Initial Invasive or Conservative Strategy for Stable Coronary Disease.
Level 2 - randomized trial
Large multicenter randomized controlled trial
PubMed 32227755 · doi:10.1056/NEJMoa1915922
What was done
5,179 patients with stable coronary artery disease and moderate or severe ischemia were randomized to an initial invasive strategy (angiography and revascularization when feasible plus medical therapy) or an initial conservative strategy (medical therapy alone, with angiography reserved for medical therapy failure). Patients were followed for a median of 3.2 years. The primary composite endpoint was cardiovascular death, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest.
What was found
Over a median follow-up of 3.2 years, 318 primary outcome events occurred in the invasive group versus 352 in the conservative group. At 6 months, cumulative event rates were higher with the invasive strategy (5.3% vs. 3.4%; difference, 1.9 percentage points; 95% CI, 0.8 to 3.0), whereas at 5 years event rates favored the invasive strategy without statistical significance (16.4% vs. 18.2%; difference, -1.8 percentage points; 95% CI, -4.7 to 1.0). All-cause mortality was similar between groups (145 deaths in invasive vs. 144 in conservative; hazard ratio, 1.05; 95% CI, 0.83 to 1.32). Primary outcome rates were sensitive to the definition of myocardial infarction, with secondary analyses yielding more procedural myocardial infarctions of uncertain clinical importance.
Why it matters
This trial demonstrates that adding routine early angiography and revascularization to optimal medical therapy does not reduce long-term mortality or major composite ischemic events in patients with stable coronary disease and moderate-to-severe ischemia.
Limits
Median follow-up was limited to 3.2 years, potentially missing differences that emerge later. Findings were sensitive to the definition of myocardial infarction used, and the invasive arm incurred early excess procedural infarctions.
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