Doubts Raised on Benefits of Angioplasty and Bypass Surgery

A new trial challenges medical dogma, revealing that early invasive strategies are no better than optimal medical therapy (OMT).

The ISCHEMIA study (funded by the U.S. Government at a cost of USD 100 million and conducted at 320 sites in 37 countries), randomly assigned 5,179 stable patients with moderate-severe ischemia to early invasive coronary catheterization followed by percutaneous coronary intervention (PCI) or coronary bypass surgery plus OMT, or to OMT alone. Angina frequency at baseline was none in 34%, several times per month in 44%, and daily or weekly in 22%. The primary outcome was a composite of cardiovascular death, myocardial infarction (MI), resuscitated cardiac arrest, or hospitalization for unstable angina or heart failure.

The results showed that at 3.3 years follow-up, the primary outcome occurred in 13.3% of the routine invasive group, compared with 15.5% of the OMT group, in multiple subgroups. Invasive therapy was associated with harm (2% absolute increase) within the first six months, and benefit within four years (2% absolute decrease). All-cause death occurred in 6.4% of the routine invasive group, compared with 6.5% of the OMT group. Improvements in quality of life (QOL) were observed among angina patients, but not in those angina-free. The study was presented at the annual American Heart Association (AHA) scientific sessions, held during November 2019 in Philadelphia (PA, USA).

“In line with evidence from prior studies, our results suggest that routine use of heart procedures was not superior in reducing risk for the five-part disease endpoint or death overall compared to treatment only with optimal medical therapy,” said senior author Professor Judith Hochman, MD, of NYU Langone Healh (New York, NY, USA). “On the other hand, patients symptomatic to start that got heart procedures, over the years, had fewer symptoms and felt better.”

“Based on our results, we recommend that all patients take medications proven to reduce the risk of a heart attack, be physically active, eat a healthy diet, and quit smoking,” said co-senior author David Maron, MD, of Stanford University School of Medicine (CA, USA). “Patients without angina will not see an improvement, but those with angina of any severity will tend to have a greater, lasting improvement in quality of life if they have an invasive heart procedure. They should talk with their physicians to decide whether to undergo revascularization.”

Angina is chest pain or discomfort that feels like pressure or squeezing in the chest, and may even feel like indigestion. It is usually a symptom of underlying coronary heart disease (CHD), most often due to ischemia. Variants include stable angina (Angina Pectoris), unstable angina, Prinzmetal angina, and microvascular angina.

Related Links:
NYU Langone Healh
Stanford University School of Medicine