Effectiveness and safety of catheter-directed thrombolysis for pulmonary embolism in key patient subgroups: results of an individual patient level analysis

Abstract Background The effectiveness of catheter-directed thrombolysis (CDT) for acute pulmonary embolism (PE) has been rarely investigated in subgroups of patients at a higher risk of complications. Furthermore, this group of patients has been excluded from prior and ongoing phase 3 trials with CDT. Purpose To assess the efficacy and safety of catheter-directed thrombolysis for pulmonary embolism among specific patient subpopulations. Material and methods We conducted an individual patient-level analysis of patient data from 16 cohort studies and randomized trials of CDT for intermediate- and high-risk acute PE. Studies were identified on the basis of a systematic review of the literature. We focused on early clinical outcomes, including haemodynamic decompensation, intracranial bleeding, major bleeding, and death, as well as on the changes in the mean pulmonary artery pressure (mPAP) before and after CDT. We predefined three subgroups of at-risk patients: (i) older age (i.e. ≥75 years), (ii) active cancer, and (iii) surgery in the prior 4 weeks. Results We studied 1244 patients, of whom 586 (47.1%) were women. The median age was 61 (Q1-Q3; 50-71) years. There were 202 (16.3% of total available) patients aged 75 years or older, 101 (10%) with active cancer, and 108 (14.8%) with prior surgery. A total of 946 (89.3%) patients had intermediate-risk PE, and 113 (10.7%) were classified in the high-risk group. Patients aged ≥75 years more frequently suffered haemodynamic decompensation (7.5% vs 1.6% aged <75 years; p< 0.001), major bleeding (12.7% vs 4.5%; p<0.001), and death (9.2% vs 2.2%; p<0.001); Table 1. In a multivariable logistic regression model, age remained associated with death, major bleeding, and haemodynamic decompensation after adjustment for a key prognostic factor (high-risk PE). The same, except for decompensation, was observed after conditioning for sex, high-risk PE, and cancer status. Patients with active cancer showed a tendency to a higher 30-day case fatality when compared with patients with no active cancer, without reaching statistical significance; Table 1. Recent surgery did not appear to influence the outcome rate in this cohort. No differences were found among the three subgroups regarding the reduction of the mPAP following CDT ; Table 2. Conclusions Our results point to age as a strong predictor of early mortality and decompensation in patients undergoing CDT, even after adjusting for the higher rate of high-risk PE in the elderly. The clinical net benefit of CDT in the elderly when accounting for bleeding and the risk of haemodynamic decompensation remains unclear.Efficacy and safety outcomes of CDTmPAP values before and after CDT