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Rationale and design of a comparison of angiography-derived fractional flow reserve-guided and intravascular ultrasound-guided intervention strategy for clinical outcomes in patients with coronary artery disease: a randomised controlled trial (FLAVOUR II)

Por: Zhang · J. · Hu · X. · Jiang · J. · Lu · D. · Guo · L. · Peng · X. · Pan · Y. · He · W. · Li · J. · Zhou · H. · Huang · J. · Jiang · F. · Pu · J. · Cheng · Z. · Yang · B. · Ma · J. · Chen · P. · Liu · Q. · Song · D. · Lu · L. · Li · S. · Fan · Y. · Meng · Z. · Tang · L. · Shin · E.-S. · Tu · S. · Koo · B.-
Introduction

Percutaneous coronary intervention (PCI) guided by coronary angiography-derived fractional flow reserve (FFR) or intravascular ultrasound (IVUS) has shown improved clinical outcomes compared with angiography-only-guided PCI. In patients with intermediate stenoses, FFR resulted in fewer coronary interventions and was non-inferior to IVUS with respect to clinical outcomes. However, whether this finding can be applied to angiography-derived FFR in significant coronary artery disease (CAD) remains unclear.

Method and analysis

The comparison of angiography-derived FFR-guided and IVUS-guided intervention strategies for clinical outcomes in patients with coronary artery disease (FLAVOUR II) trial is a multicentre, prospective, randomised controlled trial. A total of 1872 patients with angiographically significant CAD (stenoses of at least 50% as estimated visually through angiography) in a major epicardial coronary artery will be randomised 1:1 to receive either angiography-derived FFR-guided or IVUS-guided PCI. Patients will be treated with second-generation drug-eluting stent according to the predefined criteria for revascularisation: angiography-derived FFR≤0.8 and minimal lumen area (MLA)≤3 mm2 or 3 mm22 and plaque burden>70%. The primary endpoint is a composite of all-cause death, myocardial infarction and revascularisation at 12 months after randomisation. We will test the non-inferiority of the angiography-derived FFR-guided strategy compared with the IVUS-guided decision for PCI and the stent optimisation strategy.

The FLAVOUR II trial will provide new insights into optimal evaluation and treatment strategies for patients with CAD.

Ethics and dissemination

FLAVOUR II was approved by the institutional review board at each participating site (The Second Affiliated Hospital of Zhejiang University School of Medicine Approval No: 2020LSYD410) and will be conducted in line with the Declaration of Helsinki. Informed consent would be obtained from each patient before their participation. The study results will be submitted to a scientific journal.

Trial registration number

NCT04397211.

Trends in the treatment of fibromyalgia in South Korea between 2011 and 2018: a retrospective analysis of cross-sectional health insurance data

Por: Yu · J.-S. · Kim · E.-S. · Park · K. S. · Lee · Y. J. · Park · Y. C. · Nam · D. · Kim · E.-J. · Ha · I.-H.
Objectives

Fibromyalgia treatment trends vary globally; however, the trend in South Korea has not been investigated yet. This study aimed to analyse the fibromyalgia treatment trends in South Korea.

Design

Retrospective, observational study using serial cross-sectional data.

Setting

The National Patient Samples of the Korean Health Insurance Review & Assessment Service from 2011 to 2018 were used.

Participants

A total of 31 059 patients with fibromyalgia were included in this study. The basic characteristics of the patients were stratified by sex, age and comorbidity. A patient was considered to have a condition if it was recorded as a principal diagnosis at least once in a year.

Primary and secondary outcome measures

Trends in the types of medical visits and prescribed treatments were investigated and the values are presented as rates per 100 patients. The types of pharmacological treatment were presented according to the existing clinical guidelines. Additionally, combination prescription trends and associated characteristics were investigated.

Results

Of the patients, 66.2% were female. Visits to internal medicine departments showed the most significant increase (2011: 11.34; 2018: 21.99; p

Conclusions

Our findings provide basic reference data for the development and application of national guidelines for fibromyalgia.

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