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RELAX-AHF cohort atypical of most acute HF patients
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Approximately two of every 10 patients with acute HF in the United States, Latin America or Asia Pacific would meet the eligibility criteria for the RELAX-AHF trial, according to recent results.
The international, multicenter, double blind RELAX-AHF trial of 1,161 patients with acute HF indicated that treatment with serelaxin significantly improved dyspnea and reduced risk for all-cause and CV-related mortality at 180 days. The results from this retrospective study suggest that those observed in RELAX-AHF may not necessarily apply to the wider acute HF population, researchers wrote.
The study included data from 196,770 patients enrolled in the ADHERE-US (n=185,948) and ADHERE-I (n=10,822) registries. Both registries included adult inpatients with a primary or secondary diagnosis of acute decompensated HF, collected from hospitals throughout the United States for ADHERE-US and internationally for ADHERE-I.
Adult patients were considered eligible for RELAX-AHF under the following circumstances: a discharge diagnosis of acute HF, systolic BP >125 mm Hg, dyspnea at rest or upon minor exertion, use of IV diuretics, a glomerular filtration rate of 30 mL/min/1.73 m2 to 75 mL/min/1.73 m2, hemoglobin levels >8 g/dL and no use of IV vasopressors or inotropes. Outcome measures included the length of hospital stay, the number of days spent in the ICU, discharge quality-of-care measures and all-cause in-hospital mortality.
Among patients enrolled in the ADHERE registry, 20.7% fulfilled the eligibility criteria for RELAX-AF inclusion, whereas 16.2% of ADHERE-I registry patients were considered eligible. Eligible patients had a greater likelihood of advanced age, female sex, a history of hypertension, preserved ejection fraction and better kidney function than noneligible patients.
Patients in the ADHERE-I registry had a longer median hospital stay than ADHERE-US patients. Although hospital stay was similar regardless of RELAX-AHF eligibility in the US cohort (5 days in both groups), eligible patients had a longer median stay than noneligible patients in the ADHERE-I registry (7 days vs. 6 days). In both registries, RELAX-AHF-eligible patients were significantly more likely to be asymptomatic upon discharge than noneligible patients (55.2% vs. 50.8% in the United States, 66.5% vs. 59.2% internationally; P<.0001).
The in-hospital mortality rate was lower among eligible patients than in noneligible patients in both registries (4.4% vs. 1.6% for ADHERE-US; 5.7% vs. 1% for ADHERE-I). The lower mortality risk among eligible patients remained statistically significant after multivariable adjustment for baseline characteristics (HR=0.59; 95% CI, 0.53-0.66).
“The RELAX-AHF-type patient represents [approximately] two in 10 patients with [acute HF] seen in the United States, Latin America or Asia-Pacific and exhibits better outcomes than their non-RELAX-AHF-type counterparts,” the researchers concluded. “This RELAX-AHF-type population is unique, and future studies or development of other therapies will be necessary for the remainder of the [acute HF] population.”
Disclosure: Three researchers report various financial ties with the Agency for Healthcare Research & Quality, Amgen, Bayer, Bristol-Myers Squibb, Corthera, Gambro, Janssen, Johnson & Johnson, Medtronic, NIH and Novartis.
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