Compare-Acute
Trial question
What is the effect of FFR-guided multivessel angioplasty in patients with ST-segment elevation MI and multivessel disease who underwent primary PCI of an infarct-related coronary artery?
Study design
Multi-center
Single blinded
RCT
Population
Characteristics of study participants
23.0% female
77.0% male
N = 885
885 patients (202 female, 683 male).
Inclusion criteria: patients with STEMI and multivessel disease who had undergone primary PCI of an infarct-related coronary artery.
Key exclusion criteria: left main coronary artery disease, chronic total occlusion, severe stenosis, with a Thrombolysis in Myocardial Infarction (TIMI) flow grade of ≤ 2 in the non-infarct-related coronary artery, suboptimal result or complications after treatment of an infarct-related coronary artery, severe valve dysfunction, and Killip class III or IV.
Interventions
N=295 complete percutaneous coronary revascularization (FFR-guided complete revascularization of non-infarct-related coronary arteries).
N=590 infarct artery-only percutaneous coronary revascularization (no revascularization of non-infarct-related coronary arteries).
Primary outcome
All-cause death, nonfatal MI, revascularization and cerebrovascular events at 12 months
7.8%
20.5%
20.5 %
15.4 %
10.3 %
5.1 %
0.0 %
Complete percutaneous coronary
revascularization
Infarct artery-only percutaneous coronary
revascularization
Significant
decrease ▼
NNT = 7
Significant decrease in all-cause death, nonfatal MI, revascularization and cerebrovascular events at 12 months (7.8% vs. 20.5%; HR 0.35, 95% CI 0.22 to 0.55).
Secondary outcomes
No significant difference in death from any cause (1.4% vs. 1.7%; HR 0.8, 95% CI 0.25 to 2.56).
Safety outcomes
Significant difference in FFR-related serious adverse event (0 vs. 0.2%).
Conclusion
In patients with STEMI and multivessel disease who had undergone primary PCI of an infarct-related coronary artery, complete percutaneous coronary revascularization was superior to infarct artery-only percutaneous coronary revascularization with respect to a all-cause death, nonfatal MI, revascularization and cerebrovascular events at 12 months.
Reference
Smits PC, Abdel-Wahab M, Neumann FJ et al. Fractional Flow Reserve-Guided Multivessel Angioplasty in Myocardial Infarction. N Engl J Med. 2017 Mar 30;376(13):1234-1244.
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