MIST2 (tPA+DNase vs. placebo)
Trial question
What is the role of intrapleural tPA and DNase therapy in patients with pleural infection?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
35.0% female
65.0% male
N = 107
107 patients (37 female, 70 male)
Inclusion criteria: adult patients with pleural infection
Key exclusion criteria: age < 18 years; previous treatment with intrapleural fibrinolytic agents, DNase, or both for empyema; known sensitivity to DNase or tPA; coincidental stroke; major hemorrhage or trauma
Interventions
N=52 tPA-DNase (actilyse 10 mg and pulmozyme 5 mg BID for 3 days)
N=55 placebo (matching double placebo for 3 days)
Primary outcome
Reduction in pleural opacity on chest radiography on day 7
-29.5
-17.2
0.0 %
-7.4 %
-14.8 %
-22.1 %
-29.5 %
Tissue plasminogen
activator-DNase
Placebo
Significant
decrease ▼
NNH = 8
Significant decrease in reduction in pleural opacity on chest radiography on day 7 (-29.5% vs. -17.2%; ARD -7.9, 95% CI -13.4 to -2.4)
Secondary outcomes
Significant decrease in surgical referral at 3 months (4% vs. 16%; OR 0.17, 95% CI 0.03 to 0.87)
Significant decrease in duration of hospital stay (11.8 days vs. 24.8 days; AD -14.8 days, 95% CI -53.7 to -4.6)
Safety outcomes
No significant difference in adverse events.
Conclusion
In adult patients with pleural infection, tPA-DNase was superior to placebo with respect to reduction in pleural opacity on chest radiography on day 7.
Reference
Najib M Rahman, Nicholas A Maskell, Alex West et al. Intrapleural use of tissue plasminogen activator and DNase in pleural infection. N Engl J Med. 2011 Aug 11;365(6):518-26.
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