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Tenecteplase safe, effective for catheter function restoration
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51st ASH Annual Meeting
Tenecteplase, a fibrin-specific recombinant tissue plasminogen activator, was safe and effective for the restoration of catheter function in patients with dysfunctional central venous catheters.
Central venous catheters, which allow for infusion of therapeutic agents and nutritional products, withdrawal of blood and its constituents and accurate assessment of hemodynamic variables, are often dysfunctional due to occlusion.
To evaluate the efficacy and safety of tenecteplase (Tnkase, Genetech) at restoring function to occluded central venous catheters, researchers conducted a randomized, placebo-controlled study. Nashat Gabrail, MD, hematologist/oncologist at Gabrail Cancer Center in Canton, Ohio, presented the results at the 51st ASH Annual Meeting.
Patients with dysfunctional non-hemodialysis catheters were assigned to an initial dose of intraluminal tenecteplase and, if indicated, a second dose of tenecteplase, and third dose of placebo (TTP; n=50). In a second treatment group, placebo was assigned followed by up to two doses of tenecteplase, if needed for restoration of catheter function (PTT; n=47).
The primary efficacy endpoint was the number of patients with restoration of catheter function within 120 minutes after single administration of tenecteplase.
In the TTP group, 60% of patients met the primary endpoint vs. 23.4% of patients in the PTT group (P=.0002).
In the TTP group, cumulative restoration rates for central venous catheters function increased to 88% after a second dose of tenecteplase. The overall cumulative restoration rate was 86.6% after the second dose of tenecteplase in both treatment groups.
Catheter patency was 80.4% for patients who had treatment success and whose catheters were accessed within seven days after treatment. Adverse events were similar with 20.6% reporting a treatment-emergent adverse event. - by Christen Haigh
For more information:
- Gabrail N. #173. Presented at: 51st ASH Annual Meeting and Exposition; Dec. 4-8, 2009; New Orleans.
