The Ischemia Trial was presented at the American Heart Association Meeting in 2019. An international study led by NYU Grossman School of Medicine & Stanford University with statistical analysis by Duke Clinical Research Institute. 

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They randomized 5,179 patients at 320 sites in 37 countries to receive one of two treatment strategies. It evaluated not only the efficacy, but the outcomes achieved and the quality of life experienced by the patients in each strategy.

 

Their findings are not entirely new to preventive cardiology. The Courage Trial and subsequent follow-up study analyses completed years later observed similar results. Physicians and patients often demand interventions and want their cardiologist to "hurry up and do something!"  Adding medical therapy and recommending risk factor modification seems like their docs aren't really doing anything; however, much of the benefit is in the changes in risk factors like reduced stress, weight loss, lowered cholesterol levels, lower inflammation and better sleep to name a few.  

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When a patient has a positive stress test and symptoms of chest pain, they are scared and want it "fixed". They often see the fix (stenting) as reducing their risk of a heart attack or coronary event. The truth of the matter is that the patient is more in control of reducing the risk for a heart attack by changing behaviors. 

 

The idea that fixing a 90% blockage does not prevent a heart attack is confusing for most patients. Placing a stent into a heart or coronary artery works like scaffolding to improved heart flow to the muscle. It can improve symptoms and exercise tolerance. We then give the patient antiplatelet medications like Plavix, Effient or Brilinta to protect the newly placed stent from the patient since it is a foreign body. Left to its own, the body would try to clot off the stent and cause a heart attack. 

 

It actually takes longer to explain why we don't want to place a stent than to actually recommend a stent and procede. In the documentary, Escape Fire, Leslie Cho, M.D. at Cleveland Clinic discusses a female patient who had bypass surgery at age 27 and well over seven stents. None of the patient's cardiac risk factors were well controlled. She said, "When we reward physicians for doing procedures instead of talking to patients, that's what they are going do, is do procedures...If I spent five minutes with you and put in one of these stents, I would probably get paid $1,500. For me to spend 45 minutes on an established visit with a patient to make sure they are doing their exercise, make sure their diabetes is going okay, and try to figure out what their true problem is, [I would] probably get paid $15. It's a completely irrational system." 

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In addition to limitations in the clinical setting, many patients expect a fix that does not require much effort from them. They say, "I am having chest pain. My stress test is positive. Let's get this blockage fixed before I have a heart attack." They are often overweight, stressed, still smoking, eating poorly and read online that the statin therapy will kill them faster than their habits and blocked arteries. Their incorrect assumption is that the blockage is only due to genetics and any heart attack is the fault of their physician's lack of doing something fast enough. Many factors are at play in the creation and progression of heart disease. People still have heart attacks despite best efforts, bypass surgery or stenting procedures. I explain to my patients that stents are better at stopping a heart attack than preventing a heart attack, but the Ischemia Study did show that coronary stents were better at controlling heart-related chest pain than medical therapy alone .  

 

Courage Trial found that outcomes were similar with stents or medical therapy. The naysayers emphasized that there were patients on medical therapy that later had to undergo stenting or had heart attacks while being treated medically.  So you quit hearing much about Courage Trial. It is true that patients on medical therapy will sometimes have heart attacks or increased chest pain requiring them to cross over from the medical to invasive treatment.

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The Ischemia Trial has now been rolled into the yard on the little red wagon. Like a new car, the critics will begin to dismantle it. The trial was created knowing this would happen. Duke analyzed the data and St Lukes's Mid America Heart Institute collected the data on Quality of Life. It was twice as large as other studies and powered by several institutions at many international medical centers. It was not just a slice of the pie and included men and women as subjects. 

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In the second year of the Ischemia Trial, they looked at those treated aggressively with medical and lifestyle therapy. These patients weren't bringing in their Google searches and directing their care and refusing medications because some "I AM SMARTER" website demonized or misrepresented their medications, while offering to sell untested hypotheses and products. By year two, the event rate for the Ischemia Trial was roughly the same (9.0% versus 9.5%) between the two approaches.  At 4 years, the event rate was 13.3% for the invasively (stents) treated patients versus 15.5% for those in the medically treated group. So events like heart attacks and acute coronary syndromes, heart-related deaths, hospitalizations for heart failure or unstable angina, and receiving CPR - resuscitation after cardiac arrest, were similar in both groups whether stented or medically treated.

 

Those patients with chest pain caused by their heart artery narrowings or blockages (angina) had better relief of symptoms AND quality of life with the invasive therapy (stents); however, this was not done to decrease their risk of heart attack, death or other events. It helped relieve the chest pain and improve their quality life.

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Heart-related death or heart attack (myocardial infarction) occurred in 11.7% of the routine invasive group compared with 13.9% of the medically treated group.  All-cause death was 6.4% in the routine invasive group versus 6.5% in the medically treated group. The study demonstrates that symptomatic patients with angina had similar events with medical therapy or stenting; however, their quality of life (QOL) was significantly improved with less limiting and less frequent anginal symptoms.  

 

Angina is not simply chest pain. It can be exertional shortness of breath (dyspnea), profound and limiting fatigue with exertion, neck, jaw, arm or back pain, indigestion or other symptoms. Your physician must make this determination.  That is part of the art and science of medicine. No two patients are exactly the same in their disease presentation or treatment.  

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Coronary Artery Disease (CAD) is a complex problem with many etiologies. I believe it is important to determine the root cause of chest pain or a heart attack. Risk factor modification is used to reduce the chances that one will develop or progress cardiovascular disease. There are no guarantees. These patients in the study were being cared for by the best and brightest cardiologists in the world, and yet they still had events.

 

Patients still have heart attacks during stenting procedures, days after or years after. This was noted in the Ischemia Trial as well. This study did demonstrate that the overall rates of events have declined over the years and felt that was due to better medical therapy, directed risk factor modification, and improved stents and antiplatelet therapies.  Heart attacks can occur in the minimally plaque-filled or nonflow limiting arteries as well. A mildly diseased coronary artery can be the site of a heart attack. These will not show up on stress testing nor will they give you anginal symptom warnings. 

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KNOW YOUR RISK!  Ischemic heart disease (IHD) is the leading cause of death and disability worldwide and affects 17,600,000 Americans, resulting in about 450,000 deaths in the US annually.  Globally, 7.2 million deaths are caused by IHD each year.  You can read more at ischemiatrial.org.