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PEITHO: Tenecteplase benefits patients with pulmonary embolism
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SAN FRANCISCO — In patients with acute pulmonary embolism, one dose of tenecteplase prevented death or circulatory collapse and appears to be particularly effective for patients aged younger than 75 years.
The prospective, randomized, double blind PEITHO study enrolled 1,006 patients with confirmed acute pulmonary embolism in 13 countries. Patients were randomly assigned heparin plus tenecteplase or heparin plus placebo.
Stavros Konstantinides
The primary endpoint was death from any cause or hemodynamic collapse after 7 days of randomization. At the American College of Cardiology Scientific Sessions, researchers reported that the primary endpoint was reduced by 56% in patients assigned heparin plus tenecteplase compared with heparin plus placebo. Hemodynamic collapse occurred in 1.6% of patients assigned heparin plus tenecteplase vs. 5% assigned heparin plus placebo. Death rates were low and similar in both groups (1.2% heparin/tenecteplase vs. 1.8% heparin/placebo). However, major bleeding was increased with tenecteplase: 6.3% vs. 1.5%. Ten hemorrhagic strokes were reported in the heparin plus tenecteplase group compared with one in the heparin plus placebo group.
"This is more or less the rate we have seen in previous thrombolytic trials," Stavros Konstantinides, MD, PhD, professor for clinical trials at the Center for Thrombosis and Hemostasis at University of Mainz, Germany, said in a press release.
Patients aged younger than 75 years gained the most benefit from the addition of tenecteplase and had fewer hemorrhagic strokes, according to the researchers.
“Our future priorities are now to refine our risk stratification concept even further, to better identify those patients who will benefit most with less risk of bleeding. Also, the dose of the drug that we used could be lowered in older patients, and alternative methods of delivering thrombolytics could be explored,” Konstantinides stated.
Tenecteplase is not currently approved by the FDA for the treatment of acute pulmonary embolism.
For more information:
Konstantinides S. Late-breaking clinical trials V: Heart failure. Presented at: American College of Cardiology Scientific Sessions; March 9-11, 2013; San Francisco.
Disclosure: The study was sponsored by Assistance Publique–Hôpitaux de Paris and funded by the French Ministry of Health, German Ministry of Education and Research, and Boehringer Ingelheim. Konstantinides reports no relevant financial disclosures.