OBJECTIVES The goal of this study was to assess the short- and long-term ef
ficacy of different thrombolytic therapy regimens in patients with leg or p
elvic deep venous thrombosis (DVT).
BACKGROUND It is unclear whether locoregional or systemic thrombolysis is s
uperior in treating acute leg DVT or even whether lysis is more effective t
han anticoagulation therapy in preventing postthrombotic syndrome.
METHODS A total of 250 patients averaging 40 years of age with acute DVT we
re randomized into five groups to receive full heparinization (1,000 IU/h)
and compression treatment, with four groups also administered locoregional
tissue plasminogen activator (20 mg/day) or urokinase (100,000 IU/day) or s
ystemic streptokinase (3,000,000 IU daily) or urokinase (5,000,000 IU daily
). AU groups then received anticoagulation and compression treatment for on
e year. Primary efficacy criteria included the change after one year in the
number of dosed vein segments and the occurrence of postthrombotic syndrom
e.
RESULTS Systemic thrombolytic therapy significantly reduced the number of c
losed vein segments after 12 months in patients with acute DVT compared wit
h conventional treatment (p < 0.05). Postthrombotic syndrome also occurred
with less frequency in systemically treated patients versus controls (p < 0
.001). High-dose thrombolysis led to better rates of complete recanalizatio
n after seven days (p < 0.01) than locoregional lysis. However, 12 patients
receiving thrombolysis (9 systemic, 3 local) suffered major bleeding compl
ications; 9 patients on systemic treatment developed pulmonary emboli.
CONCLUSIONS Systemic thrombolytic treatment for acute DVT achieved a signif
icantly better short- and long-term clinical outcome than conventional hepa
rin/anticoagulation therapy but at the expense of a serious increase in maj
or bleeding and pulmonary emboli. Given the inherent risks for such serious
complications, systemic thrombolysis, although effective, should be used s
electively in limb-threatening thrombotic situations. (J Am Coll Cardiol 20
00;36:1336-43) (C) 2000 by the American College of Cardiology.