Fractional flow reserve-guided percutaneous coronary intervention vs. medical therapy for patients with stable coronary lesions: meta-analysis of individual patient data

• Published in: European heart journal Vol. 40; no. 2; pp. 180 - 186
• Main Authors: Zimmermann, Frederik M, Omerovic, Elmir, Fournier, Stephane, Kelbæk, Henning, Johnson, Nils P, Rothenbühler, Martina, Xaplanteris, Panagiotis, Abdel-Wahab, Mohamed, Barbato, Emanuele, Høfsten, Dan Eik, Tonino, Pim A L, Boxma-de Klerk, Bianca M, Fearon, William F, Køber, Lars, Smits, Pieter C, De Bruyne, Bernard, Pijls, Nico H J, Jüni, Peter, Engstrøm, Thomas
• Format: Journal Article
• Language: English
• Published: England Oxford University Press 07.01.2019
• Subjects: Cardiac and Cardiovascular Systems; Cardiology and Cardiovascular Disease; Clinical Medicine; Coronary Artery Disease - diagnosis; Coronary Artery Disease - mortality; Coronary Artery Disease - therapy; Editor's Choice; Fast Track; Fast Track Clinical Research; Female; Fractional Flow Reserve, Myocardial - physiology; Humans; Kardiologi; Kardiologi och kardiovaskulära sjukdomar; Klinisk medicin; Male; Medical and Health Sciences; Medicin och hälsovetenskap; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention - adverse effects; Percutaneous Coronary Intervention - mortality; Percutaneous Coronary Intervention - statistics & numerical data; Prognosis; Randomized Controlled Trials as Topic; Fractional flow reserve; Percutaneous coronary intervention; Prognosis
• ISSN: 0195-668X; 1522-9645; 1522-9645
• DOI: 10.1093/eurheartj/ehy812

Abstract 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.