Super rehab: can we achieve coronary artery disease regression? (a randomised controlled feasibility study)

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Abstract Background Coronary artery disease (CAD) is treated with medication and lifestyle advice to reduce disease progression and risk of future major adverse cardiovascular events. Despite this, many patients remain at heightened risk, particularly those with metabolic syndrome (MetS) or coronary inflammation. Cardiac rehabilitation is offered in secondary, but not in primary prevention where there is insufficient evidence of benefit. Purpose To investigate the feasibility of delivering a multicentre RCT testing Super Rehab (SR), a 12-month high-intensity interval training (HIIT) and dietary intervention, tracking newly diagnosed CAD on CTCA. Methods A multicentre randomised-controlled feasibility study (ISRCTN14603929, Feb 2022-Sept 2024) of SR versus usual care (UC) in 18–75-year-olds with: ≥25% stenosis in ≥1 vessel, metabolic syndrome and coronary inflammation (CaRi-Heart® fat-attenuation-index [FAI] >-70.1HU and/or FAI-score >75th percentile for age/sex LAD-RCA/>90th LCx). Baseline,6,12,15-month assessments recorded body composition (DEXA), aerobic capacity, BP, Seattle Angina Questionnaire-7 score, resource-use and feasibility outcomes. 12-month CTCA tracked FAI, plaque composition (CaRi-Plaque®), end-vessel fractional-flow-reserve (FFRCT) and coronary-volume:myocardial-mass (v/m, HeartFlow®). ANCOVA analysis measured 12-month mean differences (95% CI) between SR and UC adjusted for baseline measurements and sex. Results 43 participants (58±8 years, 72% male) were recruited, 21 SR and 22 UC. Pre-set feasibility success conditions were met and SR met criteria for HIIT delivery (Table 1). SR improved weight (-4.8kg 95% CI [-7.9,-1.8],p=0.003), BMI (-1.7 kg/m2[-2.7,-0.6],p=0.003), visceral fat mass (-126g[-10,-2410],p=0.03), VO2-peak (+3.7ml/kg/min[1.1,6.3],p=0.006), angina (+6.2[0.2,12.3],p=0.04) and diastolic BP (-3.9mmHg[-7.4,-0.4],p=0.03) without change in anti-hypertensives (p=0.58). Across 34 paired baseline/12-month CTCAs, no significant difference was observed in FAI-score within-group (UC:8.7±3.6 / 7.9±2.8,p=0.08; SR:9.6±4.7 / 8.6±3.9,p=0.29) or between-group (-1.9[-4.6,0.9],p=0.18). Calcific plaque (CP) rose in UC (27.6±44.0mm³/36.5±51.5mm³,p=0.01) and SR (23.9±39.4mm³/30.8±40.7mm³,p=0.02), with no difference between-groups in CP, plaque burden (+0.1%[-4.6,4.8],p=0.96), non-CP (+12.8mm³[-30.6,56.3],p=0.55), mean FFRCT (+0.002 [-0.03,0.04],p=0.91) or v/m ratio (+0.5 mm³/g[-1.7,2.7],p=0.64). SR mean cost was £1288. Excluding this, estimated healthcare costs were lower in SR, with a greater downwards trend across time (12-month mean cost per-participant £242.52 [UC] vs £111.16 [SR]). Conclusions SR is feasible in newly diagnosed CAD, significantly improves many indices of cardiovascular health and may be cost effective. Further work is required to understand how and whether these improvements reduce CAD progression and individualised cardiovascular risk, induce beneficial CAD remodelling and sustained health economic benefits.Figure 1.Super Rehab programme.

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