Management of Coronary Disease in Patients with Advanced Kidney Disease

Abstract

Background: Clinical trials that have assessed the effect of revascularization in patients with stable coronary disease have routinely excluded those with advanced chronic kidney disease.

Methods: We randomly assigned 777 patients with advanced kidney disease and moderate or severe ischemia on stress testing to be treated with an initial invasive strategy consisting of coronary angiography and revascularization (if appropriate) added to medical therapy or an initial conservative strategy consisting of medical therapy alone and angiography reserved for those in whom medical therapy had failed. The primary outcome was a composite of death or nonfatal myocardial infarction. A key secondary outcome was a composite of death, nonfatal myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest.

Results: At a median follow-up of 2.2 years, a primary outcome event had occurred in 123 patients in the invasive-strategy group and in 129 patients in the conservative-strategy group (estimated 3-year event rate, 36.4% vs. 36.7%; adjusted hazard ratio, 1.01; 95% confidence interval [CI], 0.79 to 1.29; P = 0.95). Results for the key secondary outcome were similar (38.5% vs. 39.7%; hazard ratio, 1.01; 95% CI, 0.79 to 1.29). The invasive strategy was associated with a higher incidence of stroke than the conservative strategy (hazard ratio, 3.76; 95% CI, 1.52 to 9.32; P = 0.004) and with a higher incidence of death or initiation of dialysis (hazard ratio, 1.48; 95% CI, 1.04 to 2.11; P = 0.03).

Conclusions: Among patients with stable coronary disease, advanced chronic kidney disease, and moderate or severe ischemia, we did not find evidence that an initial invasive strategy, as compared with an initial conservative strategy, reduced the risk of death or nonfatal myocardial infarction. (Funded by the National Heart, Lung, and Blood Institute and others; ISCHEMIA-CKD ClinicalTrials.gov number, NCT01985360.).

Figure 1.. Primary Outcome and Key Secondary Outcome.

Shown are the results of the time-to-event analysis for the primary outcome (a composite of death or nonfatal myocardial infarction) (Panel A) and a key secondary outcome (a composite of death, nonfatal myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest) (Panel B) among patients in the invasive-strategy group and the conservative-strategy group.

Figure 2. Death, Myocardial Infarction, and Hospitalization for Unstable Angina or Heart Failure.

Shown are the results of time-to-event analyses of death (Panel A), myocardial infarction (Panel B), hospitalization for unstable angina (Panel C), and hospitalization for heart failure (Panel D) in the two trial groups. In each panel, the insets show the same data on an enlarged y axis.

Figure 3.. Subgroup Analysis of Treatment Effect for the Primary Outcome.

Shown are the adjusted hazard ratios for the primary outcome of death or nonfatal myocardial infarction according to prespecified subgroup. GBMT denotes guideline-based medical therapy.