Frederik M Zimmermann1, Angela Ferrara2, Nils P Johnson3, Lokien X van Nunen4, Javier Escaned5, Per Albertsson6, Raimund Erbel7, Victor Legrand8, Hyeong-Cheol Gwon9, Wouter S Remkes10, Pieter R Stella11, Pepijn van Schaardenburgh12, G Jan Willem Bech13, Bernard De Bruyne2, Nico H J Pijls14. 1. Department of Cardiology, Catharina Hospital Eindhoven, Michelangelolaan 2, Eindhoven 5623 EJ, The Netherlands. 2. Cardiovascular Center, Aalst, Belgium. 3. Weatherhead PET Center For Preventing and Reversing Atherosclerosis, Division of Cardiology, Department of Medicine, University of Texas Medical School and Memorial Hermann Hospital, Houston, TX, USA. 4. Department of Cardiology, Catharina Hospital Eindhoven, Michelangelolaan 2, Eindhoven 5623 EJ, The Netherlands Department of Biomedical Engineering, Eindhoven University of Technology, Eindhoven, The Netherlands. 5. Hospital Clínico San Carlos/Faculty of Medicine, Complutense University of Madrid, and Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain. 6. Department of Cardiology, Sahlgrenska University Hospital Gothenburg, Sweden. 7. Department of Cardiology, West-German Heart and Vascular Centre, University Hospital of Essen, Essen, Germany. 8. Department of Cardiology, University Hospital of Liège, Liège, Belgium. 9. Division of Cardiology, Cardiac and Vascular Center, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. 10. Department of Cardiology, Isala Klinieken, Zwolle, The Netherlands. 11. Department of Interventional Cardiology, University Medical Center Utrecht, Utrecht, The Netherlands. 12. Department of Cardiology, VieCuri, Venlo, The Netherlands. 13. Department of Cardiology, HagaZiekenhuis, The Hague, The Netherlands Reinier de Graaf Groep, Delft, The Netherlands. 14. Department of Cardiology, Catharina Hospital Eindhoven, Michelangelolaan 2, Eindhoven 5623 EJ, The Netherlands Department of Biomedical Engineering, Eindhoven University of Technology, Eindhoven, The Netherlands nico.pijls@inter.nl.net carias@cze.nl.
Abstract
AIMS: Stenting an angiographically intermediate but functionally non-significant stenosis is controversial. Nevertheless, it has been questioned if deferral of a functionally non-significant lesion on the basis of fractional flow reserve (FFR) measurement, is safe, especially on the long term. Five-year follow-up of the DEFER trial showed that outcome after deferral of percutaneous coronary intervention (PCI) of an intermediate coronary stenosis based on FFR ≥ 0.75 is excellent and was not improved by stenting. The aim of this study was to investigate the validity of this position on the very long term. METHODS AND RESULTS: In 325 patients scheduled forPCI of an intermediate stenosis, FFR was measured just before the planned intervention. If FFR was ≥0.75, patients were randomly assigned to deferral (Defer group; n = 91) or performance (Perform group; n = 90) of PCI. If FFR was <0.75, PCI was performed as planned (Reference group; n = 144). Clinical follow-up was 15 years. There were no differences in baseline clinical characteristics between the randomized groups. Complete 15-year follow-up was obtained in 92% of patients. After 15 years of follow-up, the rate of death was not different between the three groups: 33.0% in the Defer group, 31.1% in the Perform group, and 36.1% in the Reference group (Defer vs. Perform, RR 1.06, 95% CI: 0.69-1.62, P = 0.79). The rate of myocardial infarction was significantly lower in the Defer group (2.2%) compared with the Perform group (10.0%), RR 0.22, 95% CI: 0.05-0.99, P = 0.03. CONCLUSION: Deferral of PCI of a functionally non-significant stenosis is associated with a favourable very long-term follow-up without signs of late 'catch-up' phenomenon. Published on behalf of the European Society of Cardiology. All rights reserved.
RCT Entities:
AIMS: Stenting an angiographically intermediate but functionally non-significant stenosis is controversial. Nevertheless, it has been questioned if deferral of a functionally non-significant lesion on the basis of fractional flow reserve (FFR) measurement, is safe, especially on the long term. Five-year follow-up of the DEFER trial showed that outcome after deferral of percutaneous coronary intervention (PCI) of an intermediate coronary stenosis based on FFR ≥ 0.75 is excellent and was not improved by stenting. The aim of this study was to investigate the validity of this position on the very long term. METHODS AND RESULTS: In 325 patients scheduled for PCI of an intermediate stenosis, FFR was measured just before the planned intervention. If FFR was ≥0.75, patients were randomly assigned to deferral (Defer group; n = 91) or performance (Perform group; n = 90) of PCI. If FFR was <0.75, PCI was performed as planned (Reference group; n = 144). Clinical follow-up was 15 years. There were no differences in baseline clinical characteristics between the randomized groups. Complete 15-year follow-up was obtained in 92% of patients. After 15 years of follow-up, the rate of death was not different between the three groups: 33.0% in the Defer group, 31.1% in the Perform group, and 36.1% in the Reference group (Defer vs. Perform, RR 1.06, 95% CI: 0.69-1.62, P = 0.79). The rate of myocardial infarction was significantly lower in the Defer group (2.2%) compared with the Perform group (10.0%), RR 0.22, 95% CI: 0.05-0.99, P = 0.03. CONCLUSION: Deferral of PCI of a functionally non-significant stenosis is associated with a favourable very long-term follow-up without signs of late 'catch-up' phenomenon. Published on behalf of the European Society of Cardiology. All rights reserved.
Authors: Hak Seung Lee; Joo Myung Lee; Chang-Wook Nam; Eun-Seok Shin; Joon-Hyung Doh; Neng Dai; Martin K C Ng; Andy S C Yong; Damras Tresukosol; Ajit S Mullasari; Rony Mathew; Praveen Chandra; Kuang-Te Wang; Yundai Chen; Jiyan Chen; Kai-Hang Yiu; Nils P Johnson; Bon-Kwon Koo Journal: Cardiol J Date: 2019-06-21 Impact factor: 2.737
Authors: Firas Al-Janabi; Grigoris Karamasis; Chritopher M Cook; Alamgir M Kabir; Rohan O Jagathesan; Nicholas M Robinson; Jeremy W Sayer; Rajesh K Aggarwal; Gerald J Clesham; Paul R Kelly; Reto A Gamma; Kare H Tang; Thomas R Keeble; John R Davies Journal: Cardiol J Date: 2019-03-26 Impact factor: 2.737