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Circulation. 2014 Jan 28;129(4):479-86. doi: 10.1161/CIRCULATIONAHA.113.005544. Epub 2013 Nov 13.

Randomized, controlled trial of ultrasound-assisted catheter-directed thrombolysis for acute intermediate-risk pulmonary embolism.

Author information

  • 1Division of Vascular Medicine, Swiss Cardiovascular Center, University Hospital Bern, Bern, Switzerland (N.K., I.B.); Helios Hospital Siegburg, Siegburg, Germany (P.B., J.H., R.M.); Internal Medicine III, University Hospital Heidelberg, Heidelberg, Germany (O.J.M., E.B.); Großhadern Hospital, Ludwig-Maximilians University Munich, Munich, Germany (C.K., M.G., P.L.); University Hospital Carl Gustav Carus of Technical University Dresden, Dresden, Germany (J.B.-W., R.H., S.W.); Dortmund Hospital, Dortmund, Germany (T.H., A.B.); Hospital Lippe-Detmold, Detmold, Germany (U.T., D.H.); and University Hospital of Ernst-Moritz-Arndt University, Greifswald, Germany (H.G., K.E.).

Abstract

BACKGROUND:

In patients with acute pulmonary embolism, systemic thrombolysis improves right ventricular (RV) dilatation, is associated with major bleeding, and is withheld in many patients at risk. This multicenter randomized, controlled trial investigated whether ultrasound-assisted catheter-directed thrombolysis (USAT) is superior to anticoagulation alone in the reversal of RV dilatation in intermediate-risk patients.

METHODS AND RESULTS:

Fifty-nine patients (63±14 years) with acute main or lower lobe pulmonary embolism and echocardiographic RV to left ventricular dimension (RV/LV) ratio ≥1.0 were randomized to receive unfractionated heparin and an USAT regimen of 10 to 20 mg recombinant tissue plasminogen activator over 15 hours (n=30; USAT group) or unfractionated heparin alone (n=29; heparin group). Primary outcome was the difference in the RV/LV ratio from baseline to 24 hours. Safety outcomes included death, major and minor bleeding, and recurrent venous thromboembolism at 90 days. In the USAT group, the mean RV/LV ratio was reduced from 1.28±0.19 at baseline to 0.99±0.17 at 24 hours (P<0.001); in the heparin group, mean RV/LV ratios were 1.20±0.14 and 1.17±0.20, respectively (P=0.31). The mean decrease in RV/LV ratio from baseline to 24 hours was 0.30±0.20 versus 0.03±0.16 (P<0.001), respectively. At 90 days, there was 1 death (in the heparin group), no major bleeding, 4 minor bleeding episodes (3 in the USAT group and 1 in the heparin group; P=0.61), and no recurrent venous thromboembolism.

CONCLUSIONS:

In patients with pulmonary embolism at intermediate risk, a standardized USAT regimen was superior to anticoagulation with heparin alone in reversing RV dilatation at 24 hours, without an increase in bleeding complications.

CLINICAL TRIAL REGISTRATION URL:

http://www.clinicaltrials.gov. Unique identifier: NCT01166997.

KEYWORDS:

pulmonary embolism

PMID:
24226805
[PubMed - indexed for MEDLINE]
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