TOPLINE

Among patients with intermediate-to high-risk pulmonary embolism (PE), catheter-directed thrombolysis with alteplase plus anticoagulation reduced the risk for the composite of death, recurrent PE, cardiorespiratory decompensation or collapse within 7 days compared with anticoagulation alone.

METHODOLOGY

• Researchers conducted a randomized trial to assess whether catheter-directed thrombolysis combined with anticoagulation led to better clinical outcomes than anticoagulation alone in patients with intermediate-to high-risk PE.
• They included 558 patients (median age, 64 years; 40.9% women) from 11 centers in the Czech Republic from October 2022 to March 2026.
• Intermediate- to high-risk PE was defined by hemodynamic stability, a simplified Pulmonary Embolism Severity Index score of at least 1 (range, 0-6; higher scores indicated a greater risk for death or serious complications at 30 days), and right ventricular dysfunction plus an elevated level of cardiac troponin or natriuretic peptide.
• Patients underwent catheter-directed thrombolysis with alteplase plus anticoagulation therapy (thrombolysis group; n = 280) or anticoagulation therapy alone (standard-care group; n = 278) according to a prespecified protocol.
• The primary outcome was a composite of death from any cause, recurrence of PE, or cardiorespiratory decompensation or collapse within 7 days.

TAKEAWAY

• Across all randomly assigned patients, those in the thrombolysis group had a 90% lower risk for the composite primary outcome than those in the standard-care group (0.7% vs 6.8%; relative risk [RR], 0.10; P < .001).
• The difference was driven mainly by fewer events of cardiorespiratory decompensation or collapse in the thrombolysis group than in the standard-care group (RR, 0.13; 95% CI, 0.03-0.57).
• No deaths occurred in the thrombolysis group within 7 days, whereas four deaths occurred in the standard-care group; between days 8 and 30, there was one death in the thrombolysis group and none in the standard-care group.
• The incidence of clinically relevant and major bleeding events did not differ significantly between groups at 7 days; intracranial hemorrhage occurred in two patients in the thrombolysis group and in none in the standard-care group.

IN PRACTICE

"In patients with intermediate-high-risk acute pulmonary embolism, catheter-directed thrombolysis with alteplase plus anticoagulation therapy led to a lower risk of death from any cause, recurrent pulmonary embolism, or cardiorespiratory decompensation or collapse at 7 days than anticoagulation therapy alone," the researchers wrote.

SOURCE

The study was led by Josef Kroupa, MD, PhD, Department of Cardiology, Charles University, Prague, Czech Republic. It was published online on August 31, 2026, in The New England Journal of Medicine.

LIMITATIONS

The trial was conducted in a single country with a predominantly White population. The open-label design and awareness of trial-group assignments by the clinical events committee may have influenced management decisions and outcome reporting. Moreover, the trial excluded patients older than 80 years and was not powered to detect small differences in rare but serious adverse events.

DISCLOSURES

The study was supported by the Ministry of Health of the Czech Republic and a partnership between Charles University and CarDia, which is supported by the EXCELES Program and NextGenerationEU. Some authors reported serving as consultants or speakers for various device and pharmaceutical companies, receiving research grants, or holding stock in pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.