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BALTIMORE -- Patients increasingly undergo thrombolysis for deep vein thrombosis, but this treatment significantly boosted the risk of major bleeding and death, according to representative data collected in 1998-2003 from across the United States.

On the basis of these findings, thrombolysis should not be used as an adjunctive treatment for deep vein thrombosis (DVT) in patients who are at high risk for a bleeding complication, according to Dr. Carlos H. Timaran at the Vascular Annual Meeting.

Thrombolysis has been advocated as an adjunct to anticoagulant treatment for iliofemoral DVT by certain medical societies because of its effectiveness at reducing postthrombotic syndrome. And until now, thrombolysis has been viewed as safe, said Dr. Timaran, chief of endovascular surgery at the Dallas Veterans Affairs Medical Center.

High-risk patients who should not get thrombolytic treatment for DVT include those with a history of peptic ulcer disease, stroke, intracranial hemorrhage, or brain surgery. These patients are especially vulnerable to developing a new gastric or intracranial bleed following thrombolytic therapy, he said in an interview.

Dr. Timaran and his associates used data collected in the National Inpatient Sample, a representative, 20% sample of patients treated at academic and community hospitals in 35 states sponsored by the Agency for Healthcare Quality and Research. They analyzed data on thrombolysis for DVT in 1998-2003.

In 1998, about 485,000 hospitalized patients in the United States were diagnosed with DVT, which increased to about 800,000 patients by 2003. Overall, in-hospital mortality rates in these patients rose from 1.07% in 1998 to 1.22% in 2003. Among these patients, the percent treated with thrombolysis jumped from 0.4% in 1998 to 2.1% in 2003, a fivefold increase.

In a multivariate analysis that controlled for differences in the incidence of pulmonary embolism and in the prevalence of comorbidities, patients with DVT who were treated with thrombolysis had a 54% increased risk of developing a major bleed and a 4.9-fold increased risk of having an intracranial hemorrhage, compared with patients who weren't treated with thrombolysis. Thrombolytic therapy also boosted the risk of in-hospital death by 75%, compared with DVT patients who did not undergo thrombolysis.

During the period studied, the in-hospital mortality rate of DVT patients who weren't treated with thrombolysis and had no major bleeding was 1.1%, but in those who received thrombolysis and had major bleeding the mortality rate was 8.2%, about sevenfold higher, he said.

"The increased risk of death with thrombolysis is primarily associated with an increased risk of major bleeding," he said in an interview.

The study was unable to evaluate the type of thrombolytic treatment that patients received, but Dr. Timaran speculated that most patients received the drug locally through a catheter rather than systemically. The drugs commonly used for DVT thrombolysis are tissue plasminogen activator, urokinase, tenecteplase, and reteplase, he added.

When asked to comment on this article, Dr. Ali F. AbuRahma, chief, Vascular \& Endovascular Surgery, Robert C. Byrd Health Sciences Center, West Virginia University, Charleston, stated: "This is a remarkable study signifying the morbidity of thrombolytic therapy, if it is not used in the proper patients. Strict criteria must be followed prior to recommending thrombolytic therapy for patients with iliofemoral DVT

"However, three recently published reports (Mewissen, Comerota, and Bjarnason) have demonstrated a satisfactory outcome with thrombolytic therapy with a major bleeding complication rate that varies from 5%-10%.

"In these three studies, 422 patients were treated with remarkably consistent rates of success and complications with 0%<1% intracranial bleeding, which echoes the notion that in properly selected patients, major bleeding and/or intracranial bleeding can be very low.

"The main message of this study is that if patients are not properly selected for lytic therapy, major bleeding events and/or intracranial hemorrhage can be very significant.

"It would have been interesting to see if there were any differences in the bleeding complication rates according to the type of lytic therapy used, i.e., TPA, urokinase, tenecteplase, and/or reteplase." Dr. AbuRahma is an associate medical editor for VASCULAR SPECIALIST