Findings at three years for tenecteplase vs placebo in patients with intermediate-risk pulmonary embolism
MONDAY, March 27, 2017 (HealthDay News) — Among patients with intermediate- to high-risk pulmonary embolism (PE), thrombolytic treatment with tenecteplase does not affect long-term mortality rates or rates of other complications, according to a study published in the March 28 issue of the Journal of the American College of Cardiology.
Stavros V. Konstantinides, M.D., Ph.D., from the University Medical Center in Mainz, Germany, and colleagues conducted a multisite randomized controlled trial in an effort to compare thrombolysis with tenecteplase (359 patients) versus placebo (350 patients) in normotensive patients with acute PE, right ventricular (RV) dysfunction on imaging, and a positive cardiac troponin test result. Both groups received standard anticoagulation.
The researchers found that overall mortality rates were 20.3 percent in the thrombolysis arm and 18.0 percent in the placebo arm (P = 0.43). At long-term follow-up examination of survivors (median 37.8 months), persistent dyspnea (mostly mild) or functional limitation was reported by 36.0 percent in the thrombolysis group versus 30.1 percent of the placebo group (P = 0.23). Among those receiving echocardiography, no significant differences in residual pulmonary hypertension or RV dysfunction were seen. Chronic thromboembolic pulmonary hypertension was diagnosed in four thrombolysis patients versus six placebo patients (P = 0.79).
“An expectant strategy of anticoagulation, early monitoring, and rescue reperfusion in cases of hemodynamic decompensation is the preferable initial approach to patients with intermediate-risk PE,” the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Boehringer Ingelheim, which funded the study.
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