Author + information
- Received April 2, 2012
- Revision received June 4, 2012
- Accepted June 21, 2012
- Published online October 1, 2012.
- Hyun-Sook Kim, MD⁎,†,
- Pim A.L. Tonino, MD, PhD‡,
- Bernard De Bruyne, MD, PhD§,
- Andy S.C. Yong, MBBS, PhD⁎,
- Jennifer A. Tremmel, MD, MS⁎,
- Nico H.J. Pijls, MD, PhD‡,
- William F. Fearon, MD⁎,⁎ (, )
- FAME Study Investigators
- ↵⁎Reprint requests and correspondence:
Dr. William F. Fearon, Division of Cardiovascular Medicine, Stanford University Medical Center, 300 Pasteur Drive, Room H2103, Stanford, California 94305
Objectives This study sought to evaluate the impact of sex differences on fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI).
Background The FAME (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) study demonstrated that FFR-guided PCI improves outcomes compared with an angiography-guided strategy. The role of FFR-guided PCI in women versus men has not been evaluated.
Methods We analyzed 2-year data from the FAME study in the 744 men and 261 women with multivessel coronary disease, who were randomized to angiography- or FFR-guided PCI. Statistical comparisons based on sex were stratified by treatment method.
Results Although women were older and had significantly higher rates of hypertension than men did, there were no differences in the rates of major adverse cardiac events (20.3% vs. 20.2%, p = 0.923) and its individual components at 2 years. FFR values were significantly higher in women than in men (0.75 ± 0.18 vs. 0.71 ± 0.17, p = 0.001). The proportion of functionally significant lesions (FFR ≤ 0.80) was lower in women than in men for lesions with 50% to 70% stenosis (21.1% vs. 39.5%, p < 0.001) and for lesions with 70% to 90% stenosis (71.9% vs. 82.0%, p = 0.019). An FFR-guided strategy resulted in similar relative risk reductions for death, myocardial infarction, and repeat revascularization in men and in women. There were no interactions between sex and treatment method for any outcome variables.
Conclusions In comparison with men, angiographic lesions of similar severity are less likely to be ischemia-producing in women. An FFR-guided PCI strategy is equally beneficial in women as it is in men.
The FAME study was supported by unrestricted research grants from Radi Medical Systems, Uppsala, Sweden, and Stichting Vrienden van het Hart Zuidoost Brabant, the Netherlands. Dr. Tonino has received lecture fees from St. Jude Medical. Drs. De Bruyne and Fearon have received institutional research grants from St. Jude Medical. Dr. Pijls has received an educational grant for the Catharina Hospital from St. Jude Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received April 2, 2012.
- Revision received June 4, 2012.
- Accepted June 21, 2012.
- American College of Cardiology Foundation