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, Dr. Carlos H. Timaran reported at the Vascular Annual Meeting.
Thrombolysis has been advocated as an adjunct to anticoagulant treatment for iliofemoral DVT by certain medical societies because the procedure is very effective at reducing postthrombotic syndrome.
And until now, thrombolysis has been widely viewed as safe, said Dr. Timaran, who is 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.
Patients with these comorbidities are especially vulnerable to developing a new gastric or intracranial bleed following thrombolytic therapy, Dr. Timaran 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.
The sample was sponsored by the Agency for Healthcare Quality and Research.
They researchers 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 percentage 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 increased the risk of in-hospital death by 75% in treated patients, compared with the risk in 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 seven times higher, Dr. Timaran reported.
“The increased risk of death with thrombolysis is primarily associated with an increased risk of major bleeding,” he explained 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.