We read the comment by Ciampi-Dopazo et al. with interest and we would like to thank them for their contributions to the recently published consensus1. The objective of the consensus as a clinical guideline was to provide recommendations for the optimal management of patients with pulmonary embolism (PE), generated from a systematic review of the evidence and an assessment of the risks and benefits of each intervention.
The consensus document recommends full-dose systemic fibrinolysis as a reperfusion treatment of choice in patients in whom it is not contraindicated. It suggests catheter-directed treatment or low-dose systemic fibrinolysis in patients with absolute or relative contraindications for full-dose systemic fibrinolysis1.
There are two rationales behind these recommendations:
- 1
Meta-analyses (from clinical trials) evaluating the efficacy and safety of systemic fibrinolysis (compared with anticoagulation) in more than 2000 patients with acute PE have shown statistically significant reductions in mortality2. In contrast, only 1 clinical trial has been published that evaluated the efficacy and safety of catheter-directed treatment (ultrasound-enhanced fibrinolysis) in 59 patients with acute PE and right ventricular dilatation on echocardiography3. The trial used an echocardiographic event as an endpoint, but it lacked statistical power to detect differences in clinical events (mortality, recurrent venous thromboembolism, or bleeding). Although clinical records provide useful medical information and can be used to generate hypotheses, they are subject to numerous biases and confounding factors, and should not be used routinely to assess the efficacy and safety of medical interventions.
- 2
The authors have extensive experience in the clinical management of patients with PE and in the application of catheter-directed treatments, but this is not the case for most clinicians and centers that routinely see patients of this type.
Ongoing (NCT04088292, NCT03389971) or pending clinical trials may provide robust evidence of the efficacy and safety of different reperfusion treatments for patients with PE. In the meantime, this consensus provides an updated framework of information that will help clinicians make the most appropriate decisions for each individual patient.
Conflict of interestsThe authors declare that they have no conflict of interest.
Please cite this article as: Lobo JL, Jiménez D. Consenso español sobre el manejo de la tromboembolia de pulmón. Arch Bronconeumol. 2021;57:612.