Fractional flow reserve-guided percutaneous coronary intervention vs. medical therapy for patients with stable coronary lesions: meta-analysis of individual patient data.
- Zimmermann FM Department of Cardiology, Catharina Hospital, Michelangelolaan 2, EJ Eindhoven, The Netherlands.
- Omerovic E Department of Cardiology, Sahlgrenska University Hospital, Blå stråket 5, Gothenburg, Sweden.
- Fournier S Cardiovascular Center Aalst, OLV-Clinic, Moorselbaan, Aalst, Belgium.
- Kelbæk H Department of Cardiology, Zealand University Hospital, Sygehusvej 10, Roskilde, Denmark.
- Johnson NP Division of Cardiology, Department of Medicine, Weatherhead PET Center, McGovern Medical School, UTHealth and Memorial Hermann Hospital, Fannin Street, Houston, TX, USA.
- Rothenbühler M Clinical Trials Unit, University of Bern, Mittelstrasse 43, Bern, Switzerland.
- Xaplanteris P Cardiovascular Center Aalst, OLV-Clinic, Moorselbaan, Aalst, Belgium.
- Abdel-Wahab M Department of Cardiology, Heart Center, Segeberger Am Kurpark 1, Bad Segeberg, Germany.
- Barbato E Cardiovascular Center Aalst, OLV-Clinic, Moorselbaan, Aalst, Belgium.
- Høfsten DE Department of Cardiology, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, Copenhagen, Denmark.
- Tonino PAL Department of Cardiology, Catharina Hospital, Michelangelolaan 2, EJ Eindhoven, The Netherlands.
- Boxma-de Klerk BM Department of Cardiology, Maasstad Ziekenhuis, Maasstadweg 21, DZ Rotterdam, The Netherlands.
- Fearon WF Division of Cardiovascular Medicine, Stanford University, Stanford, CA, USA.
- Køber L Department of Cardiology, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, Copenhagen, Denmark.
- Smits PC Department of Cardiology, Maasstad Ziekenhuis, Maasstadweg 21, DZ Rotterdam, The Netherlands.
- De Bruyne B Cardiovascular Center Aalst, OLV-Clinic, Moorselbaan, Aalst, Belgium.
- Pijls NHJ Department of Cardiology, Catharina Hospital, Michelangelolaan 2, EJ Eindhoven, The Netherlands.
- Jüni P Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, Department of Medicine, University of Toronto, Medical Sciences Building, 1 King's College Cir, Toronto, Ontario, Canada.
- Engstrøm T Department of Cardiology, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, Copenhagen, Denmark.
- 2019-01-01
Published in:
- European heart journal. - 2019
Coronary Artery Disease
Female
Fractional Flow Reserve, Myocardial
Humans
Male
Middle Aged
Myocardial Infarction
Percutaneous Coronary Intervention
Prognosis
Randomized Controlled Trials as Topic
English
Aims
To assess the effect of fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) with contemporary drug-eluting stents on the composite of cardiac death or myocardial infarction (MI) vs. medical therapy in patients with stable coronary lesions.
Methods and results
We performed a systematic review and meta-analysis of individual patient data (IPD) of the three available randomized trials of contemporary FFR-guided PCI vs. medical therapy for patients with stable coronary lesions: FAME 2 (NCT01132495), DANAMI-3-PRIMULTI (NCT01960933), and Compare-Acute (NCT01399736). FAME 2 enrolled patients with stable coronary artery disease (CAD), while the other two focused on non-culprit lesions in stabilized patients after acute coronary syndrome. A total of 2400 subjects were recruited from 54 sites world-wide with 1056 randomly assigned to FFR-guided PCI and 1344 to medical therapy. The pre-specified primary outcome was a composite of cardiac death or MI. We included data from extended follow-ups for FAME 2 (up to 5.5 years follow-up) and DANAMI-3-PRIMULTI (up to 4.7 years follow-up). After a median follow-up of 35 months (interquartile range 12-60 months), a reduction in the composite of cardiac death or MI was observed with FFR-guided PCI as compared with medical therapy (hazard ratio 0.72, 95% confidence interval 0.54-0.96; P = 0.02). The difference between groups was driven by MI.
Conclusion
In this IPD meta-analysis of the three available randomized controlled trials to date, FFR-guided PCI resulted in a reduction of the composite of cardiac death or MI compared with medical therapy, which was driven by a decreased risk of MI.
To assess the effect of fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) with contemporary drug-eluting stents on the composite of cardiac death or myocardial infarction (MI) vs. medical therapy in patients with stable coronary lesions.
Methods and results
We performed a systematic review and meta-analysis of individual patient data (IPD) of the three available randomized trials of contemporary FFR-guided PCI vs. medical therapy for patients with stable coronary lesions: FAME 2 (NCT01132495), DANAMI-3-PRIMULTI (NCT01960933), and Compare-Acute (NCT01399736). FAME 2 enrolled patients with stable coronary artery disease (CAD), while the other two focused on non-culprit lesions in stabilized patients after acute coronary syndrome. A total of 2400 subjects were recruited from 54 sites world-wide with 1056 randomly assigned to FFR-guided PCI and 1344 to medical therapy. The pre-specified primary outcome was a composite of cardiac death or MI. We included data from extended follow-ups for FAME 2 (up to 5.5 years follow-up) and DANAMI-3-PRIMULTI (up to 4.7 years follow-up). After a median follow-up of 35 months (interquartile range 12-60 months), a reduction in the composite of cardiac death or MI was observed with FFR-guided PCI as compared with medical therapy (hazard ratio 0.72, 95% confidence interval 0.54-0.96; P = 0.02). The difference between groups was driven by MI.
Conclusion
In this IPD meta-analysis of the three available randomized controlled trials to date, FFR-guided PCI resulted in a reduction of the composite of cardiac death or MI compared with medical therapy, which was driven by a decreased risk of MI.
- Language
-
- English
- Open access status
- hybrid
- Identifiers
-
- DOI 10.1093/eurheartj/ehy812
- PMID 30596995
- Persistent URL
- https://folia.unifr.ch/global/documents/234593
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