ISCHEMIA Trial Examines Invasive vs. Conservative Strategy in SIHD Patients
An invasive management strategy may not demonstrate a reduced risk vs. a conservative management strategy of optimal medical therapy in patients with stable ischemic heart disease (SIHD) and moderate or severe ischemia, according to results of the ISCHEMIA trial presented Nov. 16 during AHA 2019 in Philadelphia, PA.
Judith S. Hochman, MD, FACC, et al., looked at 5,179 patients with SIHD and moderate or severe ischemia over a median of 3.3 years who were randomized to an invasive strategy of routine cardiac catheterization followed by optimal revascularization with PCI or CABG surgery vs. a conservative strategy with cardiac catheterization if there was failure of optimal medical therapy.
Results showed that the cumulative incidence of the primary endpoint a composite of cardiovascular death, MI, resuscitated cardiac arrest, or hospitalization for unstable angina or heart failure was 15.5 percent in the conservative group vs. 13.3 percent in the invasive group after 4 years. In addition, the cumulative incidence of the major secondary endpoint cardiovascular death or MI was 13.9 percent in the conservative group vs. 11.7 percent in the invasive group after 4 years.
Of note, the researchers explain that "the curves cross for the primary endpoint and the major secondary endpoint at approximately 2 years from randomization." Further, "the probability of at least a 10 percent benefit of the invasive group on all-cause mortality was <10 percent, based on pre-specified Bayesian analysis."
Meanwhile, in a separate ISCHEMIA quality of life outcomes analysis also presented during AHA 2019, John A. Spertus, MD, MPH, FACC, et al., found "significant, durable improvements in angina control and quality of life with an invasive strategy if they had angina." However, in patients without angina, "an invasive strategy led to minimal symptom or quality of life benefits," vs. a conservative strategy.
They conclude that moving forward, "in patients with angina, shared decision-making should occur to align treatment with patients' goals and preferences."
The ISCHEMIA-CKD trial by Sripal Bangalore, MBBS, FACC, et al., also presented during AHA 2019, further showed that an invasive strategy was not superior to a conservative strategy in patients with advanced CKD and moderate or severe ischemia.
The investigators looked at 777 patients randomized to the invasive or conservative strategy. The median age was 63 years and 53 percent were on dialysis. For those patients not on dialysis, 86 percent had CKD stage 4 and 14 percent had CKD stage 5 at baseline.
Results showed that the cumulative incidence of the primary endpoint a composite of death or nonfatal MI was 36.7 percent in the conservative group vs. 36.4 percent in the invasive group after 3 years. In addition, the cumulative incidence of the major secondary endpoint a composite of death, nonfatal MI, hospitalization for unstable angina, hospitalization for heart failure, or resuscitated cardiac arrest was 39.7 percent in the conservative group vs. 38.5 percent in the invasive group after 3 years.
A separate ISCHEMIA-CKD quality of life outcomes analysis also presented during AHA 2019 by Spertus, et al., found that in patients with stable CAD, advanced CKD and moderate to severe ischemia, there was not a "substantial improvement" in angina control and quality of life over time.
Keywords: AHA19, AHA Annual Scientific Sessions, Myocardial Revascularization, Angiography, Percutaneous Coronary Intervention, Dyslipidemias
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