News Daily News

Catheter-Directed Thrombolysis for DVT Increases Bleeding Compared With Standard Anticoagulation

By L.A. McKeown

 Download this article's Factoid (PDF & PPT for Gold Subscribers) 


While catheter-directed thrombolysis and anticoagulation for deep vein thrombosis (DVT) does not appear to increase mortality over standard anticoagulation alone, it leads to bleeding complications that may merit deterring its use. The therapy should be restricted to patients at low risk for bleeding and high risk for postthrombotic syndrome, according to findings from a nationwide observational study published online July 21, 2014, ahead of print in JAMA Internal Medicine.

The data were presented in part at the 2012 American Heart Association Sessions in Los Angeles, CA.

Methods
Riyaz Bashir, MD, of Temple University School of Medicine (Philadelphia, PA), and colleagues utilized the National Inpatient Sample to compile and assess 2 matched groups of patients treated with catheter-directed thrombolytic therapy or anticoagulation alone (n = 3,594 each) between 2005 and 2010. All patients had a principal diagnosis of lower extremity proximal or caval DVT.
The vast majority of catheter-directed procedures (94.8%) were performed within the first 6 days of hospitalization. Patients less likely to be treated with thrombolysis included women, patients older than 65 years, and African-American and Hispanic minorities (all P < .001). Additionally, thrombolysis was more likely to be performed in urban and academic centers (both P < .001). 


Similar Mortality but More Bleeding With Thrombolysis

Over the 6-year study period, use of catheter-directed thrombolysis increased steadily from 2.3% to 5.9% (P < .001), and in-hospital mortality decreased from 1.3% to 1.0% (P < .005). Centers performing more than 5 such cases per year had lower in-hospital mortality than those doing fewer cases (0.6% vs 1.6%; P = .01). The venous angioplasty rate was 57.7% in patients undergoing catheter-directed thrombolysis, and 26.3% received stents.

Adjusted in-hospital mortality rates were similar between the thrombolysis and anticoagulant-alone groups, while rates of blood transfusion, pulmonary embolism, intracranial hemorrhage, and vena cava filter placement were higher in the thrombolysis group. Thrombolysis patients also had longer mean hospital stays and higher hospital charges (table 1).

Table 1. Results in Propensity-Matched Groups

 

Catheter-Directed Thrombolysis
(n = 3,594)

Anticoagulation
(n = 3,594)

OR (95% CI)

P Value

In-Hospital Death

1.2%

0.9%

1.41 (0.88-2.25)

.15

Transfusion

11.1%

6.5%

1.85 (1.57-2.20)

< .001

Pulmonary Embolism

17.9%

11.4%

1.69 (1.49-1.94)

< .001

Intracranial Hemorrhage

0.9%

0.3%

2.72 (1.40-5.30)

.03

Vena Cava Filter

34.8%

15.6%

2.89 (2.58-3.23)

< .001

Mean Length of Stay, days

7.23

5.02

2.27 (1.49-1.94)

< .001

Mean Hospital Charges

$85,094

$28,164

$57,417 ($54,796-60,037)a

< .001

a Estimated difference between the groups. 

Independent predictors of death or intracranial hemorrhage in patients undergoing thrombolysis were:

  • Shock
  • Cancer
  • Paralysis
  • Age greater than75 years
  • Hispanic ethnicity
  • Low institutional volume of cases
  • Renal failure
  • Congestive heart failure 

According to the study authors, the decrease in in-hospital mortality with thrombolysis across the study period “may reflect a learning curve, and use of newer pharmacomechanical therapies may result in lower doses and shorter durations of use of thrombolytic agents.”

On the other hand, they say, the high rate of inferior vena cava filter placement in the thrombolysis group is concerning since these devices have shown no clear benefit in this population. Also, given the higher initial resource utilization associated with catheter-directed thrombolysis, “it is crucial that rigorous economic analyses from ongoing and completed randomized trials be incorporated into future guideline recommendations,” the researchers stress.

Risk/Benefit Clarification Needed From Larger Studies

“The major issue here is that thrombolysis is not performed in patients with DVT to reduce mortality but rather to reduce acute symptoms of venous congestion and long-term risk of venous valvular incompetence and venous insufficiency,” Michael R. Jaff, DO, of Massachusetts General Hospital (Boston, MA), said in an email with TCTMD.

“In addition, the National Inpatient Sample does not define the route of administration or dose of thrombolysis for DVT,” he continued. “The authors mention that systemic lysis is not routinely performed for DVT; however, they cannot be certain of this.”

Dr. Jaff added that clinical judgments about catheter-directed thrombolysis for DVT should await the results of the ongoing multicenter, randomized ATTRACT study, which aims to determine whether the therapy is safe, prevents postthrombotic syndrome, improves quality of life, and is cost-effective.

However, Dr. Bashir and colleagues suggest ATTRACT may not have enough acute adverse events to detect a safety difference between catheter-directed thrombolysis and anticoagulation. In the absence of clear-cut data, they add, “it may be reasonable to restrict [the former] to those patients who have a low bleeding risk and a high risk for postthrombotic syndrome, such as patients with iliofemoral DVT.”

 

Source: Bashir R, Zack CJ, Zhao H, et al. Comparative outcomes of catheter-directed thrombolysis plus anticoagulation vs anticoagulation alone to treat lower-extremity proximal deep vein thrombosis.  JAMA Intern Med. 2014;Epub ahead of print. 

Disclosures:

  • Dr. Bashir reports no relevant conflicts of interest.
  • Dr. Jaff reports serving as a uncompensated member of the data safety monitoring board of Ekos Corporation and as a steering committee member for the ATTRACT trial.

Related Stories:

Comments

Venous