Catheter-directed thrombolysis vs. anticoagulant therapy alone in deep vein thrombosis: results of an open randomized, controlled trial reporting on short-term patency.
BACKGROUND
Approximately one in four patients with acute proximal deep vein thrombosis (DVT) given anticoagulation and compression therapy develop post-thrombotic syndrome (PTS). Accelerated removal of thrombus by thrombolytic agents may increase patency and prevent PTS.


OBJECTIVE
To assess short-term efficacy of additional catheter-directed thrombolysis (CDT) compared with standard treatment alone.


METHODS
Open, multicenter, randomized, controlled trial. Patients (18-75 years) with iliofemoral DVT and symptoms < 21 days were randomized to receive additional CDT or standard treatment alone. After 6 months, iliofemoral patency was investigated using duplex ultrasound and air-plethysmography assessed by an investigator blinded to previous treatment.


RESULTS
One hundred and three patients (64 men, mean age 52 years) were allocated additional CDT (n = 50) or standard treatment alone (n = 53). After CDT, grade III (complete) lysis was achieved in 24 and grade II (50%-90%) lysis in 20 patients. One patient suffered major bleeding and two had clinically relevant bleeding related to the CDT procedure. After 6 months, iliofemoral patency was found in 32 (64.0%) in the CDT group vs. 19 (35.8%) controls, corresponding to an absolute risk reduction (RR) of 28.2% (95% CI: 9.7%-46.7%; P = 0.004). Venous obstruction was found in 10 (20.0%) in the CDT group vs. 26 (49.1%) controls; absolute RR 29.1% (95% CI: 20.0%-38.0%; P = 0.004). Femoral venous insufficiency did not differ between the two groups.


CONCLUSIONS
After 6 months, additional CDT increased iliofemoral patency from 36% to 64%. The ongoing long-term follow-up of this study will document whether patency is related to improved functional outcome.
Department of Hematology, Oslo University Hospital, Ullevål, Norway. tone.enden@medisin.uio.no
T
T
Enden
N-E
NE
Kløw
L
L
Sandvik
C-E
CE
Slagsvold
W
W
Ghanima
G
G
Hafsahl
P A
PA
Holme
L O
LO
Holmen
A M
AM
Njaastad
G
G
Sandbaek
P M
PM
Sandset
D000293:Adolescent; D000328:Adult; D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage* / Q000627:therapeutic use; D002406:Catheterization, Peripheral; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D054070:Postthrombotic Syndrome / Q000517:prevention & control; D015912:Thrombolytic Therapy / Q000379:methods*; D016896:Treatment Outcome; D014654:Vascular Patency / Q000187:drug effects; D014689:Venous Insufficiency / Q000188:drug therapy; D020246:Venous Thrombosis / Q000150:complications / Q000188:drug therapy*; D055815:Young Adult
D000925:Anticoagulants