"Fractional Flow Reserve-Guided PCI for Stable Coronary Artery Disease".
The New England Journal of Medicine. 2012.
PubMed•Full text•PDF

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

Clinical Question

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?

Bottom Line

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.

Major Points

Guidelines

As of the last knowledge update, specific guidelines reflecting the results of this trial may not be available.

Design

- 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

Population

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

Interventions

- 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

Outcomes

Primary Outcome
- Death, myocardial infarction, or urgent revascularization within 7 months
- PCI group: 4.3%
- Medical therapy group: 12.7%

Secondary Outcomes
- 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

Funding

- Funded by St. Jude Medical

Further Reading

- Full text available through The New England Journal of Medicine
- ClinicalTrials.gov number, NCT01132495