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FAME 2: FFR-guided PCI leads to better outcomes than medical therapy in stable CAD

Among patients with stable CAD and angiographically significant stenoses, an initial fractional flow reserve-guided PCI strategy conferred better outcomes than medical therapy, according to 5-year results of the FAME 2 trial presented at EuroPCR.

As Cardiology Today’s Intervention previously reported, for the FAME 2 trial, Panagiotis Xaplanteris, MD, PhD, from Cardiovascular Center Aalst, Onze-Lieve-Vrouw Clinic, Aalst, Belgium, and colleagues performed FFR in 1,220 patients with stable CAD to determine hemodynamically significant stenosis, defined as at least one stenosis with FFR of 0.8 or less. Of the cohort, 888 patients had at least one hemodynamically significant stenosis and were randomly assigned to FFR-guided PCI plus medical therapy (mean age, 64 years; 80% men) or medical therapy alone (mean age, 64 years; 77% men).

The primary endpoint was a composite of death, MI or urgent revascularization.

Bernard De Bruyne, MD, PhD
Bernard De Bruyne

“The role of PCI in patients with stable coronary artery disease remains very controversial,” Bernard De Bruyne, MD, PhD, co-director of Cardiovascular Center Aalst, said in an interview. “There are a lot of positive data for PCI in patients with unstable syndromes, but in stable disease, we have very few data. The aim of the study was to compare the rates of death, MI and urgent revascularization after fractional flow reserve-guided PCI plus medical therapy vs. medical therapy alone in patients with stable coronary artery disease.”

At 5 years, the primary endpoint occurred in 13.9% of the PCI group vs. 27% of the medical therapy group (HR = 0.46; 95% CI, 0.34-0.63), according to the researchers.

The difference was driven by urgent revascularization, which occurred in 6.3% of the PCI group and 21.1% of the medical therapy group (HR = 0.27; 95% CI, 0.18-0.41), but also by spontaneous MI. In addition, the difference between the two groups kept increasing after 3 years, according to the researchers.

“The 5-year results of the FAME 2 trial confirm the importance of an FFR-based selection for PCI of both patients and lesions,” Xaplanteris said during a presentation. “It is confirmed that when FFR is above 0.8, the outcome is really favorable with medical therapy. What is new is that when FFR is equal to or less than 0.8, PCI with second-generation drug-eluting stents provides sustained benefits in the need for urgent revascularization, in the rate of spontaneous myocardial infarctions and in symptomatic relief. These come without the late catch-up phenomenon.”

There were no significant differences between the groups in death (PCI, 5.1%; medical therapy, 5.2%; HR = 0.98; 95% CI, 0.55-1.75) or MI (PCI, 8.1%; medical therapy, 12%; HR = 0.66; 95% CI, 0.43-1).

The patients who did not have at least one stenosis with FFR of 0.8 or less were not included in the randomized trial but were put in a registry and given medical therapy. Those patients did not significantly differ from the PCI group in the primary endpoint at 5 years (PCI, 13.9%; registry, 15.7%; HR = 0.88; 95% CI, 0.55-1.39).

“The event rate of [the patients in the registry] was almost identical to that of the patients who got a stent, which means that if we target the stenosis, and we alleviate the ischemia-producing lesions by stenting with drug-eluting stents, we put the patients exactly on the event curve as if they never had ischemia,” De Bruyne said in an interview. “That is a very important finding.”

There were also no significant differences between the groups in the endpoints of death/MI, cardiac death, cardiac death/MI, stroke or definite or probable stent thrombosis.

Angina relief occurred to a greater degree in the PCI group than in the medical therapy group. According to the researchers, the differences were significant at 6 months, 1 year, 2 years and 3 years, but not at 5 years. – by Erik Swain

References:

Xaplanteris P, et al. Outcomes of PCI for stable angina. Presented at: EuroPCR; May 22-25, 2018; Paris.

Xaplanteris P, et al. N Engl J Med. 2018;doi:10.1056/NEJMoa1803538.

Disclosure: The study was funded in part by Abbott. Xaplanteris reports no relevant financial disclosures. De Bruyne reports he has received grants from Abbott and Opsens.

Among patients with stable CAD and angiographically significant stenoses, an initial fractional flow reserve-guided PCI strategy conferred better outcomes than medical therapy, according to 5-year results of the FAME 2 trial presented at EuroPCR.

As Cardiology Today’s Intervention previously reported, for the FAME 2 trial, Panagiotis Xaplanteris, MD, PhD, from Cardiovascular Center Aalst, Onze-Lieve-Vrouw Clinic, Aalst, Belgium, and colleagues performed FFR in 1,220 patients with stable CAD to determine hemodynamically significant stenosis, defined as at least one stenosis with FFR of 0.8 or less. Of the cohort, 888 patients had at least one hemodynamically significant stenosis and were randomly assigned to FFR-guided PCI plus medical therapy (mean age, 64 years; 80% men) or medical therapy alone (mean age, 64 years; 77% men).

The primary endpoint was a composite of death, MI or urgent revascularization.

Bernard De Bruyne, MD, PhD
Bernard De Bruyne

“The role of PCI in patients with stable coronary artery disease remains very controversial,” Bernard De Bruyne, MD, PhD, co-director of Cardiovascular Center Aalst, said in an interview. “There are a lot of positive data for PCI in patients with unstable syndromes, but in stable disease, we have very few data. The aim of the study was to compare the rates of death, MI and urgent revascularization after fractional flow reserve-guided PCI plus medical therapy vs. medical therapy alone in patients with stable coronary artery disease.”

At 5 years, the primary endpoint occurred in 13.9% of the PCI group vs. 27% of the medical therapy group (HR = 0.46; 95% CI, 0.34-0.63), according to the researchers.

The difference was driven by urgent revascularization, which occurred in 6.3% of the PCI group and 21.1% of the medical therapy group (HR = 0.27; 95% CI, 0.18-0.41), but also by spontaneous MI. In addition, the difference between the two groups kept increasing after 3 years, according to the researchers.

“The 5-year results of the FAME 2 trial confirm the importance of an FFR-based selection for PCI of both patients and lesions,” Xaplanteris said during a presentation. “It is confirmed that when FFR is above 0.8, the outcome is really favorable with medical therapy. What is new is that when FFR is equal to or less than 0.8, PCI with second-generation drug-eluting stents provides sustained benefits in the need for urgent revascularization, in the rate of spontaneous myocardial infarctions and in symptomatic relief. These come without the late catch-up phenomenon.”

There were no significant differences between the groups in death (PCI, 5.1%; medical therapy, 5.2%; HR = 0.98; 95% CI, 0.55-1.75) or MI (PCI, 8.1%; medical therapy, 12%; HR = 0.66; 95% CI, 0.43-1).

The patients who did not have at least one stenosis with FFR of 0.8 or less were not included in the randomized trial but were put in a registry and given medical therapy. Those patients did not significantly differ from the PCI group in the primary endpoint at 5 years (PCI, 13.9%; registry, 15.7%; HR = 0.88; 95% CI, 0.55-1.39).

“The event rate of [the patients in the registry] was almost identical to that of the patients who got a stent, which means that if we target the stenosis, and we alleviate the ischemia-producing lesions by stenting with drug-eluting stents, we put the patients exactly on the event curve as if they never had ischemia,” De Bruyne said in an interview. “That is a very important finding.”

There were also no significant differences between the groups in the endpoints of death/MI, cardiac death, cardiac death/MI, stroke or definite or probable stent thrombosis.

Angina relief occurred to a greater degree in the PCI group than in the medical therapy group. According to the researchers, the differences were significant at 6 months, 1 year, 2 years and 3 years, but not at 5 years. – by Erik Swain

References:

Xaplanteris P, et al. Outcomes of PCI for stable angina. Presented at: EuroPCR; May 22-25, 2018; Paris.

Xaplanteris P, et al. N Engl J Med. 2018;doi:10.1056/NEJMoa1803538.

Disclosure: The study was funded in part by Abbott. Xaplanteris reports no relevant financial disclosures. De Bruyne reports he has received grants from Abbott and Opsens.

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