Lisbeth Cart1, Guillaume Serzian1, Sébastien Humbert2, Nicolas Falvo3, Mathilde Morel-Aleton4, Benjamin Bonnet5, Gabriel Napporn6, Elsa Kalbacher7, Laurent Obert8, Gilles Cappelier9, Yves Cottin10, François Schiele1, Nicolas Meneveau1, Romain Chopard11. 1. Department of cardiology, EA3920, university hospital Besançon, boulevard Fleming, 25030 Besançon, France. 2. Department of internal medicine, hospital Besançon, boulevard Fleming, 25030 Besançon, France. 3. Department of internal medicine, university hospital, 2, boulevard du Maréchal-de-Lattre-de-Tassigny, 21000 Dijon, France. 4. Department of cardiology, general hospital, 2, faubourg Saint-Étienne, 25300 Pontarlier, France. 5. Department of cardiology, general hospital of Vesoul, 2, avenue René-Heymes, 70000 Vesoul, France. 6. Department of cardiology, hospital center Louis-Pasteur, 73, avenue Léon-Jouhaux, 39100 Dole, France. 7. Medical oncology unit, university hospital Besançon, boulevard Fleming, 25030 Besançon, France. 8. Orthopedic, trauma, plastic, reconstructive and hand surgery department, university hospital Besançon, boulevard Fleming, 25030 Besançon, France. 9. Medical intensive care unit, EA3920, university hospital Besançon, boulevard Fleming, 25030 Besançon, France. 10. Department of cardiology, university hospital, 2, boulevard du Maréchal-de-Lattre-de-Tassigny, 21000 Dijon, France. 11. Department of cardiology, EA3920, university hospital Besançon, boulevard Fleming, 25030 Besançon, France. Electronic address: chopardromain@yahoo.fr.
Abstract
BACKGROUND: Evidence-based clinical practice guidelines define initial management of acute pulmonary embolism (PE) according to risk stratification for early death. AIMS: The aims of the present study were to investigate patterns of non-compliance with guidelines for the acute PE treatment, and the associated risk of adverse events. METHODS: We performed an observational, multicentre, cohort study of acute PE. Inclusion criteria were all patients with pulmonary embolism admitted to the participating centres between January 2011 and April 2017. The measure of 100% compliance was used to allocate patients in the compliant or non-compliant groups. The primary outcome was all-cause death at 6 months. Secondary outcomes included recurrent venous thromboembolism and major bleeding. RESULTS: In total, 1285 patients were included. Treatment was not in compliance with the guidelines in 172 patients (13.4%). Four factors were identified to be related to non-compliance with the guidelines: shock or hypotension (relative risk [RR] 5.23, 95% confidence interval [CI] 2.64-10.30; P<0.001), renal insufficiency (RR 1.80, 95% CI 1.41-2.28; P<0.001), active cancer (RR 1.35, 95% CI 1.24-1.48; P<0.001) and right ventricular dysfunction at admission (RR 1.06, 95% CI 1.01-1.11; P=0.01). The primary endpoint of all-cause death at 6 months occurred in 62 of 172 patients (36.0%) in the non-compliant group and in 131 of 1113 patients (11.8%) in the compliant group (hazard ratio 2.02, 95% CI 1.45-2.81; P<0.001). The rates of recurrent venous thromboembolism (8.7% vs 1.1%; P<0.001) and major bleeding (13.4% vs 4.9%, P=0.04) from admission to 6-month follow-up were higher in the non-compliant group. CONCLUSION: Non-compliance with guidelines was independently associated with worse outcomes, including death, recurrent venous thromboembolism and bleeding.
BACKGROUND: Evidence-based clinical practice guidelines define initial management of acute pulmonary embolism (PE) according to risk stratification for early death. AIMS: The aims of the present study were to investigate patterns of non-compliance with guidelines for the acute PE treatment, and the associated risk of adverse events. METHODS: We performed an observational, multicentre, cohort study of acute PE. Inclusion criteria were all patients with pulmonary embolism admitted to the participating centres between January 2011 and April 2017. The measure of 100% compliance was used to allocate patients in the compliant or non-compliant groups. The primary outcome was all-cause death at 6 months. Secondary outcomes included recurrent venous thromboembolism and major bleeding. RESULTS: In total, 1285 patients were included. Treatment was not in compliance with the guidelines in 172 patients (13.4%). Four factors were identified to be related to non-compliance with the guidelines: shock or hypotension (relative risk [RR] 5.23, 95% confidence interval [CI] 2.64-10.30; P<0.001), renal insufficiency (RR 1.80, 95% CI 1.41-2.28; P<0.001), active cancer (RR 1.35, 95% CI 1.24-1.48; P<0.001) and right ventricular dysfunction at admission (RR 1.06, 95% CI 1.01-1.11; P=0.01). The primary endpoint of all-cause death at 6 months occurred in 62 of 172 patients (36.0%) in the non-compliant group and in 131 of 1113 patients (11.8%) in the compliant group (hazard ratio 2.02, 95% CI 1.45-2.81; P<0.001). The rates of recurrent venous thromboembolism (8.7% vs 1.1%; P<0.001) and major bleeding (13.4% vs 4.9%, P=0.04) from admission to 6-month follow-up were higher in the non-compliant group. CONCLUSION: Non-compliance with guidelines was independently associated with worse outcomes, including death, recurrent venous thromboembolism and bleeding.