Archive for July, 2009
The Benefits of Statins
Statins, which if you haven’t guessed by now are one of my favorite topics and are making news again! Two new recently published studies continue to show the tremendous value of these drugs both before you develop the disease of atherosclerosis and after it’s treatment.
A meta-analysis is a process were multiple studies are analyzed together to increase the ability to define value to drugs or medical process. This process has some statistical problems as studies are often enrolled in different ways but in general the technique is regarded as useful to inform us as physicians how to best treat our patients.
Dr Jasper Brugts recently published such a study in the British Medical Journal BMJ 2009; 338:b2376. Titled “The benefits of statins in people without established cardiovascular disease but with cardiovascular risk factors” the analysis showed that statins cut deaths by 12%, coronary events by 30% and cardiovascular events by 19%.
This study looked at ten trials including the recently blogged Jupiter trial ( June 15, 2009). A total of 70,388 subjects without cardiovascular disease but with risk factors for its development were included in this analysis. This effect was seen regardless of age, gender, or diabetic status. It is also important to realize that this effect is in addition to diet and exercise and represents “real world” use.
It is important to discuss with your physicians the use of statins in your case. Targets are LDL < 100. If you already have coronary artery disease the target LDL is < 70. These targets are easily obtained in most cases with today’s drugs. It is not the amount of drug you take it is the drugs measured effect on you. In general, taking more of the drug tends to lead to greater clinical benefit. There is an extremely wide variability to these drugs so comparing your dose to your friend’s dose is of no value. Also, these drugs are everyday drugs and taking them every other day is not advised.
Next…using statins before angioplasty.
Adult Cell Treatment Looks into Healing Heart Muscle after Myocardial Infarction
As discussed in my blog of July 16, 2009, researchers at Cedars Sinai Heart Institute in Los Angeles have devised a way to use adult autologous (meaning they come from the person who is receiving them) cardiac cells. They have now reported the first in man use in a study they are conducting with sponsorship from the National Institute of Health.
This study will utilize 24 patients who have had a myocardial infarction followed by emergency rescue angioplasty. They were left with severely impaired heart muscle. They undergo MRI scanning and then a biopsy of their heart through a vein. It is a simple procedure. The cells are then processed in their lab for four to six weeks. 12 million to 25 million are then put back into the heart by injecting them into the artery, which caused the heart attack but is now open because of the previous angioplasty. 6 months later, a second MRI will be done for comparison.
These cells known as cardiosphere-derived cells are very exciting. As in all studies more questions will be raised than answered, how best to administer the cells, by artery or direct injection into the area of heart muscle damaged? What is the proper timing? Can the cells be processed more quickly?
The important point is that this work is being done and cell based therapy is a promising avenue to allow the heart to heal itself. We are proud to be one of the few places in the United States working in this field. I will continue to blog frequently about it.
Endoscopic vs. Open Vein-Graft Harvesting in Coronary-Artery Bypass Surgery
As discussed last time, an article was published in N. Engl. J. Med. 361 (3): 235-44 titled “Endoscopic versus Open Vein-Graft Harvesting in Coronary-Artery Bypass Surgery.” This article evaluated the data from another study the PREVENT IV. The PREVENT IV study was a randomized trial of 3,014 patients, who underwent surgery and had three-year-follow-event data.
Compared to standard open harvesting, endoscopic harvesting had higher rates of vein graft failure (46.7% vs. 38.0%) when analyzed by patient or by graft (27.2% vs. 22.6%). The primary clinical outcome measure was the composite of death, myocardial infarction and repeat revascularization. This measured 20.0% vs. 17.04%. The study showed that the recognized short term benefits of less pain, less infection and better cosmetic result was offset by higher graft failure leading to a wide array of problems.
If you have had coronary bypass and are wondering which type of harvesting you had, look at your legs. If you had standard harvesting, you will have long incisions. If you have several very short incisions, you had endoscopically harvested veins. Your doctors should be aware of which type of procedures you had. At present, there is no knowledge of how best to proceed. The use of additional antiplatet medications such as Plavix, better control of lipids with higher dose statins and better control of high blood pressure may be helpful. Stress testing may be of value to identify bypass grafts before they close, but this is not proven or recommended.
If you are going to have bypass surgery, you should discuss this issue with your cardiologist and surgeon.
New Information on Endoscopic Harvesting Device
Last week an article was published that once again proved the value of research. We often take for truth what seems simpler when the use of a new device or drug appears when they have never been proved to be better or safer. Medical procedures and techniques often seem easier but in general are not proven to be. Drugs and devices are often approved because they are NO WORSE than standard not because they are better.
One of the drivers of medical costs is devices that cost significant amounts of money but add no real benefit. This concept is one of my main focuses of my blogging. I am attempting to provide the public with the information that we as doctors often have, but are very difficult to transmit to patients. I believe that the majority of doctors want to do what’s right by what we call evidenced based medicine but often they don’t know that these studies are in the literature.
One such device is used in endoscopic harvesting of saphenous vein grafts during bypass surgery. Although this device has been in use for several years only now has important information come to light. Briefly, at coronary bypass surgery the surgeon utilizes the greater saphenous vein from the leg as conduits for the graft. This procedure can be done the “classic” way or the “new way.” The classic way is to make a long incision in the leg and remove the vein by hand. The “new” way is to make several small incisions in the leg and with a tool known as an endoscope to remove the vein. It was assumed that this would be better. It is true that the healing of the leg incisions is one of the more trying parts of bypass surgery. Although they always heal it can take some time and the procedure often leaves scars.
Next…why this study may save your life.
The Importance of Bone Marrow Cell Therapy
An important stem cell therapy article was published June 16, 2009 in the Journal of the American College of Cardiology 2009; 53:2262-9. This study, the BALANCE study, used bone marrow cell (BMC) therapy to reduce the size of myocardial infarctions.
If you want to limit the size of your heart attack, go as quickly as possible to a hospital like Holy Cross that has a 24-hour team of interventional cardiologists who will quickly open the occluded artery. The goal is to have the artery open 90 minutes after you arrive. The best results are seen in those patients that arrive early. After the heart attack, we have no current options for fixing the damaged muscle. We treat the heart with medication to improve its strength, but we have no way to treat the actual muscle damage.
This study done from 2002 to 2003 in a single center in Germany now reports their 5-year data. A total of 62 patients were treated and 62 control patients were matched in the group that refused therapy. These patients underwent standard emergency angioplasty and then 7 +/- 2 days later had autologous bone marrow cells infused down their infarct related artery. These cells are harvested from the patient in the standard way and then processed to remove the red blood cells.
Long term survival analysis shows that BMC therapy reduces mortality in treated patients with no long-term side effects. In the treated group, it was 0.35%/year and in the control group 2.35%/year. The five year mortality was 1.6%. Published reports that analyze long-term mortality in patients with myocardial infarction range from13 to 24% after five years.
This study is small and nonrandomized. In an accompanying editorial it is put into perspective. Presently the search is on for better cells. At present it is possible to take skin fibroblasts and reprogram them by inserting specific transgenes into the fibroblast nucleus. These cells are referred to as induced pluripotent stem cells (iPS). They can be further altered by proteins that regulate the development of cardiac cells. The result can produce beating cardiomyocytes. These cells could then be implanted.
As I have discussed before, it is difficult to biopsy the heart and derive enough useful cells. This now may have been overcome by a process that cultures the biopsy material which is then harvested to form multicellular structures called cardiospheres. These are referred to as cardiosphere-derived cells (CDC). These cells are set to be applied in a first in human study to be done at Cedars-Sinai Medical Center.
Ask the Cardiologist
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Posts are published by Holy Cross Hospital to provide general health information. They are not intended to provide personal medical advice, which should be obtained directly from your physician.
Best outcome for those with Diabetes and Coronary Disease
In my last blog reviewing the BARI 2D, I discussed the results of the diabetic issues. As an interventional cardiologist, I am most interested in the revascularization issues. First, some background. Dr. Andreas Gruentzig invented coronary angioplasty in the mid 1970s. He built the original balloons by hand in his kitchen. The first human angioplasty took place in September 1975. This patient was recatheterized on live TV 10 years later and was found to have an open artery. Dr. Gruentzig believed that angioplasty was to be used to treat symptomatic angina that was not responding to medical management. At the time, angioplasty started coronary bypass surgery was the only option; so, many patients had single artery bypass.
As angioplasty developed, attempts were made to determine if one treatment was superior — angioplasty or bypass surgery. A study was conducted comparing the two called BARI.
BARI, the Bypass Angioplasty Revascularization Investigation began in 1988 and was published in the Journal of the American College of Cardiology 2000; 35: 1122-1129.
The first patient was enrolled in August 1988 and the last in August 1991, for a total of 1,829 patients at 18 sites in North America. The patients were symptomatic and had multi vessel disease. They were randomized between surgery and angioplasty. There was no medical treatment group. At the end of 7 years, the survival rate of 86% was the same whether you had angioplasty or surgery if you did not have diabetes. Estimates of the 7 year survival with surgery and diabetes were 76% vs. 55% if you had angioplasty and diabetes. Clearly, having diabetes alters the equation in favor of surgery in those patients who have multi vessel disease.
This was the background for BARI 2D. The best outcome in BARI 2D was obtained in the patients who had multi vessel disease and prompt revascularization with surgery and took oral insulin medications. Forty-two percent of those randomized to medical management eventually underwent revascularization again, pointing out the ongoing disease process of diabetes and coronary disease. Angioplasty did not reduce major cardiovascular events compared to medical management.
An accompanying editorial asked the question whether this outcome will change what we as physicians offer our patients who come to us for answers to important health care problems. More than one million angioplasty procedures with drug eluting stents are done annually. The evidence-based approach would indicate that for symptomatic relief of angina in patients with diabetes and multi vessel coronary disease bypass surgery is the preferred choice.
Free Cholesterol Screenings…
…Good for your heart; great for preventing heart disease. Appointments for free cholesterol screenings at the Jim Moran Heart & Vascular Center are available every Monday, Wednesday and Friday through July 31. Call 1-877-724-7222 to schedule an appointment today!
Treatment for Diabetics with Heart Disease
One of the many purposes of this blog is to share useful medical information about heart disease and its related conditions. Some of this work we have participated in and some not. All of it is useful to those patients who are troubled by the conditions discussed.
BARI 2D was published in the NEJM on June 11, 2009. My team and I had the privilege of participating in this National Insitutes of Heart, Blood & Lung (NIHBL) government study. This study started in 2000 and took 8 years to complete. This trial set out to determine if the rates of death and cardiovascular events in diabetics with multi vessel coronary artery disease could be improved by choosing one type of therapy over another. It tried to answer two questions simultaneously:
a. Which treatment method is better for diabetics with symptomatic multi vessel coronary artery disease, bypass surgery or angioplasty?
b. Was insulin better than oral drugs in diabetics with coronary disease?
This study enrolled 2,368 patients with type 2 diabetes and referred to coronary angiography for the evaluation of coronary artery disease. If multi vessel disease was found they could be entered in the study. 763 were in the CABG arm and 1,605 in the angioplasty arm. This choice was made by the investigators based on the coronary anatomy. The patients were then randomly divided within each group, half to medical management and half to surgery or angioplasty. Each group was further divided to receive either insulin or oral drugs. Eight groups were arrived at covering all the options.
The answer may surprise you. At 5 years, rates of survival did not differ significantly between the revascularization group and the medical therapy group or between the insulin-sensitization group and the insulin-provision group.
If you have diabetes and multi vessel coronary disease there is no difference in the rates of death or cardiovascular events whether you are treated with insulin or oral agents. It does not matter which oral agents with which you are treated. The study did it’s best to optimize the control of diabetes and the doctors treating the patients are experts at it. In our case it was Dr. Cristina Mata, who serves on our Clinical Advisory Board. The mean difference between the groups was less than 0.5% for their glycated hemoglobin values. Each group was close to the target of 7.0%
Next…the revascularization issues.
NOGA and Protein Combine to Beat Angina
Our team has begun enrolling participants in our third stem cell therapy trial. This trial is unique in many ways.
First and foremost, we will be utilizing the NOGA machine to restudy patients at the study’s conclusion. At this time, we will obtain some very unique data not usually collected on participants. Most of the “success” of trials for heart failure and angina depends on a decrease in the symptoms that the patient had at the study’s start. Treadmill and walking tests are also used. However, the NOGA enables us to revisit the exact sites of injections so those areas of heart muscle can be analyzed for improvement in blood supply and movement.
The second unique part of this study is it does not use cells but rather a manufactured human protein which has been altered slightly. This protein is understood to provide stimulation of the growth of new blood vessels and of new muscle. This may allow those patients that need this type of therapy to not have to endure the arduous and expensive process of harvesting the cells from each donor. The manufactured protein can go in any patient without concern for rejection.
Like the BAXTER study before it (see blogs on 06-25-09 and 06-29-09), this study is enrolling patients who are limited by their angina and have failed medical management and are not angioplasty or coronary bypass candidates.
Candidates must walk on the treadmill and qualify, then undergo catheterization and nuclear stress testing. If they pass all the qualifying tests, they are then injected by NOGA mapping with either active protein or placebo. This is a safety study and does not have the statistical power to determine whether the treatment works or not. We know from other work that patients can have marked benefit. You will soon be able to hear some of these patient success via video on our website toward the end of the summer.
If you have angina and would like to discuss treatment options with us further, we can be reached at 954-229-8400.
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