PHILADELPHIA, PA – The use of catheter-based thrombolysis plus anticoagulation does not significantly reduce the risk of death among patients with lower-extremity deep vein thrombosis (DVT) compared with anticoagulation alone, suggests a study. In fact, new observational data show that catheter-based thrombolysis may be associated with an increased risk of adverse outcomes, including higher rates of bleeding, pulmonary embolism, and intracranial hemorrhage [1].
Dr Riyaz Bashir (Temple University School of Medicine, Philadelphia, PA) and colleagues state that the higher bleeding rate, despite technological and pharmacological advances, means that catheter-directed thrombolysis should only be given to patients at low risk of bleeding.
The study was published July 21 in JAMA Internal Medicine.
"In light of the findings of this study, it is imperative that the magnitude of benefit from catheter-directed thrombolysis be substantial to justify the increased initial resource utilization and bleeding risks of this therapy," state the investigators.
Catheter-directed thrombolysis, which involves the breakdown of the thrombus causing DVT, remains controversial. The American College of Chest Physicians recommends against the procedure, saying it is too complex and risky to justify its use. The American Heart Association, on the other hand, says catheter-directed thrombolysis can be performed as a first-line treatment in patients with iliofemoral DVT and low bleeding risk.
In their comparative safety and efficacy analysis, the researchers identified 90 618 patients hospitalized for DVT between 2005 and 2010. Of these, 3649 underwent catheter-directed thrombolysis. Researchers then compared the risk of in-hospital mortality and other outcomes among two cohorts of propensity-matched patients: 3594 patients who received anticoagulation alone and 3594 who underwent thrombolysis plus anticoagulation.
The comparative analysis provided reassuring results on the primary outcome of in-hospital mortality, with no significant differences between the two treatment options; however, all secondary outcomes favored treatment with anticoagulation alone. In the final two years of the analysis, the in-hospital mortality rate between the two therapies was similar, which might reflect a learning curve with catheter-directed thrombolysis, improved equipment, and better anticoagulation, say investigators.
Comparative Efficacy and Safety of Treatments Outcome Catheter-Directed Thrombolysis Plus Anticoagulation (n=3594) Anticoagulation Alone (n=3594) p In-hospital mortality (%) 1.2 0.9 0.15 Blood transfusion (%) 11.3 6.5 <0.001 Pulmonary embolism (%) 17.9 11.4 <0.001 Intracranial hemorrhage (%) 0.9 0.3 0.03 Vena cava filter placement (%) 34.8 15.6 <0.001 Hospital length of stay (days) 7.2 5.0 <0.001 Hospital charges ($) 85 094 28 164 <0.001
In their paper, Bashir and colleagues point out that small studies of the invasive procedure have suggested it can reduce the risk of post-thrombotic syndrome and improve venous function, but these results remain inconclusive. Uptake of catheter-directed thrombolysis is substantially limited by the known bleeding risks and physicians are uncomfortable recommending the procedure to reduce the risk of nonfatal post-thrombotic syndrome.
Given that observational studies are limited by nature, the researchers recommend performing a randomized trial to study the effect of thrombolysis on mortality, post-thrombotic syndrome, and DVT recurrence. "In the absence of such data, it may be reasonable to restrict this form of therapy to those patients who have a low bleeding risk and a high risk for post-thrombotic syndrome, such as patients with iliofemoral deep vein thrombosis," conclude Bashir et al.
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Poster Comment:
chart at link easier to read.