The efficacy and tolerance of intra-arterial rt-PA infusion was tested in 27 patients
with a thrombotic occlusion of the femoro-popliteal artery. The mean length of the
occluding thrombus was 10 cm (range : 2-25 cm). The occlusion was recent (<1 week
old) in 7 patients; in 2 it existed for more than 6 months. The rt-PA solution was
infused through an angiographic catheter embedded into the thrombus at a rate of 10
mg/hr in the first 11 patients, 5 mg/hr in the next 11 and 3 mg/hr in the last 5.
The maximal dose foreseen in the protocol was 50 mg; the mean dose infused was 42
mg. Heparin (400 IU/hr) was infused concomitantly. Thrombolysis occurred in all 27
patients. Angiographic restoration of patency was obtained in 25 (93%); it first appeared
after a mean dose of 27 mg rt-PA (range : 10 to 50 mg). In 21 patients, a percutaneous
transluminal angioplasty was needed to dilate a residual stenotic lesion or remaining
mural thrombi. This secondary procedure initiated reocclusion in 2 patients by causing
a distal embolus and a subintimal dissection, respectively. Early rethrombosis occurred
spontaneously in 3 other patients. Thus, 20 (74%) patients had a clinical improvement
at discharge from the hospital.
rt-PA infusion was complicated by bleeding in 10 (37%)
patients: a groin hematoma at the catheter entry site occurred in 9 patients, a hematoma
from a previous venous in 2 and gingival oozing in 3. None required blood transfusion.
Premature interruption of the infusion because of local hematoma formation was the
cause of failure in one patient.
This pilot trial confirms the feasibility of thrombolysis with local infusion of rt-PA
in peripheral arterial thrombosis. The early clinical results and the incidence of
bleeding complications appear similar to those observed with local low-dose streptokinase,
although initial patency seems easier to restore with rt-PA. A prospective trial comparing
rt-PA to streptokinase in this condition is thus warranted
