. We must continue to address those concerns at the same time we continue to support the advances that we know are saving lives today.”
The reduction in the death rates for coronary heart disease and stroke equates to approximately 160,000 lives saved in 2005 (the most recent year for which data is available) compared to the 1999 baseline data. If the current mortality trends hold (which will not be the case if the current trends in risk factors are not improved and current quality of care improvements do not continue), the American Heart Association analysts projects that there may be a 36% decline in the age-adjusted coronary heart disease death rate and a 34% decline in the age-adjusted stroke death rate when the 2008 data are released in a few years (in comparison with the 1999 data). The population size in 2008 will also be larger, so it is projected that the estimated lives saved in 2008 will be approximately 240,000.
Multiple factors appear to have led to the reduction in deaths. Ongoing scientific research has led to improvements in medications and in technology. The development of evidence-based practice guidelines has helped healthcare providers know what is effective both for the treatment and prevention of heart attacks and strokes. Some of the advances are complex and others are quite simple, though important.
Among those practice measures making a difference is better control of blood pressure and cholesterol levels, both with lifestyle change and with medications. In addition, a variety of strategies to reduce smoking in this country have made a difference, including tobacco excise taxes, clean indoor air legislation and smoking cessation efforts. But not everyone is receiving the proven medicines and treatments that save lives.
Coronary heart disease age-adjusted death rates for women have dropped 26.9% since 1999. But age-adjusted stroke death rates among women are down by only 23.7%, lower than the overall age-adjusted stroke death rate reduction and the age-adjusted stoke death rate reduction for men, which is 25.8%. The age-adjusted death rate for blacks is down 23.8% for coronary heart disease (compared to 25.6% for whites) and 20.3% for stroke (compared to 25% for whites.) These disparities in the outcomes for women and minority populations are echoed in the statistics for those living in certain parts of the country, such as the Stroke Belt in the South, and for those with lower income levels.
“These disparities are unacceptable,” Jones said. “We are actively seeking ways to better address these issues so that we can ensure that every person has the appropriate care they need to live a healthier, longer life.”
He said this will require reaching the American Heart Association goals for reducing the major modifiable risk factors for heart disease and stroke. Those include hypertension, high blood cholesterol, obesity, diabetes, physical inactivity and tobacco use. Because of progress in research, each of these risk factors can be controlled to goal levels for nearly everyone with either lifestyle changes alone or lifestyle combined with medications.
However, the data show that while there is progress on some of these risk factors, others are not being reduced nearly enough. The number of people with uncontrolled hypertension has fallen by 16% since the American Heart Association set its 25% 2010 strategic goals. The number of people with elevated blood cholesterol is down 19.2% and tobacco use is down 15.4%. Perhaps most alarming, the rate of physical inactivity has only declined by 2.5% and the prevalence rates for obesity and type II diabetes are actually increasing, and are appearing at earlier ages than ever before.
“We’re working on this, but much more needs to be done,” Jones pointed out. “If we don’t make a concerted effort to reduce these risks, we will lose the momentum we celebrate today. We will see our children developing heart disease earlier, experiencing early deaths or needing major medical care sooner. The financial and, more importantly, the emotional toll is too great.” “We are pleased with the progress this new data shows, but we know we can do much more,” Jones said. “We need to continue to push for more research and new medical advances, along with improved adherence to our practice guidelines. Most importantly, we must make it a priority to institute lifestyle and behavior changes, and the patient-healthcare provider partnership that can control risk factors and reduce the risk of developing cardiovascular disease in the first place.”
The 2005 mortality report can be accessed at www.cdc.gov/nchs/data/nvsr/nvsr56/nvsr56_10.pdf.
Anti-Platelet Therapy for Pint-Sized Patients
Tiny babies sometimes have big heart problems, but when that happens, doctors are often left scratching their heads over how much medication to give them.
“That’s because 75 percent of the drugs we use in children have never been tested in kids, so often, we’re working with a best-guess situation,” says Dr. Jennifer Li, a pediatric cardiologist at Duke University Medical Center.
Li and colleagues from 22 research centers around the world are hoping to change that. They’ve just completed the first-ever study examining use of clopidogrel (Plavix) in children under age two. “We were astonished at how little of the drug they needed to reap the same benefits as adults,” says Li. “It was only about a fifth of the amount that we were expecting.”
The study, known as the PICOLO Trial, appears in the January 29 issue of the journal Circulation.
Studies show clopidogrel can reduce the risk of heart attack, stroke, or death in adults who are high risk for cardiovascular problems. But children with heart disease can benefit from clopidogrel, too, says Li. It’s just not been clear what the optimal dose should be.
“Just because a kid is one-eighth the size of an adult doesn’t mean you give them one-eighth the amount of medicine,” says Li, who is chief of cardiovascular research in the division of pediatric cardiology. “Kids are not just small adults. Their bodies are changing faster; they metabolize drugs differently; they are just biologically different.”
Li recruited 92 participants for the study. All had heart disease that put them at high risk of developing life-threatening blood clots. Most had been diagnosed with hypoplastic left heart syndrome, a disorder involving a poorly performing, small ventricle that left them weak and blue in color. Others had problems with floppy or imperfect valves and one had Kawasaki disease, a condition that causes inflammation in coronary arteries. Many of the children were facing multiple surgeries to correct the defects and three-quarters of them had already had shunts implanted in their hearts to keep their blood flowing properly.
The patients were randomized into one of two groups: Some got clopidogrel, others, a placebo. Those in the treatment group were given one of four doses of clopidogrel, ranging from .01 to .20 milligrams per kilogram of weight over a period of one to four weeks.
Li notes that adults, with an average weight of 75 kilograms, are typically given 75 milligrams of clopidogrel per day to inhibit clot formation. When extrapolated, would predict an optimal dose of about one milligram per day for children under age two. But the study showed that the optimal dose for infants and toddlers up to 24 months was actually only .2 milligrams per day — about a fifth of that amount.
“It just goes to show you that you can’t simply extrapolate from what you do in adults and apply it to children,” says Li.
Li says using even optimal dosing with clopidogrel in children may involve some side effects. While there were no reports of serious bleeding, one patient did develop lower platelet counts, a condition investigators say may have been related to treatment. Bristol-Myers Squibb and sanofi-aventis, the makers of Plavix, sponsored the study.
