Author + information
- Received August 21, 2017
- Revision received November 15, 2017
- Accepted November 21, 2017
- Published online February 19, 2018.
- Eric Van Belle, MD, PhDa,∗ (, )
- Robert Gil, MD, PhDb,
- Volker Klauss, MDc,
- Mohammed Balghith, MDd,
- Martijn Meuwissen, MD, PhDe,
- Jérôme Clerc, MDf,
- Bernhard Witzenbichler, MDg,
- Miha Cercek, MDh,
- Marios Vlachojannis, MDi,
- Irene Lang, MDj,
- Philippe Commeau, MDk,
- Flavien Vincent, MDa,
- Luca Testa, MD, PhDl,
- Wojciech Wasek, MD, PhDm,
- Nicolas Debry, MDa,
- Stephan Kische, MD, PhDn,
- Gabriele Gabrielli, MDo and
- Gennaro Sardella, MD, PhDp,∗∗ ()
- aDepartment of Cardiology, Institut Coeur-Poumon-CHU Lille and INSERM U1011, Lille, France
- bDepartment of Invasive Cardiology, Central Clinical Hospital of the Ministry of Interior, Warsaw, Poland
- cDepartment of Cardiology, Isar Kliniken München, Munich, Germany
- dDepartment of Cardiology, Obeid Specialized Hospital Riyadh, Riyadh, Saudi Arabia
- eDepartment of Cardiology, Amphia Ziekenhuis, Breda, the Netherlands
- fDepartment of Cardiology, CH Compiegne-Noyon, Compiègne, France
- gDepartment of Cardiology, HELIOS-Amperklinikum Dachau, Dachau, Germany
- hDepartment of Cardiology, UKC Ljubljana, Ljubljana, Slovenia
- iDepartment of Cardiology, Herz- und Diabeteszentrum Bad Oeynhausen, Bad Oeynhausen, Germany
- jDepartment of Cardiology, AKH Wien, Vienna, Austria
- kDepartment of Cardiology, Clinique des Fleurs Ollioules, Ollioules, France
- lDepartment of Cardiology, H. San Donato Milano, Milan, Italy
- mDepartment of Cardiology, Military Hospital Warsaw, Warsaw, Poland
- nDepartment of Cardiology, Klinikum im Friedrichshain Berlin, Berlin, Germany
- oDepartment of Cardiology, Ospedali Riuniti Umberto I Ancona, Ancona, Italy
- pDepartment of Cardiovascular Sciences, Policlinico Umberto I Roma, Rome, Italy
Objectives This study sought to prospectively assess the impact of routine invasive physiology at the time of angiography on reclassification of therapeutic management of multivessel disease (MVD) patients, and to assess how implementation of instantaneous wave-free ratio (iFR) alters the process.
Background Routine invasive physiology in intermediate coronary lesions at the time of diagnostic angiography, primarily in patients with single-vessel disease and using fractional flow reserve (FFR), reclassifies coronary revascularization management in 26% to 44% of patients. The role of invasive physiology in patients with MVD is unclear.
Methods In 18 centers, 484 patients undergoing diagnostic angiography disclosing MVD with lesions >40% by visual assessment were included. Investigators were asked to prospectively define their initial management strategy based on angiography and clinical information. Invasive physiology (FFR or iFR driven) was then performed and final strategy defined. Initial and final vessel, patient, procedural, and overall management were described. Reclassification was defined as the difference between initial and final strategy.
Results The majority of patients were clinically stable (82.2%). Two- and 3-vessel disease was present in 73.3% and 26.7% of patients, respectively. Lesions investigated were “intermediate” with median percent stenosis, median FFR, and median iFR at 60% (interquartile range [IQR]: 50% to 70%), 0.84 (IQR: 0.78 to 0.90), and 0.92 (IQR: 0.85 to 0.96), respectively. Vessel management was reclassified by physiology in 30.0% (249 of 828) of vessels. Patient and overall management were reclassified in 26.9% (130 of 484) and 45.7% (211 of 484) of patients, respectively. Reclassification rates were high irrespective of initial management (optimal medical therapy, percutaneous coronary intervention, or coronary artery bypass grafting), and performance and results of pre-procedural noninvasive tests. Reclassification of overall management in particular increased with the number of vessels investigated (1 vessel: 37.3%; 2 vessels: 45.0%; 3 vessels: 66.7%; p = 0.002). Incorporating iFR in the decision process was associated with investigation of more vessels (p = 0.04) and higher reclassification (p = 0.0001).
Conclusions In patients with MVD and intermediate coronary lesions, invasive physiology at time of angiography reclassifies revascularization strategy in a large proportion of cases (26.9%) and investigation of more vessels is associated with higher reclassification rates.
The DEFINE REAL study was supported by Philips-Volcano. Dr. Van Belle has served as a consultant for St. Jude Medical; and received speaker fees from Philips-Volcano. Dr. Witzenbichler has received trial compensation from Volcano. Dr. Commeau has served as a consultant for St. Jude Medical. Dr. Wasek received lecturer fees from Boston Scientific and Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Van Belle, Gil, and Sardella contributed equally to this work.
- Received August 21, 2017.
- Revision received November 15, 2017.
- Accepted November 21, 2017.
- 2018 American College of Cardiology Foundation