Comparison of Patients Undergoing Percutaneous Coronary Intervention in Contemporary U.S. Practice With ISCHEMIA
Saurav Chatterjee1, Alexander C Fanaroff2, Craig Parzynski3
1Division of Cardiovascular Medicine, North Shore-Long Island Jewish Medical Centers, Northwell Health, Donald and Barbara Zucker School of Medicine New York at Hofstra/Northwell, Hempstead, New York, USA.
Insights
Only 32.28% of patients with stable ischemic heart disease (SIHD) undergoing percutaneous coronary intervention (PCI) met ISCHEMIA trial criteria. This highlights variability in applying trial eligibility in real-world U.S. practice.
Area of Science:
- Cardiology
- Interventional Cardiology
- Clinical Trials
Background:
- The ISCHEMIA trial evaluated revascularization in stable ischemic heart disease (SIHD), finding improved angina but little impact on mortality or myocardial infarction.
- Understanding the generalizability of ISCHEMIA trial findings to current U.S. interventional practice is crucial.
Purpose of the Study:
- To determine the proportion of patients undergoing percutaneous coronary intervention (PCI) for SIHD in the U.S. who meet ISCHEMIA trial enrollment criteria.
- To assess the variation in the proportion of eligible SIHD patients across different hospitals.
Main Methods:
- A cross-sectional analysis of 388,212 patients undergoing PCI for SIHD was conducted using the National Cardiovascular Data Registry CathPCI Registry (v5.0).
- Patients were evaluated based on adherence to ISCHEMIA trial inclusion and exclusion criteria.
- 1,662 U.S. hospitals were included in the analysis.
Main Results:
- 32.28% (125,302 patients) of all SIHD patients undergoing PCI met the ISCHEMIA trial enrollment criteria.
- Significant variation existed among hospitals, with the median center enrolling 32.1% of eligible SIHD patients.
- Patients meeting trial criteria had lower unadjusted in-hospital mortality (0.11%) compared to those who did not.
Conclusions:
- A minority of contemporary U.S. patients undergoing PCI for SIHD meet the strict enrollment criteria of the ISCHEMIA trial.
- Substantial inter-center variability exists in the application of ISCHEMIA trial eligibility criteria in routine clinical practice.
Objectives:
The study sought to assess the proportion of patients in modern U.S. interventional practice that fulfilled criteria for enrollment in the ISCHEMIA (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches) trial.
Background:
The ISCHEMIA trial, which enrolled patients with stable ischemic heart disease (SIHD), showed that revascularization improved angina symptoms with little effect on death or myocardial infarction.
Methods:
A cross-sectional analysis of the National Cardiovascular Data Registry CathPCI Registry (v5.0), including 1,662 hospitals, was performed. Patients undergoing percutaneous coronary intervention (PCI) for SIHD in routine clinical practice meeting ISCHEMIA trial inclusion criteria and those that did not were evaluated.
Results:
During the study period, 388,212 patients underwent PCI for SIHD, comprising 41.88% of all patients undergoing PCI during the study period. Of these, 125,302 (32.28%; 13.52% of all patients undergoing PCI) met criteria for enrollment in the ISCHEMIA trial. Among SIHD patients that did not meet criteria, 71,852 (18.51%) had SIHD with high-risk features (35.2% left main disease, 43.7% left ventricular systolic dysfunction, 16.8% end-stage renal disease), 67,159 (17.3%) had SIHD with negative or low-risk functional testing, and 123,899 (31.92%) either had no stress testing or did not have ischemic burden reported. At the median hospital, 32.1% (interquartile range: 23.5%-40.6%) of SIHD patients met criteria for enrollment in the ISCHEMIA trial, with these patients experiencing lower unadjusted in-hospital mortality rate than comparator groups who met exclusion criteria for the trial (0.11%) (P < 0.01 for all comparisons).
Conclusions:
Among contemporary U.S. patients undergoing PCI for SIHD, 32.28% clearly met enrollment criteria for the ISCHEMIA trial. There was significant variation among individual centers in the proportion of SIHD patients meeting criteria for the ISCHEMIA trial.
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