Journal Club 12 September 2012

Paper

Fractional Flow Reserve–Guided PCI versus Medical Therapy in Stable Coronary Disease

Presenter

SC

Summary

Background

The preferred initial treatment for patients with stable coronary artery disease is the
best available medical therapy. We hypothesized that in patients with functionally
significant stenoses, as determined by measurement of fractional flow reserve (FFR),
percutaneous coronary intervention (PCI) plus the best available medical therapy
would be superior to the best available medical therapy alone.

Methods

In patients with stable coronary artery disease for whom PCI was being considered,
we assessed all stenoses by measuring FFR. Patients in whom at least one stenosis
was functionally significant (FFR, .0.80) were randomly assigned to FFR-guided
PCI plus the best available medical therapy (PCI group) or the best available medical
therapy alone (medical-therapy group). Patients in whom all stenoses had an FFR of
more than 0.80 were entered into a registry and received the best available medical
therapy. The primary end point was a composite of death, myocardial infarction, or
urgent revascularization.

Results

Recruitment was halted prematurely after enrollment of 1220 patients (888 who
underwent randomization and 332 enrolled in the registry) because of a significant
between-group difference in the percentage of patients who had a primary endpoint
event: 4.3% in the PCI group and 12.7% in the medical-therapy group (hazard
ratio with PCI, 0.32; 95% confidence interval [CI], 0.19 to 0.53; P<0.001). The difference
was driven by a lower rate of urgent revascularization in the PCI group than
in the medical-therapy group (1.6% vs. 11.1%; hazard ratio, 0.13; 95% CI, 0.06 to 0.30;
P<0.001); in particular, in the PCI group, fewer urgent revascularizations were triggered
by a myocardial infarction or evidence of ischemia on electrocardiography
(hazard ratio, 0.13; 95% CI, 0.04 to 0.43; P<0.001). Among patients in the registry,
3.0% had a primary end-point event.

Conclusions

In patients with stable coronary artery disease and functionally significant stenoses,
FFR-guided PCI plus the best available medical therapy, as compared with the best
available medical therapy alone, decreased the need for urgent revascularization. In
patients without ischemia, the outcome appeared to be favorable with the best
available medical therapy alone.

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