Patients in Britain with heart failure are being given larger doses of drugs at the start of their treatment after a global study found that this led to a huge fall in deaths – an approach that experts have called a game-changer.
The regime means those with the potentially fatal condition start receiving their ideal amount of medication within two weeks of diagnosis rather than over many months, reports The Guardian.
Evidence from other countries that have already used the treatment found it cut deaths from heart failure by 62% and lowered their risk of ending up back in hospital by 30%, according to key findings of the Strong-HF trial – published in The Lancet – involving 87 hospitals in 14 countries.
St George’s Hospital in London and Morriston Hospital in Swansea have begun treating patients with the innovative method, which those involved say “is a total game-changer” for the condition.
Clinical staff likened the approach – known as “rapid titration” – to how cancer patients are given a full dose of chemotherapy medication from the start of their treatment to improve their chances of recovery.
“Heart failure is a silent killer, so this new way of treating patients is a total game-changer that I never thought I’d see in my lifetime. It will save many lives and bring hope to so many families,” said Matthew Sunter, the lead heart failure nurse at St George’s.
“In the past, we would start patients on a very low dose and increase it by tiny doses. It could take nine to 12 months to reach the optimal dose.
“Strong-HF has allowed us to think completely differently. Now, we offer patients a review one week after discharge and we can catch them before they get sick enough to need to come back into hospital.
“And we can get them on to the recommended therapy for their heart failure within two to three weeks instead of nine to 12 months.”
The global trial showed that once patients were establishd on those drugs, their chance of dying was cut by 62% and their chances of rehospitalisation for heart failure by 30%.
“That is huge and means we can prevent avoidable deaths while easing the pressures on our hospital,” Sunter added.
St George’s has used the approach with 14 patients who have been taken to hospital with heart failure and plans to use it with 100 more such cases a year.
Morriston plans to treat 500 people from Swansea and Neath Port Talbot that way this year.
Dr Parin Shah, a consultant cardiologist at Morriston specialising in heart failure, said the drugs patients receive are so strong that they will have their blood pressure and kidney function checked before joining their trial to assess their suitability.
“Not everyone will be eligible for this. Some people may not be able to tolerate such intensive treatment. We knew it would suit relatively few people, but it would benefit them considerably,” Shah said.
Study details
Safety, tolerability and efficacy of up-titration of guideline-directed medical therapies for acute heart failure (STRONG-HF): a multinational, open-label, randomised, trial
Alexandre Mebazaa, Beth Davison, Ovidiu Chioncel, Alain Cohen-Solal, Rafael Diaz, Gerasimos Filippatos et al.
Published in The Lancet in 3 December 2022
Summary
Background
There is a paucity of evidence for dose and pace of up-titration of guideline-directed medical therapies after admission to hospital for acute heart failure.
Methods
In this multinational, open-label, randomised, parallel-group trial (STRONG-HF), patients aged 18–85 years admitted to hospital with acute heart failure, not treated with full doses of guideline-directed drug treatment, were recruited from 87 hospitals in 14 countries. Before discharge, eligible patients were randomly assigned (1:1), stratified by left ventricular ejection fraction (≤40% vs >40%) and country, with blocks of size 30 within strata and randomly ordered sub-blocks of 2, 4, and 6, to either usual care or high-intensity care. Usual care followed usual local practice, and high-intensity care involved the up-titration of treatments to 100% of recommended doses within 2 weeks of discharge and four scheduled outpatient visits over the 2 months after discharge that closely monitored clinical status, laboratory values, and N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentrations. The primary endpoint was 180-day readmission to hospital due to heart failure or all-cause death. Efficacy and safety were assessed in the intention-to-treat (ITT) population (ie, all patients validly randomly assigned to treatment). The primary endpoint was assessed in all patients enrolled at hospitals that followed up patients to day 180. Because of a protocol amendment to the primary endpoint, the results of patients enrolled on or before this amendment were down-weighted.
Findings
Between May 10, 2018, and Sept 23, 2022, 1641 patients were screened and 1078 were successfully randomly assigned to high-intensity care (n=542) or usual care (n=536; ITT population). Mean age was 63·0 years (SD 13·6), 416 (39%) of 1078 patients were female, 662 (61%) were male, 832 (77%) were white or Caucasian, 230 (21%) were black, 12 (1%) were other races, one (<1%) was Native American, and one (<1%) was Pacific Islander (two [<1%] had missing data on race). The study was stopped early per the data and safety monitoring board's recommendation because of greater than expected between-group differences. As of data cutoff (Oct 13, 2022), by day 90, a higher proportion of patients in the high-intensity care group had been up-titrated to full doses of prescribed drugs (renin-angiotensin blockers 278 [55%] of 505 vs 11 [2%] of 497; β blockers 249 [49%] vs 20 [4%]; and mineralocorticoid receptor antagonists 423 [84%] vs 231 [46%]). By day 90, blood pressure, pulse, New York Heart Association class, bodyweight, and NT-proBNP concentration had decreased more in the high-intensity care group than in the usual care group. Heart failure readmission or all-cause death up to day 180 occurred in 74 (15·2% down-weighted adjusted Kaplan-Meier estimate) of 506 patients in the high-intensity care group and 109 (23·3%) of 502 patients in the usual care group (adjusted risk difference 8·1% [95% CI 2·9–13·2]; p=0·0021; risk ratio 0·66 [95% CI 0·50–0·86]). More adverse events by 90 days occurred in the high-intensity care group (223 [41%] of 542) than in the usual care group (158 [29%] of 536) but similar incidences of serious adverse events (88 [16%] vs 92 [17%]) and fatal adverse events (25 [5%] vs 32 [6%]) were reported in each group.
Interpretation
An intensive treatment strategy of rapid up-titration of guideline-directed medication and close follow-up after an acute heart failure admission was readily accepted by patients because it reduced symptoms, improved quality of life, and reduced the risk of 180-day all-cause death or heart failure readmission compared with usual care.
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