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

Kucher, Nils; Boekstegers, Peter; Müller, Oliver J; Kupatt, Christian; Beyer-Westendorf, Jan; Heitzer, Thomas; Tebbe, Ulrich; Horstkotte, Jan; Müller, Ralf; Blessing, Erwin; Greif, Martin; Lange, Philipp; Hoffmann, Ralf-Thorsten; Werth, Sebastian; Barmeyer, Achim; Härtel, Dirk; Grünwald, Henriette; Empen, Klaus; Baumgartner, Iris (2014). Randomized, controlled trial of ultrasound-assisted catheter-directed thrombolysis for acute intermediate-risk pulmonary embolism. Circulation, 129(4), pp. 479-86. Lippincott Williams & Wilkins 10.1161/CIRCULATIONAHA.113.005544

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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.

Item Type:	Journal Article (Original Article)
Division/Institute:	04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Angiology
UniBE Contributor:	Kucher, Nils, Baumgartner, Iris
Subjects:	600 Technology > 610 Medicine & health
ISSN:	0009-7322
Publisher:	Lippincott Williams & Wilkins
Language:	English
Submitter:	Catherine Gut
Date Deposited:	09 Oct 2014 09:11
Last Modified:	05 Dec 2022 14:33
Publisher DOI:	10.1161/CIRCULATIONAHA.113.005544
PubMed ID:	24226805
Uncontrolled Keywords:	pulmonary embolism
URI:	https://boris.unibe.ch/id/eprint/50717