Thrombolysis of occluded peripheral arteries and veins with tenecteplase: a pilot study

To prospectively assess the feasibility, risk profile, and effect on fibrinogen levels of tenecteplase in transcatheter thrombolysis for peripheral arterial and venous occlusive disease.

Between March 2001 and January 2002, 18 consecutive patients (14 men, four women) with arterial (n = 13) or venous (n = 5) occlusive disease were treated with tenecteplase infusions of 0.25 mg/h. Technical success was defined as restoration of antegrade flow and removal of more than 95% of thrombus. Clinical success was defined in arterial cases as immediate limb salvage and relief of ischemic rest pain and in venous cases as resolution or improvement in extremity pain and swelling. Major bleeding was defined as an intracranial bleeding episode, bleeding that resulted in death, or bleeding that required transfusion, surgery, or cessation of thrombolytic therapy.

Technical success was achieved in all 18 patients (100%). Clinical success was achieved in 11 of 13 arterial cases (85%) and in four of five (80%) venous cases. The mean duration of thrombolysis treatment was 21.5 hours +/- 6.2 (range, 7-35 h), with total tenecteplase doses of 7.1 mg +/- 4.3 (range, 1.75-18.75 mg). Major bleeding occurred in one patient (5.5%) because of slow oozing from bilateral femoral groin access sites, which caused a 25% decrease in hematocrit level. There were no deaths, intracranial hemorrhages, remote sites of bleeding, or minor bleeding complications. The serum fibrinogen level dropped to a mean of 77.4% +/- 19.2% of baseline.

In this initial study, tenecteplase was shown to be a feasible treatment for peripheral arterial and venous thrombolysis with only moderate effect on fibrinogen levels.