Initial invasive strategy did not improve survival at 5 years in advanced CKD with ischemia
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Routine coronary angiography with revascularization when appropriate did not reduce 5-year mortality risk in patients with advanced chronic kidney disease and ischemia compared with an initial strategy of medical therapy.
Data from an interim, 5-year analysis of the ongoing ISCEHMIA-CKD trial, presented at the European Society of Cardiology Congress, also showed that adults with advanced CKD and at least moderate ischemic disease on stress testing are at very high risk for all-cause and CV death and therapies are “urgently” needed, according to Sripal Bangalore, MD, MHA, professor of medicine at NYU Langone Health.
“The death rate was close to around 39%,” Bangalore said during a press conference. “[Patients] had a very high rate of CV death, at 38%. An initial invasive strategy and an initial conservative strategy resulted in similar survival at a median of 5 years of follow-up.”
No differences between groups
As Healio previously reported, ISCHEMIA-CKD comprised a separate population from the main ISCHEMIA trial, with 777 participants (median age, 63 years; 31% women) who had CKD and stable ischemic heart disease. Within this high-risk cohort, 57% had diabetes, 53% were on dialysis, 38% had severe ischemia and 51% had multivessel CAD. For the invasive strategy, participants received optimal medical therapy plus diagnostic catheterization, and underwent PCI or CABG based on results of the catheterization. Patients assigned the conservative strategy received optimal medical therapy alone and diagnostic catheterization if they failed optimal medical therapy.
“This makes [ISCHEMIA-CKD] the largest treatment strategy trial of stable coronary artery disease and advanced CKD,” Bangalore said.
Initial findings at 3 years showed the primary endpoint of death or MI occurred in 36.4% of the invasive group vs. 36.7% of the conservative group (aHR = 1.01; 95% CI, 0.79-1.29). The major secondary endpoint of death, MI, hospitalization for HF or unstable angina or resuscitated cardiac arrest also did not differ between the groups.
Now, at a median follow-up of 5 years, there were 305 deaths, including 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 between-group difference in all-cause death (aHR = 1.12; 95% CI, 0.89-1.41; P = .322). In a Bayesian analysis, the probability of a 1% reduction in death risk at 5 years with invasive strategy was 11%, compared with 74% for a conservative strategy, Bangalore said.
For CV death, there was similarly no between-group difference, with an adjusted HR of 1.04 (95% CI, 0.8-1.37; P = .753). In a Bayesian analysis for CV death, the probability of a 1% reduction at 5 years with invasive strategy was 27.9%, compared with 47.6% for a conservative strategy, Bangalore said.
“In the randomized phase, the invasive strategy had a lower risk of spontaneous MI but higher rates of procedure-related MI,” Bangalore said.
“Longer-term follow-up will evaluate the impact at a median of 9 years,” Bangalore said. “Urgent therapies are need to reduce the risk for death in this cohort of patents.”
Revascularization safe when indicated
Bangalore said clinicians are often hesitant to intervene with patients with advanced CKD and ischemic disease; the ISCHEMIA-CKD findings did demonstrate that intervention was safe.
“What we showed in the trial, at least, is that an invasive strategy is safe,” Bangalore said. “If patients have an indication for revascularization — for example, if they come in with ACS — if you follow protocol and strategies to minimize risk, you can safely go ahead and do it. What this study also shows, is that in patients who have stable CAD, routine revascularization may not have significant benefit.”
Perspective
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The ISCHEMIA-CKD EXTEND study found that patients with advanced CKD and at least moderate ischemia on stress test had high rates of death (~39%), which was mostly related to CVD, at a longer 5-year follow-up. However, an initial invasive strategy of coronary angiography with revascularization did not reduce mortality risk compared with an initial conservative strategy of guideline-directed medical therapy alone.
When combined with guideline-directed medical therapy, an initial invasive management strategy did not reduce the high mortality risk in patients with advanced CKD and myocardial ischemia. This emphasizes that optimal medical management should be the main cardioprotective strategy patients with advanced CKD.
We should keep in mind that the ISCHEMIA-CKD trial excluded patients ACS, highly symptomatic patients and patients with left ventricular ejection fraction < 35%. Furthermore, unlike the main ISCHEMIA trial, ISCHEMIA-CKD did not perform screening coronary CTA to rule out left main or nonobstructive CAD. Approximately one-fourth of the ISCHEMIA-CKD participants had no obstructive CAD despite presence of moderate-to-severe ischemia on stress testing, highlighting a potentially higher prevalence of microvascular disease in patients with advanced CKD, which may have contributed to the current findings.
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Bangalore S, et al. Hot Line 8. Presented at: European Society of Cardiology Congress; Aug. 26-29, 2022; Barcelona, Spain (hybrid meeting).
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