Assessment of thrombotic adverse events and treatment patterns associated with varicose vein treatment.

OBJECTIVE: This retrospective study assessed varicose vein treatment patterns and associated thrombotic complications in a real-world setting.

METHODS: A retrospective study was conducted with health care claims data from Truven Health, covering more than 40 million insured lives per year and representing all U.S. census regions. The study sample included subjects aged ≥ 18 years with a new diagnosis of varicose veins who had received at least one invasive treatment (eg, surgery, endovenous thermal ablation [radiofrequency or laser], or sclerotherapy [liquid or foam]). The adverse events of interest included a coded diagnosis of deep venous thrombosis (DVT) or pulmonary embolism within 30 days of a claim for invasive treatment. Patients treated between January 1, 2008, and June 30, 2012, were observed for up to 2 years after diagnosis.

RESULTS: There were 985,632 unique subjects diagnosed with varicose veins; of them, a total of 131,887 subjects met all of the study criteria: 63,033 (47.8%) having multiple therapies; 22,980 (17.4%) having laser ablation; 21,637 (16.4%) having radiofrequency ablation; 12,708 (9.6%) having sclerotherapy; and 11,529 (8.7%) having surgery. The mean age of the sample was 52.8 years, ranging from 51.5 years (surgery cohort) to 54.5 years (radiofrequency ablation cohort); 77% of the sample was female, ranging from 71% (radiofrequency ablation cohort) to 92% (sclerotherapy cohort). The mean time to treatment after diagnosis was 105 days, ranging from 75 days (sclerotherapy cohort) to 116 days (radiofrequency ablation cohort). The diagnosed prevalence (percentage of subjects within each treatment cohort) of DVT was as follows: radiofrequency ablation, 4.4%; multiple therapies--same day, 3.4%; laser ablation, 3.1%; multiple therapies--deferred, 2.6%; surgery, 2.4%; and sclerotherapy, 0.8%. For pulmonary embolism, the diagnosed prevalence was as follows: radiofrequency ablation, surgery, and laser ablation, 0.3% each; and multiple therapies--same day, multiple therapies--deferred, and sclerotherapy, 0.2% each.

CONCLUSIONS: Thrombotic complications associated with invasive varicose vein treatments in the real-world setting may be higher than what has been reported in clinical trials, particularly in regard to DVT after endovenous thermal ablation therapy. A better understanding of these patterns of adverse events may have an impact on new strategies to safely and effectively manage patients with varicose veins.