Author + information
- Received September 5, 2019
- Revision received September 18, 2019
- Accepted September 19, 2019
- Published online September 29, 2019.
- Francesco Burzotta, MD, PhD1,2,∗∗∗ (, )
- Antonio Maria Leone, MD, PhD1,∗,
- Cristina Aurigemma, MD, PhD1,
- Aniello Zambrano, MD1,2,
- Giuseppe Zimbardo, MD1,2,
- Manfredi Arioti, MD1,2,
- Rocco Vergallo, MD, PhD1,2,
- Giovanni Luigi De Maria, MD, PhD3,
- Emma Cerracchio, MD1,2,
- Enrico Romagnoli, MD, PhD1,2,
- Carlo Trani, MD1,2,§ and
- Filippo Crea, MD1,2,§
- 1Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italia
- 2Università Cattolica del Sacro Cuore, Roma, Italia
- 3Department of Cardiology, John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, UK
- ↵∗∗Address for Correspondence: Francesco Burzotta, MD, PhD Institute of Cardiology Fondazione Policlinico Universitario A. Gemelli IRCCS Università Cattolica del Sacro Cuore L.go A. Gemelli 1 00168 Rome, Italy fax + 39-06-3055535 tel. +39-06-30154187
Background Fractional flow reserve (FFR) and optical coherence tomography (OCT) may help both in assessment of angiographically-intermediate coronary lesions (AICL) and in percutaneous coronary interventions (PCI) optimization.
Objectives: To compare OCT-guidance and FFR-guidance in patients with AICL in a single-center, prospective, 1:1 randomized trial (acronym: FORZA, NCT01824030).
Methods Patients with AICL were randomized to FFR or OCT. In the FFR arm, PCI was performed if FFR was ≤0.80. In the OCT arm, PCI was performed if area stenosis was ≥75% or 50%-75% with minimal lumen area <2.5 mm2 or plaque rupture. Angina (evaluated by Seattle Angina Questionnaire, SAQ), major adverse cardiac events (MACE) and cost were assessed at the end of follow up. Predefined primary end point was the composite of MACE or significant angina (defined as SAQ frequency scale<90) at 13-month.
Results A total of 350 patients (with 446 AICL) were enrolled (176 randomized to FFR and 174 to OCT). The primary end point of MACE or significant angina at 13-month occurred in 14.8% patients of FFR arm and in 8.0% of OCT arm (P=0.048). This result was driven by a not statistically significant lower occurrence of all primary end-point components. Up to 13- month, rate of medically managed patients was significantly higher (p<0.001) and total cost significantly lower (P<0.001) with FFR in comparison to OCT.
Conclusions In patients with AICL, OCT-guidance is associated with lower occurrence of the composite of MACE or significant angina. FFR-guidance is associated with a higher rate of medical management and lower costs.
- Fractional Flow Reserve
- Optical Coherence Tomography
- Percutaneous Coronary Interventions
- Personalized Medicine
↵∗ these two authors are the co-principal investigators and should be considered co-first authors
↵§ these two senior authors equally contributed to the manuscript and should be considered co-last authors
The FORZA TRIAL was funded by the academic grants (Bando Linea D. 1 - Università Cattolica del Sacro Cuore, Roma).
F.B, C.T and C.A received speaker’s fees from Abbott, Medtronic, and Abiomed. A.M.L. received speaking honoraria from St. Jude Medical/Abbott, Medtronic, Abiomed and from Bracco Imaging.
The other authors have no conflicts of interest.
Tweet: What’s best between OCT-guidance or FFR-guidance in the management of angiographically-intermediate coronary lesions? New insights from FORZA trial.
- Received September 5, 2019.
- Revision received September 18, 2019.
- Accepted September 19, 2019.
This article requires a subscription or purchase to view the full text. If you are a subscriber or member, click Login or the Subscribe link (top menu above) to access this article.