Quantitative flow ratio–guided strategy versus angiography-guided strategy for percutaneous coronary intervention: Rationale and design of the FAVOR III China trial - 06/05/20
, Bo Xu, MBBS a, b, ⁎ for the FAVOR III China Investigators
Abstract |
Background |
Quantitative flow ratio (QFR) is a novel angiography-based approach enabling fast computation of fractional flow reserve without use of pressure wire or adenosine. The objective of this investigator-initiated, multicenter, patient- and clinical assessor-blinded randomized trial is to evaluate the efficacy and cost-effectiveness of a QFR-augmented angiography-guided (QFR-guided) strategy versus an angiography-only guided (angiography-guided) strategy for percutaneous coronary intervention (PCI) in patients with coronary artery disease.
Methods |
Approximately 3,830 patients will be randomized in a 1:1 ratio to a QFR-guided or an angiography-guided strategy. Included subjects scheduled for coronary angiography have at least 1 lesion eligible for PCI with 50%-90% stenosis in an artery with ≥2.5 mm reference diameter. Subjects assigned to the QFR-guided strategy will have QFR measured in each interrogated vessel and undergo PCI when QFR ≤0.80, with deferral for lesions with QFR >0.80. Those assigned to the angiography-guided strategy will undergo PCI based on angiography. Optimal medical therapy will be administered to all treated and deferred patients. The primary end point is the 1-year rate of major adverse cardiac events (MACE), a composite of all-cause mortality, any myocardial infarction, or any ischemia-driven revascularization. The major secondary end point is 1-year MACE excluding periprocedural myocardial infarction. Other secondary end points include the individual components of MACE and cost-effectiveness end points. The sample size affords 85% power to demonstrate superiority of QFR guidance compared with angiography guidance.
Conclusions |
The FAVOR III China study will be the first randomized trial to examine the effectiveness and cost-effectiveness of a QFR-guided versus an angiography-guided PCI strategy in coronary artery disease patients.
Il testo completo di questo articolo è disponibile in PDF.Mappa
| Funding: FAVOR III China is an investigator-initiated clinical trial with external funding from Beijing Municipal Science and Technology Project (Z19110700660000) issued by Beijing Municipal Commission of Science and Technology and the Clinical and Translational Project (2019XK320056) issued by the Chinese Academy of Medical Sciences. Pulse Medical Imaging Technology (Shanghai, China) provides the QFR system and software at no charge for the study. RCT# NCT03656848. |
|
| Author disclosures: Dr Tu has received research support from Medis Medical Imaging and Pulse Medical Imaging Technology. Dr Fearon has received research support from Abbott Vascular, CathWorks, and Medtronic and has minor stock options with HeartFlow. Dr Kirtane receives institutional funding to Columbia University and/or Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, and ReCor Medical. Dr Wijns receives institutional grants and honoraria from MicroPort. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. |
Vol 223
P. 72-80 - maggio 2020 Ritorno al numero
Articolo precedente
- Is there sex bias against women reflected in industry payments and does it matter?
- Andrea M. Russo
- Rivaroxaban versus warfarin in patients with nonvalvular atrial fibrillation and stage IV-V chronic kidney disease
- Matthew R. Weir, Veronica Ashton, Kenneth T. Moore, Shubham Shrivastava, Eric D. Peterson, Eric M. Ammann
Benvenuto su EM|consulte, il riferimento dei professionisti della salute.
L'accesso al testo integrale di questo articolo richiede un abbonamento.
Già abbonato a @@106933@@ rivista ?