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FAME substudy: FFR-guided PCI benefits women, men equally
Angiographic lesions of similar severity were less likely to produce ischemia in women than men, and a fractional flow reserve-guided PCI strategy benefited both sexes equally, substudy results of the FAME trial found.
In all, researchers analyzed data of 744 men and 261 women from the FAME trial who had multivessel coronary disease and were randomly assigned to angiography- or FFR-guided PCI to evaluate the effect of sex on treatment methods.
Men and women had similar rates of MACE (20.2% vs. 20.3%; P=.923), death (3.4% vs. 2.7%; P=.591), MI (8.1% vs. 7.7%; P=.837), repeat revascularization (11.4% vs. 12.3%; P=.717) and 2-year MACE-free survival (78.8 ± 1.5% vs. 78.6 ± 2.6%; P=.82).
Women had significantly higher FFR values than men (0.75 ± 0.18 vs. 0.71 ± 0.17; P=.001). Functionally significant lesions (FFR ≤0.8) were lower in women for lesions with 50% to 70% stenosis (21.1% vs. 39.5%; P<.001) and for lesions with 70% to 90% stenosis (71.9% vs. 82%; P=.019). Patients with functionally significant lesions of 91% to 99% did not differ between the sexes (97.5% vs. 96.2%; P=.682).
Researchers said women had a lower proportion of functionally significant lesions than men with coronary stenoses between 50% and 90% narrowed; that an FFR-guided PCI strategy benefited men and women equally; and 2-year rates of cardiac events were similar between the sexes regardless of treatment strategy, although women were older and tended to have higher rates of baseline comorbidities.
“Because women appear to have higher FFR values for a given stenosis, it may be even more relevant to measure FFR in women to confirm hemodynamic significance before performing PCI,” researchers wrote.
Perspective
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There is a lot of interest in identifying differences in men and women undergoing PCI. The researchers of this FAME substudy analyzed a population of patients, both men and women, who underwent FFR-guided PCI for multivessel disease. Their findings suggested that women had a lower incidence of functionally significant lesions for the same grouping of stenoses. That was an interesting difference. But overall the outcomes and approach were identical when you employed the FFR-guided strategy. Although they had less functionally significant lesions, for what appeared to be functionally significant lesions, when guided by function (FFR) their outcomes were better than when guided by angiography alone, which makes good sense. Some lesions in women looked less severe, but were actually more severe than they really were. These results emphasize the need to use an objective measurement of lesion severity, rather than just the angiogram, eyeball approach. Ultimately, there is no reason to think that men are different than women when it comes to functionally important CAD.
In all of PCI, women differentiate themselves mostly in two ways: one, their symptom presentation is atypical and occurs later; and two, they have smaller arteries because they are generally smaller in stature, so the problems with smaller arteries are more frequently found in women. However, overall, the results of complications, including bleeding problems and restenosis, are similar. There is some issue with regard to microvascular disease being more frequent in women than men for reasons unknown. So the results of this FAME substudy are not a surprise. They're confirmatory and reassuring. They reemphasize the benefits of ischemia-driven PCI rather than angiogram-alone PCI, which is important for best outcomes.