Table 2.
Stenting or angioplasty plus BMP and thrombolysis compared to BMP and thrombolysis for the treatment of acute deep vein thrombosis (intermediate time point).
| Patient or population: acute deep vein thrombosis (intermediate time point) Setting: In-hospital Intervention: Stenting or angioplasty plus BMP and thrombolysis Comparison: BMP and thrombolysis | ||||||
|---|---|---|---|---|---|---|
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with BMP and thrombolysis | Risk with Stenting or angioplasty plus BMP and thrombolysis | |||||
| Post-thrombotic syndrome assessed with: Villalta score (0–33, lower = better) and VCSS (0–30, lower = better) follow-up: mean 24 mo | The mean post-thrombotic syndrome was −0.69 points | MD 1.82 points lower (2.8 lower to 0.84 lower) |
- | 252 (3 RCTs) |
⨁◯◯◯ Very low†,‡,§,∥ |
Stenting or angioplasty plus BMP and thrombolysis may reduce/have little to no effect on post-thrombotic syndrome but the evidence is very uncertain. Absolute percent difference = 5.5% absolute improvement (95% CI 2.6% improvement to 8.5% improvement). SMD = −7.87 (95% CI −12.13 to −3.61) |
| Post-thrombotic syndrome assessed with: Villalta score (0–33, lower = better) and CEAP-C (0–6, lower = better) follow-up: mean 24 mo | The mean post-thrombotic syndrome was 2.39 points | MD 0.6 points lower (1.2 lower to 0.1 higher) |
- | 252 (3 RCTs) |
⨁◯◯◯ Very low†,§,∥,¶ |
Stenting or angioplasty plus BMP and thrombolysis may reduce/have little to no effect on post-thrombotic syndrome but the evidence is very uncertain. Absolute percent difference = 10% absolute improvement (95% CI 1.7% worsening to 20% improvement). SMD = −2.43 (95% CI −5.17 to 0.31) |
| VTE - recurrent DVT assessed with: Count of events (less = better) follow-up: mean 24 mo | 54 per 1.000 |
64 per 1.000 (15 to 272) |
RR 1.19 (0.28 to 5.07) |
119 (1 RCT) |
⨁◯◯◯ Very low†,# |
Stenting or angioplasty plus BMP and thrombolysis may increase/have little to no effect on incidence of venous thromboembolism - recurrent deep venous thrombosis but the evidence is very uncertain. Absolute percent difference = 1% more events (95% CI 3.9% fewer to 21.8% more) |
| Mortality | No studies measured this outcome | |||||
| Major Bleeding | No studies measured this outcome | |||||
| Secondary patency assessed with: Count of events (less = better) follow-up: mean 24 mo | 500 per 1.000 |
130 per 1.000 (55 to 295) |
RR 0.26 (0.11 to 0.59) |
133 (2 RCTs) |
⨁ ⨁◯◯ Low†,** |
Stenting or angioplasty plus BMP and thrombolysis may result in little to no difference in secondary patency. Absolute percent difference = 37% fewer events (95% CI 44.5% fewer to 20.5% fewer) |
| Duration of hospitalization | No studies measured this outcome | |||||
| Quality of life assessed with: CIVIQ (0–100, higher = better) follow-up: mean 24 mo |
The mean quality of life was 60.66 points | MD 15.05 points higher (1.6 lower to 31.7 higher) |
- | 252 (3 RCTs) |
⨁◯◯◯ Very low†,§,∥,¶ |
Stenting or angioplasty plus BMP and thrombolysis may increase/have little to no effect on quality of life but the evidence is very uncertain. Absolute percent difference = 15.1% absolute improvement (95% CI 1.6% worsening to 31.7% improvement). SMD = 2.26 (95% CI −0.24 to 4.76) |
| Quality of life assessed with: CIVIQ (0–100, higher = better) follow-up: mean 24 mo |
The mean quality of life was 60.66 points | MD 14.92 points higher (2.07 lower to 31.9 higher) |
- | 252 (3 RCTs) |
⨁◯◯◯ Very low†,§,∥,¶ |
Stenting or angioplasty plus BMP and thrombolysis may increase/have little to no effect on quality of life but the evidence is very uncertain. Absolute percent difference = 14.9% absolute improvement (95% CI 2.1% worsening to 31.9% improvement). SMD = 2.24 (95% CI −0.31 to 4.79) |
| Quality of life assessed with: CIVIQ (0–100, higher = better) follow-up: mean 24 mo |
The mean quality of life was 60.66 points | MD 14.92 points higher (2.13 lower to 31.9 higher) |
- | 252 (3 RCTs) |
⨁◯◯◯ Very low†,§,∥,¶ |
Stenting or angioplasty plus BMP and thrombolysis may increase/have little to no effect on quality of life but the evidence is very uncertain. Absolute percent difference = 14.9% absolute improvement (95% CI 2.1% worsening to 31.9% improvement). SMD = 2.24 (95% CI −0.32 to 4.79) |
| Quality of life assessed with: CIVIQ (0–100, higher = better) follow-up: mean 24 mo |
The mean quality of life was 60.66 points | MD 14.92 points higher (2 lower to 31.8 higher) |
- | 252 (3 RCTs) |
⨁◯◯◯ Very low†,§,∥,¶ |
Stenting or angioplasty plus BMP and thrombolysis may increase/have little to no effect on quality of life but the evidence is very uncertain. Absolute percent difference = 14.9% absolute improvement (95% CI 2% worsening to 31.8% improvement). SMD = 2.24 (95% CI −0.3 to 4.78) |
| Adverse events assessed with: Count of events (less = better) follow-up: mean 24 mo |
48 per 1.000 |
61 per 1.000 (18 to 209) |
RR 1.26 (0.37 to 4.34) |
186 (2 RCTs) |
⨁◯◯◯ Very low†,# |
Stenting or angioplasty plus BMP and thrombolysis may increase/have little to no effect on adverse events but the evidence is very uncertain. Absolute percent difference = 1.3% more events (95% CI 3% fewer to 16.1% more) |
CEAP-C = Clinical, Etiologic, Anatomic, and Pathophysiologic classification, CI = confidence interval, CIVIQ = Chronic Venous Insufficiency Questionnaire, DVT = deep venous thrombosis, GRADE = Working Group grades of evidence, MD = mean difference, RCT = randomized controlled trial, RR = risk ratio, VCSS = Venous Clinical Severity Score, VTE = venous thromboembolism
The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
Downgraded 1 level due to serious study limitations (risk of bias). Unclear or high risk of bias for several domains.
Downgraded 2 levels due to very serious inconsistency. High unexplained heterogeneity (I2 = 99%).
Downgraded 1 level due to serious indirectness.
Downgraded 1 level due to serious imprecision. Less than 400 participants were analyzed in the meta-analysis.
Downgraded 2 levels due to very serious inconsistency. High unexplained heterogeneity (I2 = 98%).
Downgraded 2 levels due to very serious imprecision. Less than 300 events were analyzed in the analysis and wide confidence interval of the absolute difference.
Downgraded 1 level due to serious imprecision. Less than 300 events were analyzed in the meta-analysis.