The rationale, design, and methods of a randomized, controlled trial to evaluate the efficacy and safety of an active strategy for the diagnosis and treatment of acute pulmonary embolism during exacerbations of chronic obstructive pulmonary disease

Jiménez, David; Agustí, Àlvar; Monréal, Manuel; Otero, Remedios; Huisman, Menno V.; Lobo, José Luís; Quezada, Andrés; Jara-Palomares, Luis; Hernando, Ascensión; Tabernero, Eva; Marcos, Pedro J.; Ruiz-Artacho, Pedro; Ballaz, Aitor; Bertoletti, Laurent; Couturaud, Francis; Yusen, Roger D.

doi:10.1002/clc.23161

Cited by 10 publications

(8 citation statements)

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“…21 It remains to be determined in larger studies if, after a negative computed tomographic angiographic scan, a leg compression ultrasound should be systematically added when patients with COPD and acutely worsening respiratory symptoms are admitted. 24 It is an important question because this practice is no longer recommended for patients with suspected pulmonary embolism. 14 Consistent with other studies, mortality was higher among patients with pulmonary embolism than it was for patients without it.…”

Section: Discussionmentioning

confidence: 99%

Prevalence of Pulmonary Embolism Among Patients With COPD Hospitalized With Acutely Worsening Respiratory Symptoms

Couturaud

Bertoletti

Pastré

et al. 2021

JAMA

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IMPORTANCEThe prevalence of pulmonary embolism in patients with chronic obstructive pulmonary disease (COPD) and acutely worsening respiratory symptoms remains uncertain.OBJECTIVE To determine the prevalence of pulmonary embolism in patients with COPD admitted to the hospital for acutely worsening respiratory symptoms. DESIGN, SETTING, AND PARTICIPANTSMulticenter cross-sectional study with prospective follow-up conducted in 7 French hospitals. A predefined pulmonary embolism diagnostic algorithm based on Geneva score, D-dimer levels, and spiral computed tomographic pulmonary angiography plus leg compression ultrasound was applied within 48 hours of admission; all patients had 3-month follow-up. Patients were recruited from January 2014 to May 2017 and the final date of follow-up was August 22, 2017.EXPOSURES Acutely worsening respiratory symptoms in patients with COPD. MAIN OUTCOMES AND MEASURESThe primary outcome was pulmonary embolism diagnosed within 48 hours of admission. Key secondary outcome was pulmonary embolism during a 3-month follow-up among patients deemed not to have venous thromboembolism at admission and who did not receive anticoagulant treatment. Other outcomes were venous thromboembolism (pulmonary embolism and/or deep vein thrombosis) at admission and during follow-up, and 3-month mortality, whether venous thromboembolism was clinically suspected or not. RESULTS Among 740 included patients (mean age, 68.2 years [SD, 10.9 years]; 274 women [37.0%]), pulmonary embolism was confirmed within 48 hours of admission in 44 patients (5.9%; 95% CI, 4.5%-7.9%). Among the 670 patients deemed not to have venous thromboembolism at admission and who did not receive anticoagulation, pulmonary embolism occurred in 5 patients (0.7%; 95% CI, 0.3%-1.7%) during follow-up, including 3 deaths related to pulmonary embolism. The overall 3-month mortality rate was 6.8% (50 of 740; 95% CI, 5.2%-8.8%). The proportion of patients who died during follow-up was higher among those with venous thromboembolism at admission than the proportion of those without it at admission (14 [25.9%] of 54 patients vs 36 [5.2%] of 686; risk difference, 20.7%, 95% CI, 10.7%-33.8%; P < .001). The prevalence of venous thromboembolism was 11.7% (95% CI, 8.6%-15.9%) among patients in whom pulmonary embolism was suspected (n = 299) and was 4.3% (95% CI, 2.8%-6.6%) among those in whom pulmonary embolism was not suspected (n = 441).CONCLUSIONS AND RELEVANCE Among patients with chronic obstructive pulmonary disease admitted to the hospital with an acute worsening of respiratory symptoms, pulmonary embolism was detected in 5.9% of patients using a predefined diagnostic algorithm. Further research is needed to understand the possible role of systematic screening for pulmonary embolism in this patient population.

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Section: Discussionmentioning

confidence: 99%

Prevalence of Pulmonary Embolism Among Patients With COPD Hospitalized With Acutely Worsening Respiratory Symptoms

Couturaud

Bertoletti

Pastré

et al. 2021

JAMA

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“…Similarly, patients with AECOPD combined with PE had slightly higher average length of hospitalization (15.7 vs. 14.2 days, P = 0.07) and in‐hospital mortality (6.1% vs. 5.1%, P = 0.62) compared with those of patients without PE 7 . Some previous studies have suggested that PE has a higher prevalence during AECOPD, and it also leads to higher morbidity and mortality in COPD patients 64 . Hassen et al 2 have showed that the risk of ICU hospitalization and mortality in patients with severe COPD increased with the increase in the incidence of PE.…”

Section: Prognosismentioning

confidence: 77%

“… 7 Some previous studies have suggested that PE has a higher prevalence during AECOPD, and it also leads to higher morbidity and mortality in COPD patients. 64 Hassen et al 2 have showed that the risk of ICU hospitalization and mortality in patients with severe COPD increased with the increase in the incidence of PE. Recently, the results of the ELOPE prospective cohort study demonstrated that nearly half of COPD patients with acute PE, most of whom were at low risk, continued to have dyspnea, movement restriction, and other sequelae within 1 year after the disease, which adversely influences the health-related quality of life.…”

Section: Prognosismentioning

confidence: 99%

Pulmonary embolism with chronic obstructive pulmonary disease

Yang

Liu

Deng

2021

Chronic Diseases and Translational Medicine

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Chronic obstructive pulmonary disease (COPD) is a common, preventable, and treatable disease. The incidence of COPD is growing annually in China, and it is a significant and growing public health burden. Multivariate analysis showed that COPD was one of the independent risk factors for the occurrence of pulmonary embolism (PE), and the incidence of PE was significantly higher in COPD patients than in normal subjects. However, PE is often overlooked in patients with acute exacerbation of COPD (AECOPD) because there are many similarities in clinical symptoms between PE and AECOPD, which are difficult to distinguish, resulting in the failure of timely treatment and poor prognosis. Therefore, it is of great significance to understand the clinical manifestations, diagnosis, and treatment of COPD combined with PE for making a more accurate diagnosis, providing timely and effective treatment, and improving the prognosis of such patients.

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“…SLICE was a multicenter, open-label, randomized, clinical trial aimed at evaluating whether an active search for PE might improve clinical outcomes in patients with exacerbations of COPD who required hospital admission. The rationale, design and main results of the SLICE study were described previously [ 11 , 12 ]. The trial was conducted in 18 academic hospitals across Spain.…”

Section: Methodsmentioning

confidence: 99%

Adjusted D-dimer cutoff levels to rule out pulmonary embolism in patients hospitalized for COPD exacerbation: results from the SLICE trial

et al. 2022

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Background For patients with suspected pulmonary embolism (PE), age- or clinically-adjusted D-dimer threshold level can be used to define a negative test that safely excludes PE and reduces the use of imaging. However, the utility of this approach in patients hospitalized for chronic obstructive pulmonary disease (COPD) exacerbation is undefined. Methods We ran an analysis of the patients hospitalized for COPD exacerbation and randomized to the intervention in the SLICE trial. Using the conventional strategy as the reference, we compared the proportion of patients with a negative D-dimer result, and the negative predictive value and sensitivity of three D-dimer threshold strategies for initial PE or subsequent diagnosis of venous thromboembolism (VTE): the age-adjusted strategy, the Wells-adjusted strategy, and the YEARS-adjusted strategy. Results We included 368 patients. Using a conventional threshold, 182 (49.5%) patients had negative D-dimer values, of whom 1 (0.6%) had PE (sensitivity, 94.1%). The use of an age-adjusted threshold increased the number of patients in whom PE could be excluded from 182 to 233 patients (63.3%), and the proportion of false-negative findings increased from 0.5% to 1.7% (sensitivity, 76.5%). With the use of the Wells or YEARS strategies, 64.4% and 71.5% had negative values, and the proportion of false-negative findings was 2.5% (sensitivity, 64.7%) and 2.7% (sensitivity, 58.8%), respectively. Conclusions In patients hospitalized for COPD exacerbation, compared with the conventional strategy, age- or clinically-adjusted strategies of D-dimer interpretation were associated with a larger proportion of patients in whom PE was ruled out with a higher failure rate. Trial Registration ClinicalTrials.gov number: NCT02238639.

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The rationale, design, and methods of a randomized, controlled trial to evaluate the efficacy and safety of an active strategy for the diagnosis and treatment of acute pulmonary embolism during exacerbations of chronic obstructive pulmonary disease

Cited by 10 publications

References 26 publications

Prevalence of Pulmonary Embolism Among Patients With COPD Hospitalized With Acutely Worsening Respiratory Symptoms

Prevalence of Pulmonary Embolism Among Patients With COPD Hospitalized With Acutely Worsening Respiratory Symptoms

Pulmonary embolism with chronic obstructive pulmonary disease

Adjusted D-dimer cutoff levels to rule out pulmonary embolism in patients hospitalized for COPD exacerbation: results from the SLICE trial

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