Summary of the effects of thrombolytic treatment in patients with PE
| Outcome . | Follow-up . | No. of participants . | No. of RCTs . | RR . | 95% CI . | Anticipated absolute effects . | Certainty . | What happens . | |
|---|---|---|---|---|---|---|---|---|---|
| Baseline risk (without thrombolytic treatment) . | Difference with thrombolytic treatment . | ||||||||
| Mortality assessed with all-cause mortality | Range, 7 to 90 days | 2592 | 2314-39 | 0.61 | 0.40-0.94 | 4.5% at 30 d | 1.8% fewer (2.7%-0.3% fewer) | ⨁⨁⨁◯ Moderate*† | Thrombolytic therapy probably reduces mortality |
| Nonfatal PE assessed with any PE | Range, 7 to 90 days | 2354 | 1714-18, 20-24,27,29,30,33-35,39 | 0.56 | 0.35-0.91 | 4.0% at 30 d | 1.8% fewer (2.6%-0.4% fewer) | ⨁⨁◯◯ Low†‡ | Thrombolytic therapy may reduce the risk of nonfatal PE |
| DVT assessed with any DVT | Range, 30 to 90 days | 112 | 215,20 | 0.92 | 0.14-6.03 | 3.6% at 90 d | 0.3% fewer (3.1% fewer to 18.1% more) | ⨁⨁◯◯ Low*§ | It is uncertain whether thrombolytic therapy affects the risk of DVT |
| Limited functional class assessed with New York Heart Association functional class ≥3 | Range, 3 to 24 months | 785 | 220,27 | 0.62 | 0.17-2.25 | 7.2% at 24 mo | 2.7% fewer (6% fewer to 9% more) | ⨁⨁◯◯ Low†§|| | It is uncertain whether thrombolytic therapy affects long-term functional class |
| Major bleeding assessed with any major bleeding, including patients treated for PE or DVT | Median, 10 days | 4713 | 4414-18,20-58 ¶ | 1.89 | 1.46-2.46 | 3.5% at 30 d | 3.1% more (1.6%-5.1% more) | ⨁⨁⨁⨁ High# | Thrombolytic therapy increases the risk of major bleeding |
| Intracranial bleeding assessed with Intracranial bleeding including patients treated for PE or DVT | Median, 10 days | 4558 | 4314-18,20-32,34-58 ¶ | 3.17 | 1.19-8.41 | 0.05% at 30 d | 0.1% more (0.005%-0.34% more) | ⨁⨁⨁◯ Moderate†# | Thrombolytic therapy probably increases the risk of intracranial bleeding |
| Outcome . | Follow-up . | No. of participants . | No. of RCTs . | RR . | 95% CI . | Anticipated absolute effects . | Certainty . | What happens . | |
|---|---|---|---|---|---|---|---|---|---|
| Baseline risk (without thrombolytic treatment) . | Difference with thrombolytic treatment . | ||||||||
| Mortality assessed with all-cause mortality | Range, 7 to 90 days | 2592 | 2314-39 | 0.61 | 0.40-0.94 | 4.5% at 30 d | 1.8% fewer (2.7%-0.3% fewer) | ⨁⨁⨁◯ Moderate*† | Thrombolytic therapy probably reduces mortality |
| Nonfatal PE assessed with any PE | Range, 7 to 90 days | 2354 | 1714-18, 20-24,27,29,30,33-35,39 | 0.56 | 0.35-0.91 | 4.0% at 30 d | 1.8% fewer (2.6%-0.4% fewer) | ⨁⨁◯◯ Low†‡ | Thrombolytic therapy may reduce the risk of nonfatal PE |
| DVT assessed with any DVT | Range, 30 to 90 days | 112 | 215,20 | 0.92 | 0.14-6.03 | 3.6% at 90 d | 0.3% fewer (3.1% fewer to 18.1% more) | ⨁⨁◯◯ Low*§ | It is uncertain whether thrombolytic therapy affects the risk of DVT |
| Limited functional class assessed with New York Heart Association functional class ≥3 | Range, 3 to 24 months | 785 | 220,27 | 0.62 | 0.17-2.25 | 7.2% at 24 mo | 2.7% fewer (6% fewer to 9% more) | ⨁⨁◯◯ Low†§|| | It is uncertain whether thrombolytic therapy affects long-term functional class |
| Major bleeding assessed with any major bleeding, including patients treated for PE or DVT | Median, 10 days | 4713 | 4414-18,20-58 ¶ | 1.89 | 1.46-2.46 | 3.5% at 30 d | 3.1% more (1.6%-5.1% more) | ⨁⨁⨁⨁ High# | Thrombolytic therapy increases the risk of major bleeding |
| Intracranial bleeding assessed with Intracranial bleeding including patients treated for PE or DVT | Median, 10 days | 4558 | 4314-18,20-32,34-58 ¶ | 3.17 | 1.19-8.41 | 0.05% at 30 d | 0.1% more (0.005%-0.34% more) | ⨁⨁⨁◯ Moderate†# | Thrombolytic therapy probably increases the risk of intracranial bleeding |
RR, risk ratio.
Although most studies (51%-74%) did not blind participants and/or study investigators, we did not rate down for risk of bias (see “PE trials” and “Risk of bias” sections).
A small number of events (OIS not met) and/or 95% CIs include marginal and substantial harms.
In all, 77.5% of the weight of the pooled estimates was provided by moderate/high risk of bias trials.
The 95% CIs include both appreciable benefit and appreciable harm.
Significant unexplained heterogeneity (I2 = 64%).
Subgroup analysis did not show significant differences between patients treated for PE or DVT (test for subgroup differences P = .6).
Although 73% of the pooled estimate weight for bleeding outcomes came from studies classified as moderate/high risk of bias (mostly because participants and/or study investigators were not blinded), we did not rate down for risk of bias (see “Safety of thrombolytics” and “Analysis of the effect on bleeding outcomes” sections).