New Insights on Pulmonary Embolism Treatment Emerge from Clinical Trial

For 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 and other adverse outcomes compared with anticoagulation therapy alone, an open-label randomized trial showed.

Among 558 patients, 0.7% in the thrombolysis group experienced a composite endpoint of death from any cause, recurrence of pulmonary embolism, or cardiorespiratory decompensation or collapse within 7 days compared with 6.8% of those receiving standard-care anticoagulation alone (relative risk [RR] 0.10, 95% CI 0.02-0.44, P<0.001), reported Viktor Kocka, MD, PhD, of Charles University in Prague, at the European Society of Cardiology Congress in Munich.

This difference was mainly driven by the lower incidence of cardiorespiratory decompensation or collapse in the thrombolysis group (0.7% vs 5.4%; RR 0.13, 95% CI 0.03-0.57), Kocka and co-authors noted. No deaths occurred in the thrombolysis group by day 7, while four deaths occurred in the standard-care group. By day 30, there was one death in the thrombolysis group and no deaths in the standard-care group.

Current practice for intermediate-high-risk acute pulmonary embolism often centers on anticoagulation therapy, with rescue reperfusion used for severe clinical deterioration, the researchers explained. “The results of our trial support the concept that, in selected patients treated in interventional centers, earlier catheter-based reperfusion may prevent deterioration before overt collapse occurs and may facilitate faster recovery,” they wrote.

In-hospital mortality from pulmonary embolism is similar or higher than that for myocardial infarction, ranging from 10% to 20%, Kocka said, yet most patients are treated the same way today that they were three decades ago, with routine anticoagulation, “so there is a big clinical need.”

I hope that these data, together with the previously published data, will change [upcoming European] guidelines and will completely change the paradigm of our treatment of pulmonary embolism,” he noted. The findings translate to a number needed to treat of 17.

Inderjit Singh, MBChB, MD, director of the Pulmonary Vascular Disease Program at Yale School of Medicine in New Haven, Connecticut, stated that he was not surprised that thrombolysis had no effect on pulmonary embolism recurrence but noted it was “particularly notable” that the primary outcome was driven by the reduction in cardiorespiratory decompensation/collapse rather than a mortality advantage.

What gave Singh pause, however, was that the procedure was not risk-free, given two cases of intracranial hemorrhage in the thrombolysis group, and the current lack of data on long-term outcomes, though he remains “cautiously optimistic” about safety. He also noted that the study was conducted in highly organized tertiary centers, raising the question of effectiveness and safety in smaller institutions without access to catheter-directed thrombolysis.

If these findings are replicated and reflected in future guideline updates, there may be a shift from reactive management towards a more proactive reperfusion strategy in carefully selected intermediate-risk pulmonary embolism patients.

The trial enrolled 558 patients with intermediate-high-risk acute pulmonary embolism from 11 tertiary care cardiovascular centers in the Czech Republic. Pulmonary embolism, diagnosed by imaging and lab testing, was defined by hemodynamic stability, a simplified Pulmonary Embolism Severity Index score of at least 1, and right ventricular dysfunction plus an elevated level of cardiac troponin or natriuretic peptide.

Clinical characteristics were similar in both groups, with a median age of 64 and 40.9% being women. Initiation of catheter-directed thrombolysis occurred a median 76 minutes after randomization, with a total alteplase dose of 20 mg.

All patients were followed for 7 days, with 99.3% of thrombolysis patients and 94.6% of anticoagulation-alone patients followed for 30 days. Clinically relevant bleeding occurred in 4.6% of patients in the thrombolysis group versus 5% in the standard-care group by day 7, while major bleeding occurred in 1.4% and 2.2%, respectively.

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Fuente: https://www.medpagetoday.com/meetingcoverage/esc/122826