DANAMI-3 PRIMULTI
Trial question
What is the role of FFR-guided complete revascularization in patients with acute ST-segment elevation MI and multivessel coronary disease?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
19.0% female
81.0% male
N = 627
627 patients (121 female, 506 male).
Inclusion criteria: patients with acute ST-segment elevation MI (STEMI) who had ≥ 1 clinically significant coronary stenosis in addition to the lesion in the infarct-related artery.
Key exclusion criteria: intolerance of contrast media or of relevant anticoagulant or antithrombotic drugs, unconsciousness or cardiogenic shock, stent thrombosis, indication for CABG, or increased bleeding risk.
Interventions
N=314 complete revascularization (guided by FFR after primary PCI).
N=313 no further invasive treatment (PCI of infarct-related artery only).
Primary outcome
All-cause death, nonfatal reinfarction, and ischemia-driven revascularization of lesions in noninfarct-related arteries
13%
22%
22.0 %
16.5 %
11.0 %
5.5 %
0.0 %
Complete
revascularization
No further invasive
treatment
Significant
decrease ▼
NNT = 11
Significant decrease in all-cause death, nonfatal reinfarction, and ischemia-driven revascularization of lesions in noninfarct-related arteries (13% vs. 22%; HR 0.56, 95% CI 0.38 to 0.83).
Secondary outcomes
Significant decrease in nonurgent PCI (3% vs. 9%; HR 0.29, 95% CI 0.13 to 0.63).
Conclusion
In patients with acute ST-segment elevation MI (STEMI) who had ≥ 1 clinically significant coronary stenosis in addition to the lesion in the infarct-related artery, complete revascularization was superior to no further invasive treatment with respect to a all-cause death, nonfatal reinfarction, and ischemia-driven revascularization of lesions in noninfarct-related arteries.
Reference
Engstrom T, Kelbaek H, Helqvist S et al. Complete revascularisation versus treatment of the culprit lesion only in patients with ST-segment elevation myocardial infarction and multivessel disease (DANAMI-3-PRIMULTI): an open-label, randomised controlled trial. Lancet. 2015 Aug 15;386(9994):665-71.
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