Thrombolysis for acute deep vein thrombosis

Lorna Watson; Cathryn Broderick; Matthew P Armon

doi:10.1002/14651858.CD002783.pub4

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Figure 1

Study flow diagram.

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Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Analysis 1.1

Comparison 1 Any thrombolysis versus control, Outcome 1 Any improvement in venous patency (early).

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Analysis 1.2

Comparison 1 Any thrombolysis versus control, Outcome 2 Complete clot lysis (early).

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Analysis 1.3

Comparison 1 Any thrombolysis versus control, Outcome 3 Bleeding (early).

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Analysis 1.4

Comparison 1 Any thrombolysis versus control, Outcome 4 Stroke/intracerebral haemorrhage (early).

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Analysis 1.5

Comparison 1 Any thrombolysis versus control, Outcome 5 Mortality (early).

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Analysis 1.6

Comparison 1 Any thrombolysis versus control, Outcome 6 Pulmonary embolism (early).

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Analysis 1.7

Comparison 1 Any thrombolysis versus control, Outcome 7 Post‐thrombotic syndrome (intermediate).

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Analysis 1.8

Comparison 1 Any thrombolysis versus control, Outcome 8 Post‐thrombotic syndrome (late).

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Analysis 1.9

Comparison 1 Any thrombolysis versus control, Outcome 9 Leg ulceration (intermediate).

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Analysis 1.10

Comparison 1 Any thrombolysis versus control, Outcome 10 Leg ulceration (late).

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Analysis 1.11

Comparison 1 Any thrombolysis versus control, Outcome 11 Complete clot lysis (intermediate).

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Analysis 1.12

Comparison 1 Any thrombolysis versus control, Outcome 12 Complete clot lysis (late).

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Analysis 1.13

Comparison 1 Any thrombolysis versus control, Outcome 13 Mortality (intermediate).

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Analysis 1.14

Comparison 1 Any thrombolysis versus control, Outcome 14 Mortality (late).

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Analysis 1.15

Comparison 1 Any thrombolysis versus control, Outcome 15 Normal venous function (intermediate).

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Analysis 1.16

Comparison 1 Any thrombolysis versus control, Outcome 16 Recurrent DVT (intermediate).

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Analysis 2.1

Comparison 2 Systemic thrombolysis versus control, Outcome 1 Any improvement in venous patency (early).

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Analysis 2.2

Comparison 2 Systemic thrombolysis versus control, Outcome 2 Complete clot lysis (early).

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Analysis 2.3

Comparison 2 Systemic thrombolysis versus control, Outcome 3 Bleeding (early).

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Analysis 2.4

Comparison 2 Systemic thrombolysis versus control, Outcome 4 Stroke/intracerebral haemorrhage (early).

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Analysis 2.5

Comparison 2 Systemic thrombolysis versus control, Outcome 5 Mortality (early).

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Analysis 2.6

Comparison 2 Systemic thrombolysis versus control, Outcome 6 Pulmonary embolism (early).

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Analysis 2.7

Comparison 2 Systemic thrombolysis versus control, Outcome 7 Post‐thrombotic syndrome (intermediate).

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Analysis 2.8

Comparison 2 Systemic thrombolysis versus control, Outcome 8 Post‐thrombotic syndrome (late).

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Analysis 2.9

Comparison 2 Systemic thrombolysis versus control, Outcome 9 Leg ulceration (intermediate).

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Analysis 2.10

Comparison 2 Systemic thrombolysis versus control, Outcome 10 Leg ulceration (late).

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Analysis 2.11

Comparison 2 Systemic thrombolysis versus control, Outcome 11 Complete clot lysis (intermediate).

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Analysis 2.12

Comparison 2 Systemic thrombolysis versus control, Outcome 12 Complete clot lysis (late).

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Analysis 2.13

Comparison 2 Systemic thrombolysis versus control, Outcome 13 Mortality (intermediate).

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Analysis 2.14

Comparison 2 Systemic thrombolysis versus control, Outcome 14 Mortality (late).

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Analysis 2.15

Comparison 2 Systemic thrombolysis versus control, Outcome 15 Normal venous function (intermediate).

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Analysis 2.16

Comparison 2 Systemic thrombolysis versus control, Outcome 16 Recurrent DVT (late).

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Analysis 3.1

Comparison 3 Loco‐regional thrombolysis versus control, Outcome 1 Complete clot lysis (early).

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Analysis 3.2

Comparison 3 Loco‐regional thrombolysis versus control, Outcome 2 Bleeding (early).

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Analysis 3.3

Comparison 3 Loco‐regional thrombolysis versus control, Outcome 3 Stroke/intracerebral haemorrhage (early).

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Analysis 3.4

Comparison 3 Loco‐regional thrombolysis versus control, Outcome 4 Mortality (early).

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Analysis 3.5

Comparison 3 Loco‐regional thrombolysis versus control, Outcome 5 Pulmonary embolism (early).

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Analysis 3.6

Comparison 3 Loco‐regional thrombolysis versus control, Outcome 6 Post‐thrombotic syndrome (intermediate).

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Analysis 3.7

Comparison 3 Loco‐regional thrombolysis versus control, Outcome 7 Leg ulceration (intermediate).

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Analysis 3.8

Comparison 3 Loco‐regional thrombolysis versus control, Outcome 8 Complete clot lysis (intermediate).

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Analysis 3.9

Comparison 3 Loco‐regional thrombolysis versus control, Outcome 9 Mortality (intermediate).

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Analysis 4.1

Comparison 4 Catheter‐directed thrombolysis versus control, Outcome 1 Any improvement in venous patency (early).

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Analysis 4.2

Comparison 4 Catheter‐directed thrombolysis versus control, Outcome 2 Complete clot lysis (early).

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Analysis 4.3

Comparison 4 Catheter‐directed thrombolysis versus control, Outcome 3 Bleeding (early).

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Analysis 4.4

Comparison 4 Catheter‐directed thrombolysis versus control, Outcome 4 Stroke/intracerebral haemorrhage (early).

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Analysis 4.5

Comparison 4 Catheter‐directed thrombolysis versus control, Outcome 5 Mortality (early).

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Analysis 4.6

Comparison 4 Catheter‐directed thrombolysis versus control, Outcome 6 Pulmonary embolism (early).

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Analysis 4.7

Comparison 4 Catheter‐directed thrombolysis versus control, Outcome 7 Post‐thrombotic syndrome (intermediate).

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Analysis 4.8

Comparison 4 Catheter‐directed thrombolysis versus control, Outcome 8 Post‐thrombotic syndrome (late).

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Analysis 4.9

Comparison 4 Catheter‐directed thrombolysis versus control, Outcome 9 Leg ulceration (intermediate).

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Analysis 4.10

Comparison 4 Catheter‐directed thrombolysis versus control, Outcome 10 Complete clot lysis (intermediate).

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Analysis 4.11

Comparison 4 Catheter‐directed thrombolysis versus control, Outcome 11 Complete clot lysis (late).

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Analysis 4.12

Comparison 4 Catheter‐directed thrombolysis versus control, Outcome 12 Normal venous function (intermediate).

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Analysis 4.13

Comparison 4 Catheter‐directed thrombolysis versus control, Outcome 13 Recurrent VTE (intermediate).

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Analysis 4.14

Comparison 4 Catheter‐directed thrombolysis versus control, Outcome 14 Recurrent VTE (late).

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Analysis 4.15

Comparison 4 Catheter‐directed thrombolysis versus control, Outcome 15 Mortality (late).

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Summary of findings for the main comparison. Treatment with any thrombolysis for acute deep vein thrombosis

Treatment with any thrombolysis for acute DVT
Patient or population: patients diagnosed with acute DVT Setting: hospital Intervention: any thrombolysis Comparison: control anti‐coagulation
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with control	Risk with any thrombolysis
Complete clot lysis (intermediate, 6 months to under 5 years after treatment)	Study population		RR 2.44 (1.4 to 4.27)	630 (7 RCTs)	⊕⊕⊕⊝ MODERATE ¹	78 (of 240) patients treated with standard anticoagulation had complete clot lysis compared to 198 (of 390) in the thrombolysis group
	325 per 1000	793 per 1000 (455 to 1000)
Bleeding (early, up to 1 month after treatment)	Study population		RR 2.23 (1.41 to 3.52)	1103 (17 RCTs)	⊕⊕⊕⊝ MODERATE ¹	Although 17 studies reported on bleeding, these were small studies
	43 per 1000	96 per 1000 (61 to 152)
Post‐thrombotic syndrome (intermediate, 6 months to under 5 years after treatment)	Study population		RR 0.66 (0.53 to 0.81)	306 (3 RCTs)	⊕⊕⊕⊝ MODERATE ¹	96 (of 146) patients treated with standard anticoagulation developed PTS compared to 72 (of 160) treated with thrombolysis
	658 per 1000	434 per 1000 (348 to 533)
Post‐thrombotic syndrome (late, 5 year follow‐up after treatment)	Study population		RR 0.58 (0.45 to 0.77)	211 (2 RCTs)	⊕⊕⊕⊝ MODERATE ¹	72 (of 107) patients treated with standard anticoagulation developed PTS compared to 41 (of 104) treated with thrombolysis
	673 per 1000	390 per 1000 (303 to 518)
*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). CI: Confidence interval; DVT: deep vein thrombosis; PTS: post‐thrombotic syndrome RCT: randomised controlled trial; RR: Risk ratio
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ Downgraded by one level as the number of participants in each study is small

Summary of findings for the main comparison. Treatment with any thrombolysis for acute deep vein thrombosis

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Summary of findings 2. Treatment with catheter directed thrombolysis for acute deep venous thrombosis

Treatment with catheter directed thrombolysis for acute DVT
Patient or population: patients diagnosed with acute deep vein thrombosis Setting: hospital Intervention: catheter‐directed thrombolysis Comparison: control anti‐coagulation
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with control	Risk with catheter directed thrombolysis
Complete clot lysis (intermediate, 6 months to under 5 years after treatment)	Study population		RR 2.52 (0.52 to 12.17)	224 (2 RCTs)	⊕⊕⊕⊝ MODERATE ¹
	58 (of 116) patients treated with standard anticoagulation had complete clot lysis compared to 81 (of 108) in the CDT group
Bleeding (early, up to 1 month after treatment)	Study population		RR 7.69 (0.40 to 146.90)	224 (2 RCTs)	⊕⊕⊕⊝ MODERATE ²	None (of 116) patients in the standard anticoagulation group had bleeding complications compared to 3 (of 108) in the CDT group.
	Cannot define risk as no events reported in the standard anticoagulation group
Post‐thrombotic syndrome (intermediate, 6 months to under 5 years after treatment)	Study population		RR 0.74 (0.55 to 1.00)	189 (1 RCT)	⊕⊕⊕⊝ MODERATE ³	55 (of 99) patients in the standard anticoagulation group developed PTS compared to 37 (of 90) in the CDT group.
	556 per 1000	411 per 1000 (306 to 556)
Post‐thrombotic syndrome (late, 5 year follow‐up after treatment)	Study population		RR 0.60 (0.45 to 0.79)	176 (1 RCT)	⊕⊕⊕⊝ MODERATE ³	63 (of 89) patients in the standard anticoagulation group developed PTS compared to 37 (of 87) in the CDT group.
	708 per 1000	425 per 1000 (319 to 559)
*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). CDT: catheter‐directed thrombolysis; CI: Confidence interval; DVT: deep vein thrombosis; PTS: post‐thrombotic syndrome; RCT: randomised controlled trial RR: Risk ratio
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ Downgraded by one level as confidence intervals are wide around the estimate of the effect ² Downgraded by one level as confidence intervals wide around the estimate of effect. Studies did not report any bleeding events in standard anticoagulation group ³ Results are from one small study with a small number of events. Downgraded by one level

Summary of findings 2. Treatment with catheter directed thrombolysis for acute deep venous thrombosis

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Table 1. Level of affected leg veins in included studies

Study	Potential levels of leg vein included
Arneson 1978	proximal to calf
Common 1976	not specified
Elliot 1979	proximal
Elsharawy 2002	femoral and iliofemoral
Enden 2011	pelvic, iliofemoral, femoral
Goldhaber 1990	popliteal or more proximal
Goldhaber 1996	proximal
Kakkar 1969	not specified
Kiil 1981	not specified
Marder 1977	calf up to iliac vein
Schulman 1986	calf vein thrombosis only
Schweizer 1998	not specified
Schweizer 2000	popliteal or more proximal
Tsapogas 1973	not specified
Turpie 1990	proximal
Ugurlu 2002	popliteal up to inferior vena cava
Verhaeghe 1989	popliteal or more proximal

Table 1. Level of affected leg veins in included studies

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Comparison 1. Any thrombolysis versus control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Any improvement in venous patency (early) Show forest plot	9	421	Risk Ratio (M‐H, Random, 95% CI)	2.48 [1.35, 4.57]

2 Complete clot lysis (early) Show forest plot	8	592	Risk Ratio (M‐H, Random, 95% CI)	4.91 [1.66, 14.53]

3 Bleeding (early) Show forest plot	17	1103	Risk Ratio (M‐H, Fixed, 95% CI)	2.23 [1.41, 3.52]

4 Stroke/intracerebral haemorrhage (early) Show forest plot	17	1103	Risk Ratio (M‐H, Fixed, 95% CI)	1.92 [0.34, 10.86]

5 Mortality (early) Show forest plot	9	529	Risk Ratio (M‐H, Fixed, 95% CI)	0.76 [0.31, 1.89]

6 Pulmonary embolism (early) Show forest plot	6	433	Risk Ratio (M‐H, Fixed, 95% CI)	1.00 [0.33, 3.05]

7 Post‐thrombotic syndrome (intermediate) Show forest plot	3	306	Risk Ratio (M‐H, Fixed, 95% CI)	0.66 [0.53, 0.81]

8 Post‐thrombotic syndrome (late) Show forest plot	2	211	Risk Ratio (M‐H, Fixed, 95% CI)	0.58 [0.45, 0.77]

9 Leg ulceration (intermediate) Show forest plot	4	342	Risk Ratio (M‐H, Fixed, 95% CI)	0.87 [0.16, 4.73]

10 Leg ulceration (late) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

11 Complete clot lysis (intermediate) Show forest plot	7	630	Risk Ratio (M‐H, Random, 95% CI)	2.44 [1.40, 4.27]

12 Complete clot lysis (late) Show forest plot	2	206	Risk Ratio (M‐H, Random, 95% CI)	3.25 [0.17, 62.63]

13 Mortality (intermediate) Show forest plot	2	289	Risk Ratio (M‐H, Fixed, 95% CI)	0.96 [0.27, 3.43]

14 Mortality (late) Show forest plot	2	230	Risk Ratio (M‐H, Fixed, 95% CI)	0.61 [0.25, 1.50]

15 Normal venous function (intermediate) Show forest plot	3	255	Risk Ratio (M‐H, Random, 95% CI)	2.18 [0.86, 5.54]

16 Recurrent DVT (intermediate) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

Comparison 1. Any thrombolysis versus control

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Comparison 2. Systemic thrombolysis versus control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Any improvement in venous patency (early) Show forest plot	8	386	Risk Ratio (M‐H, Random, 95% CI)	2.18 [1.28, 3.70]

2 Complete clot lysis (early) Show forest plot	7	457	Risk Ratio (M‐H, Random, 95% CI)	4.37 [1.40, 13.61]

3 Bleeding (early) Show forest plot	15	779	Risk Ratio (M‐H, Fixed, 95% CI)	2.18 [1.37, 3.47]

4 Stroke/intracerebral haemorrhage (early) Show forest plot	15	779	Risk Ratio (M‐H, Fixed, 95% CI)	1.92 [0.34, 10.86]

5 Mortality (early) Show forest plot	8	394	Risk Ratio (M‐H, Fixed, 95% CI)	0.76 [0.31, 1.89]

6 Pulmonary embolism (early) Show forest plot	5	298	Risk Ratio (M‐H, Fixed, 95% CI)	1.73 [0.55, 5.40]

7 Post‐thrombotic syndrome (intermediate) Show forest plot	2	117	Risk Ratio (M‐H, Random, 95% CI)	0.56 [0.30, 1.03]

8 Post‐thrombotic syndrome (late) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

9 Leg ulceration (intermediate) Show forest plot	3	153	Risk Ratio (M‐H, Fixed, 95% CI)	0.87 [0.16, 4.73]

10 Leg ulceration (late) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

11 Complete clot lysis (intermediate) Show forest plot	5	300	Risk Ratio (M‐H, Random, 95% CI)	2.59 [1.27, 5.28]

12 Complete clot lysis (late) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

13 Mortality (intermediate) Show forest plot	2	189	Risk Ratio (M‐H, Fixed, 95% CI)	0.96 [0.27, 3.43]

14 Mortality (late) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

15 Normal venous function (intermediate) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

16 Recurrent DVT (late) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

Comparison 2. Systemic thrombolysis versus control

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Comparison 3. Loco‐regional thrombolysis versus control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Complete clot lysis (early) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2 Bleeding (early) Show forest plot	2	146	Risk Ratio (M‐H, Fixed, 95% CI)	4.0 [0.46, 34.75]

3 Stroke/intracerebral haemorrhage (early) Show forest plot	2	146	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

4 Mortality (early) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

5 Pulmonary embolism (early) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

6 Post‐thrombotic syndrome (intermediate) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

7 Leg ulceration (intermediate) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

8 Complete clot lysis (intermediate) Show forest plot	2	139	Risk Ratio (M‐H, Fixed, 95% CI)	2.25 [1.33, 3.80]

9 Mortality (intermediate) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

Comparison 3. Loco‐regional thrombolysis versus control

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Comparison 4. Catheter‐directed thrombolysis versus control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Any improvement in venous patency (early) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2 Complete clot lysis (early) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

3 Bleeding (early) Show forest plot	2	224	Risk Ratio (M‐H, Fixed, 95% CI)	7.69 [0.40, 146.90]

4 Stroke/intracerebral haemorrhage (early) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

5 Mortality (early) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

6 Pulmonary embolism (early) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

7 Post‐thrombotic syndrome (intermediate) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

8 Post‐thrombotic syndrome (late) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

9 Leg ulceration (intermediate) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

10 Complete clot lysis (intermediate) Show forest plot	2	224	Risk Ratio (M‐H, Random, 95% CI)	2.52 [0.52, 12.17]

11 Complete clot lysis (late) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

12 Normal venous function (intermediate) Show forest plot	2	224	Risk Ratio (M‐H, Fixed, 95% CI)	2.98 [1.75, 5.08]

13 Recurrent VTE (intermediate) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

14 Recurrent VTE (late) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

15 Mortality (late) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

Comparison 4. Catheter‐directed thrombolysis versus control

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