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Safety and efficacy of catheter-directed therapy versus anticoagulation alone in a higher-risk acute pulmonary embolism population.

ABSTRACT: There is little data comparing safety and efficacy outcomes in patients with pulmonary embolism (PE) receiving catheter directed therapies (CDT) compared to a similar-risk cohort of PE patients receiving anticoagulation alone. 1094 patients with acute PE were studied. CDT and conservatively-managed patients were compared using propensity score matching to assess safety outcomes, which included bleeding and acute kidney injury at 2 and 7 days after PE diagnosis. Efficacy outcomes included change in vital signs over 72 h and in-hospital mortality. PE patients with RV strain who underwent CDT (n = 76) had more bleeding at 2 days (additional 1.04 g/dL loss, 95% CI - 1.48 to - 0.60, p < 0.001) and 7 days (additional 1.36 g/dL loss, 95% CI - 1.88 to - 0.84, p < 0.001) compared to those receiving anticoagulation alone (n = 303). There was a significant increase in creatinine at 2 days (additional 0.22 mg/dL elevation, 95% CI 0.02 to 0.42, p = 0.03), but not at 7 days (additional 0.12 mg/dL elevation, 95% CI - 0.11 to 0.35, p = 0.30). In-hospital mortality for patients receiving CDT versus anticoagulation alone was similar (OR 1.21, 95% CI 0.53 to 2.77; p = 0.65). In patients with baseline abnormal vital signs who received CDT versus anticoagulation alone, heart rate, respiratory rate and oxygen requirement improved significantly faster and to levels closer to normal (p ≤ 0.001). CDT was associated with a small but increased risk of bleeding, but no significant worsening of renal function. CDT may be associated with more rapid improvements in heart rate, respiratory rate, and oxygen requirement.

SUBMITTER: Putnam A

PROVIDER: S-EPMC8148410 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ImportanceThe optimal treatment of intermediate-high-risk pulmonary embolism (PE) remains unknown.ObjectiveTo assess the effect of conventional catheter-directed thrombolysis (cCDT) plus anticoagulation vs anticoagulation monotherapy in improving echocardiographic measures of right ventricle (RV) to left ventricle (LV) ratio in acute intermediate-high-risk PE.Design, setting, and participantsThe Catheter-Directed Thrombolysis vs Anticoagulation in Patients with Acute Intermediate-High-Risk Pulmonary Embolism (CANARY) trial was an open-label, randomized clinical trial of patients with intermediate-high-risk PE, conducted in 2 large cardiovascular centers in Tehran, Iran, between December 22, 2018, through February 2, 2020.InterventionsPatients were randomly assigned to cCDT (alteplase, 0.5 mg/catheter/h for 24 hours) plus heparin vs anticoagulation monotherapy.Main outcomes and measuresThe proportion of patients with a 3-month echocardiographic RV/LV ratio greater than 0.9, assessed by a core laboratory, was the primary outcome. The proportion of patients with an RV/LV ratio greater than 0.9 at 72 hours after randomization and the 3-month all-cause mortality were among secondary outcomes. Major bleeding (Bleeding Academic Research Consortium type 3 or 5) was the main safety outcome. A clinical events committee, masked to the treatment assignment, adjudicated clinical outcomes.ResultsThe study was prematurely stopped due to the COVID-19 pandemic after recruiting 94 patients (mean [SD] age, 58.4 [2.5] years; 27 women [29%]), of whom 85 patients completed the 3-month echocardiographic follow-up. Overall, 2 of 46 patients (4.3%) in the cCDT group and 5 of 39 patients (12.8%) in the anticoagulation monotherapy group met the primary outcome (odds ratio [OR], 0.31; 95% CI, 0.06-1.69; P = .24). The median (IQR) 3-month RV/LV ratio was significantly lower with cCDT (0.7 [0.6-0.7]) than with anticoagulation (0.8 [0.7-0.9); P = .01). An RV/LV ratio greater than 0.9 at 72 hours after randomization was observed in fewer patients treated with cCDT (13 of 48 [27.0%]) than anticoagulation (24 of 46 [52.1%]; OR, 0.34; 95% CI, 0.14-0.80; P = .01). Fewer patients assigned to cCDT experienced a 3-month composite of death or RV/LV greater than 0.9 (2 of 48 [4.3%] vs 8 of 46 [17.3%]; OR, 0.20; 95% CI, 0.04-1.03; P = .048). One case of nonfatal major gastrointestinal bleeding occurred in the cCDT group.Conclusions and relevanceThis prematurely terminated randomized clinical trial of patients with intermediate-high-risk PE was hypothesis-generating for improvement in some efficacy outcomes and acceptable rate of major bleeding for cCDT compared with anticoagulation monotherapy and provided support for a definitive clinical outcomes trial.Trial registrationClinicalTrials.gov Identifier: NCT05172115.

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Safety and efficacy of catheter-directed therapy versus anticoagulation alone in a higher-risk acute pulmonary embolism population.

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