"Fractional Flow Reserve-Guided PCI for Stable Coronary Artery Disease". The New England Journal of Medicine. 2012. PubMed•Full
Links to original sources: Wiki Journal Post Full Journal Article
Contents 1 Clinical Question 2 Bottom Line 3 Major Points 4 Guidelines 5 Design 6 Population 6.1 Inclusion Criteria 6.2 Exclusion Criteria 6.3 Baseline Characteristics 7 Interventions 8 Outcomes 8.1 Primary Outcome 8.2 Secondary Outcomes 9 Funding 10 Further Reading
In patients with stable coronary artery disease and functionally significant stenoses, as determined by fractional flow reserve (FFR), is percutaneous coronary intervention (PCI) plus medical therapy superior to medical therapy alone in reducing death, myocardial infarction, or urgent revascularization?
FFR-guided PCI plus medical therapy, compared with medical therapy alone, significantly reduced the need for urgent revascularization in patients with stable coronary artery disease and functionally significant stenoses. The best available medical therapy alone was a favorable strategy in patients without ischemia.
The FAME 2 trial showed that, in patients with stable coronary artery disease and functionally significant stenoses (FFR ≤0.80), PCI plus optimal medical therapy resulted in improved clinical outcomes compared to optimal medical therapy alone, driven by a reduced rate of urgent revascularization. For patients with stenoses FFR >0.80, medical therapy alone was associated with a low event rate, suggesting no additional benefit from PCI in this subgroup.
As of the last knowledge update, specific guidelines reflecting the results of this trial may not be available.
- Multicenter, randomized, controlled trial - N=1,220 patients with stable coronary artery disease - Intervention: FFR-guided PCI plus best available medical therapy - Control: Best available medical therapy alone - Setting: 28 centers in Europe and North America - Enrollment: May 15, 2010 - January 15, 2012 - Mean follow-up: 7 months - Analysis: Intention-to-treat
Inclusion Criteria - Stable coronary artery disease candidates for PCI - Angiographically significant one-, two-, or three-vessel disease suitable for PCI - At least one stenosis with an FFR ≤0.80
Exclusion Criteria - Details provided in the Supplementary Appendix
Baseline Characteristics - Demographics, angiographic, and FFR characteristics provided in Table 1 of the original study
- Randomization to FFR-guided PCI plus best available medical therapy or best available medical therapy alone - Measurement of FFR during coronary angiography to assess stenoses - Patients with FFR >0.80 enrolled in a registry for medical therapy alone
Primary Outcome - Death, myocardial infarction, or urgent revascularization within 7 months - PCI group: 4.3% - Medical therapy group: 12.7%
- Lower rate of urgent revascularization in the PCI group compared to the medical therapy group (1.6% vs. 11.1%) - No significant difference in death from any cause or myocardial infarction between the PCI group and medical therapy group
- Funded by St. Jude Medical
- Full text available through The New England Journal of Medicine - ClinicalTrials.gov number, NCT01132495