Contribution of fibrinolysis to the physical component summary of the SF-36 after acute submassive pulmonary embolism

Abstract

Acute pulmonary embolism (PE) can diminish patient quality of life (QoL). The objective was to test whether treatment with tenecteplase has an independent effect on a measurement that reflects QoL in patients with submassive PE. This was a secondary analysis of an 8-center, prospective randomized controlled trial, utilizing multivariate regression to control for predefined predictors of worsened QoL including: age, active malignancy, history of PE or deep venous thrombosis (DVT), recurrent PE or DVT, chronic obstructive pulmonary disease and heart failure. QoL was measured with the physical component summary (PCS) of the SF-36. Analysis included 76 patients (37 randomized to tenecteplase, 39 to placebo). Multivariate regression yielded an equation f(8, 67), P < 0.001, with R(2) = 0.303. Obesity had the largest effect on PCS (β = -8.6, P < 0.001), with tenecteplase second (β = 4.73, P = 0.056). After controlling for all interactions, tenecteplase increased the PCS by +5.37 points (P = 0.027). In patients without any of the defined comorbidities, the coefficient on the tenecteplase variable was not significant (-0.835, P = 0.777). In patients with submassive PE, obesity had the greatest influence on QoL, followed by use of fibrinolysis. Fibrinolysis had a marginal independent effect on patient QoL after controlling for comorbidities, but was not significant in patients without comorbid conditions.

Trial registration: ClinicalTrials.gov NCT00680628.

Conflict of interest statement

Conflict of interests JAK owns stock in CP Diagnostics LLC is a consultant for Daiichi Sankyo Inc, Donawa Lifesciences Consulting, Janssen, and Stago Diagnostica, and has received funding from the Agency for Healthcare Reform, National Institutes for Health. Study funded by an investigator initiated Grant from Genentech, Inc. (Grant #: N3944). AEJ has received funding from the National Institutes of Health. DBD serves as a consultant for Daiichi Sankyo, Beckmann Coulter, Mylan and has received research support from Radiometer, Alere, DOD and the National Institutes of Health. CK is a consultant for Diagnostica Stago, Siemens Healthcare and has received grant funding to his institution from Diagnostica Stago, Siemens Healthcare, the Harvard Milton Fund and the National Institutes of Health.