Summary of subgroup analyses from the CHAMPION trial
| First author | Journal, publication year | Study details | Main analysis | Main findings | Other findings/caveats |
| Givertz20 | JACC, 2017 | Heart failure reduced ejection fraction (HFrEF) (n=456) | Annualised HFH rate during full duration of randomised follow-up (18 months) Group 1: ACEI/ARB or BB use at baseline (n=445) Group 2: ACEI/ARB and BB use at baseline (n=337) |
Group 1 HD mgmt: 0.45 HFH/patient-year Clinical mgmt: 0.68 HFH/patient-year HR 0.67 (0.54 to 0.82); p=0.0002 Group 2 HD mgmt: 0.39 HFH/patient-year Clinical mgmt: 0.69 HFH/patient-year HR 0.57 (0.45 to 0.73); p=0.0002 Significant increase in GDMT doses in HD mgmt arm |
Unadjusted all-cause mortality in patients with HFrEF Group 1: 0.63 (0.41–0.96); p=0.0293 Group 2: 0.43 (0.24–0.76); p=0.0052 Mortality adjusted for neurohormonal antagonist dose Group 1: 0.65 (0.43–0.99) Group 2: 0.45 (0.25–0.80) Mortality adjusted for vasodilator dose Group 1: 0.64 (0.42–0.98) Group 2: 0.44 (0.25–0.78) |
| Adamson19 | Circulation HF, 2014 | Heart failure preserved ejection fraction (HFpEF)* (n=119) | Annualised HFH rate during full duration of randomised follow-up (17.6 months) |
LVEF>40% (n=119) HD mgmt: 0.43 HFH/patient-year Clinical mgmt: 0.86 HFH/patient-year IRR: 0.50 (0.35 to 0.70); p<0.0001 LVEF>50% (n=66) HD mgmt: 0.41 HFH/patient-year Clinical mgmt: 1.39 HFH/patient-year IRR: 0.30 (0.18 to 0.48); p=0.0129 |
LVEF<40% (n=430) HD mgmt: 0.67 HFH/patient-year Clinical mgmt: 0.90 HFH/patient-year IRR: 0.74 (0.63 to 0.89); p<0.0001 |
| Adamson22 | Circulation HF, 2016 | Medicare eligible (n=245) | Annualised HFH rate for median follow-up time of 515 days |
Medicare-eligible cohort HD mgmt: 0.34 HFH/patient-year Clinical mgmt: 0.67 HFH/patient-year HR: 0.51 (0.37 to 0.70); p<0.0001 | Small but significant increase in ACEI/ARB and BB doses in HD mgmt but not clinical mgmt groups 93% daily transmission compliance in Medicare-eligible cohort versus 88% for entire CHAMPION cohort |
| Benza21 | JHLT, 2015 | Pulmonary hypertension (PH) (n=314) | Annualised HFH rate for mean follow-up of 449 and 437 days for HD mgmt and clinical mgmt, respectively |
PH group (n=314) HD mgmt: 0.60 HFH/patient-year Clinical mgmt: 0.94 HFH/patient-year HR: 0.64 (0.51 to 0.81); p=0.0002 Non-PH group (n=215) HD mgmt: 0.28 HFH/patient-year Clinical mgmt: 0.47 HFH/patient-year HR: 0.60 (0.41 to 0.89); p=0.0109 | All PH subgroups based on a PVR above/below 3 WU and TPG above/below 15 mm Hg had significant reductions in HFH in the HD mgmt versus clinical mgmt group |
| Krahnke18 | JCF, 2015 | Chronic obstructive pulmonary disease (COPD) (n=187) | Annualised HFH rate with mean follow-up time of 15 months |
COPD group (n=187) HD mgmt: 0.55 HFH/patient-year Clinical mgmt: 0.92 HFH/patient-year HR: 0.59 (0.44 to 0.81); p=0.0009 Non-COPD group (n=363) HD mgmt: 0.41 HFH/patient-year Clinical mgmt: 0.62 HFH/patient-year HR: 0.66 (0.51 to 0.85); p=0.0017 | Respiratory hospitalisations in COPD group HD mgmt: 0.12/patient-year Clinical mgmt: 0.31/patient-year HR: 0.38 (0.21 to 0.71); p=0.0023 Respiratory hospitalisation rates were not affected by HD mgmt in patients without COPD PFTs not part of diagnostic criteria for COPD, categorisation made on basis of clinical assessment |
| Costanzo23 | JACC HF, 2016 | Pressure-linked outpatient medication changes during the first 6 months of the CHAMPION trial | Pressure-linked increases and decreases in medication doses tied to a PA pressure-guided treatment algorithm | HD mgmt versus clinical mgmt All medication changes: 2468 vs 1061 Diuretic: 1547 vs 585 Vasodilator†: 293 vs 104 ACEI/ARB: 293 vs 144 Beta-blocker: 239 vs 160 MRA: 96 vs 68 | HD mgmt group experienced greater frequency of medication adjustments and greater increases in the doses of diuretics, vasodilators and neurohormonal antagonists without any significant change in renal function Graded increase in frequency of diuretic and vasodilator changes with increasing baseline PADP |
| Feldman29 | ASAIO, 2018 | Observational study of 27 patients who underwent LVAD implantation during the randomised period of the CHAMPION trial | Time to LVAD implantation, prevalence of renal insufficiency; post-LVAD filling pressures | Patients requiring LVAD therapy had significantly higher PA pressures, lower systemic blood pressure A trend towards earlier LVAD implantation and less renal insufficiency was observed in the HD mgmt versus clinical mgmt arm Following LVAD implantation, a greater magnitude of pressure reduction was seen in the HD mgmt versus clinical mgmt arm | Small, post hoc analysis; primarily hypothesis generating |
All HR values are point estimate with 95% CI within parentheses. All IRR values are point estimate with 95% CI within parentheses.
*Preserved ejection fraction in the CHAMPION trial was prespecified as LVEF>40%.
†Nitrates or hydralazine.
ACEI, ACE inhibitor; ARB, angiotensin receptor blocker; BB, beta-blocker; clinical mgmt, clinical management; GDMT, guideline-directed medical therapy; HD mgmt, haemodynamic management strategy; HFH, heart failure hospitalisation; HFpEF, HF with preserved ejection fraction; HFrEF, HF with reduced ejection fraction; IRR, incidence rate ratio; LVAD, left ventricular assist device; LVEF, left ventricular ejection fraction; MRA, mineralocorticoid receptor antagonist; PA, pulmonary artery; PADP, pulmonary artery diastolic pressure; PFT, pulmonary function test; PVR, pulmonary vascular resistance; TPG, transpulmonary gradient; WU, Wood unit.