A New Study Promoting More Stents in Patients with Stable Chest Pain
An Invasive, Expensive Procedure Most of Us Can Avoid
There have been around fifteen scientific studies over the last two decades that have proven conclusively that optimal medical therapy (OMT) alone is as effective as OMT plus a stent in keeping patients with stable heart artery disease from dying or having a heart attack. It is a done deal! Yet more studies continue that attempt to justify the expanded the use of this invasive procedure.
Just this last December, another study came out in the New England Journal of Medicine and it was accompanied by an editorial. “The primary aim of treating patients with stable angina is to decrease symptoms and improve quality of life. Percutaneous coronary intervention (PCI or stent placement), a treatment for patients with angina, does not reduce the risk of death from any cause, death from cardiac causes, or myocardial infarction (heart attack) In this issue of the Journal, Rajkumar and colleagues report on the results… (of a study) that was designed to address an important question: Does PCI (a stent) relieve angina in patients who have chest pain that is thought to be exertional angina and who have ….. coronary artery disease and are receiving minimal or no antianginal drug treatment?” The editorial concluded “ORBITA-2 trial will influence patient care, guidelines, and the design of new trials. It is an important trial that changes the way we think about monitoring angina symptoms and the way we implement shared patient care. The orbit around PCI for stable angina has been changed”
There are a number of problems with this opening paragraph and that pushed me to write a letter to the editor of the journal that was published March 21st. “In the editorial accompanying the article by Rajkumar and colleagues (Dec. 21 issue)1 on the results of the ORBITA-2 trial involving the use of percutaneous coronary intervention(PCI) in patients with stable angina, White begins with a flawed premise: “The primary aim of treating patients with stable angina is to decrease symptoms and improve quality of life.” That is not the primary aim of treating these patients. Relieving angina is important, but the real priority in the management of stable angina is the provision of appropriate medical therapy to reduce the risk of myocardial infarction and sudden death. Thus, we continue our orbit around PCI. Many patients undergo stent implantation at the same time that we have not made the systematic changes that are necessary to ensure that every patient receives appropriate medical therapy. That is what must be changed. The follow-up of the ORBITA-2 trial lasted only 12 weeks, and the between-group differences in the frequency of angina were modest. Five years into the COURAGE trial, 74% of patients in the PCI group and 72% of those in the medical-therapy group were free from angina. The new orbit? Appropriate medical therapy first, followed by PCI if angina is not sufficiently relieved.”
Crafting a meaningful response in a letter to the editor regarding this article was challenging. These letters to the editor are limited to 175 words and five references. They would not allow me to use the term “optimal medical therapy” and substituted instead “appropriate medical therapy” which is not the same thing at all. Their objection was “optimal as compared with what and according to whom? What does it even mean?” The landmark COURAGE trial was entitled Optimal Medical Therapy with or without PCI for Stable Coronary Disease and was published in the New England Journal itself. This article from 2007 defined OMT so I don’t get the objection. This study had over 1100 patients in each group and was followed two and a half to five years. That seems to be a much more meaningful study than this recent one I addressed in the letter to the editor.
The conclusions of the COURAGE trial were important. “Rates of angina were consistently lower in the PCI group than in the medical-therapy group during follow-up, and rates of subsequent revascularization were likewise lower. However, there was a substantial increase in freedom from angina in patients in the medical-therapy group as well, most of which had taken place at 1 year but with a further improvement at 5 years. To what extent this finding reflects a benefit of specific antianginal medications (e.g., nitrates and beta-blockers) or a favorable effect of therapies such as statins on endothelial function and atherosclerosis is unclear….As an initial management approach, optimal medical therapy without routine PCI can be implemented safely in the majority of patients with stable coronary artery disease. However, approximately one third of these patients may subsequently require revascularization for symptom control or for subsequent development of an acute coronary syndrome.”
A 2020 guidance document from the American College of Cardiology says this about stable angina management. “Observational studies have observed that patients with stable CHD (heart artery disease) most often report no or mild angina. The risk for major adverse cardiovascular events is relatively low among patients with CHD and stable chest pain. Risk factor modification with medical and lifestyle therapy is the primary recommendation for such patients. Coronary revascularization is considered if optimal medical therapy (OMT) is not effective.” Optimal medical therapy is a term in wide use in the medical literature. It is strange to me that I was not allowed to use it.
Clearly, I don’t believe the evidence supports this conclusion, “ORBITA-2 trial will influence patient care, guidelines, and the design of new trials. It is an important trial that changes the way we think about monitoring angina symptoms and the way we implement shared patient care.”
We have great evidence already that tells us what we should do. I don’t think a trial that involves stent placement in patients who are not on medication to relieve chest pain proves a thing. I have personally used optimal medical therapy in hundreds of patients. They tolerated to medication well and most of them never needed another cath and they did not need a stent.
There are several other objections to reaching broad conclusions from this new study. It was a small study and only lasted twelve weeks. Patients were not receiving medications for chest pain which maximized the reported benefits. Angina symptoms persisted in most patients who got a stent. The benefits reported were very modest.
We don’t need more stents earlier in patients with stable angina. Optimal medical therapy is non-invasive, well-tolerated, relieves most chest pain sufficiently, and dramatically reduces death rates in patients with known heart artery disease. It is currently being used in thousands of people in Colorado. Minnesota reports on optimal medical therapy achievement for most medical groups and they have the lowest heart attack mortality in the country. Even more importantly, OMT is inexpensive and can be reliably delivered in the most rural and disadvantaged settings. It is past time to make it available to more Americans. Let’s get started!
Thank you for this article from someone whose loved one had a stent in the early 1990s and maybe didn't need it. Information is certainly a gift.
These corrupt interventionists focus on the "blockages" of the large vessel plumbing and disregard the root causes, such as metabolic heart dysfunctions due to Insulin resistance/T2D, which lead to microvascular disease and, more importantly, mitochondrial power distribution dysfunctions. These dysfunctions are important targets for the prevention and reversal of chronic diseases. They are missing the boast but are chasing the money instead! Beside, in the 100 million dollar Ischemia trial, stents, bypass surgeries made no difference in outcomes when compared to conservative medical treatments. In addition, both arms of the trial left 13-15% participants with MACE, including premature deaths.