| pulmonary embolism | versus No demonstrated result for efficacy rt-PA inferior to placebo in terms of minor bleeding in Levine, 1990 | 5 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| PIOPED, 1990 | rt-PA vs placebo | | | All cause death ∞ [NaN; ∞] major bleeding ∞ [NaN; ∞] | | Levine, 1990 | rt-PA vs placebo | | minor bleeding 11.36 [1.61; 80.39] | All cause death ∞ [NaN; ∞] major bleeding NaN [NaN; NaN] recurrence of pulmonary embolism NaN [NaN; NaN] | | PAIMS 2, 1992 | rt-PA vs no fibrinolysis | | | All cause death 1.60 [0.16; 16.10] major bleeding 1.20 [0.23; 6.34] minor bleeding 2.20 [0.86; 5.61] recurrence of pulmonary embolism 0.40 [0.04; 4.02] | | Goldhaber, 1993 | rt-PA vs no fibrinolysis | | | All cause death 0.00 [0.00; NaN] major bleeding 3.59 [0.39; 33.33] recurrence of pulmonary embolism 0.00 [0.00; NaN] | | Konstantinides, 2002 | rt-PA vs placebo | | | All cause death 1.56 [0.36; 6.83] major bleeding 0.23 [0.03; 1.97] recurrence of pulmonary embolism 1.17 [0.30; 4.57] |
| Trial | Treatments | Patients | Method |
|---|
| PIOPED, 1990 | rt-PA 40–80 mg IV over 90 min plus heparin (n=9) vs. placebo+heparin (n=4) | patients with acute pulmonary embolism | double blind Parallel groups Sample size: 9/4 Primary endpoint: FU duration: 7 days | | Levine, 1990 | rt-PA 0.6 mg/kg IV over 2 min and heparin, initial bolus of 5000 U, then 30,000 U for first 24 hr continuous infusion,only interrupted for the duration of the study drug infusion (n=33) vs. placebo + heparin bolus of 5000 U, then 30,000 U for first 24 hr continuous infusion (n=25) | patients with objectively established acute symptomatic pulmonary embolism | double blind Parallel groups Sample size: 33/25 Primary endpoint: FU duration: 10 days | | PAIMS 2, 1992 | rt-PA 100 mg IV over 2 h and heparin (n=-9) vs. Heparin 1750 IU/hr i.v. for 7 to 10 days (n=-9) | patients with angiographically documented pulmonary embolism | open Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: 7 days | | Goldhaber, 1993 | rt-PA 100 mg IV over 2 h then 1000 U/hr heparin,when PTT or TT was < 2 times control. Subsequent heparin dose achieved PTT = 1.5 to 2.5 times the upperlimit of normal. (n=46) vs. heparin, initial dose 5000 U bolus followed by 1000 U/hr continuous i.v., 4 hr after the dose of heparin according to PTT. Target PTT = 1.5 to 2.5 times of normal (n=55) | haemodynamically stable patients with acute pulmonary embolism | open Parallel groups Sample size: 46/55 Primary endpoint: Right-ventricular wall motion FU duration: 14 days | | Konstantinides, 2002 | 100 mg alteplase given as 10 mg bolus followed by 90 mg i.v. infusion over 2 hours then i.v. heparin 1000 U/hr adjusted to maintain APTT of 2.0 to 2.5times the upper normal limit. Oral anticoagulation was started on day 3 (n=118) vs. placebo + i.v. heparin 1000 U/hr adjusted to maintain APTT of 2.0 to 2.5times the upper normal limit. Oral anticoagulation was started on day 3 (n=138) | patients with acute pulmonary embolism and pulmonary hypertensionor right ventricular dysfunction but withoutarterial hypotension or shock | double blind Parallel groups Sample size: 118/138 Primary endpoint: in-hospital death or clinical deterioration FU duration: <30 days |
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