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

Frederik M. Zimmermann, Elmir Omerovic, Stephane Fournier, Henning Kelbæk, Nils P. Johnson, Martina Rothenbühler, Panagiotis Xaplanteris, Mohamed Abdel-Wahab, Emanuele Barbato, Dan Eik Høfsten, Pim A.L. Tonino, Bianca M. Boxma-de Klerk, William F. Fearon, Lars Køber, Pieter C. Smits, Bernard De Bruyne, Nico H.J. Pijls, Peter Jüni, Thomas Engstrøm

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)180-186
Number of pages7
JournalEuropean Heart Journal
Volume40
Issue number2
DOIs
Publication statusPublished - 2019

Subject classification (UKÄ)

  • Cardiac and Cardiovascular Systems

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