Alteplase for treatment of occluded peripherally inserted central catheters: safety and efficacy in 240 patients.

PURPOSE

Peripherally inserted central catheters (PICCs) have dramatically improved intravenous therapy, but thrombotic occlusion remains a common problem. Despite the popularity of PICCs, there are few prospective data on the use of fibrinolytic agents to salvage these particular devices. The purpose of this study was to evaluate the efficacy and safety of alteplase treatment.

MATERIALS AND METHODS

A subgroup analysis was performed from a phase IIIB prospective, multicenter trial of 995 patients evaluating the use of alteplase to restore function in occluded venous catheters. Two hundred forty patients (126 men; mean age, 53.5 years; range, 2-90 y) with occluded single-lumen (n = 104) or double-lumen (n = 136) PICCs were identified and constitute the study population. Dysfunction was defined as the inability to withdraw 3 mL of blood. Alteplase (2 mg/2 mL) was instilled into the dysfunctional lumen and assessed at 30 and 120 minutes. If the lumen remained occluded, a second alteplase dose was instilled and assessed at 30 and 120 minutes. Patency was defined as the ability to withdraw 3 mL blood and infuse 5 mL of saline solution. The primary efficacy endpoint was the cumulative restored patency rate after a maximum of two doses of alteplase. The primary safety endpoint was the incidence of intracranial hemorrhage within 5 days of treatment. Serious adverse events were recorded for 30 days after treatment.

RESULTS

The primary efficacy endpoint was 92.9% (95% CI: 88.8%, 95.8%). Cumulative efficacy 30 and 120 minutes after first and second doses were 59.4%, 81.1%, 89.1%, and 92.9%, respectively. The primary safety endpoint was 0.0%. One major hemorrhage was reported: a patient with acute flare of ulcerative colitis experienced hematochezia 3 days after treatment. One serious adverse event (fever) was attributed to study drug.

CONCLUSIONS

Treatment with use of a maximum of two doses of alteplase is safe and effective in restoring function to occluded PICCs.