Author + information
- Received September 5, 2019
- Revision received September 18, 2019
- Accepted September 19, 2019
- Published online January 6, 2020.
- Francesco Burzotta, MD, PhDa,b,∗∗ (, )
- Antonio Maria Leone, MD, PhDa,∗,
- Cristina Aurigemma, MD, PhDa,
- Aniello Zambrano, MDa,b,
- Giuseppe Zimbardo, MDa,
- Manfredi Arioti, MDa,b,
- Rocco Vergallo, MD, PhDa,b,
- Giovanni Luigi De Maria, MD, PhDc,
- Emma Cerracchio, MDa,b,
- Enrico Romagnoli, MD, PhDa,b,
- Carlo Trani, MDa,b,† and
- Filippo Crea, MDa,b,†
- aFondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy
- bUniversità Cattolica del Sacro Cuore, Rome, Italy
- cDepartment of Cardiology, John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom
- ↵∗Address for correspondence:
Dr. Francesco Burzotta, Institute of Cardiology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, L.go A. Gemelli 1, 00168 Rome, Italy.
Objectives The aim of this study was to compare optical coherence tomographic (OCT) guidance and fractional flow reserve (FFR) guidance in patients with angiographically intermediate coronary lesions (AICLs) in a single-center, prospective, 1:1 randomized trial.
Background FFR and OCT imaging may help both in the assessment of AICLs and in percutaneous coronary intervention optimization.
Methods Patients with AICLs were randomized to FFR or OCT imaging. In the FFR arm, PCI was performed if FFR was ≤0.80. In the OCT imaging arm, PCI was performed if area stenosis was ≥75% or 50% to 75% with minimal luminal area <2.5 mm2 or plaque rupture. Angina (evaluated using the Seattle Angina Questionnaire), major adverse cardiac events, and cost were assessed at the end of follow-up. The pre-defined primary endpoint was the composite of major adverse cardiac events or significant angina (defined as Seattle Angina Questionnaire frequency scale score <90) at 13 months.
Results A total of 350 patients (with 446 AICLs) were enrolled (176 randomized to FFR and 174 to OCT imaging). The primary endpoint of major adverse cardiac events or significant angina at 13 months occurred in 14.8% of patients in the FFR arm and in 8.0% in the OCT imaging arm (p = 0.048). This result was driven by a statistically nonsignificant lower occurrence of all primary endpoint components. Up to 13 months, the rate of medically managed patients was significantly higher (p < 0.001) and total cost significantly lower (p < 0.001) with FFR in comparison with OCT imaging.
Conclusions In patients with AICLs, OCT guidance is associated with lower occurrence of the composite of major adverse cardiac events or significant angina. FFR guidance is associated with a higher rate of medical management and lower costs. FFR or OCT Guidance to Revascularize Intermediate Coronary Stenosis Using Angioplasty [FORZA]; NCT01824030)
- fractional flow reserve
- optical coherence tomography
- percutaneous coronary interventions
- personalized medicine
↵∗ Drs. Burzotta and Leone are the co-principal investigators and should be considered co-first authors.
↵† Drs. Trani and Crea contributed equally to this work and should be considered co–last authors.
The FORZA trial was funded by academic grants (Bando Linea D. 1, Università Cattolica del Sacro Cuore, Rome, Italy). Drs. Burzotta, Trani, and Aurigemma have received speaking fees from Abbott, Medtronic, and Abiomed. Dr. Leone has received speaking honoraria from St. Jude Medical/Abbott, Medtronic, Abiomed, and Bracco Imaging. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received September 5, 2019.
- Revision received September 18, 2019.
- Accepted September 19, 2019.
- 2020 American College of Cardiology Foundation
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