Fatal Pulmonary Embolism, Fatal Bleeding and Intracranial Hemorrhage with Systemic and Catheter-Directed Thrombolysis in Intermediate-High and High-Risk Pulmonary Embolism: A Systematic Review with Meta-Analysis
Bibliographic record
Abstract
Background: Thrombolysis, either systemic (ST) or catheter-directed (CDT), may reduce mortality in patients with intermediate-high and high-risk pulmonary embolism (PE), but with an increased risk of major bleeding (MB). Moreover, uncertainties remain for other efficacy and safety outcomes, such as fatal PE, fatal bleeding, and intracranial hemorrhage (ICH). Aims: To evaluate fatal PE, fatal bleeding and ICH with ST and CDT in patients with intermediate-high and high-risk PE. Methods: We performed a systematic search in MEDLINE, EMBASE and Cochrane from inception to December 2022. Randomized trials and cohort/observational studies of patients with intermediate-high and high-risk PE were included. We report fatal PE, fatal bleeding and ICH; mortality and MB have been previously reported. Pooled proportions with their 95% confidence interval (CI) were calculated for each treatment group. Results: One hundred and fifty-eight studies (87,874 patients) were included. In patients treated with ST, 30-day mortality and MB occurred in 10.4% (95%CI 6.6%-14.8%; I 2=99%) and in 8.0% (95%CI 5.8%-10.5%; I 2=96%), respectively. Fatal PE occurred in 3.9% (95%CI 2.1%-6.3%; I 2=88%), fatal bleeding in 1.7% (95%CI 1.3%-2.3%; I 2=8%) and ICH in 1.6% (95%CI 1.3%-1.9%; I 2=17%). In patients treated with CDT, 30-day mortality and MB occurred in 5.3% (95%CI 3.6%-7.3%; I 2=93%) and in 5.4% (95%CI 3.8%-7.2%; I 2=87%), respectively. Fatal PE occurred in 1.5% (95%CI 1.0%-2.0%; I 2=2%), fatal bleeding in 1.2% (95%CI 0.8%-1.6%; I 2=0%) and ICH in 0.6% (95%CI 0.4%-0.9%; I 2=7%). In patients treated with anticoagulation alone, 30-day mortality and MB occurred in 9.9% (95%CI 7.1%-13.1%; I 2=97%) and in 3.8% (95%CI 2.6%-5.4%; I 2=66%), respectively. Fatal PE occurred in 3.3% (95%CI 1.9%-5.2%; I 2=65%), fatal bleeding in 0.5% (95%CI 0.2%-0.9%; I 2=0%) and ICH in 0.7% (95%CI 0.3%-1.3%; I 2=64%). Conclusion: In patients with intermediate-high and high-risk PE, fatal PE was non-negligeable in all treatment modalities and must be balanced with equally important fatal bleeding event rates. Additional studies are needed to further assess these efficacy and safety parameters of thrombolytics in patients with intermediate-high and high risk PE.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.011 | 0.024 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.020 | 0.035 |
| Bibliometrics | 0.007 | 0.009 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.003 | 0.002 |
| Open science | 0.002 | 0.002 |
| Research integrity | 0.002 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".