In patients with advanced chronic kidney disease and chronic coronary disease, an invasive strategy does not reduce the five-year risk of death compared to a conservative strategy.
Previous trials of an invasive versus conservative strategy for the management of chronic coronary disease have excluded patients with advanced chronic kidney disease or included only a small proportion of these patients. Therefore, the optimal management of this high risk group of patients is unknown.
The primary results of the ISCHEMIA-CKD trial have been previously reported. The trial enrolled 777 patients with advanced chronic kidney disease (defined as estimated glomerular filtration rate <30 ml/min/1.73 m2 or on dialysis) and moderate or severe ischemia on stress testing. The median age of participants was 63 years and 31% were women. Patients were randomly allocated to: 1) an initial invasive strategy, which consisted of cardiac catheterization and optimal revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG), if suitable, plus guideline directed medical therapy versus 2) an initial conservative strategy of guideline directed medical therapy alone, with cardiac catheterization and revascularization with PCI or CABG, if suitable, reserved for failure of medical therapy. At a median follow up of 2.2 years, the initial invasive strategy did not reduce the primary outcome of death or nonfatal myocardial infarction.
ISCHEMIA-CKD EXTEND is following up trial participants for a median of nine years. The results of an interim analysis at five years are reported today. The analysis included all 777 patients from the trial. The primary endpoint was all-cause death and the secondary endpoints were cardiovascular death and non-cardiovascular death.
At a median follow up of five years, there were a total of 305 deaths (113 since publication of the primary results), of which 158 occurred in the invasive group and 147 occurred in the conservative group. There was no significant difference in death between groups (adjusted hazard ratio 1.12; 95% confidence interval 0.89–1.41; p=0.322).
Principal investigator Professor Sripal Bangalore of the New York University School of Medicine, U.S. said, “In this five year follow up of patients from the ISCHEMIA-CKD trial, an initial invasive management strategy did not improve survival when added to guideline directed medical therapy in patients with advanced chronic kidney disease and chronic coronary disease. Similarly, there were no significant differences in cardiovascular death or non-cardiovascular death with an invasive versus conservative strategy. Further analyses showed no significant heterogeneity of treatment effect for any subgroup. Of note, the death rate was very high with close to 40% mortality at five years indicating a very high risk group of patients who are in urgent need of therapies to reduce this risk.”