Clinical Question

In patients with multivessel coronary artery disease undergoing PCI, does FFR-guided PCI reduce major adverse cardiac events when compared with standard angiography-guided PCI?

Bottom Line

In patients with multivessel CAD undergoing PCI, FFR-guided PCI significantly reduces the rates of death, nonfatal MI, and repeat revascularization at 1 year in comparison with angiography-guided PCI.

Major Points

Guidelines

As of the time of the study, no guidelines were provided for the use of FFR-guided PCI versus angiography-guided PCI in patients with multivessel CAD.

Design

- Multicenter, randomized, controlled trial
- N=1005 patients with multivessel CAD
- Angiography-guided PCI (n=496)
- FFR-guided PCI (n=509)
- Setting: 20 centers in the United States and Europe
- Enrollment: January 2006 to September 2007
- Follow-up: 1 year
- Analysis: Intention-to-treat
- Primary outcome: Composite rate of death, nonfatal MI, and repeat revascularization at 1 year

Population

Inclusion Criteria
- Multivessel coronary artery disease (≥50% stenosis in ≥2 of the 3 major epicardial coronary arteries)
- Indication for PCI

Exclusion Criteria
- Significant left main coronary artery disease
- Previous coronary-artery bypass surgery
- Myocardial infarction with ST-segment elevation (unless occurred ≥5 days before PCI)
- Other specified clinical criteria

Baseline Characteristics
- Mean age: 64 years
- Male: 75.4%
- Mean number of lesions: 2.7 (angiography group) and 2.8 (FFR group)
- SYNTAX score: Similar between groups

Interventions

- Angiography-guided PCI underwent stenting of all indicated lesions based solely on angiographic appearance.
- FFR-guided PCI underwent stenting only if the FFR was 0.80 or less, indicating ischemia-causing stenoses.

Outcomes

Primary Outcomes
- Composite rate of death, nonfatal MI, and repeat revascularization at 1 year: 18.3% angiography group, 13.2% FFR group (P=0.02)

Secondary Outcomes
- Death: 3.0% angiography group, 1.8% FFR group (P=0.19)
- Myocardial infarction: 8.7% angiography group, 5.7% FFR group (P=0.07)
- Repeat revascularization: 9.5% angiography group, 6.5% FFR group (P=0.08)

Funding

Supported by unrestricted research grants from Radi Medical Systems and Stichting Vrienden van het Hart Zuidoost Brabant. Medtronic provided limited financial support to some centers by tailoring the price of the Endeavor stents to the local reimbursement system.

Further Reading

Complete study reference information and its findings on the advantages of FFR-guided PCI.