Summary of the effects of thrombolytic treatment in patients with DVT
| Outcome . | Follow-up . | No. of patients . | No. of RCTs . | RR . | 95% CI . | Anticipated absolute effects . | Certainty . | What happens . | ||
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline risk (without thrombolytic treatment) . | Difference with thrombolytic treatment . | |||||||||
| Mortality assessed with any death occurring in the first 30 days of treatment | Median, 10 days | 1547 | 1240-44,47-50,52,57,58 | 0.77 | 0.26-2.28 | 0.8% at 30 d | 0.2% fewer (0.6% fewer to 1% more) | ⨁⨁◯◯ Low*† | Thrombolytic therapy may not significantly affect mortality | |
| Mortality (late) assessed with: all-cause mortality excluding events occurring in the first 30 days | Range, 1 year to 6 years | 1058 | 640,42,44,50,52,57 | 0.89 | 0.47-1.69 | 4.9% at 1.6-6 y | 0.5% fewer (2.6% fewer to 3.4% more) | ⨁⨁◯◯ Low*† | Thrombolytic therapy may not significantly affect mortality | |
| Nonfatal PE assessed with: any PE | Range, 7 days to 6 years | 1165 | 940-44,47,50,52,57 | 1.33 | 0.71-2.46 | 3.0% at 7 d to 6 y | 1.0% more (0.9% fewer to 4.4% more) | ⨁⨁◯◯ Low*† | Thrombolytic therapy may not reduce the risk of nonfatal PE | |
| DVT assessed with any DVT | Range, 2 to 6 years | 726 | 340,44,57 | 0.99 | 0.56-1.76 | 11.2% at 5-6 y | 0.1% fewer (4.9% fewer to 8.5% more) | ⨁⨁◯◯ Low*† | Thrombolytic therapy may not reduce the risk of recurrent DVT | |
| PTS assessed with any symptom/s attributed-PTS | Range, 6 months to 6 years | 1343 | 840-42,44,51,52,57,58 | 0.70 | 0.59-0.83 | 61.8% at 1-6 y | 18.5% fewer (25.3% fewer to 10.5% fewer) | ⨁⨁◯◯ Low*‡ | Thrombolytic therapy may significantly reduce the risk of PTS | |
| Leg ulceration | Range, 1 to 6 years | 937 | 540,44,50,51,57 | 0.75 | 0.39-1.42 | 4.8% | 1.2% fewer (2.9% fewer to 2% more) | ⨁⨁◯◯ Low*† | Thrombolytic therapy may significantly reduce the risk of recurrent leg ulceration | |
| Major bleeding assessed with any major bleeding in patients treated for DVT or PE | 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 in patients treated for DVT or PE | 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 patients . | No. of RCTs . | RR . | 95% CI . | Anticipated absolute effects . | Certainty . | What happens . | ||
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline risk (without thrombolytic treatment) . | Difference with thrombolytic treatment . | |||||||||
| Mortality assessed with any death occurring in the first 30 days of treatment | Median, 10 days | 1547 | 1240-44,47-50,52,57,58 | 0.77 | 0.26-2.28 | 0.8% at 30 d | 0.2% fewer (0.6% fewer to 1% more) | ⨁⨁◯◯ Low*† | Thrombolytic therapy may not significantly affect mortality | |
| Mortality (late) assessed with: all-cause mortality excluding events occurring in the first 30 days | Range, 1 year to 6 years | 1058 | 640,42,44,50,52,57 | 0.89 | 0.47-1.69 | 4.9% at 1.6-6 y | 0.5% fewer (2.6% fewer to 3.4% more) | ⨁⨁◯◯ Low*† | Thrombolytic therapy may not significantly affect mortality | |
| Nonfatal PE assessed with: any PE | Range, 7 days to 6 years | 1165 | 940-44,47,50,52,57 | 1.33 | 0.71-2.46 | 3.0% at 7 d to 6 y | 1.0% more (0.9% fewer to 4.4% more) | ⨁⨁◯◯ Low*† | Thrombolytic therapy may not reduce the risk of nonfatal PE | |
| DVT assessed with any DVT | Range, 2 to 6 years | 726 | 340,44,57 | 0.99 | 0.56-1.76 | 11.2% at 5-6 y | 0.1% fewer (4.9% fewer to 8.5% more) | ⨁⨁◯◯ Low*† | Thrombolytic therapy may not reduce the risk of recurrent DVT | |
| PTS assessed with any symptom/s attributed-PTS | Range, 6 months to 6 years | 1343 | 840-42,44,51,52,57,58 | 0.70 | 0.59-0.83 | 61.8% at 1-6 y | 18.5% fewer (25.3% fewer to 10.5% fewer) | ⨁⨁◯◯ Low*‡ | Thrombolytic therapy may significantly reduce the risk of PTS | |
| Leg ulceration | Range, 1 to 6 years | 937 | 540,44,50,51,57 | 0.75 | 0.39-1.42 | 4.8% | 1.2% fewer (2.9% fewer to 2% more) | ⨁⨁◯◯ Low*† | Thrombolytic therapy may significantly reduce the risk of recurrent leg ulceration | |
| Major bleeding assessed with any major bleeding in patients treated for DVT or PE | 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 in patients treated for DVT or PE | 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 | |
None of the included studies blinded patients and clinicians, and only 1 blinded outcome assessors.
The 95% CI includes both appreciable benefit or marginal harm and appreciable harm.
Six of the included studies reported significant PTS reduction; a single trial (ATTRACT) reported the absence of significant benefits (I2 = 57%).
Subgroup analysis did not show significant differences between patients treated for PE and 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”).