The best diagnostic strategy for patients with suspected PE remains debated, Dr. Yonathan Freund with Emergency Reception Service, in Paris, and colleagues point out in JAMA.
Studies have shown that the absence of all eight PERC rule-out criteria (age 50+, pulse rate 100/min or greater, arterial oxygen saturation <95%, unilateral leg swelling, hemoptysis, recent trauma or surgery, prior PE or deep venous thrombosis, and exogenous estrogen use) or use of an age-adjusted D-dimer cutoff (age x 10 ng/mL in patients aged 50+) can safely exclude PE.
It has also been reported that the YEARS rule can safely exclude PE. The YEARS algorithm combines three clinical parameters (clinical signs of deep vein thrombosis, hemoptysis, and PE as the most likely diagnosis) and depending on the presence of one of those, a high (1,000 mcg/L) or low (500 mcg/L) cutoff value for D-dimer is applied.
But until now, the YEARS rule has not been investigated in a randomized trial, and its safety when combined with the PERC rule and the age-adjusted D-dimer threshold has not been evaluated, the researchers say.
To investigate, they did a cluster-randomized, crossover, noninferiority trial in 18 emergency departments in France and Spain. The study enrolled 1,414 adults with suspected PE, but a low clinical risk of PE not excluded by the PERC rule or a subjective clinical intermediate risk of PE.
In the intervention period that included 726 patients, PE was excluded without chest imaging in patients with no YEARS criteria and a D-dimer level lower than 1,000 ng/mL and in patients with one or more YEARS criteria and a D-dimer lower than the age-adjusted threshold (500 ng/mL if age <50 years or age in years x 10 in patients 50 years and older).
In the control period that included 688 patients, PE was excluded without chest imaging if the D-dimer level was less than the age-adjusted threshold (conventional diagnostic strategy).
The three-month risk of a missed VTE was 0.15% (one patient) using the intervention diagnostic strategy and 0.80% (five patients) using the conventional strategy. The adjusted difference (-0.64%) was within the noninferiority margin of 1.35%.
"The largest advantage of the new algorithm is probably a reduction of 10% in chest imaging (defined as CT angiography or ventilation/perfusion scanning) in the diagnostic workup (or exclusion) of pulmonary embolism," write the authors of an accompanying editorial.
However, several factors should be considered in interpreting the study findings, write Dr. Marcel Levi and Dr. Nick van Es of Amsterdam University Medical Center.
"Although the algorithms used in this study were not particularly complex, the multistep process presented in this trial could complicate the approach for evaluating suspected PE by busy emergency department physicians who evaluate and treat patients with myriad clinical conditions," they offer.
"A diagnostic sequence that requires a first clinical impression followed by calculating the PERC rule in patients judged to be at low risk, then another scoring system (YEARS) for PERC-positive patients or those judged to be at intermediate risk, which is ultimately combined with D-dimer testing using a differential threshold, might not be the most practical and easy-to-remember approach in a busy clinical setting," they caution.
"A simple diagnostic approach based on the YEARS algorithm combined with age-adjusted D-dimer testing in all patients might have been just as efficient and safe overall, while less burdensome," the editorial writers suggest.
SOURCE: https://bit.ly/3pOZy9Z and https://bit.ly/31EkZSm JAMA, online December 7, 2021.
By Reuters Staff
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