TY - JOUR

T1 - Cost-effectiveness of adding a non-invasive acoustic rule-out test in the evaluation of patients with symptoms suggestive of coronary artery disease

T2 - Rationale and design of the prospective, randomised, controlled, parallel-group multicenter FILTER-SCAD trial

AU - Bjerking, Louise Hougesen

AU - Hansen, Kim Wadt

AU - Biering-Sørensen, Tor

AU - Brønnum-Schou, Jens

AU - Engblom, Henrik

AU - Erlinge, David

AU - Haahr-Pedersen, Sune Ammentorp

AU - Heitmann, Merete

AU - Hove, Jens Dahlgaard

AU - Jensen, Magnus Thorsten

AU - Kruse, Marie

AU - Räder, Sune

AU - Strange, Søren

AU - Galatius, Søren

AU - Prescott, Eva Irene Bossano

N1 - Funding Information: Contributors EIBP, SG and KWH designed and initiated the study. LHB, KWH, EIBP and SG obtained funding. LHB wrote the manuscript. LHB, KWH, TB-S, JB-S, HE, DE, SAH-P, MH, JDH, MTJ, MK, SR, SS, SG and EIBP revised and approved the final version of the article. Funding Unrestricted grants for the study was provided by Acarix A/S, Kai Hansens Fond, Kai Houmann Nielsen Fond, and Fonden for Faglig Udvikling i Speciallægepraksis (A3068). Helsefonden (21-B-0348) has provided a grant for the study. Competing interests LHB, KWH, JB-S, HE, SAH-P, MH, JDH, MK, MTJ, SR, SS, SG and EP: None. TB-S: Steering Committee member of the Amgen financed GALACTIC-HF trial; Advisory Board: Sanofi Pasteur; Advisory Board: Amgen; Speaker Honorarium: Novartis; Speaker Honorarium: Sanofi Pasteur; Research grant: GE Healthcare; Research grant: Sanofi Pasteur. DE: Advisory board for Acarix A/S. Funding Information: Unrestricted grants for the study was provided by Acarix A/S, Kai Hansens Fond, Kai Houmann Nielsen Fond, and Fonden for Faglig Udvikling i Speciall?gepraksis (A3068). Helsefonden (21-B-0348) has provided a grant for the study. Publisher Copyright: © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

PY - 2021/8/23

Y1 - 2021/8/23

N2 - Most patients with symptoms suggestive of chronic coronary syndrome (CCS) have no obstructive coronary artery disease (CAD) and better selection of patients to be referred for diagnostic tests is needed. The CAD-score is a non-invasive acoustic measure that, when added to pretest probability of CAD, has shown good rule-out capabilities. We aimed to test whether implementation of CAD-score in clinical practice reduces the use of diagnostic tests without increasing major adverse cardiac events (MACE) rates in patients with suspected CCS. FILTER-SCAD is a randomised, controlled, multicenter trial aiming to include 2000 subjects aged ≥30 years without known CAD referred for outpatient assessment for symptoms suggestive of CCS. Subjects are randomised 1:1 to either the control group: standard diagnostic examination (SDE) according to the current guidelines, or the intervention group: SDE plus a CAD-score. The subjects are followed for 12 months for the primary endpoint of cumulative number of diagnostic tests and a safety endpoint (MACE). Angina symptoms, quality of life and risk factor modification will be assessed with questionnaires at baseline, 3 months and 12 months after randomisation. The study is powered to detect superiority in terms of a reduction of ≥15% in the primary endpoint between the two groups with a power of 80%, and non-inferiority on the secondary endpoint with a power of 90%. The significance level is 0.05. The non-inferiority margin is set to 1.5%. Randomisation began on October 2019. Follow-up is planned to be completed by December 2022. This study has been approved by the Danish Medical Agency (2019024326), Danish National Committee on Health Research Ethics (H-19012579) and Swedish Ethical Review Authority (Dnr 2019-04252). All patients participating in the study will sign an informed consent. All study results will be attempted to be published as soon as possible.

AB - Most patients with symptoms suggestive of chronic coronary syndrome (CCS) have no obstructive coronary artery disease (CAD) and better selection of patients to be referred for diagnostic tests is needed. The CAD-score is a non-invasive acoustic measure that, when added to pretest probability of CAD, has shown good rule-out capabilities. We aimed to test whether implementation of CAD-score in clinical practice reduces the use of diagnostic tests without increasing major adverse cardiac events (MACE) rates in patients with suspected CCS. FILTER-SCAD is a randomised, controlled, multicenter trial aiming to include 2000 subjects aged ≥30 years without known CAD referred for outpatient assessment for symptoms suggestive of CCS. Subjects are randomised 1:1 to either the control group: standard diagnostic examination (SDE) according to the current guidelines, or the intervention group: SDE plus a CAD-score. The subjects are followed for 12 months for the primary endpoint of cumulative number of diagnostic tests and a safety endpoint (MACE). Angina symptoms, quality of life and risk factor modification will be assessed with questionnaires at baseline, 3 months and 12 months after randomisation. The study is powered to detect superiority in terms of a reduction of ≥15% in the primary endpoint between the two groups with a power of 80%, and non-inferiority on the secondary endpoint with a power of 90%. The significance level is 0.05. The non-inferiority margin is set to 1.5%. Randomisation began on October 2019. Follow-up is planned to be completed by December 2022. This study has been approved by the Danish Medical Agency (2019024326), Danish National Committee on Health Research Ethics (H-19012579) and Swedish Ethical Review Authority (Dnr 2019-04252). All patients participating in the study will sign an informed consent. All study results will be attempted to be published as soon as possible.

KW - cardiology

KW - coronary heart disease

KW - ischaemic heart disease

U2 - 10.1136/bmjopen-2021-049380

DO - 10.1136/bmjopen-2021-049380

M3 - Review

C2 - 34426466

AN - SCOPUS:85113508763

VL - 11

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 8

M1 - e049380

ER -