When added to usual care, an active strategy for diagnosing pulmonary embolism (PE) that involved D-dimer testing and computed tomography pulmonary angiogram (CTPA) did not reduce the rate of nonfatal symptomatic venous thromboembolism (VTE), readmission for chronic obstructive pulmonary disease (COPD), or death within 90 days compared with usual care alone in patients hospitalized for an acute exacerbation of COPD (AECOPD). These were among the findings of the SLICE trial (ClinicalTrials.gov Identifier: NCT02238639) recently published in JAMA.
The study included 746 patients (mean age, 70.4 years; 26% women) who were hospitalized for AECOPD across 18 hospitals in Spain. Patients were randomly assigned to undergo either usual care for AECOPD (n=367) or usual care plus an active strategy for diagnosing PE (n=370).
Standard, usual care typically consisted of supplemental oxygen, short-acting inhaled β2 agonists as well as short-acting anticholinergic agents, systemic corticosteroids, antibiotics, and pharmacological thromboprophylaxis. The active strategy included D-dimer testing within 12 hours of randomization followed by CTPA if D-dimer was positive.
Researchers compared the 2 diagnostic approaches in terms of changes in a composite endpoint comprising nonfatal symptomatic VTE, readmission for COPD, or death within 90 days following randomization. Secondary outcomes were nonfatal new or recurrent VTE, readmission for COPD, and death from any cause within 90 days.
No significant difference was found between the usual care (the control group) and usual care plus the active PE diagnosing strategy group (the intervention group) at 90 days with respect to the primary outcome (29.2% vs 29.7%, respectively; absolute risk difference, 0.5%; 95% CI, −6.2%to 7.3%; relative risk, 1.02; 95% CI, 0.82-1.28; P =.86).
Likewise, significant differences were not found in secondary outcomes. Nonfatal new or recurrent VTE was not significantly different in the 2 groups (0.5% vs 2.5%); readmission rates for COPD by day 90 in the intervention vs control groups were 25.4% vs 22.9%, respectively; and rates of mortality for any cause in the intervention vs. control group were 6.2% vs. 7.9%, respectively.
The investigators concluded that “the addition of an active strategy for the diagnosis of PE to usual care, compared with usual care alone, did not significantly improve a composite health outcome.” However, investigators also noted that given the study’s open-label design, there was a possibility of diagnostic suspicion bias “in which clinicians more often suspect a new (or recurrent) VTE event if the patient has not undergone a CTPA.” They further added that “the study may not have had adequate power to assess individual components of the composite outcome.”
Disclosure: Multiple authors declared affiliations with the pharmaceutical industry. Please refer to the original article for a full list of disclosures.
Jiménez D, Agustí A, Tabernero E, et al. Effect of a pulmonary embolism diagnostic strategy on clinical outcomes in patients hospitalized for COPD exacerbation: A randomized clinical trial. JAMA. 2021;326(13):1277-1285. doi:10.1001/jama.2021.14846