Prognostic impact of non-compliance with guidelines-recommended treatment of acute pulmonary embolism: Results of a prospective multicenter registry

Abstract

We aimed to describe non-compliance with guidelines and identify predictors of non-compliance; and to evaluate the impact of non-compliance on the occurrence of clinical events. Observational, multicenter, multidisciplinary registry of acute pulmonary embolism (PE). Based on the ESC guidelines, we used the following indicators to assess compliance: – received reperfusion therapy to treat high-risk PE; – appropriate DOAC dose; – LMWH monotherapy for cancer-associated or pregnancy-related PE; – LMWH, fondaparinux and DOACs contraindicated in pts with severe renal failure; – implantation of inferior vena cava filter in pts with acute PE and absolute contra-indication to anticoagulation; – oral anticoagulation for at least 3 months after a first PE; – for pts with PE and cancer, extended anticoagulation (beyond the first 3–6 months) should be considered; – anticoagulation of indefinite duration is recommended for pts with a second unprovoked PE. Pts with 100% compliance were allocated to the compliant group. Primary outcome was 6-month all-cause death. Secondary outcomes were venous thromboembolism (VTE), major bleeding and chronic thromboembolic pulmonary hypertension (CTEPH). 1285 pts were included. Treatment was guidelines-compliant in 1113 (86.6%). Independent predictors of non-compliance were: Shock/hypotension (OR: 5.6; 95% CI: 2.8–10.3); renal insufficiency (OR: 1.6; 95% CI: 1.2–2.0), cancer (OR: 1.21; 95% CI: 1.1–1.3) and RV dysfunction (OR: 1.08; 95% CI 1.03–1.1). All-cause death occurred in 62/172 pts (36.1%) vs. 131/1113 (11.8%), non-compliant vs. compliant, (RR 2.02, 95% CI 1.45–2.81; P < 0.001) ( Fig. 1 ). Follow-up rates of recurrent VTE (7.0% vs. 1.3%, P < 0.001) and major bleeding (13.4% vs. 4.8%, P = 0.04) were higher in the non-compliant group. The rate of CTEPH was similar between groups ( P = 0.79). Non-compliance with guidelines was associated with worse outcomes including death, recurrent VTE and bleeding.