At the KAHN CENTER, we work with many patients trying to avoid bypass surgery or stent placement. This is a very serious undertaking with potentially important implications. One of the fundamental research studies in the last decade on this topic has been the ISCHEMIA study, first published in 2021.
The ISCHEMIA trial examined the efficacy of surgical intervention in patients with ischemic heart disease, also known as coronary artery disease. IHD occurs when plaque accumulates in the heart’s major blood vessels, reducing its blood flow. It is the most common type of heart disease in the United States and the leading cause of death worldwide, resulting in more than 9 million deaths annually.
ISCHEMIA authors first presented their research at the annual American Heart Association conference in November 2019, and the New England Journal of Medicine published the much-anticipated study in March 2020. A collaboration between researchers at NYU Langone Health and 15 other institutions, the trial followed 5,000 subjects with moderate to severe IHD. Participants were split into two groups: One group received only lifestyle counseling and medical therapy. The other group received stents or bypass surgery in addition to lifestyle counseling and medical therapy. After a median duration of four and a half years, researchers found no significant difference in rates of heart attack and death between the two groups.
NOW, a report on the 9 year follow up of patients in this study provides further support that many patients can avoid these procedures and pursue lifestyle changes, medications, cardiac rehabilitation, and even ECP.
STUDY
In this long-term follow-up study of the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA), an international trial of patients with chronic coronary disease, moderate or severe ischemia, left ventricular ejection fraction of 35% or more, and no left main coronary artery disease, unacceptable angina, or recent acute coronary syndrome, participants were randomized at 320 sites in 37 countries beginning August 2012 and followed up through December 2025. Data were analyzed using the intention-to-treat principle.
RESULTS
Among 5179 participants, median age was 64 years; 23% were female, 42% had diabetes, and median ejection fraction was 60%.
During 9-year median follow-up (range, 1 day to 13.4 years), 1071 deaths occurred (782 during extended follow-up): 672 cardiovascular, 359 noncardiovascular, and 40 unclassified.
All-cause 11-year mortality was not significantly different between groups (26% invasive vs 27% conservative).
Cardiovascular mortality at 11 years was 16% in the invasive group vs 17% in the conservative group.
Noncardiovascular mortality at 11 years was 9% in the invasive group vs 8% in the conservative group.
CONCLUSIONS
In this study, long-term all-cause mortality in patients with high-risk chronic coronary disease was not significantly different after routine invasive vs initial conservative management.
The ISCHEMIA researchers note that these findings do not apply to people having a heart attack or those with severe chest pain—cases in which emergency surgery may be indicated.
At the KAHN CENTER, we recommend the following questions during a discussion with your medical team:
What can a heart patient do when faced with a recommendation for an invasive procedure?
The ISCHEMIA study did not include patients in the midst of a heart attack or true medical emergencies. There are patients, particularly those with recurrent and life-threatening symptoms being treated as in-patients in hospitals, who are in an urgent situation requiring an invasive procedure. Fortunately, most heart patients are stable and are outpatients when they are faced with making a decision about a procedure. In my experience, it is very difficult for a patient and their families to challenge a recommendation for a procedure. A list of questions to ask may be of help. Here are some questions worth asking the medical team:
1) Are you familiar with The ISCHEMIA study and can I be treated like the conservative group?
2) Can you refer me to an intensive cardiac rehabilitation (ICR) program like Pritikin ICR and Ornish ICR which my insurance will pay for?
3) Can I have external counterpulsation therapy (ECP) which my insurance will pay for?
4) Can I be referred to a preventive cardiologist to pursue lifestyle changes that go even further than The ISCHEMIA study?
The value of a 2nd opinion from a heart specialist who has no “skin in the game” cannot be overemphasized. For outpatients contemplating invasive procedures, there is usually time to schedule a 2nd opinion. I have performed many of these assessments and, on occasion, have even done this for hospitalized patients.
