An early switch from heparin to a DOAC following standard clinical assessment is effective and safe in adult patients with intermediate-risk pulmonary embolism.
In a single arm phase 4 study across 42 hospitals and nine European countries, 402 patients received 72 hours of low-molecular-weight or unfractionated heparin before consideration of switching to 150 mg twice-daily dabigatran.
Most patients (95%) had no contraindications to an early switch to dabigatran.
During the 6-month follow-up period, recurrent symptomatic VTE or death from a pulmonary embolism-related cause occurred in 2% of patients.
Pulmonary embolism-related death, haemodynamic collapse, or haemodynamic decompensation occurred within the first 30 days in <1% of patients.
Major bleeding events occurred in 3% of patients, and non-major clinically relevant bleeding events in 4% of patients.
The study, published in The Lancet Haematology, said the findings suggested that an early switch from parenteral anticoagulation to a DOAC was safe.
The investigator said their proof-of principle study was not designed to test the safety and efficacy of the specific DOAC but rather the management approach.
“We therefore consider our main findings to be generalisable to other available and approved oral anticoagulants, and thus possess broader clinical relevance.”
A Comment article in the journal said there has been an enduring reluctance to the implementation of single-oral or early-switch strategies in patients with intermediate-risk pulmonary embolism.
“The result is a high proportion of patients with intermediate-risk pulmonary embolism remaining on low-molecular weight heparin for several days after diagnosis, even when opting for apixaban or rivaroxaban, which have been tested as single-oral drugs in phase 3 trials.”
They warned there was a wide spectrum of risk within the intermediate-risk PE patients, and some would still require a cautious approach.
“Of particular note, despite its limitations, the PEITHO-2 study paves the way for fine-tuning risk-assessment strategies with a clinically meaningful dynamic assessment of patients admitted to hospital with intermediate-risk pulmonary embolism, which could impact the future management of these patients and their duration of hospital stay.”
The study was partly funded by Boehringer Ingelheim.