N/A
Completed N=1,005
Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (F.A.M.E.)
Coronary Arteriosclerosis
Source: ClinicalTrials.gov NCT00267774 ↗
Enrolled (actual)
1,005
Serious AEs
15.7%
Results posted
Jul 2016
Primary outcomePrimary: Major Adverse Cardiac Events — 67; 91 participants
Summary
In this multicenter, international study we are evaluating two approaches to determine which coronary artery narrowings require stent placement in patients with multivessel coronary artery disease. Patients will be randomized to an angiographic strategy, where only coronary angiography is used to determine which lesions to stent or to a pressure wire strategy where fractional flow reserve, an index measured with the pressure wire, will be used to determine which lesions to stent. The primary outcome will be major adverse cardiac events at 1 year. A secondary outcome will be cost-effectiveness.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Major Adverse Cardiac Events |
67; 91 | — |
| SECONDARY Cost Effectiveness Measured as Index Procedural and Hospitalization Costs |
13,182; 14,878 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria:- at least 2 coronary lesions of 50% stenosis or greater in at least 2 major epicardial arteries
- age>/=18
Exclusion Criteria:-- STEMI 1000 U/l < 5 days ago
- Pregnancy
- Extremely tortuous or calcified coronary arteries, or other technical conditions interfering with reliable coronary pressure measurement
- Serious concomitant disease, decreasing life expectancy to <2 years
- Previous coronary bypass surgery (CABG)
- Contraindication for drug-eluting stent
- Cardiogenic shock
- Inability to give informed consent
- Suspicion of significant left main (LM) stenosis
Data sourced from ClinicalTrials.gov (NCT00267774). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.