Fractional Flow Reserve–Guided PCI for Stable Coronary Artery Disease

De Bruyne, Bernard; Fearon, William F; Pijls, Nico H J; Barbato, Emanuele; Tonino, Pim; Piroth, Zsolt; Jagic, Nikola; Mobius-Winckler, Sven; Riouffol, Gilles; Witt, Nils; Kala, Petr; MacCarthy, Philip; Engström, Thomas; Oldroyd, Keith; Mavromatis, Kreton; Manoharan, Ganesh; Verlee, Peter; Frobert, Ole; Curzen, Nick; Johnson, Jane B; ... (2014). Fractional Flow Reserve–Guided PCI for Stable Coronary Artery Disease. New England journal of medicine NEJM, 371(13), pp. 1208-1217. Massachusetts Medical Society MMS 10.1056/NEJMoa1408758

[img]
Preview
Text
DeBruyne NEnglJMed 2014.pdf - Published Version
Available under License Publisher holds Copyright.

Download (629kB) | Preview

Background We hypothesized that in patients with stable coronary artery disease and stenosis, percutaneous coronary intervention (PCI) performed on the basis of the fractional flow reserve (FFR) would be superior to medical therapy. Methods In 1220 patients with stable coronary artery disease, we assessed the FFR in all stenoses that were visible on angiography. Patients who had at least one stenosis with an FFR of 0.80 or less were randomly assigned to undergo FFR-guided PCI plus medical therapy or to receive medical therapy alone. Patients in whom all stenoses had an FFR of more than 0.80 received medical therapy alone and were included in a registry. The primary end point was a composite of death from any cause, nonfatal myocardial infarction, or urgent revascularization within 2 years. Results The rate of the primary end point was significantly lower in the PCI group than in the medical-therapy group (8.1% vs. 19.5%; hazard ratio, 0.39; 95% confidence interval [CI], 0.26 to 0.57; P<0.001). This reduction was driven by a lower rate of urgent revascularization in the PCI group (4.0% vs. 16.3%; hazard ratio, 0.23; 95% CI, 0.14 to 0.38; P<0.001), with no significant between-group differences in the rates of death and myocardial infarction. Urgent revascularizations that were triggered by myocardial infarction or ischemic changes on electrocardiography were less frequent in the PCI group (3.4% vs. 7.0%, P=0.01). In a landmark analysis, the rate of death or myocardial infection from 8 days to 2 years was lower in the PCI group than in the medical-therapy group (4.6% vs. 8.0%, P=0.04). Among registry patients, the rate of the primary end point was 9.0% at 2 years. Conclusions In patients with stable coronary artery disease, FFR-guided PCI, as compared with medical therapy alone, improved the outcome. Patients without ischemia had a favorable outcome with medical therapy alone. (Funded by St. Jude Medical; FAME 2 ClinicalTrials.gov number, NCT01132495 .).

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Pre-clinic Human Medicine > Institute of Social and Preventive Medicine
04 Faculty of Medicine > Pre-clinic Human Medicine > CTU Bern

UniBE Contributor:

Limacher, Andreas; Nüesch, Eveline and Jüni, Peter

Subjects:

600 Technology > 610 Medicine & health
300 Social sciences, sociology & anthropology > 360 Social problems & social services

ISSN:

0028-4793

Publisher:

Massachusetts Medical Society MMS

Language:

English

Submitter:

Doris Kopp Heim

Date Deposited:

13 Oct 2014 17:28

Last Modified:

03 Dec 2018 15:32

Publisher DOI:

10.1056/NEJMoa1408758

PubMed ID:

25176289

BORIS DOI:

10.7892/boris.58383

URI:

https://boris.unibe.ch/id/eprint/58383

Actions (login required)

Edit item Edit item
Provide Feedback