Diana Zuckerman, PhD, National Center for Health Research
Heart bypass surgery and stents are no better at preventing heart attacks and death in patients with stable heart disease than pills and lifestyle improvements alone, according to a very important study presented in November 2019 at the annual meeting of the American Heart Association.1
The goal of the $100 million clinical trial funded by the NIH was to resolve a major controversy in the treatment of heart disease. The researchers found that invasive procedures to unclog blocked arteries were better than medication at reducing patients’ chest pain during exercise, but there was no difference in heart attacks, heart-related hospitalizations, resuscitation after cardiac arrest, or deaths from heart disease.
Stable heart disease is defined as having clogged arteries, sometimes accompanied by chest pain (angina) when the patients exert themselves. The study, called ISCHEMIA, concluded that there was no benefit to patients who did not have chest pain. However, stents can save lives for patients who are having a heart attack.
The results for patients with stable heart disease are similar to a major study published 12 years ago – findings that were rejected by many cardiac surgeons.2 As a very well-designed study that confirms previous research findings, the ISCHEMIA trial should be considered conclusive evidence that an early invasive approach does not protect most heart disease patients against death or the overall chance of a heart attack, but it does relieve chest pain associated with exercise. The more pain, the more likely the patient will benefit. However, based on the 2019 study results, some patients who experience chest pain might decide that they will forgo the procedure since it won’t help them live longer or avoid a heart attack.
Coronary heart disease affects 17.6 million Americans. About half a million heart stent procedures are performed in the U.S every year, and researchers estimate that about 23,000 are for people with stable heart disease who do not have any chest pain. Companies that make stents make billions of dollars and the procedures provide billions to cardiologists and hospitals.
- NYU Langone Health. International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA) (ISCHEMIA). ClinicalTrials.gov Identifier: NCT01471522. https://clinicaltrials.gov/ct2/show/NCT01471522
- Boden WE, O’Rourke RA, Teo KK, et al. Optimal Medical Therapy with or without PCI for Stable Coronary Disease. New England Journal of Medicine. 2007;356:1503-1516. https://www.nejm.org/doi/full/10.1056/NEJMoa070829