Dataset Information

Randomised trial of stable chest pain investigation: 3-year clinical and quality of life results from CE-MARC 2.

ABSTRACT:

Aims

Guidelines for suspected cardiac chest pain have used historical risk stratification tools, advocating invasive coronary angiography (ICA) first-line in those at highest risk. We aimed to determine whether different strategies to manage suspected stable angina affected medium-term cardiovascular event rates and patient-reported quality of life (QoL) measures.

Methods

CE-MARC 2, a three-arm parallel group trial, randomised patients with suspected stable cardiac chest pain and a Duke Clinical pretest likelihood of coronary artery disease between 10% and 90%. Patients were randomised to either first-line cardiovascular magnetic resonance (CMR), single-photon emission computed tomography (SPECT) or the UK National Institute for Health and Care Excellence (NICE) CG95 (2010) guidelines-directed care. For the three arms, 1-year and 3-year first major adverse cardiovascular event (MACE) rates and QoL assessed by the Seattle Angina Questionnaire, Short Form 12 (V.12) Questionnaire and EuroQol-5 Dimension Questionnaire were recorded.

Results

1202 patients were randomised to CMR (n=481), SPECT (n=481) and NICE (n=240). Forty-two patients (18 CMR, 18 SPECT, 6 NICE) experienced one or more MACEs. The percentage rates (95% CIs) of MACE in the CMR, SPECT and NICE groups at 3 years were 3.7% (2.4%, 5.8%), 3.7% (2.4%, 5.8%) and 2.1% (0.9%, 4.8%), respectively. QoL scores did not significantly differ across domains.

Conclusion

Despite a fourfold increase in referrals for ICA, the NICE CG95 (2010) guidelines risk-stratified care strategy did not significantly reduce 3-year MACE or improve QoL, as compared with functional imaging with CMR or SPECT.

Trial registration number

ClinicalTrials.gov Registry (NCT01664858).

SUBMITTER: Everett CC

PROVIDER: S-EPMC10163591 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Randomised trial of stable chest pain investigation: 3-year clinical and quality of life results from CE-MARC 2.

Everett Colin C CC Berry Colin C McCann Gerry P GP Fernandez Catherine C Reynolds Catherine C Bucciarelli-Ducci Chiara C Dall'Armellina Erica E Prasad Abhiram A Foley James R JR Mangion Kenneth K Bijsterveld Petra P Brown Julia J Stocken Deborah D Walker Simon S Sculpher Mark M Plein Sven S Greenwood John P JP

Open heart 20230501 1

<h4>Aims</h4>Guidelines for suspected cardiac chest pain have used historical risk stratification tools, advocating invasive coronary angiography (ICA) first-line in those at highest risk. We aimed to determine whether different strategies to manage suspected stable angina affected medium-term cardiovascular event rates and patient-reported quality of life (QoL) measures.<h4>Methods</h4>CE-MARC 2, a three-arm parallel group trial, randomised patients with suspected stable cardiac chest pain and ...[more]

PMID: 37130657

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Project description:BackgroundThe PRECISE (Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization) demonstrated that a precision diagnostic strategy reduced the primary composite of death, nonfatal myocardial infarction, or catheterization without obstructive coronary artery disease by 65% in patients with nonacute chest pain compared with usual testing. Medical cost was a prespecified secondary end point.MethodsPRECISE randomized 2103 patients between December 2018 and May 2021 to usual testing or a precision strategy that used deferred testing for the lowest risk patients (20%) and coronary computed tomographic angiography with selective computed tomography-derived fractional flow reserve for the remainder. Resource use consumption data were collected from all study participants and hospital cost data from US participants (n=1125) to estimate total medical costs. The primary and secondary economic outcomes were total costs at 12 months and at 45 days, respectively, from the US health care system perspective. The mean cost differences between the 2 strategies were reported by intention-to-treat.ResultsAt 45 days, total costs were similar between the precision strategy and usual testing (mean difference, $182 [95% CI, -$555 to $661]). By 12 months, percutaneous coronary intervention and coronary artery bypass surgery had been performed in 7.2% and 2.0% of precision strategy patients and 3.5% and 1.7% of usual testing patients, respectively. At 1 year, precision strategy costs were $5299 versus $4821 for usual testing (mean difference, $478 [95% CI, -$889 to $1437]; P=0.43). Precision care decreased mean per-patient diagnostic cost by 27% and increased mean per-patient revascularization costs by 67%.ConclusionsIn the PRECISE trial, the precision strategy, a risk-based approach endorsed by current clinical practice guidelines, improved the clinical efficiency of testing and had similar costs to usual testing at 45 days and a nonsignificant $478 cost difference at 1 year.RegistrationURL: https://www.clinicaltrials.gov; Unique identifier: NCT03702244.

Project description:BackgroundMost people referred to rapid access chest pain clinics have non-cardiac chest pain, and in those diagnosed with stable coronary heart disease, guidance recommends that first-line treatment is usually medication rather than revascularisation. Consequently, many patients are not reassured they have the correct diagnosis or treatment. A previous trial reported that, in people with non-cardiac chest pain, a brief discussion with a health psychologist before the tests about the meaning of potential results led to people being significantly more reassured. The aim of this pilot was to test study procedures and inform sample size for a future multi-centre trial and to gain initial estimates of effectiveness of the discussion intervention.MethodsThis was a two-arm pilot randomised controlled trial in outpatient rapid access chest pain clinic in 120 people undergoing investigation for new onset, non-urgent chest pain. Eligible participants were randomised to receive either: a discussion about the meaning and implication of test results, delivered by a nurse before tests in clinic, plus a pre-test pamphlet covering the same information (Discussion arm) or the pre-test pamphlet alone (Pamphlet arm). Main outcome measures were recruitment rate and feasibility for a future multi-centre trial, with an estimate of reassurance in the groups at month 1 and 6 using a 5-item patient-reported scale.ResultsTwo hundred and seventy people attended rapid access chest pain clinic during recruitment and 120/270 participants (44%) were randomised, 60 to each arm. There was no evidence of a difference between the Discussion and Pamphlet arms in the mean reassurance score at month 1 (34.2 vs 33.7) or at month 6 (35.3 vs 35.9). Patient-reported chest pain and use of heart medications were also similar between the two arms.ConclusionsA larger trial of the discussion intervention in the UK would not be warranted. Patients reported high levels of reassurance which were similar in patients receiving the discussion with a nurse and in those receiving a pamphlet alone.Trial registrationCurrent Controlled Trials ISRCTN60618114 (assigned 27.05.2011).

Project description:BackgroundPatients with noncardiac chest pain (NCCP) report more severe symptoms and lowered health-related quality of life when they present with comorbid panic disorder (PD). Although generalized anxiety disorder (GAD) is the second most common psychiatric disorder in these patients, its impact on NCCP and health-related quality of life remains understudied. This study describes and prospectively compares patients with NCCP with or without PD or GAD in terms of (1) NCCP severity; and (2) the physical and mental components of health-related quality of life.MethodsA total of 915 patients with NCCP were consecutively recruited in two emergency departments. The presence of comorbid PD or GAD was assessed at baseline with the Anxiety Disorder Schedule for DSM-IV. NCCP severity at baseline and at the six-month follow-up was assessed with a structured telephone interview, and the patients completed the 12-item Short-Form Health Survey Version 2 (SF-12v2) to assess health-related quality of life at both time points.ResultsAverage NCCP severity decreased between baseline and the six-month follow-up (p < .001) and was higher in the patients with comorbid PD or GAD (p < .001) at both time points compared to those with NCCP only. However, average NCCP severity did not differ between patients with PD and those with GAD (p = 0.901). The physical component of quality of life improved over time (p = 0.016) and was significantly lower in the subset of patients with PD with or without comorbid GAD compared to the other groups (p < .001). A significant time x group interaction was found for the mental component of quality of life (p = 0.0499). GAD with or without comorbid PD was associated with a lower mental quality of life, and this effect increased at the six-month follow-up.ConclusionsComorbid PD or GAD are prospectively associated with increased chest pain severity and lowered health-related quality of life in patients with NCCP. PD appears to be mainly associated with the physical component of quality of life, while GAD has a greater association with the mental component. Knowledge of these differences could help in the management of patients with NCCP and these comorbidities.

Dataset Information

Randomised trial of stable chest pain investigation: 3-year clinical and quality of life results from CE-MARC 2.

Aims

Methods

Results

Conclusion

Trial registration number

Publications

Randomised trial of stable chest pain investigation: 3-year clinical and quality of life results from CE-MARC 2.

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