ISCHEMIA trial represents small fraction of sufferers present process intervention

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Results from a new study show that a wide range of patients undergoing revascularization for stable ischemic heart disease (SIHD) in the United States did not meet eligibility criteria for the ISCHEMIA study. The data, presented today at the Society for Cardiovascular Angiography & Interventions (SCAI) 2021 Scientific Sessions as Breakthrough Clinical Science, shows that a minority of SIHD patients referred for coronary interventions in today's practice are clearly similar to those who who were included in the ISCHEMIA study.

Ischemic heart disease affects more than 13 million people in the United States and is the leading cause of death and disability worldwide. Treatment for ischemia includes a variety of medical therapies, as well as procedures such as percutaneous coronary interventions (PCI) to open clogged arteries and improve blood flow to the heart. The 2020 ISCHEMIA study, which found that procedural strategy did not reduce the risk of death or myocardial infarction compared to medical therapy alone, was extensively reported and questioned the practice of coronary intervention and revascularization. The aim of the current study was to determine the proportion of PCI patients in the US who fall under the ISCHEMIA inclusion criteria.

"The ISCHEMIA study is one of the most important studies in interventional cardiology in the past decade. While the results are very valuable in decision-making in many patients, the population included does not appear to be representative of the broad range of patients modern US coronary interventionists encounter "said the study's senior author, Jay Giri, MD, MPH, Penn Medicine.

A cross-sectional analysis of the CathPCI registry of the National Cardiovascular Data Registry (NCDR) was conducted between October 2017 and June 2019 (an interval representative and including the time the ISCHEMIA study was conducted), which involved more than 1,600 hospitals and 388,212 patients . Participants included patients undergoing PCI for SIHD in routine clinical practice. This SIHD population accounted for 42.9% of all PCIs performed during the period studied, with the majority of US PCIs being performed in patients with acute coronary syndrome, cardiac arrest, or cardiogenic shock. Patients who met the ISCHEMIA study inclusion criteria (SIHD, moderate to severe ischemia on function tests, lack of anatomical or clinical features at high risk) and those who were not identified.

Of US patients who underwent PCI for SIHD between October 2017 and June 2019, 32.3% met the criteria for inclusion in the ISCHEMIA study. Among the SIHD patients who did not meet the criteria, 18.5% had SIHD with high risk characteristics (35.2% left major disease, 43.7% left ventricular systolic dysfunction, 16.8% end-stage kidney disease), 17.3% SIHD with negative or low risk function tests and 31.9% either had no stress tests or no ischemic exposure was reported. Compared to the other SIHD cohorts, the ISCHEMIA-like cohort had the lowest in-hospital mortality rate (0.1%) and comparable in-hospital bleeding (0.6%) and an acute kidney injury requiring hemodialysis (0.04%) ).

"Our study shows that most of the patients who have an intervention will not be included in the ISCHEMIA study," said Dr. Saurav Chatterjee, Principal Researcher and Cardiologist at Northwell Health. "These results help shed some light on what is really happening in Cath laboratories across the country and the types of patients referred for intervention."

The full manuscript is currently being examined.

Variation in revascularization in asymptomatic SIHD unexplained

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Society for Cardiovascular Angiography and Interventions

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