ISCHEMIA
Trial question
What is the role of coronary revascularization in patients with stable CAD?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
23.0% female
77.0% male
N = 5179
5179 patients (1191 female, 3988 male).
Inclusion criteria: patients with stable ischemic heart disease and moderate or severe ischemia on noninvasive testing.
Key exclusion criteria: recent MI, eGFR < 30 mL/min, LVEF < 35%, LM stenosis > 50%, unacceptable angina.
Interventions
N=2588 invasive management (cath +/- revascularization).
N=2591 optimal medical therapy (no routine invasive therapy).
Primary outcome
CV death, nonfatal MI, resuscitated cardiac arrest, or hospitalization for UA or HF
13.3%
15.5%
15.5 %
11.6 %
7.8 %
3.9 %
0.0 %
Invasive
management
Optimal medical
therapy
No significant
difference ↔
No significant difference in CV death, nonfatal MI, resuscitated cardiac arrest, or hospitalization for UA or HF (13.3% vs. 15.5%; HR 0.93, 95% CI 0.8 to 1.08).
Secondary outcomes
No significant difference in death from any cause (6.4% vs. 6.5%; HR 1.05, 95% CI 0.83 to 1.32).
No significant difference in CV death or MI (11.7% vs. 13.9%; HR 0.87, 95% CI 0.66 to 1.15).
Significant increase in periprocedural MI (13.2% vs. 10.5%; HR 2.98, 95% CI 1.87 to 4.74).
Conclusion
In patients with stable ischemic heart disease and moderate or severe ischemia on noninvasive testing, invasive management was noninferior to optimal medical therapy with respect to CV death, nonfatal MI, resuscitated cardiac arrest, or hospitalization for UA or HF.
Reference
David J Maron, Judith S Hochman, Harmony R Reynolds et al. Initial Invasive or Conservative Strategy for Stable Coronary Disease. N Engl J Med. 2020 Apr 9;382(15):1395-1407.
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