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Tissue Plasminogen Activator for the Treatment of Deep Venous Thrombosis of the Lower Extremity

2001; Elsevier BV; Volume: 119; Issue: 2 Linguagem: Inglês

10.1378/chest.119.2.572

1931-3543

Alan J. Forster, Philip Wells,

Blood Coagulation and Thrombosis Mechanisms

Objective To assess, by systematic review, theefficacy and safety of recombinant tissue plasminogen activator (rt-PA)in the treatment of lower extremity deep venous thrombosis (DVT). Asecondary objective is to assess the optimal dose and route ofadministration of rt-PA. Methods Included studieswere randomized, controlled trials comparing rt-PA plus unfractionatedheparin (UFH) to UFH alone, rt-PA at different doses, or rt-PA bydifferent routes of administration in the treatment of DVT. Outcomeshad to be described in terms of percent change in venographic patencyfor efficacy (>50% lysis) and in sufficient detail for complications(major and minor hemorrhages and other). The search strategy includedsearching electronic databases and contacting pharmaceutical agenciesand content experts. Study quality was assessed using the Jadad scale. A threshold quality score was used to exclude trials. Results Five studies met the following inclusion criteria: three comparing rt-PA plus UFH vs UFH alone (180 patients); onecomparing high-dose vs low-dose rt-PA (32 patients); and one comparingsystemic vs local administration of rt-PA (151 patients). In studiescomparing rt-PA vs placebo, patients assigned to rt-PA were more likelyto have > 50% lysis and complications (summary odds ratios [OR],11.7; 95% confidence interval [CI], 2.61 to 52.5; and OR, 9.95; 95% CI, 2.21 to 44.7, respectively). Major and intracerebral hemorrhageswere not significantly increased. One study comparing different dosesdemonstrated that high-dose and low-dose rt-PA were equally efficacious(OR, 0.88; 95% CI, 0.05 to 14.78). Local rt-PA was neither moreefficacious nor riskier than systemic rt-PA. Conclusion This systematic review does not support routineuse of rt-PA for DVT. To assess, by systematic review, theefficacy and safety of recombinant tissue plasminogen activator (rt-PA)in the treatment of lower extremity deep venous thrombosis (DVT). Asecondary objective is to assess the optimal dose and route ofadministration of rt-PA. Included studieswere randomized, controlled trials comparing rt-PA plus unfractionatedheparin (UFH) to UFH alone, rt-PA at different doses, or rt-PA bydifferent routes of administration in the treatment of DVT. Outcomeshad to be described in terms of percent change in venographic patencyfor efficacy (>50% lysis) and in sufficient detail for complications(major and minor hemorrhages and other). The search strategy includedsearching electronic databases and contacting pharmaceutical agenciesand content experts. Study quality was assessed using the Jadad scale. A threshold quality score was used to exclude trials. Five studies met the following inclusion criteria: three comparing rt-PA plus UFH vs UFH alone (180 patients); onecomparing high-dose vs low-dose rt-PA (32 patients); and one comparingsystemic vs local administration of rt-PA (151 patients). In studiescomparing rt-PA vs placebo, patients assigned to rt-PA were more likelyto have > 50% lysis and complications (summary odds ratios [OR],11.7; 95% confidence interval [CI], 2.61 to 52.5; and OR, 9.95; 95% CI, 2.21 to 44.7, respectively). Major and intracerebral hemorrhageswere not significantly increased. One study comparing different dosesdemonstrated that high-dose and low-dose rt-PA were equally efficacious(OR, 0.88; 95% CI, 0.05 to 14.78). Local rt-PA was neither moreefficacious nor riskier than systemic rt-PA. This systematic review does not support routineuse of rt-PA for DVT.