Pooled data from the most important recently published studies (FAME 2, Compare-Acute, and DANAMI3-PRIMULTI) conclude that there is a significant difference in favor of fractional flow reserve (FFR) as regards hard endpoints.
Coronary revascularization guided by FFR reduces the risk of death and infarction when compared with optimal medical treatment in patients with stable and unstable coronary disease.
FFR reduces the absolute risk of cardiac death and infarction by 4.5% compared with the best medical therapy (hazard ratio [HR]: 0.72; 95% confidence interval [CI]: 0.54-0.96). Mortality alone, either all-cause or cardiac, was not reduced with angioplasty, but there was a 29% reduction in the relative risk of infarction among patients undergoing FFR-guided angioplasty.
Read also: EuroPCR 2018 | FAME 2: FFR Shows 5-Year Benefit for Hard Endpoints.
This combined analysis is controversial because it includes the FAME 2 trial, with stable coronary patients, the Compare-Acute trial, and the DANAMI3-PRIMULTI trial, with patients who have undergone successful primary angioplasty and in whom FFR is used to assess the remaining non-culprit lesions.
Looking at the event curves, there is a separation in favor of FFR occurring at 1, 2, and 3 years.
The combined analysis included 2400 patients with stable coronary artery disease, of whom 1056 underwent FFR-guided angioplasty and 1344 received optimal medical treatment. The DANAMI3-PRIMULTI and Compare-Acute trials included patients with acute myocardial infarction who underwent successful primary angioplasty, but who had additional functionally significant lesions. After primary angioplasty, these stabilized patients were randomized to optimal medical treatment or FFR-guided angioplasty.
Read also: EuroPCR 2018 | SCAAR Registry at 10 years: FFR improves decision making in the long term.
The benefit was mainly driven by a reduction in the rates of infarction, which was observed in all analyzed patient subgroups.
Given the differences in the clinical characteristics of the FAME 2 patients, compared with the DANAMI3-PRIMULTI and Compare-Acute patients, several experts were cautious as regards the pooled results of these 3 trials.
Some suggest waiting a few days (about a week) before analyzing non-culprit lesions after primary angioplasty (once the patient is stable), but reality indicates that FFR results between the acute event and a few days later are similar.
FFR is unnecessary for certain patients, such as those with angina, positive functional tests, and a single-vessel angiographic lesion matching ischemic territory. However, patients who go into the cath lab with such diagnosis and then turn out to present multiple angiographic lesions are, unfortunately, increasingly frequent. Should all their lesions be revascularized?
Original title: FFR-Guided PCI Versus Medical Therapy to Reduce Cardiac Death or Myocardial Infarction.
Reference: Zimmermann FM et al. EuroPCR 2018. May 22, 2018. Paris, France.
Pool-analisis-de-DANAMI3-Primulti-FAME2-y-Compare-Acute-presentación
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