ISCHEMIA Study: Changing the Ethical Standard of Discussing Heart Care With Patients
The “New” Clinic Visit
“Have a seat Mrs. Jones. You too Mr. Jones. Mrs. Jones, as you know, your internist Dr. Smith was concerned about your complaints of shortness of breath and tightness walking up hills and ordered a stress test. He asked you to come to my cardiology office today to discuss the results. You exercised well but the pictures made of your heart show a fairly large area of the muscle apparently not receiving adequate blood flow. The strong suspicion is that you have blocked heart arteries, one or more, which is not impossible with your history of taking blood pressure and cholesterol medications. We have several approaches from here we can choose. In the past, we would schedule a procedure called a heart catheterization, threading a tube through your wrist or leg artery, and inject dye to image any blocked areas. If appropriate, we would place one or more stents at that same time unless the disease was so bad you needed to consider a bypass operation. Now we know that for most people like you, this has no better a chance of keeping you alive and well compared to adding aspirin and a medication called a beta-blocker. We would schedule an outpatient test called a CT angiogram to insure you did not have the most serious of blockages, a severe left main narrowing, and if you do not, we can proceed with the medications, education on diet, and referral to a cardiac rehabilitation exercise program. It is likely if you make significant changes to your diet and habits, you will not need any more procedures. If you worsen, then we can always do the catheterization and stents. Do you understanding the options you have?”
Why the Change? The ISCHEMIA Study
This week one of the most anticipated and expensive trials in the history of cardiology care ($100 million) was presented at the annual American Heart Association meeting in Philadelphia, The ISCHEMIA study. This study randomized just over 5,000 patients identified at a network of international treatment centers with moderate to large zones of ischemia on stress testing in the setting of suspected CAD. Many had a coronary CT angiogram to evaluate for and exclude severe disease of the left main trunk and those without it were randomized to optimal medical therapy and lifestyle changes alone or those therapies plus catheterization. Of those that underwent coronary catheterization, 80% had an intervention most of which were the placement of stents and about 25% were treated with coronary bypass surgery. The subjects were followed for up to 4 years and the results were presented. There were no differences in the 2 groups for overall death rates or cardiovascular death rates. The primary composite end point was not significantly different between the 2 groups. As was summarized by the American College of Cardiology (ACC):
“Results showed that the cumulative incidence of the primary endpoint — a composite of cardiovascular death, MI, resuscitated cardiac arrest, or hospitalization for unstable angina or heart failure — was 15.5 percent in the conservative group vs. 13.3 percent in the invasive group after 4 years. In addition, the cumulative incidence of the major secondary endpoint — cardiovascular death or MI — was 13.9 percent in the conservative group vs. 11.7 percent in the invasive group after 4 years”.
A subgroup of 777 patients enrolled with chronic kidney disease, usually viewed as higher risk, was also presented. As summarized by the ACC,
“Results showed that the cumulative incidence of the primary endpoint — a composite of death or nonfatal MI — was 36.7 percent in the conservative group vs. 36.4 percent in the invasive group after 3 years. In addition, the cumulative incidence of the major secondary endpoint — a composite of death, nonfatal MI, hospitalization for unstable angina, hospitalization for heart failure, or resuscitated cardiac arrest — was 39.7 percent in the conservative group vs. 38.5 percent in the invasive group after 3 years”.
Skin in the Game
Already the discussion at #cardiotwitter leads to the suspicion that interventional cardiologists are not planning to change, or specifically, decrease their volume of invasive procedures after the ISCHEMIA study presentation. The justification appears to be quality of life and angina control, as survival at this point is not superior with invasive treatments. One of the researchers in the study, Judith Hochman, MD, predicted that over half a billion dollars a year could be saved from the health care budget by offering patients the option of conservative care with lifestyle intervention.
The pressing question is, is it ethical to recommend a catheterization for patients similar to the ISCHEMIA Study cohort without offering and documenting a discussion about the conservative approach? Most patients can achieve control of angina with titration of medication combined with dietary and lifestyle changes as are taught at insurance covered intensive cardiac rehabilitation programs. The addition of external counterpulsation, another insurance covered treatment for angina, should be offered to more patients. It could be argued that for decades an ethical informed consent discussion with a cardiac patient should have included and documented the option of lifestyle changes and medication. After ISCHEMIA, there is no doubt that every patient not suffering acute coronary syndromes and unstable symptoms must be educated on their choice of a non -invasive path and follow up. It is anticipated that if ethical and honest conversations with patients become the norm, cardiac rehabilitation programs will see more referrals and lifestyle medicine cardiologists will be in more demand.