HJAR Nov/Dec 2023

HEALTHCARE JOURNAL OF ARKANSAS I  NOV / DEC 2023 23 trial was designed to evaluate the prevailing practice patterns of most cardiologists and health systems with regard to coronary angi- ography and stent placement. The discipline of cardiology is known for creative acronyms in their very well designed randomized con- trolled trials, which are the gold standard for advancing scientific evidence in the medical literature. COURAGE was an acronym standing for Clinical Outcomes Utilizing Revasculariza- tion and Aggressive Drug Evaluation. Essen- tially, what the authors were trying to under- stand was whether or not stents saved lives in these patients with angina compared against guideline-directed optimal medical therapy (i.e., medications alone without undergoing an invasive procedure with stent placement.) The trial randomized patients with stable an- gina and at least 70% partial obstruction to ei- ther angioplasty versus medical management. The results were striking. There was no mor- tality difference between patients. Both groups felt markedly better following intervention, including those who were treated without the risk of undergoing an invasive procedure. The angioplasty patients did get better a little quicker, but two years later, both groups felt the same. The accompanying editorial pub- lished in that same issue of the New England Journal of Medicine described it this way: “For every 1000 patients treated with a PCI-first strategy, approximately 2 would die, 28 would have a periprocedural myocardial infarction, 60 to 90 would have an incremental, transient gain in health status, and 800 or more would see neither harm nor benefit.” In this case, PCI stands for percutaneous coronary intervention (i.e., coronary angiography with stent place- ment). Periprocedural myocardial infarction refers to a heart attack occurring as a complica- tion of the procedure itself. So, in other words, if a patient were to completely understand the evidence-driven guidelines and expert recom- mendations, his routine physical included a car- diac stress test. The stress test showed some abnormalities, as would be expected for many 67-year-olds. Because of these abnormalities, he was referred for cardiac catheterization, the definitive “gold standard” test of the time, to define his coronary artery anatomy and the extent of any potential blockages. The test re- vealed some partial obstruction, again, which would be very common for almost any 67-year- old. He then underwent coronary artery an- gioplasty with stent placement. Now, this man needed to take at least two blood thinners for at least a month, possibly as long as a year, to pre- vent stenosis or recurrent blockage of the stent itself. Keep in mind that the man rides horses on his ranch often. If he were to fall off his horse while taking these blood thinners, he would be at extremely high risk for suffering a dangerous subdural hematoma. That might be a risk worth taking if the stent would prolong his life, but that simply wasn’t the case. Although stents have been shown to save lives when a person is presenting with an acute heart attack, they do not reduce mortality in patients with asymptom- atic coronary artery disease or stable angina. Why did this story make national news? It was because the 67-year old man was former president George W. Bush, and the care he received was in direct contradiction against known scientific evidence for the treatment of coronary artery disease. The landmark COUR- AGE trial was published six years prior to this news story in a 2007 issue of the New Eng- land Journal of Medicine. At the time, very large numbers of coronary stents were being placed not for acute heart attacks, but rather in patients with stable angina (or even asymp- tomatic coronary artery disease like what was found in President Bush). Angina is much more common than acute heart attacks, and so the Coronary artery stents placed during a proce- dure known as cardiac catheterization with cor- onary angiography can be lifesaving. If a per- son is presenting to the emergency room with crushing chest pain or severe pressure-like chest discomfort and an electrocardiogram showing evidence of ischemia, then the single most im- portant intervention is to get them to the cath- eterization laboratory as quickly as possible to insert a stent and restore blood flow. Hospitals understand that “time is muscle,” meaning that the magnitude of heart muscle damage and chance of death is directly correlated with the number of minutes the heart goes without adequate blood flow. The most forward think- ing of these hospitals became early adopters of process improvement methods such as Lean Six Sigma to eliminate waste and inefficiency and reduce the amount of time necessary to place a stent and restore blood flow before too much damage occurs. This is American medi- cine at its best, where doctors and teams of people are working together to ensure the ap- plication of reliable and timely evidence-driven best practices to restore health and save lives. First, do no harm Then why would Steven Nissan, MD, the nationally known and well-respected head of cardiology at the Cleveland Clinic — the very birthplace of coronary angiography — who is quoted above, speak about coronary artery stents as the worst of American medicine? In this case, it was in reference to a story that made national news 10 years ago. In 2013, a retired 67-year-old man who was known to be very active, clearing brush on his ranch regu- larly and who was also an avid biker, presented for a “routine” annual physical. He was not experiencing any symptoms — no chest dis- comfort or angina-type symptoms — and he exercised regularly. In this instance, against all “This is really American medicine at its worst. It’s one of the reasons we spend so much on health care and we don’t get a lot for it. In this circumstance, the stent doesn’t prolong life, it doesn’t prevent heart attacks, and it’s hard to make a patient who has no symptoms feel better.” — Steven Nissan, MD , Head of Cardiology, Cleveland Clinic