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Myocardial Infarction and Functional Outcome Assessment in Pigs
Published on: April 25, 2014
Three-Year Outcomes With Fractional Flow Reserve-Guided or Angiography-Guided Multivessel Percutaneous Coronary
Etienne Puymirat1,2,3, Guillaume Cayla4, Tabassome Simon3,5,6
1Department of Cardiology, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital européen Georges Pompidou, France (E.P., D.B., N.D.).
Insights
In ST-segment-elevation myocardial infarction patients with multivessel disease, a fractional flow reserve (FFR)-guided strategy for non-infarct artery treatment was not superior to angiography guidance over 3 years. Outcomes included death, myocardial infarction, or urgent revascularization.
Area of Science:
- Cardiology
- Interventional Cardiology
- Clinical Trials
Background:
- Multivessel coronary artery disease in ST-elevation myocardial infarction (STEMI) patients requires careful revascularization strategies.
- The FLOWER-MI trial initially assessed fractional flow reserve (FFR)-guided versus angiography-guided treatment of non-infarct arteries at 1 year.
- An extension phase was planned to evaluate outcomes with longer follow-up.
Purpose of the Study:
- To determine if an FFR-guided strategy for complete revascularization in STEMI patients with multivessel disease is superior to an angiography-guided strategy.
- To compare the 3-year risk of death, myocardial infarction, or unplanned urgent revascularization between FFR-guided and angiography-guided complete revascularization.
Main Methods:
- A multicenter trial randomized 1163 STEMI patients with multivessel disease and successful infarct artery percutaneous coronary intervention.
- Patients received complete revascularization guided by either FFR (n=586) or angiography (n=577).
- The primary outcome was the composite of death from any cause, myocardial infarction, or unplanned hospitalization leading to urgent revascularization, assessed up to 3 years.
Main Results:
- After 3 years, the primary outcome occurred in 9.40% of the FFR-guided group and 8.17% of the angiography-guided group (hazard ratio, 1.19; P=0.4).
- Specific event rates: death (4.00% vs 4.32%), nonfatal myocardial infarction (4.13% vs 2.56%), and urgent revascularization (3.83% vs 3.36%).
- Event rates were lower than anticipated in both groups.
Conclusions:
- In STEMI patients with multivessel disease undergoing complete revascularization, an FFR-guided strategy did not demonstrate a significant benefit over angiography guidance at 3 years.
- The study did not show superiority of FFR guidance for reducing major adverse cardiovascular events in this population.
- Further research may be needed to explore potential benefits of FFR in specific patient subgroups or with different revascularization strategies.
Background:
In patients with multivessel disease with successful primary percutaneous coronary intervention for ST-segment-elevation myocardial infarction, the FLOWER-MI trial (Flow Evaluation to Guide Revascularization in Multivessel ST-Elevation Myocardial Infarction) showed that a fractional flow reserve (FFR)-guided strategy was not superior to an angiography-guided strategy for treatment of noninfarct-related artery lesions regarding the 1-year risk of death from any cause, myocardial infarction, or unplanned hospitalization leading to urgent revascularization. The extension phase of the trial was planned using the same primary outcome to determine whether a difference in outcomes would be observed with a longer follow-up.
Methods:
In this multicenter trial, we randomly assigned patients with ST-segment-elevation myocardial infarction and multivessel disease with successful percutaneous coronary intervention of the infarct-related artery to receive complete revascularization guided by either FFR (n=586) or angiography (n=577).
Results:
After 3 years, a primary outcome event occurred in 52 of 498 patients (9.40%) in the FFR-guided group and in 44 of 502 patients (8.17%) in the angiography-guided group (hazard ratio, 1.19 [95% CI, 0.79-1.77]; P=0.4). Death occurred in 22 patients (4.00%) in the FFR-guided group and in 23 (4.32%) in the angiography-guided group (hazard ratio, 0.96 [95% CI, 0.53-1.71]); nonfatal myocardial infarction in 23 (4.13%) and 14 (2.56%), respectively (hazard ratio, 1.63 [95% CI, 0.84-3.16]); and unplanned hospitalization leading to urgent revascularization in 21 (3.83%) and 18 (3.36%; hazard ratio, 1.15 [95% CI, 0.61-2.16]), respectively.
Conclusions:
Although event rates in the trial were lower than expected, in patients with ST-segment-elevation myocardial infarction undergoing complete revascularization, an FFR-guided strategy did not have a significant benefit over an angiography-guided strategy with respect to the risk of death, myocardial infarction, or urgent revascularization up to 3 years.
Registration:
URL: https://www.clinicaltrials.gov; Unique identifier: NCT02943954.
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