Purpose: Treatment designed to eliminate thrombus in patients with iliofemoral deep venous thrombosis (DVT) is theoretically attractive; however, its benefits, compared with those of anticoagulation, have not been definitively demonstrated. Although not previously analyzed, an effective measure of treatment success is likely to be the assessment of health-related quality of life (HRQOL). This study evaluated whether catheter-directed thrombolysis for iliofemoral DVT is associated with improved HRQOL, compared with standard anticoagulation, and whether HRQOL outcome in the thrombolysis group is related to lytic success. Methods: An 80-item self-administered HRQOL questionnaire was developed. It contained the Health Utilities Index, Short Form-12, and disease-targeted scales, including health distress, stigma, health interference, physical functioning, and symptoms (eg, leg swelling, pain, ulcers). The HRQOL questionnaire was confirmed to be reliable and valid by means of psychometric testing. Questionnaires were administered to 98 retrospectively identified patients who had had iliofemoral DVT treated at least 6 months earlier. Sixty-eight patients who were identified through a DVT registry were treated with catheter-directed thrombolysis with urokinase (UK), and 30 patients who were identified by means of a medical record review were treated with anticoagulation alone. The treatment decision was made by the attending physician, and all patients were candidates for both thrombolysis and anticoagulation. Results: Most patients were women (61%), white (95%), married (65%), and had a mean interval since initial DVT of 16 months. The group treated with UK was younger (53 ± 17 years) than the group treated with heparin (61 ± 6 years; P =.039). After treatment, patients treated with UK reported better overall physical functioning (P =.046), less stigma (P =.033), less health distress (P =.022), and fewer post-thrombotic symptoms (P =.006), compared with the patients treated with anticoagulation alone. Within the UK group, phlebographically successful lysis correlated with improved HRQOL (P =.038). Patients classified as lytic failures had similar outcomes to patients treated with heparin. Conclusion: Patients with iliofemoral DVT treated with catheter-directed thrombolysis have better functioning and well-being, compared with patients treated with anticoagulation alone. Successful lysis was directly correlated with improved HRQOL, with patients who were classified as lytic failures having similar outcomes to patients treated with heparin. These data support the need for a future randomized trial, which should include an HRQOL measure as part of the outcome analysis. (J Vasc Surg 2000;32: 130-7.)
